?/EPA
United States Prevention, Pesticides EPA739-R-07-005
Environmental Protection and Toxic Substances September 2007
Agency (7510P)
Reregistration Eligibility Decision
for BiobanP-1487
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the antimicrobial Bioban P-1487. The
Reregi strati on Eligibility Decision (RED) for Bioban P-1487 was approved on September 24,
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 Bioban P-1487 and its associated human health and
environmental risks. A Notice of Availability will be published in the Federal Register
announcing the publication of the RED.
The RED and supporting risk assessments for Bioban P-1487 are available to the public
in EPA's Pesticide Docket EPA-HQ-OPP-2007-0402 at: www.regulations. gov.
The Bioban P-1487 RED was developed through EPA's public participation process,
published in the Federal Register on September 10, 2004, which provides opportunities for
public involvement in the Agency's pesticide tolerance reassessment and reregi strati on
programs. 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 Bioban P-1487 risk assessment and the attached RED document
concern only this particular pesticide. This RED presents the Agency's conclusions on the
dietary, occupational, and ecological risks posed by exposure to Bioban P-1487 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 Bioban P-1487 will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
submission of confirmatory data and labeling changes outlined in Section IV of the document.
Sections IV and V of this RED document describe the labeling amendments for end-use products
and data requirements necessary for continued registration of Bioban P-1487-containing
products. 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 requirements outlined in this document,
the Agency will have concerns about the risks posed by Bioban P-1487. 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 relevant to this reregistration
decision, please contact the Chemical Review Manager, Michelle Centra, at (703) 308-2476. For
questions about product reregistration and/or the Product DCI that will follow this document,
please contact Marshall Swindell at (703)-308-6341.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Bioban P-1487
ListD
CASE 3028
Attachment
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
September, 24 2007
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Table of Contents
Bioban P-1487 Reregistration Team 1
Glossary of Terms and Abbreviations 2
Abstract 4
I. Introduction 5
II. Chemical Overview 7
A. Regulatory History 7
B. Chemical Identification 7
C. Use Profile 8
III. Summary of Bioban P-1487 Risk Assessments 10
A. Human Health Risk Assessment 10
1. Toxicity of Bioban P-1487 10
2. FQPA Safety Factor 14
3. Dietary Risk Assessment 15
4. Residential Risk Assessment 15
5. Aggregate Risk Assessment 15
6. Occupational Risk 15
a. Summary of Use Pattern and Formulations 15
b. Occupational Handler Exposure 16
c. Occupational Handler Risk Summary 17
d. Occupational Post-application Exposure 19
e. Occupational Post-application Risk Summary 19
7. Human Incident Data 20
B. Environmental Risk Assessment 20
1. Environmental Fate and Transport 20
a. Bioaccumulation in Aquatic Organisms 21
2. Ecological Risk 21
a. Ecological Toxicity 21
b. Ecological Exposure and Risk 23
c. Risk to Listed Species 23
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 25
A. Determination of Reregistration Eligibility 25
B. Public Comments and Responses 25
C. Regulatory Position 26
a. Determination of Safety to U.S. Population 26
b. Determination of Safety to Infants and Children 26
c. Endocrine Disrupter Effects 26
d. Cumulative Risks 27
D. Regulatory Rationale 27
1. Human Health Risk Management 27
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2. Environmental Risk Management 27
3. Other Labeling Requirements 28
4. Listed Species Considerations 28
a. The Endangered Species Act 28
b. General Risk Mitigation 29
V. What Registrants Need to Do 30
A. Manufacturing-Use Products 31
1. Additional Generic Data Requirements 31
2. Labeling for Technical and Manufacturing Use Products 32
B. End-Use Products 32
1. Additional Product-Specific Data Requirements 32
2. Labeling for End-Use Products 32
a. Label Changes Summary Table 33
VI. Appendices 34
A. Table of Use Patterns for Bioban P-1487 35
B. Table of Generic Data Requirements and Studies Used to Make the 36
Reregistration Decision
C. Technical Support Documents 40
D. Bibliography Citations 41
E. Generic Data Call-In 45
F. Product Specific Data Call-In 46
G. Batching of End-Use Products 47
H. List of All Registrants Sent the Data Call-In 48
I. List of Available Forms 49
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Bioban P-1487 Reregistration Team
Health Effects Risk Assessment
Jenny Tao
Najm Shamim
Siroos Mostaghimi
Jonathan Chen
Timothy McMahon
Ecological Risk Assessment
David Bays
Environmental Fate Risk Assessment
Najm Shamim
Risk Management
Michelle Centra
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
ED STAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
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N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protection factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
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
WP S Worker Protection Standard
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for Bioban P-1487 and is issuing its risk management
decision. The risk assessments are based on review of the target database supporting the use
patterns of currently registered products and additional information received through the public
docket. After considering the revised risk assessments, comments received, and suggestions
from interested parties, the Agency developed its risk management decision for uses of Bioban
P-1487. As a result of this review, EPA has determined that Bioban P-1487-containing products
are eligible for reregi strati on, provided that confirmatory data are submitted to the Agency and
labels are amended accordingly. That decision is discussed fully in this document.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
This document presents the EPA decision regarding the reregistration eligibility of the
registered uses of Bioban P-1487. There are two active ingredients in the Bioban P-1487: 4-(2-
nitrobutyl) morpholine (PC Code 100801); and 4,4'-(2-ethyl-2-nitromethylene) dimorpholine or
4,4'-(2-ethyl-2-nitro-l,3-propanediyl) bis (PC Code 100802).
Bioban P-1487, a mixture of the two active ingredients 4-(2-nitrobutyl) morpholine and
4,4'-(2-ethyl-2-nitromethylene) dimorpholine, is registered for indoor use as a materials
preservative and as a microbial growth inhibitor of slime-forming fungi and bacteria. For
inhibition of microorganism growth, Bioban P-1487 is applied to various sites, including
industrial processes and water systems such as metalworking fluids; oil storage tank bottom
water, fuel storage tank bottom water; and to diesel oil, fuel oil, gasoline, and kerosene, as a
hydrocarbon preservative. As a materials preservative, Bioban P-1487 is formulated into
products such as metal die cast lubricants, corrosion inhibiting metal coatings, mold-release
agents (for the manufacture of plastics), and fuel conditioners (for diesel engines). It is not
registered for any direct or indirect food uses. Therefore, tolerances have not been established
for Bioban P-1487.
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. The Agency does not anticipate dietary,
drinking water or residential exposures based on the registered use patterns. Therefore, an FQPA
hazard analysis is not necessary at this time.
The risks summarized in this document reflect only the registered uses of the active
ingredient, Bioban P-1487. The Food Quality Protection Act (FQPA) requires that the Agency
consider available information concerning the cumulative effects of a particular pesticide's
residues and other substances that have a common mechanism of toxicity. The reason for
consideration of other substances is due to the possibility that low-level exposures to multiple
chemical substances that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect that would occur at a higher level of exposure to any of the
substances individually. Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding for Bioban P-1487 and any other substances. Bioban P-1487 does not appear
to produce a toxic metabolite produced by other substances. For the purposes of this action,
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therefore, EPA has not assumed that Bioban P-1487 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 Bioban P-1487. 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 Bioban P-1487 referenced in this RED. The revised risk
assessments and related addenda are not included in this document, but are available in the
Public Docket at http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-0402).
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 Bioban P-1487 and its regulatory history.
Section III, Summary of Bioban P-1487 Risk Assessments, gives an overview of the human
health and environmental assessments, based on the data available to the Agency. Section IV,
Risk Management, Reregi strati on, and Tolerance Reassessment Decision, presents the
reregi strati on eligibility and risk management decisions. Section V, What Registrants Need to
Do, summarizes the necessary label changes based on the risk mitigation measures outlined in
Section IV. Finally, the Appendices list all use patterns eligible for reregi strati on, bibliographic
information, related documents and how to access them, and Data Call-In (DCI) information.
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II.
Chemical Overview
A. Regulatory History
The first product containing Bioban P-1487 was registered on June 7, 1972. Currently,
Bioban P-1487 consists of a mixture of two active ingredients: compound I: 4-(2-nitrobutyl)
morpholine and compound II: 4,4'-(2-ethyl-2-nitromethylene) dimorpholine. This reregi strati on
case therefore, consists of two active EPA PC codes: 100801 assigned to compound I and
100802 assigned to compound II. There are currently four antimicrobial products containing the
Bioban P-1487 mixture of both active ingredients that are registered under Section 3 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
B.
Chemical Identification
1. Chemical Identity of Bioban P-1487:
Chemical Name:
Chemical Family:
Common/Trade Name:
CAS Number:
Molecular Formula:
Chemical Structures:
Compound I: 4-(2-nitrobutyl) morpholine
(PC Code 100801)
Compound II: 4,4'-(2-ethyl-2-nitromethylene) dimorpholine
or 4,4'-(2-ethyl-2-nitro-l,3-propanediyl) bis
(PC Code 100802)
Morpholines
Bioban P-1487 (Compound I + Compound II)
Compound I: morpholine
Compound II: dimorpholine
Compound I: 2224-44-4
Compound II: 1854-23-5
Compound I: CgHie ^63
Compound II: Ci3H25 N32O4
CH,
Compound I
Compound II
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Table 1. Chemical Characteristics for Technical Grade Active Ingredient Bioban
1487 (Compound I + Compound II)
P-
Physical/Chemical Properties
Molecular Weight
Color
Physical State
Odor
Melting Point
Boiling Point
Specific Gravity
Solubility
Vapor Pressure
PH
Stability
Oxidation/Reduction
Octanol-Water Partition
Coefficient (Log KOW)
Flammability
Explodability
475.59
Yellow to Brown (5 Gardner)
Liquid
Mild fish-like odor characteristic of amines
-16.5to28.0°C
99to215°Cat760mmHg
1.075 to 1.077 at 25 °C
ll,OOOmg/Lat20°C
45% in Tripropylene glycol methyl ether
50% in Hexylene glycol
50% in Dipropylene glycol methyl ether
50% in Toluene
20 to 43 mm Hg at 90 °C
9.5 to 10.0
Indefinitely stable when stored at room
temperature in original container
N/A: Product does not contain any oxidizing or
reducing agents
0.18 to -0.54
Flash Point: > 160 °F (-55 °C)
N/A: Product not explosive
N/A = Not applicable
C.
Use Profile
Information on the currently registered uses of Bioban P-1487-containing products and
an overview of use sites and application methods follows. The detailed table of uses for Bioban
P-1487 products eligible for reregi strati on is contained in Appendix A.
Type of Pesticide: Bacteriocide, Fungicide
Summary of Use:
Antimicrobial products containing Bioban P-1487 as an active ingredient are intended for
use in industrial processes and water systems (Use Site VIII), and as a materials preservative for
a variety of products (Use Site Category VII). Examples of these uses are listed below. For a
detailed use description please refer to Appendix A.
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Materials Preservatives:
Bioban P-1487 is used in metal die cast lubricants, corrosion inhibiting
metal coatings, mold-release agents (for the manufacture of plastics), and
fuel conditioners (for diesel engines).
Industrial Processes and Water Systems:
Bioban P-1487 is used in industrial processes and water systems such as
metalworking fluids; oil storage tank bottom water, fuel storage tank
bottom water; and diesel oil, fuel oil, gasoline, and kerosene, as a
hydrocarbon preservative.
Target Pests: Deterioration/spoilage bacteria, slime-forming bacteria, slime-forming fungi
Formulation Types of Bioban P-1487: Soluble concentrates, ready-to-use solutions
Method and Rates of Application:
The methods and rates of application for Bioban P-1487-containing
products vary greatly depending on use site. Please refer to Appendix A
for more detailed application rates for each use site and methods of
application.
Use Classification: General Use
Basic
Manufacturers: The Dow Chemical Company
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III. Summary of Bioban P-1487 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 Bioban P-1487. 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-
0402, 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 Bioban P-1487 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 Bioban P-1487
A brief overview of the toxicity studies used for determining endpoints in the risk
assessment is outlined below in Table 2. Further details on the toxicity of Bioban P-1487 can be
found in the "BIOBAN P-1487: Toxicology Disciplinary Chapter for the Issuance of the
Reregistration Eligibility Decision (RED) Document," dated September 20, 2007; "BIOBAN P-
1487: Revised Report of the Antimicrobials Division's Toxicology Endpoint Selection
Committee (ADTC)," dated June 27, 2007; and "BIOBAN P-1487: Antimicrobials Division's
Risk Assessment for Issuance of the Reregistration Eligibility Decision (RED) Document,"
dated September 20, 2007. These documents are available in the EPA Docket at:
http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-0402).
The Agency has reviewed all toxicity studies submitted to support guideline requirements
for Bioban P-1487. Although the toxicological database is limited, it was determined that these
data are sufficient to support a registration eligibility decision provided the registrant submits
confirmatory toxicity data to support continued registration of Bioban P-1487-containing
products.
The acute toxicity profile for Bioban P-1487 is presented below in Table 2. Bioban P-
1487 was found to be moderately toxic (Toxicity Category III) by the oral route and severely
toxic by the dermal route (Toxicity Category II). The Agency has no adequate inhalation
toxicity data for Bioban P-1487. A study utilizing a one-hour exposure was submitted showing
significant clinical toxicity (blood in the urine, porphyrin discharge, corneal opacity, and
conjunctivitis) in the rat; however, this study was classified as unacceptable for regulatory
purposes. Bioban P-1487 was shown to be a severe skin and eye irritant (Toxicity Category II
and Toxicity Category I, respectively), as well as a dermal sensitizer.
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Table 2. Summary of Acute Toxicity Data for Bioban P-1487
Guideline
No.
870.1100
870.1200
onr\ i onn
870.2400
870.2500
870.2600
Study Type
Acute oral toxicity
Acute dermal toxicity
Acute inhalation toxicity
(Purity not reported)
Acute eye irritation
Acute dermal irritation
Skin sensitization
MRID #(s)
43558901
41677602
00094944
41677603
41677604
(duplicate
41810802)
MRID
42349201
Ace No.
259676
Results
LD50 = 620 mg/kg (M+F); 81% ai
LD50 = 420 mg/kg (M+F); 92 % ai
Corrosive; 92 % ai
Severe irritant; 92 % ai
Sensitizer; 90 % ai
Toxicity
Category
III
II
Unacceptable
study
I
II
N/A
Notes: LC = Lethal Concentration; LD = Lethal Dose; NA = Not Applicable
General Toxicity Observations
Dermal reactions (erythema and edema) to Bioban P-1487 were evident at all dose
levels tested in a 90-day subchronic dermal toxicity study conducted in rats. The hematocrit
was slightly reduced in males as was the white blood cell count in females. Creatinine was
reduced in males at all dose levels. Body weight was reduced in both sexes, in the absence of
any changes in food consumption. At the high-dose level, acanthosis was observed at the site
of skin application, and histological examination showed chronic inflammation of the urinary
bladder in both males and females.
A developmental toxicity study in rabbits is not available. Other toxicity studies
indicate that rabbits appear to be more sensitive to Bioban P-1487 than rats. In the rat
developmental toxicity study submitted to the Agency, excessive salivation was observed at
the mid- and high-dose levels of Bioban P-1487. Reduced body weight gain (36% and 12%
reduction from control, respectively) was observed in maternal animals in the high-and mid-
dose groups for the 0-20 day time period. There were no significant adverse effects on fetal
body weight, crown-rump length, or external, visceral, or skeletal malformations at any dose
tested. At the high-dose level there was a slight reduction in live fetuses per dam, and total
implants per dam; however, the incidences of these effects were not significantly different
from control. No data are available to assess the chronic toxicity of Bioban P-1487.
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From the available repeat-dose toxicity study, there was no evidence of neurotoxicity in
rats following dermal exposure to Bioban P-1487. Convulsions, catalepsy, and tremors were
observed at a single oral dose of 800 mg/kg, but not at doses of 500 mg/kg or below in the acute
oral toxicity studies. The Agency concluded that there is no concern for neurotoxicity resulting
from exposure to Bioban P-1487 based on the appearance of these clinical signs only at an
excessive dose that are not likely to be encountered from the registered uses of this chemical.
Carcinogenicity Classification
There were no data available to assess the carcinogenic potential of Bioban P-1487;
therefore, a determination cannot be made at this time.
Mutagenicity Potential
Bioban P-1487 was found to be negative for mutagencity in the absence or presence of
S9 activation in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537. There
was no evidence of chromosome aberration induction in the absence or presence of S9 activation
in a chromosome aberration test using Chinese Hamster Ovary cells. Bioban P-1487 did not
promote unscheduled DNA synthesis in rat hepatocyte cultures, nor did it induce a significant
increase in micronuclei in mouse bone marrow cells in an in vivo mammalian erythrocyte
micronucleus test. Therefore, Bioban P-1487 is not mutagenic or genotoxic.
The doses and toxicological endpoints selected for the Bioban P-1487 exposure scenarios
are summarized in Table 3 below:
Table 3. Summary of Toxicological Endpoints for Bioban P-1487
Exposure
Scenario
Dermal
Short-Term
(1-30 days)
Dermal
Intermediate-
Term
(1-6 months)
Dose Used in Risk
Assessment, UF
LOAEL (dermal)
= 30 mg/kg/day
NOAEL (systemic)
= 300 mg/kg/day
Special FQPA SF* and Level of
Concern for Risk Assessment
MOE = 30
(3x inter-species extrapolation,
3x intra-species variation, 3x for
use of a LOAEL value)
MOE = 100 (lOx inter-species
extrapolation, lOx intra-species
variation)
Study and Toxicological Effects
90-Day (Dermal) Subchronic
Toxicity Study in Rats (MRID
42440001, 41619302)
LOAEL = 30 mg/kg/day based on
skin irritation (erythema and
edema) at all doses tested.
90-Day (Dermal) Subchronic
Toxicity Study in Rats (MRID
42440001, 41619302)
LOAEL = 1000 mg/kg/day based
on decreased body weight, chronic
inflammation of the urinary bladder
in males and females.
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Exposure
Scenario
Dose Used in Risk
Assessment, UF
Special FQPA SF* and Level of
Concern for Risk Assessment
Study and Toxicological Effects
Dermal
Long-Term
(> 6 months)
NOAEL (systemic)
= 300 mg/kg/day
MOE = 300 (lOx inter-species
extrapolation, lOx intra-species
variation, 3x for use of a
subchronic endpoint for the long-
term endpoint)
90-Day (Dermal) Subchronic
Toxicity Study in Rats (MRID
42440001, 41619302)
LOAEL = 1000 mg/kg/day based
on decreased body weight, chronic
inflammation of the urinary bladder
in males and females.
Inhalation
(All Durations)
NOAEL(maternal)
= 10 mg/kg/day
MOE = 300 (lOx inter-species
extrapolation, lOx intra-species
variation, 3x for severe adverse
effects observed in the acute
inhalation toxicity study, the lack
of repeat inhalation exposure
study, severe skin irritation and
dermal sensitization. An
additional 10X is used to
determine the need for additional
data due to the need to use of
route extrapolation in the
assessment.
Developmental Toxicity Study in
Rats (MRID 416738801,
41978802)
LOAEL = 30 mg/kg/day based on
excessive salivation and decreased
body weight
Carcinogenicity
(oral, dermal,
inhalation)
No carcinogenicity data available for Bioban P-1487.
Notes: UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level.
Dietary and Incidental Oral
Dietary and incidental oral endpoints were not selected for Bioban P-1487 based on the
current registered use patterns.
Short-, Intermediate- and Long-term Dermal
The short-term LOAEL of 30 mg/kg/day is based on skin irritation (erythema and edema)
at all doses tested in the 90-day dermal subchronic toxicity study in rats. The target MOE is 30
(3X inter-species extrapolation, 3X intra-species variation, 3X for use of a LOAEL). The target
MOE was chosen because the established endpoint is for dermal irritation, not a systemic toxic
effect. In addition, dermal irritation is considered a reversible and short-term effect, thus
supporting a lOx uncertainty factor (3x for interspecies extrapolation and 3x for intraspecies
variation). The additional 3X uncertainty factor has been added since no NOAEL was
established in the study chosen to set the endpoint.
The intermediate- and long-term dermal NOAEL of 300 mg/kg/day is based on decreased
body weight and chronic inflammation of the urinary bladder observed in male and female rats in
the 90-day dermal toxicity study. The target MOE for intermediate-term dermal exposures is
100 (10X inter-species extrapolation, 10X intra-species variation). The target MOE, for long-
13
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term dermal exposure is 300 (lOx for inter-species extrapolation, lOx for intra-species variation,
3x for use of a sub chronic endpoint for the long-term endpoint).
Short- and Intermediate-term Inhalation
The short- and intermediate-term inhalation NOAEL is 10 based on excessive salivation
and decreased body weight observed at the LOAEL of 30 mg/kg/day in the developmental
toxicity study conducted in rats. In the absence of route-specific data, it was conservatively
assumed that inhalation absorption is equivalent to oral absorption (100%). The target MOE for
Bioban P-1487 is 300 for short-, intermediate-, and long-term durations (lOx for inter-species
extrapolation, lOx for intra-species variation, 30x (3X for lack of repeat inhalation exposure data,
severe adverse effects observed in the acute inhalation toxicity study, severe skin irritation and
dermal sensitization, and 10X use of route-to-route extrapolation). The additional lOx
uncertainty factor applied for route-to-route extrapolation is used to determine the need for
confirmatory inhalation toxicity data and not for risk management purposes.
Endocrine Disruption Potential
EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as amended
by FQPA, to develop a screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator
may designate." Following recommendations of its Endocrine Disrupter and Testing Advisory
Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's Endocrine Disrupting Screening Program (EDSP) have been developed, Bioban P-
1487 may be subjected to additional screening and/or testing to better characterize effects related
to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (lOx), 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 Agency does not anticipate
dietary, drinking water or residential exposures based on the registered use patterns. Therefore,
an FQPA hazard analysis is not necessary at this time.
14
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3. Dietary Risk Assessment
When conducting the dietary exposure assessment, all applications of a pesticide are
assessed for any dietary concerns from direct food contact or indirect migration of the pesticide
into foods, fruits and vegetables.
None of the currently registered uses of Bioban P-1487 are considered food use and are
not likely to result in any indirect food migration of these chemicals into food, fruits or
vegetables in residential settings. Further, Bioban -1487 is not used for potable water treatment
and effluents containing this chemical are not expected to contact fresh water environments.
Therefore, a drinking water exposure assessment was not conducted. Therefore, the Agency did
not conduct any dietary exposure assessment for Bioban P-1487 based on existing registered
uses.
4. Residential Risk Assessment
No products containing Bioban P-1487 are labeled for residential use. Furthermore,
occupational use of Bioban P-1487-containing products as a materials preservative in
metalworking fluids and fuels is not expected to result in any appreciable exposures in a
residential setting. As a result, no residential risk assessment has been conducted.
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.
An aggregate risk assessment was not conducted for Bioban P-1487. There are no
dietary or residential uses nor are there any post-application exposures that would occur in a
residential setting.
6. Occupational Risk
a. Summary of Use Pattern and Formulations
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Bioban P-1487 is used as an antimicrobial pesticide (e.g.,
materials preservative, industrial processes and water systems, hydrocarbon preservation, and
metal working fluids). Occupational risk assessed for exposure at the time of application is
termed "handler" exposure. Post-application occupational exposures occur when workers re-
enter sites treated with a pesticide. Application parameters used in the risk assessment 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.
15
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Exposure scenarios assessed for the occupational uses of Bioban P-1487 are shown in
Table 4. These scenarios were selected to be representative of the majority of uses and provide
high-end estimates of dermal, or inhalation exposure to Bioban P-1487. In addition, this table
shows the maximum application rate associated with the representative use and the appropriate
EPA Registration number for the product label.
Table 4. Representative Exposure Scenarios Associated with Occupational
Exposures to Bioban P-1487
Representative
Use
Method of
Application
Exposure Scenario
EPA
Registration
Number
Application Rate
Material Preservatives
Metalworking
fluid
Fuel
• Liquid pour
• Liquid pump
• Use of treated
metalworking
fluid
• Liquid pour
• Liquid pump
ST and IT Handler
(worker pouring
preservative into fluid
being treated): dermal
and inhalation
ST and IT/LT
Machinist: dermal and
inhalation
ST and IT Handler:
dermal and inhalation
464-659
464-678
0.26% a.i. by weight
(3000 ppm x 86%
a.i.)
0.088% a.i. by
weight (1350 ppm x
64.6% a.i.)
lit exposure values for liquid pour and pump preservation materials were assumed to be representative of
exposure related to the addition of Bioban to hydrocarbon fuels.
b. Occupational Handler Exposure
Occupational risks for all potentially exposed populations are measured by a Margin of
Exposure (MOE), which determines how close the occupational exposure comes to a No
Observed Adverse Effect Level (NOAEL) from toxicological studies. In the case of Bioban P-
1487, the target MOE for intermediate-term dermal exposures is 100. The target MOE for short-
and intermediate-term inhalation exposures is 300.
The Agency evaluated representative occupational handler scenarios using maximum
application rates from product labels to determine dermal and inhalation exposures to Bioban P-
1487. The majority of the scenarios were assessed using proprietary Chemical Manufacturers
Association (CMA) data to estimate potential risks. However, for the metalworking fluid
machinist scenario, the Agency applied the ChemSTEER model. The model is available at
www.epa.gov/opptintr/exposure/docs/chemsteer.htm.
The "preservation of materials" refers to the scenario of a worker adding the preservative
to the material being treated (metalworking fluid, fuel, etc.) through either liquid pour or liquid
16
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pump methods. Liquid pour refers to a worker transferring the antimicrobial product from a
small container to an open vat. Liquid pump refers to a worker transferring the preservative by
connecting/disconnecting a chemical metering pump from a tote or by gravity flow.
Risks were assessed for the intermediate-term duration for dermal exposures and short-
and intermediate-term durations for inhalation exposures for occupational handlers using the
appropriate toxicological endpoints. Short-term dermal exposures were not assessed for
occupational uses other than the machinist handling metal working fluids. The dermal irritation
via short-term exposures for handlers other than the machinist will be mitigated through the use
of personal protective equipment (PPE) as specified on the product labels.
For these exposure scenarios, the total MOEs that account for combined exposures via
dermal and inhalation routes, were not calculated for occupational use scenarios because the
toxicological endpoints for dermal and inhalation exposures differ.
For more information on the assumptions and calculations of potential exposure risks of
Bioban P-1487 to workers, refer to the "Occupational and Residential Exposure Assessment for
the Reregi strati on Eligibility Decision Document for Bioban P-1487," dated September 5, 2007
and the "BIOBAN P-1487: Antimicrobials Division's Risk Assessment for Issuance of the
Reregi strati on Eligibility Decision (RED) Document," dated September 20, 2007.
c. Occupational Handler Risk Summary
The Agency has assessed the potential dermal and inhalation risks to occupational
handlers from exposure to Bioban P-1487, including materials preservatives and metalworking
fluids in an industrial setting.
The calculated intermediate-term dermal and short- and intermediate-term inhalation
MOEs are shown in Table 5. All of the dermal MOEs are above the target MOE of 100 and all
of the inhalation MOEs are above the target MOE of 300. Therefore the intermediate-term
dermal and short- and intermediate-term inhalation exposures are not of concern.
17
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Table 5. Short- and Intermediate-Term Exposures and Risks for Occupational Handlers using Bioban P-1487
Exposure
Scenario
Preservation of
Metalworking
Fluids
Preservation of
Hydrocarbons
Method of
Application
Liquid pour
Liquid pump
Liquid pour
Liquid pump
Unit Exposure (mg/lb a.i.)
Dermal"
0.184
0.312
0.135
0.00629
Inhalation
0.0085
0.00348
0.00346
0.000403
App. Rate
0.26% a.i. by
weight
0.26% a.i. by
weight
0.088% a.i. by
weight
0.088% a.i. by
weight
Quantity
Handled/
Treated per
day
2,502 Ibs
2,502 Ibs
16,000 Ibs
160,000 Ibs
Absorbed Daily Dose
(mg/kg/day)b
Dermal
IT
0.017
0.029
0.027
0.013
Inhalation
ST/IT
0.00079
0.00032
0.00069
0.0008
MOEC
Dermal
(Target MOE =
100)
IT
18,000
10,000
11,000
24,000
Inhalation
(Target MOE =
300)
ST/IT
13,000
31,000
14,000
12,000
ST = short-term, IT = intermediate-term, N/A= No data available, NC = Not conducted
a All dermal unit exposure estimates used for occupational handler scenariosr epresent exposures incurred assuming the use of PPE (at least aj ong-sleeve
shirt and long pants plus chemical-resistant gloves), as specified on the product labels.
b Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb ai) * absorption (1.0 for both inhalation and dermal) * application rate * quantity treated /
body weight (70 kg).
c MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Wherem^e rmediate-term NOAEL = 300 mg/kg/day for dermal exposure and the short-term and
immediate term NOAEL = 10 mg/kg/day for inhalation exposure.
18
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d. Occupational Post-application Exposure
Occupational post-application exposures occur from handling or using treated end
products. Screening-level assessments were conducted for intermediate-and long-term inhalation
exposure for workers handling treated products. These risk estimates were developed using
Occupational Safety and Health Administration's (OSHA) Permissible Exposure Limit (PEL) for
oil mist. For more information on the assumptions and calculations of potential exposure risks of
Bioban P-1487 to workers, refer to the "Occupational and Residential Exposure Assessment for
the Reregi strati on Eligibility Decision Document for Bioban P-1487," dated September 5, 2007
and the "BIOBAN P-1487: Antimicrobials Division's Risk Assessment for Issuance of the
Reregi strati on Eligibility Decision (RED) Document," dated September 20, 2007.
e. Occupational Post-application Risk Summary
Table 6 shows the dermal doses and resulting MOEs for a machinist working with
metalworking fluids. The short-term dermal exposure is not of concern because the MOE of 65 is
above the target MOE of 30. The intermediate- and long-term MOE value of 5,500 is above the
respective target MOEs of 100 for intermediate-term, and 300 for long-term exposures.
Therefore, the intermediate- and long-term dermal exposures are not of concern.
Table 6. Short- Intermediate-, and Long-term Dermal Exposures and Risks for Machinist
Exposure to Metalworking Fluids
Exposure
Scenario
Machinist -
two hand
immersion
Percent
Active
Ingredient
0.258%
Exposure
Duration
ST
IT/LT
Hand
Surface
Area (cm2)
N/A
840
Film
thickness
(mg/cm2)
10.3
1.75
Frequency
(event/day)
N/A
1
Exposure a
2.7E-02
5.4E-02
Dermal MOE
(Target MOE is
30 for ST, 100
for IT, and 300
for LT) b
65
5,500
a For ST, exposures are calculated as a.i. per area of skin exposed (mg/cm ) = (% active ingredient x film
thickness (10.3 mg/cm2). For IT/LT, exposures are calculated as an Absorbed Daily Dose normalized to
body weight (mg/kg/day) = [(% active ingredient x surface area of hands x film thickness (1.75 mg/cm2) x
Frequency (event/day)] / Body weight (70 kg).
b MOE = NOAEL (mg/kg/day) / exposure, where exposure is a.i. per skin area (mg/cm2) for ST and
Absorbed Daily Dose (mg/kg/day) for IT/LT. [Where: ST LOAEL = [(30mg/kg/day X 0.231 kg (rat
average body weight M/F)/4 cm2] =1.77 mg/cm2', where 4 cm2 is the rat surface area used to apply the
chemical and IT/LT NOAEL = 300 mg/kg/day for dermal exposures].
Table 7 shows the short- and intermediate-term inhalation doses and resulting MOEs for
a machinist working with end products treated with Bioban P-1487 metalworking fluids. The
inhalation MOE for short-, intermediate-, and long-term exposures to Bioban is above the target
MOE of 300; therefore post-application inhalation exposure from metalworking fluids is not a
concern.
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Table 7. Inhalation Post-Application Exposures and Risks
Exposure Scenario
Machinist
Percent Active
Ingredient
0.258%
OSHA
PEL
(mg/m3)
5
Inhalation
rate
(m3/hr)
1.25
Exposure
Duration
(hrs/day)
8
ST/IT/LT Absorbed
Daily Dose"
(mg/kg/day)
1.8E-03
ST/IT/LT
Inhalation MOE
(Target MOE is 300) b
5,400
a Absorbed daily dose (mg/kg/day) = % active ingredient * OSHA PEL (mg/m3) * Inhalation rate (nrVhr)
exposure duration (hr/day) / body weight (70 kg).
b MOE = NOAEL (mg/kg/day) / absorbed daily dose (mg/kg/day) [Where: ST/IT/LT NOAEL = 10 mg/kg/day for
inhalation exposures].
7.
Human Incident Data
The Agency reviewed available sources of human incident data for incidents relevant to
Bioban P-1487. EPA consulted the following sources of information for human poisoning
incidents related to Bioban P-1487 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.
In the data available to the Agency, no reports of serious illness have been associated
with human exposure to Bioban P-1487.
B.
Environmental Risk Assessment
A summary of the Agency's environmental fate and risk assessment of Bioban P-1487 is
presented below. The uses of Bioban P-1487 are considered indoor uses and were not assessed
as the Agency does not anticipate environmental exposure. For a detailed discussion of all
aspects of the environmental risk assessment, refer to the Environmental Risk Assessment in the
"Bioban P-1487 Ecological Hazard and Environmental Risk Assessment Chapter," dated
September 20, 2007; and the "Environmental Fate Assessment Bioban P-1487 for the
Reregi strati on Eligibility Decision (RED) Document," dated September 20, 2007.
1. Environmental Fate and Transport
The Agency has reviewed the available environmental fate studies and reports
submitted for Bioban P-1487 to conduct an environmental fate assessment. These data
indicate that Bioban P-1487 has a high vapor pressure (16 mm Hg) at room temperature, is
highly water soluble, and is not hydrolytically or photolytically stable under abiotic and
buffered conditions. In water, the half life of Bioban P-1487 varies depending on pH: 5 (22
hours), 7 (44 hours), and 9 (46 hours). Although Bioban P-1487 does not readily biodegrade
20
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in water or soil, it is not likely to contaminate surface or ground water, as it is hydrolytically
unstable with half lives of less than two days. Determinations showed that Bioban P-1487 has a
log Kow of 1.7 making it unlikely to bind with soils, and therefore mobile in soils.
a. Bioaccumulation in Terrestrial and Aquatic Organisms
Aquatic metabolism studies indicate that Bioban P-1487 is stable to microbial
degradation and bioaccumulation in terrestrial or aquatic organisms is not likely to occur.
Therefore, the bioaccumulation potential of Bioban P-1487 is not of concern to the Agency.
2. Ecological Risk
Generally, 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. However, the uses of Bioban P-1487 are considered
"indoor" or limited use patterns by the Agency. A summary of the submitted data is provided
below.
a. Ecological Toxicity
For the use patterns of Bioban P-1487, avian acute oral toxicity testing [(850.2100),
preferably using the bobwhite quail], freshwater fish acute toxicity testing [(850.1075),
preferably the rainbow trout], freshwater invertebrate acute toxicity testing (850.1010), and
terrestrial and aquatic plant testing are generally needed for the technical grade active ingredient
(TGAI) to establish toxicity and to support the registered uses of this chemical.
Based on the results of mammalian studies, Bioban P-1487 was shown to be moderately
toxic (Toxicity Category III) by the oral route and severely toxic (Toxicity Category II) by the
dermal route of exposure. It is severely irritating to the skin and eyes (Toxicity category II and I,
respectively), as well as a dermal sensitizer. Bioban P-1487 is also considered to be highly toxic
via the inhalation route of exposure (toxicity category I).
The results from the avian acute toxicity and dietary studies are summarized in Table 8.
These data indicate that Bioban P-1487 is practically non-toxic to both mallard duck and
bobwhite quail. All of the submitted avian studies were determined to be supplemental and do
not meet guideline requirements. The acute oral LD50 is greater than 100 mg/kg; therefore, no
hazard statement for birds is needed on the labels at this time.
Table 8. Avian Acute Oral and Subacute Dietary Toxicity for Bioban P-1487
Test and
Organism
Acute Oral
Toxicity LDso
Mallard Duck
(Anas
Results
LC5o (mg/L) or
LD50 (mg/kg)
LD50> 1000
Toxicity
Category
Practically
non-toxic
Comments
Supplemental
study
Reference
Fink, R. and
Beavers, J. 1990
MRID 93055001
21
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Test and
Organism
platyrhynchos)
Eight day dietary
LCso Bobwhite
Quail (Colinus
virginianus)
Eight day dietary
LC50 Mallard
Duck (Anas
platyrhynchos )
Results
LC5o (mg/L) or
LD50 (mg/kg)
LC50 > 3692
LC50 > 3692
NOEC = 2076
Toxicity
Category
Practically
non-toxic
Practically
non-toxic
Comments
Supplemental
study
Supplemental
study
Reference
Fink, R. and
Beavers, J. 1990
MRID 93055002
Fink, R. and
Beavers, J. 1990
MRID 93055003
Freshwater fish toxicity studies using the technical grade active ingredient are used to
establish potential toxicity to fish. Data are generally needed for only one species when
chemical use sites occur in an indoor setting only or the use patterns are limited, as is the case for
Bioban P-1487. The preferred test species are rainbow trout (a coldwater fish) or bluegill sunfish
(a warm water fish). Two freshwater fish acute toxicity studies were submitted to the Agency.
Results of these studies (Table 9) show that the toxicity ranges from 0.75 mg/L to 0.83 mg/L,
indicating that Bioban P-1487 is highly toxic to both rainbow trout and bluegill sunfish,
respectively. Since the observed toxicity is < 1.0 ppm, product labeling typically must state:
"This pesticide is toxic to fish."
Table 9. Freshwater Fish Acute Toxicity for Bioban P-1487
Test and
Organism
Acute Toxicity
LCso Rainbow
Trout
(Onchorynchus
mykiss)
Acute Toxicity
LC50 Bluegill
Sunfish
(Lepomis
macrochirus)
Results
LC50 (mg/L)
LC50 = 0.75
LC50 =0.83
Toxicity
Category
Highly toxic
Highly toxic
Comments
Core study
Core study
Reference
Griffen, J. and
Thompson, C. 1990.
MRID 93055005
Griffen, J. and
Thompson, C. 1990.
MRID 93055004
A freshwater aquatic invertebrate toxicity test (preferably using Daphnia magna or
Daphniapulex) conducted with the TGAI is needed to establish the toxicity of a pesticide to
aquatic invertebrates. No studies testing the toxicity of Bioban P-1487 to aquatic invertebrates
were submitted to the Agency.
Terrestrial and aquatic plant testing was conducted to support the registered uses of
Bioban P-1487. As shown in Table 10, Bioban P-1487 was toxic to freshwater alga at
microgram concentrations.
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Table 10. Terrestrial and Aquatic Plant Toxicity for Bioban P-1487
Test and
Organism
96-hr. Toxicity
Test Freshwater
Alga
(Selenastrum
capricornutum)
Results (mg/L)
EC50 (growth rate) = 0.844
EC50 (% inhibition) = 0.352
EC50 (cell density) = 0.356
NOEC = 0.049
Toxicity
Category
None given
Comments
Core Study
Reference
Kirk, H.D. et al.
2002
MRID 47005504
b. Ecological Exposure and Risk
The Agency has evaluated the indoor uses of Bioban P-1487 being considered for
reregi strati on. Avian, freshwater and estuarine/marine aquatic organisms and plants are not
expected to be exposed to Bioban P-1487 because of the chemical's indoor use pattern. No
modeling was conducted because Bioban P-1487 does not have any uses in once-through cooling
tower, antifoulant, ballast water or wood treatment.
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
andronomus 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
LOC 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.
23
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Bioban P-1487 is used indoors to control microbial growth in diesel oil, gasoline,
kerosene storage tanks, fuel tanks, resin, latex or other water based emulsions and typically
would fall into this category. For certain use categories, the Agency assumes there will be
minimal environmental exposure, and only a minimal toxicity data set is required (Overview of
the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental
Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04,
Appendix A, Section IIB, pg.81). Chemicals in these categories therefore do not undergo a full
screening-level risk assessment, and are considered to fall under a "no effect" determination.
The materials preservative uses of Bioban P-1487 fall into this category.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for 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 Bioban P-1487 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 Bioban P-1487.
The Agency has completed its assessment of the occupational and ecological risks
associated with the use of pesticide products containing the active ingredient Bioban P-1487.
Based on a review of these data and on public comments on the Agency's assessments for the
active ingredient Bioban P-1487, the Agency has sufficient information on the human health and
ecological effects of Bioban P-1487 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 Bioban P-1487-containing products are eligible for reregi strati on
provided that: (i) current data gaps and confirmatory data needs are addressed; and (ii) label
amendments are made as described in Section V. Appendix A summarizes the uses of Bioban P-
1487 that are eligible for reregi strati on. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregi strati on eligibility of Bioban P-1487
and lists the submitted studies that the Agency found acceptable. Data gaps are identified as
generic data requirements that have not been satisfied with acceptable data.
Based on its evaluation of Bioban P-1487, the Agency has determined that Bioban P-
1487 products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA. Accordingly, should a registrant fail to implement the submission of
confirmatory data as well as the label changes identified in this document, the Agency may take
regulatory action to address this lack of information for Bioban P-1487. If all changes outlined
in this document are fully complied with, then no risks of concern exist for the registered uses of
Bioban P-1487 and the purposes of this determination.
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 Bioban P-1487. EPA released its preliminary
risk assessment for Bioban P-1487 for public comment on July 6, 2007. The Agency received
minimal comments during the 60-day public comment period on the Bioban P-1487 risk
assessment and supporting science documents, which closed on September 4, 2007.
25
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C. Regulatory Position
The Agency has determined that, if confirmatory data are submitted as described in this
document and labels are amended to ensure that appropriate PPE is on all product labels, human
health risks as a result of exposures to Bioban P-1487 are within acceptable levels. In other
words, EPA has concluded that Bioban P-1487 meets FQPA safety standards. In reaching this
determination, EPA has considered the available information on the special sensitivity of infants
and children, as well as exposures to Bioban P-1487 from all possible sources.
a. Determination of Safety to U.S. Population
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with Bioban P-1487. The Agency has determined that Bioban P-1487, with amendments and
changes specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result
to the general population or any subgroup from the use of Bioban P-1487. In reaching this
conclusion, the Agency has considered all available information on the toxicity, use practices
and exposure scenarios, and the environmental behavior of Bioban P-1487.
b. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of Bioban P-1487, with changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and
children. The safety determination for infants and children considers the toxicity, use practices,
and environmental behavior noted above for the general population, but also takes into account
the possibility of increased susceptibility to the toxic effects of Bioban P-1487 residues in this
population subgroup.
There are no dietary or residential uses nor are there any post-application exposures that
would occur in a residential setting. Therefore, an aggregate risk assessment was not conducted
for Bioban P-1487. In addition, Bioban -1487 is not used for potable water treatment and
effluents containing this chemical are not expected to contact fresh water environments.
Therefore, a drinking water exposure assessment was not conducted.
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
26
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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, Bioban P-1487 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 Bioban P-
1487. 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 Bioban
P-1487. 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 Bioban is eligible for reregi strati on provided that
additional data identified in this RED confirm this decision and label amendments are made to
ensure that all labels contain appropriate PPE requirements. 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
No human health risk mitigation measures are necessary for the antimicrobial use of
Bioban P-1487 at this time. Additional data are required to confirm the decisions outlined in this
document. The following toxicity study are needed for Bioban P-1487:
- Chronic Toxicity/Carcinogenicity Study in Rodents (OPPTS 870.4300).
2. Environmental Risk Management
No environmental risk mitigation measures are necessary for the antimicrobial use of
Bioban P-1487 at this time. The Agency recognizes that the currently registered uses of Bioban
P-1487 are limited to indoors.
27
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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 Bioban P-1487. For the specific
labeling statements and a list of outstanding data, refer to Section V of this RED document.
4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
andronomus listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species. "50 C.F.R. 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment and are considered to fall under a "no effect" determination. The materials
preservative uses of Bioban P-1487 fall into this category.
28
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b. General Risk Mitigation
Bioban P-1487 end-use products (EPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing Bioban
P-1487 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.
29
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V. What Registrants Need to Do
The Agency has determined that Bioban P-1487 is eligible for reregi strati on provided
that: (i) additional data that the Agency intends to require confirm this decision and (ii) label
amendments are made. To implement this decision, the registrants must amend their product
labeling to incorporate the label statement set forth in the Label Changes Summary Table in
Section B below (Table 24). The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For Bioban P-1487 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 Michelle Centra at (703) 308-2476 with questions regarding generic
reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Michelle Centra Michelle Centra
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-8845
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
For end-use products containing the active ingredient Bioban P-1467, 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.
30
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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 Marshall Swindell at (703) 308-6341 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
Marshall Swindell Marshall Swindell
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
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of Bioban P-1487 has 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.
Confirmatory toxicological data must be submitted to fully characterize the following
hazards: combined chronic toxi city /carcinogen! city study to assess potential chronic toxi cities as
well as define the carcinogenic potential of Bioban P-1487 since there is the potential for long-
term exposures due to the metal working fluid use.
31
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The following ecological toxicity data must be submitted to fully characterize the
invertebrate hazards: acute toxicity to freshwater invertebrates (preferably using Daphnia magna
or Daphnia pulex).
The requested toxicolgy and ecological study are outlined in Table 11.
Table 11. Confirmatory Data Requirements for Bioban P-1487
Guideline Study Name
Combined Chronic Toxicity /Carcinogenicity -Rat
Acute Freshwater Invertebrate Study1
New OPPTS Guideline Number
870.3800
850.1010
Needed if use patterns are expanded beyond those evaluated in this RED.
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in Table
12, Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
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 12, 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.
32
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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 Bioban P-1487 RED.^, e following table describes how language on the labels should be amended.
Table 12. Labeling Changes SummaryTah
Description
Amended Labeling Language
Placement on
Label
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"This product is toxic to fish and aquatic invertebrates. 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 Occupational Use
PPE Requirements
"Wear a long-sleeve shirt, long pants, shoes, socks, and chemical-resistant gloves."
Immediately
following/below
Precautionary
Statements:
Hazards to
Humans and
Domestic Animals
33
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VI. APPENDICES
34
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Appendix A. Table of Use Patterns for Bioban P-1487
Use Site
Formulation/
Reg. No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Industrial processes and water systems.
Metalworking Fluids
Hydrocarbon
Preservations
464-674
(Ready-to
use)
464-659
(Soluble
Concentrate)
464-674
(Ready-to
use)
464-678
(Ready-to
use)
Not Listed
Not Listed
Add to storage
tanks
Add to Storage
tanks: slug dose
or intermittent
metering
A dose of 1000 to 2000ppm
2500ppm for fouled systems
In concentrates: lOOOppm
Diluted Fluid: 1000-
SOOOppm
Maintenance: 100 to
2000ppm at weekly intervals
Add 2.2 gallons of product to
each 1,000 gallons of water /
concentration of lOOOppm
180- 350ppm product to
water
None Listed
None Listed
None Listed
None Listed
Materials preservatives
Die Cast Lubricants and
mold release agents
Diesel fuel Conditioner
464-674
(Ready-to
use)
464-665
(Ready-to
use)
Pour into Fuel
tank
1,000 to 2,000ppm for initial
treatment 2,500ppm for
fouled systems.
Entire Contents (12 oz) to 10
- 26 gallon fuel tank
None Listed
None Listed
35
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Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide To Appendix B
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Bioban P-1487. These
requirements apply to Bioban P-1487 in all products, including data requirements for whicha tech nical 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.
Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic
(not product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement,
this column will identify each study by a "Master Record Identification (MRID) number. The listed studies are considered
"valid" and acceptable for satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation
of each study.
36
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DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830. 7300
830.7840
830.7860
830.7950
830.7000
830.6317
830.6314
830.6315
830.6316
830. 7300
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-12
63-13
63-14
63-15
63-16
63-7
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analyses
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
PH
Stability
Oxidation/Reduction: chemical incompatibility
Flammability
Explodability
Density
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980, 41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980,41995101
00034980
00034980
00034980
00034980,41995101
37
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DATA REQUIREMENT
New Guideline
Number
830.7840
830.7860
830.7950
Old Guideline
Number
63-8
63-9
Study Title
Solubility
Vapor Pressure
Use Pattern
7,8
7,8
CITATION(S)
MRID Number
00034980,41995101
00034980,41995101
ECOLOGICAL EFFECTS
850.2100
850.2200
850.1075
850.1075
850.1010
850.5400
71-1
71-2
72-1
72-1
72-2
123-2
Avian acute oral toxicity test - Mallard/duck
Avian dietary toxicity test - Quail
Fish acute toxicity test - Bluegill Sunfish
Fish acute toxicity - Rainbow Trout
Acute Daphnid Study
Green algae - Selenastrum capricornutum (Pseudokerscheneria
subcapitatum)
7,8
7,8
7,8
7,8
7,8
7,8
93055001
93055002
93055004
93055005
Data Gap
47005504
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3250
870.3700
870.4300
870.5100
870.5300
870. 5375
870.5550
870.5385
870.7485
81-1
81-2
81-3
81-4
81-5
81-6
82-3
83-3
83-5
84-2
84-2
84-2
84-2
84-2
85-1
Acute oral toxicity - Rat
Acute dermal toxicity - Rabbit
Acute inhalation toxicity - Rat
Acute eye irritation - Rabbit
Acute dermal irritation
Skin sensitization
90-Day dermal toxicity
Prenatal developmental toxicity study
Combined chronic toxicity/carcinogenicity
Bacterial reverse mutation test
In vitro mammalian cell gene mutation test
In vitro mammalian chromosome aberration test
Unscheduled DNA synthesis in mammalian cells in culture
Mammalian bone marrow chromosomal aberration test
Metabolism and pharmacokinetics
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
7,8
43558901
41677602
Data Gap
41677603
41677604, 41810802
00104805
Not needed
41673801, 41978802
Data Gap
41619301
45655301
41298502, 41567901
41298503
47005501, 46965903
Not needed
38
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ENVIRONMENTAL FATE
835.2110
835.3110
Non-Guideline
161-1
None
Non-Guideline
Hydrolysis as a function of pH
Ready biodegradability
Soil partition co-efficient
7,8
7,8
7,8
43494001
47005502
45900901
39
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Appendix C: Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP Public Docket EPA-
HQ-OPP-2007-0402, 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.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site: http://www.regulations.gov (EPA-
HQ-OPP-2007-0402).
These documents include:
Risk Assessment and Supporting Science Documents:
• Bioban P-1487: Antimicrobials Division's Risk Assessment for Issuance of the
Reregistration Eligibility Decision (RED) Document. Case No. 3028, PC Code: 100801,
100802, DP Barcode: 338285. 9/20/07, Jenny Tao, Risk Assessor.
• Bioban P-1487: Toxicology Disciplinary Chapter for the Issuance of the Reregistration
Eligibility Decision (RED) Document. Case No. 3028, PC Code: 100801, 100802, DP
Barcode: 338284. 9/20/07, Jenny Tao, Senior Toxicologist.
• BIOBAN P-1487: Revised Report of the Antimicrobials Division's Toxicology Endpoint
Selection Committee (ADTC). 6/27/07, Tim McMahon, Ph.D., Chair, ADTC.
• Product Chemistry Science Chapter. PC Codes 100801, 100802, Case 3028,
Antimicrobials Division, 6/20/07, A. Najm Shamim, Ph.D., Chemist.
• DIETARY EXPOSURE ASSESSMENT OF BIOBAN P-1487 FOR
REREGISTRATION ELIGIBILITY DECISION Case No. 3028, PC Code: 100801,
100802, DP Barcode: 340643. 6/21/07, A. Najm Shamim, Ph.D. Chemist.
• Occupational and Residential Exposure Assessment for Bioban BIOBAN P-1487™
Antimicrobial Agent [4-(2-nitrobutyl)morpholine and 4,4'-(2-ethyl-2-
nitrotrimethylene)dimorpholine]. Case No.: 3028, DP Barcode: D338283, 9/5/07, Siroos
Mostaghimi, Ph.D., Senior Scientist.
• Environmental Fate Risk Assessment of BIOBAN P-1487 for the Reregistration
Eligibility Decision (RED) Process. Case No. 3028, PC Code: 100801, 100802, DP
Barcode: 340652. 9/20/07, A. Najm Shamim, Ph.D., Chemist.
• Environmental Effects Assessment of 4-(2-nitrobutyl) morpholine (Bioban P-1487) for
the Reregistration Eligibility Decision (RED) Document. Case No.: 3028, DP Barcode:
D340653, 9/20/07, David C. Bays, Microbiologist.
40
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
MRID Number Citation
00034980 Commercial Solvents Corporation (1969). CSCA(R)IBiocide P-1487.
(Unpublished study received Jun 25, 1969 under 271-30; submitted by
International Minerals and Chemical Corp., Terre Haute, Ind.;
CDL:001945-A).
00094944 Goldenthal, E.I.; Wazeter, F.X.; Dean, W.P. (1973) Acute Inhalation Toxicity
Study (LC50) in Albino Rats: 267-009; Report No. PLR-11. (Unpublished
study received Jan 14, 1981 under 271-30; prepared by International
Research and Development Corp., submitted by International Minerals &
Chemical Corp., Terre Haute, Ind.; CDL:244383-F)
00104805 Wilbur, S. (1978) P-1487 Skin Sensitization: SW78/11. (Unpublished study
received Apr 25, 1979 under 271-30; submitted by Inter- national
Minerals & Chemical Corp., Terre Haute, IN; CDL: 238693-A.
41298502 Desai, L. (1989) Chromosome Aberrations in Chinese Hamster Ovary (CHO)
Cells: Bioban P-1487 Antimicrobial Agent: Lab Project Number 89G-
0095. Unpublished study prepared by Toxikon Corp. 15 p.
41298503 Desai, L. (1989) Unscheduled DNA Synthesis in Rat Liver Primary Cell Cultures:
Bioban P-1487 Antimicrobial Agent: Lab Project Number 89G-0094.
Unpublished study prepared by Toxikon Corp. 12 p.
41567901 Desai, L. (1989) Chromosome Aberration in Chinese Hamster Ovary (CHO)
Cells: Lab Project Number: 89G-0095. Unpublished study prepared by
Toxikon Corp. 6 p.
41619301 Lynn, S. (1990) Ames Mutagenicity Assay: Bioban P1487: Lab Project Number:
90G/0526. Unpublished study by Toxikon Corp. 14 p.
41619302 Griffin, T. (1990) Subchronic 90-Day Dermal Toxicity Study of Bio- ban P-1487
in Rats: Lab Project Number: 890202. Unpublished study prepared by
Coulston International, Inc. 311 p.
41673801 Griffin, T. (1990) A Teratology Study of Bioban P-1487 in Rats: Final Report:
Lab Project Number: 890402. Unpublished study prepared by Coulston
International, Inc. 84 p.
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41677602 Kreuzmann, B. (1990) Acute Dermal Toxicity in Rabbits—Median Lethal Dosage
Determination: Lab Project Number: 90-4091-21 (B). Unpublished study
prepared by Hill Top Laboratories, Inc. 109 p.
41677603 Kreuzmann, B. (1990) Primary Eye Irritation Study in Rabbits: Bioban P-1487:
Lab Project Number: 90-4091-21 (D). Unpublished study prepared by Hill
Top Laboratories, Inc. 14 p.
41677604 Kreuzmann, B. (1990) Primary Skin Irritation Study in Rabbits: Bioban P-1487:
Lab Project Number: 90-4091-21 (C). Unpublished study prepared by Hill
Top Laboratories, Inc. 14 p.
41810802 Kreuzmann, J. (1990) Primary Skin Irritation Study in Rabbits: Lab Project
Number: 90-4091-21 (C). Unpublished study prepared by Hill Top
Biolabs, Inc. 31 p.
41978802 Griffin, T. (1991) Supplemental Data to MRID No. 41673801: A Teratology
Study of Bioban P-1487 in Rats. Unpublished study prepared by
Consulton International, Inc. 12 p.
41995101 Bollmeier, A. (1990). Product Chemistry for Bioban P-1487. Unpublished study
prepared by Angus Chemical Co. 28 p.
42440001 Griffin, T. (1992) Subchronic 90-day Dermal Toxicity Study of Bioban P-1487 in
Rats (Limit Test): Lab Project Number: 910302. Unpublished study
prepared by Coulston Research, Inc. 228 p.
43494001 Burke, B. (1994) Hydrolyses of 4-(2-Nitrobutyl) morpholine and 4,4'-(2-Ethyl-2-
nitrotrimethylene)dimorpholine: Lab Project Number: PRT-23-4ANN-01:
PRT-23-4ANN-01-003. Unpublished study prepared by Plant Research
Technologies, Inc. 149 p.
43558901 Fitzgerald, G. (1995) Acute Oral Toxicity Study (in Rats): Bioban P-1487: Final
Report: Lab Project Number: 94G-1937. Unpublished study prepared by
Toxikon Corp. 18 p.
45655301 Linscombe, V.A., M.R. Schisler, and K.F. Treadway (2002) Evaluation of Bioban
P-1487 in the mouse lymphoma (L5178Y TK +/-) forward mutation assay:
Toxicology and Environmental Research and Consulting, Dow Chemical
Company, Midland, MI, Laboratory ID 011110.
45900901 Estimating the Soil Koc for a Series of Biocides by HPLC Using OECD method
121 by S.J. Gonsoir, M.A. rivard, and M.K. Stock, 2002, Biocides TS and
D, the Dow Chemical Company, Midland, Michigan.
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46965903 Cifone, M.A. (2002) In vivo/in vitro unscheduled DNA synthesis in rat primary
hepatocyte cultures at two time points with a dose range-finding assay
with Bioban P-1487: Covance Laboratories, VA, Study No. 23622-0-494,
Dow No. 021036, August 25, 2002.
47005501 Spencer, PJ. (2003) Evaluation of Bioban P-1487 in the mouse bone marrow
micronucleus test. Toxicology and Environmental Research and
Consulting, Dow, Midland, MI, Study 020146, March 14, 2003.
47005502 Gonsior, S.; Stock, M.; Rivard, M. (2002) Evaluation of the Ready
Biodegradability of Bioban P-1487 Biocide using the OECD Method
301F: Manometric Respirometry Test. Project Number: 011131.
Unpublished study prepared by Dow Chemical Co. 31 p.
47005504 Kirk, H.D., Staley, J.L., McClymont, E.L., and McFadden, L.G. 2002. Bioban P-
1487: Growth Inhibition test with the Freshwater Green Alga, Selenastrum
capricornutum Printz. Study No. 021001. Conducted by Toxicology &
Environmental Research and Consulting, The Dow Chemical Company.
93055001 Fink, R. and Beavers, IB. 1990. Bioban P-1487: An Acute Oral Toxicity Study
with the Mallard Duck. Project No. 170-103. Conducted by Wildlife
International, LTD.
93055002 Fink, R. and Beavers, J.B. 1990. Bioban P-1487; Eight-day Dietary LC50 in
Bobwhite Quail. Project No. 170-101. Conducted by Wildlife
International, LTD MRID 93055003. Fink, R. and Beavers, J.B. 1990.
Bioban P-1487: Eight-day Dietary LC50 in Bobwhite Quail. Project No.
170-102. Conducted by Wildlife International. LTD.
93055004 Griffen, J. and Thompson, C.M. 1980. Acute Toxicity of Bioban P-1487 to
Bluegill Sunfish (Lempomis machrochirus). Project No. 25061.
Conducted by Analytical Bio Chemistry Laboratories.
93055005 Griffen, J. and Thompson, C.M. 1980. Acute Toxicity of Bioban P-1487 to the
Rainbow Trout (Salmo gairdneri). Project No. 25145 Conducted by
Analyical Bio Chemistry Laboratories.
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Supporting Documentation
A Memo from Roxolana Kashuba to Steven Bradburry, Director EFED, April 2006
Dang. 1997. The Use of Models for Estimating Exposure and Risk of Antimicrobials in
Metalworking Fluids. AAMAMWF Symposium, September 15-19, 1998.
The Estimation Programs Interface (EPI) Suite. Windows based suite of physical/chemical
properties and environmental estimation models developed by the US EPA's Office of
Prevention, Pesticides, and Toxic Substances (OPPTS) and Syracuse Research Institute
(SRC), http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm
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
SEVIetric. 2005. Mass, Weight, Density, or Specific Gravity of Bulk Materials.
http://www.simetric.co.ulc/si_materials.htm, last accessed February 2007.
U.S. Environmental Protection Agency (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.
U.S. Environmental Protection Agency (EPA). 1997. Exposure Factors Handbook. Volume I-II.
Office of Research and Development. Washington, D.C. EPA/600/P-95/002Fa.
U.S. Environmental Protection Agency (EPA). 1998. PHED Surrogate Exposure Guide.
Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version
1.1. Washington, DC: U.S. Environmental Protection Agency.
U.S. Environmental Protection Agency (EPA). 1999. Chemical Manufacturers Association
Antimicrobial Exposure Study. Washington, DC. DP Barcode D247642.
U.S. Environmental Protection Agency (EPA). 2002. Bioban P-1487 - Report of the
Antimicrobials Division Toxicology Endpoint Selection Committee. Revised on January 25,
2007.
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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 Bioban
P-1487 RED for a list of studies that the Agency plans to include in the Generic Data Call-in.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G. Batching of Bioban P-1487 Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency will complete the batching for Bioban P-1487 at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Information Center (NPIC) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by
telephone at (800) 858-7378 or through their Web site: http://npic.orst.edu/
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
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encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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