Halohy dantoins RED
 United States        Prevention, Pesticides      EPA 739-R-07-001
 Environmental Protection     and Toxic Substances      September 2007
 Agency	(751 OP)	
Reregistration Eligibility
           Decision
    for Halohydantoins
         (Case 3055)

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                                                            lialohydiiiuoins RLzD
           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 (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments received
related to the preliminary risk assessments for the antimicrobial halohydantoins. The
Reregistration Eligibility Decision (RED) was approved in the form of a decision memorandum
which summarized the regulatory decision for halohydantoins on September 30, 2004.  Public
comments and additional data received were considered in this decision.

       Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED)
and risk management decision for halohydantoins 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 assessments for the halohydantoins are available to the
public in EPA's Pesticide Docket EPA-HQ-OPP-2004-0303 at: http://www.rorulations.aov.

       The halohydatnoins RED was developed through EPA's public participation process,
published in the Federal Register on July 20, 2005, which provides opportunities for public
involvement in the Agency's pesticide tolerance reassessment and reregistration programs.
Developed in partnership with USDA and with input from EPA's advisory committees and
others, the public participation process  encourages robust public involvement starting early and
continuing throughout the pesticide risk assessment and risk mitigation decision making process.
 The public participation process encompasses full, modified, and streamlined versions that
enable the Agency to tailor the level of review to the level of refinement of the risk assessments,
as well as to the amount of use, risk,  public concern,  and complexity associated with each
pesticide.  Using the  public participation process, EPA is attaining its strong commitment to both
involve the public and meet statutory deadlines.

       Please note that the halohydantoins 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 halohydantoins
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

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                                                             Halohydantoms RhD
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 halohydantoins will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measures outlined in Section IV of the document. Sections
IV and V of this RED document describe labeling amendments for end-use products and data
requirements necessary to implement these mitigation measures. Instructions for registrants on
submitting the revised labeling can be found in the set of instructions for product-specific data
that accompanies this document.

       Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by halohydantoins.
Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern.  At that time, any affected person(s) may challenge the Agency's action.

       If you have questions on this document or the label changes necessary for reregistration,
please contact the Chemical Review Manager, ShaRon Carlisle, at (703) 308-6427. For
questions about product reregistration and/or the Product DCI that accompanies this document,
please contact Emily Mitchell at (703) 308-8583.

                                        Sincerely,
                                        Frank T. Sanders, Director
                                        Antimicrobials Division (75IOC)

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                                                                Halohydantoins RED

TABLE OF CONTENTS


Glossary of Terms and Abbreviations	    v

Halohydantoins Reregistration Team	     iv

Abstract	     1

I. Introduction	   2

II. Chemical Overview
      A. Regulatory History	     4
      B. Chemical Identification  	    4
      C. Use Profile	    7

III. Summary of Halohydantoins Risk Assessments
      A. Human Health Risk Assessment	     12
             1. Toxicity of Halohydantoins	     12
             2. FQPA Safety	   17
             3. Population Adjusted Dose (PAD)	   17
                   a. Acute PAD	   17
                   b. Chronic PAD	      17
             4. Dietary Exposure Assumptions	     18
             5. Dietary (Food) Risk                                          18
Assessment	
                   a. Dietary Risk from Drinking Water	    20
             6. Residential Exposure	   20
                   a. Toxicity	   20
                   b. Residential Handler	   21
                         i. Exposure Scenarios, Data and Assumptions	   22
                         ii. Residential Handler Risk	       22
                   c. Residential Post-application	    25
                         i. Exposure Scenarios, Data and Assumptions	   25
                         ii. Residential Post-Application Risk	    25
             7. Aggregate Risk	    28
                   a. Acute Dietary Aggregate Risk	     28
                   b. Short and Intermediate Aggregate Risk	     28
                   c. Chronic Dietary Aggregate Risk	      31
             8. Occupational Exposure and Risk	   31
                   a. Occupational Toxicity	    32
                   b. Occupational Handler Exposure	     32
                   c. Occupational Post-Application Exposure	    35
                                         i

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                                                               Halohydantoins RED
                   d. Human Incident Data	   35
      B. Environmental Risk Assessment	   37
             1. Environmental Fate and Transport	   37
             2. Ecological Risk	   37
             3. Environmental Exposure Modeling	   39
             4. Listed Species Consideration	   41
                   a. The Endangered Species Act	   41

IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
      A. Determination of Reregistration Eligibility	   42
      B. Public Comments and Responses	   42
      C. Regulatory Position	   43
             1. Food Quality Protection Act Considerations	   43
                   a. "Risk Cup" Determination	   43
                   b. Determination of Safety to U.S. Population	   43
                   c. Determination of Safety to Infants and Children	   43
                   d. Endocrine Disrupter Effects	   44
                   e. Cumulative Risks	   44
             2. Tolerance Summary	    45
             3. Codex Harmonization	   45
      D. Regulatory Rationale	   45
             1. Human Health Risk Management	   45
                   a. Dietary (Food) Risk Mitigation	   45
                   b. Drinking Water Risk Mitigation	   45
                   c. Residential Risk Mitigation	   45
                   d. Occupational Risk Mitigation	   46
                         i. Handler Mitigation	   46
                         ii Post-application Risk Mitigation	   46
             2. Environmental Risk Management	      47
             3. Other Labeling Requirements	   47
             4. Threatened and  Endangered Species Considerations	   47
                   a. The Endangered Species Program	   47

V. What Registrants Need to Do	    49
      A. Manufacturing Use-Products	   51
             1. Additional Generic Data Requirements	    51
             2. Labeling for Technical and Manufacturing-Use Products	   52
      B. End-Use Products	      52
             1. Additional Product Specific Data                             52
Requirements	
             2. Labeling for End-Use Products	   53
                   a. Label Changes Summary Table	   54
                                        11

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                                                                Halohydantoins RED
VI. Appendices
      A. Table of Use Patterns for Halohydantoins	     58
      B. Table of Generic Data Requirements and Studies Used to Make the
                   Regulatory Decision	       110
      C. Technical Support Documents	    119
      D. Bibliography Citations	    121
      E. Generic Data Call-In	   135
      F. Product Specific Data Call-In	  136
      G. Batching of End-Use Products	   137
      H. List of All Registrants Sent the Data Call-In	   146
                                        in

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                                                                 Halohydantoins RED
CHEMICAL TEAM

Science Team
Tim McMahon
Michelle Centra
Najm Shamim
Timothy Leighton
Jonathan Chen
Kathryn Montague
Sanyvette Williams-Foy

Regulatory Team
ShaRon Carlisle
Heather Garvie
Diane Isbell
                                         IV

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                                                                               Halohydantoins RED
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
EDSTAC       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
LC5o           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

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                                                                               Halohydantoins RED
MP            Manufacturing-Use Product
MRID          Master Record Identification (number).  EPA's system of recording and tracking studies submitted.
MRL          Maximum Residue Level
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
RfD           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
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
                                                  VI

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                                                                      Halohydantoins RED
ABSTRACT

       The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for halohydantoins and is issuing its risk management
decision and tolerance reassessment. The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of currently
registered products and additional information received through the public docket. After
considering the risks identified in the revised risk assessments, comments received, and mitigation
suggestions from interested parties, the Agency developed its risk management decision for uses of
halohydantoins that pose risks of concern. As a result of this review, EPA has determined that the
halohydantoin groups of chemicals are eligible for reregi strati on,  provided that risk mitigation
measures are adopted and labels are amended accordingly. That decision is discussed fully in this
document.

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                                                                      Halohydantoins RED
I.  INTRODUCTION

       The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,
1984. The amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data to the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency").  Reregi strati on involves a
thorough review of the scientific database underlying a pesticide's registration. The purpose of the
Agency's review is to reassess the potential hazards arising from the currently registered uses of
the pesticide; to determine the need for additional  data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.

       On August 3,  1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment. The Agency has decided that, for
those chemicals that have tolerances and are undergoing reregi strati on, the tolerance reassessment
will be accomplished through this reregi strati on process. The Act also required 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.   At this time, the Agency has not identified  any
other chemical substances that have a mechanism  of common toxicity with that of the
halohydantoins group. For reregi strati on purposes, EPA has assumed that the halohydantoins do
not have a common mechanism of toxicity and will not perform a cumulative risk assessment as
part of the tolerance reassessment for these pesticidal chemicals. This  document presents the
Agency's revised human health and ecological risk assessments and the reregi strati on eligibility
decision for the halohydantoins.

       These antimicrobial chemicals are registered for use in indoor food and non-food, indoor
residential, aquatic non-food residential, aquatic food, aquatic  non-food, and aquatic non-food
industrial sites for control of bacteria, fungi, and algal slimes.

       The Agency has concluded that the FQPA  Safely Factor for the halohydantoins should  be
removed (equivalent to  IX). Although there is quantitative evidence of increased sensitivity of
neonatal rabbits, the Agency considered this effect not indicative of susceptibility, based upon  the
very high dose level at which the effect occurred, the minimal  nature of the effect, and the
likelihood that the effect was due to a greater dose received by pups from ingestion of both milk
and feed during the lactation period. Therefore, the Agency determined that the special hazard-
based FQPA safety factor could be removed for the halohydantoins and that the use of a standard
uncertainty factor of 100 would be sufficient.

       Risks summarized in this document  are those that result only from the use of the active
ingredient, halohydantoins.  The FFDCA 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
                                            2

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                                                                     Halohydantoins RED
effect by a common toxic mechanism could lead to the same adverse health effect that would occur
at a higher level of exposure to any of the substances individually. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common mechanism of toxicity,
EPA has not made a common mechanism of toxicity finding for the halohydantoins and any other
substances.  The halohydantoins do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this action, therefore, EPA has not assumed that the
halohydantoins have 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 reregi strati on eligibility of the
registered uses of halohydantoins. 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 halohydantoins referenced in this RED.  The revised risk assessments and
related addenda are not included in this document, but are available in the Public Docket at
http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0303).

       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 halohydantoins, and its regulatory history.
Section III, Summary of Halohydantoins Risk Assessments, gives an overview of the human
health and environmental assessments, based on the data available to the Agency.  Section IV,
Risk Management,  Reregi strati on, and Tolerance Reassessment Decision, presents the
reregi strati on 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 reregi strati on, bibliographic
information, related documents and how to access them, and Data Call-In (DCI) information.

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                                                                     Halohydantoins RED
II.  CHEMICAL OVERVIEW

       A.    Regulatory History

       The halohydantoins were first registered in October 1961.  There are currently 114 active
products containing a halohydantoin registered under Section 3 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). In 1987, EPA issued a Data Call-In (DCI) for
antimicrobial products, which covered the halohydantoins.  In response to this DCI, generic
toxicology, environmental fate and ecotoxicity data were submitted. Generic data were developed
on the breakdown products, dimethylhydantoin (DMH) and ethylmethylhydantoin (EMH).  The
primary reason for developing generic data on DMH and EMH rather than the entire
halohydantoin molecule is that these ring structures represent the persistent component of the
halohydantoins. A secondary reason for evaluating the halohydantoin moieties is that the
corrosive properties of the released halogens would limit the amount of chemical that could be
administered to laboratory animals; thereby precluding a meaningful evaluation of the
halohydantoin moieties.  The Agency also determined that data developed on DMH was applicable
to EMH and vice versa. The basis for this decision was the similarity of the chemical structure of
these two chemicals and the similarity of results from studies conducted on both the DMH and
EMH compounds.
       B.
Chemical Identification
       The halohydantoins are a group of chemicals comprised of several halogenated compounds.
 This group of chemicals includes the following: l-Bromo-3-chloro-5,5-dimethylhydantoin, 1.3-
Dibromo-5,5-dimethylhydantoin, l,3-Dichloro-5,5-dimethylhydantoin, and l,3-Dichloro-5-ethyl-5-
methylhydantoin.  In addition, the Agency has determined that the 5,5-Dimethylhydantoin (DMH)
and 5-Ethyl-5-methylhydantoin (EMH) metabolites of the halogenated hydantoins are appropriate
test substances for assessing the toxicity of this group.  However, since the
hydroxymethylhydantoins as listed above have the potential for release of formaldehyde, the risks
associated with this release need to be assessed. The Agency has determined that the risks from
exposure to formaldehyde via the hydroxymethylhydantoins will be addressed when registration
review is conducted on hydroxymethylhydantoin.

       The common names, chemical names, empirical formulas, and CAS numbers of the
halohydantoins are presented in Table 1.

Table 1.  Common Names, Chemical Names, Empirical Formulas, and CAS Numbers
Common Name
Dichlorodimethylhydantoin
Bromochlorodimethylhydantoin
Chemical Name
l,3-dichloro-5,5-
dimethylhydantoin
l-Bromo-3-Chloro-
Empirical Formula
C5H6C12N202
C5H6BrClN2O2
CAS No.
118-52-5
16079-88-2

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                                                                  Halohydantoins RED
Common Name

Dichloroethylmethylhydantoin
Dibromodimethylhydantoin
Bromochlorodimethylhydantoin
Chemical Name
Dimethylhydantoin
l,3-dichloro-5-ethyl-5-
methylhydantoin
l,3-dibromo-5,5-
dimethylhydantoin
l-Bromo-3-chloro-5,5-
dimethylhydantoin
Empirical Formula

C6H8C12N202
C5H6Br2N202
C5H6BrClN2O2
CAS No.

89415-87-2
77-48-5
32718-18-6
       Structures of the halohydantoins considered in this document are below:
                                                                     0
                                                             0
1,3 Dichloro-5,5-Dimethylhydantoin
l-Bromo-3-Chloro-Dimethylhydantoin
                    0
            0
                                                              N-
                                                                     •CH,
                   Br
l,3-Dichloro-5-Ethyl-5-Methylhydantoin
       l,3,-dibromo-5,5-dimethylhydantoin

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                                                                    Halohydantoins RED
l-bromo-3-chloro-5-5-dimethylhydantoin
   Physical and chemical properties of atypical halohydantoin are shown in Table 2.




Table 2.  Physical and Chemical properties of a typical Halohydantoin product
Parameter
Color
Physical State
Odor
Stability
Oxi dati on/Reduction
pH of water solution, 1% slurry at 25°C
Melting point
J^-ow
Water solubility at 25°C
Vapor Pressure
Value
Off-white
Solid
Slight halogen odor
Stable in the dry state. It decomposes
exothermally at 180°C. It is attacked by
strong alkali's, acids, and moisture.
Oxidizer
6.5
between 120 and 148°C
unknown
0.54 g/ 100 g
NA

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                                                                     Halohydantoins RED

       Structurally, the halohydantoins consist of a central organic hydantoin ring moiety (either
dimethylhydantoin or ethylmethylhydantoin) to which halogen atoms (bromine and/or chlorine)
can be attached at both the 1 and 3 positions on the hydantoin ring.

       In concentrated form, the halohydantoins are very stable. Upon usage, which involves
dilution in water or a water system, the halohydantoins rapidly decompose to release chlorine
and/or bromine and dimethylhydantoin (DMH) and, for certain products, ethylmethylhydantoin
(EMH). These released halogens react with water to form either hypochlorous or hypobromous
acid, which is the  actual biocidal agent. Accordingly, the halohydantoins are essentially delivery
systems for hypochlorous and hypobromous acid.
       a.     Use Profile

       The halohydantoins are used for microbial control in water and water systems. In
particular, the halohydantoins are used as disinfectants in commercial and residential swimming
pools, spas and hot tubs; as sanitizers for treatment of toilet bowl water in homes; and for
controlling bacterial and fungal contamination in a variety of industrial water systems, (i.e.,
industrial cooling water systems,  pulp and paper mill process water, wastewater treatment
systems, air washer water systems, sewage systems, industrial processing water, irrigation
systems, and ornamental ponds).

       The only food-use for the halohydantoins is as a slimicide in the manufacture of food-
contact paper and paperboard.  The 1998 Antimicrobial Regulation Technical Corrections Act
(ARTCA) gave the U.S. Food and Drug Administration (FDA) jurisdiction for regulating dietary
residues of food-contact slimicides under Section 409 of the Federal Food, Drug and Cosmetic
Act (FFDCA).  In addition, EPA is responsible for registering the slimicide product under FIFRA.
 The FDA regulation that permits the halohydantoins to be used as slimicides in the manufacture
of food-contact paper and paperboard is in 21 C.F.R. Part 176.300.

       USE SITES:

             Indoor Non-Food

                 Hydrostatic Sterilizer Water Systems
                 Pasteurizer/Warmer/Cannery /Retort Water Systems
                 Transportation Cleaning

             Indoor Residential

                 Toilet Bowls and Urinals
                 Bathroom Premises/Hard Surfaces

             Non-Food Residential

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                                                             Halohydantoins RED
          Swimming Pool Water Systems
          Air Conditioner
          Hot Tubs & Spas

       Indirect Food

          Pulp and Paper Mill Water (food contact paper)

       Aquatic Nonfood

          Ornamental Ponds/Aquaria
          Irrigation Systems

       Aquatic Non-Food Industrial

          Air Washer Water Systems (includes air scrubbing and washing)
          Evaporative Condenser Water Systems
          Pulp and Paper Mill Systems
          Sewage/Wastewater Treatment Systems
          Commercial/Industrial Water Cooling Tower Systems
          Heat Exchanger Water Systems
          Industrial Processing Water
           Photo Processing Water
           Secondary Oil Recovery Injection Water
           Oil Recovery Drilling Muds and Packer Fluids
          Recirculating Cooling Water (Greenhouses & Nurseries)

APPLICATION RATES AND METHODS:

Indoor Non-Food

       For recirculating cooling water systems the typical rate of application ranges from
0.1 to 0.75 Ibs per 1,000 gallons of water with 5-70 ppm halohydantoins with 0.5 - 5 ppm
halogen by method of Place Solid (PLS), Pour Solid (PS) Feeders, Pour Liquid (PL) and
Pour Undiluted (PU). End Use pack size ranges from 25 to 2,200 Ib. for briquettes, tablets
and in granular form. The end-use pack size for gels range from 22 oz to 400 pounds.

       For transportation cleaning,  1 to 5 ppm of halohydantoins with 1 to 3 ppm
halogen is used at a typical rate of .025 to 0.1 Ibs per 1,000 gallons of water. PLS or PS
feeder is used for briquettes and tablets in end use pack sizes that range from 20 to 50
pounds.

Indoor Residential

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                                                             Halohydantoins RED
       For toilet bowls and urinals, 1 to 5 ppm of halohydantoins with 2 to 10 ppm of
halogen is used by method of Place Solid at a typical rate of 17 to 25 grams per month in
briquette and tablet form.

       For bathroom premises and hard surf aces, 588 ppm of halohydantoins with 1,125
ppm of halogen is used at a typical rate of 0.45 ounces per every 3 gallons of water
applied by mop and brush. For bathroom and hard surface use, the product is in granular
and tablet form; end use pack sizes range from 1 to 50 pounds.

Non-food Residential

       For residential and commercial pools, 50 to 300 ppm of halohydantoins with 1 to
4 ppm of halogen is used at a weekly rate of 0.5 to 2.5 pounds per 10,000 gallons of water.
Product is dispensed through a PLS/PS feeder in tablet, briquette and granular form from
end use packs that range from 20 to 50 pounds.

       For residential and commercial spas, 30 to 100 ppm of halohydantoins with 2 to 6
ppm of halogen is used at a weekly rate of 0.1 to 0.5 pounds per 1,000 gallons of water.
Product is dispensed through a PLS/PS feeder in tablet, briquettes and granular form from
end use packs that range from 1  to 50 pounds.

       For use in air conditioner and dehumidifter basin/drip pans, one or more 20 gram
tablets are placed in the basin or drip pan from end use pack sizes of 25 or 50 pounds.

Indirect Food

       For Pulp & Paper with food contact, 5 to 25 ppm of halohydantoins with 1 to 5
ppm of halogen is used at a typical rate of 0.16 to 2.0 pounds per ton of paper. A PLS/PS
feeder or PU is used to dispense product  in briquette, granular, powder, tablet and gel
form. End use product pack sizes range from 25 to 2,200 Ibs. for briquettes, tablets and
granular formulations. The end-use pack size for gel products range from 22 oz to 400
pounds.

Aquatic Non-Food

       For Decorative Waters without fish, 50 to 260 ppm of halohydantoins with 1 to 3
ppm of Halogen is used at a weekly rate of 0.5 to 1.4 pounds per 10,000 gallons of water.
A PLS/PS feeder is used to dispense product in briquette, granular, tablet and gel form.
End use product pack size ranges from 22 oz to  400  pounds for gel  and 20 to 50 pounds
for all other forms.

       For irrigation and automatic water distribution systems (not for use on food
crops) 8 to 24 ppm of halohydantoins with 5 to 15 ppm of halogen is used at a typical rate
of 15 to 45 grams per 1,000 gallons of water. A PLS/PS feeder, PU, or PL is used to
dispense product in granular, powder and tablet form. End use products are packaged in 3
and 25 pound containers.

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                                                              Halohydantoins RED

Aquatic Non-Food Industrial

       For Recirculating cooling systems., 5 to 70 ppm of halohydantoins with 0.5 to 5
ppm of halogens is used at a typical rate of 0.1 to 0.75 pounds per 1,000 gallons of water
dependent on level of biological control. A PLS/ PS feeder, PU, or PL is used to dispense
product in granular, briquettes, tablet and gel form. End use product package sizes range
from 22 oz to 400 pounds for the gel formulation and 25 to 2,200 pounds for all other
formulations.

       For once through cooling systems., 5 to 35 ppm of halohydantoins with 0.5 to 5
ppm of halogen is used at a typical application rate of 0.1 to 0.3 pounds per 1,000 gallons
of water. A PLS/ PS feeder, PU, or PL is used to dispense product in granular, briquettes,
tablet and gel form. End use product package sizes range from 22 oz to 400 pounds for the
gel formula and 25 to 2,200 pounds for all other formulations.

       For Pulp and Paper, 5 to 25 ppm of halohydantoins with 1 to 5 ppm of halogen is
used at a typical application rate of 0.16 to 2.0 pounds per ton of paper. A PLS/ PS feeder
or PU is used to dispense the product in granular, powder, tablet and gel form. End use
product package sizes range from 22 oz to 400 pounds for gel formulations  and 25 to
2,200 pounds for all other formulations.

       For sewage and wastewater treatment systems, 5 to 35 ppm of halohydantoins
with 0.5 to 5 ppm of halogen is used at a typical application rate of 0.1 to 0.75 pounds per
1,000 gallons of water. A PLS/ PS feeder, PU, or PL is used to dispense product in
briquette, granular, tablet and gel forms. End use product package sizes range from 22 oz
to 400 pounds for gel formulations and 25 to 2,200 pounds for all other formulations.

       For photo processing, 1 to 5 ppm of halohydantoins with 1 to 3 ppm of halogen is
used at a typical application rate of 0.006 to 0.02 pounds per 1,000 gallon of water. A
PLS/ PS feeder is used to dispense product in granular, briquettes and tablet forms. End
use product package sizes range from 1 to 50 pounds.

       For secondary oil recovery injection water, 300 ppm of halohydantoins with 280
ppm of halogen is used at a typical application rate of 2.3 pounds per 1,000  gallons of
water. A PLS/ PS feeder is used to dispense the product in granular and tablet forms. End
use pack sizes range from 25 to 2,200 pounds.

       For oil recovery drilling mud & packer fluids, 940 ppm of halohydantoins with
1,800 ppm of halogen is used at a typical application rate of 15 pounds per 1,000 gallons
of water. A PLS/ PS feeder is used to dispense the product in granular and tablet form.
End use product package sizes range from 25 to 2,200 pounds.

       For recirculating cooling water for greenhouses and nurseries, 8 to 24 ppm of
halohydantoins with 5 to 15 ppm of halogen is used at a  typical rate of 15 to 45 grams per
                                    10

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                                                             Halohydantoins RED
1,000 gallons of water. A PLS/ PS feeder is used to dispense product in granular, powder
and tablet forms. End use product package sizes are 3 and 25 pounds.

TARGET PESTS:

       Slime-forming bacteria and fungi; pathogens in swimming pools, spas, hot tubs,
       toilet bowls and urinals; mollusks and algae.

FORMULATION TYPES:
       Powder, granular, tablets (including nuggets), briquettes and gel.
                                   11

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                                                                     Halohydantoins RED
III.     Summary of Halohydantoins 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 documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for halohydantoins. While the risk assessments and related addenda are not
included in this document, they are available to the public in EPA's Pesticide Docket EPA-HQ-
OPP -2004-0303 at http://www.regulations.gov . Hard copies of these documents may be found in
the OPP public  docket. The OPP public docket is located in Room S-4900, One Potomac Yard,
2777 South Crystal Drive, Arlington, VA 22202, and is open Monday through Friday, excluding
Federal holidays, from 8:30 a.m. to 4:00 p.m.
       A.     Human Health Risk Assessment

       The halohydantoins are a group of chemicals comprised of several halogenated
compounds. This group of chemicals includes the following: l-Bromo-3-chloro-5,5-
dimethylhydantoin, 1.3-Dibromo-5,5-dimethylhydantoin, l,3-Dichloro-5,5-dimethylhydantoin,
and l,3-Dichloro-5-ethyl-5-methylhydantoin. In addition, the Agency has determined that the
5,5-Dimethylhydantoin (DMH) and 5-Ethyl-5-methylhydantoin (EMH) metabolites of the
halogenated hydantoins are appropriate test substances for assessing the toxicity of this group.
However, since the hydroxymethylhydantoins as listed above have the potential for release of
formaldehyde, the risks associated with this release need to be assessed. The Agency has
determined that the risks from exposure to formaldehyde via the hydroxymethylhydantoins will
be addressed when registration review is conducted on hydroxymethylhydantoin. Therefore, this
reregi strati on eligibility decision (RED) document assesses the eligibility of the halohydantoins
and their metabolites for reregi strati on.

       The Agency's use of human studies in the halohydantoins risk assessment is in accordance
with the Agency's Final Rule promulgated on January 26, 2006, related to Protections for
Subjects in Human Research, which is codified in 40 CFR Part 26.

              1.     Toxicity of Halohydantoins

       A brief overview of the toxicity studies used for determining endpoints in the dietary risk
assessments are outlined in this section; other toxicity endpoints will be presented later in this
document. Further details on the toxicity of halohydantoins can be found in the Halohydantoins
Revised Risk Assessment for the Reregistration Eligibility Decision.,  dated June 25, 2007. This
document is available to the public in EPA's Pesticide Docket EPA-HQ-OPP-2004-0303 at:
http://www.regulations.gov

       The Agency has reviewed all toxicity studies submitted for halohydantoins and has
determined that the toxicological database is sufficient for reregi strati on.  The studies have been
submitted to support guideline requirements. Major features of the toxicology profile are
presented below. In acute toxicity studies, summarized in Table 3 below, the halohydantoins were
shown to be of low toxicity by the oral and dermal routes of exposure (Toxicity categories III and


                                          12

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                                                                       Halohydantoins RED
IV, respectively). Acute toxicity by the inhalation route is more significant (Toxicity category II).
The halohydantoins are significant eye and skin irritants (Toxicity category I and II, respectively).
Mixed dermal sensitization has also been observed for some of the halohydantoin compounds.
See Table 4 for the studies and toxicity endpoints that were used in the dietary risk assessment.

Table 3. Acute Toxicity of Halohydantoins
Guideline No./ Study Type
MRID No.
(TRID No.)
Results
Toxicity
Category
5 ,5 -Dimethylhy dantoin
870.1100 Acute oral (gastric intubation)
toxicity (limit test)-Mouse
45738401
LD50 (combined) > 5,000
mg/kg
IV
l-Bromo-3-chloro-5,5-dimethylhy dantoin
870. 1 100 Acute oral toxicity -Rat
870. 1 100 Acute oral toxicity -Rat
870. 1300 Acute inhalation toxicity-Rat
870.2500 Acute dermal irritation-Rabbit
870.2500 Acute dermal irritation-Rabbit
870.2600 Skin sensitization-Guinea pig
93074006,
00128244
(4226-010-01)
93077008,
00147325
(4600-950-21)
43654101
93074011,
93075014,
00128242
(4225-014-10)
93077009,
00147326
(4600-950-22)
41670001
LD50(males) =1,350 mg/kg
LD50(females) = 1,520 mg/kg
LD50(combined) =1,390
mg/kg
LD50(males) = 1,037 mg/kg
LD50(females) = 860 mg/kg
LD50(combined) = 929 mg/kg
LC50(males) = 0.157 mg/L
LC50(females) = 0.213 mg/L
LC50(combined) = 0.168 mg/L
severe skin irritant
severe skin irritant
positive sensitizer
III
III
II
I
I
N/A
l,3-Dibromo-5,5-dimethylhydantoin
870. 1 100 Acute oral toxicity-Rat
870. 1 100 Acute oral toxicity-Rat
870. 1200 Acute dermal toxicity -Rabbit
870. 1200 Acute dermal toxicity-Rat
870.1300 Acute inhalation toxicity-Rabbit
93076011,
00137105
(4334-012-01)
44988002, )
93076025,
00137110
(4334-012-07)
44988001
44988003
LD50 = 760 mg/kg
combined LD50 = 448 mg/kg
LD50 cannot be ascertained
(study is classified as
Unacceptable/non-guideline
LD50 > 2000 mg/kg
LC50 betweenO.5 1-2.02 mg/L
III
II
~
III
II
                                            13

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                                                                        Halohydantoins RED
Guideline No./ Study Type
870.2500 Primary dermal irritation-Rabbit
870.2500 Primary dermal irritation-Rabbit
870.2600 Dermal Sensitization - guinea pig
MRID No.
(TRID No.)
93076017,
00137109
(4334-012-05)
44988004
44988005
Results
severe skin irritant
corrosive
non-sensitizer
Toxicity
Category
I
I
N/A
l,3-Dichloro-5,5-dimethylhydantoin
870.1200 Acute dermal toxicity-Rabbit
870.2500 Acute dermal irritation-Rabbit
93076013,
00084176
(2402-448-05)
93076017,
00137109
(2402-448-01)
LD50 > 20,000 mg/kg
severe skin irritant
IV
I
Table 4.       Summary of Toxicological Dose and Endpoints for the Halohydantoins for Use in
              Human Risk Assessment
Exposure
Scenario
Acute Dietary
females 13-50
years of ase

Chronic
Dietary a
all populations

Chronic
Dietary a
females 13-50
years of ase

Dose Used in
Risk
Assessment,
UF
NOAEL= 100
mg/kg/day
UF = 100
Acute RfD = 1
mg/kg
NOAEL= 300
mg/kg/day
UF = 100
Chronic RfD
(gen Pop.) = 3
mg/kg/day
NOAEL= 100
mg/kg/day
UF = 100
Chronic RfD
(females 13-50)
= 1 mg/kg/day

FQPA SF = 1
aPAD = acute RfD
FQPA SF
= 1 mg/kg/day
FQPA SF = 1
cP AD = chr RfD
FQPA SF
= 3 mg/kg/day
FQPA SF = 1
cP AD = chr RfD
FQPA SF

= 1 mg/kg/day
Study and Toxicological Effects
developmental toxicity - rabbit
developmental LOAEL = 500
mg/kg/day based on skeletal variations.
(MRID 42413 101)
chronic toxicity/carcinogenicity - rats
LOAEL = 1000 mg/kg/day based on
decreased body weight/weight gain and
lymph node hyperplasia.
(MRID 43397702)
developmental toxicity - rabbit
developmental LOAEL = 500
mg/kg/day based on skeletal variations.
(MRID 42413 101)

   UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
                                             14

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                                                                       Halohydantoins RED
   observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RiD = reference dose, MOE = margin
   of exposure
   aThe HIARC selected separate chronic RfDs for females, ages 13-50, and the general population.  A separate
   endpoint for the general population was selected because this was an unusual case where the developmental
   toxicity NOAEL was lower than the NOAEL from the chronic toxicity studies.  The chronic RfD for the general
   population provides a more appropriate endpoint for individuals other than females
General Toxicity Observations
       Non-acute toxicity testing of halohydantoins (DMH/EMH) (including subchronic,
developmental, reproductive, and chronic toxicity testing) all show the presence of non-specific
toxicity only at relatively high doses of the test chemical.  Developmental and reproductive
toxicity data demonstrate no increase in susceptibility to the toxic effects of 5,5-dimethylhydantoin
with the exception of one study, where fetal and litter effects (increased incidence of 27th presacral
vertebrae) in rabbits were observed at a lower dose level than that which resulted in maternal
toxicity (decreased body weight and food consumption during the dosing period) following
treatment. The increase of 27th presacral vertebrae is a common variation found in rabbit
developmental toxicity studies and was not considered an adverse effect. In a prenatal
developmental toxicity study conducted in rabbits with 5-ethyl-5-methylhydantoin, there was no
increased susceptibility of the fetuses observed.

       Available metabolism data indicate that DMH and EMH are excreted unchanged in the
rat. However, it is known that hydroxymethylhydantoins are formaldehyde releasers.  The DMH
portion of the molecule is assumed to behave the same as the hydantoins from the halohydantoin
compounds. Any risk associated from the formaldehyde portion of the hydroxymethylhydantoin
molecule will be addressed in the registration review of the hydroxymethylhydantoins.

Uncertainty Factors
       Although there is quantitative evidence of increased sensitivity of neonatal rabbits, the
Agency does not consider this effect indicative of susceptibility, based upon the very high  dose
level at which the effect occurred, the minimal nature of the effect, and the likelihood that the
effect was due to a greater dose received by pups from ingestion of both milk and feed during the
lactational period.  Therefore, the Agency recommended that the special hazard-based FQPA
safety factor could be removed for the halohydantoins and that the use of a standard uncertainty
factor of 100 would be protective for offspring.

Dietary
       Acute and chronic dietary endpoints were selected using the no observed adverse effect
level (NOAEL) of 100 mg/kg/day for females 13-50 based on a developmental toxicity study on
rabbits, in which skeletal variations were seen at 500 mg/kg/day.  A chronic dietary endpoint of
300 mg/kg/day was selected for the general  population based on a chronic toxicity study on rats,
in which decreased body weight, weight gain, and lymph node hyperplasia were observed.

Incidental Oral
       The incidental short-term oral endpoint was selected using a NOAEL of 500 mg/kg/day,
based a developmental toxicity study on rabbits, in which decreased body weight gain in maternal
rabbits at 1000 mg/kg/day.  The intermediate- term oral endpoint was selected using a NOAEL of

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                                                                     Halohydantoins RED
300 mg/kg/day, based on a subchronic oral toxicity study in which decreased body weight and
liver weight were observed at 1000 mg/kg/day.

Short-, Intermediate- and Long-term Dermal
       An endpoint for dermal toxicity (all times exposure durations) was selected using a
NOAEL of 390 mg/kg/day based on the results of a 90-day dermal subchronic toxicity study
(MRID 43173901) in which no systemic toxicity was found at the highest dose tested. The
LOAEL is greater than 390 mg/kg/day.

 Inhalation (all durations)
       The short-term inhalation endpoint was selected to be the same as the oral endpoint of 100
mg/kg/day, due to skeletal effects in the offspring at 500 mg/kg/day in a developmental toxicity
study in rabbits.  For inhalation exposures, a 100% inhalation absorption value is used for route-
to-route extrapolation.

Carcinogenicity
       Cancer studies in rats and mice indicated no systemic effects other than decreased body
weight and body weight gains in females (rats) and males (mice) and increased hyperplasia of
submandibular lymph nodes in males (rats).  No evidence of carcinogenicity of the test material
was reported. 5,5-dimethylhydantoin is classified as 'not likely' to be a carcinogen based upon
the negative evidence for carcinogenicity in both the rat and mouse studies as well as the negative
evidence of mutagenicity.

Mutagenicity
       The data on mutagenicity of dimethylhydantoin shows, in large part, negative responses in
the studies conducted. Literature reports indicate a positive effect for 2 in vitro mammalian
cytogenetic assays in Chinese Hamster Ovary cells.

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

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

                                           16

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                                                                     Halohydantoins RED

             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 database for reproductive or
developmental toxicity testing of 5,5-dimethylhydantoin is complete. Based on the overall
examination of the effects of DMH, the HIARC concluded that there was some evidence for
increased susceptibility,  because a developmental endpoint was selected for dietary risk
assessment, an additional safety  factor to address FQPA concerns is not necessary.

             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.  The Agency has
conducted a dietary exposure and risk assessment for the use of halohydantoins as a slimicide in
food contact paper and paperboard, and for use as a preservative in inorganic slurries which are
used as fillers for food contact paper and paperboard.

                    a.      Acute PAD

       Acute dietary risk 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 (1 mg/kg/day) modified by the FQPA
safety factor.  The acute reference dose was derived from a developmental toxicity study in
rabbits in which both the NOAEL (100 mg/kg/day) and the LOAEL  (500 mg/kg/day) were
determined.  Acute dietary exposure was estimated for females ages  13-50 only since the
endpoint chosen is based on a developmental effect. The halohydantoins aPAD is 1 mg/kg/day.
Uncertainty factors were included for inter-species extrapolation (lOx) and intra-species variation
(lOx).

                    b.      Chronic PAD

       Chronic dietary risk for halohydantoins was 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 (1
mg/kg/day females 13-50 and 3 mg/kg/day all populations) modified by the FQPA safety factor.
The cPAD was derived from a developmental toxicity study in rabbits and a chronic toxicity  in
rats;  in which both the NOAELs and LOAELs were determined. The halohydantoins cPAD is 3
mg/kg/day based on a reference dose of 3 mg/kg/day for the general  populations group and 1
mg/kg/day for females age 13-50; which includes the incorporation of the FQPA safety factor
(IX) for the overall U.S.  population or any population subgroups. Uncertainty factors were also
included for inter-species extrapolation (lOx) and intra-species variation (lOx).
                                           17

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                                                                     Halohydantoins RED

              4.     Dietary Exposure Assumptions

       Dietary exposure to the halohydantoins occurs from the slimicide use in the manufacture
of paper and paperboard.  Acute and chronic dietary exposures were assessed for these indirect
food-contact uses. No pesticide tolerances have been established for halohydantoins. The Agency
has used available methods to estimate halohydantoin residues on food due to migration of these
chemicals or their breakdown products, when these substances come into contact with food-
contact paper and paperboard. In this regard, the Food and Drug Administration (FDA) has
developed guidelines to estimate the residues of pesticides used as slimicides on food contact
paper and paperboard. The Agency has decided to use FDA methodology to estimate the residues
of such chemicals and/or their breakdown products on food items and also to determine the
Estimated Daily Intake (EDI) of these pesticides.

       EPA used two methods to calculate dietary exposure for adult populations. In the first
method, the following assumptions were made:

          Food contact surface could be a onetime use/day  or repeat use material/day;
          The amount of food that comes into contact with  the treated paper is based on an FDA
          default value;
          100 percent of the active material present in the paper migrates into the food.

       In the second (alternative) method, additional consideration is given to the type of food
that is being contained in  the treated paper, and factors such  as the quantity of active ingredient in
the  paper are not considered.

       The concentration of halohydantoins in the paper slurry was calculated assuming that the
chemical was used both as a slimicide and as a preservative in paper. Although two types of use
involve different moieties (halohydantoin for slimicide, hydroxymethylhydantoin for material
preservative), the concentrations were summed together to determine a total concentration of
hydantoins (EMH and DMH) in the slurry.  The EDI was then calculated based on this
concentration for both adults and children. The results of the calculations are shown in Tables 5
and 6.

       For more details on the exposure estimates and dietary risk, see Dietary Risk Assessment of
Halohydantoins, dated October 12, 2004, available under  docket number EPA-HQ-OPP-2004-0303
on http://www.regulations.gov.

              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 Tables 5 and 6.
                                           18

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                                                                            Halohydantoins RED
       The Agency has determined that the acute dietary risk estimates do not exceed the
Agency's level of concern (less then 100% of the aPAD) for females between 13-50 years, the
pertinent sub-population tested. The acute dietary exposure for an adult female is 0.533% of the
acute PAD using method #2 for estimating exposure.

       The chronic dietary risk assessment concluded the chronic risk estimates are also below
the Agency's level of concern (less than 100% of the cPAD) for the general U.S. population
(0.533% of the cPAD) and all population subgroups. The highest exposed population subgroup
was children 3-5 years old at  1.6% of the cPAD using method #2 for estimating exposure.

        Table 5.  Summary of Dietary Exposure and Risk for Halohydantoins (1st Method)
Population
Subgroup
Adult Male
Adult Female
Children
EDI
mg/day
0.0276
0.0276
0.0138
Acute Dietary
Dietary
Exposure3
(mg/kg/day)
-
4.60xlO"4
-
% aPAD b
-
0.046
-
Chronic Dietary
Dietary
Exposure
(mg/kg/day) a
3.94xlO'4
4.60xlO"4
l.SSxlO'3
% cPAD b
0.0131
0.0153
0.046
a— acute and chronic exposure analysis based on daily consumption of 0.00276 mg/person/day for adults and body weights of 70
kg and 60 kg for males and females, respectively. For infants/children, exposure based on daily consumption of 0.0138
mg/person/day; and a 10 kg body weight.
b-%PAD = dietary exposure (mg/kg/day) * 100 / aPAD or cPAD, where aPAD for females between 13-50 years of age =1.0
mg/kg/day and cPAD for the general population =3.0 mg/kg/day
Table 6. Summary of Dietary Exposure and Risk for Halohydantoins (2nd Method)
Population
Subgroup
Adult Male
Adult Female
Children
EDI
mg/day
0.96
0.96
0.48
Acute Dietary
Dietary
Exposure3
(mg/kg/day)
-
0.016
-
% aPAD b
-
1.6
-
Chronic Dietary
Dietary
Exposure
(mg/kg/day) a
0.0137
0.016
0.048
% cPAD b
0.457
0.533
1.6
a— acute and chronic exposure analysis based on daily consumption of 0.96 mg/person/day for adults and body weights of 70 kg
and 60 kg for males and females, respectively. For infants/children, exposure based on daily consumption of 0.48 mg/person/day;
and a 10 kg body weight.
b-%PAD = dietary exposure (mg/kg/day) * 100 / aPAD or cPAD, where aPAD for females between 13-50 years of age =1.0
mg/kg/day and cPAD for the general population = 3.0 mg/kg/day
                                               19

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                                                                     Halohydantoins RED

                    b.     Dietary Risk from Drinking Water

       Drinking water exposure to pesticides can occur through surface and groundwater
contamination.  The Agency is presently relying on predicted environmental concentrations
(PECs) of pesticides in surface water to estimate drinking water exposures to halohydantoins.
Considering all of the uses of this pesticide, the once-through cooling tower water system can be
expected to have the greatest impact on water, since the scenario has the greatest quantity of
effluent being produced and has the greatest chance of bacterial fouling, needing a pesticide
application.  Using the PDM4 model, the short-term Estimated Environmental Concentration
(EEC) in surface water use was estimated to be 36 ug/L. The chronic maximum EEC using this
model was determined to be 313 ug/L.

              6.     Residential Exposure Assessment

       The residential exposure assessment considers all potential pesticide exposure, other than
exposure due to residues in food or in drinking water. Residential exposure may occur while
using household cleaning products, paint, adhesives, and deodorizers. For the purposes of this
screening level assessment, handler scenarios have been developed that encompass multiple
products but represent a worst-case scenario for all products represented in the assessment. Each
route of exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed
as a Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate No
Observed Effect Level (NOAEL) dose.
                    a.     Residential Toxicity

       The toxicity endpoints and associated uncertainty factors used for assessing the non-
dietary risks for halohydantoins are listed in Table 7.  Although the dermal endpoint represents
short-, intermediate-, and long-term durations, the exposure duration of most homeowner
applications of cleaning products is believed to be best represented by the short-term duration.
The inhalation endpoint used in the assessment represents the short-term duration. The calculated
dermal and inhalation MOEs are not of concern for any of the scenarios (MOE greater than
10,000 for all scenarios).

       However, since the hydroxymethylhydantoins have the potential for release of
formaldehyde, the risks associated with this release need to be assessed.  The Agency has
determined that the risks from exposure to formaldehyde via the hydroxymethylhydantoins will
be addressed when registration review is conducted on hydroxymethylhydantoin.
                                           20

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                                                                     Halohydantoins RED
                              Table 7. Toxicological Endpoints
     Exposure
      Scenario
  Dose Used in
Risk Assessment,
       UF
                      Study and Toxicological
                              Effects
Short-Term Oral (1-
30 days)

(Incidental)
oral study
NOAEL= 500
mg/kg/day
UF = 100
Residential,
includes the Ix
FQPA SF
developmental toxicity - rabbit
maternal LOAEL = 1000
mg/kg/day based on decreased
body weight gain in maternal
rabbits.
(MRID 42413101)
Intermediate-Term
Oral (1 to 6 months)

(Incidental)
oral study
NOAEL= 300
mg/kg/day
UF = 100
Residential,
includes the Ix
FQPA SF
sub chronic oral toxicity - rat
LOAEL = 1000 mg/kg/day
based on decreased body
weight and liver weight.
(MRID 42009201)
Dermal- all time
periods
Short-,(l-30 days),
Intermediate-, (1 to t
months), Long-term
(>6 months)
(Occupational/
Residential)
dermal study
NOAEL= 390
mg/kg/day
(HOT)
UF = 100 for all
populations
MOE= 100
(Occupational)

Residential,
includes the Ix
FQPA SF
subchronic dermal toxicity -
rats
No systemic toxicity at the
highest dose tested
(MRID 43173 901)
Short-Term
Inhalation (1-30
days)
(Occupational/
Residential)
OralNOAEL= 100
mg/kg/day
(inhalation
absorption rate =
100%)
UF= 100 for all
populations
Residential,
includes the Ix
FQPA SF
developmental toxicity - rabbit
developmental LOAEL = 500
mg/kg/day based on skeletal
effects in offspring.
(MRID 42413101)
        It should be noted that this exposure assessment identifies short-term (1-30 days) and
 intermediate-term (1-6 months) noncancer exposure doses based on the reported toxicology
 endpoints for Halohydantoin. Because of the shorter exposure durations of these toxicological
 endpoints, conservative event-based exposure assumptions are used to calculate upper bound
 daily dose estimates.  The noncancer doses are not amortized over a lifetime. However, MOEs for
 all scenarios are much greater than the target MOE of 100 and are not of concern.
                                           21

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                                                                      Halohydantoins RED
               b.
Residential Handler Exposure
                           i. Exposure Scenarios, Data and Assumptions

       Halohydantoins may be added to residential-use products as disinfectants and sanitizers in
in-tank toilet bowl, swimming pool and spa products.  The pool/spa and air conditioner drip pan
uses are represented by the application to residential (i.e., backyard) swimming pools and spas.

       Hydroxymethylhydantoins may be added as a material preservative to control bacteria and
fungi (EPA Reg No. 6836-271) in residential-use products such as household cleaning products,
paints, adhesives, and deodorizers. For the purposes of this screening-level assessment, handler
scenarios have been assessed for residential uses that represent high-end exposures for the wide
variety of products.  Therefore, not all products are assessed individually.  Table 8 presents the
handler scenarios considered to represent the high end conservative estimates of exposure for the
residential assessment.
Table 8. Residential Handler Scenarios
Handler Scenario
Handling of liquid general purpose cleaner
Solid placement of in-tank toilet cleaner
Painting of a house using brush, roller, or airless
sprayer
Solid placement into swimming pools & spas
Typical Products Represented
(but not limited to)
Household cleaning products, carpet shampoo,
deodorizer
In-tank toilet tablet
Paint, adhesives, caulk
Pools/spas and air conditioner drip pans
                           ii. Residential Handler Risk

       Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments.  A summary of the residential handler exposures and
risks for the representative scenarios are presented in Table 9. Although the dermal endpoint
represents short-, intermediate-, and long-term durations, the exposure duration of most
homeowner applications of cleaning products is believed to be best represented by the short-term
duration. The inhalation endpoint used in the assessment represents only the short-term duration.
The calculated dermal and inhalation MOEs indicate that risks are not of concern for any of the
scenarios (MOE greater than 1,000 for all scenarios).  Further details on the residential risk can be
found in the Halohydantoins Revised Risk Assessment for the Reregistration Eligibility Decision,
dated June 25, 2007. This document is available to the public in EPA's Pesticide Docket EPA-
HQ-OPP-2004-0303 at: http://www.regulations.gov . As stated previously, formaldehyde is a
metabolite of hydroxymethylhydantoins and there may be risk associated with this exposure. Any
                                           22

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                                                                     Halohydantoins RED
risks associated with formaldehyde will be in the Registration Review Document for
hydroxymethylhydantoins.
                                          23

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Table 9. Calculation of Short-term Dermal and Inhalation MOE for Residential Handlers
                                                                                                            Halohydantoins RED
Exposure Scenario
Household Cleaning
Products
Toilet Bowl Tablets
Painting
Method of Application
Wipes
Mopping
Solid Placed
Brash/ Roller
Airless Sprayer
Dermal Dose (mg/kg/day)
0.014
0.0053
0.036
0.69
1.8
Dermal MOE
28,000
73,000
11,000
570
220
Inhalation Dose (mg/kg/day)
0.00033
0.00018
0.00091
0.00084
0.019
Inhalation MOE "
300,000
570,000
110,000
120,000
5,400
Swimming Pools / Spas
Swimming Pools
(Residential — backyard)
Spas
Solid Place
Solid Pour
Solid Place
Solid Pour
0.12
0.85
0.396
2.8
3200
460
984
139
0.000015
0.00046
0.0000506
0.00151
6500000
220000
1,970,000
66,500
                                           24

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                                                                   Halohydantoins RED

                 c.     Residential Post-application
                        i.      Exposure Scenarios, Data and Assumptions

       Residential postapplication exposures result when adults and children come into
contact where pesticide end use products have recently been applied (e.g., treated hard surface
floors), or when children incidentally ingest the pesticide residues through mouthing the
treated products/treated articles, through hand-to-mouth or object-to-mouth contact.  For the
purposes of this screening level assessment, postapplication scenarios have been developed
that represent high-end exposure scenarios for all products represented. Table 10 presents the
postapplication scenarios considered in this assessment.  Three scenarios have been
considered: (1) exposure to residue from hard floors that have been cleaned/mopped with a
general cleaner preserved with hydroxymethylhydantoins, (2) exposure to residue on clothing
that has been treated with halohydantoin during textile processing, and (3) exposure to
swimmers in treated pools. For this screening-level assessment, fabric softeners have been
grouped with textile processing chemicals for calculating exposure.
   Table 10.  Residential Postapplication Scenarios
Handler Scenario
Toddler exposed to residue from a hard floor
Adult and toddler exposed to residue on
clothing
Adult and Children exposed to residue in a
swimming pool
Products Represented
Hard surface cleaner/floor
Textile processing chemicals,
fabric softener
Pool and spa products
                        ii.     Post Application Risk

                               a.  Residential Post Application Risk (Hard Surfaces)

   There is the potential for toddlers playing on treated floors to be exposed to hydantoins
contributed by the hydroxymethylhydantoin material preservatives. Due to limited data, the
following assumptions have been made to determine toddler exposure while playing on
treated hard floors:

   •   Toddlers (3 years old) are used to represent the 1 to 6 year old age group.
   •   As a conservative estimate, it has been assumed that one gallon of mopping solution
       can treat 1000 ft2 of floor surface.
   •   No data could be found regarding the quantity of treatment solution residue left on the
       floor after treatment. It has been assumed that 25% of the solution remains after the
       final mop.
   •   No leaching data were available that could be used to estimate the residue transfer
                                        25

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                                                                     Halohydantoins RED
          from the hard surface (i.e., floor). Therefore, the Residential SOP estimate of 10
          percent of the amount on the floor is available for dermal transfer.

          The short- and intermediate-term dermal MOE calculated is 700, which is above the
   target MOE of 100. See the Occupational Residential Exposure Chapter for a more detailed
   review, available under docket number EPA-HQ-OPP-2004-0303 on http://www.regulations.gov .

          In addition  to the dermal exposure from toddlers playing on treated floors, there is the
   potential for incidental oral exposure via hand-to-mouth activities. Although residential
   floors are believed to be washed/moped on  an intermittent basis, facilities such as day care
   centers may clean the floors more frequently; therefore, both the short- and intermediate-term
   incidental oral endpoints are provided to assess the potential risks. Due to limited data, the
   following assumptions from the Residential SOPs (in addition to the assumptions listed
   above) have been made to estimate hand-to-mouth exposures for toddlers playing on treated
   carpets:

       •  The surface area of the portion of the hand-to-mouth per event is 20 cm2;
       •  The number of hand-to-mouth events per hour is 20;
       •  Exposure time is 4 hours/day;
       •  Saliva extraction efficiency is 50 percent

       Based on these assumptions, the potential dose rate using these assumptions is 0.07
mg/kg/day resulting in a hand-to-mouth MOE for toddlers of 7100 (short-term) and 4300
(intermediate-term) and thus, are not a concern to the  Agency.

                                  b.  Residential  Post Application Risk (Clothing)

       Although hydroxymethylhydantoin has  been listed for use in textile processing, it is
unclear in what capacity the chemical is to be used. It has been assumed, for this risk assessment,
that the chemical is impregnated into the material in the same manner as a dye would impregnate.
 Data on which these calculations could be based were generally unavailable; therefore, a number
of conservative assumptions have been made:

       •  Toddlers (3 years old) are used to represent the 1 to 6 year old age group and are
          assumed to weigh 15 kg, the median for male and female toddlers (USEPA, 2000b).
          The median surface area for a 3 year old, minus the head, is 0.657 m2.  Median values
          for body weights and surface areas for adults have been used (70 kg and 1.69 m2, not
          including head surface area).
       •  Based on rough estimates provided by the  American Association of Textile Chemists
          and Colorists (AATCC), dyes are used  on  fabric at a rate of about 4% by weight
          (AATCC, 2003). A medium-sized polo cotton shirt of regular knit construction
          weighs about 250 g. Assuming that the shirt covers 0.659 m2 of the body's surface
          area (based on the mean adult surface area for the torso, including the neck (USEPA,
          1997)), the  cloth weight to surface area ratio is 379  g/m2. If an adult wears clothing of
          a similar weight over all parts of the body, minus the head (1.69 m2 (USEPA, 1997)),
                                           26

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                                                                    Halohydantoins RED
          then the weight of clothing worn by an adult is 641 g. Using the same cloth weight to
          surface area ratio, the weight of clothing worn by a toddler is 214 g.  Area mouthed,
          for lack of data, is assumed to be equivalent to the area of fingers used in the hand-to-
          mouth exposure estimates (i.e., 20 cm2 or 20 cm2 / 10,000 = 0.002 m2).
       •  No leaching data were available that could be used to estimate a flux rate of the
          chemical from clothing.  It has been conservatively assumed that, over the course of a
          day, the amount of chemical transferred is the  full quantity of chemical present in the
          clothing. This is a conservative assumption and should not be considered as
          representative of the true rate at which the chemical would be transferred. However,
          as a screening-level assessment the risks are not of concern.

       The dermal MOE's calculated for both toddler and adult scenarios are not of concern
(MOE's =119 and 185 for toddlers and adults, respectively). The short-term incidental oral
MOE, as a result of mouthing treated fabric, is not of concern (MOE = 45,000). The short-term
NOAELs were used instead of the intermediate-term NOAELs because all of the residues were
assumed to be available for exposure in one day (for lack of any residue data). See the
Occupational Residential Exposure Chapter for a more detailed review, available under docket
number EPA-HQ-OPP-2004-0303 on http://www.regulations.gov .

                                  c. Residential Post Application Risk (Swimming)

       There are potential postapplication exposures to halohydantoin associated with use of
swimming pools  and spas. Because the amount of exposure will most likely be much greater for
swimming pools  than for spas, based on the amount of time spent in the water, only swimming
pool scenarios have been considered.

       The SWIMODEL 3.0 was developed by EPA as a screening tool to conduct exposure
assessments of pesticides found in swimming pools and spas (Dang, 2003). The  SWIMODEL
uses well-accepted screening exposure assessment equations to calculate the total worst-case
exposure for swimmers expressed as a mass-based intake value (mg/event). The model focuses
on potential chemical intakes only and does not take into account metabolism or excretion of the
chemical of concern. Detailed information and the downloadable executable  file are available at
http ://www. epa. gov/oppadOO 1 /swimodel. htm.

       It should be noted that this exposure assessment identifies short-term (1-30 days) and
intermediate-term (1-6 months) noncancer exposure doses based on the reported toxicology
endpoints for halohydantoins.  Because of the shorter exposure durations of these toxicological
endpoints, conservative event-based exposure assumptions are used to calculate upper bound
daily dose estimates. The noncancer doses are not amortized over a lifetime. However, as shown
below in Table 11, MOEs for all scenarios are much greater than the target MOE of 100 and are
not of concern.
                                          27

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                                                                       Halohydantoins RED
    Table 11.  Margins of Exposure for Swimming Pool"
Age
Adult
Adult
Child7-10yrs
Child7-10yrs
Child7-10yrs
Child 1 1-14 yrs
Child 1 1-14 yrs
Type of Swimmer
Competitive
Non-competitive
Competitive
Non-competitive
Non-competitive
Competitive
Non-competitive
Dermal MOE
3,100,000
1,900,000
7,100,000
1,400,000
1,400,000
4,100,000
2,800,00
Inhalation MOE
47,000
90,000
100,000
38,000
38,000
81,000
100,000
Ingestion MOE
190,000
56,000
60,000
12,000
12,000
96,000
32,000
   aMOE = NOAEL (mg/kg/day)/Dose(mg/kg/day). Dermal route is based on an absorbed dose, and therefore, the oral endpoint is used to
   estimate risk. The inhalation and ingestion NOAELs are 100 mg/kg/day and 300 mg/kg/day (intermediate-term), respectively.  Target MOE
   = 100.

              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.  Results of the aggregate risk assessment are
summarized here, and are discussed more extensively in the document, Revised Halohydantoins
Risk Assessment, dated June 25, 2007, which is available in the public docket at
http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0303).

                     a.  Acute Dietary Aggregate Risk

       The acute aggregate assessment includes dietary and drinking water exposures only. The
acute dietary risk estimates from indirect food uses (i.e., use in food-contact packaging and
treated articles) are less than 2% of the aPAD in all considered scenarios.  Thus, the acute dietary
(food) risk estimate associated with halohydantoins is below the Agency's level of concern.

       Drinking water exposure could occur from application of the pesticide to industrial water
systems but is not expected.  Drinking water monitoring data are not available; therefore, the
Agency calculated a drinking water level of comparison (DWLOC) to account for potential
drinking water exposures from the  exposure from once-through cooling tower uses.  The short-
term EEC for halohydantoin in surface was 36 ppb, or 36 ug/L.   See the Ecological Hazard
Chapter for a more detailed review, available under docket number EPA-HQ-OPP-2004-0303 on
http://www.regulations.gov. As shown in Table  12, the acute DWLOCs are greater than the EEC,
indicating that acute aggregate food and drinking water exposure  do not exceed the Agency's
level of concern.
                                            28

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                                                                       Halohydantoins RED
Table 12.  Acute Aggregate Exposure and Risk
Population
Subgroup

Females 13-
50 years
Females 13-
50 years
(alternate
FDA
method)
aPAD
mg/kg/day

1.0






Acute Food
Exp1
mg/kg/day
4.6xlO"4

0.016




Max Acute
Water Exp2
mg/kg/day
0.999

0.984




Surface
Water EEC3
mg/L
0.036






Acute
DWLOC4
mg/L
29986

29520




Potential
Risk Concern

No

No




'Acute food exposure = estimated daily intake (mg/person/day) / body weight (70 kg)
2 Maximum acute water exposure (mg/kg/day) = [(aPAD (mg/kg/day) - acute food exposure (mg/kg/day)]
3 Based on PDM4 model.
4 Acute DWLOC(ng/L) = [maximum acute water exposure (mg/kg/dav) x body weight (kg)l
                        [water consumption (L) x 10 3 ing/jig]

                     b.  Short-and Intermediate-term Aggregate Risk

       Only dermal and inhalation aggregate risks were considered for the short-term duration in
the aggregate risk evaluation. This is because homeowner cleaning scenarios are considered
short-term exposures only and thus do not involve intermediate or long-term exposure. Further,
not all of the non -dietary scenarios mentioned in this risk assessment have been aggregated, as it
is unlikely that all of the scenarios mentioned in the exposure assessment have a reasonable
probability of occurring together.  For purposes of this aggregate assessment, the dietary exposure
(food + water) is aggregated only with the cleaning scenarios involving wiping of hard surfaces,
mopping, and cleaning of toilets for adults.  Table 13  presents a summary of the aggregate dermal
and inhalation short-term risk for  adults. As shown, the aggregate MOE for both the dermal and
inhalation exposure was is not of concern.

       For toddlers, the dietary exposure is aggregated with the single dermal scenario of floor
contact, and the dietary exposure is aggregated separately with the single incidental oral floor
scenario. These scenarios are aggregated separately because exposures and MOEs for short- and
intermediate-term aggregate exposure risk assessment (oral, dermal, and inhalation exposures)
cannot be combined due to the lack of a common endpoint of toxicity from the different routes of
exposure. Clothing is not included in the aggregate risk because a screening level assessment was
performed in which it was assumed that, over the course of a day, the amount of chemical
transferred is the full quantity of chemical present in the clothing. This is a conservative
assumption and should not be considered as representative of the true rate at which the chemical
would be transferred.

       Calculation of aggregate MOE's for toddlers from dietary exposure and either dermal or
inhalation exposure from the floor treatment also showed no risk of concern.  Short-term
aggregate MOE's were calculated as 1000 and 5000 for the dermal and inhalation exposure
scenario, while intermediate-term aggregate MOE's were calculated as 909 and 3333 for the
dermal and inhalation exposure scenario respectively.
                                            29

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                                                                                                                            Halohydantoins RED
Table 13 Short-Term Aggregate Risk and DWLOC Calculations for Adults

Population



Adult
Short-Term Scenario



Target
Aggreg.
MOE
100



MOE
food1
36496



MOE
dermal2
7090



MOE
inhalation3
196000

Short-Term

Aggregate
MOE
(food and
dermal
residential)4
5988


Short-term
Aggregate
MOE (food +
inhalation
residential)5
31250



MOE
water6
101



Allowable
water
exposure7
(mg/kg/day)
4.9



Surface
Water
EEC8
(Mg/L)
4



DWLOC9
(Mg/L)
147000
1 MOE food = [( short-term oral NOAEL)/(chronic dietary exposure)] OralNOAEL of 500 mg/kg/day with chronic exposure of 0.0137.
2MOE dermal = [(short -term dermal NOAEL)/dermal residential exposure)] dermal NOAEL of 390 mg/kg/day used with total exposure of 0.055 mg/kg/day from cleaning
scenarios.
3 MOE inhalation = [(inhalation NOAEL)/(high-end inhalation residential exposure)] Inhalation NOAEL of 100 mg/kg/day used with total exposure of 0.00051
mg/kg/day
4 Aggregate MOE (food and dermal residential) = 1-K [(UMOE food) + (UMOE dermal)]]
5 Aggregate MOE (food and inhalation residential) = 1^[ [(l^MOE food) + (l^MOE inhalation)]]
6 Water MOE = 1-f- [[(1^- Target Aggregate MOE) - (1^-Aggregate MOE (food and residential)]]
7  Allowable water exposure = Short or Intermediate Term Oral NOAEL -f- MOE water
8using PDM4 model
9 DWLOC(ug/L) = [allowable water exposure (4.9mg/kg/dav) x body weight (60kg)1
                    [water consumption (2L) x 10"3 mg/ug]
                                                 30

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                                                                       Halohydantoins RED
                     c.  Chronic Dietary Aggregate Risk
       Table 14 presents the total chronic dietary exposure estimate for halohydantoins, and the
chronic DWLOCs.  The chronic PAD and the chronic dietary (food) exposure for that subgroup
were used to calculate the chronic DWLOC. Two methods were used to calculate dietary
exposure, and calculations are presented using both methods. Based on the use of the PDM4
model the chronic maximum EEC for dihalodialkylhydantoin in surface water was calculated as
313 ppb, or 313 ug/L.  As shown in Table 14, the chronic DWLOCs are greater than the EEC,
indicating that aggregate food and drinking water exposure do not exceed the Agency's level of
concern.
Table 14. Chronic Ag
Population
Subgroup

General
Population
General
Population
(alternate FDA
method)

Females 13-50
years
Females 13-50
years
(alternate FDA
method)
cPAD
mg/kg/
day


3.0




1.0





gregate Exposure and Risk
Chronic Food
Exp1 mg/kg/day


3.94xlO'4
0.0137




4.60xlO'4


0.016


Max Chronic
Water Exp2
mg/kg/day

2.999
2.986




0.999

0.984



Surface
Water EEC3
mg/L






0.3






Chronic
DWLOC4
mg/L

104986
104520




29986

29520



    Chronic food exposure = estimated daily intake (mg/person/day) / body weight (70 kg [M]; 60kg[F])
    2 Maximum chronic water exposure (mg/kg/day) = [(cPAD (mg/kg/day) - chronic food exposure (mg/kg/day)]
    3 Based on PDM4 model.
    4 Chronic DWLOC(ug/L) = [maximum chronic water exposure (mg/kg/dav) x body weight (kg)1
                              [water consumption (L) x 10"3 mg/ug]

              8.      Occupational Exposure and Risk

       Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Occupational handlers of halohydantoins products use them
in a variety of industrial applications, including recirculating cooling water, once-through cooling
tower water, pulp and paper process water, photo processing water, and transportation cleaning
systems. Concentrations of halohydantoin in these products range from 90% to 98%, and are
generally formulated as tablets, pellets, briquettes, or granules.  The remaining formulations are
gels, powders, or ready-to-use solutions, and all may be considered as solid (as opposed to liquid)
formulations.
                                            31

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                                                                     Halohydantoins RED
       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
halohydantoins, MOEs greater than 100 are not of concern to the Agency. For workers entering a
treated site, MOEs are calculated for each day after application to determine the minimum length
of time required before workers can safely re-enter.

       For more information on the assumptions and calculations of potential risk of
halohydantoins to workers, see the Occupational Exposure Assessment (Section 6) in the Revised
Halohydantoins Risk Assessment, dated June 25, 2007, available at http://www.regulations.gov
(EPA-HQ-OPP-2004-0303).

                    a.     Occupational Toxicity

       The toxicological endpoints used in the occupational assessment can be  found in Table 7
above.

                    b.     Occupational Handler Exposure

       EPA has assessed the exposures and risks to occupational workers that handle and apply
halohydantoin in the Occupational Exposure Assessment in the Revised Halohydantoins Risk
Assessment,  dated June 25, 2007, available at http://www.regulations.gov (EPA-HQ-OPP-2004-
0303). This section summarizes the results of the occupational exposure/risk assessment. The
following handler exposure scenarios were assessed and represent high-end exposures to
industrial uses of the formulated product:

       •  Placing the halohydantoin tablets/pellets into cooling and process water systems, and
       •  Pouring halohydantoin granules/powders into a feeder for cooling and process water
          systems.

       These two types of exposure scenarios were assessed for each of the water systems in
question. The methods for applying gels, briquettes, and ready-to-use solutions are nearly
identical to at least one of the two methods described above, based on the directions on the label.
Therefore, although the two exposure scenarios considered include only products that are tablets,
pellets, granules, or  powders, these scenarios should be sufficient to describe the risks associated
with all formulations.

                           i. Industrial Process (Handlers)

        Occupational handler risk estimates have been assessed for halohydantoins using
surrogate unit exposure data from the Chemical Manufacturers Association (CMA) database,
application rates from labels, and EPA  estimates of daily amount handled.  The handlers were
identified as those individuals who use dihalodialkylhydantoin in industrial/commercial water
systems (recirculating cooling water, once-through cooling tower water, pulp and paper process
water, photo processing water, and transportation cleaning systems) to limit microbial growth.
The application rates were assumed to be the maximum rates listed on the product labels. The
amounts of pesticide handled were based on a report containing use information for selected
                                           32

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                                                                     Halohydantoins RED
scenarios related to antimicrobials (Dang, 1996).

       For industrial use, the short- and intermediate-term dermal and inhalation MOEs for the
primary were determined.  Dermal MOEs range from a high of 151,000 for solid pour in photo
processing water systems, to 76 for solid place in once-through cooling tower water systems.
Except for once-through cooling tower water systems, all MOEs are above the target margin of
exposure (100). For more information, see the Revised Halohydantoins Risk Assessment, dated
December 15, 2004, available at http://www.regulations.gov (EPA-HQ-OPP-2004-0303).
Material Preservatives and Commercial/Institutional/Industrial Premises and Equipment and Swimming
Pools

       Use of dihalodialkylhydantoin in a commercial setting is similar in purpose to industrial
use; used to prevent-slime formation in water systems. In addition, it is used as a material
preservative in paints. Six scenarios have been identified to represent potential high-end
exposures for these uses.:

       Liquid pour of product into paint during manufacturing as a material preservative;
       Solid place of product in air conditioner / humidifier drip pans;,
       Solid place of product in ornamental fountains;,
       Solid place of product for use in transportation cleaning water systems;,
       Commercial painters (brush/airless sprayer); and
       Solid place/pour of product in commercial swimming pools and spas.

       The occupational material preservative use assessed for paints is believed to be
representative of the other preservative uses on the labels such as detergents, fabric softeners,
household cleaning products, surfactants, etc.  Therefore, a separate commercial use of household
cleaning products has not been conducted.

       Very little data are available at this time regarding typical amounts of product handled by
workers. For a-workers performing air conditioning maintenance in a large institution, it has been
assumed that 3 air-conditioner units were maintained one day. A large ornamental fountain was
assumed to be the same size as an average residential swimming pool.  Assumptions for the in-
bay car wash are based on information from the International Carwash  Association and from
anecdotal evidence.  The EPA calculated the exposures for workers at a commercial/public
swimming pool, using the assumption that a large commercial/public swimming pool size is
200,000 gallons, and that a large commercial spa's volume is approximately 1000 gallons.

       For commercial uses, the short- and intermediate term dermal MOEs for the handlers
wearing PPE range from 140 to 151,000. An MOE lower than the target MOE was found for
only one scenario; placing tablets into public swimming pools ungloved (MOE=46). However,
the product labels state that gloves should be worn when placing tablets into swimming pools.
When gloves are used risks are mitigated for the placing of tablets  (MOE = 7,500). For more
information, see the Revised Halohydantoins Risk Assessment, dated June 25, 2007, available at
http://www.regulations.gov (EPA-HQ-OPP-2004-0303).

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                                                                    Halohydantoins RED

Metal Workins Fluids

       Potential inhalation and dermal exposures to occupational handlers may exist when using
treated metal working fluid. The Agency conducted the screening level assessment for metal
working fluids using the Chemical Engineering Branch (CEB) model (U.S. EPA, 1991).
Exposure assumptions used in the model are presented in Dang, 1997.  The CEB model uses
measured and/or assumed airborne oil mist concentrations for metal working operations.  Since
no measured concentrations are available for halohydantoins, the high-end oil mist concentration
is based on the OSHA's Permissible Exposure Limit (PEL) of 5 mg/m3 (NIOSH, 1998). The label
indicates that 0.45% (i.e.,  0.0045) of the product is added to metal working fluids and of that,
only 52.4% is the active ingredient.  Therefore, the upper bound air concentration of
halohydantoins that a worker is exposed to is 5 mg/m3 x 0.0045 x 0.524 or an air concentration of
 0.012 mg/m3.  Additionally, the following assumptions were made in the assessment:  the
inhalation rate for adults is 1.25 m3/hr; the exposure duration is 8 hours; and body weight is 70
kg.  Using these assumptions, the long-term dose was calculated to be  0.0017 mg/kg/day,
resulting in a long-term MOE of 59,000.  Therefore, the calculated MOE indicates that the
inhalation risks do not exceed the Agency's level of concern for a  machinist exposure to metal
working fluid that is treated with halohydantoins.

       A screening-level long-term dermal exposure estimate was derived from the 2-Hand
Dermal Immersion in Liquid Model in ChemSTEER (EPA/OPPT). The model is available at
www.epa.gov/opptintr/exposure/docs/chemsteer.htm . The weight fraction of halohydantoin in
metal working fluids is  0.0024 (0.0045 formulated product added to oil x 0.524 ai in formulated
product = 0.0024).  Based on the model for emersion of hands in metal working fluids, the long-
term dermal dose is estimated at 0.3 mg/kg/day. The long-term dermal MOE is 1,300 (i.e.,
dermal NOAEL of 390  mg/kg/day / potential dose of 0.3 mg/kg/day). The dermal MOE is above
the target MOE of 100,  and therefore, the risk is not of concern. For more information, see the
Revised Halohydantoins Risk Assessment, dated June 25, 2007, available at
http://www.regulations.gov (EPA-HQ-OPP-2004-0303).

                        ii.     Agricultural Premises and Aquatic Area Uses (Handlers)

       For occupational handlers, one agricultural premise use and one aquatic area use have
been identified.

              Solid pour/place of product into chemigation systems,
              Solid pour  of product into vehicle and foot baths at greenhouse entrances.

       Use of halohydantoin  in chemigation systems is via loading of a brominator feed system,
through which the product is dispensed via dissolution as feed water is passed through the tank.
The amount of halohydantoin that will be used in the irrigation systems will depend  greatly on the
size of the greenhouse/nursery and the amount of irrigation necessary for the particular
crop/climatic conditions.  The amount of footbaths that should be used for the assessment is  also
in question. From anecdotal evidence, 1 gallon of water is used for each footbath, and 1" of water
use for irrigation can be assumed. It has also been assumed that, for  chemigation, the product

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                                                                     Halohydantoins RED
will be used on 10 acres of crop.  From these assumptions, the total amount of water applied for
chemigation is 270,000 gallons. This scenario is not representative of the available exposure data
and the uncertainty level is deemed high. The exposures maybe overestimated because of the
extrapolation to such a high amount of water applied.  All MOEs calculated are of concern (i.e.,
MOEs less than the target MOE of 100). No postapplication exposures were considered. For
more information, see the Revised Halohydantoins Risk Assessment, dated June 25, 2007,
available at http://www.regulations.gov (EPA-HQ-OPP-2004-0303).

                     c.     Postapplication Exposure (All Occupational Uses)

          Postapplication inhalation exposures may occur in the industrial settings around the
   water systems via inhalation, and dermal exposures may occur while maintaining industrial
   equipment.  However, occupational postapplication dermal and inhalation exposures to
   halohydantoins are likely to be minimal compared to handler exposure because of dilution
   during processing. No postapplication exposures were evaluated for the agricultural premise
   use and aquatic area use as this exposure is anticipated to be negligible. No postapplication
   exposure data have been submitted to the agency to determine the extent of postapplication
   exposures in the industrial settings.  Inhalation exposures are expected to be minimal because
   aerosol generation is not expected and the vapor pressure of dihalodialkylhydantoin is low.

                     d.     Human Incident Data

       Halohydantoins are active ingredients used in a variety of products (e.g. for treatment of
swimming pools, spas and hot tubs, and toilet bowl water). The purpose of this chapter is to
review the evidence of health effects in humans resulting from exposure to Halohydantoins.

       Two approaches are used in this section:

       •   The potential health effects of halohydantoins in humans, reported as incident reports
          from different sources, are summarized.

       •   A literature search of chronic health effects associated with halohydantoin exposure,
          including results of epidemiological studies, is summarized.

       There are many incidences that have been reported associated with exposure to end-use
products containing halohydantoins. Dermal, ocular, and inhalation are the primary routes of
exposure.  Most of the incidences are related to irritation and/or allergic type reaction. The most
common symptoms reported for cases of dermal exposure were skin irritation/burning, rash,
itching, skin discoloration/redness, blistering, allergic  type reactions including hives/welts,
allergic contact dermatitis, and bleeding also have been reported. The most common symptoms
reported for cases of ocular exposure were eye irritation/burning. Eye pain and swelling of eyes
also has been reported in some incidences.
       The most common symptoms reported for cases of inhalation exposure were respiratory
irritation/burning, irritation to mouth/throat/nose, coughing/choking, shortness of breath,
dizziness, flu-like symptoms, and headache. Seizure and heart palpitation also have been


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                                                                      Halohydantoins RED
reported.

       Although oral exposure is considered a minor route of exposure for halohydantoin use,
irritation to mouth/throat/nose, vomiting/nausea/abdominal pain have been reported in the cases
of ingestion.
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                                                                     Halohydantoins RED

       B.     Environmental Risk Assessment

       The following environmental risk characterization is intended to describe the magnitude
of the estimated environmental risks associated with halohydantoins use. For more information,
see the Revised Halohydantoins Risk Assessment, dated June 25, 2007, available at
http://www.regulations.gov (EPA-HQ-OPP-2004-0303).


              1.   Environmental Fate and Transport

       The Agency does not have a complete database for environmental fate studies on
dihalodialkylhydantoin.  However, hydrolysis appears to be the major route for dissipation.
Dihalodialkylhydantoin has been shown to hydrolyze relatively rapidly. It also degrades rapidly
in an anaerobic aquatic environment with an observed half-life of less than 4 hours; there are
indications that this short half-life appeared to be independent of aerobic or anaerobic conditions.
The rapid hydrolysis, under abiotic conditions, show half-lives of less than 30 days in pH 5, pH 7,
and pH 9 (in buffered solutions), which indicated that hydrolysis is an early step in the
degradation process. However, the major degradate, dimethylhydantoin (DMH), was
hydrolytically stable at pH 5, 7, and 9, and may possibly leach in the soil profile or move with
surface water runoff and may pose environmental concerns. An aqueous photolytic study on
dimethylhydantoin, conducted at pH 7 and at 25±1°C in the presence of xenon arc as light source,
yielded a first order rate  constant of 7.89xlO"4/day which translates into a half life of 878 days.
Aqueous photolytic stability means that surface water runoff of DMH can be a source of concern
for drinking water contamination.  The Agency lacks any data on halohydantoins as far as
mobility (soil column leaching) is concerned, as well as binding constants to soils to indicate if
dihalodialklhydantoins will be persistent in soils. Because of lack of data, the Agency cannot
assess if halohydantoins  are bioaccumulative and if these can be potentially a source of concern
for the aquatic organisms.

       Dihalodialkylhydantoin degrades relatively rapidly in water under abiotic conditions.
However, there is environmental concern for soil or surface water contamination from the major
degradate DMH, as DMH is hydrolytically and photolytically stable. DMH is also stable under
aerobic conditions and shows a moderate tendency toward binding with soils (Kd's).  If present in
the environment, it may cause a concern for ground- and surface water contamination.

              2.  Ecological Risk

       Most of the halohydantoins uses are considered indoor uses. However, there is potential
environmental exposure  from the once-through cooling tower use. Halogenated halohydantoins
show varying toxicity, depending on the number of halogens (bromine or chlorine) on the
molecule. The halogens dissociate from the DMH  core upon exposure to water; therefore, DMH
was considered to be the moiety of concern for environmental exposure and ecological toxicity.
A summary of ecotoxicological endpoints for DMH is provided in the Table 15. As indicated in
the table, DMH demonstrates low toxicity to terrestrial and aquatic animals.
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Table 15: Summary of Ecotoxicity Endpoints
                                                                          Halohydantoins RED
Test type
Avian acute oral
(71-1/850.2100)
Avian dietary (71-
2/850.2200)
Avian dietary (71-
2/850.2200)
Freshwater fish
acute
(72-1/850.1075)
Freshwater fish
acute
(72-1/850.1075)
Fish early life-
stage
(72-4/850.1300)
Freshwater
invertebrate acute
(72-2/850.1010)
Marine/estuarine
fish acute
(72-3a/850.1075)
Marine/estuarine
invertebrate acute
(72-3C/850.1045)
Marine/estuarine
bivalve acute
(72-3b/850.1025)
Species
Northern
bobwhite
(Colinus
virginianus
Northern
bobwhite
(Colinus
virginianus)
Mallard (Anas
platyrhynchos)
Rainbow trout
(Oncorhynchus
mykiss)
Bluegill
(Lepomis
macrochirus)
Fathead minnow
(Pimephales
promelas)
Daphnia magna
Sheepshead
minnow
(Cyprinodon
variegatus)
Mysid
(Mysidopsis
bahia)
Eastern oyster
(Crassostrea
virginica)
shell deposition
% a.i.
96
96
97.2
97.1
97.1
99.9
97.1
97.1
97.1
97.2
Endpoint
LD50 = 1839mg/kg
NOEL =1350 mg/kg
LC50 > 5620 ppm
>5000 ppm
NOEC = 5000 ppm
LC50 >972 mg/L
NOEC = 972 mg/L
LC50> 1,017 mg/L
NOEC = 1,017 mg/L
NOEC = 14
mg/L(dry weight)
LOEC = 29 mg/L
EC50 > 1070 mg/L
NOEC = 1070 mg/L
LC50 > 1006 mg/L
NOEC = 1006 mg/L
LC50 > 921mg/L
(limit test)
EC50 > 125 mg/L
NOEC = 125 mg/L
EPA MRID #
147319
147321
432899-03
423736-01
423685-01
427217-02
423736-03
423747-01
423736-02
432899-02
Toxicity
Category
Slightly toxic
Practically non-
toxic
Practically non-
toxic
Practically non-
toxic
Practically non-
toxic
(chronic endpoints
are not assigned a
toxicity category)
Practically non-
toxic
Practically non-
toxic
Practically non-
toxic
Practically non-
toxic
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                                                                    Halohydantoins RED
             3.  Environmental Exposure Modeling
       The PDM4 Model was used to estimate exposure from once-through cooling tower uses.
A low-flow power plant (100+10 million gallons per day) was used as the scenario providing the
maximum concentrations of DMH in the receiving water, e.g., the "worst case" scenario.  Actual
concentrations in receiving waters are likely lower, and will likely not show the increasing trend
indicated in Table 16, due to higher flow rates and possible degradation/dissipation of DMH by
mechanisms other than hydrolysis. Based on the modeling, a summary of the estimated
environmental concentrations (EECs) over time is provided below:

Table 16: Summary of Estimated Environmental Concentrations of DMH in Rivers Receiving
Outfall from Low-Flow Power Plants Using Once-through cooling tower Systems
Time Period Modeled
4 days
30 days
60 days
Peak Concentration of DMH
(EEC)
36.0 ppb
210 ppb
3 13 ppb
Duration of Peak Concentration
24 hours
24 hours
24 hours
The model was also used to determine the percent of days per year various "concentrations of
concern" were exceeded for several power plant scenarios. For more information, see the
Revised Halohydantoins Risk Assessment, dated December 15, 2004, available at
http://www.regulations.gov (EPA-HQ-OPP-2004-0303).
                    a. Terrestrial Organisms:

       No model is available to estimate exposure and risk to birds and mammals from discharge
of once-through cooling tower system effluents into surface waters. The low EECs, coupled with
the generally low toxicity of DMH to birds and mammals, indicate that risks to these organisms
are unlikely. There are no data available to assess the phytotoxicity of DMH at this time;
therefore, the risk to terrestrial/semi-aquatic plants cannot currently be assessed.

                    b. Aquatic Organisms:

       Using the worst-case scenario of a low-flow power plant using halohydantoins for once-
through cooling tower system treatment, the following risk quotients (RQ) were calculated for
aquatic organisms in Table 17.
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                                                                     Halohydantoins RED
Table 17: Aquatic Organism Risk Quotients for DMH Used in Once-through cooling tower of Low-
Flow Power Plants
Endpoint Type
Freshwater Fish
Acute
Freshwater
Invertebrate
Acute
Freshwater Fish
Chronic
Species
Rainbow trout
(Oncorhynchus
mykiss)
Daphnia magna
Fathead minnow
(Pimephales
promelas)
Value
LC50 >972
mg/L
(MRID-
423736-01)
EC50 > 1070
mg/L
NOEC = 1070
mg/L (MRID
423736-03)
NOEC = 14
mg/L
LOEC = 29
mg/L (MRID -
427217-02)
EEC (from Table 16)
36.0 ppb
(0.036 mg/L)
36.0 ppb
(0.036 mg/L)
3 13 ppb
(0.3 13 mg/L)
RQ (EEC/LC50)
0.000037
0.000034
0.022
       Using the very conservative EECs provided by modeling the once-through cooling tower,
no LOCs are exceeded. Expressed as number of days exceedance, using the most sensitive
parameter of 14.0 mg/L (14000 ppb) (freshwater fish chronic NOEC) as the "concentration of
concern" and the exceedance curve generated by modeling, the chance of this concentration being
exceeded by any of the once-through plant scenarios is extremely low, less than once every two
years.  Other uses of halohydantoin products are indoor or contained (e.g., swimming pool) uses,
and should not result in appreciable environmental exposure when products are used as labeled.
As indicated in Table 16 above, risks to freshwater fish and aquatic invertebrates are not
anticipated from the use of halohydantoins in once-through cooling tower systems as the RQs do
not exceed the Agency's level of concern.  Marine/estuarine fish are generally less sensitive than
freshwater fish to halohydantoins, and marine/estuarine invertebrates are comparably as sensitive
to DMH as freshwater invertebrates. Therefore, the freshwater RQs are presumed to be protective
of marine/estuarine species.  Risks to aquatic plants cannot be assessed due to the lack of
phytotoxicity data.
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                                                                         Halohydantoins RED
              4.  Listed Species Consideration

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

       For certain use categories, the Agency assumes there will be minimal environmental exposure,
and only a minimal toxicity data set is  required (Overview of the Ecological Risk Assessment Process
in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section II B, 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.  Based on low toxicity and the use of halohydantoins products
low exposure, risk to endangered birds and mammals is not anticipated. Calculated RQs for fish and
aquatic invertebrates from the once-through cooling tower use are well below LOCs for Endangered
species; other uses of halohydantoin products are indoor or contained (e.g., swimming pool) uses, and
should not result in appreciable environmental exposure when products are used as labeled. Therefore,
risk to Endangered fish and aquatic invertebrate species is not anticipated from the use of
halohydantoin products. Risk to Endangered plants cannot be addressed due to the lack of
phytotoxicity data.
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                                                                      Halohydantoins RED
   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 reregi strati on.  The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing halohydantoins as active ingredients. The Agency has completed its
review of these generic data, and has determined that the data are sufficient to support
reregi strati on of all supported products containing halohydantoins.

       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
halohydantoins. Based on a review of these data and on public comments on the Agency's
assessments for the active ingredient halohydantoin, the Agency has sufficient information on the
human health and ecological effects of halohydantoins to make decisions as part of the tolerance
reassessment process under FFDCA and reregi strati on process under FIFRA, as amended by
FQPA. The Agency has determined that products containing halohydantoins are eligible for
reregi strati on provided that: (i) current data gaps and confirmatory  data needs are addressed; (ii)
the risk mitigation measures outlined in this document are adopted; and (iii) label amendments
are made to reflect these measures. Label changes are described in Section V.  Appendix A
summarizes the uses of halohydantoins that are eligible for reregi strati on. Appendix B identifies
the generic data requirements that the Agency reviewed as part of its determination of
reregi strati on eligibility of halohydantoins 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.

       Based on its evaluation of halohydantoins, the Agency  has determined that halohydantoins
products, unless labeled and used as specified in this document, would present risks inconsistent
with FIFRA.  Accordingly, should a registrant fail to implement any of the risk mitigation
measures identified in this document, the Agency may take regulatory action to address the risk
concerns from the use of halohydantoins. If all changes outlined in this document are
incorporated into the product labels, then all current risks for halohydantoins will be substantially
mitigated for the purposes of this determination.

       B.     Public Comments and Responses

       Through the Agency's public participation process, EPA worked with stakeholders and the
public to reach the regulatory decisions for halohydantoins. During the public comment period on the
risk assessments, which closed on September 29, 2004, the Agency received comments from the ACC
Brominated Biocides Panel and other interested parties.  These comments in their entirety are
available in the public docket; http://www.regulations.gov (EPA-HQ-OPP-2004-0303). The Agency's
responses to these comments are incorporated into  the revised risk assessment, which is also available
in the public docket.
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                                                                     Halohydantoins RED
       C.    Regulatory Position

             1.     Food Quality Protection Act (FQPA) Considerations

                    a.     "Risk Cup" Determination

       As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with this pesticide. The Agency has concluded that the tolerance exemption for halohydantoins
meets the FQPA safety  standards and that the risk from dietary (food sources only) exposure is
within the "risk cup." An aggregate assessment was conducted for exposures from food and
residential use.  The Agency has determined that the human health risks from these combined
exposures are within acceptable levels provided that the mitigation contained in this document is
implemented. 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, water and
residential exposures.

                    b.     Determination of Safety to U.S. Population

       As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with halohydantoins. The Agency has determined that, the established tolerance exemptions for
halohydantoins with amendments and changes as specified in this document, meet 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
halohydantoins.  In reaching this conclusion, the Agency has considered all available information
on the toxicity, use practices and exposure scenarios, and the environmental behavior of
halohydantoins.  As discussed in Section III, the acute and chronic dietary (food and drinking
water) risks from halohydantoins are below the Agency's level of concern.

                    c.     Determination of Safety to Infants and Children

       EPA has determined that the tolerance exemptions for halohydantoins meet the safety
standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is a
reasonable certainty of no harm for infants and children. The safety determination for infants and
children considers toxicity, use practices, and environmental behavior noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the
specific consumption patterns of infants and children, as well as the possibility  of increased
susceptibility to the toxic effects of halohydantoins in this population subgroup.

       In determining whether infants and children are particularly susceptible to toxic effects
from exposure to residues of halohydantoins, the Agency considered the completeness  of the
hazard database for developmental and reproductive effects, the nature of the effects observed,
and other information.  On the basis of this information, the FQPA safety factor has been reduced

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                                                                    Halohydantoins RED
to IX for halohydantoins. The rational for the decisions are based on:  the developmental
endpoint is sufficiently protective of effects that may occur in infants and children from exposure
to dimethylhydantoin. Even though, there is quantitative evidence of increased sensitivity of
neonatal rabbits, the Agency considered this effect not indicative of susceptibility, based upon:
(1) the very high dose level at which the effect occurred; (2) the minimal nature of the effect and
(3) the likelihood that the effect was due to a greater dose received by pups from ingestion of both
milk and feed during the lactation period.

                    d. Endocrine Disrupter Effects

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

      When the appropriate screening and/or testing protocols being considered under the
Agency's Endocrine Disrupting Screening Program (EDSP) have been developed, halohydantoins
may be  subjected 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
halohydantoins. 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
halohydantoins. 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

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                                                                     Halohydantoins RED
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

       No pesticide tolerances have been established for the halohydantoins. The Agency has
determined that, the established tolerance exemptions for halohydantoins with amendments and
changes as specified in this document, meet 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 halohydantoins.
             3.     Codex Harmonization

       No CODEX maximum residue levels (MRLs) have been established for halohydantoins.


       D.    Regulatory Rationale

       The Agency has determined that the halohydantoins are eligible for reregi strati on
provided that additional required data confirm this decision, the risk mitigation measures outlined
in this document are adopted, and label amendments are made to reflect these measures.

       The following is a summary of the rationale for managing risks associated with the use of
halohydantoins.  Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V of this document.

             1.     Human Health Risk Management

                    a.      Dietary (Food) Risk Mitigation

       Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does
not exceed the Agency's risk concerns. For all supported uses, acute and chronic dietary risk
estimates are not of concern.  Therefore, no risk mitigation measures are required.

                    b.     Drinking Water Risk Mitigation

       Based on modeling, the once-through cooling tower use of the halohydantoins is not likely
to result in risks to drinking water. Therefore, no risk mitigation is required.


                    c.      Residential Risk Mitigation

       Residential risks for handlers were calculated for short- and intermediate-term dermal and
inhalation exposures. For all supported uses, residential exposure risk estimates are not of

                                          45

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                                                                     Halohydantoins RED
concern.  However, as formaldehyde is a metabolite of dihalodialkylhydantoins, there may be risk
associated with this exposure, particularly for use of products that produce a greater chance of
inhalation exposure to formaldehyde, such as air fresheners. Risks associated with the exposure to
formaldehyde via the hydroxymethylhydantoins will be addressed when registration review is
conducted on hydroxymethylhydantoin. Therefore, no risk mitigation measures are necessary.

                    d.     Occupational Risk Mitigation

                           i.      Handler Mitigation

Dermal and Inhalation Risk for Agricultural Premises

       Dermal and inhalation risk concerns have been identified for occupational handlers
treating agricultural premises. All MOEs calculated are of concern  (i.e. scenarios are of concern
with MOEs less than the target MOE of 100). No postapplication exposures were considered.


       To reduce occupational exposure, the following label language will be required:

              •   For irrigation/chemigation rates that are greater than 35,000 gallons per day,
                 applicators must use "solid pour." For smaller applications less than 35,000
                 gallons per day, applicators can "place" the solids.
              •   Confirmatory exposure data will be required

Dermal Risk for Swimming Pools

       Occupational risks of concern were identified for handlers placing tablets into public
swimming pools ungloved (MOE=46). However, the product labels state that gloves should be
worn when placing tablets into swimming pools. When gloves are used for the placing of tablets
the MOE is not of concern (MOE = 7,500).  The risk will be mitigated by requiring the use of
gloves.

Once-through Cooling Tower

       Occupational risks of concern were identified for handlers applying halohydantoins to
once-through cooling towers.  To reduce exposure and mitigate risks, handlers will be required to
use gloves when applying these products to once-through cooling towers.

                           ii.     Post-Application Risk Mitigation

       Post-application inhalation exposures may occur in the industrial settings around the water
systems via inhalation. Dermal exposures may occur while maintaining industrial equipment.
However, occupational postapplication dermal and inhalation exposures to
dihalodialkylhydantoin are likely to be minimal compared to handler exposure because of dilution

                                           46

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                                                                      Halohydantoins RED
during application. No exposure data has been submitted to the Agency to determine the extent
of post-application exposures in the industrial settings. Inhalation exposures are expected to be
minimal because aerosol generation is not expected and the vapor pressure of
dihalodialkylhydantoin is low. The Agency does not believe that any mitigation is necessary at
this time.

              2.      Environmental Risk Management

       Most of the halohydantoins uses are considered indoor uses. However, there is potential
environmental exposure from the once-through cooling tower use.  Risks to freshwater fish and
aquatic invertebrates are not anticipated from the use of halohydantoins in once-through cooling
tower systems as the RQs do not exceed the Agency's level of concern. Marine/estuarine fish are
generally less sensitive than freshwater fish to halohydantoins, and marine/estuarine invertebrates
are comparably as sensitive to DMH as freshwater invertebrates. No risk mitigation is required.

              3.      Other Labeling Requirements

       In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing halohydantoins.  For the specific
labeling statements and a list of outstanding data, refer to Section V of this RED document.
              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

                                            47

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                                                                     Halohydantoins RED
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.

       For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and 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. The current active
ingredient uses of halohydantoins fall into this category.  Risks to endangered birds and mammals
are not anticipated from the use of hydantoin products due to low exposure and low toxicity.
Calculated RQ's for fish and aquatic invertebrates from the once-through cooling tower use are
well below LOCs for endangered species; other use of hydantoin products are indoor or contained
(e.g., swimming pool) uses, and should not result in appreciable environmental exposure when
products  are used as labeled. Therefore, risk to endangered fish and aquatic invertebrate species is
not anticipated from the use of hydantoin products. Risk to endangered plants cannot be
addressed due to the lack of phytotoxicity data.
                                           48

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                                                                    Halohydantoins RED
V.     What Registrants Need to Do
       The Agency has determined that halohydantoins are eligible for reregi strati on provided
that: (i) additional data that the Agency intends to require confirm this decision; and (ii) the risk
mitigation measures outlined in this document are adopted, and (iii) label amendments are made
to reflect these measures.  To implement the risk mitigation measures, the registrants must amend
their product labeling to incorporate the label statements set forth in the Label Changes Summary
Table in Section B below (Table 17). The additional data requirements that the Agency intends to
obtain will include, among other things, submission of the following:

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

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

       1.  completed response forms to the generic DCI (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 generic DCI:

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

Please contact ShaRon Carlisle at (703) 308-6427 with questions regarding generic reregi strati on.
By US mail:
Document Processing Desk (DCI/AD)
(DCI/AD)
ShaRon Carlisle
US EPA (751 OP)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
       Document Processing Desk

ShaRon Carlisle
Office of Pesticide Programs (751 OP)
One Potomac Yard (South Building),
2777 South Crystal Drive
Arlington, VA 22202
                                          49

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                                                                    Halohydantoins RED

For end use products containing the active ingredient halohydantoins, 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 reregi strati on (EPA Form 8570-1). Indicate on the
       form that it is an "application for reregi strati on";

       3. five copies of the draft label incorporating all label amendments outlined in Table 13 of
       this document;

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

       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 Emily Mitchell at (703) 308-8583 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:

By US mail:                                   By express or courier service:
Document Processing Desk (PM-32)              Document Processing Desk (PM-32)
Emily Mitchell                                        Emily Mitchell
US EPA (751 OP)                               Office of Pesticide Programs (751 OP)
1200 Pennsylvania Ave., NW                   One Potomac Yard (South Building),
Washington, DC 20460                         2777 South Crystal Drive
                                              Arlington, VA 22202
                                          50

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                                                                      Halohydantoins RED
       A.     Manufacturing Use Products

                     1.     Additional Generic Data Requirements

       The generic database supporting the reregi strati on of halohydantoins 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 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.

       The following ecological  effects data are required to support the once through cooling
tower system uses for halohydantoin products:

              •  72-4/850.1400 Aquatic invertebrate life-cycle test with DMH
In addition, the following phytotoxicity studies are needed to address the Endangered Species Act
identified by the Agency:
              •   122-1 Seedling emergence/vegetative vigor in rice (at 1 ppm DMH, mixed in the soil
                 and applied to the foliage in the same test)
              •   122-2 Tier I Aquatic plant toxicity using Lemna sp. (at 1 ppm DMH)
              •   122-2 Tier 1 Algal toxicity using the green alga Selenastrum capricornutum (at
                 1 ppm DMH)

       Reserved data requirements (pending the results of the plant tests described above):
              •   123-1/850.4225 and 850.4250 Tier II (dose-response) seedling
                 emergence/vegetative vigor with rice
              •   123-2/850.4400 Tier II (dose-response) aquatic plant toxicity using Lemna sp.
              •   123-2/850.5400 Tier II (dose-response) algal toxicity, 4 species (green alga,
                 freshwater diatom, marine diatom, and blue-green cyanobacteria)
                                           51

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                                                                    Halohydantoins RED
Table 18. Confirmatory Data Requirements for Reregistration
Guideline Study Name
Dermal Indoor Exposure
Inhalation Indoor Exposure
Descriptions of Human Activity
Aquatic invertebrate life-cycle test with DMH
Seedling emergence/vegetative vigor in rice (at 1 ppm DMH,
mixed in the soil and applied to the foliage in the same test)
Tier I Aquatic plant toxicity using Lemna sp. (at 1 ppm DMH)
Tier 1 Algal toxicity using the green alga Selenastrum
capricornutum (at 1 ppm DMH)
New OPPTS
Guideline No.
875.1200,875.1600
875.1400,875.1600
875.2800
850.1400



Old Guideline No.
233 and 236
234 and 236
133-1
72-4
122-1
122-2
122-2
Studies Held in Reserve
Tier II (dose-response) seedling emergence/vegetative vigor
with rice
Tier II (dose-response) aquatic plant toxicity using Lemna sp.
Tier II (dose-response) algal toxicity, 4 species (green alga,
freshwater diatom, marine diatom, and blue-green
cyanobacteria)
850.4225 and
850.4250
850.4400
850.5400
123-1
123-2
123-2
                    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 19, 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
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 follow this
                                          52

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                                                                     Halohydantoins RED
RED.be sent to the registrants at a later date. The PDCI will be based upon current efficacy-
related requirements for antimicrobial pesticide products, claims, or use patterns.
              2.     Labeling for End-Use Products

       Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 19.

       Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on 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 mitigation 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.
                                           53

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                                                                                                          Halohydantoins RED
             a.     Label Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The
following table describes how language on the labels should be amended.


Table 19.  Labeling Changes Summary Table
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Product
Supported Use Sites
"Only for formulation into antimicrobial products for use in: agricultural/farm premises,
structures, buildings, and equipment; dairy farm milk handling facilities, equipment, storage
rooms, houses, and sheds; food processing plants, food handling, food distribution equipment
and premises; eating establishments premises and equipment; commercial, institutional, and
industrial premises and equipment (floors, walls, storage areas); domestic dwellings, food
handling areas, indoor premises; and medical institutional critical care and non-critical care
premises, human water systems, swimming pools and industrial processes and water systems."
For Formulation into antimicrobial products for use in: animal transportvenides, carpets,
fountains/water displays/decorative ponds/, once- through and recirculatingjncjustrial
commercial cooling water systems, pulp/paper mill water systems, and swimming pools,
mushroom facilities/premises and equipment, egg handling equipment and rooms, egg washing
treatment, chick room, poultry houses chiller water/carcass spray, food processing
plants/equipment, dairies/breweries and bottling plants/equipment, fruit and vegetable
rinse/process water and tank lines, potable drinking water, water storage systems (aircrafts
boats, RVs, off-shore oil rigs), water filtration systems, ventilation systems.
Directions for Use
End Use Products Intended for Occupational Use
                                          54

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                                                                                                                             Halohydantoins RED
         Description
                            Amended Labeling Language
 Placement on Label
Application Restrictions-For
Occupational Handler -Dermal
(Tablets into public swimming
pools)
"Must wear chemical resistant gloves while placing the tablet in the swimmingp00i"
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
(Immediately
Following Engineering
Controls
Application Restrictions-For
Occupational Handler -Dermal
(Once through cooling tower -
"solid place ")
"Must wear chemical resistant gloves while placing the tablet in the once through cooling tower
system"
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
(Immediately
Following Engineering
Controls
Application Restrictions-For
Residential Handler -Dermal
(Tablets into public
swimmingpools)
"Must wear chemical resistant gloves while placing the tablet in the swimmingp00i/Spas"
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
(Immediately
Following Engineering
Controls
                                                 55

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                                                                                                                               Halohydantoins RED
         Description
                             Amended Labeling Language
 Placement on Label
Application Restrictions-For
Occupational Handler
(Greenhouse Irrigation)
1)  Must have label language that states for application rates greater than 35, 000 gallons per
    day applicators must use "solid pour" and for smaller applications less than 35,000 gallons
    per day, applicators can must "place solids" into a metered feeding system

2)  "Occupational handler must wear chemical resistant gloves while placing granules and
    tablets in nursery and greenhouse irrigation systems"
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
(Immediately
Following Engineering
Controls
                                                 56

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                                  Halohydantoins RED
  VI. APPENDICES
57

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                                                                                                             Halohydantoins RED
                                                   Halohydantoins Appendix A
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
Residential and public access premises
Hard non-porous non-food
contact surfaces, such as
bathrooms, flooring, walls,
garbage cans. Etc.	
6836-324
(soluble
solid)
Spray, brush,
mop or sponge
Igram of product per 7.8
gallons of water. preclean
areas. 10 minute contact
time.
Avoid breathing spray.
Kennels
6836-324
(soluble
solid)
Spray, brush,
mop or sponge
1 gram of productper  7.8
gallons of water. Preclean
areas. 10 minute contact
time.
Avoid breathing spray.
In- Tank- Sanitizer
777-106
777-107
5185-446
5185-469
5813-65
5813-66
6836-255
6836-256
6836-263
6836-264
6836-265
6836-272
6836-273
6836-274
6836-275
6836-279
Place tablet in
tank
                                                         Clean toilet bowl
                                                         thoroughly and flush the
                                                         toilet. When water level is
                                                         low and valve closed, place
                                                         tablet into the right corner
                                                         of the tank. When tablet
                                                         dissolved replace it with a
                                                         new tablet. Tablets should
                                                         be used in toilets flushed
                                                         daily.
                           Do not touch tablet directly. Wash hands
                           thoroughly if there is any skin contact.
                                           58

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Halohydantoins RED
Use Site








In Tank Sanitizer/Necktie








Reg. no./
Formulatio
n
6836-287
6836-288
6836-291
6836-299
6836-300
(Tablet)
5813-84
(Tablet)







Method of
Application







Place tablet in
tank







Application Rate/ No. of
applications







Clean toilet bowl
thoroughlyincludmg under
rim. Flush toilet and
remove toilet tank lid.
Hang unit(s) on toilet tank
wall with tablet holder on
inside of tank and
fragrance gel (holder) on
the outside of the tank.
Use Limitations








Immediately wash your hands after handling
unit.







Industrial Process and Water Systems
Air Gas Scrubber Systems







3377-62
3377-71
(Ready to
Use)




Open
Pour/Ready to
Use





Initial Dose: When system
is noticeably fouled add
product to achieve a
residual bromine level of
0.5-5ppmor as needed to
maintain control. Repeat
until control is achieved.
Subsequent Dose: When
None listed.







59

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                                                                                                            Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         microbial control is evident
                                                         apply product to achieve a
                                                         residual bromine level of
                                                         0.5-5ppmor as needed to
                                                         maintain control.
Pulp and Paper Systems
Pulp and Paper Systems
1448-356
1448-428
5785-63
6836-282
63838-4
75361-1
83451-4
(Tablet)
6836-297
(Tablet)
                           1448-420
                           3377-62
                           3377-63
                           3377-71
                           5785-57
Place tablet in
the system at a
point where
sufficient
mixing can
occur
When system is noticeably
fouled add at a of 12^o 20
ppm
When biological control is
evident: 12 to 90 ppm.
0.5-2.0 Ibs of product per
ton.
Do not exceed 2.21bs of thisproc[uct per
metric ton fiber when this product is used in
the manufacture of paper and paperboard
products that contain food.
Place tablet in
the system at a
point where
sufficient
mixing can
occur
0.5-2.0 Ibs of product per
ton. To produce 0.1-1.0
ppm of available halogen
as chlorine.
May be used in the manufacture of food
contact paper and paperboard products.
             Open
             Pour/ready to
             use
                 When systemis noticeably
                 fouled add at a rate of 0.5
                 to 120ppm. When
                 biological control is
                 evident add at a rate of 12
                           Do not exceed 1.0 kilograms per 1,000kg per
                           dry metric ton fiber in paper and paperboard
                           components that contact food.
                                           60

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                                                                                                  Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  (Ready to
                  Use)
                             to 90 ppm.
                  8622-29
                  83451-3
                  5785-65
                  (Granular)
             Open
             Pour/Granules
               When system is noticeably
               fouled add 12 to 20 ppm.
               When biological control is
               evident add 12 to 90 ppm.
                         Used in the manufacture of paper and
                         paperboard products that does not contact
                         food.
                  8622-28
                  (wettable
                  powder)
             Open
             Pour/Powder
               When systemis noticeably
               fouled add 12 to 20 ppm.
               When biological control is
               evident add 12 to 90 ppm.
                          Used in the manufacture of paper and
                          paperboard products that do not contact food
                  83451-10
                  (Soluble
                  Concentrate
             Open
             Pour/Soluble
             Concentrate
               When systemis noticeably
               fouled add 28.8 to 288ppm.
               When biological control is
               evident add 28.8 to 216
               ppm.
                         Used in the manufacture of paper and
                         paperboard products that does not contact
                         food.
                  83451-11
                  (Gel)
             Open Pour/Gel
               When system is noticeably
               fouled add 32.9 to 329ppm.
               When biological control is
                          Used in the manufacture of paper and
                          paperboard products that contact food.
                                  61

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                                                                                                              Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
   Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         evident add 32.9 to 247
Paper and Paperboard
Process Water
(Continued)
6836-113
6836-115
6836-314
(Tablet)
Place tablet in
system
Initial Dose: When system
is noticeably fouled apply
0.5to2.01bsperton0f
paper produced to achieve
0.1- 1.0 ppm total available
halogen as chlorine. Repeat
treatment until residual is
achieved.

Subsequent Dose: When
microbial control isevident
apply 0.5-2.0 Ibs perton of
paper produced toachieve
0.1-1.0 ppmtotai available
halogen as chlorine. Repeat
periodically as needed to
maintain control.
None listed
                           6836-317
                           (Tablet)
             Place tablet in
             system
                 Initial Dose: When system
                 is noticeably fouled apply
                 0.1-lOlbs of tablets to
                 1,000 gallons (0.1 to 1.0
                 Ibs of tablets per dry metric
                 ton of paper produced)
                 Repeat treatment until
                 residual of up to 5 ppm
                 bromine is achieved.
                           None listed.
                                            62

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                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Paper and Paperboard
Process Water
(Continued)
                              Subsequent Dose: When
                              microbial control is evident
                              apply 0.1 to 0.75 Ibs of this
                              product to 1,000 gallons of
                              water. (0.1 to 0.75 Ibs of
                              tablets per dry metric ton
                              of paper produced). Repeat
                              treatment until achieve 0.1-
                              1.0ppmtotai available.
                              Repeat treatment until
                              residual of up to 1 ppm is
                              achieved.
                           83451-10
                           (Soluble
                           Concentrate
             Open
             Pour/Soluble
             Concentrate
               Initial Dose: When system
               is noticeably fouled add
               0.0238 to 0.238 gallons to
               1,000 gallons of water in
               the system.

               Subsequent Dose: When
               biological control is
               evident add 0.0238 to
               0.179 gallons to 1,000
               gallons of water in the
               system.
                          None listed.
                                           63

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                                                                       Halohydantoins RED
Use Site
Paper and Paperboard
Process Water
(Continued)
Reg. no./
Formulatio
n

6836-237
6836-280
6836-281
6836-296
(Granular)
6836-312
6836-315
6836-319
Method of
Application

Open
Pour/Granules
Open Pour/
Powder
Application Rate/ No. of
applications

Initial Dose: When
system is noticeably fouled
apply 0.5-2.01bs perton of
paper produced to achieve
0.1-1.0 ppm total available
halogen as chlorine. Repeat
treatment until residual is
achieved.
Subsequent Dose: When
microbial control isgyident
apply 0.5-2.0 Ibs perton of
paper produced toachieve
0.1-1.0ppmtotai available
halogen as chlorine. Repeat
periodically as needed to
maintain control.
Initial Dose: When system
is noticeably fouled apply
0.1-2.01bs perton of paper
Use Limitations

None listed.
None listed.
64

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                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                           (Wettable
                           Powder)
                              produced toachieye 0.1-
                              1.0 ppm total available
                              halogen as chlorine. Repeat
                              treatment until residual is
                              achieved.
                                                         Subsequent Dose: When
                                                         microbial control is evident
                                                         apply 0.1-2.0 Ibs per ton of
                                                         paper producedto achieve
                                                         0.1-1.0 ppmtotai available
                                                         halogen as chlorine. Repeat
                                                         periodically  as needed to
                                                         maintain control.
Pasteurizer, Can Warmer,
Cannery, Retort Water
Systems
1448-356
1448-428
5185-420
69681-16
83451-4
(Tablet)
Place tablet in
system
Initial Dose: When the
system is noticeably fouled
add 0.2 to 0.6 pounds
/1,000 gallons. Repeat in 1
to 3 ppm bromine residual
is established for at least 4
hours.

Subsequent Dose: When
control is evident add 0.1
to 0.3 pounds 71,000
None listed.
                                           65

-------
                                                                                                            Halohydantoins RED
         Use Site
  Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         gallons. Repeat as needed
                                                         to maintain 1 to 3 ppm
                                                         bromine residual for at
                                                         least 4 hours.
Pasteurizer, Can Warmer,
Cannery, Retort Water
Systems
(Continued)
1448-420
(Ready to
Use)
Open
Pour/Ready to
Use
Initial Dose: When the
system is noticeably fouled
add 0.2 to 0.6 pounds
/1,000 gallons. Repeat in 1
to 3 ppm bromine residual
is established for at least 4
hours.

Subsequent Dose: When
control is evident add 0.1
to 0.3 pounds/1,000
gallons. Repeat as needed
to maintain 1 to 3 ppm
bromine residual for at
least 4 hours.
None listed
                           83451-3
                           (Granular)
             Open
             Pour/Granules
                 Initial Dose: When the
                 system is noticeably fouled
                 add 0.2 to 0.6 pounds	
                           None listed.
                                           66

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                         /I,000 gallons. Repeat in 1
                                                         to 3 ppm bromine residual
                                                         is established for at least 4
                                                         hours.

                                                         Subsequent Dose: When
                                                         control is evident add 0.1
                                                         to 0.3 pounds A,000
                                                         gallons. Repeat as needed
                                                         to maintain 1 to 3 ppm
                                                         bromine residual for at
                                                         least 4 hours.
                           83451-10
                           (Soluble
                           Concentrate
             Open Pour/
             Soluble
             Concentrate
Pasteurizer, Can Warmer,
Cannery, Retort Water
Systems
(Continued)
               Initial Dose: When the
               system is noticeably fouled
               add 0.0477 to 0.143
               gallons /1,000 gallons of
               water. Repeat in 1 to 3 ppm
               bromine residual is
               established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add
               0.0238 to 0.072 gallons
               /1,000 gallons. Repeat as
               needed to maintain 1 to 3
               ppm bromine residual for
               at least 4 hours
                          None listed.
                                           67

-------
                                                                                                    Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  83451-12
                  (Ready to
                  Use)
             Open Pour/
             Ready to Use
               Initial Dose: When the
               system is noticeably fouled
               add 0.2 to 0.6 pounds
               /1,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add 0.1
               to 0.3 pounds 71,000
               gallons. Repeat as needed
               to maintain 1 to 3 ppm
               bromine residual  for at
               least 4 hours.
                          None listed.
                  83451-11
                  (Gel)
             Open
             Pour/Ready to
             Use
               Initial Dose: When the
               system is noticeablyfouie(j
               add 0.0545 to 0.1634
               gallons /1,000 gallons of
               water. Repeat in 1 to 3 ppm
               bromine residual is
               established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add
               0.0272 to 0.0823 gallons
               /I, OOP gallons of water.
                          None listed.
                                  68

-------
                                                                                                            Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                        Repeat as needed to
                                                        maintain 1 to 3 ppm
                                                        bromine residual for at
                                                        least 4 hours
Evaporative Cooler
Evaporative Cooler
(Continued)
1448-356
1448-428
5785-63
5785-100
5185-420
69681-16
75361-1
83451-4
(Tablet)
                           1448-420
                           83451-12
                           (Ready to
                           Use)
Place tablet in
system
Initial Dose: When the
system is noticeably fouled
ass 0.2 to 0.6 pounds
/1,000 gallons. Repeat in 1
to 3 ppm bromine residual
is established for at least 4
hours.

Subsequent Dose: When
control is evident add 0.1
to 0.3 pounds /1,000
gallons. Repeat as needed
to maintain 1103 ppm
bromine residual for at
least 4 hours.
None listed.
             Open
             Pour/Ready to
             Use
                 Initial Dose: When the
                 systemjg noticeably fouled
                 add 0.2 to 0.6 pounds
                 /1,000 gallons. Repeat in 1
                 to 3 ppm bromine residual
                 is established for at least 4
                 hours.

                 Subsequent Dose: When
                          None listed.
                                           69

-------
                                                                                                            Halohydantoins RED
         Use Site
  Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
Use Limitations
                                                         control is evident add 0.1
                                                         to 0.3 pounds 71,000
                                                         gallons. Repeat as needed
                                                         to maintain 1 to 3 ppm
                                                         bromine residual for at
                                                         least 4 hours
                           83451-12
                           (Wettable
                           Powder)
             Open
             Pour/Powder
                 Initial Dose: When the
                 system is noticeably fouled
                 add 0.2 to 0.6 pounds
                 71,000 gallons. Repeat in 1
                 to 3 ppm brominej-esidual
                 is established for at least 4
                 hours.
                 Subsequent Dose: When
                 control is evident add 0.1
                 to 0.3 pounds 71,000
                 gallons. Repeat as needed
                 to maintain 1 to 3 ppm
                 bromine residual for at
                 least 4 hours
Evaporative Cooler
(Continued)
83451-10
(Ready to
Use)
Open
Pour/Ready to
Use
Initial Dose: When system
is noticeably fouled add
0.0477 to 0.143
gallons/1,000 gallons of
water in the system. Repeat
initial dose until 1 to 3 ppm
bromine residual is
established for at least 4
                                                                                   None listed.
                                           70

-------
                                                                                                     Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                 hours.
                                                 Subsequent Dose: When
                                                 microbial control is evident
                                                 add 0.0238 to 0.072
                                                 gallons/1,000 gallons of
                                                 water in the system. Repeat
                                                 as needed to maintain 1 to
                                                 3 ppm bromine residual for
                                                 at least 4 hours.
                  75361-1
                  (Tablet)
             Place tablet in
             the system
               Place tablets into
               condensate line dispenser
               or floatation device into
               reservoir. Maintain 1 to 4
               ppm activebro mine.
                          Do not place tablet on metal surfaces.
                  83451-3
                  (Granular)
             Open
             Pour/Granules
               Initial Dose: When the
               system is noticeably fouled
               add 0.2 to 0.6 pounds
               /1,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
               hours.
                                                 Subsequent Dose: When
                                                 control is evident add 0.1
                                                 to 0.3 pounds 71,000
                          None listed.
                                   71

-------
                                                                                                            Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
Use Limitations
                                                         gallons. Repeat as needed
                                                         to maintain 1 to 3 ppm
                                                         bromine residual for at
                                                         least 4 hours.
                           83451-11
                           (Gel)
             Open Pour/Gel
                 Initial Dose: When the
                 system is noticeably fouled
                 add 0.0545 to 0.1634
                 gallons /1,000 gallons of
                 water. Repeat in 1103 ppm
                 bromine residual is
                 established for at least 4
                 hours.
                                                         Subsequent Dose: When
                                                         control is evident add
                                                         0.0272 to 0.0823 gallons
                                                         /1,000 gallons of water.
                                                         Repeat as needed to
                                                         maintain 1 to 3 ppm
                                                         bromine residual for at
                                                         least 4 hours
                           None listed.
Recirculating Cooling
Water
1448-356
1448-428
5185-420
Place tablet in
system.
Initial Dose: When the
system is noticeably fouled
ass 0.2 to 0.6 pounds	
                                           None listed
                                           72

-------
                                                                       Halohydantoins RED
Use Site

Reg. no./
Formulatio
n
5185-421
5785-63
5785-100
63838-4
6836-314
6836-315
6836-317
69681-16
83451-4
(Tablet)
8622-77
63838-7
(powder)
1448-420
(Ready to
Use)
Method of
Application


Open
Pour/Ready to
Use
Application Rate/ No. of
applications
71, 000 gallons. Repeat in 1
to 3 ppm bromine residual
is established for at least 4
hours.
Subsequent Dose: When
control is evident add 0. 1
to 0.3 pounds 71,000
gallons. Repeat as needed
to maintain 1 to 3 ppm
bromine residual for at
least 4 hours
Initial Dose: When the
system isnoticeably fouled
add 1.7to6.0pouncjs
71 0,000 gallons. Repeat
until 1 ppm bromine
residual is established for
at least 4 hours.
Subsequent Dose: When
control is evident add 0.8
to 3.0 pounds 710,000
gallons. Repeat as needed
to maintain l-3ppm
bromine residual for at
least 4 hours
Initial Dose: When the
system is noticeably fouled
add 0.2 to 0.6 pounds
Use Limitations


None listed.
73

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Recirculating Cooling
Water (Continued)
                              /I,000 gallons. Repeat in 1
                              to 3 ppm bromine residual
                              is established for at least 4
                              hours.

                              Subsequent Dose: When
                              control is evident add 0.1
                              to 0.3 pounds /I,000
                              gallons. Repeat as needed
                              to maintain 1 to 3 ppm
                              bromine residual for at
                              least 4 hours
                           8622-30
                           (Tablet)
             Place tablet in
             system
               Initial Dose: When system
               is noticeably fouled, add
               0.75 to 6.0 lbs/1000
               gallons of water. Repeat in
               dosage until one ppm
               halogen residual, measured
               as free chlorine for at least
               4 hours.
                                                         Subsequent Dose: When
                                                         system is noticeably
                                                         fouled, add 0.1 to 3.0
                                                         lbs/1000 gallons of water.
                                                         Repeat as needed to
                                                         maintain one ppm halogen
                          None listed.
                                           74

-------
                                                                       Halohydantoins RED
Use Site



Recirculating Cooling
Water
(Continued)

Reg. no./
Formulatio
n


5785-62
66397-1
75361-1
8622-73
(Tablet)



5785-69
Method of
Application


Place tablet in
system




Place tablet in
Application Rate/ No. of
applications
residual, measured as free
chlorine for at least 4
hours.
Initial Dose: When system
is noticeably fouled, add
0.75 to 6.0 lbs/1000
gallons of water. Repeat in
dosage until one ppm
halogen residual, measured
as free chlorine for at least
4 hours.
Subsequent Dose: When
system is noticeably
fouled, add 0.1^o 3 Q
lbs/1000 gallons of water.
Repeat as needed to
maintain one ppm halogen
residual, measured as free
chlorine for at]e ast 4
hours.
Initial Dose: When system
Use Limitations


None listed.




None listed.
75

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                           (Tablet)
             system.
               is noticeably fouled use 1
               to 2 tablets for each 100
               gallons of water. Add
               additional tablets until a
               residual of 10 to 35 ppm
               bromine is established.
               Maintain treatment until
               system is free from
               microbial fouling.

               Subsequent Dose: Use tabs
               as needed to maintain a
               residual of 5 to 15 ppm
               bromine.
                           5785-65
                           6836-315
                           6836-316
                           83451-3
                           (Granular)
             Open
             Pour/Granules
Recirculating Cooling
Water
(Continued)
               Initial Dose: When the
               system is noticeably fouled
               ass 0.2 to 0.6 pounds
               /1,000 gallons. Repeat in 1
               to 3 ppm brominej-esidual
               is established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add 0.1
               to 0.3 pounds 71,000
               gallons. Repeat as needed
               to maintain 1 to 3 ppm
               bromine residual for at
                          None listed.
                                           76

-------
                                                                                                   Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                least 4 hours
                  6836-237
                  6836-280
                  6836-324
                  (Granular)
             Open
             Pour/Granules
               Initial Dose: When system
               is noticeably fouled add 0.1
               to l.Olbsto 1,000 gallons
               °fwater. Repeat until
               control is achieved.

               Subsequent Dose: When
               microbial control is evident
               add 0.1 to 0.75 Ibs to 1,000
               gallons of water every 3
               days or as
               needed to maintain control.
                          None listed.
                  83451-12
                  (Wettable
                  Powder)
             Open
             Pour/Powder
               Initial Dose: When the
               system is noticeably fouled
               ass 0.2 to 0.6 pounds
               /1,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add 0.1
               to 0.3 pounds 71,000
               gallons. Repeat as needed
               to maintain 1 to 3 ppm
                          None listed.
                                  77

-------
                                                                                                            Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Recirculating Cooling
Water
(Continued)
                           1448-420
                           3876-150
                           5785-57
                           6836-113
                           6836-115
                           6836-116
                           6836-120
                           6836-121
                           6836-122
                           6836-123
                           6836-124
                           6836-210
                           (Ready to
                           Use
                           Solution)
                           5785-70
                           (Granular)
                              bromine residual for at
                              least 4 hours.
             Intermittent,
             slug or
             continuous feed
             method.
               Initial Dose: When system
               is noticeably fouled add 0.1
               to l.Olbsto 1,000 gallons
               of water. Repeat until
               control is achieved.

               Subsequent Dose: When
               microbial control^ evident
               add 0.1 to 0.75 Ibs to 1,000
               gallons of water every 3
               days or as needed to
               maintain control.
                          None listed.
             Open
             Pour/Granules
               Initial Dose: Use loz per
               100 gallons of water. Add
               additional granules until
               residual of 1 to 35 ppm is
               established.

               Subsequent Dose: Use as
               needed to maintain residual
               5 to 15 ppm bromine.
                          Do not mix granules with pesticide or
                          fertilizer concentrates.
                                           78

-------
                                                                                                     Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  3377-62
                  3377-71
                  (Ready to
                  Use)
             Intermittent,
             slug or
             continuous
             method.
               Initial Dose: When system
               is noticeably fouled add 0.5
               to 5ppm as needed to
               maintain control. Applying
               !/2 ounce to 1,000 gallons
               of water yields theoretical
               average 4 ppm available
               bromine. Repeat as until
               control is evident.
               Subsequent Dose: When
               microbial control is evident
               add 05 to 5 ppmas needed
               to maintain control.
                          None listed.
                  83451-10
                  (Soluble
                  Concentrate
             Open
             Pour/Soluble
             Concentrate
               Initial Dose: When system
               is noticeably fouled add
               0.0477 to 0.143 gallons
               /1000 gallons of water.
               Repeat initial dose until
               bromine residual is
               established for at least 4
               hours.
               Subsequent Dose: When
               microbial control is evident
               add 0.0238 to 0.072
               gallons/1,000 gallons of
               water. Repeat as needed to
               maintain 1 to 3 ppm
               bromine residual for at
                          None listed.
                                   79

-------
                                                                                                            Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         least 4 hours.
                           83451-11
                           (Gel)
             Open Pour/Gel
                 Initial Dose: add 0.0545 to
                 0.1634 gallons/1000
                 gallons of water. Repeat
                 initial dosage until 1 to 3
                 ppm bromine residual is
                 established for at least 4
                 hours.
                 Subsequent Dose: add
                 0.0272 to 0.0823 gallons/
                 1000 galloons of water.
                 Repeat as needed until 1 to
                 3 ppm bromine residual is
                 established for at least 4
                 hours.
                           None listed.
Once Through Cooling
Water System
1448-356
1448-428
5785-63
63838-4
6836-115
69681-16
83451-4
8622-30
(Tablet)
Place tablet in
system
Initial Dose:
system is noticeably fouled
ass 0.2 to 0.6 pounds
/1,000 gallons. Repeat in 1
to 3 ppm bromine residual
is established for at least 4
hours.
Subsequent Dose: When
control is evident add 0.1
to 0.3 pounds 71,000
gallons. Repeat as needed
None listed.
                                           80

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                         to maintain 1 to 3 ppm
                                                         bromine.
                           5785-62
                           (Tablet)
             Place tablet in
             system
               Initial Dose: When system
               is noticeably fouled, add
               0.75to2.2551bs/1000
               gallons of water. Repeat in
               dosage until one ppm
               halogen residual, measured
               as free chlorine for at least
               4 hours
               Subsequent Dose: When
               system is noticeably
               fouled, add OA^O \ 25
               lbs/1000 gallons of water.
               Repeat as needed to
               maintain one ppm halogen
               residual, measured as free
               chlorine for at least 4
               hours.
                          None listed.
                           63838-4
                           75361-1
                           8622-73
                           (Tablet)
             Place tablet in
             system
Once Through Cooling
Water System (Continued)
               Initial Dose: When
               noticeably fouled add 2-6
               Ibsper lO.OOOgaiipns of
               water. Repeat initial
               dosage until at least one
               ppm of active residual
               bromine is established for
               at least 4 hours.
               Subsequent Dose: When
                          None listed.
                                                                                    None listed.
                                           81

-------
                                                                                                   Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  1448-420
                  3876-150
                  5785-57
                  6836-210
                  6836-113
                  6836-317
                  (Ready to
                  Use)
                  5785-65
                  6836-237
                  6836-280
                  6836-315
                  83451-3
                  (Granular)
                                                microbial controljs evident
                                                add 1 to 31bs per 10,000
                                                gallons of water.Repeat as
                                                needed to maintain one
                                                ppm of active residual
                                                bromine for at least 4
                                                hours.
             Open
             Pour/Ready to
             Use
               Initial Dose: When the
               system is noticeably fouled
               add 0.2 to 0.6 pounds
               71,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add 0.1
               to 0.3 pounds 71,000
               gallons. Repeat as needed
               to maintain 1 to 3 ppm
               bromine residual for at
               least 4 hours
                          None listed.
             Open
             Pour/Granules
               Initial Dose:
               system is noticeably fouled
               add 0.2 to 0.6 pounds
               71,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
                          None listed.
                                  82

-------
                                                                                                            Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Once Through Cooling
Water System (Continued)
                              hours.
                              Subsequent Dose: When
                              control isevident add 0.1
                              to 0.3 pounds A,000
                              gallons. Repeat as needed
                              to maintain 1 to 3 ppm
                              bromine residual for at
                              least 4 hours
                           8622-29
                           (Granular)
             Open
             Pour/Granules
               Initial Dose: When
               noticeably fouled add 2-6
               Ibs per 10,000 gallons of
               water. Repeat initial
               dosage until at least one
               ppm of active residual
               bromine is established for
               at least 4 hours.

               Subsequent Dose:  When
               microbial control is evident
               add 1 to 31bs per 10,000
               gallons of water. Repeat as
               needed to maintain one
               ppm of active residual
               bromine for at least 4
               hours.
                          None listed.
                           6836-316
                           83451-12
                           (Wettable
             Open
             Pour/Powder
               Initial Dose: When the
               system is noticeably fouled
               ass 0.2 to 0.6 pounds	
                          None listed.
                                           83

-------
                                                                                                            Halohydantoins RED
         Use Site
  Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                           Powder)
                              A,000 gallons. Repeat in 1
                              to 3 ppm bromine residual
                              is established for at least 4
                              hours.
                              Subsequent Dose: When
                              control is evident add 0.1
                              to 0.3 pounds A,000
                              gallons. Repeat as needed
                              to maintain l^o 3 nn m
                              bromine
Once Through Cooling
Water System (Continued)
8622-28
(Wettable
Powder)
Open
Pour/Powder
Initial Dose: When
None listed.
noticeably fouled^^ 2-6
Ibs per 10,000 gallons of
water. Repeat initial
dosage until at least one
ppm of active residual
bromine is established for
at least 4 hours.
Subsequent Dose: When
microbial control is evident
add 1 to 31bs per 10,000
gallons of water. Repeat as
needed to maintain one
ppm of active residual
bromine for at least 4
hours.
                           83451-10
                           (Soluble
             Open
             Pour/Soluble
                 Initial Dose: When system
                 is noticeably fouled add
                           None listed.
                                           84

-------
                                                                                                     Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  Concentrate
                  )
             Concentrate
               0.0477 to 0.143 gallons
               /1000 gallons of water.
               Repeat initial dose until
               bromine residual is
               established for at least 4
               hours.
               Subsequent Dose: When
               microbial control is evident
               add 0.0238 to 0.072
               gallons/1000 gallons of
               water. Repeat as needed to
               maintain 1 to 3 ppm
               bromine residual for at
               least 4 hours.
                  83451-11
                  (Gel)
             Open Pour/Gel
               Initial Dose: When system
               is noticeably fouled add
               0.0545 to 0.1634 gallons/
               1000 gallons of water.
               Repeat initial dosage until
               1 to 3 ppm bromine
               residual is established for
               at least 4 hours.

               Subsequent Dose: When
               microbial control is evident
               add 0.0272 to 0.0823
               gallons/1000 gallons  of
               water. Repeat as needed to
                          None listed.
                                   85

-------
                                                                                                              Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
   Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         maintain 1 to 3 ppm
                                                         bromine residual for at
                                                         least 4 hours.
Auxiliary Water and Waste
Water System
Auxiliary Water and Waste
Water System
(Continued)
1448-356
5185-420
5785-63
6836-314
6836-317
69681-16
83451-4
(Tablet)
                           5785-65
                           (Granular)
Place tablet in
system
Add 0.1 to 0.6 Ibs 71,000
gallons of water treated to
maintain 0.5 to 5.0 ppm
bromine residual at the
injection pointm ^e
disinfection contact
chamber. Adjust this
product's dosage to
achieve disinfection and
minimize the halogen
concentration at the exit of
the contact chamber.
Do not use treated wastewater to irrigate
crops.
             Open
             Pour/Granules
                 Add 0.1 to 0.6 Ibs 71,000
                 gallons of water treated to
                 maintain 0.5 to 5.0 ppm
                 bromine residual at the
                 injection point in the
                 disinfection contact
                 chamber. Adjust this
                 product's dosage to
                 achieve disinfection and
                 minimize the halogen
                 concentration at the  exit of
                 the contact chamber.
                           Do not use treated wastewater to irrigate
                           crops.
                                            86

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                                                                                                   Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  1448-420
                  5785-57
                  (Ready to
                  Use)
             Open
             Pour/Ready to
             Use
               Add 0.1 to 0.6i bs 71,000
               gallons of water treated to
               maintain 0.5 to 5.0 ppm
               bromine residual at the
               injection point in the
               disinfection contact
               chamber. Adjust this
               product's dosage to
               achieve disinfection and
               minimize the halogen
               concentration at the exit of
               the contact chamber.
                          Do not use treated wastewater to irrigate
                          crops.
                  3377-62
                  3377-71
                  (Ready to
                  Use)
             Open
             Pour/Ready to
             Use
               The quantity required
               varies with degree of
               fouling. Add sufficient
               amount to achieve residual
               bromine levels 0.5 -5ppm.
               Applying Bounce to 1,000
               gallons of water yields a
               theoretical average of 4
               ppm of available bromine.
               Higher dosages may be
               necessary depending upon
               the system.
                          None listed
                                  87

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                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
                                n
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Auxiliary Water and Waste
Water System
(Continued)
                           83451-10
                           (Soluble
                           Concentrate
             Open
             Pour/Soluble
             Concentrate
               Add 0.0238 to 0.143
               gallons of water treated to
               maintain 0.5 to 5.0 ppm
               bromine residual at the
               injection point in the
               contact chamber. Adjust
               this product's dosage to
               achieve sanitizationan(j
               minimize the halogen
               concentration at the exit of
               the contact chamber.
                          Do not use treated wastewater to irrigate
                          crops.
                           6836-316
                           (Wettable
                           Powder)
             Open
             Pour/Powder
               Add 0.1 to 0.6 Ibs 71,000
               gallons of water treated to
               maintain 0.5 to 5.0 ppm
               bromine residual at the
               injection ofwater treated to
               maintain 0.5 to 5.0 ppm
               bromine residual at the
               injection point in the
               contact chamber.
                          Do not use treated wastewater to irrigate
                          crops.
                           83451-11
                           (Gel)
             Open Pour/Gel
               Add 0.0272 to 0.1634
               gallons 71,000 gallons of
               water treated to maintain
                          Do not use treated wastewater to irrigate
                          crops
                                           88

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                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         0.5 to 5.0 ppm bromine
                                                         residual at the injection
                                                         point in the contact
                                                         chamber. Adjust this
                                                         product's dosage to
                                                         achieve sanitization and
                                                         minimizethe halogen
                                                         concentration at the exit of
                                                         the contact chamber.
Industrial air washer
systems
6836-113
6836-115
6836-210
6836-314
6836-316
(Tablet)
Place tablet in
system
Initial Dose: When system
is noticeably fouled add to
airwasher sump or chill
water sump to insure
uniform mixing. Add 0.1 to
1.0 Ibs per 1,000 gallons of
water.
                                                         Subsequent Dose: When
                                                         microbial control is evident
                                                         add 0.1 to 0.6 Ibs per 1,000
                                                         gallons of water.
None listed.
Industrial air washer
systems	
6836-314
6836-316
Place tablet in
system	
Initial Dose: When the
system is noticeably fouled
Badly fouled systems should be cleaned
before treatment is done.
                                           89

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                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
(Continued)
(Tablet)
               add 0.2 to 0.6 pounds
               /1,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add 0.1
               to 0.3 pounds 71,000
               gallons. Repeat as needed
               to maintain 1 to 3 ppm
               bromine residual  for at
               least 4 hours.
                           6836-237
                           6836-280
                           6836-324
                           (Granular)
             Open
             Pour/Granules
               Initial Dose: When system
               is noticeably fouled add to
               airwasher sump or chill
               water sump to insure
               uniform mixing. Add 0.1 to
               1.0 Ibs per 1,000 gallons of
               water.

               Subsequent Dose: When
               microbial control ise vident
               add 0.1 to 0.6 Ibs per 1,000
               gallons of water.
                          Badly fouled systems should be cleaned
                          before treatment is done.
                           6836-315
                           (Granular)
             Open
             Pour/Granules
               Initial Dose : When the
               system is noticeably fouled
                          Badly fouled systems should be cleaned
                          before treatment is done.
                                           90

-------
                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Industrial air washer
systems
(Continued)
                              ass 0.2 to 0.6 pounds
                              71,000 gallons. Repeat in 1
                              to 3 ppm bromine residual
                              is established for at least 4
                              hours.

                              Subsequent Dose: When
                              control is evident add 0.1
                              to 0.3 pounds 71,000
                              gallons. Repeat as needed
                              to maintain 1 to 3 ppm
                              bromine residual for at
                              least 4 hours.
                           6836-316
                           (Wettable
                           Powder
             Open
             Pour/Powder
               Initial Dose: When the
               system is noticeably fouled
               ass 0.2 to 0.6 pounds
               71,000 gallons. Repeat in 1
               to 3 ppm bromine residual
               is established for at least 4
               hours.

               Subsequent Dose: When
               control is evident add 0.1
               to 0.3 pounds 71,000
               gallons. Repeat as needed
               to maintain 1 to 3 ppm
               bromine residual for at
                          Badly fouled systems should be cleaned
                          before treatment is done.
                                           91

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                                                                       Halohydantoins RED
Use Site






Photo Processing Water
Reg. no./
Formulatio
n

3377-62
3377-63
3377-71
(Ready to
Use)




6836-115
Method of
Application

Open
Pour/Ready to
Use





Place in system
Application Rate/ No. of
applications
least 4 hours
Initial Dose: When system
is noticeably fouled^
sufficient amount to
achieve a residual bromine
level of 0.5 -5ppmor as
needed to maintaincon^roi
Apply l/2 ounce to 1,000
gallons of water. Yields a
theoretical average 4ppm
available bromine. Repeat
until control is achieved.
Subsequent Dose: When
microbial control is evident
apply sufficient amount to
achieve area residual
bromine level 0.5 to 5ppm
or as needed to maintain
control.
Place tabs with the
Use Limitations

None listed.





Do not use water from this line to mix
92

-------
                                                                                                   Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  6836-317
                  6836-314
                  69681-16
                  83451-4
                  (Tablet)
                  6836-237
                  6836-315
                  6836-324
                  (Granular)
                  6836-316
                  (Wettable
                  Powder)
                              regulating valve at a low
                              setting. If biological
                              growth is observed
                              increase the flow in small
                              increments until growth is
                              controlled. 1.0to3.0ppm
                              of residual bromine should
                              be introduced into water
                              supply line. Three to (3) to
                              9 grams oftabs will
                              introduce 1.0 to 3.0 ppm
                              residual bromine in 1,000
                              gallons of water.
                                         chemicals.
             Open
             Pour/Granules
               It is intended that 0.5 to 3.0
               ppm of residual bromine
               should be introduced into
               water supply line. Three to
               (3) to 12 grams oftabs will
               introduce 1.0 103 Q ppm
               residual bromine in 1,000
               gallons of water.
                          Do not use water from this line to mix
                          chemicals.
             Open
             Pour/Powder
               Adjust pH between 7.2 to
               7.6 when using other
               products as outlined in
               directions for other
               products. A bromine or
                          Do not use water from this line to mix
                          chemicals.
                                  93

-------
                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         chlorine residual of 1-2
                                                         ppm must first be
                                                         established in the water.
                                                         When bromine residual
                                                         reaches 1-2 ppm adjust
                                                         feeder accordingly. To
                                                         maintain bromine residual
                                                         adjust the feeder feed rate
                                                         to assure constant
                                                         treatment level of 1-3 ppm.
Automobile wash water
systems
6836-210
(Tablet)
Place tablet in
system
Initial Dose: If a heavily
fouled system exists and
physical cleaning is not
possible add 0.05 to  0.2 Ibs
per 1,000 gallons of water
for two weeks. Then
reduce maintenance  levels.

Maintenance Dose:
Effective control under
normal circumstances is
maintained by adding
0.025 to 0.1 pounds per
1,000 gallons of water.
None listed.
Commercial, Institutional and Industrial Premises and Equipment
                                           94

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
Air Conditioner/Humidifier
Drip Pans
Air Conditioner/Humidifier
Drip Pans (Continued)
1448-356
5785-63
5785-100
5185-420
69681-16
83451-3
(Granular)
                           75361-1
                           (Tablet)
                           83451-4
                           8622-30
                           (Tablet)
Open
Pour/Granules
Place this product in the
basin or drip pan close to
the outlet drain. Use one or
more tablets as necessary
to maintain cleanliness of
the system. The amount of
tablets needed will vary
with temperature humidity,
and condensate volume.
Do not place tablets directly onto metal
surfaces.
             Place tablet in
             system
                 Place tablet into
                 condensate
                 or floatation device into
                 reservoir. Maintain 1-4
                 ppm active bromine. Check
                 once every month or more
                 often as required. The life
                 °Mhe tablet will vary
                 depending on atmospheric
                 conditions and temperature
                 requirements.
                           Do not place tablets directly onto metal
                           surfaces
             Place tablet in
             system
                 Place this product in the
                 basin or drip pan close to
                 the outlet drain. Use one or
                 more tablets as necessary
                           None listed
                                           95

-------
                                                                                                    Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                to maintain cleanliness of
                                                the system. The amount of
                                                tablets needed will vary
                                                with temperature humidity,
                                                and condensate volume.
                  1448-420
                  8622-30
                  (Ready to
                  Use)
             Open Pour/
             Ready to Use
               Place this product i
               basin or drip pan close to
               the outlet drain. Use one or
               more tablets as necessary
               to maintain cleanliness of
               the system. The amount of
               tablets needed will vary
               with temperature humidity,
               and condensate volume.
                          None listed.
                  83451-3
                  (Granular)
             Open
             Pour/Granules
               Place this product in the
               basin or drip pan close to
               the outlet drain. Use one or
               more tablets as necessary
               to maintain cleanliness of
               the system. The amount of
               tablets needed will vary
               with temperature humidity,
               and condensate volume.
                          None listed.
                  8622-29
                  (Granular)
             Open
             Pour/Granules
               Place this product in the
               basin or drip pan close to
                          None listed.
                                  96

-------
                                                                                                           Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
Air Conditioner/Humidifier
Drip Pans (Continued)
                              the outlet drain. Use one or
                              more tablets as necessary
                              to maintain cleanliness of
                              the system. The amount of
                              tablets needed will vary
                              with temperature humidity,
                              and condensate volume.
                           8622-29
                           (Granular)
             Open
             Pour/Granules
                 Place this product in the
                 basin or drip pan close to
                 the outlet drain. Use one or
                 more tablets as necessary
                 to maintain cleanliness of
                 the system. The amount of
                 tablets needed will vary
                 with temperature humidity,
                 and condensate volume.
                          None listed.
Swimming Pools, Spas, Hot Tubs
Swimming Pools
1448-428
3377-72
57787-24
63838-4
66397-1
66397-2
67262-23
Place tablet into
system
Initial Application: Adjust
phto7.2-7.8.Adjustthe
feeder flow of water
according to the
manufacturer's directions
to maintain bromine
residual between 1-4 ppm
None listed.
                                           97

-------
                                                                                                           Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
Swimming Pools
(Continued)
                          6836-116
                          6836-118
                          6836-197
                          6836-211
                          6836-314
                          6836-317
                          69681-16
                          7124-102
                          7124-104
                          75361-1
                          (Tablet)
8622-41
8622-70
8622-73
(Tablet)
                              in the pool per 1,000
                              gallons.

                              Continued Application:
                              Check feeder periodically a
                              refill with additional
                              product. Adjust feeder flow
                              water according to
                              manufacturer's directions
                              to maintain bromine levels
                              between 1-4 ppminpool
Place tablet into
system
Newly Filled Pools:
Establish an effective
active bromine residual of
between 2-3 ppm.

Residential: Add 17 tablets
per 10,000 gallons every 5-
7 days as needed to
maintain a bromine
residual of 2-3 ppm at all
times.

Commercial: Add 31
Keep pH between 7.2-7.6 and never allow it
to fall below 7.0.
                                           98

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                         tablets per 10,000 gallons
                                                         every 5-7 days or as
                                                         needed to maintain and
                                                         achieve bromine residual
                                                         between 3-5 ppm at all
                                                         times.
                           3377-61
                           6836-211
                           (Soluble
                           Concentrate
             Open
             Pour/Soluble
             Concentrate
Swimming Pools
(Continued)
               Initial Application:
               Chemically
               balance calcium hardness
               to 200 ppm and total
               alkalinity to!oo to 150
               ppm. Adjust pH to 7.2-7.8
               Adjust the flow0f water
               into feeder according to
               manufacturer's directions
               to maintain active bromine
               residual between 1-4 ppm.
                              Continued Application:
                              Check the feeder weekly
                              and refill with additional
                              product. Adjust the flow of
                              water into feeder according
                              to manufacturer's
                              directions to maintain an
                              active bromine level
                          Do not mix this product in concentrated form
                          w any other chemicals. Do not add other
                          chemicals to the feeding device when using
                          this product. A violent reaction leading to fire
                          and explosion could result.
                                           99

-------
                                                                                                  Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  42177-74
                  6836-123
                  (Ready to
                  Use)
                  6836-316
                  (Wettable
                  Powder)
                  6836-250
                  6836-251
                  5185-490
                  (Granular)
                                               between 1-4 ppm.
             Open
             Pour/Ready to
             Use
               Balance calciuman(j
               alkalinity and thenacyust
               pH to between 7.2-7.6.
               Superoxidate to 1020ppm
               bromine.  Water is safe
               when bromine is below 5
               ppm. If bromine residual
               content is below 1-3 ppm,
               add 0.2-2.0 oz per 1000 as
               needed to maintain
                         Do not mix with other chemicals. Always add
                         product to large quantities of water.
             Open
             Pour/Powder
               Adjust pH between 7.2-7.6.
               A bromine or chlorine
               residual of 1 to 3 ppm must
               first be established in the
               pool. To maintain bromine
               residual adjust feeder feed
               rate to assure a constant
               treatment level.
                         None listed
             Open
             Pour/Granules
               Add product to maintain 1-
               3 ppm as bromine. Use a
               reliable test kit to monitor
               for bromine regularly.
               Maintain the pool water pH
               between 7.2-7.8.
                         None listed.
                                 100

-------
                                                                                                          Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
                               n
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
Spas and Hot Tubs
Spas and Hot Tubs
(Continued)
1448-428
3377-72
5185-420
5185-421
63838-4
66397-1
66397-2
6836-116
6836-196
6826-211
6836-242
6836-243
(Tablet)
6836-314
6836-317
69681-16
7124-102
7124-103
7124-104
71654-13
75361-1
75562-1
(Tablet)
                          6836-316
                          (Wettable
                          Powder)
Place tablet in
system
Adjustthe feede r according
to manufacturer's
directions to maintain a
bromine level between 1-4
ppm in residential spas and
3-6 ppm in commercial
spas. Check feeder
regularly and add
additional product as
needed.
Do not heat above manufacturer's
recommended temperature.
Place tablet in
system
Adjust the feeder according
to manufacturer's
directions to maintain a
bromine level between 1-4
ppm in residential spas and
3-6 ppm in commercial
spas. Check feeder
regularly and add
additional product as
needed.
Do not heat above manufacturer's
recommended temperature.
             Open
             Pour/Powder
                Adjust the feeder according
                to manufacturer's
                directions to maintain a
                bromine level between 1-4
                ppm in residential spas and
                          Do not heat above manufacturer's
                          recommended temperature.
                                          101

-------
                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                                                        3-6 ppm in commercial
                                                        spas. Checkfeecjer
                                                        regularly and add
                                                        additional product as
                                                        needed.
                           57787-24
                           8622-41
                           8622-70
                           (Tablet)
             Place tablet in
             system
Spas and Hot Tubs
(Continued)
               Introduce 3 tablets per 300
               gallons of spater with
               the use of
               feeder or automatic
               brominator.
               feeder or brominator to
               obtain an active bromine
               residual of at least 2 ppm.
               Maintain spa by adding 3
               tablets per 300 gallons
               every 5-7 days or as
               needed to maintain an
               active bromine residual of
               2ppm at all times.
                          Keep pH between 7.2-7.6 and never allow it
                          to fall below 7.0.
                           5185-490
                           6836-251
                           (Granular)
             Open
             Pour/Granules
               Adjust the feeder according
               to manufacturer's
               directions to maintain a
               bromine level between 2-4
               ppm in residential spas and
               3-6 ppm in commercial
               spas. Check feeder
               regularly and add	
                          Do not heat above manufacturer's
                          recommended temperature.
                                          102

-------
                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Spas and Hot Tubs
(Continued)
                                                         additional product as
                                                         needed.
                           3377-61
                           6836-211
                           (Soluble
                           Concentrate
             Openp0 ur/
             Soluble
             Concentrate
               Adjust the feeder according
               to manufacturer's
               directions to maintain a
               bromine level between 1-4
               ppm in residential spas and
               3-6 ppm in commercial
               spas. Check feeder
               regularly and add
               additional product as
               needed.
                          Do not mix this product in concentrated form
                          w any other chemicals. Do not add other
                          chemicals to the feeding device when using
                          this product. A violent reaction leading to fire
                          and explosion could result.
                           5185-433
                           (Soluble
                           Concentrate
             Open
             Pour/Soluble
             Concentrate
               Use one dispenser per 350
               gallons of spaor hot tub
               water. Under heavy bather
               loading or reduced water
               circulation, additional
               dispensers may be used to
               maintain constant active
               bromine residuals of 2 to 4
               ppm in residential spas.
                          None listed.
                           42177-75
                           67262-23
                           6836-123
             Open Pour/
             Ready to Use
               Adjust the feeder according
               to manufacturer's
               directions to maintain a
                          Do not heat above manufacturer's
                          recommended temperature.
                                           103

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                           (Ready to
                           use)
                              bromine level between 1-4
                              ppm in residential spas and
                              3-6 ppm in commercial
                              spas. Check feeder
                              regularly and add
                              additional product as
                              needed.
                           53735-10
                           (Ready to
                           use)
             Open
             Pour/Ready to
             Use
                 Use one dispenser per 350
                 gallons of spa or hot tub
                 water. Under heavy bather
                 loading or reduced water
                 circulation, additional
                 dispensers may be used to
                 maintain constant active
                 bromine residuals of 2 to 4
                 ppm in residential spas.
                           None listed
                           5185-480
                           (cartridge)
             Install Cartridge
             in Spa feeder
                 Adjust pH to between 7.2-
                 7.6. Place this product in
                 spa feeder. To Install insert
                 canister into opening lining
                 up canister tabs with key
                 ways. While pushing
                 canister rotate counter
                 clockwise, pull to remove
                 from opening.	
                           This product can only be used in conjunction
                           with polaris precis spa feeder.
Foot Spas
3377-61
Place tablet in
Add one tablet to the foot
None listed.
                                           104

-------
                                                                                                             Halohydantoins RED
         Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                           75562-1
                           (Tablet)
             system
                 spa water and agitate to
                 dissolve. Onetabietin 1-
                 1.25 gallons of spa water
                 will provide an active
                 bromine concentration of
                 40 ppm.
Aquatic Areas
Chemigation
Chemigation (continued)
5785-69
(Tablet)
                           5785-70
                           (Granular)
Open
Pour/Tablet
             Open
             Pour/Granules
Maintain residual between
5-15 ppm bromine in the
water. To insure even
distribution of tablets, it is
important^ level treated
mats. If microbial growth
developsadd additional
tablets until bromine
residual reaches 10-35
ppm. Continue until
fouling is eliminated, then
resume treatment between
5-15ppm bromine.	
                 Maintain residual between
                 5-15 ppm bromine in the
                 water. To insure even
                 distribution of granules, it
                 is important to level treated
                 mats. If microbial growth
                 develops add additional
Do not mix with pesticide or fertilizer
concentrates
                           Do not mix with pesticide or fertilizer
                           concentrates
                                           105

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                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
                                                         granules until bromine
                                                         residual reaches 10-35
                                                         ppm. Continue until
                                                         fouling is eliminated, then
                                                         resume treatment^et ween
                                                         5-15ppm bromine.	
Ornamental Fountains
1448-356
1448-428
3377-71
3377-72
5185-420
63838-4
6836-115
83451-4
(Tablet)
                           63838-4
                           6836-115
                           (Tablet)
                           3377-72
                           (Tablet)
Place tablet in
system
Adjust pH to 7.2-7.6. A
bromine residual of 1-2
ppm must be established in
the water. To maintain a
bromine residual adjust the
brominator feed rate to
assure a constanttrea tment
of l-3ppm.
None listed.
             Place tablet in
             system
                 Initial Dose: Add 0.1 to
                 61bs per 10,000 gallons of
                 water. Repeat initial dose
                 until control is achieved.
                 Subsequent Dose: 4 dd 0.1
                 to 31bs per 10,000 gallons
                 daily or as needed to
                 maintain control.
                           None listed.
             Place tablet in
             system
                 Add sufficient amount to
                 achieve and maintain a
                 bromine residual 0.5-5ppm
                 or as needed to control the
                 system. If using a	
                           Do not mix this product in concentrated form
                           w any other chemicals. Do not add other
                           chemicals to the feeding device when using
                           this product. A violent reaction leading to fire
                           and explosion could result.	
                                           106

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                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
Ornamental Fountains
(Continued)
                              dispensing device adjust
                              the device feedrate ^o
                              assure a constant treatment
                              between 0.5-5ppm residual
                              bromine.
                           5785-70
                           (Granular)
             Open
             Pour/Granules
               Maintain residual between
               5-15 ppm bromine in the
               water. To insure even
               distribution of granules, it
               is importantto level treated
               mats. If microbial growth
               develops add additional
               granules until bromine
               residual reaches 10-35
               ppm. Continue until
               fouling is eliminated, then
               resume treatment between
               5-15ppm bromine.	
                          Do not mix with pesticide or fertilizer
                          concentrates.
                           5185-490
                           (Granular)
             Open
             Pour/Granules
               A bromine or chlorine
               residual of l-2ppm must be
               established. To maintain
               bromine residual, adjust
               brominator feed rate to
               assure a constant treatment
               level of 1-3 ppm.
                          None listed.
                           3377-61
                           3377-62
             Open Pour/
             Soluble
               Add sufficient amount to
               achieve and maintain a
                          Do not mix this product in concentrated form
                          with any other chemicals. Do not add other
                                          107

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                                                                                                            Halohydantoins RED
        Use Site
 Reg. no./
Formulatio
  Method of
  Application
 Application Rate/ No. of
       applications
             Use Limitations
Ornamental Fountains
(Continued)
                           (Soluble
                           Concentrate
             Concentrate
                 bromine residual 0.5-5ppm
                 or as needed to control the
                 system. If using a
                 dispensing device adjust
                 the device feed rate to
                 assure a constant treatment
                 between 0.5-5ppm residual
                 bromine.
                           chemicals to the feeding device when using
                           this product. A violent reaction leading to fire
                           and explosion could result
83451-10
(Soluble
Concentrate
Open
Pour/Soluble
Concentrate
A bromine or chlorine
residual of l-2ppm must be
established. To maintain
bromine residual, adjust
brominator feed rate to
assure a constant treatment
level of 1-3 ppm.
None listed.
                           1448-420
                           (Ready to
                           Use)
             Open
             Pour/Ready to
             Use
                 A bromine or chlorine
                 residual of l-2ppm must be
                 established. To maintain
                 bromine residual, adjust
                 brominator feed rate to
                 assure a constant treatment
                 level of 1-3  ppm.
                           None listed
                           3377-71
                           (Ready to
             Open
             Pour/Ready to
                 Add sufficient amount to
                 achieve and maintain a
                           Do not mix this product in concentrated form
                           w any other chemicals. Do not add other
                                          108

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                                                                                                    Halohydantoins RED
Use Site
 Reg. no./
Formulatio
 Method of
Application
Application Rate/ No. of
      applications
Use Limitations
                  Use)
             Use
               bromine residual 0.5-5ppm
               or as needed to control the
               system. If using a
               dispensing device adjust
               the device feedrate to
               assure a constant treatment
               between 0.5-5ppm residual
               bromine.
                          chemicals to the feeding device when using
                          this product. A violent reaction leading to fire
                          and explosion could result
                                  109

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                                                                                                                     Halohydantoins RED
   APPENDIX B:  Dihalodialkylhydantoins (case 3055)

   Appendix B lists the generic (not product specific) data requirements which support the re-registration of dihalodialkylhydantoins.  These
   requirements apply to dihalodialkylhydantoins in all products, including data requirements for which a technical grade active ingredient is the
   tests ubstance.  The data table is organized in the following formats:

   1.      Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number.  The first columniists me new part ^53 Guideline
          numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test protocol set forth in the
          Pesticide Assessment Guidance, which are available on the EPA website.

   2.      Guideline Description (Column 3). Identifies the guideline type.

   3.      Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not product
          specific) data requirements apply. The number designations are used in Appendix B.

          (1) Agricultural premises and equipment
          (3) Commercial, institutional and industrial premises and equipment
          (4) Residential and public access premises
          (7) Materials preservatives
          (8) Industrial processes and water systems
          (11) Swimming pools
          (12) Aquatic areas

   3 .Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column will identity
   each study by a "Master Record Identification  (MRID) number. The listed studies are considered "valid" and acceptable for satisfying the Guideline
   requirement. Refer to the Bibliography appendix for a complete citation of each study.
DATA REQUIREMENT
CITATION(S)
                                               110

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                                                                      Halohydantoins RED
New Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
MRID Number
TECHNICAL GRADE ACTIVE INGREDIENT (TGAD CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
61-1
61-2 A
61-2 B
62-1
62-2
62-3
63-2
63-3
63-4
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
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
MRID# 350 11701
MRID# 350 11701
MRID# 350 11701
MPJD# 4 1952701
MPJD# 4 1952801
MRID# 42478501
MRID#43315902
MPJD# 4 1952701
MRID# 4 1952801
MRID#35011701
MRID#35011701
MRID# 350 11701
MRID#35011701
N/A
MRID# 350 11701
MRID#35011701
N/A
N/A
111

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                                                                      Halohydantoins RED
DATA REQUIREMENT
New Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6316
830.6317
830.6320
Old
Guideline
Number
63-11
63-12
63-13
63-14
63-16
63-17
63-20
Study Title
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Explodability
Storage Stability
Corrosion Characteristics
Use Pattern
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
CITATION(S)
MRID Number
Data Gap
MRID# 350 11701
MRID# 350 11701
MRID# 350 11701
N/A
MRID#35011701
MRID#35011701
ECOLOGICAL EFFECTS
850.2100
850.2200
71-1 A
7 1-2 A
Avian Acute Oral Toxicity Test - Quail/duck
Avian Acute Dietary - Quail
1,3,4,7,8,11,12
1,3,4,7,8,11,12
Acc# 253966
Acc# 253972
Acc# 253071
Acc# 253073
Acc# 252719
Acc# 137088
Acc# 147319
MRID# 43289905
Acc# 147321
Acc# 253071
MRID# 43289904
112

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                                                                      Halohydantoins RED
DATA REQUIREMENT

New Guideline
Number





850.2200









850.1075

850.1075









850.1075
Old
Guideline
Number





71-2B









72-1 A

72-1 B









72-1 C


Study Title





Avian Acute Dietary - Duck









Fish Acute Toxicity - Bluegill

Fish Acute Toxicity - Minnow









Fish Acute Toxicity - Rainbow Trout


Use Pattern





1,3,4,7,8,11,12









1,3,4,7,8,11,12

1,3,4,7,8,11,12









1,3,4,7,8,11,12
CITATION(S)


MRID Number
Acc# 147321
Acc# 253071
Acc# 253073
Acc# 253966
Acc# 253972
MRID# 43289903
Acc# 145356
Acc# 147322
Acc#252719
Acc# 253071
Acc# 253072
Acc# 253074
MRID# 42368501
MRID# 42373601
MRID# 42374702
MRID# 43 179706
MRID# 46053
MRID# 42374702
Acc# 145358
Acc# 147322
Acc# 147323
Acc# 252719
Acc# 253071
Acc# 253072
Acc# 253074
MRID# 46053
MRID# 42373601
MRID# 43 179705
113

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                                                                      Halohydantoins RED
DATA REQUIREMENT
New Guideline
Number
850.1010
850.1025
850.1035?
850.1045?
850.1300
850.1400
850.4225
850.4250
850.4400
Old
Guideline
Number
72-2 A
72-3 A
72-3 B
72-3 C
72-4 A
72-4 B
123-1
123-1
123-2
Study Title
Acute Aquatic Invertebrate Toxicity
Estu/Mari tox. Fish
Estu/Mari tox. Mollusk
Estu/Mari tox. Shrimp
Early Life Stage Fish
Life Cycle Invertebrate
Seedling emergence dose-response in rice
Vegetative vigor dose-response in rice
Aquatic vascular plant dose-response toxicity- Lemna sp.
Use Pattern
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
CITATION(S)
MRID Number
Acc# 252719
Acc# 253071
Acc# 253072
Acc# 253074
Acc# 147324
Acc# 145357
MRID# 46053
MRID# 42373603
MRID# 43 179707
MRID# 40993 103
MRID# 42076102
MRID# 42374701
MRID# 43687301
MRID# 40993 101
MRID# 42076101
MRID# 43289902
MRID# 43687302
MRID# 40993 101
MRID# 42076103
MRID# 43687303
MRID# 42373602
MRID# 4272 1702
Data Gap
Data Gap
Data Gap
Data Gap
114

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                                                                      Halohydantoins RED
DATA REQUIREMENT
New Guideline
Number
850.5400
Old
Guideline
Number
123-2
Study Title
Acute algal dose-response toxicity. 4 snecies
Use Pattern
1,3,4,7,8,11,12
CITATION(S)
MRID Number
Data Gap
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3050
870.3100
870.3150
870.3200
870.3250
81-1
81-2
81-3
81-4
81-5
81-6

82-1 A
82-1 B
82-2
82-3
Acute Oral - Rat, Mouse
Acute Dermal - Rabbit
Acute Inhalation - Rat
Acute Eye Irritation - Rabbit
Acute Skin Irritation - Rabbit
Dermal Sensitization
28-Day Oral Toxicity - Mouse
90-Day feeding-Rodent
90-Day feeding-Non-rodent/dog
21/28-Day Dermal Toxicity - Rat
90 Day Dermal-Rodent
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
MRID# 4573 8401
MRID# 93074006
MRID# 930760 11
MRID# 93077008
MRID# 93076013
MRID# 93076025
MRID# 43654101
N/A
MRID# 93076017
MRID# 930740 11
MRID# 93075014
MRID# 93077009
MRID# 4 1670001
MRID# 45738402
MRID# 42009201
No study is available. However,
a chronic toxicity study is
available
No study is available. However,
a 90-day dermal toxicity study is
available.
MRID #43 173 901
115

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                                                                      Halohydantoins RED
DATA REQUIREMENT
New Guideline
Number
870.3465
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
870.5100
870.5300
Old
Guideline
Number
82-4
83-1 A
83-1 B
83-2 A
83-2 B
83-3 A
83-3 B
83-4
83-5
84-2 A
84-2 B
Study Title
90-Day Inhalation - Rat
Chronic Toxicity-Rodent
Chronic Toxicity-Non-rodent/dog
Oncogenicity-Rat
Oncogenicity -Mouse
Prenatal Developmental Toxicity -Rat
Prenatal Developmental Toxicity - Rabbit
Reproduction and fertility effects - Rat
Combined Chronic toxicity/carcinogenicity
Bacterial Reverse Mutation Test - Ames
Gene Mutation In vitro Mammalian Cell Assay
Use Pattern
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
CITATION(S)
MRID Number
Study required to assess risks
from formaldehyde exposure,
will be assessed in the RED
assessment for formaldehyde.
MRID# 43397702
MRID# 44095901
MRID# 43553101
MRID# 43813301
MRID# 43397702
MRID# 44095901
MRID#43397701
MRID# 44063901
MRID# 42432701
MRID# 42413101
MRID# 42205401
MRID# 42462502
MRID# 43397702
Acc# 137100
Acc#164o36
MRID# 265457
TRID#433401118
Acc# 132165
Acc# 137089
TRID#433401121
TRID#433401127
116

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                                                                      Halohydantoins RED
DATA REQUIREMENT
New Guideline
Number
870.5375
870.5550
870.7485
Old
Guideline
Number
84-2 C
84-4
85-1
Study Title
In Vitro Mammalian Chromosome Aberration Test
Unscheduled DNA Synthesis in Mammalian Cells in Culture
General Metabolism
Use Pattern
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
CITATION(S)
MRID Number
Acc# 137096
Acc# 137101
Acc# 164037
Acc# 265457
MRID# 40348201
TRID#433401119
TRID#433401125
TRID# 470264004
Acc# 132166
Acc# 137097
Acc# 164038
Acc# 265457
TRID#433401120
TRID#433401126
TRID# 470264005
MRID# 42 123802
MRID# 42 173901
ENVIRONMENTAL FATE
835.2120
835.2240
835.4400
161-1
161-2
162-3
Hydrolysis of Parent and Degradates
Photodegradation - Water
Anaerobic Aquatic Metabolism
1,3,4,7,8,11,12
1,3,4,7,8,11,12
1,3,4,7,8,11,12
MRID# 4328 1801
MRID# 42466201
MRID# 42466202
MRID# 4273 8401
REENTRY PROTECTION
875.1200
875.1600
875.1400
875.1600
233
236
234
236
Dermal Indoor Exposure
Inhalation Indoor Exposure
1,3,4,7,8,11,12
1,3,4,7,8,11,12
Data Gap
Data Gap
117

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                                                                      Halohydantoins RED
DATA REQUIREMENT
New Guideline
Number
875.2800
Old
Guideline
Number
133-1
Study Title
Descriptions of Human Activity
Use Pattern
1,3,4,7,8,11,12
CITATION(S)
MRID Number
Data Gap
RESIDUE CHEMISTRY
860.1100
860.1200
171-2
171-3
Chemical Identity
Directions for Use
1,3,4,7,8,11,12
1,3,4,7,8,11,12
N/A
N/A
118

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                                                                  Halohydantoins RED

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 Street, Arlington, VA. It is open Monday
through Friday, excluding legal holidays, from 8:30 am to 4 pm.

OPP public docket is located in Room S-4400, One Potomac Yard (South Building), 2777 South
Crystal Drive, Arlington, VA, 22202 and is open Monday through Friday, excluding Federal
holidays, from 8:30 a.m. to 4:00 p.m.

       The docket initially contained the September 10, 2004 preliminary risk assessment and
the related documents.  EPA then considered comments on these risk assessments (which are
posted to the e-docket) and revised the risk assessments. The revised risk assessments will be
posted in the docket at the same time as the RED.

       All documents,  in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at www.regulations.gov

These documents include:

•      Halohydantoins Preliminary Risk Assessment; Notice of Availability, 9/10/04.
•      Halohydantoins Case Overview Reregi strati on Case Number 3055, 3/17/03

Preliminary Risk Assessment and Supporting Science Documents:
•      Halohydantoins: Preliminary Risk Assessment for the Reregi strati on Eligibility Decision,
       PC Codes 006135, 006137, 028501, 128826, Case 3055, Antimicrobials Division,
       12/15/03.
•      Product Chemistry Science Chapter on halohydantoins.  PC Codes 006135, 006137,
       028501, 128826, Case 3055, Antimicrobials Division, 9/21/00, Chris Jiang.
•      Environmental Modeling for Halohydantoins PDM4 Model, PC Codes 006135, 006137,
       028501, 128826, Case 3055, Antimicrobials Division, 08/05/04.
•      Dihalodialkylhydantoins: Ecological Hazard and Environmental Risk Assessment, PC
       Codes 006135, 006137, 028501, 128826, Case 3055,  Antimicrobials Division, 09/07/04,
       Kathryn Montague, M.S.
•      Halohydantoins Toxicology Chapter. PC Codes 006135, 006137, 028501, 128826, Case
       3055, Antimicrobials Division, 10/01/02.
•      Dimethylhydantoin [Acute, Probabilistic, Chronic, Cancer] Dietary Exposure
       Assessments] for the [Section (3, 18) Reregi strati on Eligibility Decision, etc.]. PC
       Codes 006135, 006137, 028501, 128826, Case 3055,  Antimicrobials Division, 05/08/03,
       A. Najm Shamim, Ph.D.
•      Dihalodialkylhydantoin Occupational Residential Exposure Assessment.  PC Codes
       006135, 006137, 028501, 128826, Case 3055, Antimicrobials Division, Timothy F.
       McMahon, Ph.D.
•      Incident Reports Associated with Halohydantoins. PC Codes 006135, 006137, 028501,
       128826, Case 3055, Antimicrobials Division, 7/27/04.
                                         119

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                                                            Halohydantoins RED
Environmental Fate Assessment of hydantoins. PC Codes 006135, 006137, 028501,
128826, Case 3055, Antimicrobials Division Antimicrobials Division, 12/11/02, A. Najm
Shamim, Ph.D.
Comments from the Regional Water Quality Control Board, SF Bay Region. 9/23/04, Bill
Johnson, Pesticicde TMDL Coordinator.
Comments from the Sanitation Districts of LA County. 9/24/04, James F. Stahl,
Industrial Waste Section.
Comments from the Natural Resource Defense Council (NRDC). 9/24/04, Aaron
Colangelo, staff attorney NRDC
Comments from the California Regional Water Quality Control Board, SF Bay Region.
9/28/04, Bill Johnson, Pesticicde TMDL Coordinator.
Comments from the ACC Brominated Biocides Panel. 9/29/04.
Comments from the ACC Brominated Biocides Panel. 10/05/04.
Comments from the California Regional Water Quality Board SF Bay Region. 10/12/04,
Bill Johnson, Pesticicde TMDL Coordinator.
                                   120

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

1. MRID Studies

MRID #            Citation
46053        Home, J.D.; Groover, R.D.; Afzal, M.; et al. (1980) 96-Hour Static Bioassays
                   Using Two Great Lakes Chemical Corporation Compounds with Three
                   Marine and Three Freshwater Species. (Unpublished study received Aug
                   1, 1980 under 1729-122; prepared by NUS Corp., submitted by Tesco,
                   Inc., Marietta, Ga.;  CDL:243015-B)

132165       Kirby, P.; Pizzarello, R.; Rogers-Back, A.;  et al. (1983) L5178Y TK+/- Mouse
                   Lymphoma Mutagenesis Assay: Test Article 447:34-2: Study No.
                   T1803.701001. (Unpublished study received May 9, 1983 under 38906-5;
                   prepared by Microbiological Assoc., submitted by Glyco, Inc., Greenwich,
                   CT;CDL:250313-J)

 132166      Thilagar, A.; Pant, K.; Kumaroo, P. (1982) Unscheduled DNA Synthe- sis in
                   Primary Cultures of Rat Hepatocytes (by Autoradiography): Test Article
                   447:34-2: Study No. T1803.380002. (Unpublished study received May 9,
                   1983 under 38906-5; prepared by Microbiological Assoc., submitted by
                   Glyco, Inc., Greenwich, CT; CDL: 250313-K)

137088       Fink, R.; Beavers, 1; Joiner, G.; et al. (1981) Acute Oral LD50- Bobwhite Quail:
                   Dibromodimethylhydantoin: Project No. 178-106. Final rept.
                   (Unpublished study received Dec 27, 1983 under 38906-7; prepared by
                   Wildlife International Ltd., submitted by Glyco, Inc., Greenwich, CT;
                   CDL:252094-B)

 137089      Fink, R.; Beavers, J.; Brown, R.; et al. (1981) Eight-day Dietary LC50-Mallard
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 137095      Haworth, S.; Lawlor, T.; Gaudette, L.; et al. (1982) Salmonella/ Mammalian-
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 137096      Thilagar, A.; Gaudette, L.;  Kumaroo, P. (1982) Cytogenicity Study- Chinese
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                                         121

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 137097      Thilagar, A.; Gaudette, L.; Pant, K. (1982) Unscheduled DNA Syn- thesis in
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 137100      Haworth, S.; Gaudette, L.; Lawlor, T.; et al. (1982) Salmonella/ Mammalian-
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 137101      Thilagar, A.; Gaudette, L.; Kumaroo,  P.; et al. (1982) Cytogenicity Study--
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145356       Larkin, J. (1984) The Acute Toxicity of l,3-Dichloro-5-ethyl-5- methylhydantoin
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145357       Larkin, J. (1984) The Acute Toxicity of l,3-Dichloro-5-ethyl-5- methylhydantoin
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145358       Larkin, J. (1984) The Acute Toxicity of l,3,-Dichloro-5-ethyl-5-methylhydantoin
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147319       Beavers, J. (1985) An Acute Oral Toxicity Study in the Bobwhite with Halobrom:
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147321       Beavers, J. (1985) A Dietary LC50 Study in the Bobwhite with Halobrom: Final
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147322       McAllister, W.; Cohle, P. (1984) Acute  Toxicity of Halobrom to Bluegill Sunfish
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147323       McAllister, W; Cohle, P. (1984) Acute Toxicity of Halobrom  to Rainbow Trout

                                         122

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147324       Forbis, A.; Burgess, D.; Georgie, L. (1984) Acute Toxicity of Halobrom to
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 164036      Lawlor, T. (1986) Salmonella/Mammalian-microsome Plate Incorporation
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 164037      Putman, D. (1986) Chromosome Aberration Assay in Chinese Hamster Ovary
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 164038      Curren, R. (1986) Unscheduled DNA Synthesis in Rat Primary Hepatocytes:
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252719(1)    Fink, R.; Beavers, J.; Joiner, G.; et al. (1981) Acute Oral LD50- Bobwhite Quail:
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252719(2)    Graney, R.; Spare, W.; Hutchinson, C. (1981) The Acute Toxicity of Glybrom to
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252719(3)    Graney, R.; Spare, W.; Hutchinson, C. (1981) The Acute Toxicity of Glybrom to
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252719(4)    Graney, R.; Spare, W.; Hutchinson, C.; et al. (1981) The Acute Toxicity of
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253071(1)    Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: Acute Oral LD50-
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253071(2)    Graney, R.L.; Spare, W.C.; Hutchinson, C.  (1981) The Acute Toxicity of

                                         123

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                                                                   Halohydantoins RED
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253071(3)    Graney, R.L.; Spare, W.C.; Hutchinson, C. (1981) The Acute Toxicity of
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253073(1)    Fink, R.; Beavers, J.; Joiner, G.; et al. (1981) Acute Oral LD50- Bobwhite Quail:
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                                         124

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                                                                   Halohydantoins RED
253073(2)    Fink, R.; Beavers, I; Brown, R.; et al. (1981) Eight-day Dietary LC50-Mallard
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253966       Beavers, J. (1984) An Acute Oral Toxicity Study in the Bobwhite with 1,3-
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253972(2)    Beavers, J. (1984) A Dietary LC50 Study in the Mallard with 1,3-Di- chloro-5-
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                                         125

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265457(1)    Lawlor, I.E., B. Head, V.O. Wagner, B.E. Carter, S.M. Olewine, and RJ.
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                                                                 Halohydantoins RED
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 43281801    Mao, J. (1994) Halobrom (Bromo,Chloro-5,5-Dimethylhydantoin): Hydrolysis
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                                        129

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                                                                  Halohydantoins RED
43289902    McElwee, C. (1993) (Inert ingredient): Acute Effect on New Shell  Growth of the
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43687301     Surprenant, D. (1995) Supplement to: Halobrom (BCDMH, N,N1-
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                   Bromochlorodimethylhydantoin)-Acute Toxicity to Mysids
         (Mysidopsis                   bahia) Under Flow-Through Conditions: Lab
      Project Number: 91-6-3795:               11192.0590.6113.515. Unpublished study
      prepared by Springborn Lab.,                    Inc. 10 p.

43813301     Chengelis, C. (1995)  One-Year Oral Toxicity Study in Dogs with DMH: Final
                   Report: Lab Project Number: WIL-12274. Unpublished study prepared by
                   WIL Research Labs, Inc. 892 p.

 44063901    Naas, DJ. (1996).  18-Month Dietary Oncogenicity Study in Mice with DMH.
                   WIL Research Laboratories, Inc. Ashland, OH. Lab Study No. WIL-
                   12257. May 23, 1996. Unpublished.

 44095901    Naas, D. (1996). Combined 24-month toxicity/oncogenicity study in rats with
                   DMH. WIL Research Laboratories, Inc. Ashland, Ohio. Lab study No.
                   WIL-12258. July 30, 1996. Unpublished.

 44243001    supplement to multi-generation reproduction.

 45738401    Naas, D. (1989) Acute Oral Toxicity (LD50) Study in Albino Mice with DMH:
                   Lab Project Number: WIL-12158. Unpublished study prepared by Wil
                   Research Laboratories, Inc. 30 p.  (OPPTS 870.1100}

45738402     Naas, D. (1991) 28-Day Dietary Study in Mice with DMH: Lab Project Number:
                   WIL-12164. Unpublished study prepared by Wil Research Laboratories,
                   Inc. 227 p.
93074006     Handy, R. (1990) Hydrotech Chemical Corporation Phase 3 Summary of MRID
                    00128244. Acute Oral Toxicity (LD50) Study in Albino Rats with
                    Bromochlorodimethylhydantoin, #806-91-1: WIL Study No. WIL-12012.
                    Prepared by WIL Research Laboratories. 22 p.

93074011     Handy, R. (1990) Hydrotech Chemical Corporation Phase 3 Summary of MRID
                                         131

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                                                                 Halohydantoins RED
                   00128242. Primary Dermal Irritation Study in Albino Rabbits with
                   Bromochlorodimethylhydantoin, #806-91-1: WIL Study No.: WIL-12015.
                   Prepared by WIL Research Laboratories. 10 p.

93075014     Handy, R. (1990) Great Lakes Chem Corp Phase 3 Summary of MRID 00128242.
                   Primary Dermal Irritation Study in Albino Rabbits with Bromochloro
                   dimethylhydantoin, #806-91-1; WIL Study No.: WIL 12015. Prepared by
                   WIL Research Laboratories. 10 p.

93076011     Ertefaie, S. (1990) Lonza Inc Phase 3 Summary of MRID 00137105. Acute Oral
                   Toxicity Study in Rats-Dantoin DBDMH: Report No. 4741-77. Prepared
                   by Biodynamics Inc. 13 p.

93076013     Ertefaie, S. (1990) Lonza Inc Phase 3 Summary of MRID 00084176. Acute
                   Dermal Toxicity Study in Rabbits-Dantoin DCDMH: Project No. 4740-
                   77. Prepared by Biodynamics, Inc. 7 p.

93076017     Ertefaie, S. (1990) Lonza Inc Phase 3 Summary of MRID 00137109. Primary
                   Dermal Irritation Study in Rabbits-Dantoin DBDMH: Study No. 4743-77.
                   Prepared by Biodynamics Inc. 8 p.

93076025     Fassuliotis, K. (1990) Lonza Inc Phase 3 Summary of MRID 00137110. Acute
                   Dermal Toxicity Study in Rabbits [with] Dibromodimethylhydantoin:
                   Project No. 4742-77. Prepared by Bio/dynamics Inc. 8 p.

93077008     Cohen, T. (1990) Ameribrom Inc. Phase 3 Summary of MRID 00147325.
                   Halobrom- Acute Oral Toxicity in the Rat: Project No. DSB/057/HLB.
                   Prepared by Life Science Research Israel Ltd. 8 p.

93077009     Cohen, T. (1990) Ameribrom Inc. Phase 3 Summary of MRID 00147326.
                   Halobrom- Primary Dermal Irritation Study in Rabbits-Project No.
                   DSB/049/DIH. Prepared by Life Science Research Israel Ltd. 9 p.
                                        132

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                                                                  Halohydantoins RED
Open Literature

Citation

Brown, C. 2002. Water Use in the Professional Car Wash Industry. Published by
       International Carwash Association, Inc.

Clearon Corp. Material Safety Data Sheet for Halogene G.
       http://www.dsbg.com/Brome/brome.nsf/Oa03dde88bb2d9c7422567760036799d/cla588a
       37cc806a942256c2a003ea436/$FILE/8424GU_EN-MTR-CLRR.pdf, last accessed
       March, 2003.

Clements, JB. 2003. The In-Bay Automatic: An Additional Profit Center.
       http://www.wonderwash-wonderlube.com/aln_nov96.doc, last accessed February, 2003.

Cloete TE, Smith Z, Saayman G.  A Cooling Water System as a Biofilm Reactor for the
       Treatment of Municipal Wastewater. Water SA Vol. 25 No. 3 July 1999. Available on
       website http://www.wrc.org.za.

Dang W,  1996. Antimicrobial Pesticides, Uses, Human Exposures, and Risk Assessments.
       March, 1996.

Dang, W. (1996)  The Swimmer Exposure Assessment Model (SWIMODEL) and Its Use in
       Estimating Risks of Chemical Use In Swimming Pools.

DiToro, D. M. 1984.  Probability Model of Stream Quality Due to Runoff. ASCE.  Journal of
       Environmental Engineering. 110(3):607-628.

Gould, D.J. 1983. Dermatoses associated with brominated swimming pools. Br. Med. J.
       287:913.

Loughney, L. And Harrison, J.  1998.  Irritant  contact dermatitis due to  l,bromo-3-chloro-5,5-
       dimethylhydantoin in a hydrotherapy Pool. Risk Assessment: the need for continuous
       evidence-based assessment. Occup. Med. 48:461-463

Malten K.E. and den Arend J. A. 1985.  Irritant contact dermatitis.  Traumiterative and
       cumulative impairment by cosmetics, climate, and other daily loads. Derm Beruf
       Umwelt 33(4): 125-32.
Morgan, J.M. 1983. Dermatoses associated with brominated swimming pools. Br. Med. J.
       287:913.

Penny, P.T.  1991. Hydrotherapy pools of the future - the avoidance of health problems.  J.
       Hosp. Infect. 18:535-542.

Rycroft, R.J. and Penny, P.T. 1983. Dermatosis associated with brominated swimmingpools.
       Br. Med.  J287:462.
                                         133

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                                                                Halohydantoins RED

2. Website References

Citation


EFAST Help, beta version, 2004.

USEPA, 2002. Pesticide Product Information System.
      http://www.epa.gov/opppmsdl/PPISdata/index.html, last accessed September 2002.

USEPA, 2002. ECOTOX User Guide: ECOTOXicology Database System. Version 3.0.
      Available:  http://www.epa.gov/ecotox/



3. Other Supporting Documents

Citation

American Association of Textile Chemists and Colorists. 2003. Phone conversation with Tricia
      Day, Technical Assistant, July 2003.

Genest, Dan, Dominion Power. Telephone interview.  June 14, 2004.

USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research and
      Development. Washington, D.C. EPA/600/P-95/002Fa.

USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
      Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie
      Fairfax, USEPA. Dated November 4, 1999. DP Barcode D247642.

USEPA. 2000a. Dihalodialkylhydantoin - 2nd Report of the Hazard Identification Assessment
      Review Committee. Dated August 28, 2000. HED Doc. No. 014298.

USEPA. 2000b.  Residential SOPs. EPA Office of Pesticide Programs-Human Health Division.
      Dated April 5, 2000.

USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
      Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie Fairfax,
      USEPA. Dated November 4, 1999. DP Barcode D247642.

USEPA, 2001. General Principles for Performing Aggregate Exposure and Risk Assessments.
      USEPA, Office of Pesticide Programs.
                                        134

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                                                                   Halohydantoins RED
Appendix E. Generic Data Call-In

The Agency intends to issue a Generic Data Call-In at a later date for Halohydantoins.
Case # 3055, PC code # 006315
                                         135

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                                                                  Halohydantoins RED
Appendix F. Product Specific Data Call-In




The Agency intends to issue a Product Specific Data Call-In at a later date for:




Halohydantoins Case #3055 PC Code #006315
                                         136

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                                                                     Halohydantoins RED
Appendix G.  Batching of Halohydantoin 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 reregi strati on of products containing any of the
halohydantoins 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, or 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

                                           137

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                                                                     Halohydantoins RED
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
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
needs to 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. 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.

       One hundred and five (105)  products were found which contain one of the
halohydantoins as an active ingredient. These products have been placed into ten batches and a
"No Batch" category  in accordance  with the  active and inert ingredients and type of formulation.
Any product in a batch may cite new or previously submitted acute toxicity data (if it meets
current Agency standards) from any other product in the same batch, except as specified below:

       • In Batches 1, 4, 5, and 7, the highest-concentration products in the batch should not cite
        data from the lowest-concentration products in the batch: Reg. No. 5185-457 in Batch
        1, Reg. No.  5185-469 in Batch 4, Reg. No. 5185-487 in Batch 5, and Reg. No.
        6836-120 in Batch 7.

       • In the No Batch category,  each product must cite its own data.
Batch 1

EPA Reg. No.
1448-356
1448-420
1448-428
3876-150
5185-420
5185-446
5185-452
5185-454
5185-455
5185-456
5185-457
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 99%
l-Bromo-3-chloro-5,5-dimethylhydantoin 97%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 94%
                                           138

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                           Halohydantoins RED
Batch 1

EPA Reg. No.
5185-480
5185-489
5185-490
5785-57
5785-63
5785-65
5785-69
5785-70
5785-105
6836-314
6836-315
6836-316
6836-317
6836-318
8622-25
8622-28
8622-29
8622-30
8622-41
8622-70
42177-74
42177-75
53735-10
67262-23
69681-16
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 97.41%
l-Bromo-3-chloro-5,5-dimethylhydantoin 97.7%
l-Bromo-3-chloro-5,5-dimethylhydantoin 97.7%
l-Bromo-3-chloro-5,5-dimethylhydantoin 97.7%
l-Bromo-3-chloro-5,5-dimethylhydantoin 97.7%
l-Bromo-3-chloro-5,5-dimethylhydantoin 98%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 98%
l-Bromo-3-chloro-5,5-dimethylhydantoin 98%
l-Bromo-3-chloro-5,5-dimethylhydantoin 98%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
l-Bromo-3-chloro-5,5-dimethylhydantoin 96%
139

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                           Halohydantoins RED
Batch 2

EPA Reg. No.
3377-61
3377-62
3377-63
3377-71
3377-72
% Active Ingredient
l,3-Dibromo-5,5-dimethylhydantoin 99.4%
l,3-Dibromo-5,5-dimethylhydantoin 99.4%
l,3-Dibromo-5,5-dimethylhydantoin 99.4%
l,3-Dibromo-5,5-dimethylhydantoin 96.4%
l,3-Dibromo-5,5-dimethylhydantoin 96.4%
Batch 3

EPA Reg. No.
6836-109
6836-319
% Active Ingredient
l,3-Dichloro-5,5-dimethylhydantoin 97%
l,3-Dichloro-5,5-dimethylhydantoin 97%
Batch 4

EPA Reg. No.
5185-421
5185-433
5185-469
5785-100
5785-106
5785-107
5785-108
7124-102
7124-103
7124-104
8622-26
8622-27
57787-24
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 93.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 88%
l-Bromo-3-chloro-5,5-dimethylhydantoin 89.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 93.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 93.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
l-Bromo-3-chloro-5,5-dimethylhydantoin 92.5%
140

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                           Halohydantoins RED
Batch 5

EPA Reg. No.
5185-483
5185-487
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 40%
l-Bromo-3-chloro-5,5-dimethylhy dantoin 35%
Batch 6

EPA Reg. No.
6836-110
6836-124
6836-211
6836-312
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 90%
l,3-Dibromo-5,5-dimethylhydantoin 9%
l-Bromo-3-chloro-5,5-dimethylhydantoin 88.7%
l,3-Dibromo-5,5-dimethylhydantoin 8.8%
l-Bromo-3-chloro-5,5-dimethylhy dantoin 90%
l,3-Dibromo-5,5-dimethylhydantoin 9%
l-Bromo-3-chloro-5,5-dimethylhydantoin 90%
l,3-Dibromo-5,5-dimethylhydantoin 9%
Batch 7

EPA Reg. No.
6836-120
6836-121
6836-122
6836-123
66397-1
66397-2
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 81 .9%
l,3-Dibromo-5,5-dimethylhydantoin 8. 1%
l-Bromo-3-chloro-5,5-dimethylhydantoin 84.1%
l,3-Dibromo-5,5-dimethylhydantoin 8.4%
l-Bromo-3-chloro-5,5-dimethylhydantoin 85.1%
l,3-Dibromo-5,5-dimethylhydantoin 8.4%
l-Bromo-3-chloro-5,5-dimethylhy dantoin 86.4%
1 ,3 -Dibromo-5 , 5 -dimethylhy dantoin 8 . 6%
l-Bromo-3-chloro-5,5-dimethylhydantoin 86.4%
l,3-Dibromo-5,5-dimethylhydantoin 8.6%
l-Bromo-3-chloro-5,5-dimethylhy dantoin 86.4%
1 ,3 -Dibromo-5 , 5 -dimethylhy dantoin 8 . 6%
141

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                                                               Halohydantoins RED
Batch 8

EPA Reg. No.
6836-113
6836-114
6836-256
6836-263
6836-280
6836-287
6836-288
6836-291
6836-296
6836-297
% Active Ingredient
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
l,3-Dichloro-5,5-dimethylhydantoin 81.1%
l,3-Dichloro-5-ethyl-5-methylhydantoin 16. 1%
Batch 9
EPA Reg. No.
% Active Ingredient
                6836-115
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                6836-116
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                6836-117
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                6836-118
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                                     142

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                                                               Halohydantoins RED
Batch 9
EPA Reg. No.
Yo Active Ingredient
                6836-196
                6836-197
                6836-210
                6836-237
                6836-242
                6836-243
                6836-250
                6836-251
                6836-255
                6836-272
                6836-273
                6836-274
                               l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                 l,3-Dichloro-5-ethyl-5-methylhydantoin  10.6%
                 l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
                 l,3-Dichloro-5,5-dimethylhydantoin 27.4%
                                     143

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                           Halohydantoins RED
Batch 9

EPA Reg. No.

6836-275
6836-281
6836-282
6836-299
6836-300
% Active Ingredient
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
l,3-Dichloro-5,5-dimethylhydantoin 27.4%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
l,3-Dichloro-5,5-dimethylhydantoin 27.4%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
l,3-Dichloro-5,5-dimethylhydantoin 27.4%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
l,3-Dichloro-5,5-dimethylhydantoin 27.4%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
l-Bromo-3-chloro-5,5-dimethylhydantoin 60%
l,3-Dichloro-5,5-dimethylhydantoin 27.4%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.6%
Batch 10

EPA Reg. No.
6836-264
6836-265
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 57%
l,3-Dichloro-5,5-dimethylhydantoin 26%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10. 1%
l-Bromo-3-chloro-5,5-dimethylhydantoin 57%
l,3-Dichloro-5,5-dimethylhydantoin 26%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10. 1%
144

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                            Halohydantoins RED
No Batch
Each "No
Batch" product
must cite its
own data.
EPA Reg. No.
5785-62
5813-65
5813-66
6836-279
% Active Ingredient
l-Bromo-3-chloro-5,5-dimethylhydantoin 25.2%
l-Bromo-3-chloro-5,5-dimethylhydantoin 51%
l,3-Dichloro-5,5-dimethylhydantoin 23.3%
l,3-Dichloro-5-ethyl-5-methylhydantoin 9%
l-Bromo-3-chloro-5,5-dimethylhydantoin 45%
l,3-Dichloro-5,5-dimethylhydantoin 20.6%
l,3-Dichloro-5-ethyl-5-methylhydantoin 8%
l,3-Dichloro-5,5-dimethylhydantoin 52.7%
l,3-Dichloro-5-ethyl-5-methylhydantoin 10.5%
145

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                                                            Halohydantoins RED

Appendix H.  List of All Registrants Who Will Be Sent the Data Call-In
BUCKMAN LABORATORIES, INC.
1256 NORTH MCLEAN BLVD
MEMPHISTN38108
(901)278-0330


GE BETZ, INC.
4636 SOMERTON ROAD
TREVOSE, PA 190536783
(215)953-5588

BIO-LAB, INC
PO Box 300002
LAWRENCEVILLE GA, 300491002
(678)502-4149

GREAT LAKES CHEM CORP
PO Box 2200
WEST LAFAYETTE, IN 479962200
(765) 497-6391

CLOROXCO.,THE
PO Box 493
PLEASANTON, CA 945660803
(925) 425-6842

LONZA INC.
90 BOROLINE ROAD
ALLENDALE, NJ 07401
(201)785-9011

ALDEN LEEDS INC.
55 JACOBUS AVE
SOUTH KEARNY, NJ 07032
(973) 589-3544

AMERIBROM, INC.
95 MACCORKLE AVENUE, SOUTHWEST
SOUTH CHARLESTON WV 253031411
(304)746-3101
ALLIANCE TRADING, INC.
109NORTHPARKBLVD,
COVINGTON LA 70433
109 NORTHPARK BLVD, 4™ FLOOR
KING TECHNOLOGY INC.
530 11™ AVENUE SOUTH
HOPKINS MN 55343
(952)933-6118
                                     146

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                                                            Halohydantoins RED
HAVILAND CONSUMER PRODUCTS, INC.
421 ANN STREET, NW
GRAND RAPIDS, Ml 495042075
(616)361-6691

ENVIRO TECH CHEMICAL SERVICES, INC.
500 WINMOORE WAY
MODESTO CA 95358
(209)581-9576

MID-CONTINENT PACKAGING INC.
1200N54THST
ENID, OK 73701
(201) 589-3544

RECREATIONAL WATER PRODUCTS, INC.
PO Box 1449
BUFORDGA 305151449
(678)5024149

ALLCHEM PERFORMANCE PRODUCTS, LP
601ONW FIRST PLACE
GAINESVILLE, FL 32607
(352) 333-7357

E.I. DUPONT DE NEMOURS AND COMPANY
PO Box 80402
WILMINGTON DE  198800402
(302)695-2910

CONNECT CHEMICAL USA, LLC
107 COLONY PARK DRIVE, SUITE 100
CUMMINGSGA 30040
(678)947-4410

SANI-CARE SALON PRODUCTS INC.
5295 WEBB PKWY
LILBURN GA 30047
(770) 279-7722

BWA WATER ADDITIVES US, LLC
1979 LAKESIDE PARKWAY, SUITE 925
TUCKER GA 30084
(678) 802-3024

ALBEMARLE
451 FLORIDA ST
BATON ROUGE LA 70801
(504) 388-7650
                                     147

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