United States Prevention, Pesticides EPA 739-R-07-011
Environmental Protection and Toxic Substances December 2007
Agency (7510P)
Reregistration
Eligibility Decision
(RED) for Busan 77
(Case 3034)
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Busan 77 RED
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 draft risk assessments for the antimicrobials, Busan 77. The enclosed
Reregi strati on Eligibility Decision (RED) document was approved on December 21 2007.
Public comments and additional data received were considered in this decision.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for Busan 77 and the 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 Busan 77 are available to the public in
EPA's Pesticide EPA-HQ-OPP-2007-0834 at: http://www.regulations.gov.
The Busan 77 RED was developed through EPA's public participation process, published
in the Federal Register on September 28, 2007 provides opportunities for public involvement in
the Agency's pesticide tolerance reassessment and reregi strati on 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 Busan 77 risk assessment and the attached RED document concern
only this particular pesticide. This RED presents the Agency's conclusions on the dietary,
residential, occupational and ecological risks posed by exposure to Busan 77 alone. This
document also contains both generic and product-specific data that the Agency intends to require
in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to
registrants at a later date. Additionally, for product-specific DCIs, the first set of required
responses will be due 90 days from the receipt of the DCI letter. The second set of required
responses will be due eight months from the receipt of the DCI letter.
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As part of the RED, the Agency has determined that Busan 77 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 Busan 77. 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, (703) 308-6427. For questions
about product reregistration and/or the Product DCI that will follow this document, please
contact Adam Heyward at (703) 308-6422.
Sincerely,
Frank Sanders, Director
Antimicrobials Division (75IOC)
in
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REREGISTRATION ELIGIBILITY
DECISION
for
Busan 77
Case Number 3034
Approved by:
Frank T. Sanders, Direct^
Antimicrobials Division
/ 09-
Date
IV
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TABLE OF CONTENTS
Busan 77 Reregistration Team iv
Glossary of Terms and Abbreviations v
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
III. Summary of Busan 77 Risk Assessments 7
A. Human Health Risk Assessment 7
1. Toxicity of Busan 77 7
2. FQPA Safety 9
3. Dietary Risk Assessment 10
a. Dietary Risk from Drinking Water 10
4. Residential Risk Assessment 10
a. Toxicity 11
b. Residential Handler 12
i. Exposure Assessment 12
ii. Risk Assessment 13
c. Residential Post-application 16
i. Exposure Assessment 16
a. Dermal Exposure 16
b. Incidental Ingestion 17
ii. Post-Application Risk Estimates 17
5. Aggregate Risk Assessment 19
a. Short and Intermediate Aggregate Exposure Risk 19
6. Occupational Risk 20
a. Occupational Toxicity 20
b. Occupational Handler Exposure 20
c. Occupational Handler Risk Summary 26
d. Occupational Post-Application Risk Summary 30
7. Human Incident Data 30
B. Environmental Risk Assessment 30
1. Environmental Fate and Transport 31
2. Ecological Risk 33
a. Environmental Toxicity 33
b. Ecological Exposure and Risk 40
c. Risk to Listed Species 42
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 44
A. Determination of Reregistration Eligibility 44
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Busan 77 RED
B. Public Comments and Responses 44
C. Regulatory Position 45
a. Determination of Safety to U.S. Population 45
b. Determination of Safety to Infants and Children 45
c. Endocrine Disrupter Effects 46
d. Cumulative Risks 46
D. Regulatory Rationale 46
1. Human Health Risk Management 47
a. Dietary Risk Mitigation 47
b. Drinking Water Risk Mitigation 47
c. Residential Risk Mitigation 47
d. Occupational Risk Mitigation 48
2. Environmental Risk Management 48
3. Other Labeling Requirements 49
4. Listed Species Considerations 49
a. The Endangered Species Act 49
b. General Risk Mitigation 50
V. What Registrants Need to Do 51
A. Manufacturing Use-Products 53
1. Additional Generic Data Requirements 53
2. Labeling for Technical and Manufacturing-Use Products 53
B. End-Use Products 54
1. Additional Product Specific Data Requirements 54
2. Labeling for End-Use Products 54
a. Label Changes Summary Table 55
VI. Appendices 56
A. Table of Use Patterns for Busan 77 57
B. Table of Generic Data Requirements and Studies Use to Make the
Reregistration Decision 71
C. Technical Support Documents 77
D. Bibliography Citations 78
E. Generic Data Call-In 87
F. Product Specific Data Call-In 88
G. Batching of End-Use Products 89
H. List of All Registrants Sent the Data Call-In 90
I. List of Available Forms 91
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Busan 77 Reregistration Team
Antimicrobials Division
Science Team
Najm Shamim, PhD., Chemist
Jonathan Chen, Ph.D., Toxicologist
Genevieve Angle, Biologist
James Breithaupt, Agronomist
Cassi Walls, Ph.D., Chemist
Tim McMahon, Ph.D., Senior Toxicologist
Siroos Mostaghimi, Ph.D
Risk Management
ShaRon Carlisle
Diane Isbell
in
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Busan 77 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
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume of
water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
IV
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Busan 77 RED
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
NTP National Toxicology Program
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
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RAC Raw Agricultural Commodity
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 24(c) of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
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Busan 77 RED
Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for Busan 77 and is issuing its risk management
decision. 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 Busan 77 that pose risks
of concern. As a result of this review, EPA has determined that Busan 77 containing products
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.
VI
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Busan 77 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 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregi strati on Eligibility Decisions. 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 by the U.S. Environmental Protection Agency (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 or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that,
for those chemicals that have tolerances and are undergoing reregi strati on, the tolerance
reassessment will be initiated through this reregi strati on process. The Act also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's revised human health and ecological risk assessments; and the Reregi strati on
Eligibility Decision (RED) for Busan 77.
This document presents the EPA decision regarding the reregi strati on eligibility of the
registered uses of the Poly [oxyethylene(dimethylminino) ethylene(dimethyliminio)ethylene
dichloride], which is commonly referred to as Busan 77. There is one active PC Code (069183)
in the Busan 77 case.
Busan 77 is currently registered as an active ingredient in end use products (EUPs) as an
algaecide, bacteriostat, fungicide, microbiocide/microbiostat and molluscicide. The registered
Busan 77 products are formulated as liquid concentrates and granules. Examples of these use
sites with products containing Busan 77 are: swimming pools, spas, whirlpools, hot tubs, metal
working fluids, fire water protection systems, cooling water towers, petroleum secondary
recovery systems, paper mill process water, air washer water systems, ornamental ponds,
aquariums and various fabrics. Concentrations of Busan 77 in these products range from 1.7% to
60%. There are no current registrations for Busan 77 as an inert ingredient.
The Agency has concluded that no special hazard-based safety factor under the Food
Quality Protection Act (FQPA) of 1996 is needed for Busan 77 based on an acceptable
developmental and reproductive toxicity studies that adequately characterize the dose-response
of this compound along with the lack of evidence for any sensitivity of offspring to the adverse
effects of Busan 77.
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Busan 77 RED
Risks summarized in this document are those that result only from the use of the active
ingredients Busan 77. The Food Quality Protection Act (FQPA) requires that the Agency
consider available information concerning the cumulative effects of a particular pesticide's
residues and other substances that have a common mechanism of toxicity. The reason for
consideration of other substances is due to the possibility that low-level exposures to multiple
chemical substances that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect that would occur at a higher level of exposure to any of the
substances individually. Unlike the pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not yet initiated a review to
determine if there were any other chemicals that have a mechanism of toxicity common with that
of Busan 77. For the purposes of this action, therefore, EPA has not assumed that Busan 77 has a
common mechanism of toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of Busan 77. In an effort to simplify the RED, the information presented
herein is summarized from more detailed information, which can be found in the technical
supporting documents for Busan 77 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
www.reeulations.gov (EPA-HQ-OPP-2007-0834).
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 Busan 77 and its regulatory history.
Section III, Summary of Busan 77 Risk Assessment, 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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Busan 77 RED
II. Chemical Overview
A. Regulatory History
EPA registered the first product containing Busan 77 on January 12, 1971. The Busan 77
case consists of a single pc code, 069183. It is registered as a microbicide concentrate used for
the control of algae in swimming pools, hot tubs, whirlpools and fountains without fish. It is
also registered to control and combat the growth of algae, bacteria, and fungi in recirculating
cooling towers, industrial air washing systems, and metal cutting fluids. Currently there are 151
active products containing Busan 77. There are no current inert applications and no tolerances
listed for this chemical.
B. Chemical Identification
r
~i
0,3
9*3
e
0*3
1.
L— , -.„--—.' „-% " j.
J
Figure 1. Molecular Structure of Busan 77
Common Name: Busan 77
Chemical Name:
Other Name(s):
CAS Registry Number:
OPP Chemical Code:
Case Number:
Poly (oxyethylene (dimethylminino) ethylene (dimethy
liminio) ethylenedichloride)
Poly (oxy-1, 2-ethanediyl (dimethylminio)-l, 2-
ethanediyl (dimethylimio)-l, 2-ethanediyl dichloride
31512-74-0
069183
3034
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Busan 77 RED
Empirical Formula:
Molecular Weight:
Manufacturer:
Highest Percent of
Active Ingredient:
Chemical Properties:
Variable as the polymeric units differ
3,886 g/mol
Buckman Laboratories
60%
Busan 77 is a light amber/pale yellow colored clear liquid of
mildly unpleasant fishy odor. It has a density of 1.103- 1.1417
g/cc. The melting point for Busan 77 is not applicable. The
boiling point for Busan 77 is 111 °C. The vapor pressure for
Busan 77 is_10.8 mm Hg (20 °), 14.4 mm Hg (25 ° C). Busan 77 is
completely soluble in water. The pH for Busan 77 is 6.9-7.3 ± 0. It
has a viscosity of 1.52 (20 ° C).
C.
Use Profile
The following is information on the currently registered uses of Busan 77, including an
overview of use sites and application methods. The various EUP can be listed in five categories,
which are residential, and public access, materials preservation, industrial process and water
systems swimming pools and aquatic areas. A detailed table of the Busan 77 uses eligible for
reregi strati on is available in Appendix A.
Summary of Uses:
Target Pests:
Residential and Public Access:
Used in residential and non-commercial environments including
swimming pools, spas, whirlpools and hot tubs, waterbed mattress water,
aquariums and ornamental ponds and fountains.
Materials Preservatives:
Used in the production of industrial items such as metal working fluids.
Industrial Process and Water Systems:
Used on fresh water supplies for commercial and industrial systems such
as water cooling towers (recirculating and once-through), air washer water
systems, fire protection systems, textile water systems and pulp and paper
water systems
Algae, bacteria, and fungi.
Formulation Types: Formulation intermediate, ready to use, soluble concentrate,
granular/pelleted.
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Busan 77 RED
Methods and Rates of Application:
To inhibit the growth of bacteria in waterbed mattresses. Eight (8) fluid ounces
of product is applied to fiber waterbed mattress of 90-180 gallons capacity. Add
4 to 12 gallons capacity to a twin or hybrid type waterbed up to 90 gallons
capacity. Repeat 10-12 months in fiber or foam beds. In free flow waterbeds
repeat 18-24 months.
To control the growth of algae, bacteria and fungi in recirulating cooling
towers. An initial slug addition of .9 to 94 fluid ounces per 1000 gallons of water.
Subsequent slug additions .2 to 59 fluid ounces per 1000 gallons of water should
be employed every 1 to 5 days or as needed. Slug additions should be made in
the sump of water cooling towers.
To control the growth of algae, bacteria and fungi in air washer water systems.
An initial slug dose of 3.3 to 83.25 fluid ounces per 1000 gallons of water.
Subsequent slug additions 2.25 to 83.25 fluid ounces per 1000 gallons of water
should be employed 1 to 5 days or as needed.
To control microbial growth that causes degradation of cooked starch used in
paper manufacture. Add 75 to 750 ppm based on total weight of the starch and
water. Do not use in paper and paperboard that will contact food.
To control slime-forming and sulflde-producing bacteria in petroleum
secondary recovery systems. Using a continuous feed method add 11.6 to 92.8
fluid ounces.
To inhibit the growth of bacteria in metalworking fluids employed as lubricants
or coolants in machinery and processing metals. Add to diluted metalworking
fluid at a concentration of .01 to .10 percent based on total weight of the
metalworking fluid.
To help control microorganisms that may foul or cause corrosion in fire water
protection systems. For the initial dose add 11.6 to 6.4 fluid ounces per 1000
gallons.
To control the growth of algae in swimming pools add an initial dose of 13 to 24
fluid ounces per 1000 gallons of water. Add subsequent additions of 2 to 27 fluid
ounces per 10,000 gallons of water every 5 to 7 days after initial treatment for
maintenance.
To control the growth of algae in spas, whirlpools or hot tubs. Add an initial
dose of 0.5 to 12 fluid ounces per 1000 gallons of water. Subsequent additions of
.2 to 9 fluid ounces per 1000 gallons of water should be made every 5 to 7 days
after initial dose for maintenance.
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Busan 77 RED
To control the growth of algae in aquarium water systems. Add 1 ml to 480 ml
according to volume of water. Do not use in aquariums with invertebrates or
crustaceans e.g. crabs, shrimps, or crayfish.
To control the growth of algae in ornamental ponds. Add an initial dose of 0.5
to 24 fluid ounces per 1000 gallons of water. Subsequent additions of .2 to 9 fluid
ounces per 1000 gallons of water should be made every 5 to 7 days after initial
dose for maintenance.
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Busan 77 RED
III. Summary of the Busan 77 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 the Busan 77. While the risk assessments and related addenda are not
included in this document, they are available from the OPP Public Docket EPA-HQ-OPP-2007-
0834, and may also be accessed from 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.
The Agency's use of human studies in the Busan 77 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.
A. Human Health Risk Assessment
1. Toxicity of the Busan 77
A brief overview of the toxicity studies used for determining endpoints in the risk
assessment is outlined below in Table 1. Further details on the toxicity of Busan 77 can be found
in the "Revised Busan 77: Toxicology Chapter for Issuance of the Reregi strati on Eligibility
Decision (RED) Document," dated September 30, 2007. This document is available on the
Agency's website in the EPA Docket at: http://www.regulations.gov (Docket ID #EPA-HQ-
OPP-2007-0834).
The Agency has reviewed all toxicity studies submitted for Busan 77 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 in Table 1
below.
Table 1. Acute Toxicity Profile for Busan 77
Guideline
Number
870.1100
(§81-1)
870.1200
(§81-2)
870.1300
(§81-3)
870.2400
(§81-4)
Study Type/Test substance
(% a.i.)
Acute Oral- Rat
purity 61.6% -Busan 77
Acute Dermal- Rabbit
purity 6 1 .6% - Busan 77
Acute Inhalation- Rabbit
Purity 60% - Busan 77
Primary Eye Irritation- Rabbit
purity 61.6% -Busan 77
MRID
Number/Citation
41373401/
93062009
41327101/
93062010
41877501
41361701/
93062011
Results
LD50= 1951 (1727-2203)
mg/kg (M); LD50 = 2587
(2059-3250) mg/kg (F)
LD50 > 2000 mg/kg
LC50 = 4.0 (2.3-7. l)mg/L
(M); 2.4 (1.7-3.3) mg/L
(F); 2.9 (2.3-3.7) mg/L
(combined)
Redness cleared on day 3
Toxicity
Category
III
III
III
III
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Busan 77 RED
Guideline
Number
870.2500
(§81-5)
870.2600
(§81-6)
Study Type/Test substance
(% a.i.)
Primary Dermal Irritation-
Rabbit
6 1.6% -Busan 77
Dermal Sensitization - Guinea
Pig
purity 60. 1 % - Busan 77
MRID
Number/Citation
41298601/
93062012
40750301/
93062013
Results
Slight Irritant
Not a sensitizer.
Toxicity
Category
IV
NA
General Toxicity Observations
Acute Toxicity
Busan 77 exhibits moderate toxicity (Category III) for oral, dermal, inhalation, and
primary eye irritation. Acute dermal studies indicate that Busan 77 is classified as a slight
irritant.
Dietary
A dietary assessment was generated for Busan 77 based on the potential for dietary
exposure Busan 77 is used in the paper manufacturing processes as a slimicide for pulp and
paper mill technologies or for starch preservation. No toxic effects were identified that were
attributable to a single exposure. Therefore, an acute dietary assessment is not required.
Incidental Oral
The NOAEL for the short-term (1 - 30 days) incidental oral endpoint is 500 mg/kg/day,
based on a developmental toxicity study in the rat in which increased mortality was observed.
For intermediate-term (30 days - 6 months) incidental oral exposure, a NOAEL of 221
mg/kg/day was selected based on a subchronic toxicity study in rats and was based on renal
tubular mineralization. The target margin of exposure (MOE) for both is 100 for the short- and
intermediate-term (10X for inter-species extrapolation and 10X for intra-species variation).
Dermal
The short-term dermal NOAEL is 10 mg/kg/day, based on dermal irritation, selected
from a 90-day dermal toxicity study in rats. The target MOE is 10 for the Short-term dermal
duration. There were no endpoints identified for intermediate and long-term durations.
Inhalation
The short-term inhalation exposure assessment (<30 days), is based on a developmental
toxicity study in the rat, in which increased mortality was observed; an oral NOAEL of 500
mg/kg/day was selected. For intermediate-term (30 days - 6 months) inhalation exposure, an
oral NOAEL of 221 mg/kg/day was selected based on a subchronic toxicity study in rats and was
based on renal tubular mineralization. The long-term inhalation exposoure (>60 months), was
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Busan 77 RED
derived from the chronic toxicity /carcinogen!city study in rats using the NOAEL of 100
mg/kg/day based on effects observed at 300 mg/kg/day (decreased body weight gain, decreased
albumin and total protein, increased urine pH). The target margin of exposure (MOE) is 100 for
short-, intermediate-, and long-term durations.
Carcinogenicity
Busan 77 is currently classified as a 'Group D' (inadequate evidence) carcinogen.
Negative results were observed in a mouse carcinogenicity study, but in a rat chronic
toxicity/carcinogenicity study, increases in the incidence of thyroid C-cell adenomas were
observed in female rats at doses of 300 and 900 mg/kg/day. The increase in thyroid C-cell
adenoma was statistically significant at 300 mg/kg/day.
Mutagenicity
In mutagenicity studies (reverse mutation assay, mouse micronucleus assay, unscheduled
DNA synthesis assay, sex-linked recessive lethal assay), Busan 77 was found to be non-
mutagenic.
Endocrine Disruption
The EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act (FQPA), to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may
have an effect in humans that is similar to an effect produced by a naturally occurring estrogen,
or other endocrine effects as the Administrator may designate." Following recommendations of
its Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA
determined that there was a scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted
EDSTAC's recommendation that EPA include evaluations of potential effects in wildlife. For
pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to require the wildlife
evaluations. As the science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, Busan 77 may be subject to additional screening and/or
testing to better characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The Antimicrobials Division's
9
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Busan 77 RED
Toxicology Endpoint Selection Committee (ADTC) has recommended that the special hazard-
based FQPA safety factor for Busan 77 be removed. This conclusion is based upon the (1)
availability of acceptable developmental and reproductive toxicity studies with Busan 77 that
adequately characterize the dose-response of this compound (2)the lack of evidence for any
sensitivity of offspring to the adverse effects of Busan 77 and (3) the risk assessment does not
underestimate the potential exposure for infants and children.
3. Dietary Risk Assessment
A chronic dietary assessment for Busan 77 is warranted based on the use in the paper
manufacturing processes as a slimicide for pulp and paper mill technologies or for starch
preservation. No toxic effects were identified that were attributable to a single exposure.
Therefore, an acute dietary assessment is not required. The registrant has indicated that they no
longer support the starch uses, and that they will be removed from product labels. Further, based
on the very low application rates for the slimicide use in pulp and paper mills (lOppm) the
Agency believes that exposures will be negligible and, therefore does not have dietary risk
concerns. This conclusion is supported by the fact that previous assessments for other chemicals
with similar toxicological endpoints but much higher application rates (1000-1200 ppm) resulted
in very low exposure and risk estimates. Additional information can be found in the document
titled, "Dietary Risk Assessment (Indirect Food Contact) Uses in Paper Manufacturing Process
of Poly[(oxyethylene)(dimethylimino)ethylene(dimethylimino) ethylene dichloride] [Busan 77],"
dated September 30, 2007.
a. Dietary Risk from Drinking Water
The chemical adsorbs strongly to soil, such that a drinking water exposure is not likely.
The modeled results for incidental oral exposures, based on the swimming pool use, are higher
than those resulting from the conservative modeling of the once through cooling water use.
Considering that the risk estimates for the highest exposure swimming scenario yielded MOEs
greater than 50,000, the Agency does not expect drinking water exposures resulting from the
once through cooling water system use to be of concern because the low potential for exposure.
4. Residential Risk Assessment
The residential uses of Busan 77 are primarily aquatic and include pools, spas,
whirlpools, hot tubs, ornamental ponds/fountains, and aquariums. In addition, it can be used to
control odor-causing and slime-forming bacteria in waterbed mattress water. 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.
For this screening level assessment, the Agency selected scenarios based on the
application/handling methods and use amounts specified on product labels. The specific
scenarios assessed were selected because they are believed to be representative of the majority of
the residential uses and provide the high-end estimates for exposure and risk. For additional
10
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Busan 77 RED
information, please refer to "Occupational and Residential Exposure Chapter for the Busan 77
Reregistration Eligibility Decision (RED) Document (Case 3034)," dated July 27, 2007.
a. Residential Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the
residential and occupational risks for Busan 77 are listed in Table 2.
Table 2: Summary Table of Toxicological Doses and Endpoints for Busan 77
Exposure Scenario
Dose (mg/kg/day) UF /
MOE
Hazard Based
Special FQPA Safety
Factor
Study and Toxicological
Effects
Dietary Risk Assessments
Acute Dietary (gen pop)
Acute Dietary (females 13+)
Chronic Dietary
Incidental Oral
Short-Term
(1 - 30 Days)
Incidental Oral
Intermediate-Term
(1-6 Months)
This risk assessment is not required.
This risk assessment is not required.
NOAEL = 100 mg/kg/day
UF=100
Chronic RfD = 1.0
mg/kg/day
NOAEL = 500 mg/kg/day
MOE = 100
NOAEL = 221 mg/kg/day
MOE = 100
Ix
Ix
Ix
Chronic toxicity in rats
LOAEL = 300 mg/kg/day
based on clinical alterations
and reduced body weight
gain
Developmental Toxicity -
Rat
LOAEL = 700 mg/kg/day
(increased mortality)
Subchronic toxicity in Rats
LOAEL = 752 mg/kg/day
Based on renal tubular
mineralization
Non-Dietary Risk Assessments
Dermal
Short-Term
Dermal
Intermediate and Long-Term
Inhalation
Short-Term
(1 - 30 Days)
NOAEL = 10 mg/kg/day
(125 ug/cm2)
MOE =10
NOAEL = 500 mg/kg/day
MOE = 100
Ix
Ix
Ix
90 -day dermal toxicity
study in rats
MRID 40 170601
LOAEL = 100 mg/kg/day,
based on dermal irritation.
No endpoint identified in the
database.
Developmental Toxicity -
Rat
LOAEL = 700 mg/kg/day
(increased mortality)
11
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Busan 77 RED
Exposure Scenario
Dose (mg/kg/day) UF /
MOE
Hazard Based
Special FQPA Safety
Factor
Study and Toxicological
Effects
Dietary Risk Assessments
Inhalation
Intermediate-Term
(1-6 Months)
Inhalation
Long-Term
(> 6 Months)
Cancer
NOAEL = 221 mg/kg/day
MOE = 100
NOAEL = 100 mg/kg/day
UF=100
MOE = 100
Ix
Ix
Subchronic toxicity in Rats
LOAEL = 752 mg/kg/day
Based on renal tubular
mineralization
Chronic toxicity in rats
LOAEL = 300 mg/kg/day
based on clinical alterations
and reduced body weight
gain
Group "D" based on increased thyroid C-cell adenomas by ad hoc committee.
Referred to the full HED CARC for evaluation of carcinogenic potential.
Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect
level, and MOE = margin of exposure.
For Busan 77, the target MOE is 100 for all routes and duration of exposure. It should be
noted that since the inhalation NOAEL is based on an oral study that an additional 10X (i.e.,
MOE = 1,000) may be warranted to request that an inhalation-specific study be conducted.
b.
Residential Handlers
i. Exposure Assessment
Residential exposure to Busan 77 can occur in a variety of residential settings. For the
residential exposure risk assessment, the EPA selected high-end exposure scenarios that are
considered to be representative of all residential handler exposure scenarios. These scenarios
were evaluated using maximum application rates as stated on product labels. To assess the
handler and post-application exposures and risks, the Agency used standard assumptions,
surrogate unit exposure data from the Chemical Manufacturers Association (CMA) antimicrobial
exposure study.
Busan 77 is currently registered for several residential aquatic uses. It is used to control
algal growth in swimming pools, spas, hot tubs, ornamental ponds, decorative fountains, and
aquariums. Furthermore, Busan 77 can also be used to control odor-causing and slime-forming
bacteria in waterbed mattress water. Table 3 identifies the representative residential exposure
scenarios assessed in this document.
Table 3. Representative Uses Associated with Residential Exposure
Representative Use
Exposure Scenario
Application
Method
Reg.#
Application Rate
12
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Busan 77 RED
Representative Use
Swimming Pool
Spa/whirlpool/hot
tub/ornamental ponds
Aquarium
Waterbed mattress
water
Exposure Scenario
ST handler: dermal
(irritation) and
inhalation (aerosol)
ST and IT post-app:
incidental oral and
dermal2
ST handler: dermal
(irritation) and
inhalation (aerosol)
ST handler: dermal
(irritation) and
inhalation (aerosol)
ST handler: dermal
(irritation) and
inhalation (aerosol)
Application
Method
• Open pour
(solid)1
• Open pour
(liquid)
NA
• Open pour
(liquid)
• Open pour
(liquid)
• Open pour
(liquid)
Reg.#
3432-28
57787-11
57787-11
1448-346
14802-8
42373-6
Application Rate
0.0012flozai/gal
(30 oz/5,000 gal x 20%ai)
0.0012ozai/gal
(1 17 fl oz/10,000 gal x 10%ai)
(product density = 8.51b/gal)
9.3 mg ai/L
(1 17 fl oz/10,000 gal x 10%ai x
gal/128oz x 8.5 Ib/gal x 4.54E5
mg/lb x 0.264 gal/L)
0.0012flozai/gal
(3 fl oz/1000 gal x 40%ai)
(product density =9.121b/gal)
0.00023 fl oz ai/gal
(5ml/40galx5.4%aixfl
oz/29.57ml)
(product density = 8.41b/gal)
0.0044 fl oz ai/gal
(8floz/180galxlO%ai)
(product density = 8.51b/gal)
1 Note: since the application rates are the same, the dermal irritation exposure from the open solid pour scenario was represented by the open pour
liquid scenario. Furthermore, the open liquid pour scenario is considered worst-case as compared to the solid pour for dermal irritation due to
physical nature of the product and its potential to contact skin during the application.
Note: post-application exposure to swimming pool residues is representative for post-application exposure to spa/whirlpool residues since the
application rates are the same for both uses
11.
Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments. A MOE greater than or equal to 10 is considered
adequately protective for the residential exposure assessment for the short-term dermal route of
exposure. An MOE of 100 is considered adequately protective for the residential inhalation
route of exposure for all durations.
For the Busan 77, the target MOE for identifying risks of concern is 100 and the target
MOE for identifying the need for inhalation toxicity data is 1,000 (lOx inter-species
extrapolation, lOx intra-species variation, lOx route extrapolation). In cases where inhalation
endpoints are set using oral toxicity studies the Agency will consider requiring an inhalation
toxicity study to confirm that the use of route-to-route extrapolation does not underestimate risk.
The Agency determines the need for confirmatory inhalation data by evaluating the inhalation
13
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Busan 77 RED
MOEs. For the Busan 77, if MOEs are greater then 100 there are no risks of concern. However,
if MOEs are less than 1,000 confirmatory inhalation toxicity data are necessary to account for the
use of route-to-route extrapolation.
In order to conduct the comprehensive risk assessment, the Agency used standard
assumptions, surrogate unit exposure data from the Chemical Manufacturers Association
(CMA) antimicrobial exposure study, EPA's Health Effects Division's (HED) Standard
Operating Procedures (SOPs) for Residential Exposure Assessments, and EPA's SWIMODEL.
The specific input parameters and assumptions are discussed in the supplementary exposure
assessment. It is important to note that most of the CMA data are of poor quality therefore, the
Agency needs additional confirmatory monitoring data be generated to support the values used
in these assessments. In addition, the values utilized for the quantities handled/treated were
estimated based on information from various sources and these can be further refined with input
from registrants.
All of the calculated MOEs were above the target of 10 for dermal and of 100 for
inhalation for all scenarios. Furthermore, all inhalation MOEs exceeded 1,000 therefore, a
confirmatory inhalation toxicity study is not warranted based on the results of these exposure
scenarios. The resulting short- and intermediate-term exposures and MOEs for the
representative residential handler scenarios are presented in Table 4.
14
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Busan 77 RED
Table 4 Residential Handler Exposures and MOEs for Busan 77
Exposure
Scenario
Swimming pools
Spas/whirlpools/
ponds
Aquariums
Waterbed mattress
Application
Method
Open pour -
liquid
Open pour -
solid
Open pour -
liquid
Open pour -
liquid
Open pour -
liquid
Unit Exposure
Dermal
(mg/lb
ai/cm2)
0.00023
NA
0.00023
0.00023
0.00023
Inhal
(mg/lb ai)
0.00346
0.0119
0.00346
0.00346
0.00346
Amount
treated
(gal/day)
20,000
20,000
1,000
100
180
Use Rate
0.0012 fl°Z,
ai/gal
0.0012 oz ai/gal
0.0012 fl°Z,
ai/gal
0.00023 fl°Z,
ai/gal
0.0044 fl°Z,
ai/gal
Amount ai
handled
(Ib ai/day)b
1.6
1.5
0.086
0.0015
0.053
ST/IT Exposure
Dermal
(mg/cm2)c
3.6E-04
NA
2.0E-05
3.4E-07
1.2E-05
Inhalation
(mg/kg/day)
7.7E-05
2.6E-04
4.2E-06
7.4E-08
2.6E-06
ST MOEsf
Dermal
Target
MOE=10
350
NA
6,400
360,000
10,000
Inhalation
Target
MOE=100
6,500,000
2,000,000
120,000,000
6,800,000,000
190,000,000
IT MOEsf
Target MOE
Inhalation
2,900,000
870,000
52,000,000
3,000,000,000
84,000,000
b: Liquid Amt ai handled (Ib ai/day) = use rate (fl oz ai/gal) x gal/128oz x product density (Ib/gal) x amt treated (gal treated/day)
Solid Amt ai handled (Ib ai/day) = use rate (oz ai/gal) x lb/16oz x amt treated (gal treated/day)
c: Dermal exposure (mg/cm2) = Dermal unit exposure (mg/lb ai/cm2) x Amt ai handled (Ib ai/day)
e: Inhalation exposure (mg/kg/day) = Inhalation unit exposure (mg/lb ai) x Amt ai handled (Ib ai/day)/70 kg
f: MOE = NOAEL / Exposure; where ST dermal NOAEL = 125 ug/cm2 (or 0.125 mg/cm2); ST inhalation NOAEL = 500 mg/kg/day; IT inhalation NOAEL = 221 mg/kg/day
15
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Busan 77 RED
c. Residential Post-application
i. Exposure Assessment
Residential post-application dermal exposures result when adults and children come in
contact with Busan 77 in areas where pesticide end-use products have recently been applied
(e.g., swimming pool and spas/whirlpool ), or when children incidentally ingest the pesticide
residues through swallowing treated swimming pool water. It is anticipated that absorbents such
as textiles will absorb Busan 77 and post-application residential dermal and incidental oral
exposures to treated textiles may occur. Note that inhalation exposures (vapor) are not expected
due to the extremely low vapor pressure of Busan 77; therefore, these exposures were not
assessed.
a. Dermal Exposure
Textile Freshwater System Use
Busan 77 can be used "to control the growth of bacteria and fungi in holding and
processing tanks of industrial fresh water systems supplying water to pulp and paper mills,
textile mills, and other manufacturing plants" (EPA Reg. No. 1448-42). As stated on the label
"absorbents rapidly absorb the product. " Therefore, it is anticipated that absorbents such as
textiles will absorb Busan 77 and post-application residential dermal and incidental oral
exposures to treated textiles may occur. However, the level of residues remaining on the textile
is unknown and can not be accurately modeled at this time. Busan 77 is intended to control
microorganism growth in the water used in the facility not to preserve the textile. Since the
application rate is in terms of volume of water not textile, the rate cannot be extrapolated to
estimate the amount of residue remaining on the textile that comes in contact with the treated
water. Therefore, a textile residue study is needed in order to conduct the post-application
residential exposures.
Swimming Pool and Spa Uses
There are post-application dermal exposures to Busan 77 associated with the swimming
pool and spa use. The SWIMODEL 3.0 was developed by EPA as a screening tool to conduct
exposure assessments of pesticides found in swimming pools and spas (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
estimates absorbed dermal exposure based on the chemical's permeability constant (Kp). For
Busan 77, the dermal toxicological effect is based on skin irritation not an absorbed systemic
effect. Therefore, the SWIMODEL is not appropriate to use to estimate dermal exposure for
Busan 77.
The film thickness methodology was used to estimate dermal exposure to pool and spa
treated water. The following equation was used to develop the short-term dermal doses:
16
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Busan 77 RED
Dose = Cw x FT
where:
Dose = Daily dose for pools (jig/cm2);
Cw = Chemical concentration in pool water (mg ai/L = jig ai/cm3); and
FT = Film thickness of water on the skin (cm).
It should be noted that adults and children, competitive and noncompetitive swimmers,
and pool users and spa users will all have the same exposures and MOEs using the film thickness
approach.
b. Incidental Ingestion
Swimming Pool and Spa Uses
The SWIMODEL 3.0 was used to estimate post-application incidental ingestion of
treated swimming pool water. Although, the actual model was not used in this assessment, the
same equations and default parameters as provided in the SWIMODEL User's Manual (version
3.0) were used in a spreadsheet format to estimate post-application incidental oral exposures.
Incidental ingestion of treated water is typically associated with use of swimming pools not spas
or whirlpools therefore; the oral exposures were only estimated for swimming pool use. Both
short- and intermediate-term exposures durations were assessed since there is a potential for
exposure every day for competitive swimmers.
ii. Post-Application Risk Assessment
Based on the registered use patterns, toxicological criteria and potential for exposure,
the Agency has conducted dermal and incidental oral exposure assessments. The scenarios
included in the risk assessment are considered to represent high-end exposures. A MOE greater
than or equal to 10 for dermal and 100 for inhalation exposures is considered adequately
protective for the residential post-application exposure assessment for all routes of exposure.
Swimming Pool and Spa Uses (Dermal)
The short-term dermal doses and MOEs for adults and children are presented in Table 5.
It should be noted that adults and children, competitive and noncompetitive swimmers, and pool
users and spa users will all have the same exposures and MOEs using the film thickness
approach. The resulting MOE is above the target MOE of 10 and therefore not of concern.
17
-------
Busan 77 RED
Table 5: Short-term Adult and Child Dermal Exposures and MOEs for Busan 77 used in
Swimming Pools and Spas
Scenario
ST Adult and Child Dermal Exposures and MOEs From
the Use of Pools and Spas3
Child (7-10 years) Incidental Ingestion exposures for
both competitive and non-competitive swimmers in
pools'3
ST Child (11-14 years) Incidental Ingestion exposures
for both competitive and non-competitive swimmers in
pools'3
ST Adult competitive swimmers in pools; Incidental
Ingestion Exposure13
ST Adult non-competitive swimmers in pools;
Incidental Ingestion Exposure13
Dose
fag/cm2)
0.046
0.016
0.0097
0.0050
0.0030
MOEa
2,700
32,0000 (ST) and 14,000 (IT)
52,000 (ST) and 23,000 (IT)
100,000 (ST) and 44,000 (IT)
150,000 (ST) and 66,000 (IT)
a: MOE = NOAEL mg/kg/day/ Dose (mg/kg/day). ST Oral NOAEL = 500 mg/kg/day, IT Oral NOAEL = 221 mg/kg/day; ST and IT Target
MOE = 10
Swimming Pool Uses (Incidental Oral)
The water concentration in pool water is based on information provided in the labels.
The ingestion rate used in the SWIMODEL 3.0 is based on the value used in EPAs Residential
SOPs (U.S. EPA, 1997a) and an EPA pilot study as discussed in ACC's swimmer survey (ACC,
2002). The exposure time is based on ACC's swimmer survey for competitive swimmers (ACC,
2002) and the NHAPs data for non-competitive/recreational swimmers (US EPA, 1996). Table
6 presents the incidental ingestion exposures and MOEs for swimmers in Busan 77 treated pools.
All of the MOEs are above the target MOE of 100 and are therefore not of concern.
Table 6. Short-and Intermediate-term Adult and Child Incidental Ingestion Exposures and MOEs for Busan
77 used in Swimming Pools
Cw (mg/L)
IR (L/hr)
ET(hr/day)
BW(kg)
Dose (mg/kg/day)
A
Comp.
9.31
0.0125
o
J
70
0.0050
dult
Non-Comp.
9.31
0.0125
1
70
0.0033
Ch
7-10
Comp.
9.31
0.05
1
30
0.016
ild
yrs
Non-
Comp.
9.31
0.05
1
30
0.016
C
11-
Comp.
9.31
0.025
2
48
0.0097
'hild
14 yrs
Non-Comp.
9.31
0.05
1
48
0.0097
18
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Busan 77 RED
STMOE
ITMOE
Adult
Comp.
100,000
44,000
Non-Comp.
150,000
66,000
Child
7-10 yrs
Comp.
32,000
14,000
Non-
Comp.
32,000
14,000
Child
11-14 yrs
Comp.
52,000
23,000
Non-Comp.
52,000
23,000
aMOE = NOAEL mg/kg/day/ Dose (mg/kg/day). ST Oral NOAEL = 500 mg/kg/day, IT Oral NOAEL = 221 mg/kg/day; ST and IT Target MOE
5. Aggregate Risk Assessment
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 typically includes exposures from food, drinking water, residential uses of a pesticide,
and other non-occupational sources of exposure.
The aggregate risk assessment is designed to provide estimates of risks likely to result
from exposures to the pesticide or pesticide residues in food, water, and from residential (or
other non-occupational) pesticide uses. An acute aggregate assessment was not conducted
because there was no tox endpoint selected.
The chemical adsorbs strongly to soil, such that a drinking water exposure is not likely.
The modeled results for incidental oral exposures, based on the swimming pool use, are higher
than those resulting from the conservative modeling of the once through cooling water use.
Considering that the risk estimates for the highest exposure swimming scenario yielded MOEs
greater than 50,000, the Agency does not expect drinking water exposures resulting from the
once through cooling water system use to be of concern because the low potential for exposure.
Short-Term Aggregate Exposures and Risks
Short- and intermediate-term aggregate exposures and risks were considered for adults and
children that could be exposed to Busan 77 from the use of products in non-occupational
environments. The use patterns of Busan 77 products and probability of co-occurrence were
addressed when selecting scenarios for incorporation in the aggregate assessment. The exposure
scenarios that were considered for the aggregate assessment are summarized in Table 7, and it is
important to note that because the use on paper is no longer being supported, there are no
identified routes of dietary exposures to Busan 77.
It should be noted that there is a potential for an adult to apply a Busan 77 product to a
swimming pool and subsequently swim in the treated pool in one day. However, because the
dermal toxicological effect is skin irritation and not a systemic effect, any product remaining on
the residential handler following an application would be diluted or "washed off'once the
handler enters the swimming pool. Therefore, an aggregate assessment incorporating these
scenarios would actually overestimate dermal exposure and is thus was not included in the
19
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Busan 77 RED
assessment.
The Agency determined that an aggregate assessment could not be conducted at this time
due to the lack of textile residue data. The aggregate assessment would need to include post-
application exposures to swimming pool water residues along with post-application exposure to
textile residues.
6. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Based on examination of product labels describing uses for
Busan 77, it has been determined that exposure to handlers can occur in a variety of occupational
environments such as material preservation as well as industrial processes and water systems via
liquid pour and liquid pump applications. In addition, there is the potential for occupational
handlers to come into contact with treated products (e.g., metalworking fluids, etc).
a. Occupational Toxicity
The toxicological endpoints used in the occupational handler assessment of Busan 77 can
be found in Table 2, "Residential and Occupational Toxicological Doses and Endpoints for
Busan 77", of this document.
b. Occupational Handler Exposure
Occupational risk for all 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. Occupational risk is
assessed for exposure at the time of application (termed "handler" exposure). Application
parameters are generally defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use site and by the
application rate required to achieve an efficacious dose.
The exposure scenarios assessed in this document for the representative uses selected by
the Agency are shown in Table 8. For handlers, the representative uses assessed include:
material preservative (metalworking fluid), industrial water systems biocide and, swimming pool
and spa algaecide.
Potential occupational handler exposures can occur during the application of Busan 77
through either liquid/solid pour or liquid pump methods. Liquid/solid pour refers to transferring
the antimicrobial product from a small container to an open vat. Liquid pump refers to
transferring the preservative by connecting/disconnecting a chemical metering pump from a tote
or by gravity flow. There is also the potential for dermal and inhalation exposure when a worker
handles treated metalworking fluids. This route of exposure occurs after the chemical has been
incorporated into the metalworking fluid and a machinist is using/handling this treated end-
product.
20
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Busan 77 RED
Short-term dermal exposures were not assessed for most occupational handler scenarios
because the endpoint is based on dermal irritation. Instead, dermal irritation exposures and risks
will be mitigated using default personal protective equipment requirements based on the toxicity
of the end-use product. To minimize dermal exposures, the minimum PPE required for mixers,
loaders, and others exposed to end-use products that result in classification of category I, II, or
III for skin irritation potential will be a long-sleeve shirt, long pants, shoes, socks, chemical-
resistant gloves, and a chemical-resistant apron. Note that chemical-resistant eyewear will be
required if the end-use product is classified as category I or II for eye irritation potential. Most
of the labels currently do not require PPE; based on this assessment all of these labels will need
to be updated to reflect the PPE requirement.
Since gloves are also not a viable mitigation option for a machinist using biocide treated
metalworking fluids, the short-term dermal exposure was assessed for this scenario.
Table 8. Representative Exposure Scenarios Associated with Occupational Exposures to Busan 77
Representative
Use
Method of
Application
Exposure Scenario
Registration #
Application Rate
Residential Premises
Swimming Pools
• Liquid pour
• Solid pour
HandlerST and IT
inhalation
3432-28
57787-11
0.0012 flozai/gal
(30oz/5,000galx20%ai)
0.0012 oz ai/gal
(117 fl oz/1 0,000 gal x 10%ai)
Product density = 8.51b/gal
Material Preservatives
Metalworking
fluid
• Liquid pour
• Liquid pump
• Use of treated
metalworking
fluid
Handler (worker
pouring preservative
into fluid being treated):
ST and IT inhalation
Machinist: ST dermal
and IT
ST and IT/LTinhalation
1448-42
0.006% to 0.06% ai
(or 60 to 600 ppm ai)
(0.01 to 0.1% product based on
total weight of fluid x 60% ai)
Product density = 9.6 Ib/gal
Industrial Processes and Water Systems
Pulp/paper and
textile water
systems
• Liquid pump
Handler: ST and IT
inhalation
1448-42
0.0007 fl oz ai/gal
(1 1 fl oz/10,000 gal x 60% ai)
Product density = 9.6 Ib/gal
21
-------
Busan 77 RED
Representative
Use
Cooling tower
waters
(recirculating)
Cooling tower
waters
(once-through)
Air washer water
systems
Fire protection
systems
Petroleum
secondary
recovery systems
Method of
Application
• Liquid pour
• Liquid pump
• Liquid pour
• Liquid pump
• Liquid pour
• Liquid pump
• Liquid pour
• Liquid pump
• Liquid pour
• Liquid pump
Exposure Scenario
Handler: ST and IT
inhalation
Handler: ST and IT
inhalation
Handler: ST and IT
inhalation
Handler: ST and IT
inhalation
Handler: ST and IT
inhalation
Registration #
1448-398
55137-1
402-123
1448-398
1448-398
Application Rate
Initial dose:
0.0042 fl oz ai/gal
(69.6 fl oz/1,000 gal x 6%ai)
Maintenance dose:
0.0021 fl oz ai/gal
(34.8 fl oz/1,000 gal x 6%ai)
Product density = 8.7 Ib/gal
0.0012% ai
(60 ppm x 20%ai)
Product density = 8.69 Ib/gal
0.0042 fl oz ai/gal
(83.25 fl oz/1,000 gal x5%ai)
Product density = 8.4 Ib/gal
0.0056 fl oz ai/gal
(92.8 fl oz/1,000 gal x 6%ai)
Product density = 8.7 Ib/gal
0.0056 fl oz ai/gal
(92.8 fl oz/1,000 gal x 6%ai)
Product density = 8.7 Ib/gal
Note: inhalation exposure refers to exposure to the aerosols not the vapor
Swimming Pool Systems
Busan 77 can be used to control the growth of algae in swimming pools (EPA Reg. No.
57787-11 and 3432-28). Table 8 above, presents the scenarios and associated application rates
assessed for this algaecide use. Based on standard assumptions, the Agency assumed that a
professional pool maintenance worker can treat ten 20,000 gallon pools per day (e.g., 200,000
gallons of pool water are treated per day). It should be noted that the spa/whirlpool algaecide use
is represented by the pool use since the application rates are the same.
The potential for occupational exposure was based on the loading of the product by liquid
open pouring and granular open pouring. Chemical-specific exposure data were not submitted to
support the algaecide use. Therefore, the Agency developed a screening-level assessment using
surrogate data to determine the potential risks associated with swimming pool treatments. The
most representative data available are the monitoring data from the CMA study data. The
following lists the unit exposures used in this assessment:
• liquid open pour: CMA inhalation UE of 0.00346 mg/lb ai from the liquid open pour
preservative study, which was based on only 2 replicates, was used. Although this exposure
scenario is based on minimal replicates, the exposure values are similar to those found in
Pesticide Handler's Exposure Data (PHED) for similar scenarios.
• solid open pour: CMA inhalation UE of 0.0119 mg/lb ai from the solid open pour
preservative study, which was based on 10 replicates, was used.
22
-------
Busan 77 RED
Metal Working Fluid
Busan 77 can be used "for the inhibition of bacterial degradation of aqueous solutions or
emulsions of the cutting fluids or oils employed as lubricants in the machining and processing of
metals" (EPA Reg. No. 1448-42). Table 8 presents the scenarios and associated application
rates assessed for this materials preservative (e.g., metalworking fluid) use. Based on standard
assumptions, the Agency assumed that 300 gallons of fluid is preserved per day.
The potential for occupational exposure was based on the loading of the product by liquid
open pouring and connecting/disconnecting a chemical metering pump from a tote. Chemical-
specific exposure data were not submitted to support the materials preservative use. Therefore,
the Agency developed a screening-level assessment using surrogate data to determine the
potential risks associated with metalworking fluid preservation. The most representative data
available are the monitoring data from the CMA study data. The following lists the unit
exposures used in this assessment:
• liquid open pour: CMA inhalation UE of 0.00854 mg/lb ai from the metalworking fluid
study, which was based on 8 replicates, was used.
• liquid pump: CMA inhalation UE of 0.00348 mg/lb a.i. from the metalworking fluid study,
which was based on 2 replicates, was used.
Industrial Freshwater Systems: Pulp/Paper and Textile Mills
Busan 77 can be used "to control the growth of bacteria and fungi in holding and
processing tanks of industrial fresh water systems supplying water to pulp and paper mills,
textile mills, and other manufacturing plants. In pulp and paper mills, treatments of the fresh
water with Busan 77 can make an important contribution to slime control. The use of Busan 77
as described will reduce the development of slime in fresh water pipes, fresh water spraying
nozzles, and on the pulp and paper mill machining parts contacted by fresh water. However,
Busan 77 is not recommended for use as the primary microbiocide for pulp and paper mill slime
control since absorbents such as wood pulp rapidly absorb the product and greatly reduce its
concentration in the circulating water " (EPA Reg. No. 1448-42). Table 8 presents the
scenarios and associated application rates assessed for this freshwater microbiocide use. Based
on standard assumptions, AD assumed that 20,000 gallons of water is treated per day.
It should be noted that Busan 77 can also be used to preserve starch used in paper
manufacturing (EPA Reg. No. 1448-42 and 55137-1). However, the technical registrant recently
stated that this use will be cancelled. Therefore, all labels listing the starch preservation use must
be updated to reflect this cancellation.
The potential for occupational exposure was based on the loading of the product by and
connecting/disconnecting a chemical metering pump from a tote. Chemical-specific exposure
data were not submitted to support the pulp and paper and textile manufacturing uses. Therefore,
23
-------
Busan 77 RED
AD developed a screening-level assessment using surrogate data to determine the potential risks
associated with pulp and paper and textile manufacturing. The most representative data available
are the monitoring data from the CMA study data. The following lists the unit exposures used in
this assessment:
• liquid pump: CMA inhalation UE of 0.000265 mg/lb ai from the pulp and paper preservative
loading study, which was based on 7 replicates, was used.
Cooling Water Systems and Air Washer Systems
Busan 77 can be used "to control the growth of microorganisms including bacteria,
algae, and fungi in recirculating cooling water system " (EPA Reg. No. 1448-398). Furthermore,
Busan 77 can be used "to control mollusks such as Corbicula species in once-through cooling
water systems" as well as "control algae and mollusks such as Corbicula andDreissena species
in potable water treatment systems" (EPA Reg. No. 55137-1). Table 8 presents the scenarios
and associated application rates assessed for the various cooling water system uses. It should be
noted that the once-through cooling water system scenario also represents the potable water
system scenario.
At this time, a screening-level assessment has been developed for the recirculating use as
well as the once through use. The daily amount of biocide handled that was used in this
assessment was based on the following information provided by the registrant: Workers in small
systems could manually pour 5 to 10 gallons of biocide into the system but larger systems would
utilize chemical pumps in order to save time and labor expense. Recirculating cooling water
systems can vary tremendously in volume and are believed to be generally less than 50 million
gallons. The range of volume assessed for the large scale once through power generators (label
does not restrict the product to power generators but they represent the high end) includes 2 to
500 million gallons. The 2 million gallons were selected as the low range based on it
representing the "fife minimus'" flow for EPA's Cooling Water Intake Structure Rule
(40CFR125.90). Although a few power generators may have water flows of approximately 1 to
3 billion gallons, these few utilities are atypical. EPA assumed that if the large utilities apply
Busan 77 it would be applied as a continuous feed over 6 days (i.e., 500 million gallons treated/6
days = 83.3 million gallons of water treated per day).
Based on the above information, EPA assumed that workers handle 10 gallons of biocide
per day when making open pour applications. Furthermore, EPA assessed exposure to workers
of recirculating cooling water systems ranging from 20,000 to 50 million gallons treating via
chemical metering pumps as well as, exposure to workers of once-through cooling water systems
ranging from 2 to 83 million gallons treating via chemical metering pumps.
The potential for occupational exposure is based on the loading of the product by liquid
open pouring and connecting/disconnecting the chemical metering pump. Chemical-specific
exposure data were not submitted to support the cooling tower use. Therefore, the Agency has
developed a screening-level assessment using surrogate data to determine the potential risks
24
-------
Busan 77 RED
associated with the cooling tower uses. The most representative data available for industrial
scenarios are the monitoring data from the CMA study. The following lists the unit exposures
used in this assessment:
• liquid open pour: CMA inhalation UE of 0.45 mg/lb ai from the cooling water systems
liquid open pour study, which was based on only 5 replicates, was used. Although this
exposure scenario was based on minimal replicates, the exposure value is similar to those
found in PHED for similar scenarios.
• liquid pump in small systems: CMA inhalation UE of 0.00432 mg/lb ai from the cooling
water system liquid pump loading study, which was based on 4 replicates, was used.
• liquid pump in large systems: CMA inhalation UE of 0.000265 mg/lb ai from the pulp and
paper preservative loading study, which was based on 7 replicates, was used. It should be
noted that the UE from the pulp and paper study was selected for this scenario rather than
data from the cooling water study because the pulp and paper scenario is more representative
of large scale systems such as those in large cooling water systems.
Air Washer Systems and Fire Water Protection systems
Busan 77 can be used to control algae, bacteria and fungi in industrial air washing
systems (EPA Reg. No. 402-123). Based on the use information provided by the registrant via
personal communication, it was assumed that 10,000 gallons of air washer water is treated per
day. Busan 77 can also be used to control "microorganisms which may foul or cause corrosion in
firewater protection systems" (EPA Reg. No. 1448-398). Based on the use information provided
by the registrant, it was assumed that 50,000 gallons of fire protection water is treated per day.
Table 8 presents the scenarios and associated application rates assessed for air washer system
uses.
Oil-Weil Uses
Busan 77 can be used to maintain bacterial control in oil field water systems (EPA Reg.
No. 1448-398). Table 8 presents the scenarios and associated application rates assessed for the
various oilfield uses.
The following use information provided by the registrant was used to estimate the
amount of product handled per day during oil-well activities. Biocide is typically added directly
to drilling rig mud tanks via open pouring. Over a 3 to 6 week period, while a 13,000 ft well is
being drilled, 1 to 2 drums (1 drum = 42 gallons) of biocide may be used if microbiological
problems are encountered. Therefore, the short-term exposure assessment used 5.6 gallons for
the amount of biocide handled per day by the drilling rig worker [i.e., (2 drums x 42 gal/drum) /
(5 days/week x 3 weeks) = 5.6 gal/day]. The intermediate-term exposure assessment used 2.8
gallons for the amount of biocide handled per day by the drilling rig worker [i.e., (2 drums x 42
gal/drum) / (5 days/week x 6 weeks) = 2.8 gal/day]. For the secondary recovery application, the
biocide is meter pumped into the produced water before it is reinjected into the formation or
25
-------
Busan 77 RED
well. In large operations produced water volume can exceed 10,000 barrels/day (1 barrel = 42
gallons); therefore 420,000 gallons of water can be treated in secondary recovery operations.
Furthermore, although crew changes may occur in drilling rig operations, typically a designated
customer representative is responsible for the biocide feeding. Therefore, one person would be
involved with the biocide application activities on a daily basis.
c. Occupational Handler Risk Summary
The occupational handler risk assessment for the antimicrobial uses of the Busan 77
includes both dermal and inhalation exposure scenarios. The target MOEs are 10 for dermal and
100 for inhalation. Table 9 presents the potential ST and IT inhalation exposures and risks for
the previously mentioned scenarios. All of the MOEs are above the target MOE and therefore not
a concern. Furthermore, the inhalation MOEs are also above 1,000 therefore a confirmatory
inhalation toxicity study is not warranted based on these uses.
26
-------
Busan 77 RED
Table 9. Occupational Handler Exposures and MOEs for Busan 77
Exposure Scenario
Application
Method
Unit Exposure
Inhalation
(mg/lb ai)
Amount
handled/
treated
(gal/day)
Use Rate
Amount ai
handled
(Ib ai/day)
ST/IT
Exposure
Inhalation
(mg/kg/day)
ST MOEs
Target MOE = 100
Inhalation
IT MOEs
Ta rapt MfYR — 1 00
Inhalation
Residential Premises
Swimming pools
Open pour -
liquid
Open pour -
solid
0.00346
0.0119
200,000
200,000
0.0012 flozai/gal
0.0012 oz ai/gal
15.5
15.0
7.7E-04
2.6E-03
650,000
200,000
290,000
87,000
Materials Preservative
Metal working fluid
Open pour -
liquid
Metering pump
0.00854
0.00348
300
300
0.06% %ai
0.06% %ai
1.73
1.73
2.1E-04
5.2E-08
2,400,000
9,700,000,000
1,000,000
4,300,000,000
Industrial Processes and Water Systems
Paper/Textile Mills
Oil Field:
Water-based drilling
fluids
Oil Field:
Secondary recovery
Recirculating
Cooling Water
Once-through
Cooling Water
Air washer systems
Fire water
protection systems
Metering pump
Open pour -
liquid
Metering pump
Open pour -
liquid
Metering pump
Metering pump
Open pour -
liquid
Metering pump
Metering pump
Open pour -
liquid
Metering pump
Open pour -
liquid
Metering pump
0.000265
0.00346
0.000265
0.45
0.00432
0.000265
0.45
0.000265
0.000265
0.00346
0.000403
0.00346
0.000403
20,000
5.6 (ST)
2.8 (IT)
420,000
10
20,000
50,000,000
10
2,000,000
83,000,000
10,000
10,000
50,000
50,000
0.0007 fl oz ai/gal
0.0056 fl oz ai/gal
0.0056 fl oz ai/gal
0.0042 fl oz ai/gal
0.0042 (ST) ,, ...
0.0021 (IT) flozal/gal
0.0042 (ST) „ ...
0.0021 (IT) flozal/gal
0.0012% %ai
0.0012% %ai
0.0012% %ai
0.0042 fl oz ai/gal
0.0042 fl oz ai/gal
0.0056 fl oz ai/gal
0.0056 fl oz ai/gal
0.99
0.0021 (ST)
0.0011 (IT)
158.9
0.0028
5.68 (ST)
2.84 (IT)
14192(ST)
7096 (IT)
0.0010
208.56
8655.24
2.73
2.73
18.92
18.92
2.5E-09
1.0E-07(ST)
5.2E-08 (IT)
6.02E-04
1.8E-05
3.5E-04 (ST)
1.8E-04(IT)
5.4E-02 (ST)
2.7E-02 (IT)
6.7E-06
7.9E-04
3.3E-02
1.4E-04
1.6E-05
9.4E-04
1.1E-04
200,000,000,000
4,800,000,000
830,000
27,000,000
1,400,000
9,300
75,000,000
630,000
15,000
3,700,000
32,000,000
530,000
4,600,000
90,000,000,000
4,200,000,000
370,000
12,000,000
1,300,000
8,200
33,000,000
280,000
6,700
1,600,000
14,000,000
240,000
2,000,000
27
-------
Busan 77 RED
Metal working Fluids: Machinist
There is the potential for dermal and inhalation exposure when a worker handles treated
metalworking fluids. This route of exposure occurs after the chemical has been incorporated into
the metalworking fluid and a machinist is using/handling this treated end-product.
Dermal Exposure
Exposure Calculations
Short-term exposures for machinists were assumed to pose potential risks due to dermal
irritation. Short-term exposure estimates based on surface area were derived using the following
equation:
PE = % ai x FT
where:
PE
%ai
FT
Potential exposure (mg/cm2)
Fraction active ingredient in treated metalworking fluid (unitless)
Film thickness of paint on hands (mg/cm2)
• The percent active ingredient in the treated fluid was assumed to be the highest use rate for
metalworking use scenarios (60 -600 ppm ai, or 0.006 - 0.06%, a.i. in treated metalworking
fluid; Reg. No. 1448-217).
• It was assumed that exposure to a machinist's hands would occur in the absence of gloves.
• For short-term duration exposures, the film thickness on the hands was assumed to be 10.3
mg/cm2 (US EPA, 1992). This film thickness is based on a machinist completing a double dip
in which both hands are immersed and remain wet. The film thickness was chosen because
the dermal endpoint for short-term durations is based on dermal irritation effects and
represents an estimate in the absence of more specific data
Results
Table 10 shows the calculation of the dermal doses and dermal MOEs for a machinist
working with metalworking fluids. The MOE value at the low application rate is above the target
MOE of 10 and therefore not a concern.
Table 10. Short- term Dermal Exposures and MOEs for Machinist Exposure to Metalworking Fluids
Exposure
Scenario
Machinist - two
hand immersion
%ai
0.006
0.06
Film thickness
(mg/cm2)
10.3
10.3
Exposure
(mg ai/cm2)
6.2E-04
6.2E-03
Dermal MOE
(Target MOE = 10)
200
20
28
-------
Busan 77 RED
Inhalation Exposures
The screening-level intermediate and long term inhalation exposure estimate for treated
metalworking fluids have been developed using the OSHA PEL for oil mist. The equation used
for calculating the inhalation dose is:
PDR = PEL x IR x % ai x ED
BW
where:
PDR
PEL
IR
%ai
ED
BW
Assumptions
Potential dose rate (mg/kg/day);
OSHA PEL (mg/m3);
Inhalation rate (m3 /hr)
Fraction active ingredient in treated metalworking fluid (unitless)
Exposure duration (hrs/day);
Body weight (kg)
• The high-end oil mist concentration is based on OSHA's Permissible Exposure Limit (PEL)
of 5 mg/m3(NIOSH, 1998).
• The percent active ingredient was selected from the label that provides an application rate for
the non-concentrate fluid (EPA Registration No. 1448-217).
• The inhalation rate for a machinist is 1.25 m3 /hr.
• A machinist is exposed to the metalworking fluid 8 hours a day, for 5 days a week.
• The body weight of an adult is 70 kg (US EPA 1997b).
Results
Table 11 shows the calculation of the inhalation doses and MOEs for a machinist
working with metalworking fluids. The inhalation ST and IT/LT MOE values for Busan 77 are
above the target MOE of 100. Furthermore, these MOEs are also above 1,000 therefore a
confirmatory inhalation toxicity study is not warranted based on the results of this scenario.
Table 11. Short-, Intermediate- and Long-Term Inhalation Exposures and MOEs Associated with
Metalworking Fluids Treated with Busan 77 (Machinist)
Exposure
Scenario
Machinist
% a.i.
0.06%
OSHA PEL
(mg/m3)
5
Inhalation
rate
(nrVhr)
1.25
Exposure
Duration
(hrs/day)
8
Exposure
(mg/kg/day)
ST/IT/LT
4.3E-04
Inhalation MOEs
(Target MOE is 100)
ST
1,200,000
IT
520,000
LT
230,000
29
-------
Busan 77 RED
d. Occupational Post-application Exposure and Risk Summary
No occupational post-application exposures are assumed to occur for the scenarios
summarized in Table 8; any post-application exposures from these uses are expected to occur in
a residential setting. These exposure scenarios are assessed in the residential exposure section of
this document.
7. Human Incident Data
The Agency reviewed available sources of human incident data for incidents relevant to
Busan77. EPA consulted the following sources of information for human poisoning incidents
related to Busan 77 use: (1) OPP Incident Data System (IDS) - The Office of Pesticide Programs
(OPP) Incident Data System contains reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies and individual consumers,
submitted to OPP since 1992; (2) California Department of Pesticide Regulation (1982-2004) -
The California Department of Pesticide Regulation pesticide poisoning surveillance program
consists of reports from physicians of illness suspected of being related to pesticide exposure
since 1982; (3) National Pesticide Information Center (NPIC) - NPIC is a toll-free information
service supported by OPP That provides a ranking of the top 200 active ingredients for which
telephone calls were received during calendar years 1984-1991; (4) National Poison Control
Centers (PCC) (1993-1996): and (5) Published Scientific Literature on Incidents.
There were 34 incidents reported from use of Busan 77; although limited, incidents
reported in OPP IDS support that exposure to Busan 77 may cause some irritation through
dermal, inhalation, and/or ocular exposures. Most of the symptoms are considered minor. The
most common symptoms reported for cases of dermal exposure were skin irritation/burning,
rash, itching and skin discoloration/redness. The most common symptoms reported for cases of
inhalation exposure were minor respiratory irritation/burning. In some cases, a headache is
reported after inhalation exposure. The symptoms associated with ocular exposure include
blurred vision, edema and irritation around eyes.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below.
The majority of the uses for Busan77 are considered indoor and to have minimal to no
environmental exposure potential, with the exception of the once-through cooling water use.
For a detailed discussion of all aspects of the environmental risk assessment, refer to the
Environmental Risk Assessment in the "Revised Preliminary Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Busan 77 Reregistration Eligibility
Decision (RED) Document," dated September 30, 2007; the "Revised Environmental Fate
Science Chapter for the Busan 77 Reregistration Eligibility Decision (RED) Document", dated
September 30, 2007 and the "Revised Environmental Exposure Assessment for Releases of
BUSAN 77 from Once-through Cooling Water System", dated September 30, 2007.
30
-------
Busan 77 RED
1. Environmental Fate and Transport
The available data indicate that Busan 77, is a water-soluble, cationic ionene polymer
(WSCP) with an average molecular weight of 3,386 g/mol. Based on its miscibility in water and
high molecular weight, volatility from water is highly unlikely. It is also stable to both abiotic
degradation (hydrolysis and photolysis) and to metabolism in soil and sediment water systems.
In the presence of soil or sediment, tight sorption of nearly all residues was observed almost
immediately. Busan 77 was almost exclusively (96 %) found in the top two inches of 12 inch
columns leached with water. Less than 1 % was found in the leachate collected at the bottom of
the columns. These conclusions on mobility are consistent with the fact that Busan 77 is
positively charged and soil/sediment is negatively charged. As a result, Busan 77 is not expected
to contaminate surface and ground waters.
In addition, the results from the study on the bioconcentration in fish, indicate that
bioconcentration is not likely to occur. This conclusion is consistent with the fact that Busan 77
is a cation that will not concentrate in fat. However, it is important to recognize that in some
conditions the presence of Busan 77 in the water may cause some acute risk to fish.
The environmental fate database is considered to be complete. The various studies that
were considered for the environmental fate assessment are identified and summarized below in
Table 12.
Table 12: Environmental Fate Properties of Busan 77
Guideline No./
Study Type
Results
Reference Information
835.2110
Hydrolysis
Mean: 103-137mg/L over 30 day period
The hydrolytic stability of aqueous solutions
of Busan 77 was tested at pH 5, 7 and 9. No
degradation was observed at any tested pH
over a 30 day period at 25 °C in the dark.
41407401/93062026
Smith, A. (1990) Determination of
Aqueous Hydrolysis Rate Constant
and half-life of Busan 77: Final
Report: Lab Project Number: 995-
1089-6116-715: Lab Report Number
90-2-3216. Unpublished study
prepared by Springborn Laboratories,
Inc. 32 p.
Acceptable
835.2210
Direct photolysis
rate in water by
sunlight
Avg. mean recovery: 79.5 ± 3.5%
Under the aseptic test conditions employed
with a solution temperature of 25.6 ± 1.6 °C
for the pH 5 and 7 phase of this study and
25.7 ± 1.7 °C forthe pH 9 phase of this
study, Busan 77 is photolytically stable.
Definitive testing was performed over a 30
day period with no appreciable degradation
observed, within experimental error, in any
31
41420901/93062027
Smith, A. (1990) Determination of
Aqueous Photolysis Rate Constant
and half-life of Busan 77: Lab
Project Number: 995-1089-6117-
720; 90-3-3251. Unpublished study
prepared by Springborn Laboratories,
Inc. 37 p.
Acceptable
-------
Busan 77 RED
Guideline No./
Study Type
Results
Reference Information
solution at any of the pHs tested. Busan 77 is
considered photolytically stable (EPA
Standard Evaluation Procedure, 1985).
835.3100
Aerobic aquatic
biodegradation
First Experiment. Under aerobic aquatic
conditions, 14C-Busan77 (5.07 ppm) rapidly
became sediment-bound. In this experiment,
sediment bound residues increased from
approximately 11% at Day 0 to 53% at Day 2
and retained in the range of 52% to 70% for
the 30-day study. Approximately 4.0% of the
total dose was trapped as CO2 and 0.1% of
the applied radioactivity was trapped as
organic volatiles by Day 30. Total recoveries
averaged approximately 63% for the
experiment, which resulted from strong
adsorption of the test material to laboratory
glassware during sale extraction.
Second Experiment. In the second
experiment, 14C Busan 77 (4.77 ppm) rapidly
because sediment bound in aerobic aquatic
samples. This sediment bound radioactivity
increased from approximately 31% at Day 0
to 94% at Day 1, and then remained fairly
constant for the 31 day study. Approximately
5% of the total applied radioactivity was
trapped as CO2. No radioactivity was
detected as organic volatiles. Total recoveries
averaged 100.0% for the experiment.
MRID 40334101
Obrist, J. (1987) Aerobic Aquatic
Metabolism of Busan 77: Laboratory
Project ID: HLA 6015-251: Final
Report. Unpublished study prepared
by Hazleton Laboratories America,
Inc. 69 p.
Acceptable
835.3300
Anaerobic
biodegradability of
organic chemicals
Under laboratory conditions at 25°C ±2°.
Busan 77 rapidly became sediment-bound in
an anaerobic aquatic system (Lake Mendota
water and sediment) following treatment at
4.75 ppm. Sediment bound residues
accounted for more than 90% of the total
applied dose at all sampling points (except
Day 0) through 365 days. The majority of the
sediment bound radioactivity was associated
with the humic fraction after treatment with a
sodium hydroxide solution. Approximately
0.7% of the total applied dose was detected
in the carbon dioxide trap, and less than
0.1% of the applied radioactivity was found
in the organic volatiles trap.
40165201
Obrist, J. 1987. Anaerobic Aquatic
Metabolism of Busan 77. Hazelton#
6015-250. Unpublished study
prepared by Hazelton Laboratories
Inc. 50 p.
Acceptable
835.3300
Aerobic Soil
Metabolism
Under laboratory conditions at 23-25°C ± 1
°C, Busan 77 was stable to aerobic soil
metabolism. Good material balance was
observed
40165202
Das, Y. (1987) Aerobic Soil
Metabolism of WSCP: Biospheric
No. 84E-301A. Unpublished study
32
-------
Busan 77 RED
Guideline No./
Study Type
Results
Reference Information
prepared by Biospheric Inc. 50 p.
No record review, based on
material balance it appears to be
valid.
835.1220
Soil Column
Leaching
Busan 77 was found almost exclusively (96
%) in the top 2 inches of 12-inch columns
(average). <1 % was found in the leachate of
the columns.
00157906
Cargile, N. (1986). Soil column
leaching of 14C-WSCP. Final Report
Project No. 84E-303L. Study
conducted by Biospherics, Inc.
00157907
Cargile, N. Leaching characteristics
ofAged!4C-WSCP. Final Report
Project No. 34E-303 AL. Study
conducted by Biospherics, Inc.
Acceptable
850.1730
Bioconcentration in
Fish
Busan 77 did not bioconcentrate (BCF=2) in
channel catfish.
00159308
Barrows, B.A. 1985.
Bioconcentration of 14C-
Radiolabeled WSCP in the Channel
Catfish, Ictalurus punctatus. in a
Static Test System. Study conducted
by Biospherics, Inc., and submitted
by Buckman Laboratories.
Unacceptable
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics and pesticide use data. A summary of the submitted data is provided below.
a. Environmental Toxicity
Toxicity Birds
Available data indicate that Busan 77 is moderately to slightly toxic to birds on an acute
oral basis and slightly to relatively non-toxic to birds on a sub-acute dietary basis. Therefore, an
avian environmental hazard statement for birds is not required on Busan 77 labels.
Toxicity to Terrestrial Animals
33
-------
Busan 77 RED
Based on the results of mammalian studies conducted to meet human toxicity data
requirements, Busan 77 exhibits moderate oral, dermal, inhalation toxicity and eye irritation
(toxicity category III). Busan 77 is not a dermal sensitizer.
Toxicity to Aquatic Animals
On an acute basis, Busan 77 is very highly toxic to highly toxic to fish. The submitted
studies fulfill the guideline requirements, however because acute toxicity values to fish is < 1.0
mg/L, the environmental hazard section of Busan 77 labels must state: "This pesticide is toxic to
fish."
Busan 77 is also highly toxic to moderately toxic to estuarine/marine invertebrates on an
acute basis and relatively nontoxic to estuarine/marine fish on an acute basis, however because
the estuarine/marine acute toxicity values are < 1.0 mg/L, the environmental hazard section of
Busan 77 labels must state: "This pesticide is toxic to clams."
Toxicity to Plants
Testing has been conducted with Busan 77 on several aquatic and terrestrial plant species.
The guideline requirement for an algal toxicity test (850.5400, 123-2) is partially fulfilled. Two
additional algal toxicity tests under 850.5400 are outstanding because they do not meet guideline
requirements; which require a test with the freshwater green alga, Selenastrum capricornutum,
and a test with the marine diatom, Skeletonema costatum. The other non-target aquatic plant
toxicity requirement, floating freshwater aquatic macrophyte duckweed (Lemna gibba) -
guideline 850.4400 - is not satisfied. A study on the rooted freshwater macrophyte rice (Oryza
sativa) - 850.4225 (seedling emergence test) - has not been submitted.
A summary of the submitted ecological toxicity data for Busan 77 are provided in
Tables 13, 14, 15 and 16.
34
-------
Busan 77 RED
Table 13. Toxicity to Birds
Species
Chemical,
% Active
Ingredient
(a.i.)
Tested
Endpoint
(mg/kg a.i.)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
(MRID No.)
Acute Avian Toxicity
Mallard duck
(Anas
platyrhynchos}
Bob-white quail
(Colinus
virginianus)
Busan 77
61.7%
Busan 77
% purity
unknown
LD50 = 497
NOAEL = 51
LD50 = 690
NOAEL = <172
(based on the
assumption of
60% a.i.)
Moderately
toxic
Slightly
toxic
Yes (core)
- 14-day test
duration
- 36 weeks of age
No (supplemental)
- 21 -day test
duration
i i ,
- young adult
- study conducted
before adoption of
GLP principles
416548-01
ID 0522-010-
20
Subacute Avian Toxicity
Mallard duck
(Anas
platyrhynchos)
Bobwhite quail
(Colinus
virginianus)
Busan 77
60.3%
Busan 77
61.6%
LC50 (diet) =
>12,000
NOAEC =
3,000
LC50 (diet) =
>3,462
NOAEC =
3,462
Relatively
nontoxic
Slightly
toxic
No (supplemental)
8-day test
duration
10 days of
age
- study conducted
before adoption of
GLP principles
Yes (core)
- 8-day test duration
- 1 1 days of age
414115-01
001593-07
35
-------
Table 14. Toxicity to Aquatic Animals
Busan 77 RED
Species
Chemical,
% Active
Ingredient
(a.i.)
Tested
Endpoint
(mg a.i./L)
Toxicity
Category
Satisfies Guidelines/
Comments
Reference
(MRID
No.)
Acute Toxicity to Freshwater Fish
Rainbow Trout
(Oncorhynchus
mykiss)
Bluegill sunfish
(Lepomis
macrochirus)
Rainbow Trout
(Oncorhynchus
mykiss)
Busan 77
61.9%
Busan 77
61.9%
Busan 77
60%
LC50 = 0.047
NOAEC =
0.037
LC50 = 0.21
NOAEC =
0.13
LC50 = 0.26
NOAEC =
0.11
Very
highly
toxic
Highly
toxic
Highly
toxic
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
No (supplemental)
- 96-hr test duration
- static test system
- study lacks
important
information
- study conducted
before adoption of
GLP principles
413520-01
413520-02
001072-07
Acute Toxicity to Freshwater Invertebrates
Waterflea
(Daphnia
magna)
Busan 77
61.9%
EC50= 0.280
NOAEC =
0.130
Highly
toxic
Yes (core)
- 48-hr test duration
- static test system
413520-03
Acute Toxicity of Busan 77 to Estuarine and Marine Organism
Sheepshead
minnow
(Cyprinodon
varigates}
Mysid shrimp
(Mysidopsis
bahia)
Quahog clam
(Mercenaria
mercenarid)
Busan 77
60.0%
Busan 77
60.0%
Busan 77
60.0%
LC50 > 360
NOAEC =
360
LC50 = 7.8
NOAEC <7.8
EC50 = 0.21
NOAEC =
0.14
Relatively
nontoxic
Moderatel
y toxic
Highly
toxic
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 96-hr test duration
- static test system
Yes (core)
- 48-hr test duration
- static test system
- embryo/larval stage
401392-02
401392-03
403342-01
36
-------
Busan 77 RED
Table 15. Chronic Toxicity to Freshwater Organisms
Species
Waterflea
(Daphnia magnd)
Chemical,
% Active
Ingredient
Tested
Busan 77
60.3%
Endpoint
(mg a.i./L)
LOEC = 0.020
NOAEC = 0.012
Satisfies Guidelines/
Comments
No (supplemental)
- 2 1 -day test duration
- static renewal test
system
- organisms not
distributed or fed
properly
- excess mortality
Reference
(MRID
No.)
424796-01
37
-------
Busan 77 RED
Table 16. Toxicity to Plants
Species
Chemical,
% Active
Ingredient
Tested
Endpoint
(mg a.i./L)
Satisfies Guidelines/
Comments
Reference
(MRID No.)
Seedling Emergence (Tier I) Toxicity of Busan 77 to Terrestrial Plants
Monocot
Oat (Avena
sativa)
Dicot
Lettuce (Lactuca
sativa)
Busan 77
60.3%
60.3%
NOAEC = 73
Ff\c — >73
NOAEC = 73
Yes (core)
- 14-day test duration
-most sensitive
parameter: shoot length
(14% reduction)
Yes (core)
- 14-day test duration
- most sensitive
parameter: shoot length
(17% reduction)
420381-01
420381-01
Vegetative Vigor (Tier I) Toxicity of Busan 77 to Terrestrial Plants
Monocot
Corn (Zea mays)
Dicot
Cucumber
(Cucumis sativus)
Busan 77
60.3%
Busan 77
60.3%
EC25 = >74
NOAEC = 74
EC25 = >74
NOAEC = 74
Yes (core)
- 14-day test duration
- most sensitive
parameter: shoot length
(17% reduction)
Yes (core)
- 14-day test duration
- most sensitive
parameter: root length
(31% reduction
420381-01
420381-01
Vegetative Vigor (Tier II) Toxicity of Busan 77 to Terrestrial Plants
38
-------
Busan 77 RED
Species
Monocot
Ryegrass (Lolium
perenne)
Dicot
Tomato
(Lycopersicon
esculentum)
Chemical,
% Active
Ingredient
(a.i.)
Tested
Busan 77
60.3%
Busan 77
60.3%
Endpoint
(mg a.i./L)
f r* ^7 A
C,^25 ~ •> I**
NOAEC = 74
EC25 = >74
NOAEC = 74
Satisfies Guidelines/
Comments
No (supplemental)
- 14-day test duration
- most sensitive
parameter: root
length (0% reduction)
No (supplemental)
- 14-day test duration
- most sensitive
parameter: shoot length
(15% reduction)
Reference
(MRID No.)
420381-01
420381-01
Toxicity of Busan 77 to Aquatic Plants
Marine diatom
(Skeletonema
costatum)
Freshwater diatom
(Navicula
pelliculosa)
Bluegreen
cyanobacteria
(Anabaena flos-
aquae)
Green alga
(Selenastrum
capricornutum)
Duckweed (Lemna
gibbd)
Busan 77
60.3%
Busan 77
60.3%
Busan 77
60.3%
Busan 77
60.3%
Busan 77
60.3%
EC50 = 0.090
NOEC < 0.024
EC50 = 0.083
NOEC = 0.044
EC50 = 0.11
NOEC = 0.05
EC50 = 0.0088
NOEC < 0.001
EC50 > 0.65
NOEC = 0.043
No (supplemental)
- 120-hour test
duration
- static test system
Yes (core)
- 96-hour test duration
- static test system
Yes (core)
- 120-hour test
duration
- static test system
No (supplemental)
- 120-hour test
duration
- static test system
No (supplemental)
- 14-day test duration
- static renewal test
system
- maximum
concentration tested
produced only 30%
growth inhibition
420133-02
420133-03
420133-04
420133-05
420133-01
39
-------
Busan 77 RED
b. Ecological Exposure and Risk
An ecological risk assessment is not typically conducted for the types of uses registered
for Busan 77 except for the once-through cooling water use. The Agency has evaluated the
once-through cooling water use being considered for reregi strati on. A risk assessment for once-
through cooling water uses using maximum application rates and the toxicity values for various
organisms has been conducted. All other uses are considered indoor and have minimal to no
environmental exposure potential and an ecological risk assessment was not needed.
The Agency performed environmental exposure and risk assessments for releases of
Busan 77 when it used for the control of mollusks in once-through cooling water systems. The
Probabilistic Distribution Model (PDM) (version 4) was used to estimate the number and
percentage of days per year that Busan 77 concentrations exceed ecotoxicity concentrations of
concern (COCs)l. The treatment scenarios that were utilized for the analyses of Busan 77 were
derived from product label information. The approach used to generate the ecological risk
assessment is based on the methodology used on other similar antimicrobial pesticides. The
comprehensive discussion of the parameters, calculations, model output conclusions and data
limitations and uncertainties are all available in the supporting "Revised Environmental
Exposure Assessment for Releases of BUSAN 77 from Once-through Cooling Water System",
dated September 30, 2007; and the "Revised Preliminary Ecological Hazard and Environmental
Risk Assessment Science Chapter for the Busan 77 Reregi strati on Eligibility Decision (RED)
Document", dated September 30, 2007.
The PDM is a screening-level exposure assessment tool developed by EPA to model
chemical releases from point sources to flowing surface waters. For this analysis, the PDM
component within EPA's Exposure and Fate Assessment Screening Tool Version 2.0 (E-FAST2)
was used.2 PDM uses detailed U.S. Geological Survey (USGS) stream flow data and facility-
specific data from National Pollutant Discharge Elimination System (NPDES) permits to model
chemical releases from actual facilities. For a modeling period of a given number of days, PDM
calculates the probability distribution of the chemical concentration in the receiving stream, and
then estimates the number of days during which the in-stream chemical concentration is expected
to exceed a COC. PDM counts a day as having an exceedence of a COC if the COC is exceeded
for any part of a 24-hour day. As a screening-level model, PDM outputs do not include the
duration, location, or aerial extent of exceedences. The COCs identified and selected from the
ecological effects information for Busan 77 are provided in Table 18.
1 "Environmental Exposure Assessment for Releases of Bromonitrostyrene from Once-through Cooling Water
Systems," memorandum to David Bays, EPA OPP/AD, from Joshua Cleland and Keith Drewes, ICF International,
April 26, 2007. Also, see "Environmental Exposure Assessment for Releases of Busan 77 From Once-through
Cooling Water Systems," memorandum to Norm Cook, EPA OPP/AD, from Siroos Mostaghimi, EPA OPP/AD,
July 27, 2007.
2 The E-FAST2 model is available from EPA at http://www.epa.gov/opptintr/exposure/pubs/efastdl.htm and
documentation is available at http://www.epa.gov/opptintr/exposure/pubs/efast2man.pdf.
40
-------
Table 17: Concentrations of Concern
Busan 77
Busan 77 RED
Selected for the Environmental Exposure Assessment of
coc
12 Mg/La
130 ng/L
140 (ig/L
260 (ig/La
7,800 ng/L
360,000
Mg/L
Test Species
Waterflea (Daphnia
magna)
Waterflea (Daphnia
magna)
Quahog clam
(Mercenaria
mercenarid)
Rainbow trout
(Oncorhynchus
mykiss)
Mysid shrimp
(Mysidopsis bahid)
Sheepshead minnow
(Cyprinodon
varigates}
Endpoint
Type
NOEC
NOEC
NOEC
LCso
NOEC
NOEC
Study Type
Life -cycle toxicity
to freshwater
invertebrates
Acute toxicity to
freshwater
invertebrates
Acute toxicity to
estuarine and
marine organisms
Acute toxicity to
freshwater fish
Acute toxicity to
estuarine and
marine organisms
Acute toxicity to
estuarine and
marine organisms
Reference
(MRID)
42479601
41352003
40334201
00107207
40139203
40139202
The model estimated the number of days exceeding each COC, as a result, the averages
and standard deviations were calculated. In addition, the percent of days per year above the
COCs was calculated along with the percent of days during the release period above COCs
(maximum 100 percent). The results are provided in Table 19 and the percentage of facilities
that had exceedences at least once (i.e., on at least one day) for each COC are provided in Table
20. If the number of days a COC is exceeded is greater than the number of days used to
determine the endpoint in toxicity testing, risk is assumed. This assumes that the number of days
exceeded are consecutive, a conservative but not impossible assumption. Based on this
assumption, Table 19 shows there will be risk at the average number of days exceeded to
freshwater fish, freshwater invertebrates (both acute and chronic), and estuarine/marine
invertebrates.
Table 18: Number and Percent of Days with Downstream Busan 77 Concentrations
Exceeding COCs
COC
(ug/L)
12 ng/La
130 ng/L
140 ng/L
260 ng/La
Number of Days With
Exceedences
Average
Days COC
Exceeded
207
152
149
129
Standard
Deviation
72
94
94
92
Percent of Days with
Exceedences per Year
Average
Days COC
Exceeded
57%
42%
41%
35%
Standard
Deviation
20%
26%
26%
25%
Percent of Release Days
with Exceedences
Average
Days COC
Exceeded
83%
61%
60%
51%
Standard
Deviation
29%
37%
37%
37%
41
-------
Busan 77 RED
Table 18: Number and Percent of Days with Downstream Busan 77 Concentrations
Exceeding COCs
COC
(ug/L)
7,800 ng/L
360,000
Hg/L
Number of Days With
Exceedences
Average
Days COC
Exceeded
12
1
Standard
Deviation
18
5
Percent of Days with
Exceedences per Year
Average
Days COC
Exceeded
3%
<1%
Standard
Deviation
5%
2%
Percent of Release Days
with Exceedences
Average
Days COC
Exceeded
5%
<1%
Standard
Deviation
7%
2%
1 COC is based on a study that does not fulfill the guideline requirements.
Table 19: Percent of Facilities with Downstream Busan 77 Concentrations
Exceeding COCs on at Least One Day (n = 30)
COC
(HS/L)
12 ng/La
130 ng/L
140 pig/L
260 ng/La
7,800 ng/L
360,000 ng/L
Percent of Facilities with at Least One Day with an
Exceedence
97%
87%
87%
87%
57%
10%
a COC is based on a study that does not fulfill the guideline requirements
c. Risk to Listed Species
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species" (50 C.F.R. ' 402.02).
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
42
-------
Busan 77 RED
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.
This preliminary analysis for the once-through cooling water uses of Busan 77 indicates
that there is a potential for Busan 77 use to overlap with listed species and that a more refined
assessment is warranted, to include direct, indirect and habitat effects. The more refined
assessment should involve clear delineation of the action area associated with proposed once-
through use of Busan 77 and best available information on the temporal and spatial co-location
of listed species with respect to the action area. This analysis has not been conducted for this
action and an endangered species effect determination is unable to be made at this time.
43
-------
Busan 77 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 Busan 77 as an active ingredient. 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 Busan 77.
The Agency has completed its assessment of the occupational, residential, and ecological risks
associated with the use of pesticide products containing the active ingredients Busan 77. Based
on a review of these data and on public comments on the Agency's assessments for the active
ingredients Busan 77, the Agency has sufficient information on the human health and ecological
effects of Busan 77 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 Busan 77 products 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 Busan 77 that are
eligible for reregi strati on. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of the reregi strati on eligibility of Busan 77and 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 Busan 77, the Agency has determined that Busan 77products,
unless labeled and used as specified in this document, would present risks inconsistent with
FIFRA. Accordingly, should a registrant fail to implement the risk mitigation measure identified
in this document, the Agency may take regulatory action to address the risk concerns from the
use of Busan 77. If all changes outlined in this document are incorporated into the product labels,
then all current risks for Busan 77 will be substantially mitigated for the purposes of this
determination. Once an Endangered Species assessment is completed, further changes to these
registrations may be necessary as explained in Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, the EPA worked with stakeholders
and the public to reach the regulatory decision for Busan 77. The EPA released its preliminary
risk assessment for Busan 77 for public comment on September 28, 2007. The Agency received
no comments during the 60-day public comment period on the Busan 77 risk assessment and
supporting science documents, which closed on November 27, 2007.
44
-------
Busan 77 RED
C. Regulatory Position
The EPA assessed the risks associated with Busan 77 use. The Agency has determined
that if the mitigation described in this document is adopted and labels are amended, human
health risks as a result of exposures to Busan 77 are within acceptable levels. In reaching this
determination, EPA has considered the available information on the special sensitivity of infants
and children, as well as exposures to Busan 77 from all possible sources.
a. Determination of Safety to U.S. Population
The Agency has determined that the Busan 77, with amendments and changes specified
in this document, meets the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of Busan 77. In reaching this conclusion, the
Agency has considered all available information on the toxicity, use practices and exposure
scenarios, and the environmental behavior of the Busan 77.
A chronic dietary assessment for Busan 77 is warranted based on the use in the paper
manufacturing processes as a slimicide for pulp and paper mill technologies or for starch
preservation. No toxic effects were identified that were attributable to a single exposure.
Therefore, an acute dietary assessment is not required. The registrant has indicated that they no
longer support the starch uses, and that they will be removed from product labels. Further, based
on the very low application rates for the slimicide use in pulp and paper mills (lOppm) the
Agency believes that exposures will be negligible and, therefore does not have dietary risk
concerns. This conclusion is supported by the fact that previous assessments for other chemicals
with similar toxicological endpoints but much higher application rates (1000-1200 ppm) resulted
in very low exposure and risk estimates. Additional information can be found in the document
titled, "Dietary Risk Assessment (Indirect Food Contact) Uses in Paper Manufacturing Process
of Poly[(oxyethylene)(dimethylimino)ethylene(dimethylimino) ethylene dichloride] [Busan 77],"
dated September 30, 2007.
b. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of Busan 77, with changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, and that there is a reasonable certainty of no harm for infants and
children. The safety determination for infants and children considers the toxicity, use practices,
and environmental behavior noted above , but also takes into account the possibility of increased
susceptibility to the toxic effects of Busan 77 residues in this population subgroup.
The Agency has determined that analysis of the potential need for a special hazard-based
safety factor under the FQPA is not needed at this time. This conclusion is based upon the
availability of acceptable developmental and reproductive toxicity studies with Busan 77 that
adequately characterize the dose-response of this compound along with the lack of evidence for
any sensitivity of offspring to the adverse effects of Busan 77. The Agency does not anticipate
dietary or drinking water or residential exposures based on the registered use patterns and there
45
-------
Busan 77 RED
are no tolerances or tolerance exemptions for the use of the Busan 77 as active ingredients.
Therefore, an FQPA hazard analysis is not necessary at this time.
c. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of potential
effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife
may help determine whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations. As the science develops and resources allow, screening of
additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
When the appropriate screening and/or testing protocols being considered under the
EDSP have been developed, the Busan 77 may be subject to additional screening and/or testing
to better characterize effects related to endocrine disruption.
d. Cumulative Risks
Risks summarized in this document are those that result only from the use of Busan 77.
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 Busan
77. 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/.
D. Regulatory Rationale
The Agency has determined that the Busan 77 is 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.
46
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Busan 77 RED
The following is a summary of the rationale for managing risks associated with the uses
of Busan 77. 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
A dietary assessment was generated for Busan 77 based on the use patterns potential for
dietary exposure. Busan 77 is used in the paper manufacturing processes as a slimicide for pulp
and paper mill technologies or for starch preservation. The Agency has previously conducted
dietary risk assessments for various REDs with application rates in the range of 1,000 to 1,200
ppm levels for pulp and paper mill uses and concluded for these rates that there were not any
dietary risks to any set of population groups. Based on this, it is assumed that the low
application rate of 10 ppm for the label Busan 77 is not of a concern. Therefore, no mitigation
measures are necessary at this time.
b. Drinking Water Risk Mitigation
Busan 77 adsorbs strongly to soil, such that a drinking water exposure is not likely. The
modeled results for incidental oral exposures, based on the swimming pool use, are higher than
those resulting from the conservative modeling of the once through cooling water use.
Considering that the risk estimates for the highest exposure swimming scenario yielded MOEs
greater than 50,000, the Agency does not expect drinking water exposures resulting from the
once through cooling water system use to be of concern because the low potential for exposure.
Therefore, no mitigation measures are necessary at this time.
c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler dermal and inhalation risks were assessed for the use of Busan 77 in
swimming pools, spas/whirlpools/ponds, aquariums and waterbed mattresses. All of the
calculated MOEs were above the target for all scenarios. Furthermore, all inhalation MOEs
exceeded 1,000 therefore, a confirmatory inhalation toxicity study is not warranted based on the
results of these exposure scenarios. No mitigation measures are necessary at this time.
ii. Post-Application Risk Mitigation
Residential post-application dermal exposures result when adults and children come in
contact with Busan 77 in areas where pesticide end-use products have recently been applied
(e.g., swimming pool and spas/whirlpool ), or when children incidentally ingest the pesticide
residues through swallowing treated swimming pool water. It is anticipated that absorbents such
as textiles will absorb Busan 77 and post-application residential dermal and incidental oral
exposures to treated textiles may occur. The inhalation exposures (vapor) were not assessed due
47
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Busan 77 RED
to the extremely low vapor pressure of Busan 77. All MOEs were above the target and not of
concern. Therefore, no risk mitigation measures are necessary at this time.
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
Potential occupational handler exposures can occur during the application of Busan 77
through either liquid/solid pour or liquid pump methods. Liquid/solid pour refers to transferring
the antimicrobial product from a small container to an open vat. Liquid pump refers to
transferring the preservative by connecting/disconnecting a chemical metering pump from a tote
or by gravity flow. There is also the potential for dermal and inhalation exposure when a worker
handles treated metalworking fluids. This route of exposure occurs after the chemical has been
incorporated into the metalworking fluid and a machinist is using/handling this treated end-
product.
Short-term dermal exposures were not assessed for most occupational handler scenarios
because the endpoint is based on dermal irritation. Instead, dermal irritation exposures and risks
will be mitigated using default personal protective equipment requirements based on the toxicity
of the end-use product. To minimize dermal exposures, the minimum PPE required for mixers,
loaders, and others exposed to end-use products that result in classification of category I, II, or
III for skin irritation potential will be a long-sleeve shirt, long pants, shoes, socks, chemical-
resistant gloves, and a chemical-resistant apron. Note that chemical-resistant eyewear will be
required if the end-use product is classified as category I or II for eye irritation potential. Most of
the labels currently do not require PPE; based on this assessment all of these labels will need to
be updated to reflect the PPE requirement.
Since gloves are also not a viable mitigation option for a machinist using biocide treated
metalworking fluids, the short-term dermal exposure was assessed for this scenario. This route of
exposure occurs after the chemical has been incorporated into the metalworking fluid and a
machinist is using/handling this treated end-use product. The MOE value is above the target of
10 and therefore not a concern.
ii. Post-Application Risk Mitigation
No occupational post-application exposures are expected to occur from these uses.
Therefore, no risk mitigation is necessary.
2. Environmental Risk Management
The majority of the uses for Busan77 are considered indoor and to have minimal to no
environmental exposure potential, with the exception of the once-through cooling water use.
Busan 77 is used for the control of mollusks in once-through cooling water systems. The
Probabilistic Distribution Model (version 4) was used to estimate the number and percentage of
48
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Busan 77 RED
days per year that Busan 77 concentrations exceed ecotoxicity concentrations of concern (COCs)
3. The treatment scenarios that were utilized for the analyses of Busan 77 were derived from
product label information. Upon execution of the model, the number of days exceeding each
COC were provided and the averages and standard deviations were calculated. In addition, the
percent of days per year above the COCs was calculated along with the percent of days during
the release period above COCs (maximum 100 percent). If the number of days a COC is
exceeded is greater than the number of days used to determine the endpoint in toxicity testing,
risk is assumed. This assumes that the number of days exceeded are consecutive, a conservative
but not impossible assumption. Based on this assumption, there will be risk at the average
number of days exceeded to freshwater fish, freshwater invertebrates (both acute and chronic),
and estuarine/marine invertebrates.
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 Busan 77. For the specific labeling
statements and a list of outstanding data, refer to Section V of this RED document.
The following statement must be added to all product labels because the acute toxicity to
fish, aquatic invertebrates, and estuarine/marine species are less than 1.0 mg/L:
"This product is toxic to fish, aquatic invertebrates, and clams"
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a National
Pollution Discharge Elimination System (NPDES) permit and the permitting authority
has been notified in writing prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office of the EPA."
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
3 "Environmental Exposure Assessment for Releases of Bromonitrostyrene from Once-through Cooling Water
Systems," memorandum to David Bays, EPA OPP/AD, from Joshua Cleland and Keith Drewes, ICF International,
April 26, 2007. Also, see "Environmental Exposure Assessment for Releases of Busan 77 From Once-through
Cooling Water Systems," memorandum to Norm Cook, EPA OPP/AD, from Siroos Mostaghimi, EPA OPP/AD,
July 27, 2007.
49
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Busan 77 RED
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and 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.
This preliminary analysis for the once-through cooling water uses of Busan 77 indicates
that there is a potential for Busan 77 use to overlap with listed species and that a more refined
assessment is warranted, to include direct, indirect and habitat effects. The more refined
assessment should involve clear delineation of the action area associated with proposed once-
through use of Busan 77 and best available information on the temporal and spatial co-location
of listed species with respect to the action area. This analysis has not been conducted for this
action and an endangered species effect determination is unable to be made at this time.
b. General Risk Mitigation
Busan 77 end-use products (EPs) may also contain other registered pesticides. Although
the Agency is not proposing any mitigation measures for products containing Busan 77 specific
to federally listed species, the Agency needs to address potential risks from other end-use
products. Therefore, the Agency requires that users adopt all listed species risk mitigation
measures for all active ingredients in the product. If a product contains multiple active
ingredients with conflicting listed species risk mitigation measures, the more stringent
measure(s) should be adopted.
50
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Busan 77 RED
V. What Registrants Need to Do
The Agency has determined that the Busan 77 are eligible for reregi strati on provided
that: (i) additional data that the Agency intends to require confirm this decision; (ii) the risk
mitigation measure outlined in this document is adopted; and (iii) label amendments are made to
reflect this measure. To implement the risk mitigation measure, the registrants must amend their
product labeling to incorporate the label statement set forth in the Label Changes Summary
Table in Section B below. The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For the Busan 77 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: By express or courier service:
Document Processing Desk Document Processing Desk
ShaRon Carlisle ShaRon Carlisle
Office of Pesticide Programs Office of Pesticide Programs
(751OP) (751OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
51
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Busan 77 RED
For end-use products containing the Busan 77 as an active ingredient 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 23
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Adam Heyward at (703) 308-6422 with questions regarding product 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 Document Processing Desk
Adam Heyward Adam Heyward
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
52
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Busan 77 RED
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of the Busan 77 have been reviewed
and determined to be substantially complete. However, the following additional data
requirements have been identified by the Agency as confirmatory data requirements and are
included in the generic data call in (DCI) for this RED.
Ecological Effects:
• 850.1300: Aquatic invertebrate life-cycle study (using TGAI and most sensitive species -
freshwater or estuarine/marine)
• 850.1400: Fish early-life stage study (using TGAI and most sensitive species - freshwater
or estuarine/marine)
• 850.4225: Seedling emergence study - dose response using rice (Oryza saliva)
• 850.4400: Freshwater floating macrophyte duckweed study
• 850.5400: Aquatic plant growth (algal toxicity) - 2 studies outstanding (marine diatom -
Skeletonema costatum and green algae - Selenastrum capricormitum); Tier II
(using TGAI or TEP)
• 850.1735: Whole sediment, acute invertebrates (freshwater) (using TGAI)
• 850.1740: Whole sediment, acute invertebrates (estuarine/marine) (using TGAI)
• Depending on the results of the whole sediment, acute invertebrate studies, the following
data may be required: Whole sediment - chronic invertebrates (freshwater and/or
estuarine/marine) (using TGAI or TEP)
• Special Aquatic Field Monitoring Once-Through Cooling Water Systems)
Residential/Occupational Data Gaps:
* A textile residue study for the fresh water microbiocide use in textile manufacturing
facilities is needed to conduct the post-application residential dermal and incidental oral
exposure assessment.
* Confirmatory monitoring data be generated to support the values used in the risk
assessment due to poor quality of the CMA data that was used.
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
20, Label Changes Summary Table.
53
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Busan 77 RED
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 will be issued at a later date.
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 20, Label Changes Summary
Table.
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.
a. Label Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measure outlined in Section IV of the Busan 77 RED. The
following table describes how language on the labels should be amended.
54
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Table 20: Labeling Changes Summary Table
BUSAN 77
Description
Amended Labeling Language
Placement on Label
All End Use Products
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
"This pesticide is toxic to fish, aquatic invertebrates, and claims. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in
accordance with the requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing prior to discharge.
Do not discharge effluent containing this product to sewer systems without previously notifying
the local sewage treatment plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."
Precautionary
Statements
End Use Products Intended for
Starch Preservation Use
All labels listing the starch preservation use must be updated to reflect the cancellation of this
use
Directions For Use
End Use Products Intended for
Occupational use
In order to reduce potential occupational handler exposures the following
mitigation is required:
• Personal Protective Equipment (PPE) is required for end-use products
that result in classification of category I, II, or III for skin irritation.
(long-sleeve shirt, long pants, shoes, socks, chemical-resistant gloves,
and a chemical-resistant apron)
• Personal Protective Equipment (PPE) is required for end-use products
that result in classification of category I or III for eye irritation.
(Chemical-resistant eyewear)
Directions for Use
55
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VI. APPENDICES
56
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Busan 77 Appendix A
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Residential and public access premises
Fabric
42373-6
Add product to
mattress.
Add 8 fluid ounces to fiber
waterbed mattress of 90-180
gallons capacity. Add 4 to 12
gallons capacity to a twin or
hybrid type waterbed up to
90 gallons capacity. Repeat
10-12 months in fiber or
foam beds. In free flow
waterbeds repeat 18-24
months.
None Listed
Industrial Processes and Water Systems
Cooling Water Tower
402-123
527-106
527-122
527-127
1020-14
1448-42
1448-60
1448-61
1448-62
1448-63
1448-108
1448-109
1448-110
1448-113
1448-114
1448-205
1448-206
Slug or sump
method
(Soluble
Concentrate)
Initial dose:
An initial slug addition of .9
to 94 fluid ounces per 1000
gallons of water. Repeat
initial dose until control is
evident.
Subsequent Dose:
Subsequent slug additions .2
to 59 fluid ounces per 1000
gallons of water should be
employed every 1 to 5 days
or as needed. Slug additions
should be made in the sump
of water cooling towers.
Prior to initial dose systems must be
cleaned to remove algal growth,
microbiological slime, and other deposits.
57
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Use Site
Formulation
1448-207
1448-208
1448-211
1448-212
1448-232
1448-233
1448-234
1448-235
1448-236
1448-237
1448-302
1448-305
1448-379
1448-380
1448-396
1448-397
1448-398
1448-400
1706-159
1757-100
3525-65
3635-273
3635-274
3635-275
3635-277
3862-153
5185-339
6836-159
8540-8
10088-40
12005-4
Method of
Application
Application Rate/ No. of
applications
Use Limitations
58
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Use Site
Petroleum Secondary
Recovery Systems
Paper Mill Process Water
Air Washer Water
Systems
Formulation
15300-1
15300-2
15300-11
15300-22
15300-23
35571-1
38635-2
39959-1
39959-2
39959-3
43553-1
44392-2
45309-38
51219-2
52867-1
55137-1
56244-2
66806-1
1448-396
1448-398
55137-1
402-123
527-106
527-122
1448-42
1448-60
1448-61
Method of
Application
Added directly
to mill system
Intermittent or
Slug method
Application Rate/ No. of
applications
Add 11. 6 to 92.8 fluid
ounces
Add 75 to 750 ppm based on
total weight of the starch and
water.
Initial dose:
An initial slug dose of 3.3 to
83.25 fluid ounces per 1000
gallons of water. Repeat
initial dosage until control is
evident.
Use Limitations
None Listed
Do not use in paper and paperboard that
will contact food.
Prior to initial dose systems should be
cleaned to remove bacterial slime and
other deposits
59
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Use Site
Formulation
1448-62
1448-63
1448-108
1448-109
1448-110
1448-113
1448-114
1448-205
1448-206
1448-207
1448-208
1448-211
1448-212
1448-232
1488-233
1448-234
1448-235
1448-236
1448-237
1448-302
1448-305
1448-396
1448-397
1448-398
1448-400
1706-159
1757-100
3635-273
3635-274
3635-275
3635-277
Method of
Application
Application Rate/ No. of
applications
Subsequent Dose:
Subsequent slug additions
2.25 to 83.25 fluid ounces
per 1000 gallons of water
should be employed 1 to 5
days or as needed. Slug
additions may be made to the
sump or to the water
collection trays of the air-
wash systems.
Use Limitations
60
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Use Site
Formulation
5185-339
12005-4
15300-1
15300-2
15300-11
15300-22
15300-23
38635-2
39959-1
39959-2
39959-3
43553-1
44392-2
45309-38
52867-1
55137-1
56244-2
66806-1
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Material Preservatives
Metal Working Fluid
Fire Water Protection
Systems
1448-216
1448-217
1448-218
1448-315
1448-396
1448-397
1448-398
(Soluble
Concentrate)
1448-396
1448-397
1448-398
(Sump Dose
Soluble)
Pour
Add to diluted metalworking fluid at a
concentration of .01 to .10 percent
based on total weight of the
metalworking fluid. Treatment of the
diluted metalworking fluid should be
repeated every four weeks as long as
the fluid is used.
Add to undiluted metalworking fluid at
a concentration which will provide .01
to . 10 percent concentration when
diluted with water for use.
Initial Dose: Add 1 1 .6 to 6.4 fluid
ounces per 1000 gallons
Subsequent doses should be evaluated
None Listed
None Listed
61
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
based on microbiological activity and
product level testing
Use Limitations
Swimming Pools
Swimming Pool
Water Systems - Pools
527-122
1258-1078
1258-1269
1258-1272
1258-1274
1448-42
1448-60
1448-61
1448-62
1448-63
1448-108
1448-109
1448-110
1448-113
1448-114
1448-205
1448-207
1448-208
1448-211
1448-212
1448-232
1448-233
1448-234
1448-235
1448-236
1448-237
1448-346
1448-347
1448-378
Initial Dose: Range of dose
is 13 to 24 fluid ounces per
1000 gallons of water.
Subsequent Dose:
Subsequent additions of 2 to
27 fluid ounces per 10,000
r^ ~
gallons of water every 5 to 7
days after initial treatment
for maintenance.
Do not mix with concentrated dry or
liquid chlorine products.
62
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Use Site
Formulation
1448-379
1448-380
1448-400
2230-51
3432-26
3432-28
3432-31
3432-42
3432-74
3432-80
3525-66
3525-71
3525-109
3525-117
3525-133
3635-277
5185-339
7124-77
7124-91
7124-92
7364-22
7364-81
7364-82
7364-87
7364-93
7616-57
7616-58
7616-73
8959-26
Method of
Application
Application Rate/ No. of
applications
Use Limitations
63
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Use Site
Formulation
8959-37
8959-37
10088-78
10897-13
11411-11
19369-2
41547-1
42177-9
42177-32
42177-33
44392-1
44392-2
45309-1
45309-2
45309-11
45309-30
45309-31
45309-37
45309-79
45309-80
45458-21
45458-22
46043-4
46043-24
46978-4
47158-2
Method of
Application
Application Rate/ No. of
applications
Use Limitations
64
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Use Site
Swimming Pool
Water Systems - Pools
Swimming Pool
Water Systems - Pools
Formulation
48520-15
48520-16
48520-17
53842-5
54998-4
55137-1
57787-2
57787-11
57787-23
57787-25
62498-6
67262-10
67262-20
69461-2
69681-1
69681-2
3635-277
45309-10
48520-14
7364-82
Method of
Application
Application Rate/ No. of
applications
Initial dose: ^d ™ to ^41
fluid ounces per 10,000
gallons of water.
Subsequent dose: Subsequent
additions of 13.6 to 54 fluid
ounces per 10,000 gallons of
water.
Solid Covered pools 1A
gallon per 20,000 gallons of
Use Limitations
Do not mix with concentrated dry or
liquid chlorine products.
Do not mix with concentrated dry or
liquid chlorine products.
65
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Use Site
Spas, Whirlpools, or Hot
Tubs
Formulation
527-122
1258-1078
1258-1080
1448-42
1448-62
1448-108
1448-109
1448-110
1448-113
1448-114
1448-205
1448-207
1448-208
1448-211
1448-212
1448-232
1448-233
1448-234
1448-235
1448-236
1448-237
1448-346
1448-347
1448-379
1448-380
1448-400
2230-51
Method of
Application
Application Rate/ No. of
applications
water.
Mesh or uncovered pools 1
gallon per 20,000 gallons of
water.
Initial dose:
An initial dose of 0.5 to 12
fluid ounces per 1000 gallons
of water.
Subsequent dose:
Subsequent additions of .2 to
9 fluid ounces per 1000
gallons of water should be
made every 5 to 7 days after
initial dose for maintenance.
Use Limitations
Do not mix with concentrated dry or
liquid chlorine products.
66
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Use Site
Formulation
3432-80
3525-71
3525-114
3635-277
7124-91
7124-92
7364-93
7616-57
7616-73
8959-27
10088-78
10897-13
11411-11
19369-2
35571-1
42177-9
42177-32
42177-33
42373-6
44392-1
44392-2
45309-10
45309-79
45309-80
45458-21
45458-22
46043-24
46978-4
47158-2
48520-14
48520-15
Method of
Application
Application Rate/ No. of
applications
Use Limitations
67
-------
Use Site
Spas Whirlpools, or Hot
Tubs
Spas Whirlpools, or Hot
Tubs
Aquariums
Water Systems - Pools
Ornamental Ponds
Formulation
48520-16
48520-17
53842-5
54998-4
57787-2
57787-23
67262-8
67262-20
69461-2
69681-1
69681-2
45309-1
45309-2
45309-11
7124-85
8709-8
14802-8
81584-1
1258-1078
1448-62
Method of
Application
Application Rate/ No. of
applications
Initial dose: Add V2 to 2 V2
teaspoons per 100 gallons.
Subsequent dose:
Subsequent additions 1A to V2
teaspoons per 100 gallons.
Initial dose: Add 4 to 13
fluid ounces per 500 gallons.
Subsequent dose: Subsequent
additions of 1 to 5 fluid
ounces per 500 gallons of
water.
Add 1ml to 480 ml according
to volume of water.
Initial dose:
An initial dose of 0.5 to
Use Limitations
Do not mix with concentrated dry or
liquid chlorine products.
Do not mix with concentrated dry or
liquid chlorine products.
Do not use in aquariums with
invertebrates or crustaceans e.g. crabs,
shrimps, or crayfish.
68
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Use Site
Formulation
1448-108
1448-109
1448-110
1448-113
1448-114
1448-205
1448-207
1448-208
1448-211
1448-212
1448-232
1448-233
1448-234
1448-235
1448-236
1448-237
1448-346
1448-347
1448-379
1448-380
1448-400
1448-434
1706-159
1757-100
2230-51
3635-277
5185-339
7124-91
7124-92
7364-93
7616-57
Method of
Application
Application Rate/ No. of
applications
24fluid ounces per 1000
gallons of water.
Subsequent Dose:
Subsequent additions of .2 to
9 fluid ounces per 1000
gallons of water should be
made every 5 to 7 days after
initial dose for maintenance.
Use Limitations
69
-------
Use Site
Formulation
7616-73
8709-8
8959-26
10088-78
10897-13
11411-11
14802-8
44392-2
45309-11
45309-79
45309-80
45458-21
45458-22
46043-24
46978-4
47158-2
48520-14
48520-15
48520-16
48520-17
53842-5
54998-4
55137-1
69681-2
81584-1
Method of
Application
Application Rate/ No. of
applications
Use Limitations
APPENDIX B: Busan 77* (Case 3034)
70
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Appendix B lists the generic (not product specific) data requirements which support the re-registration of Busan 77. These
requirements apply to Busan 77 in all products, including data requirements for which a technical grade active ingredient is the test
substance. The data table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not
product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
(12) 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.
71
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7300
830.7840
830.7860
830.7950
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
63-5
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
Density
Solubility
Vapor Pressure
Dissociation Constant
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
41898401,
41898401
41898401
41898401,41898402
41898401, 41898402
41898401,41898402
41898401, 41898402, 41898403
42372401, 46832601
41898401, 41898403, 42372401,
46832601
41898401, 41898403, 42372401,
46832601
41898401, 41898403, 42372401
41898401, 41898403, 42372401,
46832601
41898401, 41898403, 42372401
41898401, 41898403, 42372401
41898401, 41898403, 42372401
72
-------
DATA REQUIREMENT
New Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6317
Old Guideline
Number
63-11
63-12
63-13
63-17
63-18
63-20
Study Title
Partition Coefficient (Octanol/Water)
pH
Stability
Storage Stability
Viscosity
Corrosion characteristics
Use Pattern
4,7,8,H
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
4,7,8,11
CITATION(S)
MRID Number
41898401
41898401, 41898403, 42372401
41898401, 41898403, 42372401
42615901
Required
Required
ECOLOGICAL EFFECTS
850.1300
850.1400
850.4225
850.4250
840.4400
850.4400
850.5400
850.2100
850.2200
8502200
72-4
72-4b
122-2
122-la
122-lb
123-1
123-1
123-la
123-2
123-2
123-2
71-1
71-2a
71-2b
Fish early life-stage testing-freshwater
Invertebrate life-cycle testing - freshwater
Aquatic plant growth
Seed germ/seedling emerg
Vegetative vigor
Seedling emergence dose-response in rice
Vegetative vigor dose-response in rice
Seed germ / seedling emerg
Aquatic plant growth
Aquatic vascular plant dose-response toxicity
Acute algal dose-response toxicity - 4 species
Avian Acute Oral Toxicity Test (Quail/Duck)
Acute avian diet. Quail
Acute avian diet. Duck
Data gap
Data gap.
42038101
42038101
42038101
Data gap
Data gap
42038101
42013301, 42013302 , 42013303,
42013304 , 42013305
Data gap
Data gap
41654801
159307, 052201020
41411501
73
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DATA REQUIREMENT
New Guideline
Number
850.1075
850.1075
850.1010
850.1025
850.1025
850.1025
850.1300
850.1300
Old Guideline
Number
72-la
72-lc
72-2a
72-3a
72-3b
72-3c
72-4a
72-4b
Study Title
Fish toxicity bluegill
Fish Acute Toxicity - Freshwater (Rainbow Trout)
Acute Aquatic Invertebrate Toxicity
Estu/mari tox. Fish
Estu/mari tox. Mollusk
Estu/mari tox. Shrimp
Early life stage fish
Life cycle invertebrate
Use Pattern
CITATION(S)
MRID Number
41352002, 41352003
41352001, 107207
41352003
40139202
40334201
40139203
42479601
41108401
TOXICOLOGY*
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3050
870.3100
870.3150
870.3200
870.3250
870.3465
870.4100
870.4100
81-1
81-2
81-3
81-4
81-5
81-6
82-la
82-lb
82-2
82-3
82-4
83-la
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
28-day oral (mice)
90-Day Feeding-Rodent
90 day feeding-nonrodent
21/28-Day Dermal Toxicity - Rat
90-day dermal rodent
28/90-Day Inhalation - Rat
Chronic tox - dog
Chronic tox - rodent
41373401, 93062009
41327101, 93062010
41877501
41361701,93062011
41298601, 93062012
40750301, 93062013
40362601
40025001, 93662014
Required
Data Gap
40170601/93062015
Data gap
41234501/93062016
42543801, 41561301, 41809101
74
-------
DATA REQUIREMENT
New Guideline
Number
870.4100
870.4200
870.4200
870.4300
870.3700
870.3700
870.3700
870.3800
870.5265
870.5275
870.5100
870.5300
870.5385
870.5300
870.5380
870.6300
870.5550
870.4200
870.7485
870.7600
Old Guideline
Number
83-lb
83 -2a
83 -2b
83-3
83-3a
83-3b
83-4
84-2
84-2
84-2
84-2a
84-2b
84-4
83-2
85-1
85-2
Study Title
Chronic tox - non rodent
Oncogenicity - rat
Oncogenicity - mouse
Combined chronic toxicity/carcinogenicity
Developmental Toxicity -Rat
Teratogenicity - rat
Teratogenicity - rabbit
2 - generation repro. -rat
Bacterial Reverse Mutation Assay
Sex - linked recessive lethal test
Reverse mutation assay - salmonella typh.
Detection of gene mutations in somatic cells
Micronucleus Assay
Gene mutation - ames
Struct, chrom. aberration
Other genotoxic effects
Unscheduled DNA synthesis in mammalian cells in culture - rat
Carcinogenicity
General Metabolism
Dermal penetration - rat
Use Pattern
CITATION(S)
MRID Number
41234501, 93062016
41809101
41494301/93062017
41809101,41561301
41423001/93062018
40578201,41423001
41248001, 93062019
40578201/93062020
Data gap
151205
41573701
Data gap
151206
41573701
151205, 151206,93062021
40978701, 93062022
40978701
Data gap.
40268601
40139201
Environmental Fate
160-5
Chemical Identity
41898401
75
-------
DATA REQUIREMENT
New Guideline
Number
835.2120
835.2240
835.4400
835.4300
835.1230
840.1100
850.1730
850.1950
Old Guideline
Number
161-1
161-2
162-3
162-4
163-1
164-2
165-4
165-5
Study Title
Hydrolysis of Parent and Degradates
Photodegradation - Water
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching and Absorption/desorption
Aquatic Field Dissipation
Bioaccumulation in Fish
Bioaccumulation in Aquatic non-target organisms
Use Pattern
CITATION(S)
MRID Number
41407401, 159309
41420901, 159310
40165201
4033410 , 40165202
157906, 157907, 159311, 159312
Waived
159308
Data Gap.
RESIDUE CHEMISTRY
860.1100
171-2
Chemical Identity
41898401
76
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located
in Room 119, Crystal Mall #2, 1801 Bell 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 (date) 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:
Preliminary Risk Assessment and Supporting Science Documents:
• Poly(oxyethylene(dimethylminino)ethylene(dimethyliminio) ethylenedichloride):
Preliminary Risk Assessment for the Reregi strati on Eligibility Decision, PC Code 069183,
Case 3034, Antimicrobials Division, 8/04/07.
• Product Chemistry Science Chapter on Busan 77 . PC Code 069183, Case 3034,
Antimicrobials Division, 7/13/07, A. Najm Shamim, Ph.D.
• Environmental Exposure Assessment for Releases of BUSAN 77 from
Once-through Cooling Water Systems. PC Code 069183, Case 3034,
Antimicrobials Division, July 27, 2007, Siroos Mostaghimi, Senior Scientist
• Poly(oxyethylene (dimethylminino) ethylene(dimethyliminio) ethylenedichloride)
Busan 77: Toxicology Disciplinary Chapter for the Reregi strati on Eligibility Decision
Document, PC Code 069183, Case 3034, Antimicrobials Division, 726/07, Timothy F.
McMahon, Ph.D.
• Busan 77 Dietary Exposure Assessments for the Reregi strati on Eligibility Decision. PC
Code 069183 , Case 3034, Antimicrobials Division, 7/23/07, A. Najm Shamim, Ph.D.
• Busan 77 Occupational/Residential Exposure Assessment. PC Code 069183, Case 3034,
Antimicrobials Division, 7/27/07, Cassi Walls, Ph.D.
• Busan 77 - Incident Report Summary. PC Code 069183, Case 3034, Antimicrobials
Division, 8/03/07, Jonathan Chen, Ph.D.
• Environmental Fate Assessment of Busan 77 for the Reregi strati on Eligibility Decision
(RED). PC Code 069183, Case 3034, Antimicrobials Division, 7/27/07, A. Najm Shamim,
Ph.D.
• Ecological Hazard and Environmental Risk Assessment: Poly(oxyethylene
(dimethylminino) ethylene(dimethyliminio) ethylenedichloride) PC Code 069183,
Case 3034, Antimicrobials Division, 7/27/07, Genevieve Angle, Biologist
77
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision of Busan 77 (Bibliography)
1. MRID Studies
MRID# Citation
00151205 McCarroll, N. (1985) Drosophila Sex-linked Recessive Lethal Assay [with WSCP
(Busan 77)]: Final Report: Project No. 197-183. Un- published study prepared by
Hazleton Laboratories. 20 p.
00151206 Cortina, T. (1984) In vivo Micronucleus Assay in Mice: WSCP: Final Report:
Project No. 197-182. Unpublished study prepared by Hazleton Laboratories
America, Inc. 38 p.
40025001 Tisdel, M. (1986) Busan 77-Thirteen-week Subchronic Toxicity Study in Rats:
Project ID: Study No. 6176-106. Unpublished study prepared by Hazleton
Laboratories of America, Inc. 285 p.
40139201 Bosch, A. (1987) Dermal Absorption of [Carbon 14]-Busan 77 (WSCP) in Male
Rats: HLA Study No. 6176-117: Final Report. Unpublished study prepared by
Hazleton Laboratories America, Inc. 52 p.
40170601 Spindler, M. (1987) 13-Week Dermal Toxicity Study with Busan 77 in Rabbits:
Laboratory Project ID: HLA 6176-118. Unpublished study prepared by Hazleton
Laboratories America, Inc. 290 p.
40268601 Puhl, R. (1987) Metabolism Study with Busan 77 (WSCP) in Rats: Final Report:
Laboratory Project ID: HLA 6176-115. Unpublished study prepared by Hazleton
Laboratories America, Inc. 98 p.
40578201 MacKenzie, K. (1988) Two-Generation Reproduction Study with Busan 77 in Rats
(One Litter per Generation): Project ID: HLA 6176-104. Unpublished study
prepared by Hazleton Laboratories America, Inc. 952 p.
40750301 Glaza, S. (1987) Dermal Sensitization Study in Guinea Pigs with WSCP: Proj. ID
70303995. Unpublished study prepared by Hazleton Laboratories America, Inc. 30 p.
40978701 Cifone, M. (1989) Mutagenicity Test on Busan 77 in the in vivo/in vitro Rat
Primary Hepatocyte Unscheduled DNA Synthesis Assay: Project ID: HLA Study
No. 10280-0-494. Unpublished study pre- pared by Hazleton Laboratories America,
Inc. 26 p.
41234501 Kehoe, D. (1989) One-Year Chronic Toxicity Study with Busan 77 in Dogs:
Laboratory Project ID HLA 6176-111. Unpublished study prepared by Hazleton
Laboratories America, Inc. 301 p.
78
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41248001 Rodwell, D. (1989) Teratology Study in rabbits with Buan 77: SLS Study No.
3138.29. Unpublished study prepared by Springborn Life Sciences, Inc. 229 p
41298601 Rush, R. (1989) Primary Skin Irritation Study in Rabbits with Busan 77: SLS Study
No. 3138.49. Unpublished study prepared by Springborn Laboratories, Inc. 19 p.
41327101 Rush, R. (1989) Acute Dermal Toxicity Study in Rabbits with Busan 77: Lab
Project Number: 3138.50. Unpublished study prepared by Springborn Laboratories,
Inc. 26 p.
41361701 Rush, R. (1989) Primary Eye Irritation Study in Rabbits with Busan 77 (EPA-
FIFRA): Lab Project Number: 3138/52. Unpublished study prepared by Springborn
Laboratories, Inc. 25 p.
41373401 Rush, R. (1990) Acute Oral Toxicity Study in Rats with Busan 77: SLS Study No.
3138.51. Unpublished study prepared by Springborn Laboratories, Inc. 65 p.
41423001 Nemec, M. (1987) A Teratology Study in Rats with Busan 77: Final Report: Lab
Project Number: WIL-94020. Unpublished study prepared by WIL Research
Laboratories, Inc. 281 p.
41494301 Kehoe, D. (1990) 18-Month Study with Busan 77 in Mice: Lab Project Number:
HLA 6176-109. Unpublished study prepared by Hazleton Labs America, Inc. 924 p.
41561301 Kehoe, D. (1990) Combined Chronic Toxicity and Carcinogenicity Study with
Busan 77 in Rats: Draft Report: Lab Project Number: HLA 6176-107. Unpublished
study prepared by Hazleton Laboratories America, Inc. 1511 p.
41573701 Lawlor, T.; DaCosta, K. (1990) Mutagenicity Test on Busan 77 in the
Salmonella/Mammalian-Microsome Reverse Mutation Assay (Ames Test) with
Confirmatory Assay: Lab Project Number: 12144-0-401R. Unpublished study
prepared by Hazleton Laboratories America, Inc. 33 p
41809101 Kehoe, D. (1991) Combined Chronic Toxicity and Carcinogenicity Study with
Busan 77 in Rats: Final Report (Supplement to MRID 41561301): Lab Project
Number 6176-107. Unpublished study pre- pared by Hazleton Labs America, Inc.
1511 p.
41877501 Hoffman, G. (1991) An Acute Inhalation Toxicity Study of Busan 77 in the Rat:
Lab Project Number: 90-8305. Unpublished study prepared by Bio/dynamics, Inc.
105 p.
93062009 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41373401. Busan
77- Acute Oral Toxicity Study in Rats: Laboratory ID: 3138/51. Prepared by
Springborn Laboratories, Inc. 9 p.
79
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93062010 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41327101.
Busan 77- Acute Dermal Toxicity Study in Rabbits: Laboratory ID 3138/50.
Prepared by Springborn Laboratories, Inc. 6 p
93062011 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41361701.
Busan 77- Primary Eye Irritation in the Rabbit: Laboratory ID 3138.52. Prepared
by Springborn Laboratories, Inc. 7 p.
93062012 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41298601.
Busan 77- Primary Dermal Irritation in the Rabbit: Laboratory ID 3138/49.
Prepared by Springborn Laboratories, Inc. 6 p.
93062013 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40750301.
Busan 77- Dermal Sensitization in the Guinea Pig (Close Patch Technique):
Laboratory ID 70303995. Prepared by Hazleton Laboratories America, Inc. 6 p
93062013 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40750301.
Busan 77- Dermal Sensitization in the Guinea Pig (Close Patch Technique):
Laboratory ID 70303995. Prepared by Hazleton Laboratories America, Inc. 6 p
93062014 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40025001.
Busan 77- Thirteen Week Subchronic Toxicity Study in Rats Laboratory ID: HLA
6176-106. Prepared by Hazleton Laboratories America, Inc. 12 p.
93062015 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40170601.
Busan 77- 13 Week Dermal Toxicity Study in Rabbits: Laboratory ID 6176-118.
Prepared by Hazleton Laboratories America, Inc. 6 p
93062016 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41234501.
Busan 77- One Year Chronic Toxicity Study in Dogs: Laboratory ID HLA 6176-
111. Prepared by Hazleton Laboratories America, Inc. 8 p
93062017 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41494301. Busan
77- 18 Month Study in Mice: Laboratory ID: HLA 6176-109. Prepared by Hazleton
Laboratories America, Inc. 10 p.
93062019 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41248001. Busan
77- Teratology Study in Rabbits: Laboratory ID: SLS Study No. 3138-29. Prepared
by Springborn Laboratories, Inc. 9 p.
93062020 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40578201. Busan
77- Two Generation Reproduction Study in Rats: Laboratory ID HLA 6176-104.
Prepared by Hazleton Laboratories America, Inc. 9 p.
93062021 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 00151206. Busan
77- in Vivo Mouse Micronucleus Assay: Laboratory ID 197-182. Prepared by
80
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Hazleton Biotechnologies Corporation. 8 p.
93062022 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40978701. Busan
77- in Vivo/In Vitro Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay:
Laboratory ID: 10280-0-494. Prepared by Hazleton Laboratories America, Inc. 8 p.
93062024 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40268601.
Busan 77- Metabolism Study in Rats: Laboratory ID HLA 6176-115. Prepared by
Hazleton Laboratories America, Inc. 17 p.
93062025 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40139201. Busan
77- Dermal Absorption: Laboratory ID: HLA 6176-117. Prepared by Hazleton
Laboratories America, Inc. lip.
157906 Cargile, N. (1986) Soil Column Leaching of [Carbon-14]- WSCP: Final Report:
Project No. 84E-303L. Unpublished study prepared by Biospherics Inc. 13 p.
157907 Cargile, N. (1986) Leaching Characteristics of Aged [Carbon-14]- WSCP:Final
Report: Project No. 84E-303AL. Unpublished study prepared by Biospherics Inc. 9
P-
159308 Barrows, B. (1985) Bioconcentration of [Carbon 14]-radiolabelled WSCP in the
Channel Catfish, Ictalurus punctatus, in a Static Test System: Biospherics Project
No. 84E-301. Unpublished study prepared by Biospherics Inc. 18 p.
159309 Martinson, J. (1985) Solution Hydrolysis of WSCP: Final Report: Biospherics
Project No. 83-E-605H. Unpublished study prepared by Biospherics Inc. 58 p.
159310 Martinson, J. (1985) Photodegradation of WSCP in Water: Final Re- port: Project
No. 83-E-605P. Unpublished study prepared by Bio- spherics Inc. 28 p.
159311 Biospherics, Inc. (1986) Summary of [Carbon 14]-WSCP Soil Column Leaching
Study Conditions: Project No. 84E-303L. Unpublished study. 6 p.
159312 Cargile, N. (1986) Leaching Characteristics of Aged [Carbon 14]- WSCP: Draft
Final Report: Project No. 84E-303AL. Unpublished study prepared by Biospherics
Inc. 8 p.
40165201 Obrist, J. (1987) Anaerobic Aquatic Metabolism of Busan 77: Final Report:
Laboratory Project Identification: HLA 6015-250. Unpub- lished study prepared by
Hazleton Laboratories America, Inc. 50 p.
40165202 Das, Y. (1987) Aerobic Soil Metabolism of WSCP: Biospheric No. 84E-301 A.
Unpublished study prepared by Biospheric Inc. 50 p.
81
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40334101 Obrist, J. (1987) Aerobic Aquatic Metabolism of Busan 77: Labora- tory Project
ID: HLA 6015-251: Final Report. Unpublished study prepared by Hazleton
Laboratories America, Inc. 69 p.
41407401 Smith, A. (1990) Determination of Aqueous Hydrolysis Rate Constant and Half-life
of Busan 77: Final Report: Lab Project Number: 995-1089-6116-715: Lab Report
Number 90-2-3216. Unpublished study prepared by Springborn Laboratories, Inc.
32 p.
41420901 Smith, A. (1990) Determination of Aqueous Photolysis Rate Constant and Half-life
of Busan 77: Lab Project Number: 995-1089-6117-720; 90-3-3251. Unpublished
study prepared by Springborn Laboratories, Inc. 37 p.
46276202 Watson, C.; Eickhoff, J. (2004) Bubond 60 Tolerance Exemption Petition: Data
Evaluation Records (DERs) for Ecotoxicology, Environmental Fate and Plant
Protection Studies Submitted in Support of Busan 77 and WSCP. Project Number:
BUBOND/2004/3. Unpublished study prepared by Toxcel LLC. 253 p.
93062026 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41407401. Busan
77- Determination of Aqueous Hydrolysis Rate Constant and Half-Life: Laboratory
ID: 90-2-3216. Prepared by Springborn Laboratories, Inc. lip.
93062027 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 41420901. Busan
77- Determination of Aqueous Photolysis Rate Constant and Half-Life: Laboratory
ID: 90-3-3251. Prepared by Springborn Laboratories, Inc. 17 p.
93062028 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40165201. Busan
77- Anaerobic Aquatic Metabolism: Laboratory ID: HLA 6015-250. Prepared by
Hazleton Laboratories America, Inc. 10 p.
93062029 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 40334101. Busan
77- Aerobic Aquatic Metabolism: Laboratory ID: HLA 6015-251. Prepared by
Hazleton Laboratories America, Inc. 10 p
93062030 Drake, K. (1990) Buckman Labs Inc Phase 3 Summary of MRID 00157906 and
Related MRIDs 00157907. Busan 77 - Soil Leaching: Laboratory ID. 84E-303-L.
84E-303-AL. Prepared by Biospherics, Inc. 13 p.
418984-01 Summers, W. (1991) Product Chemistry for WSCP: Lab Project Number: 105.01.
Unpublished study prepared by Buckman Labs, Int. 31 p.
418984-03 Bowles, D. (1991) Product Chemistry for WSCP: Lab Project Number: 20/90-
BUC.8: NA 90 9218/1. Unpublished study prepared by Twin City Testing Corp.
and Natec...GmbH. 88 p.
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423724-01 Bowles, D. (1991) Product Chemistry for WSCP: Lab Project Number: NA
909218/1. Unpublished study prepared by Twin City Testing Corp. and NATEC
Institut fur Naturwissenschaftlich-technische Dienste GmbH. 88 p.
42615901 Whetzel, J. (1992) Determination of Storage Stability and Corrosion Characteristics
of WSCP: A Supplement: Lab Project Number: 71/91-BUC.2. Unpublished study
prepared by Twin City Testing Corp. 29 p.
46832601 Wo, C. (2006) Physical and Chemical Characteristics: Color, Physical State, Odor,
Oxidation/Reduction, Flammability, pH, Viscosity, and Density/Relative Density.
Project Number: 19425, P801. Unpublished study prepared by Product Safety
Laboratories. 17 p.
46915602 Wo, C. (2006) Physical and Chemical Character!stis (830 Series, Group B): Algae
Clean Out W. Unpublished study prepared by Product Safety Laboratories. 6 p.
47120304 Tillman, A. (2007) Waiver Request for Certain Data Requirements for WSCP
MUP. Project Number: KT/200704. Unpublished study prepared by Kerley
Trading, Inc. 7 p.
00107207 Knott, W.; Johnston, C. (1970) Busan 77 (WSCP): Evaluation of Acute LC50 for
Rainbow Trout. (Unpublished study received Apr 6, 1970 under 1448-33; prepared
by Woodard Research Corp., submitted by Buckman Laboratories, Inc., Memphis,
TN;CDL:130682-G)
00159307 Beavers, J. (1985) Busan 77: A Dietary LC50 Study with the Bob- white: Final
Report: Wildlife International Ltd. Project No. 210-104. Unpublished study
prepared by Wildlife International Ltd. 16 p.
0522-010-20 WARF Institute Inc. 1971. Report on Acute Oral LD50 in Bobwhite Quail.
Prepared for Buckman Laboratories, Inc., Memphis, TN
40139202 Surprenant, D. (1987) Acute Toxicity of Busan 77 to Sheepshead Minnow
(Cyprinodon variegatus): Bionomics Report #BW-87-2-2294: Bionomics Study
#995.0986.6104.500. Unpublished study prepared by Springborn Bionomics, Inc.
17 p.
40139203 Surprenant, D. (1987) Acute Toxicity of Busan 77 to Mysid Shrimp (Mysidopsis
bahia): Bionomics Report #BW-87-3-2346: Bionomics Study #995.0986.6104.510.
Unpublished study prepared by Spring- born Bionomics, Inc. 18 p.
40334201 Surprenant, D. (1987) Acute Toxicity of Busan 77 to Embryos-larvae of the
Quahog Clam (Mercenaria mercenaria): SLS Rept. #BW-87-8- 2459: SLS Study
#995.0986.6104.514. Unpublished study prepared by Springborn Life Sciences, Inc.
16 p.
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41352001 LeLievre, M. (1990) Busan 77: Acute Toxicity to Rainbow Trout (Oncorhynchus
mykiss) under Static Conditions: Final Report: Report No. 89-12-3182: Study No.
995.1189.6118.103. Unpublished study prepared by Springborn Laboratories, Inc.
26 p.
41352002 LeLievre, M. (1990) Busan 77: Acute Toxicity to Bluegill (Lepomis macrochirus)
under Static Conditions: Final Report: Report No. 89-12-3176: Study No.
995.1189.6118.100. Unpublished study pre pared by Springborn Laboratories, Inc.
26 p.
41352003 LeLievre, M. (1990) Busan 77: Acute Toxicity to Daphnids (Daphnia magna) under
Static Conditions: Final Report: Report No. 89-11- 3181; Study No.
995.1189.6118.110. Unpublished study prepared by Springborn Laboratories, Inc.
24 p.
41411501 Bodden, R. (1974) Busan 77-Acute Avian Dietary Toxicity Study in Mallard
Ducks: Lab Project ID: 4043621. Unpublished study prepared by WARF Institute,
Inc. 13 p.
41654801 Campbell, S.; Hoxter, K.; Smith, G. (1990) Busan 77: An Acute Oral Toxicity
Study with the Mallard: Lab Project Number: 210/114A. Unpublished study
prepared by Wildlife International Ltd. 22 p.
42013301 Hoberg, J. (1991) Busan 77: Toxicity to the Duckweed, Lemna gibba G3: Final
Report: Lab Project Number: 91-5-3749: 995.1290.6132. 410. Unpublished study
prepared by Springborn Labs, Inc. 45 p.
42013302 Hoberg, J. (1991) Busan 77: Toxicity to the Marine Diatom, Skeleto- nema
costatum: Final Report: Lab Project Number: 91-9-3864: 995.290.6132.450.
Unpublished study prepared by Springborn Labs Inc. 46 p.
42013303 Hoberg, J. (1991) Busan 77: Toxicity to the Freshwater Diatom, Nav- icula
pellicosa: Final Report: Lab Project Number: 91-4-3728: 995.1290.6132.440.
Unpublished study prepared by Springborn Labs, Inc. 49 p.
42013304 Hoberg, J. (1991) Busan 77: Toxicity to the Freshwater Bluegreen Algae, Anabaena
flos-aquae: Final Report: Lab Project Number: 91-4-3726: 995.1290.6132.420.
Unpublished study prepared by Springborn Labs, Inc. 50 p.
42013305 Hoberg, J. (1991) Busan 77: Toxicity to the Freshwater Green Algae, Selenastrum
capricornutum: Final Report: Lab Project Number: 91- 4-3732: 995.1290.6132.430.
Unpublished study prepared by Springborn Labs, Inc. 50 p.
42038101 Hoberg, J. (1991) Busan 77: Determination of Effects on Seed Germi- nation,
Seedling Emergence and Vegetative Vigor of Ten Plant Species: Final Report: Lab
Project Number: 91-3-3695: 995.1290. 6131.610. Unpublished study prepared by
84
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Springborn Labs, Inc. 134 p.
42479601 Putt, A. (1992) Busan 77-Chronic Toxicity to Daphnids (Daphnia magna) under
Static Renewal Conditions (Draft): Lab Project Number: 92-7-4353:
995.0390.6121.130. Unpublished study pre- pared by Springborn Labs, Inc. 99 p.
2. Open Literature
Citation
American Chemistry Council (ACC). 2002. An Analysis of the Training Patterns and Practices of
Competitive Swimmers. Alexandria, Virginia: Prepared by Richard Reiss. Sciences
International, Inc.
National Institute for Occupational Safety and Health (NIOSH). 1998. Criteria for a
Recommended Standard-Occupational Exposure to Metalworking Fluids. Department of
Health and Human Services (DHHS) NIOSH Publication #98-102.
3. Website References
Citation
FDA, 2003, A Guidance For Industry: Preparations of food Contact Notifications and Food
Additive Petitions for Food Contact Substances, Chemistry Recommendations. Final
Guidance, April 2003. http://www.cfsan.fda.gov
FDA, 2003. Sanitizing Solutions: Chemistry Guidance for Food Additive Petitions, January
2003. Http://www.cfsan.fda.gov
4. Other Supporting Documents
Citation
US EPA. 1987. Methods for Assessing Exposure to Chemical Substances: Volume 7, Methods
for Assessing Consumer Exposure to Chemical Substances. Office of Toxic Substances.
EPA/560/5-85/007
US EPA. 1992. A Laboratory Method to Determine the Retention of Liquids on the Surface of
Hands. Prepared by C. Cinalli, C. Carter, A. Clark and D. Dixon, under EPA contract No.
68-02-4254. EPA - 747/R-92-003. Exposure Evaluation Division, Office of Pollution
Prevention and Toxics. September 1992.
85
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US EPA. 1996. Office of Research and Development, Descriptive Statistics Tables from a
Detailed Analysis of the National Human Activity Pattern (NHAPS) Data; EPA/600/R-
96/148, July. Data Collection Period October 1992-September 1994.
US EPA.1997a. Standard Operating Procedures (SOPs) for Residential Exposure Assessments.
EPA Office of Pesticide Programs, Human Health Effects Division. December
18, 1997.
US EPA. 1997b. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa.
US EPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie Faifax.
US EPA. 2007. Exposure and Fate Assessment Screening Tool (E-FAST) Version 2.0.
Demonstration Manual. Office of Pollution Prevention and Toxics Exposure Assessment
Branch. March 2007.
Versar. 2003. User's Manual Swimmer Exposure Assessment Model (SWIMODEL) Version 3.0.
Prepared for the US EPA Antimicrobials Division. November 2003.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the Busan 77
RED for a list of studies that the Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In for Busan 77 at a later date.
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Appendix G. Batching of Busan 77 Products for Meeting Acute Toxicity Data Requirements
for Reregistration
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