?/EPA
United States Prevention, Pesticides EPA739-R-06-009
Environmental Protection and Toxic Substances August 2006
Agency (751OC)
Reregistration Eligibility Decision
for Alkyl Dimethyl Benzyl
Ammonium Chloride (ADBAC)
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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 Alkyl Dimethyl Benzyl
Ammonium Chloride (ADBAC). The Reregi strati on Eligibility Decision (RED) was approved
in the form of a decision memorandum which summarized the regulatory decision for ADBAC
on August 3, 2006. 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 ADBAC 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 ADBAC are available to the public in
EPA's Pesticide Docket EPA-HQ-OPP-2006-0339 at: http://www.regulations.gov.
The ADBAC RED was developed through EPA's public participation process, published
in the Federal Register on April 26, 2006, which provides opportunities for public involvement
in the Agency's pesticide tolerance reassessment and reregi strati on programs. Developed in
partnership with USDA and with input from EPA's advisory committees and others, the public
participation process encourages robust public involvement starting early and continuing
throughout the pesticide risk assessment and risk mitigation decision making process. The
public participation process encompasses full, modified, and streamlined versions that enable the
Agency to tailor the level of review to the level of refinement of the risk assessments, as well as
to the amount of use, risk, public concern, and complexity associated with each pesticide. Using
the public participation process, EPA is attaining its strong commitment to both involve the
public and meet statutory deadlines.
Please note that the ADBAC risk assessment and the attached RED document concern
only this particular pesticide. This RED presents the Agency's conclusions on the dietary,
drinking water, occupational and ecological risks posed by exposure to ADBAC alone. This
document also contains both generic and product-specific data that the Agency intends to require
in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to
registrants at a later date. Additionally, for product-specific DCIs, the first set of required
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responses will be due 90 days from the receipt of the DCI letter. The second set of required
responses will be due eight months from the receipt of the DCI letter.
As part of the RED, the Agency has determined that ADBAC will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measure 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 to implement this mitigation measure. Instructions for registrants on
submitting the revised labeling can be found in the set of instructions for product-specific data
that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by ADBAC. 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, Jacqueline Campbell-McFarlane, at
(703) 308-6416. For questions about product reregistration and/or the Product DCI that
accompanies this document, please contact Velma Noble at (703) 308-6233.
Sincerely,
//rank jTSahders
/ Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
ADBAC
CASE 0350
Appro
Sanders
Director, Antimicrobials Division
August 3, 2006
Attachment
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Table of Contents
ADBAC Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 6
III. Summary of ADBAC Risk Assessments 10
A. Human Health Risk Assessment 10
1. Toxicity of ADBAC 10
2. FQPA Safety Factor 13
3. Population Adjusted Dose (PAD) 14
a. Acute PAD 14
b. Chronic PAD 14
4. Dietary Exposure Assumptions 14
5. Dietary Risk Assessment 15
a. Dietary Risk from Food 15
b. Dietary Risk from Drinking Water 17
6. Residential Risk Assessment 18
a. Residential Toxicity 18
b. Residential Handlers 19
i. Exposure Scenarios, Data and Assumptions 19
ii. Risk Assessment 21
c. Residential Post-Application 25
i. Exposure Assessment 25
ii. Risk Assessment 25
7. Aggregate Risk 27
a. Chronic Aggregate Risk 27
b. Short-and Intermediate-Term Aggregate Risk 28
8. Occupational Risk 30
a. Occupational Toxicity 31
b. Occupational Handler Exposure 31
c. Occupational Handler Risk Summary 34
d. Occupational Post Application Exposures 39
i. Fogging (Food Processing Plant and Hatchery) 39
e. Wood Preservation 40
i. Non-Pressure Treatment Scenarios (Handler and 40
Post-Application)
a. Scenarios Assessed by Worker Function 40
ii. Pressure Treatment Scenarios (Handler and Post- 43
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Application)
9. Human Incident Data 44
B. Environmental Risk Assessment 45
1. Environmental Fate and Transport 45
2. Ecological Risk 45
a. Toxicity (Hazard) Assessment 45
b. Exposure and Risk 46
c. Risk to Listed Species 48
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 50
A. Determination of Reregistration Eligibility 50
B. Public Comments and Responses 50
C. Regulatory Position 50
1. Food Quality Protection Act Findings 50
a. "Risk Cup" Determination 51
b. Determination of Safety to U.S. Population 51
c. Determination of Safety to Infants and Children 51
d. Endocrine Disrupter Effects 52
e. Cumulative Risks 52
2. Tolerance Summary 52
D. Regulatory Rationale 53
1. Human Health Risk Management 53
a. Dietary (Food) Risk Mitigation 53
b. Drinking Water Risk Mitigation 53
c. Residential Risk Mitigation 54
i. Handler Risk Mitigation 54
ii. Post-Application Risk Mitigation 54
d. Occupational Risk Mitigation 54
i. Handler Risk Mitigation 54
ii. Post-Application Risk Mitigation 55
2. Environmental Risk Management 55
3. Labeling Requirements 56
4. Listed Species Considerations 57
a. The Endangered Species Act 57
b. General Risk Mitigation 58
V. What Registrants Need to Do 59
A. Manufacturing-Use Products 61
1. Additional Generic Data Requirements 61
2. Labeling for Technical and Manufacturing-Use Products 62
B. End-Use Products 62
1. Additional Product-Specific Data Requirements 62
2. Labeling for End-Use Products 65
a. Label Changes Summary Table 65
VI. Appendices 73
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A. ADBAC Master Label 74
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 83
C. Technical Support Documents 91
D. Bibliography Citations 93
E. Generic Data Call-In 108
F. Product Specific Data Call-In 109
G. List of All Registrants Sent the Data Call-In 110
H. List of Available Forms Ill
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ADBAC Reregistration Team
Health Effects Risk Assessment
Jonathan Chen
Timothy Leighton
Tim McMahon
Najm Shamim
Matthew Lloyd
Ecological Risk Assessment
Richard Petrie
Kathryn Montague
Brian Kiernan
Marietta Echeverria
Environmental Fate Risk Assessment
Srinivas Gowda
Chemistry Assessment
Chris Jiang
Registration Support
Velma Noble
Dennis Edwards
Risk Management
Jacqueline Campbell-McFarlane
Tracy Lantz
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
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
ii
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N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
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
ill
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ABSTRACT
The Environmental Protection Agency (EPA or The Agency) has completed the human
health and environmental risk assessments for alkyl dimethyl benzyl ammonium chloride,
ADBAC, and is issuing its risk management decision and tolerance reassessment. The risk
assessments, which are summarized below, are based on the review of the required target
database supporting the use patterns of currently registered products and additional information
received through the public docket. After considering the risks identified in the revised risk
assessments, comments received, and mitigation suggestions from interested parties, the Agency
developed its risk management decision for uses of ADBAC that pose risks of concern. As a
result of this review, EPA has determined that ADBAC-containing products are eligible for
reregi strati on, provided that risk mitigation measures are adopted and labels are amended
accordingly. That decision is discussed fully in this document.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that,
for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. The Act also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's revised human health and ecological risk assessments and the Reregistration Eligibility
Decision (RED) for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC).
ADBAC is an antimicrobial used in agricultural, food handling, commercial/
institutional/ industrial, residential and public access, and medical settings. Examples of
registered uses for ADBAC in these settings include application to indoor and outdoor hard
surfaces (e.g., walls, floors, tables, toilets, and fixtures), eating utensils, laundry, carpets,
agricultural tools and vehicles, egg shells, hands and gloves, shoes, milking equipment, and
udders, humidifiers, RV tanks, medical instruments, human remains, ultrasonic tanks, reverse
osmosis units, and water storage tanks. There are also ADBAC end-use products that are used in
residential and commercial swimming pools, in aquatic areas such as decorative ponds,
decorative fountains, and agricultural watering lines, and in industrial process and water systems
such as once-through and re-circulating cooling water systems, cooling towers, evaporative
condensers, pasteurizers, drilling mud, packer fluids, oil well injection and wastewater systems,
and in pulp and paper products, water, and chemicals. Additionally, ADBAC end-use products
are used for wood preservation.
The Agency has concluded that the FQPA Safety Factor for ADBAC should be removed
(equivalent to IX) based on: (1) there is no concern for developmental neurotoxicity resulting
from exposure to ADBAC because there is no evidence ADBAC will induce neurotoxic effects;
(2) there is no evidence of increased susceptibility to the fetus following in utero exposure in the
prenatal developmental toxicity studies or to the offspring when adults are exposed in the two-
generation reproductive study; and (3) the risk assessment does not underestimate the potential
exposure for infants and children.
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Risks summarized in this document are those that result only from the use of the active
ingredients ADBAC. 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 ADBAC and any other substances. ADBAC does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA
has not assumed that ADBAC 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 ADBAC. In an effort to simplify the RED, the information presented
herein is summarized from more detailed information that can be found in the technical
supporting documents for ADBAC 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.epa.gov/edocket.
This document consists of six sections. Section I is the introduction. Section II provides
a chemical overview, a profile of the use and usage of ADBAC, and its regulatory history.
Section III, Summary of ADBAC 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 ADBAC was registered in 1947. The oldest active
product containing an ADBAC was registered in 1956 under chemical code 069105.
These pesticides are classified as List A chemicals for which a registration standard was
issued by EPA in 1985. When the list of active ingredients undergoing reregistration was
published in 1989, 43 additional active ingredients were added to this case. Since
issuance of the list, one active ingredient has been placed into a separate chemical case,
and 18 active ingredients have been canceled thus resulting in 24 active ingredients in
this case.
The ADBAC Quat Steering Committee/Joint Venture comprised of Lonza, Inc.,
Mason Chemical Company, and Stepan Company was formed to support the
reregistgration activities of this chemical case. Along with the Quat Steering
Committee/Joint Venture, Albemarle Corporation produces chemicals within the
ADBAC case. These chemicals are formulated into countless products that are used in
residential, commercial, industrial, institutional, and agricultural settings.
In 1988, EPA issued PR Notice 88-2 outlining "Clustering of Quaternary
Ammonium Compounds." In this Notice, Quats were clustered into 4 groups as follows:
Group I: The alkyl or hydroxyalkyl (straight chain) substituted Quats
Group II: The non-halogenated benzyl substituted Quats (including
hydroxybenzyl, hydroxyethylbenzyl, naphylmethyl, dodecyhlbenzhyl, and alkyl benzyl)
Group III: The di- and tri-chlorobenzyhl substituted Quats
Group IV: Quats with unusual substitutes (charged heterocyclic compounds).
The Agency agreed for data development purposes that the pesticide, alkyl
(50%Ci4, 40% Ci2, 10% Ci6) dimethyl benzyl ammonium chloride (PC code 069105),
would serve as the model compound.
B. Chemical Identification
The alkyl dimethyl benzyl ammonium chloride (ADBAC) chemical case is
comprised of 24 compounds that are structurally similar quaternary ammonium
compounds (quats) that are characterized by having a positively charged nitrogen
covalently bonded to three alkyl group substituents and a benzyl substituent. In finished
form, these quats are salts with the positively charged nitrogen (cation) balanced by a
negatively charged molecule (anion). The most common anion for the quats in this
cluster is chloride. However, other anions, such as saccharine and bromide are also used.
Table 1 below provides the common chemical name, active ingredient code, CAS
number, and chemical structure.
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Table 1: Active Ingredients in Group II Cluster
Pesticide
Code
69104
69105
69106
69107
69119
69137
69140
69141
69157
69175
69189
69184
69192
CASRN
53516-76-0
68424-85-1
8001-54-5
139-08-2
73049-75-9
68424-85-1
61789-71-7
68424-85-1
68424-85-1
68391-01-5
68391-01-5
68424-85-1
85409-22-9
Name
ADBAC
ADBAC
ADBAC
ADBAC
Dialkyl Methyl BAC
ADBAC
ADBAC
ADBAC
ADBAC
ADBAC
ADBAC
ADBAC
ADBAC
Structure
Cu><;
V
CH3
V
R
V
V
CH3
V
V
V
V
CH3
Chain Lengths
R = C12 (5%)
C14 (60%)
C16 (30%)
C 18 (5%)
R = C12(40%)
C14 (50%)
C16 (10%)
R = C12(50%)
C14 (30%)
C16 (17%)
C18(3%)
R = C12 (1%)
C14 (98%)
R = C12(5%)
C14 (60%)
C16 (30%)
C18(5%)
R = C12(25%)
C14 (60%)
C16 (15%)
R = C8-10(2.5%)
C14 (61%)
C16 (23%)
C18(2.5%)
R = C12(14%)
C14 (58%)
C16 (28%)
R = C12(65%)
C14 (25%)
C16 (10%)
R = C12(67%)
C14 (25%)
C16(7%)
R = C12(61%)
C14 (23%)
C18(5%)
R = C12 (3%)
C14 (95%)
C16(2%)
R = C12(70%)
C14 (30%)
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Pesticide
Code
69194
128928
69171
69154
69111
069112
069125
169159
69122
69129
CASRN
68424-85-1
63449-41-2
68989-01-5
85409-23-0
8045-21-4
53516-75-9
1330-85-4
N/A
121-54-0
1399-80-0
Name
ADBAC
ADBAC
ADBA Saccharinate
ADEBAC
ADEBAC
n-Alkyl dimethyl 1-
naphtylmethyl
ammonium chloride
Dodecyl benzyl
trimethyl ammonium
chloride
n-alkyl dimethyl
dimethyl ammonium
chloride
Diisobutylphenoxy-
ethyoxyethyl dimethyl
benzyl ammonium
chloride
[Benzethonium
Chloride]
Methyl dodecyl benzyl
tri methyl ammonium
chloride - 80%
Methyl dodecyl xylene
bis tri methyl
ammonium chloride -
20%
Structure
^/^^ Cl
r i R
I JL V/Ch3
\H,
l^^^l R C'
^^VC
f\ \/CH, V^XX,
A
H3C^CXjxH3
CH3
H C^X^^I C
X^L3cCH3
CH3
Chain Lengths
R = C12 (5%)
C14 (90%)
C16(5%)
R = C8 - Not specified
CIO -Not specified
C12 (67%)
C14 (25%)
C16(7%)
Cl 8 -Not specified
R = C12 (40%)
C14 (50%)
C16 (10%)
R = C12(68%)
C14 (32%)
R = C12(50%)
C14 (30%)
C16 (17%)
C18(3%)
R=C12(98%)
C14(2%)
R= C12 (68%)
C14 (32%)
CH3
CH3 "XV ^^^
H3C^^^OL ° r^(~^}
CH3 X/^o/^XX' ^^N'x^ \=/
H3C
"^~ " ^*
^f*^ *^ T"1\^1)S,J
rji % I
\ ^"**r.
•* ^*\ ^*%
\ ^n. *f, \*^
Tr*rf (, /
^*W
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Pesticide
Code
CASRN
Name
Structure
Chain Lengths
69134
25155-18-4
Diisobutyl
cresoxyethoxyethyl
dimethyl benzyl
ammonium chloride
monohydrate
Common name:
Chemical name:
Chemical family:
Case number:
ADBAC
n-Alkyl dimethyl benzyl ammonium chloride
Quaternary amines
0350
Basic manufacturers: Albemarle Corporation
Lonza, Inc.
Mason Chemicals Company
Stepan Company
Chemical properties: ADBAC is a clear yellow to straw colored liquid with an amine
odor that is soluble in water and alcohols. ADBAC has a melting
point of 241.02°C, vapor pressure of 3.53x 10"12 mm HG, and a
density of 0.9429 g/cm2 at 25°C.
C.
Use Profile
The following is information on the uses of ADBAC products, currently registered as of
April 26, 2006, and an overview of use sites and application methods. A detailed table of the
uses of ADBAC eligible for reregi strati on is contained in Appendix A.
Type of Pesticide: Algicide, bacteriocide, bacteriostat, wood preservative, fungicide,
fungistat, virucide, tuberculocide, insecticide, microbiocide, microbiostat,
molluscide, deodorant, disinfectant, and sanitizer
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Summary of Uses:
Use Category
Use Site
Industrial processes and water
systems
Industrial re-circulating water systems, pulp and paper
facilities, cooling water towers, disposal water, oil field
operations, and oilfield water flood or saltwater disposal.
Swimming Pools
Swimming Pools, Outside Spas, Whirlpools, and hot tubs
Aquatic Areas
Golf courses, recreational parks, amusement parks,
universities, cemeteries, and greenhouse/nurseries
Wood Treatment
Pressure Treatment, Double vacuum, and dip/spray surface
treatment
Agricultural Premise and
Equipment
Hatcheries, swine/poultry/turkey farms, animal housing
facilities, farrowing barns, dressing plants, mushroom farms,
citrus farm, florist/flower shops, and greenhouses/nurseries
Residential and Public Access
Premises
Homes, mobile homes, cars, boats, playgrounds, boats,
public facilities, campgrounds, trailers, campers, trailers, and
trucks
Medical Premises and
Equipment
Hospitals, health care facilities, medical/ dental offices,
nursing homes, autopsy rooms, funeral homes, mortuaries,
medical research facilities, acute care institutions, alternative
care institutions, newborn nurseries, day-care facilities, and
sick rooms
Commercial, Institutional, and
Industrial Premise and
Equipment
Athletic/recreational facilities, exercise facilities, health
clubs, dressing/locker rooms, schools, colleges, universities,
transportation terminals, libraries, motels, hotels, barber and
beauty salons, convenience stores, offices, commercial/
institutional laundry mats, emergency vehicles, factories,
commercial florist, and correctional facilities
Food Handling/Storage
Establishments Premises and
Equipment
Restaurants, food service establishments, food
processing/storage/handling plants and facilities, beverage
processing plants, supermarkets, breweries, bars, cafeterias,
fishery/citrus/wine/ice cream/ potato processing plants, egg
processing plants, dairies, institutional kitchens, fast food
operations, rendering plants, school lunchrooms, and packing
plants
Target Pests:
Slime-forming bacteria, odor causing/staining bacteria, Gram-negative and
Gram-positive bacteria, Pseudomonas aemginosa, pathogenic fungi
(Trichophyton mentagrophytes), envelope and non-envelope viruses,
mold/mildew, algae
Formulation Types: Formulation intermediate, aerosol, soluble concentrate/tablet, impregnated
wipes, ready-to-use solution, wettable powder, pressurized liquid, and
water-soluble packaging.
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Method and Rates of Application:
Methods:
Application Rates:
ADBAC formulations are added directly to water in swimming pools,
decorative ponds/fountains, spas, cooling water towers, oil field drilling
muds and packing fluids, small process water systems, humidifiers, and
cut flower applications. ADBAC formulations are diluted in water to treat
hard nonporous surfaces in institutional, commercial, industrial, and
residential settings by fogging, immersion, wiping, mopping,
aerosol/trigger spray, and low pressure and high-pressure spray. Some
impregnated wipes are dampened with water prior to use while others are
pre-moistened. For the treatment of wood, ADBAC is applied by a
blender/spray system, diptank, spray box, or pressure treatment.
For details about specific use sites for ADBAC, refer to Appendix A.
The following rates are a representation of the maximum rate documented
in the label table by use category.
Use 14 oz of 50% end-use product per 10,000 of water to produce a 5
ppm active solution for treatment of swimming pools and spas.
Use 1 oz of 20% end-use product per gallon of water to produce a
781.5 ppm active solution for treatment of aquatic areas such as
decorative ponds, fountains, and water displays.
Use 6 pounds of 50% end use product diluted to 3% active ingredient
solution per cubic foot of wood for dip, brush, spray, and pressure
treatment for wood preservation.
Use 9 oz of 3.2% end use product per gallon of water to achieve a
2250 ppm active solution for treatment of agricultural premises and
equipment such as animal housing facilities, animal life science
laboratories, farms, ornamental nurseries, and animal transportation
vehicles.
Use 115 oz of 9.0% end use product per 2.5 gallons of water to
achieve 44,000 ppm active solution for treatment in egg processing
plants and hatcheries by fogging.
Use 53.2 grams of 40% end-use product per 2 gallons of water to
achieve 2800 ppm active solution for treatment in ornamental
nurseries on plants and trees.
Use 0.5 oz of 20% end-use product per gallon of water every 40 sq.
feet to achieve 781 ppm active solution for treatment of lawns, turf,
and golf courses greens and tees.
Use 1 oz of 20% end-use product to one gallon of water to achieve
1532 ppm active solution or use Ready-to-Use formulation for
treatment of medical premises and equipment such as hospitals, day-
care centers, mortuaries, and EMS facilities.
Use 9 oz of 3.2% end-use product to one gallon of water to achieve
2250 ppm active solution or use Ready-to-Use formulation for
treatment of commercial and industrial premises and equipment such
-------
as barber/beauty salons, athletic facilities, libraries, manufacturing
facilities, and hotels. Also, use 155 oz of 9.0% end-use product per
2.5 gallons of water to achieve 44,000 ppm active solution for
treatment of commercial and industrial premises by fogging.
Use 2 oz of 10% end-use product per gallon of water to achieve 3000
ppm active solution or use Ready-to-Use formulation for treatment of
residential and public access premises such as homes, campgrounds,
and recreational facilities.
Use 1 oz of 20% end-use product per gallon of water to achieve a 400
ppm active solution for food contact sanitizing treatment in food
handling/storage establishments such as restaurants, food storage
areas, meat, poultry, and vegetable processing facilities.
Use 6 oz of 4.5% end-use product per gallon of water to achieve a
2100 ppm active solution for disinfection in food handling/storage
establishments such as restaurants, food storages areas, meat, poultry,
and vegetable processing facilities.
Use 24 oz of 9.0% end-use product per gallon of water to achieve
16,875 ppm active solution for treatment of carpets in medical,
commercial, and residential settings.
Use 8 oz of 20% end-use product per 100 pounds of dry laundry to
achieve 1154 ppm active solution from treatment of clothing/laundry
in medical and commercial settings.
Use Classification: General use.
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III. Summary of ADBAC 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 ADBAC. While the risk assessments and related addenda are not
included in this document, they are available from the OPP Public Docket,
http:/www.regulations.gov. Hard copies of these documents may be found in the OPP public
docket under docket number OPP-2006-0339. The OPP public docket is located in Room S-
4400, One Potomac Yard (South Building), 2777 South Crystal Drive, Arlington, VA 22202 and
is open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
A. Human Health Risk Assessment
1. Toxicity of ADBAC
The Agency's use of human studies in the ADBAC 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 brief overview of the toxicity studies used for determining endpoints in the risk
assessments are outlined below in Table 1. Further details on the toxicity of ADBAC can be
found in the "Toxicology Disciplinary Chapter for the Reregi strati on Eligibility Decision
Document on Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)," dated February 27,
2006; "Draft Preliminary Risk Assessment for Alkyl Dimethyl Ammonium Chloride
(ADBAC)," dated April 20, 2006; and "ADBAC - Report of the Antimicrobials Division
Toxicity Endpoint Committee (ADTC) and the Hazard Identification Assessment Review
Committee (HIARC)," dated April 20, 2006. These documents are available at
http://www.regulations.gov.
The Agency has reviewed all toxicity studies submitted for ADBAC and has determined
that the toxicological database is sufficient for reregi strati on. The acute toxicology data shows
that ADBAC is toxicity category II by the oral and inhalation routes and toxicity category III via
the dermal route. ADBAC is also considered to be highly irritating to the eyes and skin (toxicity
category I) and is not a dermal sensitizer. Major features of the acute toxicology profile are
presented below
Table 1. Summary of Acute Toxicity Data for ADBAC
Guideline
Number
870.1100
Test Substance
Acute oral, rat
BQ451-8Biocide
(Purity 82.26%)
MRID
45109204
Results
LD50 =304.5 mg/kg (combined)
LD50 =510.9 mg/kg (males)
LD50 =280.8 mg/kg (females)
Toxicity
Category
II
10
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Guideline
Number
870.1200
870.1300
870.2400
870.2500
870.2600
Test Substance
Acute dermal, rat
BQ451-8Biocide
(Purity 82.26%)
Acute inhalation,
rat
(Purity 82.26%)
Primary Eye
Irritation
Primary Dermal
Irritation, , rabbit
BQ451-8Biocide
(Purity 82.26%)
Dermal
sensitization,
guinea pigs
BQ451-8Biocide
(Purity 82.26%)
MRID
45109202
44885201
Waived
45109201
45109201
Results
LD50 =930 mg/kg (combined)
LD50 =1 100 mg/kg (males)
LD50 =704 mg/kg (females)
0.054
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Dietary
Acute dietary risks were not assessed because an endpoint appropriate for acute dietary
assessment was not identified in the available ADBAC database.
For ADBAC, a chronic toxicity/carcinogenicity study was conducted in rats. This study
established the RfD of 0.44 mg/kg/day based on decreased body weight and weight gain in male
rats at 88 mg/kg/day. An uncertainty factor of 100 (10X for interspecies extrapolation, 10X for
intraspecies variation) was applied to the NOAEL to obtain the chronic RfD.
Incidental Oral
The short- and intermediate-term incidental oral NOAEL is 10 mg/kg/day from a rat
developmental toxicity study that noted decreased body weight and decreased food consumption
at 30 mg/kg/day.
Short-term Dermal
The short-term dermal NOAEL is 20 mg/kg/day based on denuded non-vascularized
epidermal layer from a 21-day dermal toxicity study on a 4% active ingredient formulated
product. The uncertainty factor or "target" MOE for ADBAC dermal exposures is 10 for
occupational and residential scenarios. 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). It should be noted that the
determination to reduce the lOOx UF to 10X UF for irritation endpoints is made on a case-by-
case basis.
Intermediate-Term Dermal
The intermediate-term dermal NOAEL is 20 mg/kg/day since it was the highest dose
tested before irritation became significant at day 43. The uncertainty factor or "target" MOE for
ADBAC dermal exposures are 10 for occupational and residential scenarios. The target MOE
was chosen because the established endpoint is for dermal irritation, not a systemic toxic effect.
The Agency has reevaluated this value 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). It should be noted that the determination to reduce the lOOx UF to 10X
UF for irritation endpoints is made on a case-by-case basis.
Short,- Intermediate,- and Long-term Inhalation
The short-, intermediate-, and long-term inhalation NOAEL is 3 mg/kg/day based on the
hyperactivity and labored breathing at 9 mg/kg/day in an oral developmental study in rabbits. In
the absence of route-specific data, it was conservatively assumed that inhalation absorption is
equivalent to oral absorption (i.e., 100%). For inhalation exposures, the target MOE is 100 for
occupational and residential scenarios, (lOx interspecies extrapolation and lOx interspecies
12
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variability). However, if the resulting MOE is not at least 100, the Agency can request a repeat
dose inhalation study of at least 28 days in duration.
Carcinogenicity Classification
The database for carcinogencity is complete, and ADBAC is not carcinogenic based on
studies in rats and mice.
Mutagenicity Potential
The data base for mutagenicity is considered adequate and indicates that ADBAC is not
mutagenic or genotoxic.
Endocrine Disruption Potential
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 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
EDSP have been adopted, ADBAC may be subject to additional screening and/or testing to
better characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The FQPA Safety Factor has been
removed (i.e., reduced to IX) for ADBAC based on (1) the existence of a complete
developmental and reproductive toxicity database, (2) the lack of evidence for increased
susceptibility in these data, and (3) the risk assessment does not underestimate the potential riks
for infants and children. The FQPA Safety Factor assumes that the exposure databases (food,
drinking water, and residential) are complete, the risk assessment for each potential exposure
scenario includes all metabolites and/or degradates of concern, and does not underestimate the
potential risk for infants and children. These criteria have been met for ADBAC. The Agency
13
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determined that no special FQPA Safety Factor was needed since there were no residual
uncertainties for pre- and/or postnatal toxicity.
3. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A
risk estimate that is less than 100% of the acute or chronic PAD is not of concern.
a. Acute PAD
Acute dietary risks for ADBAC were not assessed because an endpoint appropriate for
acute dietary assessment was not for ADBAC.
b. Chronic PAD
Chronic dietary risk for ADBAC is assessed by comparing chronic dietary exposure
estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic dietary risk
is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.44 mg/kg/day)
modified by the uncertainly factor. The cPAD was derived from a chronic toxicity/
carcinogencity study in the rat, in which the NOAEL (44 mg/kg/day) and the LOAEL (88
mg/kg/day) were determined based on decreased body weight and weight gain. The ADBAC
cPAD is 0.44 mg/kg/day based on a reference dose of 0.44 mg/kg/day and a FQPA safety factor
of IX.
4. Dietary Exposure Assumptions
The antimicrobial use of ADBAC on food contact surfaces, agricultural premises,
poultry premises including hatcheries and application to food-grade eggs may result in pesticide
residues in human food. Residues from the use of ADBAC for food contact sanitization on
treated surfaces, such as food utensils, countertops, equipment, and appliances, can migrate to
food coming into contact with the treated surfaces and can be ingested by humans.
In addition to food contact surface sanitizer uses, this assessment also analyzed residues
from hard nonporous surfaces that have been treated with ADBAC as a disinfectant after rinsing
with potable water. In the absence of transfer residue data for these ADBAC disinfectant uses,
the Agency assumed that rinsing with potable water cannot remove all residues deposited on the
treated surfaces. Therefore, residues from the treated and rinsed surfaces may migrate to food
coming into contact with these surfaces and then be ingested by humans.
In the absence of data for residues of ADBAC on treated food contact surfaces, the
Agency estimated residue levels that may occur in food from the application rates on food
contact surfaces such as utensils and countertops. In addition, the food packaging and beverage
bottling uses have also been evaluated.
ADBAC products may be applied to the shells of food grade-eggs in egg processing
plants. Although it is possible that some sanitizer/disinfectant chemicals may penetrate egg
14
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shells, at this time, the Agency believes that the amount of the chemical transferred into eggs is
likely to be minimal because the eggs must be subjected to a potable water rinse if they are to be
immediately broken for use in the manufacturing of egg products.
There is no evidence that there will be residues of ADBAC in mushrooms following its
use as a mushroom house disinfectant. Further, if dietary exposures from mushroom house uses
occurred they would be expected to be much lower than the dietary exposures resulting from the
surface disinfectant and sanitizing uses because the label states that the product is not be applied
to the mushroom crop, compost or casing and treated surfaces are to be rinsed with potable water
before contact with the crop, compost, or casing. Since these exposures are not likely to pose
risks of concern, and the sanitizing uses represent a "worse-case" scenario, these uses were not
assessed.
The Agency assessed the chronic dietary exposure due to ADBAC use as a disinfectant
and food contact sanitizer on direct and indirect food-contact surfaces. This assessment
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI). The assessment
considered: application rates, residual solution or quantity of solution remaining on the treated
surface without rinsing with potable water, surface area of the treated surface which comes into
contact with food, pesticide migration fraction, and body weight. These assumptions are based
on FDA guidelines (FDA, 2003). However, in assessing dietary exposures from ADBAC in
food packaging and beverage bottling, a number of assumptions were made based on the EPA
guidelines (2005) for the pesticide migration fraction residual solution, daily food intake rates,
application rate, and grams of food per surface area of container.
The EDI calculations presented in this assessment assumes that food can contact
2,000cm2 or 4,000 cm2 (50% and 100% of the FDA worse case scenario) of treated surfaces, and
that 10% of the pesticide would migrate to food. The use of the 10% transfer rate instead of the
use of a 100% transfer rate was used for all indirect food contact surfaces except for food
packaging and bottling surfaces. The 10% migration rate is based on Agency Residential
Standard Operation Procedures. These daily estimates were conservatively used to assess
chronic dietary risks (i.e., percent chronic population adjusted dose or %cPAD).
5. Dietary Risk Assessment
A summary of the chronic risk estimates are shown in Table 4a and b. Based on a review
of product labels containing ADBAC, food handling establishments and food processing
facilities, have been identified as having the potential to cause indirect dietary exposure due to
indirect food contact on the following surfaces:
1. Utensils
2. Countertops
3. Food bottling/Packaging
a. Dietary Risk from Food
A dietary risk assessment was conducted for three of the five direct and indirect food
contact surfaces listed above; as explained previously exposures from poultry hatcheries and
mushroom houses were not assessed. Acute dietary risks were not assessed because an acute
15
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toxicity value was not identified. However, the chronic dietary assessment concluded that for all
included uses, the chronic risk estimates are below the Agency's level of concern for adults and
the most highly exposed population subgroup, children (<4% of the cPAD). Any potential
additional exposure as the result of the egg and mushroom house uses of ADBAC would not be
expected to contribute significantly to overall dietary exposure and would not impact the
%cPAD in a significant way.
Table 4a: Calculated EDIs and cPAD for Utensils and Countertops (The Aggregate represents
the total chronic population adjusted dose (cPAD) for both surfaces)
Exposure
Group
Adult
males
Adult
females
Children
Utensils
EDI
(mg/day)
0.0815
0.0815
0.0815
DDD
(mg/kg/d)
0.00116
0.00136
0.00543
% cPADa
0.265
0.309
1.23
Countertops
EDI
(mg/day)
0.0815
0.0815
0.170
DDD
(mg/kg/d)
0.00243
0.00284
0.0113
% cPADa
0.265
0.309
1.23
Aggregate
EDI
(mg/day)
0.252
0.252
0.252
DDD
(mg/kg/d)
0.00359
0.00419
0.0168
% cPADa
0.530
0.680
2.46
a % PAD = exposure (DDD) /(cPAD) x 100.
EDI is the estimated daily intake (mg/day).
DDD is the dietary daily dose (mg/kg/day).
For food and beverage packaging/bottling, EDI values were calculated using an approach
similar to that used for treated food contact surfaces and utensils. The maximum application rate
for ADBAC for bottling/packing of beverages and food is 0.0103 Ibs a.i. per gallon of treatment
solution. Exposure was assumed to occur through the ingestion of three food products that might
be packaged with treated material: milk, egg products, and beverages (alcoholic and non-
alcoholic). None of the calculated % cPad values exceeded 100% are not of concern. The
results of the EDI and %cPAD are presented in Table 4b.
16
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Table 4b. Calculated EDIs and cPAD for Representative Dairy and Beverage Consumption
Food Type
Milk
Egg product
Beverages, non-
alcoholic
Beverages,
alcoholic, beer
Exposure
Group
Adult Male
Adult Female
Childa
Adult Male
Adult Female
Child a
Adult Male
Adult Female
Childa
Adult Male
Adult Female
EDI (mg/day)
3.8x 10'3
2.4 x 10'3
2.8 x 10'5
1.58xlO'5
3.2 x 10'4
2.0 x 10'4
2.4 x 10'5
DDD
(mg/kg/d)
5.37 xlO'5
3.86xlO'4
1.66xlO'4
4.06 xlO'7
4.69 xlO'7
1.20xlO'6
4.57 xlO'6
1.96xlO'6
1.37 xlO'5
3.47xlO'6
4.04 xlO'6
% cPAD
1.2x 10'2
1.4x 10'2
3.6x 10'2
9.1x 10'5
l.lx 10'4
2.7 x 10'4
l.Ox 10'3
1.2x 10'3
3.1x 10'3
7.9 x 10'4
9.0 x 10'4
b. Dietary Risk from Drinking Water
As an outdoor pesticide, ADBAC is applied to nursery ornamentals and turf, and is used
for mosquito control in ponds and puddles and as an algaecide in decorative pools. Since the
uses are ornamental and periodic in nature, disconnected from the larger watershed, the Agency
believes exposures to drinking water sources from these uses are not expected to be significant.
For the drinking water assessment, only the turf and nursery uses for ADBAC were considered.
Foliar spray, drench and "dribble" applications are allowed.
The Tier 1 surface water and groundwater model was used to assess applications to
ornamental plants, this use represents the highest application rate of all labeled uses, of 302 Ibs.
a.i/Acre, and a maximum of 3 applications per year. Since the tier I models are not dependent on
"crop" type, the Estimated Drinking Water Concentrations (EDWCs) determined for the nursery
ornamental use are also protective of all other uses with lower application rates. The EDWCs for
the human health risk assessment are in Table 5.3 and are based on the nursery ornamental use
pattern. There were no major degradates of ADBAC in the laboratory studies (EFED Memo by
Marietta Echeverria to Jacqueline Campbell-McFarlane: Tier I Drinking Water Assessment for
alkyl*dimehtyl benzyl ammonium chloride (50%C14, 40%C12, 10%C10) (ADBAC) and
Didecyl dimethyl ammonium chloride, (DDAC), dated 2006).
An acute oral toxicological endpoint was not established for ADBAC. Therefore, only
the chronic drinking water exposure is calculated. The adult chronic drinking water dose is
0.009 mg/kg/day (i.e., average EDWC 331 ug/L x 2 L/day consumption x 1/70 kg BW). The
chronic drinking water dose for children is 0.022 mg/kg/day (i.e., average EDWC 331 ug/L x 1
L/day consumption x 1/15 kg BW). There are no drinking water concerns with ADBAC as the
concentrations are much lower than level of concern.
17
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Table 5.3. Tier I Estimated Drinking Water Concentrations (EDWCs) Based on Aerial
Application of ADBAC on Nursery Ornamentals
Drinking Water Source (Model)
Surface water (FIRST)
Acute (peak)
- Chronic (annual average)
Groundwater (SCIGROW)
Use rate (Ibs ai/A/year)
906
906
EDWC (ppb)
13,129
331
5.4
It should be noted that the Agency estimated concentrations for exposure to aquatic
animals resulting from the antisapstain and cooling tower uses. These levels were not considered
appropriate for use in the drinking water assessment due to the very conservative nature of the
models used, that the model estimates runoff/point source concentrations and not water body
concentrations, and the fact that the models does not account for dilution.
6.
Residential Risk Assessment
The residential exposure assessment considers all potential pesticide exposure, other than
exposure due to residues in food or in drinking water. Exposure may occur during and after
application as a hard surface disinfectant or non-food contact sanitizer (e.g., walls, floors, tables,
fixtures), to textiles (e.g. clothing), and to carpets. Each route of exposure (oral, dermal,
inhalation) is assessed, where appropriate, and risk is expressed as a Margin of Exposure (MOE),
which is the ratio of estimated exposure to an appropriate NOAEL.
a. Toxicity
A MOE of 100 for inhalation exposure and oral exposures and a 10 for dermal exposure
are considered protective. The MOE of 100 is based on a lOx interspecies and lOx intraspecies
variability while the MOE of 10 is based on a 3x interspecies and 3x intraspecies variability.
The toxicological endpoints and associated uncertainty factors used for assessing the non-dietary,
residential risks for ADBAC are listed in Table 6a.
Table 6a. Toxicological Endpoints Selected for Residential and Occupational Toxicological
Risks for ADBAC
Exposure
Scenario
Incidental Oral
(short-term)
Dose Used in
Risk Assessment
(mg/kg/day)
NOAEL = 10
mg/kg/day
Target MOE or UF,
Special FQPA SF
for Risk Assessment
FQPA SF = 1
UF = 100 (lOx inter-species
extrapolation, lOx intra-species
variation)
Study and Toxicological Effects
Developmental Toxicity - Rat,
MRID 42351501
LOAEL = 100 mg/kg/day, based
on decreased body weight and
food consumption
18
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Exposure
Scenario
Incidental Oral
(intermediate-term)
Short-Term
Dermal-
Intermediate-Term
Dermal
Long-Term Dermal
(TGAI)
Inhalationa
(Any time point)
Dose Used in
Risk Assessment
(mg/kg/day)
NOAEL = 10
mg/kg/day
NOAEL= 20 mg
ai/kg/day
(333 ug/cm2)
NOAEL=20 mg
ai/kg/day
(80 ug/cm2)
Target MOE or UF,
Special FQPA SF
for Risk Assessment
FQPA SF = 1
UF = 100 (lOx inter-species
extrapolation, lOx intra-species
variation)
FQPA SF = 1
UF = 10 (3x inter-species
extrapolation, 3x intra-species
variation)
UF = 10 (3x inter-species
extrapolation, 3x intra-species
variation)
Study and Toxicological Effects
Developmental Toxicity - Rat,
MRID 42351501
LOAEL = 100 mg/kg/day, based
on decreased body weight and
food consumption
21 -day dermal toxicity- guinea
pigs MRID 4 1105801
LOAEL = 1000 mg/kg/day,
based on denuded non-
vascularized epidermal layer
90-day dermal toxicity in rats
MRID 41499601
20 mg/kg/day is the highest dose
tested before irritation became
significant
No appropriate endpoint identified. No systemic effects observed up to 20 mg/kg/day, highest
dose of technical grade that could be tested without irritation effects.
NOAEL= 3
mg/kg/day
MOE = 100C
UF = 100 (lOx inter-species
extrapolation, lOx intra-species
variation)
Note: an additional lOx is used for
route extrapolation to determine if a
confirmatory study is needed
Developmental Toxicity - rabbit,
MRID 42392801
LOAEL = 9 mg/kg/day, based on
clinical signs of toxicity in
maternal rabbits
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
lowest observed adverse effect level, MOE = margin of exposure, NA = Not Applicable.
aAn additional uncertainty factor of lOx is applied for use of an oral endpoint for rout-to-route extrapolation to
determine if confirmatory inhalation toxicity study is warranted.
b Dermal endpoint = (20 mg/kg guinea pig x 0.4 kg guinea pig x 1000 ug/mg) / 25.8ug/cm2 area of guinea pig
dosed = 333 ug/cm2.
c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1000 ug/mg) / 100ug/cm2 area of rat dosed = 40
ug/cm2 .
b.
Residential Handlers
i. Exposure Scenarios, Data and Assumptions
For antimicrobial uses, residential exposure may occur during application of ADBAC as a
hard surface disinfectant or sanitizer (e.g. walls, floors, tables, fixtures), to textiles, musical
instrument mouthpieces, carpets, swimming pools, and humidifiers. In addition to the traditional
antimicrobial uses of ADBAC described above, it may also be used outdoors to treat ornamental
plants, lawns, and puddles/ponds/swimming pools. For this assessment, homeowners are
assumed to complete all elements of an application (mix/load/apply) without the use of personal
protective equipment.
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The following exposure scenarios were assessed for ADBAC:
Indoor hard surfaces (e.g., mopping, wiping, trigger pump sprays)
Air deodorizers
Carpets
Swimming Pools (e.g., liquid pour)
RV holding tanks (e.g., liquid pour)
Textiles (e.g. clothing, treated during washing);
Musical instrument mouthpieces; and
Humidifiers
Ornamental Plants
Lawns
The antimicrobial residential handler scenarios were assessed to determine dermal and
inhalation exposures. Surrogate dermal and inhalation unit exposure values were estimated
using Pesticide Handler Exposure Database (PHED) data, the Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (USEPA, 1999), Outdoor Residential
Exposure Task Force data (ORETF).
The quantities handled/treated for the handler scenarios were estimated as indicated
below: For additional information, please review the Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) Occupational and Residential Exposure Assessment (Antimicrobial Uses)
dated July 27, 2006.
• For mopping scenarios, it is assumed that 1 gallon of diluted solution is used.
• For wiping and trigger pump spray scenarios, it is assumed that 0.5 liter (0.13 gal) of
diluted solution is used.
• For aerosol sprays, it is assumed that one can is used. The net weight of the can was not
provided on the label; therefore, it was assumed that the can contained 16-oz of product.
• For low pressure hand wand, it was assumed that 2 gallons are used in all indoor
applications.
• For liquid pour in swimming pool scenario, it was assumed that a residential pool
contains 20,000 gallons of water.
• For liquid pour in RV holding tank scenario, it was assumed that one tank would be
treated. The product label states a maximum application rate of 4 oz (0.031 gallons)
product per tank.
• For mixer/loader/applicators scenarios:
For agricultural exposures, residential exposures may occur during the application of
ADBAC to ornamental plants, shrubs, trees as well as seedlings, seeds, and cuttings,
residential/commercial turf, golf courses, and fountains/water displays, sewage treatment
systems, standing water for mosquito control. As with the antimicrobial use, homeowners are
assumed to complete elements of an application (mix/load/apply) without the use of personal
protective equipment.
20
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The quantitative exposure/risk assessment developed for residential handlers is based on
these scenarios. For additional information, please review the Alkyl Dimethyl Benzyl
Ammonium Chloride (ADBAC) Occupational and Residential Exposure Assessment
(Agricultural Uses) dated August 1, 2006
Mixer/Loader/Applicators:
(1) Liquid Formulations: Low Pressure Handwand (PHED data for dermal and
ORETF data for inhalation)
(2) Dry Flowable Formulations: Low Pressure Handwand (using liquid concentrate
PFIED data for dermal and liquid concentrate ORETF data for inhalation)
(3) Liquid Concentrates: Hose-End Sprayer (PHED data for dermal and ORETF data
for inhalation)
(4) Dry Flowable Formulations: Hose-End Sprayer (no data)
(5) Ready-to-Use Formulations: Hose-End Sprayer (no data)
(6) Liquid Concentrates: Watering Can (using PHED hose-end sprayer data for
dermal and ORETF hose-end data for inhalation)
(7) Ready to Use Formulations via Trigger-Pump Sprayer (PHED data for aerosol
can for dermal and ORETF data for inhalation), and
(8) Dip or Soak Applications (no data)
Since no toxicological endpoint of concern was identified for dermal systemic adverse
effects, both the handler and the post-application dermal risks were assessed using the
toxicological endpoint for dermal irritation. The duration of exposure for homeowner handler
exposures is believed to be the short-term duration (1 to 30 days). The short term duration was
chosen because the handler and post-application scenarios are assumed to be episodic, not a daily
occurrence.
11.
Risk Assessment
Based on toxicological criteria and the potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments. As noted previously, MOEs greater than or equal
to 100 for the inhalation route of exposure and 10 for dermal exposure are considered protective
for the residential exposure assessment.
Antimicrobial Uses
A summary of the residential handler inhalation risks are presented in Table 6b. The
calculated inhalation MOEs for all scenarios are above the target MOE of 100, and not of
concern.
Table 6b Short-Term Residential Handler Inhalation Exposures and MOEs
Exposure Scenario
Application Method
Application to indoor hard surfaces
Application Method
Mopping
Wiping
Application Ratea
0.025 Ib ai/gal
0.025 Ib ai/gal
Quantity Handled/
Treated per dayb
1 gallon
0.1 3 gallon
MOEC
(Target MOE = 100)
3,000
820
21
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Exposure Scenario
Application Method
Air deodorization
Application to Carpets
Application to Swimming Pools
Application to RV holding tanks
Application Method
Trigger Spray
Aerosol Spray
Low Pressure Spray
Liquid Pour
Liquid Pour
Application Ratea
0.025 Ib ai/gal
0.2% ai by weight
0.014 Ib ai/gal
0.000052 Ib ai/gal
0.834 Ib ai/gal
Quantity Handled/
Treated per dayb
0.1 3 gallon
lean (lib)
2 gallons
20,000 gallons
0.031 gal (1 tank
at 4 oz
product/tank)
MOEC
(Target MOE = 100)
23,000
38,000
9,200
50,000
3,700
a Application rates are the maximum application rates determined from EPA registered labels for ADBAC.
b Amount handled per day values are estimates or label instructions.
c MOE = NOAEL / Absorbed Daily Dose. [Where short-term NOAEL = 3 mg/kg/day for inhalation]. Target MOE :
100.
A summary of the residential handler dermal risks are presented in Table 6c. The dermal
MOEs for all formulations assessed are above the target MOE of 10, and therefore, are not of
concern.
Table 6c: Short-Term Residential Handler Dermal Risks
Exposure Scenario
Application to indoor
hard surfaces
Air deodorization
Application to
Carpets
Application to RV
holding tanks
Application to
swimming pools
Application
Method
Wiping
T '
1 rigger Spray
Aerosol Spray
Low Pressure
Spray
Liquid Pour
Liquid Pour
Application
Rate"
(Ib ai/gal)
0.025 Ib ai/gal
0.0070 Ib ai/gal
0.025 Ib ai/gal
0.0070 Ib ai/gal
0.025 Ib ai/gal
0.014 Ib ai/gal
0.2% ai by
weight
0.014 Ib ai/gal
0.834 Ib ai/gal
0.000052 Ib
ai/gal
Quantity
Handled/ Treated
per dayb
1 gallon
0.13 gallon
013 gallon
1 can (1 Ib)
2 gallons
0031 gal(l tank
at 4 oz
product/tank)
20,000 gallons
Hand Unit
Exposure
Adjusted for
Surface
Area
(mg/lb
ai/cm2)0
n nf,i
1.341
n no
0.129
0.161
0.000239
0.000239
Dermal Skin
Irritation
Exposure d
(Hg/cm2)
1.587
0.44
4.363
1.22
0.420
0.24
0.259
4.615
0.0062
0.25
MOEe
(Target MOE =
10)
210
760
76
270
790
1,400
1,300
72
54,000
1,300
Application rates are the maximum application rates determined from EPA registered labels for ADBAC.
Amount handled per day values are estimates or label instructions.
Unit Exposure (mg/lb ai/cm2) = Unit Exposure from PHED or CMA (mg/lb ai) / surface area of hand (820 cm2).
Dermal Skin Irritation Exposure (|ig /Ib ai/cm2) = Unit Exposure (mg/lb ai/cm2) x Application Rate (Ib ai/gal) x
Quantity Treated (gal/day) x 1,000 :g/mg
MOE = NOAEL (jig /cm2)/ Surface Residue on Skin (jig/cm2). [Where short-term dermal formulated-based NOAEL :
333 ng/cm2]. Target MOE = 10.
22
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Agricultural Uses
A summary of the agricultural residential handler inhalation risks are presented in Table
6d. The calculated inhalation MOEs for all scenarios are above the target MOE of 100, and not
of concern.
Table 6d: ADBAC Short-term Inhalation Risks to Residential Handlers
Scenario
ML/A Liquid
Concentrates wi!h LP
Handwand(l)
ML/A DF wi!h Low
Pressure Handwand
(liquid concentrate
PHED date as
surrogate) (3)
ML/A Liquid
Concentiates wi!h a
Hose-end Sprayer (4)
M/L/A Liquids with a
Watering Can (PHED
residential hose-end
data as surrogate) (8)
Applying Ready to
Use Formulations via
Trigger-Pump
Sprayer (9)
Crop/Target
Residential Turf,
Ornamental Bulbs and
Orchids
Ornamental
Herbaceous Plants,
Ornamental Shrubs,
Ornamental Trees,
Seedlings (planted in
garden), Seedlings,
Seeds, Cuttings
(preplan! or a! plan!)
Residential Turf,
Ornamental Bulbs and
Orchids
Ornamental
Herbaceous Plan!s,
Ornamental Shrubs,
Ornamental Trees,
Seedlings (planted in
garden), Seedlings,
Seeds, Cuttings
(preplan! or a! plan!)
Residential Turf
Ornamental
Herbaceous Plan!s,
Ornamental Shrubs,
Ornamental Trees,
Seedlings (planted in
garden)
Ornamental Palms
Seedlings, Seeds,
Cuttings (preplan! or
a! plan!)
Ornamental Shrubs,
Seedlings, Seeds,
Cuttings (preplan! or
a! plan!)
Application
Ratea
0.0065 Ib
ai/gal water
0.0043 Ib
ai/gal water
0.0065 Ib
ai/gal water
0.0043 Ib
ai/gal water
7 Ib ai/A
0.43 Ib ai/A
0.013 Ib
ai/gal water
ai/gal water
0.0043 Ib
ai/gallon
Quantity
Handled/
Treated
per day5
5 gal/day
5 gal/day
5 gal/day
5 gal/day
0.5
acres/day
0.25
acres/day
5 gal/day
5 gal/day
1 gal/day
Inhalation
Uni!
Exposure
(ug/lb ai)°
30
30
30
30
17
1.6
1.6
1.6
19
Inhalation
Exposure*
0.000975
0.00065
0.000975
0.00065
0.06
0.00017
0.001
0.000034
0.000082
Inhalation
Dose6
0.000016
0.000011
0.000016
0.000011
0.00099
2.9E-6
1.7E-6
5.7E-7
1.4E-6
Inhalation
MOEf
180,000
280,000
180,000
280,000
3,000
1,000,000
1,700,000
5,200,000
2,200,000
a Application rates are the maximum application rates determined from EPA registered labels for ADBAC
b Amount handled per day values are based on Exposure SAC SOP #12, and HED estimates.
c Baseline Inhalation: no respirator.
d Baseline inhalation exposure (mg/day) = application rate (Ib ai/gal) x amount handled per day (gal/day) x inhalation unit exposure
(ug/lb ai) x conversion factor from ug to mg (0.001)
e Baseline inhalation dose (mg/kg/day) = baseline inhalation exposure (mg/day) x inhalation absorption factor (100%) / female
bodyweight (kg)
23
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f Inhalation MOE = inhalation NOAEL ( 3 mg/kg/day) / inhalation dose (mg/kg/day)
A summary of the residential handler dermal risks are presented in Table 6c. The dermal
MOEs for all formulations assessed are above the target MOE of 10, and therefore, are not of
concern.
Table 6e: ADBAC Short-term Dermal Risks to Residential Handlers
Scenario
M/L/A Liquid
Concentrates with LP
Handwand(l)
M/L/A DF with LP
Handwand (liquid
concentrate PHED data as
surrogate) (3)
M/L/A Liquid
Concentrates with a Hose-
end Sprayer (4)
M/L/A Liquids with a
Watering Can (PHED
residential hose-end data
as surrogate) (8)
Applying Ready to Use
Formulations via Trigger-
Pump Sprayer (PHED data
for aerosol can used as
surrogate) (9)
Crop/Target
Residential Turf,
Ornamental Bulbs
and Orchids
Ornamental
Herbaceous Plants,
Ornamental Shrubs,
Ornamental Trees,
Seedlings (planted in
garden), Seedlings,
Seeds, Cuttings
(preplan! or at plant)
Residential Turf,
Ornamental Bulbs
and Orchids
Ornamental
Herbaceous Plants,
Ornamental Shrubs,
Ornamental Trees,
Seedlings (planted in
garden), Seedlings,
Seeds, Cuttings
(preplan! or at plant)
Residential Turf
Ornamental
Herbaceous Plants,
Ornamental Shrubs,
Ornamental Trees,
Seedlings (planted in
garden)
Ornamental Palms
Seedlings, Seeds,
Cuttins (preplant or
at plant)
Ornamental Shrubs,
Seedlings, Seeds,
Cuttings (preplant or
at plant)
Application
Ratea
0 0065 Ih
\J.\J\J\J~} LU
cii/Scil waiter
0.0043 Ib
ai/gal water
0.0065 Ib
ai/gal water
0.0043 Ib
ai/gal water
0 0063 Ih
\J.\J\J\JJ LU
ai/gal water
0.0043 Ib
ai/gal water
0.013 Ib
ai/gal water
Of)04'2 IK
.V_/V_/Tj 1U
ai/gal water
0.0043 Ib
ai/gallon
Quantity
Handled Per
Dayb
5 gal/day
5 gal/day
5 gal/day
5 gal/day
100 gal/day
100 gal/day
5 gal/day
5 gal/day
1 gal/day
Unit
Exposure for
Hands0
(mg/lb ai)
102
102
102
102
27.5
27.5
27.5
27.5
106
Estimated
Residue
Transferred
to Skin on
Hands (ug
ai/cm2/day)d
4.0
2.7
4.0
2.7
21
14
0.7
0.1
2.8
Dermal
MOE
(UF =
10)e
82
120
82
120
16
23
460
2,300
120
Footnotes:
a Application rates are the maximum application rates determined from EPA registered labels for ADBAC
b Amount handled per day values are based on Exposure SAC SOP #12 and HED estimates.
c From residential PHED unit exposures values for hands for the scenarios listed.
d Application rate (Ib ai/gal) * amount handled per day (gal/day) * dermal unit exposures value (mg/lb ai) * conversion factor mg to ug
(1000) / surface area of adult hands (820 cm2) from Exposure Factors Handbook.
24
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f Dermal MOE = Estimated Residue transferred to Skin of Hands (|ig/cm2/day)/ Dermal Endpoint (333 ug/cm2/day)
c. Residential Post-Application
i. Exposure Assessment
Residential post application exposures result when bystanders (adults and children) come
in contact with ADBAC in areas where products have been applied (e.g.. treated floors and
carpets), or when children inadvertently ingest the pesticide residues through mouthing treated
items (e.g., toys and fabric). The post-application scenarios have been developed to represent a
high end exposure scenario. Representative post-application scenarios for antimicrobial uses
assessed include children crawling on treated hard surfaces, carpets, and treated lumber such as
decks/play sets (dermal and incidental oral exposure to children), wearing treated clothing
(dermal exposure to adults and children and incidental oral exposure to children), using air
deodorizers (adult and child inhalation exposure), using portable humidifiers (adult and child
inhalation exposure), swimming in treated pools (adult and child incidental ingestion), and using
treated instrument mouthpieces and reeds (child and adult incidental exposure). Dermal post
application exposure to swimmers was not assessed because ADBAC is readily mixed in the
water to a low concentration that it does not pose any risk. Representative post-application
scenarios for agricultural uses assessed include adults contacting treated lawns and ornamental
plants (adult derma exposure) and children's incidental oral activities on treated lawns such as
hand-to-mouth activity, object to mouth, and soil ingestion. Data sources and methodologies
include the HED Residential SOPs (USEPA 2000, 2001), Residential and Residential Exposure
Test Guidelines: Group B Post application Exposure Monitoring Test Guidelines (1998), Human
and Environmental Risk Assessment (HERA) Guidance Document (2003 and 2005), the DDAC
wood preservative task force study (MRID 455243-04), the Multi-Chamber Concentration and
Exposure Model (MCCEM), and the SWIMODEL.
Since no toxicological endpoint of concern was identified for dermal systemic adverse
effects, post-application dermal risks were assessed using the toxicological endpoint for dermal
irritation. The residential post-application dermal risks were assessed by comparing the surface
residue on the skin (dermal irritation exposure) to the short-term dermal irritation endpoint. It
was assumed that during the exposure period the skin repeatedly contacts the treated surface until
a steady-state concentration of residue is achieved on the skin. Adults and children post
application dermal risks were assessed for the antimicrobial uses; however, only adults were
assessed for post-application dermal risks for the agricultural uses because the Agency believes
these are individuals that are exposed to the chemical by engaging in activities at their residences
previously treated with a pesticide.
ii. Risk Assessment
Based on toxicological criteria and the potential for exposure, the Agency has conducted
dermal, inhalation, incidental oral exposure assessment for ADBAC. The inhalation and
incidental oral target MOE of 100 is based on lOx interspecies and lOx intraspecies variability.
The dermal target MOE of 10 is based on 3x interspecies and 3x intraspecies variability.
25
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Antimcirobial Uses
The calculated dermal MOEs are above the target MOE of 10 and are, therefore, not of
concern. The inhalation and incidental oral MOEs are above the target MOE of 100 for all
scenarios, except for the inhalation exposure from the humidifier. The inhalation MOEs for
adults and children are 10 and 4, respectively. A summary of the residential post application are
presented in Table 6d.
Table 6d. Residential Post-Application Risk Summary
Exposure Scenario
Child playing on floor
Child playing on carpet
Clothing
(1% residue transfer)
Child playing on decks/play sets
(maximum exposure)
Air deodorizer
Swimming
Humidifiers
Instrument mouthpiece/reed
Dermal MOE
1,100
1,200
210 adults and
children
110
NA
NA
NA
NA
Incidental Ingestion MOE
610
330
1900
360
NA
Ranges from 500 to 5,600
for adults and children
NA
No data
Inhalation MOE
NA
NA
NA
NA
5,700 adults
1,800 children
NA
Adult 10 (24-hrs)
Child 4 (24-hrs)
NA
NA = not assessed because negligible exposure is assumed by that route for the exposure for the
scenario of concern.
Agricultural Uses
Table 6g presents the postapplication MOE values calculated for adults after home
greenhouse, garden or turfglass applications of ADBAC for a short-term exposure duration. The
dermal MOEs were not of concern (i.e., MOEs <10) on the day of application for any of the
three scenarios with the different application rates. An MOE of less than 10 represents a risk of
concern to the Agency.
Table 6g: ADBAC: Adult Residential Short-Term Dermal Risks for Postapplication
Exposure
Exposure Scenario
Exposure To Treated
Ornamental Plants
Exposure to Treated Turf
Route of
Exposure
Dermal
Formulation
Spray
Application
Ratea
(Ib ai/acre)
0.43
7
0.9
Residue on
Skinb
0.96
3.9
0.5
MOEC
at Day 0
350
85
660
Maximum application rate on label (Ib ai/A).
26
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b Residue concentration available to be transferred on day 0 = application rate in |ig/cm2 (Ib ai/gal * conversion factors
(Ib to p.g and A to cm2) * fraction of DFR or TTR available on day 0 * percent of DFR or transferable to skin (100%).
c Short-term Dermal MOE = dermal endpoint (333 ug/cm )/ residue concentration on skin
A summary of the combined risks from incidental exposure for toddlers for applications
to home lawn for maximum label application rate as well as the lower application rate (i.e. hand-
to-mouth activity, object-to-mouth activities, and incidental soil ingestion and for hand-to-mouth
activity at the lower application rate) is represented in table 6h. An MOE of less than 100
represents a risk of concern to the Agency. For this scenario, the maximum application rate (7 Ib
ai/A) resulted in a MOE of 76 while the lower concentration rate (0.9 Ib ai/A) was not of concern
with a MOE of 590.
Table 6h: ADBAC: Combined Incidental Oral Risk Estimates - Toddlers
Postapplication Exposure Scenario
Turf application at 7 Ib ai/acre
Turf application at 0.9 Ib ai/acre
Hand to Mouth
Object to Mouth
Incidental Soil
Ingestion
Hand to Mouth
Object to Mouth
Incidental Soil
Ingestion
Margins of Exposure (MOEs)
(UF=100)
Short-Term Oral
(Non-Dietary)
96
380
29,000
740
3,000
220,000
Short-Term Oral:
Combined
(Non-Dietary)
76
590
7. Aggregate Risk
The Food Quality Protection Act (FQPA) amendments to the Federal Food, Drug, and
Cosmetic Act section 408 (b)(2)(A)(ii) require "that there is reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable information." Aggregate
exposure will typically include exposures from food, drinking water, residential uses of a
pesticide, and other non-occupational sources of exposure.
a.
Chronic Aggregate Risks
An acute toxicological endpoint was not identified for ADBAC. Therefore, an acute
aggregate risk assessment was not conducted. The chronic aggregate risk assessment includes
only dietary and drinking water exposures because chronic exposures are not expected from
residential uses. Chronic dietary risk estimates from direct and indirect food uses are presented
in Section 5a, and drinking water exposure estimates are presented in Section 5b. Table 7a
presents a summary of these exposures, including the aggregate indirect and direct dietary
exposure (i.e., all direct and indirect food contact exposures) as well as a total dietary aggregate
27
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exposure estimate (i.e., drinking water plus direct/indirect dietary exposures). Based on the
results of the chronic aggregate assessment, the %cPAD for adults and children are 3.5% and
10.3%, respectively. Therefore, the chronic dietary risks are not of concern (i.e., less then 100 %
ofcPAD).
Table 7a. ADBAC Chronic Aggregate Exposures and Risks (cPAD)
Exposure Routes
Chronic Dietary Exposures (mg/kg/day)
Indirect
Dietary
Exposures3
Direct Food
Contact
Dietary
Exposures3
Drinking
Water
Exposures
Aggregate
Dietary
Exposures'3
% cPADc
(MOE)
Adults
Oral Ingestion
0.0042
0.0024
0.009
0.0066
3.5%
(2,800)
Children
Oral Ingestion
0.017
0.0061
0.022
0.023
10.3
(980)
a Dietary (indirect + direct food contact) exposures are presented in Tables 5.1 and 5.2.
b Aggregate Dietary Exposures = indirect dietary + direct food contact + drinking water exposures.
c %cPAD (percent chronic population adjusted dose) = (aggregate exposures / cPAD) x 100. Where cPAD = NOAEL 44
mg/kg/day / lOOx uncertainty factor = 0.44 mg/kg/day. MOE = NOAEL of 44 mg/kg/day / aggregate dietary exposures
mg/kg/day.
b. Short- and Intermediate-Term Aggregate Risk
The short- and intermediate-term aggregate risks include pesticide exposures from
dietary, drinking water, and residential sources. The following list summarizes all of the
potential sources of ADBAC exposures for adults and children.
Adult ADBAC exposure sources:
handling of cleaning products containing ADBAC as an active ingredient during
wiping, mopping, and spraying activities;
applying products containing ADBAC to lawns/ornamentals;
applying ADBAC as an air deodorizer using an aerosol spray;
applying ADBAC to carpets using a low pressure sprayer;
applying ADBAC to swimming pools via open pouring;
applying ADBAC to RV holding tanks via open pouring;
contacting pressure treated wood;
wearing treated clothing;
use of ADBAC in humidifiers; and
eating food having ADBAC residues from indirect or direct food contact.
Child ADBAC exposure sources:
post-application exposures to cleaning product residues containing ADBAC that are
used on hard surfaces (e.g, floors/carpets);
breathing air treated with an air deodorizer or humidifier;
swimming in treated pools;
28
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contacting pressure treated wood;
wearing treated clothing/diapers;
eating food having ADBAC residues from indirect or direct food contact.
The use patterns of the products and probability of co-occurrence must be considered
when selecting scenarios for incorporation in the aggregate assessment. Table 6-2 summarizes
the scenarios included in the short- and intermediate-term aggregate assessments.
Table 7b. Exposure Scenarios Included in the Aggregate Assessments
Short-term (ST) Aggregate
Intermediate-Term (IT) Aggregate
Adults
chronic dietary (direct and indirect)
handling cleaning products (wipe + trigger
pump spray)
wearing treated clothing
humidifier
Oral: ST and IT endpoints are the same for
both durations.
Dermal: ST endpoint only.
Inhalation: All durations same endpoint.
Children
chronic dietary - (direct and indirect)
post-application to cleaning product on
carpets (dermal and oral)
wearing treated clothing
humidifier
Oral: ST and IT endpoints are the same for
both durations.
Dermal: ST endpoint only.
Inhalation: All durations same endpoint.
The chronic dietary exposures were used in both the short- and intermediate-term
aggregate assessment because chronic dietary exposures occur nearly every day (as opposed to
acute dietary exposures occurring on a one-time basis). Therefore, short- or intermediate-term
non-dietary exposures have a much higher probability to co-occur with the chronic dietary
intake.
Cleaning activities in a residential setting occur on a short-term basis. However, the
ADBAC-containing cleaning products are also labeled for use in institutional settings such as
day-care facilities where cleaning activities can occur on an intermediate-term basis. Therefore,
children could have exposure to cleaning product residues on a more continuous basis in a day
care facility, thus, these post-application scenarios were included in the intermediate-term
aggregate assessment.
Since the ADBAC toxicity endpoints for the oral, dermal, and inhalation routes of
exposure are based on different toxic effects, these three routes of exposure are not aggregated
together. Instead, the aggregate assessment is based solely on the co-occurrence of the same
route of exposure. Aggregate risks were calculated using the total MOE approach outlined in
OPP guidance for aggregate risk assessment (August 1, 1999, Updated "Interim Guidance for
Incorporating Drinking Water Exposure into Aggregate Risk Assessments").
Table 7c presents a summary of the short- and intermediate-term aggregate risks (i.e.,
MOEs). The short- and intermediate-term aggregate is identical because the endpoints for
incidental oral as well as inhalation are identical for the short- and intermediate-term durations.
29
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Only a short-term dermal endpoint was identified (i.e., no intermediate- and/or long-term dermal
endpoints were identified). The aggregate risks are not of concern for adults for any of the three
routes of exposure as the total aggregate MOE is 2,800 for oral, 42 dermal, and 630 for
inhalation which are greater than the target MOE. For children, the aggregate risk estimate for
each of the routes of exposure are also above the target MOE (MOE=220 for the oral route, 180
for the dermal route) and thus are not of concern. It is important to note, however, that some of
the individual risks are of concern by themselves (e.g., the humidifier use).
Table 7c. Short- and Intermediate-term Aggregate Risk (MOE) Assessment
Exposure
Routes
Chronic
Dietary
MOE
Cleaning Product MOEs
(Adult Applicators & Children
Playing)
Humidifier
MOE
Wearing
Treated
Clothing
MOE
Route-
Specific
Aggregate
MOE
Adults
Oral Ingestion
Dermal
Inhalation
2,800
NA
NA
NA
210
(mop)
3,000
(mop)
76
(wipe)
820
(wipe)
790
(spray)
23,000
(spray)
NA
NA
Not
included,
risk of
concern
NA
2,500
NA
2,800
42
630
Children
Oral Ingestion
Dermal
(ST only)
Inhalation
980
NA
NA
330 (hand-to-mouth carpets)
1,200 (playing on
carpets)
NA
NA
NA
Not
included,
risk of
concern
1,900
210
(1% residue
transfer)
NA
220
180
No co-
occurrence
Aggregate MOE = l/((l/MOEsameroute) + (1 /MOE same route) + etc)
8. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide or by entering treated sites. For ADBAC, potential occupational handler exposure can
occur from treatment of the following uses: agricultural premises, industrial processes and water
systems, food handling premises, commercial/institutional/industrial premises, medical premises,
swimming pools, and aquatic areas. In addition to the "antimicrobial" exposures scenarios,
ADBAC is used to treat ornamental plants in nurseries and greenhouses, commercial turf and
golf courses. Additionally, occupational exposure can occur during the preservation of wood.
For the preservation of wood, the procedure for treatment can occur in different ways, such that
multiple worker functions were analyzed. Due to the complexity of the wood preservative
analysis, the results for handler and post-application exposures are presented separately in
Section 8.e.
30
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Occupational risk for all potentially exposed populations is measured by a Margin of
Exposure (MOE) which determines how close the occupational exposure comes to a NO
Observed Adverse Effect Level (NOAEL) from toxicity studies. In the case of AD AC, A MOE
greater than or equal to 100 is considerably adequately protective for the occupational exposure
assessment for inhalation routes of exposure. The MOE of 100 includes lOx for interspecies
extrapolation and lOx for intraspecies variation. A MOE of 10 is considered adequately
protective for the dermal route of concern; it includes 3x interspecies extrapolation and 3x
intraspecies variation.
Occupational risk is assessed for exposure at the time of application (termed "handler"
exposure) and is assessed for exposure following application, or post-application exposure.
Application parameters are generally defined by the physical nature of the formulation (e.g.,
formula and packaging), by equipment required to deliver the chemical to the use site, and by the
application rate required to achieve an efficacious dose.
For more information on the assumptions and calculations of potential risk of ADBAC to
workers, see the Occupational Exposure Assessment (Section 8.0) in the Alkyl Dimethyl Benzyl
Ammonium Chloride (ADBAC): Risk Assessment for the Reregi strati on Eligibility Decision,"
dated July 27,2006 and the "Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)
Occupational/Residential Exposure Assessment," dated August 3, 2006.
a. Occupational Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, residential risks for ADBAC were listed previously in Table 6a.
b. Occupational Handler Exposure
Potential occupational handler exposure can occur in various antimicrobial and
agricultural use sites which include: agricultural premises, industrial processes and water
systems, food handling premises, commercial/institutional/industrial premises, medical premises,
swimming pools, ornamental greenhouses/nurseries, golf courses, and aquatic areas.
Additionally, occupational exposure can occur during the preservation of wood. For the
preservation of wood, the procedure for treatment can occur in different ways, such that multiple
worker functions were analyzed. Due to the complexity of the wood preservation analysis, the
handler and post-application exposures are presented separately in section e.
The Agency has assessed exposures to handlers mixing/loading/applying antimicrobial
and agricultural use products containing ADBAC. The following handler exposure scenarios
represent high end exposure estimates.
-------
Antimicrobial Use - Mixer/Loader/Applicators:
• For the liquid pour scenarios, the unit exposure depends on the material being treated.
The following CMA unit exposures were available and used for the assessment of the risk
associated with the treatment of the specified materials.
o Swimming pools, carpets, and oilfield operations (drilling muds and packer
fluids): CMA preservative data (gloved). The inhalation unit exposure is 0.00346
mg/lb a.i. and is based on 2 replicates. Although this unit exposure is based on
minimal replicates, the exposure value is similar to the one found in PHED for a
similar scenarios.
o Indoor hard surfaces (immersion, flooding and circulation) and medical
instruments in Use Site Categories II and V: The inhalation unit exposure value
for disinfectant liquid pour (1.89 mg/lb a.i.) was used.
o Small process water systems: CMA cooling tower data (gloved). The inhalation
unit exposure is 0.450 mg/lb a.i. and is based on 5 replicates.
• For the mopping scenarios, the CMA inhalation unit exposure value for ungloved
mopping was used (2.38 mg/lb a.i.). This value is based on data collected from six
replicates in which the applicator mopped the floor and received exposure via contact
with the mop or with the bucket.
• For the wiping scenarios, the CMA inhalation unit exposure value for ungloved wiping
was used (67.3 mg/lb a.i.). This value is based on data collected from six replicates
(dental technicians) who used a finger pump sprayer to apply the product and then wiped
the surfaces with a paper towel
• For the low pressure hand wand scenario, the CMA inhalation unit exposure value for
low pressure spray was used (0.681 mg/lb a.i.). This value is based on data collected
from eight replicates in which the applicator hand sprayed carpet using 200 psi, then used
a push broom rake to raise the carpet nap
• For the aerosol spray and trigger pump spray scenarios, the PFLED inhalation unit
exposure value for aerosol applications (PHED scenario 10) was used. The inhalation
unit exposure is 1.3 mg/lb a.i.
• For the liquid/metering pump scenarios, the unit exposure depends on the material being
treated. The following CMA unit exposures were available and used for the assessment of
the risk associated with the treatment of the specified materials.
o Pulp and paper, Papermaking chemicals, and Once-through cooling water
systems: CMA pulp and paper gloved data were used. The inhalation unit
exposure is 0.000265 mg/lb a.i. The value is based on 7 replicates where the
test subjects were wearing a single layer of clothing and chemical resistant
gloves. This unit exposure was used for the once through cooling water
system because no representative data exists for the volume of water treated in
power plant facilities.
o Small process water systems: CMA cooling tower data. The inhalation unit
exposure is 0.00432 mg/lb a.i. and is based on 4 replicates.
• For the high-pressure/high volume spray and medium pressure spray scenarios, the
PFIED inhalation unit exposure value for liquid/open pour/high pressure spray (PFLED
scenario 35) was used (0.12 mg/lb a.i.).
32
-------
• For the fogging, VLV/mist sprayer and automated system scenarios, it was assumed that
most of the exposure to the handler will be due to preparing the fogger, and that the
handler leaves the room immediately after fogging commences. Therefore, the available
CMA disinfectant liquid pour inhalation unit exposure value was used. The inhalation
unit exposure value is 1.89 mg/lb a.i., respectively. This value is based on data collected
from two gloved replicates involving pouring a disinfectant product from a jug into
sterilization trays designed for dental instruments, adding water and instruments to the
tray, removing the instruments, and discarding the old solution.
Agriculture Use - Mixer/Loader/Applicators:
• Mixing/Loading Liquids Concentrates for Groundboom Applications (PHED) (la)
• Mixing/Loading Liquid Concentrates to Support LCO Handgun Applications
(mixing/loading supports 20 LCOs) (PHED) (Ib)
• Mixing/Loading Liquids Concentrates for Airblast Applications (PHED) (Ic)
• Mixing/Loading Liquid Concentrates via Dip or Soak (PHED) (Id)
• Mixing/Loading Dry Flowables for Groundboom Applications (PHED) (2a)
• Mixing/Loading Dry Flowables for Airblast Applications (PHED) (2b)
• Mixing/Loading Dry Flowables to Support LCO Handgun Applications (mixing/loading
supports 20 LCOs) (PHED) (2c)
• Mixing/Loading Dry Flowables via Dip or Soak (PHED) (2d)
• Applying Sprays via Groundboom Equipment (PHED) (3)
• Applying Sprays via Airblast Equipment (PHED) (4)
• Applying Sprays via Handgun Equipment (PHED) (5)
• Applying as a Soak or Dip (no data) (6)
• Mixing/Loading/Applying Liquid Concentrates with Low Pressure Handwand (ORETF
data) (7)
• Mixing/Loading/Applying Dry Flowables with Low Pressure Handwand (using liquid
concentrate ORETF data) (8)
• Mixing/Loading/Applying Liquid Concentrates with a Handgun Sprayer (LCO ORETF
data) (9)
• Mixing/Loading/Applying Water Soluble Bags with Handgun Sprayer (LCO ORETF
data) (10)
• Mixing/Loading/Applying Dry Flowables Concentrates with a Handgun Sprayer (LCO
ORETF data) (11)
• Mixing/Loading/Applying Liquid Concentrates with a High Pressure Handwand (PHED)
(12)
• Applying Ready to Use Formulations via Trigger-Pump Sprayer (ORETF) (13)
• Mixing/Loading/Applying Liquids with a Watering Can (using ORETF residential hose-
end data) (14)
• Mixing/Loading/Applying Dip or Soak (no data) (15)
ADBAC dermal irritation exposures and risks were not estimated for occupational handler
exposures. These risks are addressed using personal protective equipment (PPE) requirements
33
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already existing on labels. The level of PPE required is based on the toxicity of the end-use
product.
To minimize dermal exposures, the minimum PPE required for mixers, loaders, and
applicators exposed to end-use products containing concentrations off ADBAC that result in
classification of toxicity category I, II, or III for skin irritation potential will be long-sleeve shirt,
long pants, shoes, socks, chemical-resistant gloves, and chemical-resistant apron. For a diluted
product, the classification of a toxicity category IV for skin irritation potential would result in the
elimination of the required personal protective clothing and gloves; such as, chemical-resistant
gloves and chemical-resistant apron, for applicators and others exposed to the end-use product.
Note that chemical-resistant eyewear will be required if the end-use product is classified as
category I or II for eye irritation potential.
Inhalation exposures and risks were assessed based on the oral toxicity endpoint (i.e.,
route-specific inhalation study not available). The surrogate unit exposure values were taken
from the proprietary Chemical Manufacturers Association (CMA) surrogate exposure data
(USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database
(USEPA, 1998). The specific inhalation unit exposures and quantity of ADBAC handled are
provided in the Occupational and Residential Exposure Assessment for ADBAC dated July 27,
2006.
The inhalation MOEs were calculated for the short- and intermediate-term durations for
occupational handlers.
c. Occupational Handler Risk Summary
Based on toxicological criteria and the potential for exposure, the Agency has
conducted inhalation exposure assessments. As noted previously, MOEs greater than or equal to
100 for the inhalation route of exposure are considered protective for the occupational handler
exposure assessment.
Antimicrobial Uses
The resulting inhalation exposures and MOEs for the representative occupational handler
scenarios are presented in Table 8.1. The calculated MOEs were above the target MOE of 100
for all scenarios, except those listed below.
• Agricultural fogging (mixing and loading): ST/IT Inhalation MOE = 26
• Pulp and paper, liquid pump: ST/IT Inhalation MOE = 33
• Once-through cooling water, metering pump: Using the average flow rate for high flow
streams (153 MOD) the ST Inhalation MOE = 50
• Small process water systems, liquid pour: ST/IT Inhalation MOE = 6.
34
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Table 8.1: Short- , Intermediate- and Long-Term Inhalation Risks Associated with
Occupational Handlers
Exposure Scenario
Method of Application
Inhalation
Unit
Exposure
(mg/lb
a.i.)
Application Rate
Quantity
Handled/
Treated per day
Inhalation
Daily Dose
(mg/kg/day)a
Inhalation
MOEb'c
(Target MOE
= 100)
Agricultural Premises and Equipment (Use Site Category I)
Application to hard surfaces,
equipment, and vehicles
Fogging (mix/load only)
Mop
High pressure/high
volume spray
Low pressure hand
wand
Trigger pump sprayer
Wipe
Liquid pour
2.38
0.12
0.681
1.3
67.3
1.89
0.012 Ibai/gal
0.017 Ibai/gal
0.017 Ibai/gal
0.017 Ibai/gal
0.017 Ibai/gal
2.46E-05 lb/ft3
2 gallons
40 gallons
10 gallons
0.26 gallons
0.26 gallons
150,000ft3
0.00091
0.0014
0.002
0.000098
0.0051
0.12
3,300
2,200
1,500
31,000
590
26
Food Handling/Storage Establishments Premises And Equipment (Use Site Category II)
Application to indoor hard
surfaces (including dishes,
utensils, equipment)
Low pressure hand
wand
Mop
Wipe
Trigger pump sprayer
Immersion, Flooding,
Circulation
0.681
2.38
67.3
1.3
1.89
0.0176 Ibai/gal
0.0176 Ibai/gal
0.0176 Ibai/gal
0.025 Ib ai/gal
0.00325 Ib ai/gal
2 gallons
2 gallons
0.26 gallons
0.26 gallons
2 gallons
0.0004
0.0014
0.0051
0.00014
0.0002
7,500
2,100
580
21,000
15,000
Commercial, Institutional and Industrial Premises and Equipment (Use Site Category III )
Application to indoor hard
surfaces
Air deodorization
Application to carpets
Low pressure hand
wand
Mop
Wipe
Trigger pump sprayer
Immersion
Aerosol spray
Liquid pour
0.681
2.38
67.3
1.3
1.89
1.3
0.00346
0.0283 Ib ai/gal
0.0283 Ib ai/gal
0.0283 Ib ai/gal
0.0283 Ib ai/gal
0.025 Ib ai/gal
0.20% a.i. by
weight
0.141 Ibai/gal
2 gallons
2 gallons
0.26 gallons
0.26 gallons
2 gallons
3.0 Ibs
32 gallons
0.00064
0.0022
0.0083
0.00016
0.0016
0.00013
0.00026
4,700
1,300
360
19,000
1,900
23,000
12,000
Medical Premises and Equipment (Use Site Category V)
Application to hard surfaces
Application to dental
instruments
Mop
Immersion
(Liquid pour)
2.38
1.89
0.0176 Ibai/gal
0.0209 Ib ai/gal
45 gallons
2 gallons
0.031
0.0013
95
2,300
Industrial Processes and Water Systems (Use Site Category VHI)
Pulp and Paper
Papermaking Chemicals
Once-through Cooling Water
System - Power plant
Metering pump
Metering pump
Metering pump
0.000265
0.000265
0.000265
41.71bai/ton
paper
0.0019 Ibai/gal
additive
Initial Dose
(ST): 8.86E-5 Ib
ai/gal water
500 tons
1,000 gallons
5,900,000
gallons
0.092
8.5E-6
0.0023
33
350,000
ST=1300
35
-------
Exposure Scenario
Small process water systems:
Recirculating cooling
tower/evaporative
condenser/pasteurizers
Oil field operations - drilling
mud and packing fluids
Metal/wood cooling tower
surface spray
Method of Application
Liquid pour
Metering pump
Liquid pour
Airless spray
Inhalation
Unit
Exposure
(mg/lb
a.i.)
0.45
0.00432
0.00346
0.83
Application Rate
Maintenance
Dose (IT):
4.69E-5 Ib ai/gal
Initial Dose
(ST): 8.86E-5 Ib
ai/gal water
Maintenance
Dose (IT):
4.69E-5 Ib ai/gal
6.67 Ib ai/gal
product
Initial Dose
(ST): 3.34E-4 Ib
ai/gal water
Maintenance
Dose (IT):
1.25E-41b ai/gal
water
1. 00 Ib ai/gal
product
0.000168 Ib
ai/gal water
Quantity
Handled/
Treated per day
5,900,000
gallons
153,000,000
gallons
153,000,000
gallons
10 gallons
20,000 gallons
20,000 gallons
5.6 gallons
2.8 gallons
100 gallons
1,000 gallons
Inhalation
Daily Dose
(mg/kg/day)a
0.0012
0.06
0.032
0.5
0.00048
0.00018
ST = 0.00032
IT = 0.00016
0.00023
0.0023
Inhalation
MOEb'c
(Target MOE
= 100)
IT=2,500
ST=50
IT=95
6
ST=6,200
IT= 17,000
ST = 9,300
IT =19,000
13,000
1,300
Swimming Pools (Use Site Category X)
Application to swimming
pools
Liquid pour
0.00346
Winterizing
Dose (ST):
0.000052 Ib
ai/gal
Maintenance
Dose (IT/LT):
0.0000098 Ib
ai/gal
200,000 gallons
200,000 gallons
0.0006
0.00011
ST =5,000
IT/LT =27,000
ST = short-term, IT = intermediate-term, LT = long-term, N/A= No data available
a Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x absorption factor (1.0 for inhalation) x application rate x quantity treated / Body weight
(60 kg for inhalation).
b MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where NOAEL = 3 mg/kg/day for all inhalation exposure durations]. Target MOE = 100.
c The MOEs refer to short-term and intermediate-term duration unless indicated otherwise.
Agricultural Uses
In all occupational handler scenarios, the inhalation MOEs are above the level of concern
of 100 at baseline PPE (i.e., no respirator).
36
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TABLE 8.2: ADBAC: Occupational Handler Inhalation Risks
Exposure Scenario
Crop or Target
Application
Rate3
Area
Treated
Daily "
Inhalation
MOEsc
Baseline
Mixer/Loader
Mixing/Loading (M/L) Liquids for
Groundboom Applications (la)
ML Liquid to Support LCO Handgun
Applications (mixing/loading supports
20 LCDs) (Ib)
M/L Liquids for Airblast (Ic)
M/L Liquid via Dip or Soak (Id)
M/L DF for Groundboom (2a)
M/L DF for Airblast (2b)
M/L DF to Support LCO Handgun
Applications (mixing/loading supports
20 LCDs) (2c)
M/L DF via Dip or Soak (2d)
Carnations (drench)
Ornamental Herbaceous
Plants (drench)
Sodfarm Turf
Seedlings (planted in field)
Mosquito Control in
Decorative Ponds, Sewage
Treatment Systems, and
Standing Water
Mosquito Control in
Decorative Ponds, Sewage
Treatment Systems, and
Standing Water
Mosquito Control in
Decorative Ponds, Sewage
Treatment Systems, and
Standing Water
Residential & Commercial
Turf
Residential & Commercial
Turf
Ornamental Trees
Ornamental Herbaceous
Plants,
Seedlings, Seeds, Cuttings
(preplan! or at plant)
Carnations (drench)
Ornamental Herbaceous
Plants (drench)
Sodfarm Turf
Seedlings (planted in field)
Ornamental Trees
Residential & Commercial
Turf
Residential & Commercial
Turf
Ornamental Herbaceous
Plants,
Seedlings, Seeds, Cuttings
(preplan! or at plant)
256 Ib ai/acre
72 Ib ai/acre
0.9 Ib ai/acre
0.43 Ib ai/acre
0.0017 Ibai/gal
of water to be
treated
0.0017 Ibai/gal
of water to be
treated
0.0017 Ibai/gal
of water to be
treated
7 Ib ai/acre
0.9 Ib ai/acre
0.65 Ib ai/acre
0.0065 Ib ai/gal
0.0043 Ib ai/gal
256 Ib ai/acre
72 Ib ai/acre
0.9 Ib ai/acre
0.43 Ib ai/acre
0.65 Ib ai/acre
7 Ib ai/acre
0.9 Ib ai/acre
0.0065 Ib ai/gal
0.0043 Ib ai/gal
1 acres
1 acres
1 acres
1 acres
800,000
gallons of
water
100,000
gallons of
water
20,000
gallons of
water
1 acres
1 acres
2 acres
100 gallons
100 gallons
1 acres
1 acres
1 acres
1 acres
1 acres
1 acres
1 acres
100 gallons
100 gallons
590
2100
170,000
350,000
110
880
4,400
21,000
170,000
120,000
230,000
350,000
910
3,200
260,000
540,000
360,000
33,000
260,000
360,000
540,000
Applicator
Applying Sprays via Groundboom
Equipment (3)
Carnations (drench)
Ornamental Herbaceous
Plants (drench)
Sodfarm Turf
Seedlings (planted in field)
Mosquito Control in
256 Ib ai/acre
72 Ib ai/acre
0.9 Ib ai/acre
0.43 Ib ai/acre
0.0017 Ibai/gal
1 acres
1 acres
1 acres
1 acres
800,000
950
3,400
270,000
570,000
180
Decorative Ponds, Sewage
37
ot water to be
gallons ot
-------
Exposure Scenario
Applying Sprays via Airblast Equipment
(4)
Applying Sprays via Handgun (5)
Crop or Target
Treatment Systems,
Swimming Pools and
Standing Water
Mosquito Control in
Decorative Ponds, Sewage
Treatment Systems,
Swimming Pools and
Standing Water
Mosquito Control in
Decorative Ponds, Sewage
Treatment Systems,
Swimming Pools and
Standing Water
Ornamental Trees
Residential and Commercial
Turf
Application
Rate3
treated
0.0017 Ibai/gal
of water to be
treated
0.0017 Ibai/gal
of water to be
treated
0.65 Ib ai/acre
7 Ib ai/acre
0.9 Ib ai/acre
Area
Treated
Daily "
water to be
treated
100,000
gallons of
water to be
treated
20,000
gallons of
water to be
treated
1 acres
0.05 acres
0.05 acres
Inhalation
MOEsc
Baseline
1,400
7,200
62,000
370,000
2,900,000
Mixer/Loader/Applicator
Mixing/Loading/Applying Liquid
Concentrates with a Handgun Sprayer
(LCOORETFdata)(10)
Mixing/Loading/Applying Liquid
Concentrates with a Handgun Sprayer
(LCD ORETF data) (7)
Mixing/Loading/Applying Water Soluble
Bags with Handgun Sprayer (LCO
ORETF data) (10)
Mixing/Loading/Applying Dry
Flowables Concentrates with a Handgun
Sprayer (LCO ORETF data) (11)
Mixing/Loading/Applying Liquid
Concentrates with a High Pressure
Handwand (PHED) (12)
Carnations (drench)
Ornamental Herbaceous
Plants (drench)
Ornamental Trees and
Ornamental Herbaceous
Plants
Ornamental Shrubs, Seedlings
(planted in field)
Carnations (drench)
Ornamental Trees and
Ornamental Herbaceous
Plants
Ornamental Shrubs, Seedlings
(planted in field)
Carnations (drench)
Ornamental Herbaceous
Plants (drench)
Ornamental Trees and
Ornamental Herbaceous
Plants
Ornamental Shrubs, Seedlings
(planted in field)
Carnations (drench)
Ornamental Herbaceous
Plants (drench)
Ornamental Trees and
Ornamental Herbaceous
Plants
Ornamental Shrubs, Seedlings
(planted in field)
Ornamental Herbaceous
Plants and Ornamental Trees
Ornamental Shrubs
256 Ib ai/acre
72 Ib ai/acre
0.65 Ib ai/acre
0.43 Ib ai/acre
0.0235 Ib
ai/gallon
0.0065 Ib
ai/gallon
0.0043 Ib ai/acre
256 Ib ai/acre
72 Ib ai/acre
0.65 Ib ai/acre
0.43 Ib ai/acre
256 Ib ai/acre
72 Ib ai/acre
0.65 Ib ai/acre
0.43 Ib ai/acre
0.0065 Ib
ai/gallon
0.0043 Ib
ai/gallon
0.05 acres
0.05 acres
0.05 acres
0.05 acres
0.04 acres
0.04 acres
0.04 acres
0.05 acres
0.05 acres
0.05 acres
0.05 acres
0.05 acres
0.05 acres
0.05 acres
0.05 acres
1,000 gallons
1,000 gallons
2,000
6,900
770,000
1,200,000
71,000,000
260,000,000
390,000,000
2,000
6,900
770,000
1,200,000
640
2,300
250,000
380,000
230
350
38
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Exposure Scenario
Applying Ready to Use Formulations
via Trigger-Pump Sprayer (ORETF) (13)
Mixing/Loading/Applying Liquids with a
Watering Can (using ORETF residential
hose-end data) (14)
Crop or Target
Ornamental Shrubs,
Seedlings, Seeds, Cuttins
(preplan! or at plant)
Ornamental Palms
Seedlings, Seeds, Cuttins
(preplan! or at plant)
Mosquito Control in
Decorative Ponds, Sewage
Treatment Systems,
Swimming Pools, and
Standing Water
Mosquito Control in
Fountains, Water Displays,
Decorative Pools
Application
Rate3
0.0043 Ib
ai/gallon
0.013 Ibai/gallon
0.0043 Ib
ai/gallon
0.0017 Ib
ai/gallon of water
to be treated
0.0017 Ib
ai/gallon of water
to be treated
Area
Treated
Daily "
1 gallons
5 gallons
5 gallons
20,000
gallons to be
treated
1,000 gallons
to be treated
Inhalation
MOEsc
Baseline
2,200,000
160,000
490,000
310
6,200
a Application rates are the maximum application rates determined from EPA registered labels for ADBAC
b Amount handled per day values are HED estimates of gallons applied per day based on Exposure SAC SOP #9 Standard Values for
Daily Acres Treated in Agriculture, industry sources, and HED estimates.
c Inhalation MOE = inhalation NOAEL (mg/kg/day) / baseline inhalation dose (mg/kg/day), where baseline inhalation exposure
(mg/day) = application rate (Ib ai/gal ) x amount handled per day (gal/day) x baseline inhalation unit exposure (ug/lb ai) x conversion
factor from jig to mg (0.001) and the baseline inhalation dose (mg/kg/day) = baseline inhalation exposure (mg/day) x inhalation
absorption factor (100%) / female bodyweight (60 kg)
d. Occupational Post-Application Exposures
Post-Application exposure may occur from entering food processing plants, hatcheries,
wood treatment facilities, ornamental greenhouse/nurseries, or from handling treated wood or
turf. Except for the post-application scenarios assessed for fogging (food processing plants and
hatcheries) in Section 8.2.2, occupational post-application dermal and inhalation exposures are
assumed to be negligible.
i. Fogging (Food Processing Plant and Hatchery)
There is a potential for post-application inhalation exposure for workers re-entering a
treated hatchery or food processing plants, because dermal post application is presumed to be
negligible, it was not assessed. The inhalation exposure assessment was conducted using the
Multi-Chamber Concentration and Exposure Model (MCCEM vl .2). MCCEM estimates
average and peak indoor air concentrations of chemicals released from products or materials in
houses, apartments, townhouses, or other residences. Although the data libraries contained in
MCCEM are limited to residential settings, the model can be used to assess other indoor
environments. MCCEM has the capability to estimate inhalation exposures to chemicals,
calculated as single day doses, chronic average daily doses, or lifetime average daily doses. (All
dose estimates are potential doses; they do not account for actual absorption into the body.)
The fogging application to a food processing plant was assessed using a maximum
application rate of 0.011 Ib ai/gal, one quart of the diluted product per 1,000 cubic feet of the
treated area. For fogging applications, a two hour restricted entry interval is required on current
labels for this use. The inhalation MOE for fogging is 1 which is considerably below the target
MOE of 100. The risks of concern immediately after fogging are attributed to low air changes
39
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per hour assumed (i.e., 0.18 ACH as a default parameter in MCCEM to represent low air flow).
The assessment for fogging in food processing plants could be refined if more accurate
ventilation rate information could be obtained.
The fogging application to hatcheries and incubators was assessed using a maximum
application rate of 0.24 Ib ai/gal. For fogging applications, the Agency estimated risks from 0-8
hours and 2-10 hours following treatment. The 8-hr inhalation MOE from 0-8 hours
(immediately after fogging) is below the target MOE of 100 at 0.5; however, the 8-hr MOE from
2 to 10 hours was above the target MOE of 100.
e. Wood Preservation
ADB AC is used in products that are intended to preserve wood through both non-
pressure treatment methods and pressure treatment methods. Section 1 presents the exposure
analysis for the handler and post-application scenarios for non-pressure treatment scenarios, and
Section 2 presents the exposure analysis for the handler and post-application scenarios for
pressure treatment scenarios. Dermal irritation exposures from post-application activities in the
wood preservation treatment facility will be mitigated using default personal protective
equipment requirements based on the toxicity of the end-use product. Therefore, only inhalation
exposures and risks are presented.
i. Non-Pressure Treatment Scenarios (Handler and Post-
application)
a. Scenarios Assessed by Worker Function
A proprietary study, "Measurement and Assessment of Dermal and Inhalation Exposures
to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase
III) " (Bestari et al., 1999, MRTD 455243-04) was used to assess various worker
functions/positions for individuals that handle DDAC-containing wood preservatives for non-
pressure treatment application methods and post-application risk scenarios for individuals that
could into contact with the preserved wood. The worker functions/positions identified in the
DDAC study are presented below. It was assumed that similar tasks are performed when
handling ADB AC products and ADB AC treated-wood as, therefore, these same functions were
assessed for ADB AC.
Handler:
• Blender/spray operators are workers that add the wood preservative into a blender/sprayer
system for composite wood via closed-liquid pumping.
• Diptank Operators can be in reference to wood being lowered into the treating solution
through an automated process (i.e., elevator diptank, forklift diptank). This scenario can also
occur in a smaller scale treatment facility in which the worker can manually dip the wood
into the treatment solution.
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• Chemical operators for spray box system consist of chemical operators, chemical assistants,
chemical supervisors, and chemical captains. These individuals maintain a chemical supply
balance along with flushing and cleaning spray nozzles.
The post-application scenarios identified in the aforementioned DDAC study are
presented below based on the assumption that these scenarios are the same for ADBAC.
Post-application:
• Graders, positioned right after the spray box, grade dry lumber by hand (i.e., detect faults).
• Millwrights repair all conveyer chains and general up-keep of the mill.
• Clean-up crews perform general cleaning duties at the mill.
• Trim saw operators operate the hula trim saw and consist of operators and strappers.
• Construction workers install treated plywood, oriented strand board, medium density
fiberboard, and others.
As very little chemical specific data were available regarding typical exposures to
ADBAC as a wood preservative, surrogate data were used to estimate exposure risks. The
blender/spray operator position was assessed using CMA unit exposure data and the remaining
handler and post-application positions were assessed using data from the DDAC study (Bestari et
al., 1999).
Blender/Spray Operators
The inhalation exposures and risks to the composite wood blender/spray operators are
reported in Table 8.2. The inhalation MOE is below the target MOE of 100 for short-,
intermediate-, and long-term inhalation exposures (MOE = 84).
Table 8.2: Short-, Intermediate-, and Long-Term Inhalation Exposures and MOEs for
Blender/Spray Operator
Exposure
Scenario
Inhalation Unit
Exposure3
(mg/lb ai)
Application Rate
(% ai in solution/
day)
Wood Slurry
Treated13
(Ib/day)
Daily Dose0
(mg/kg/day)
ST/IT/LT
MOEd
(Target MOE =
100)
Occupational Handler
Blender/spray
operator
0.000403
3
178,000
0.036
84
ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term.
a. Inhalation unit exposure: Baseline.
b. Wood slurry treated = (8 batches/day x 7,000 gallons/batch x 0.003785 nvVgallon x 380 kg/m3 x 2.2 Ib/kg)
c. Daily Dose = unit exposure (mg/lb ai) x App Rate (% ai/day) x Quantity treated (Ib/day) x absorption factor (100% for inhalation) / BW
(60 kg)
d. MOE = NOAEL (mg/kg/day)/ Daily dose [Where ST/IT/LT NOAEL = 3 mg/kg/day for inhalation. Target MOE = 100.
Chemical Operators, Graders, Millwrights, Clean-up Crews, and Trim Saw Operators
The inhalation exposures (all durations) to chemical operators, graders, millwrights, trim
saw operators, and clean-up crews are presented in Table 8.3. The inhalation MOEs are above
the target MOE of 100 for all worker functions. Any dermal irritation exposures from post-
41
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application activities will be mitigated using default personal protective equipment requirements
based on the toxicity of the end-use product.
Table 8.3: Short-, Intermediate, and Long-Term Inhalation Exposures and MOEs for
Wood Preservative Chemical Operators, Graders, Trim Saw Operators, and Clean-Up
Crews (Handler and Post-application Activities)
Exposure Scenario3
(number of volunteers)
Inhalation UEb
(mg/day)
Conversion Ratio0
Daily Dosed
(mg/kg/day)
MOEe (Target
MOE = 100)
Occupational Handlers
Chemical Operator (n=l 1)
0.0281
0.625
0.000292
10,000
Occupational Post-Application
Grader (n= 13)
Trim Saw (n=2)
Millwright (n=3)
Clean-Up (n=6)
0.0295
0.061
0.057
0.60
0.625
0.625
0.625
0.625
0.000307
0.00063
0.00059
0.0063
9,800
4,800
5,100
480
Short-term duration, IT = Intermediate-term duration, LT = Long-term duration
The exposure scenario represents a worker wearing short-sleeved shirts, cotton work trousers, and cotton glove
dosimeter gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the
mill.
Inhalation unit exposures are from Bestari et. al. (1999). Refer to Table E-l in Appendix E for the calculation of the
dermal and inhalation exposures. Inhalation exposure (mg/day) was calculated using the following equation: Air
concentration (|ig/m3) x Inhalation rate (1.0 m3/hr) x Sample duration (8 hr/day) x Unit conversion (1 mg/1000 |ig).
The inhalation rate is from USEPA, 1997.
Conversion Ratio = 50% ADBAC / 80% DDAC
Daily dose (mg/kg/day) = exposure (mg/day) x conversion ratio (0.625) x absorption factor (100% for inhalation)/body
weight (60 kg).
MOE = NOAEL (mg/kg/day)/ Daily dose [Where inhalation NOAEL = 3 mg/kg/day]. Target MOE = 100.
Diptank Operators
Exposures to diptank operators were also assessed using surrogate data from the DDAC
study (Bestari et al., 1999). The diptank scenario assessment was conducted differently than for
the other job functions because the concentration of DDAC in the diptank solution was provided.
The exposure data for diptank operators were converted into unit exposures in terms of mg a.i.
for each 1% of concentration of the product. Table 8.4 provides the short-, intermediate- and
long-term inhalation dose and MOEs for diptank operators. The inhalation MOE is above the
target MOE of 100 and, therefore, is not of concern.
Table 8.4: Short-, Intermediate-, and Long-Term Inhalation Exposures and MOEs for
Diptank Operator (Handler Activity)
Exposure Scenario3
(number of replicates)
Inhalation Unit Exposure13
(mg DD AC/1% solution)
App Rate
(% a.i. in solution/ day)
Daily Dose0
(mg/kg/day)
MOEd
Occupational Handler
Dipping, (n=7)
0.046
3
0.0023
1,300
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a The exposure scenario represents a worker not wearing a respirator.
b Inhalation unit exposures are from DDAC study (MRID 455243-04). Refer to Table E-2 in
Appendix E for the inhalation unit exposure calculations. Inhalation exposure (mg) was calculated
using the following equation: Air concentration (mg/m3) x Inhalation rate (1.0 m3/hr) x Sample
Duration (8 hr). The inhalation rate is from USEPA, 1997.
c Daily dose (mg/kg/day) = unit exposure (mg/1% ai solution) x percent active ingredient in
solution (3% ai) x absorption factor (100% for inhalation) / body weight (60 kg).
d MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 3 mg/kg/day. Target
MOE = 100.
ii. Pressure Treatment Scenarios (Handler and Post-
Application)
ADB AC may be used to treat wood and wood products using pressurized application
methods such as double vacuum. According to the product labels, the maximum retention rate is
0.6 lb/ft3. An application rate was not provided on the product labels; therefore, an application
rate of 3% ai solution was used in this assessment, based on the master label. Since ADBAC-
specific exposure data are not available to assess pressure treatment exposure, surrogate
chromated copper arsenate (CCA) data (ACC, 2002b) was utilized and using the approach
described in a previous exposure assessment (USEPA, 2003b).
The estimated inhalation exposures and risks for ADBAC are presented in Table 8.6.
The calculated inhalation MOEs are above the target MOE of 100 for all scenarios and not of
concern.
Table 8.6: Short-, Intermediate-, and Lc
Pressure Treatment Handler and Post-a
Exposure Scenario
Inhalation Unit
Exposure3
(ug As/ppm)
•ng-Term Inhalation Exposures and MOEs for
pplication Scenarios
Application Rate
(% ai solution)
Daily Dosesb
(mg/kg/day)
Inhalation
MOEsc
(Target MOE =
100)
Occupational Handler
Treatment Operator (TO)
Treatment Assistant (TA)
0.00257
0.000802
o
J
o
J
0.0013
0.00040
2,300
7,500
Occupational Post-application
All (Tram setter, stacker
operator, loader operator,
supervisor, test borer, and
tallyman)
0.00160
o
J
0.00080
3,800
i. Unit exposure values taken from CCA study and are shown in Table 6.11.
3. Daily Dose (mg/kg/day) = Unit Exposure (ug As/ppm) x [% ADBAC in solution (3) x 10,000 (parts per million
conversion)] x (0.001 mg/ug) x absorption factor (100% for inhalation) / Body weight (60 kg).
;. MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 3 mg/kg/day for all durations. Target MOE =
100.
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9.
Human Incident Data
The Agency reviewed available sources of human incident data for incidents related to
the use of the quaternary ammonium chlorides. As stated earlier, the Agency clustered the
quaternary ammonium chloride chemicals into four groups. However, the available incident
information does not differentiate between the specific groups; therefore, all the incident data are
discussed together.
The Agency consulted the following sources of human incidents related to the use of ADBAC:
(1) OFF 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) - Since 1982,
California's Department of Pesticide Regulation Pesticide Poisoning Surveillance
Program consists of reports from physicians who document all illnesses they suspect
are related to pesticide exposure.
(3) National Pesticide Information Center(NPIC) - NPIC is a toll-free information
service supported by OPP. The network provides information on the top 200 active
ingredients by answering telephone calls during calendar years 1984-1991.
(4) Published Incident Reports - Some incident reports associated with Quats that are
related to human health hazard are published in the scientific literature.
There have been nearly 2700 incidents reported to the OPP Incident Data System (IDS
and the California Department of Pesticide Regulation (1982-2004) associated with exposure to
end-use products containing Quats. Most of the incidents are related to dermal, ocular and
inhalation irritation. Allergic type reaction is also been reported in some incidents. Although
risk associated with eye exposure is not assessed in the risk assessment process, symptoms
associated with eye are the most commonly reported associated with Quat exposure.
Incidents Associated with Quat Use
Type of Incident Reported
Inhalation
Dermal
Allergic
Oral
Ocular
Most Common Symptom
respiratory irritation/burning, irritation to
mouth/throat/nose, coughing/choking, chest pain,
disorientation, dizziness, shortness of breath
irritation/burning, rash, itching, and blistering
hives and allergic contact dermatitis
irritation to mouth/throat/nose, vomiting/ nausea/
abdominal pain, dizziness, and headache
irritation/burning, eye pain, conjunctivitis,
swelling of eye and eyelid
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B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. The
following risk characterization is intended to describe the magnitude of the estimated
environmental risks for ADBAC use sites and any associated uncertainties. For detailed
information on the environmental risk assessment on ADBAC, see the following documents,
"Environmental Fate Assessment of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)"
dated July 31, 2006, "Ecological Risk Assessment on Antimicrobial Uses for Alkyl Dimethyl
Benzyl Ammonium Chloride (ADBAC)" dated August 2, 2006, and "Ecological Risk
Assessment on Agricultural Uses for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)"
dated February 3, 2006.
1. Environmental Fate and Transport
The environmental fate assessment for ADBAC is based on the available data submitted
to fulfill the reregi strati on data requirements. However, the data set is incomplete for the wood
preservation use. An aqueous availablility study evaluating the teachability of ADBAC from
treated wood is required.
Based on the available data, ADBAC is hydrolytically stable under abiotic and buffered
conditions over the pH 5-9 range. The calculated half-lives for ADBAC were 379 days at pH 9,
150-183 days at pH 5 and pH 7. ADBAC is also stable to photodegradation in pH 7 buffered
aqueous solutions. However, in the presence of a photosensitizer (e.g., acetone), ADBAC has
been shown to degrade with an estimated half-life of 7.1 days.
Based on a biodegradation study, ADBAC readily degrades into 60% carbon dioxide in
13 days. ADBAC is immobile in soil. The available soil mobility study shows that ADBAC has a
strong tendency to bind to sediment/soil with Freundlich Kads values range from 5,123 to 32,429
depending on the soil type where as the corresponding Koc values range from 640,389 to
6,171,657 depending on the soil type. Due to its strong adsorption to soils, ADBAC is not
expected to contaminate surface and ground waters.
Although the estimated Kow is high, bioaccumulation of ADBAC in freshwater fish nor is
bioconcentration in aquatic organisms expected to pose a concern because ADBAC has broken
down into its' degrades before it reaches the aquatic ecosystems.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimate environmental concentrations based on environmental fate
characteristics and pesticide use data.
a. Toxicity (Hazard) Assessment
ADBAC is categorized as highly toxic to fish (LCso = 280 ug ai/L) and very highly toxic
to aquatic invertebrates (LCso = 5.9 ug ai/L) on an acute exposure basis. Chronic effects were
seen in fish at a concentration of 32.2 ug ai/L and a no observable adverse effect concentration
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(NOAEC) of 4.15 ug ai/L was established for aquatic invertebrates. The results of the dietary
avian studies categorized ADBAC as moderately toxic to birds on an acute basis (LCso = 136
mg/kg-bw, with no chronic data available. ADBAC is categorized as slightly toxic to mammals
on an acute basis (LD50 = 430 mg/kg-bw) and a chronic NOAEC of 44 mg/kg/day was
established.
b. Exposure and Risk
ADBAC INDOOR USES
The majority of ADBAC uses are spray applications to indoor surfaces, truck interiors,
kennels, institutional areas, household areas, recirculating cooling towers, evaporative
condensers, pulp/paper mills, swimming pools and spas, and oil field mud treatments. The indoor
uses of ADBAC make it unlikely that any appreciable exposure to terrestrial or aquatic organism
would occur. However, the commercial/industrial facilities using ADBAC for indoor
applications are required to have NPDES permits prior to discharging effluents into receiving
waters.
ADBAC OUTDOOR USES
Risk Quotients (RQs) are calculated by dividing acute and chronic estimated
environmental concentrations (EECs), based on environmental fate characteristics and pesticide
use data, ecotoxicity values for various wildlife and plant species. RQs are then compared to
levels of concern (LOCs). When the RQ exceeds the LOG for a particular category, the Agency
presumes risks of concern for that category.
Ornamental Nursery Plants
Expected environmental concentrations (EECs) of ADBAC resulting from runoff
following application to ornamentals in nurseries were calculated using available ecotoxicity
data and the EPA aquatic exposure model PRZM/EXAMS. Risk quotients (RQs) for freshwater
fish ranged from 1.99 to 5.26, RQs for freshwater invertebrates ranged from 94.41 to 249.66,
exceeding the acute risk LOG by greater than 180-fold. The chronic risk LOG (1.0) is exceeded
many-fold for freshwater fish ranging from RQs 10-28 and for freshwater invertebrates ranging
from RQs 87-222. Using the EPA terrestrial animal exposure model (TERX), acute avian RQs
ranged from 19 to 2101, exceeding the acute LOG up to 4000-fold. Chronic avian RQs could not
be calculated due to the lack of toxicity data, but chronic risk is presumed. Mammalian acute
RQs for the nursery use range from 1.2 to 182 and chronic RQs range from 11 to 1782.
Turf and Golf Courses
Expected EECs of ADBAC resulting from runoff following application to turf and golf
courses were calculated using available ecotoxicity data and the EPA aquatic exposure model
PRZM/EXAMS. Risk quotients for freshwater fish range from 0.06 to 0.91, exceeding the
endangered species and acute risk LOCs. Acute risk RQs for freshwater invertebrates range
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from 2.3 to 10.6, exceeding the acute risk LOG. Using the EPA terrestrial animal exposure
model (TERX), acute avian RQs range from 0.11 to 12.35, exceeding the endangered species
LOG for all size classes and forage items. Chronic RQs cannot be calculated, but chronic risk to
avian species is presumed. Acute risk mammalian RQs from the turf/golf course use ranged
from 0.01 to 7.9, with exceedance of the endangered species LOG for all mammal size classes
foraging on short grass, tall grass, broadleaf plants and small insects. Chronic RQs for mammals
range from 0.07 to 77.2, and exceed the LOG for all mammal size classes foraging on short
grass, tall grass, broadleaf plants and small insects.
(http://www.epa.gov/oppefedl/models/terrestrial/index.htm).
Ornamental Ponds, Pools, and Puddles
Other outdoor uses of ADBAC on ornamental ponds, pools and puddles are not expected
to result in appreciable exposure to aquatic ecosystems due to their limited size and confined use
of ADBAC within the structure through the use of impermeable materials.
(http ://www. epa. gov/oppefed 1 /model s/water/index. htm).
Algae Control and Mosquitocide
Although the algae control and mosquitocide uses are intended for waterbodies that are
disconnected from the larger watershed to reduce nontarget environmental exposure, these uses
may result in potential exposure to amphibians in treated water for a portion of their lifecycle and
to birds and mammals utilizing treated waterbodies for drinking water. The mosquito control use
has an initial concentration of 200 ppm ADBAC and represents the greatest risk to terrestrial
animals. The algal control initial target concentration is 5 ppm ADBAC. At 200 ppm, RQs for
amphibians are 0.71 for acute risk and 6.2 for chronic risk. RQs for birds drinking treated water
range from 0.09 to 0.32. Smaller birds face greater acute risk. Chronic risk to birds is presumed
due to lack of data. Neither acute nor chronic mammalian acute RQs exceed the LOCs at the 200
ppm initial concentration.
Once-through Cooling Tower Use
Tier I once-through cooling tower modeling indicates that ADBAC use will result in
acute and chronic risk to non-endangered and endangered/threatened freshwater fish and acute
risk to other aquatic animals at all 3 dosages modeled: 2.0 ppm, 5.0 ppm, and lO.Oppm. High
water flow, and intermittent dosing at 10.0 ppm had less acute and chronic impact on non-
endangered freshwater fish than medium to low stream flow. However, LOC's for all aquatic
animals were triggered at the 2.0 ppm dosage using continuous dosing regardless of high,
medium, or low stream flow. Green algae were only adversely affected from use of continuous
dosing in combination with low stream flow conditions. The continuous dosing, low flow
nontarget plant LOG is triggered at all 3 dosages modeled. The aquatic plant risk assessment is
incomplete due to a number of outstanding studies. Direct ADBAC exposure to terrestrial
animals is not expected to occur from the once-through cooling tower use.
47
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Antisapstain Wood Treatment Use
Terrestrial animal species are not expected to be directly impacted by this ADBAC use.
Nontarget aquatic species (fish, invertebrates, green algae) are not expected to be at risk (acute or
chronic) based on LOCs. Endangered/threatened fish and green algae species are not expected to
be at risk from the ADBAC antisapstain use. Freshwater and marine aquatic invertebrates are
expected to be at risk from ADBAC antisapstain use unless methods are used to prevent runoff
from the treatment site (Ex. store treated wood indoors, cover treated wood and use berms or
plastic barriers in outdoor storage areas). However, ADBAC is tightly adsorbed to clay and
organic matter which greatly reduces potential for ADBAC to leach downward through soil to
groundwater or move via surface runoff. The Tier I screening model is only intended as a
screening-level model, and, as such, has inherent uncertainties and limitations which may result
in inaccurate exposure estimations.
c. Risk to Endangered (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
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.
The endangered species Alternative Consultation Agreement (ACA) with NMFS, and
FWS will take time to implement fully, depending on available resources. The Agency is
currently preparing risk assessments with the services on 9 high priority agricultural pesticides.
Endangered species assessments of antimicrobial and additional agricultural pesticides will
commence in 2008 under the Registration Review program.
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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 active ingredient
uses of ADBAC with the exception of the ornamental nurseries, golf/turf/lawns, once-through
cooling tower, and antisapstain wood preservation uses, fall into this category. Using Tier I
screening modeling to assess potential exposure from the ornamental nurseries, golf/turf/lawns,
once-through cooling tower, and antisapstain wood preservation uses of ADBAC risks to Listed
Species are indicated. Since the model is only intended as a screening-level model, and, as such,
has inherent uncertainties and limitations which may result in inaccurate exposure estimations,
further refinement of the model is recommended before any regulatory action is taken regarding
the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and antisapstain uses of
ADBAC. Additionally, impacts from the antisapstain use could potentially be mitigated with
precautions to prevent leaching and runoff when wood is stored outdoors and impacts from the
cooling tower use could potentially be mitigated by the reduction of risk mitigation. Due to
these circumstances, the Agency defers making a determination for the ornamental nurseries,
golf/turf/lawns, once-through cooling tower, and antisapstain uses of ADBAC until additional
data and modeling refinements are available. At that time, the environmental exposure
assessment of the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and
antisapstain use of ADBAC will be revised, and the risks to Listed Species will be reconsidered.
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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 ADBAC 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 ADBAC.
The Agency has completed its assessment of the dietary, occupational, drinking water,
and ecological risks associated with the use of pesticide products containing the active ingredient
ADBAC. Based on a review of these data and on public comments on the Agency's assessments
for the active ingredient, ADBAC, the Agency has sufficient information on the human health
and ecological effects of ADBAC 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 ADBAC-containing products are eligible for reregi strati on provided
that: (i) current data gaps and confirmatory data needs are addressed; (ii) the risk mitigation
measure outlined in this document is adopted; and (iii) label amendments are made to reflect this
measure. Label changes are described in Section V. Appendix A summarizes the uses of
ADBAC 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 ADBAC 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 ADBAC, the Agency has determined that ADBAC products,
unless labeled and used as specified in this document, would present risks inconsistent with
FIFRA. Accordingly, should a registrant fail to implement the risk mitigation measure identified
in this document, the Agency may take regulatory action to address the risk concerns from the
use of ADBAC. If all changes outlined in this document are incorporated into the product labels,
then all current risks for ADBAC will be substantially mitigated for the purposes of this
determination. Once an Endangered Species assessment is completed, further changes to these
registrations may be necessary as explained in Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decision for ADBAC. During the public comment period on
the risk assessments, which closed on June 26, 2006, the Agency received comments from the
ADBAC Consortium, Reckitt Benckiser, and The Clorox Company regarding the risk
assessments assumptions. These comments in their entirety are available in the public docket, at
http://www.regulations.gov (OPP-2006-0339).
C. Regulatory Position
1. Food Quality Protection Act Findings
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a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with ADBAC. The Agency has concluded that the risk from dietary exposure is within the "risk
cup." An aggregate assessment was conducted for exposures through food, drinking water, and
residential uses. The Agency has determined that the human health risks from these combined
exposures are within acceptable levels. In reaching this determination, EPA has considered the
available information on the special sensitivity of infants and children, as well as aggregate
exposure from food and residential uses.
b. Determination of Safety to U.S. Population
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with ADBAC. The Agency has determined that food uses of ADBAC, 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 ADBAC. In reaching this conclusion, the Agency has considered all available information on
the toxicity, use practices and exposure scenarios, and the environmental behavior of ADBAC.
As discussed in Section III, the chronic dietary aggregate risks from direct and indirect
food contact as well as drinking water exposures for adults and children are below the Agency's
level of concern provided that mitigation measures outlined in this document are adopted and
labels are amended.
Since ADBAC toxicity endpoints for oral, dermal, and inhalation routes of exposure are
based on different toxic effects, these three routes of exposure are not aggregated together for the
short- and intermediate-term aggregate assessment. Instead, the short- and intermediate-term
aggregate assessment is based solely on the co-occurrence of the same route of exposures. Only
the short -term aggregate is presented because the endpoints for incidental oral and inhalation
are identical for the short- and intermediate-term durations, and only a short term dermal
exposure duration was identified. The aggregate risks are not of concern for adults and children
for any of the three routes of exposure; the risk estimates were above the target MOE.
c. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of ADBAC, 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 factors of the toxicity, use
practices, and environmental behavior noted above for the general population, but also takes into
account the possibility of increased susceptibility to the toxic effects of ADBAC residues in this
population subgroup.
No Special FQPA Safety Factor is necessary to protect the safety of infants and children.
In determining whether or not infants and children are particularly susceptible to toxic effects
from ADBAC residues, the Agency considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other
51
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information. The FQPA Safety Factor has been removed (i.e., reduced to IX) for ADBAC based
on (1) the existence of a complete developmental and reproductive database (2) the lack of
evidence for increased susceptibility in the data (3) the risk assessment does not underestimate
the potential exposure for infants and children.
d. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
EDSP have been developed, ADBAC may be subject to additional screening and/or testing to
better characterize effects related to endocrine disruption.
e. Cumulative Risks
Risks summarized in this document are those that result only from the use of ADBAC.
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
ADBAC. For information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the
policy statements released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from substances found to have
a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
2. Tolerance Summary
Alkyl Dimethyl Benzyl Ammonium Chloride, (ADBAC) has tolerance exemptions in 40
CFR 180.940 (a) as a food contact sanitizer for use in public eating places, in dairies on
processing equipment, and in food processing plants on equipment and utensils not to exceed the
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limit of 200 ppm and (c) as a food contact sanitizer for use in food processing plants on
equipment and utensils not to exceed the limit of 400 ppm.
Table 9: Tolerance Reassessment Summary for ADBAC
Tolerance Exemption Listed Under 40 CFR 180.940 (a)
Use Site
Public eating places, dairies on
processing equipment and
utensils, and food processing
plants on equipment and
utensils
Current Limit
(ppm)
Total quat
concentration
does not exceed
200
Tolerance
Reassessment
(ppm)
Total quat
concentration
does not exceed
200
Correct
Definition/Comment
No change
Tolerance Exemption Listed Under 40 CFR 180.940 (c)
Use Site
Food processing plants on
equipment and utensils
Current Limit
(ppm)
Specific quat
concentration
does not exceed
200; total quat
concentration
does not exceed
400
Tolerance
Reassessment
(ppm)
Specific quat
concentration
does not exceed
200; total quat
concentration
does not exceed
400
Correct
Definition/Comment
No change
D. Regulatory Rationale
The Agency has determined that ADBAC is eligible for reregi strati on provided that
additional required data confirm this decision, the risk mitigation measures outlined in this
document are adopted, and label amendments are made to reflect these measure.
The following is a summary of the rationale for managing risks associated with the use of
ADBAC. 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
Dietary (Food) Risk Mitigation
a.
The chronic dietary risks from ADBAC residues on food, estimated using conservative
measures, are below the Agency's level of concern. Therefore, no mitigation measures are
necessary at this time.
b. Drinking Water Risk Mitigation
As an outdoor pesticide for use on nursery ornamentals, turf, and mosquito control in
decorative fountain/ponds and puddles, ADBAC is expected to impact either surface or ground
53
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water resources. There are no drinking water concerns since the risk estimates for children and
adults were below the level of concern. Therefore, no mitigation measures are necessary at this
time.
c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler risks were calculated for the short-term duration because it best
represents most homeowner applications. The residential handler risks did exceeded the target
MOEs for all scenarios. Therefore, no mitigation measures are needed at this time.
ii. Post-Application Risk Mitigation
As with the residential handler risk assessment, the post-application risks were also
calculated for the short-term duration because it best represents most homeowner applications.
All residential post application risks were above the Agency's level of concern except for
inhalation exposures due to use in humidifiers, based on the 24 hr inhalation MOEs for adults
and children, 10 and 4, respectively and incidental oral exposure for children due to residential
treatment of lawns, MOE 76.
At this time, there are no available mitigation measures for the humidifier use. Because of
remaining residential exposure concerns, the registrants for ADBAC have agreed to conduct a
inhalation exposure study that would allow the Agency to refine the risks associated with this
uses. However, this study will not be completed in time for inclusion in this RED. Until
acceptable data are submitted, the Agency has determined that the residential use of ADBAC in
humidifiers is ineligible for reregi strati on and this use must be deleted. Once the data has been
received and determined to be acceptable, and if it is established that the risks are not of concern,
the registrants can request that this use be reinstated.
In order to mitigate the risks of concern scenario, the Agency is requiring that the
maximum application rate for use on residential lawns must be reduced to 5.4 Ib ai/A. The MOE
at this application rate achieves the target of 100.
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
EPA determined that the greatest potential for handler exposure appears to be the short-
and intermediate-term inhalation exposure scenarios. In order to reduce the occupational handler
risk, the following mitigation measures must be adopted:
Fogging in Agricultural Premises and Equipment: All labels must indicate that a dust mist
respirator will be used when pouring the product into the fogging equipment.
Pulp and Paper: In order to mitigate the risks of concern for occupational handlers in pulp and
paper mills, the Agency is requiring that the maximum application rate must be reduced to 14 Ibs
ai/ton of paper for products coupled with the use of a metering pump system (a closed system).
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The MOE at this application rate achieves the target of 100, and thus addresses the inhalation
risk of concern.
Once-through Cooling Water (average flow rate for high flow streams): In order to mitigate the
risks of concern for occupational handlers in once-through cooling tower, the Agency believes
that the maximum number of applications per year for this use pattern must be reduced to four.
This reduction, together with the fact that application of these products utilizes metered pump (a
closed system) addresses the inhalation risk of concern. (The reduction in the # of applications
should also be added to the eco risk mitigation piece for cooling towers.)
Small Process Water Systems: All labels must indicate that a dust mist respirator will be used
when applying the product to the water system.
Blender/Spray Application for Wood Preservation: Due to the conservative nature of the risk
assessment and the proximity of the MOE to the target of 100 (MOE = 84) the Agency believes
that actual exposures do not exceed the Agency's level of concern.
Mopping in Medical Premises: Due to the conservative nature of the risk assessment and the
proximity of the MOE to the target of 100 (MOE = 95) the Agency believes that actual
exposures do not exceed the Agency's level of concern.
ii. Post-Application Risk Mitigation
Except for the post-application scenario assessed for fogging in hatcheries and food
processing plants, the occupational post-application dermal and inhalation exposures are
assumed to be negligible. Based on the inhalation risk estimates for fogging in hatcheries, a 2
hour re-entry interval must be prescribed to all labels with this use to mitigate the inhalation risk.
In regard to food processing plants, the label must indicate a 2 hour reentry interval as well as a
minimum requirement of 4 air changes per hour (ACH). The registrants for ADBAC have agreed
to conduct air monitoring data and/or provide additional air exchange information that would
allow the Agency to further refine the risks associated with this use.
2. Environmental Risk Management
There is minimal environmental exposure from the indoor uses of products containing
ADBAC therefore no mitigation measures are needed for these use patterns at this time.
Conversely, there is significant environmental exposure from the outdoor uses from
products containing ADBAC; such as ornamental nurseries, golf/turf, once-through cooling
water towers, and antisapstain wood treatment, each of which resulted in RQs that exceeded the
Agency's level of concern. . In order to reduce the environmental risk, the following mitigation
measures must be adopted:
Ornamental Nurseries: Application is limited to Spot Treatment of diseased ornamental plants
and flowers at a maximum rate of 800 ppm and total use of 5 Ibs A.I/ acre. Treatment is
restricted to indoor uses or uses in which controlled conditions prevent runoff and exposure to
the environment. In the case of diseased trees, the spot treatment of trees must be at least 100 feet
from any pond, lake, stream, or river to prevent possible runoff of the product into the waterway.
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The label must state "Do Not Apply by Aerial Spray."
Golf/Turf: For commercial application to golf courses, treatment is be limited to the "Greens
and Tees" at a rate of 0.8 Ibs A.I./acre (200 ppm) not to exceed treatment of 10 acres (2000
gallons) with retreatment at 10 day intervals not to exceed 6 treatments per year.
For residential application to turf/lawns, application is limited to Spot Treatment of diseased
areas of the lawn/turf only at a maximum rate of 5.4 Ibs A.I/acre not to exceed 25 gallons per
1000 sq. ft. Treatment must be repeated up to 6 times a year at 10 day intervals.
Mosquitocide: The product labels supporting this use must state:
This product is not intended to be used for broadcast mosquitocide application but rather is
limited to small residential ponds, decorative ponds, and similar areas. The product labels must
be revised to reflect the following:
This product is not to be used in open waterways connected to larger watersheds or in waters that
serve as natural habitats for aquatic and amphibious organisms. This product controls
mosquitoes where they breed (fountains, water displays, decorative pools, decorative ponds,
sewage treatment systems, spas, hot tubs, swimming pools and standing water in old tires, empty
tin cans, barrels, puddles, and water drains around buildings). Do not exceed 10 applications at
a minimum of 10-day intervals per year. NOTE: Only out-of-season, not-in-service, or inactive
spas, hot tubs, swimming pools require treatment for mosquito control. Do not treat during the
swimming season. Spray from fountains treated with this product will not harm poolside
plantings. DO NOT use when fish or other wildlife (for example, amphibians) are present.
Once-Through Cooling Water Tower: All labels must state "Do Not Apply This Product more
than 4 times per year." Also, all labels supporting this use must carry the NPDES statement per
PR Notice 93-10 and 95-5 as well as directions for Bentonite Clay Treatment, a method to treat
the water before it is release.
Antisapstain Wood Treatment: All product labels supporting this use must add the following
text:
Treated lumber must be stored under cover, or indoors, or at least 100 feet from any
pond, lake, stream, wetland, or river to prevent possible runoff of the product into the water way.
Treated lumber stored outdoors within 100 feet of a pond, lake, stream, wetland, or river must be
either covered with plastic or surrounded by berm to prevent surface water runoff into the nearby
waterway. If a berm is used around the site, it must consist of impermeable material (clay,
asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events.
3. 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 ADB AC. For the specific labeling
statements and a list of outstanding data, refer to Section V of this RED document.
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4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
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 active ingredient
uses of ADBAC with the exception of the ornamental nurseries, golf/turf/lawns, once-through
cooling tower, and antisapstain wood preservation uses, fall into this category. Using Tier I
screening modeling to assess potential exposure from the ornamental nurseries, golf/turf/lawns,
once-through cooling tower, and antisapstain wood preservation uses of ADBAC risks to Listed
Species are indicated. Since the model is only intended as a screening-level model, and, as such,
has inherent uncertainties and limitations which may result in inaccurate exposure estimations,
further refinement of the model is recommended before any regulatory action is taken regarding
the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and antisapstain uses of
ADBAC. Additionally, impacts from the antisapstain use could potentially be mitigated with
precautions to prevent leaching and runoff when wood is stored outdoors and impacts from the
cooling tower use could potentially be mitigated by the reduction of risk mitigation. Due to
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these circumstances, the Agency defers making a determination for the ornamental nurseries,
golf/turf/lawns, once-through cooling tower, and antisapstain uses of ADBAC until additional
data and modeling refinements are available. At that time, the environmental exposure
assessment of the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and
antisapstain use of ADBAC will be revised, and the risks to Listed Species will be reconsidered.
b. General Risk Mitigation
ADBAC end-use products (EPs) may also contain other registered pesticides. Although
the Agency is not proposing any mitigation measures for products containing ADBAC 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.
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V. What Registrants Need to Do
The Agency has determined that ADBAC is eligible for reregi strati on provided that: (i)
additional data that the Agency intends to require confirm this decision; (ii) the risk mitigation
measure outlined in this document is adopted; and (iii) label amendments are made to reflect this
measure. To implement the risk mitigation measure, the registrants must amend their product
labeling to incorporate the label statement set forth in the Label Changes Summary Table in
Section B below (Table 13). The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For ADBAC 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 Jacqueline Campbell-McFarlane at (703) 308-6416 with questions
regarding generic reregi strati on.
By US mail:
Document Processing Desk (DCI/AD)
Jacqueline Campbell-McFarlane
US EPA (751 OP)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (DCI/AD)
Jacqueline Campbell-McFarlane
Office of Pesticide Programs (751 OP)
Room S-4900, 1 Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
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For end-use products containing the active ingredient ADBAC, the registrant needs to submit the
following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. two copies of the confidential statement of formula (EPA Form 8570-4);
2. a completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. five copies of the draft label incorporating all label amendments outlined in Table 23
of this document;
4. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. the product-specific data responding to the PDCI.
Please contact Velma Noble at (703) 308-6233 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 (PDCI/AD) Document Processing Desk (PDCI/AD)
Velma Noble Velma Noble
US EPA (751 OP) Office of Pesticide Programs (751 OP)
1200 Pennsylvania Ave., NW Room S-4900, 1 Potomac Yard
Washington, DC 20460 2777 South Crystal Drive
Arlington, VA 22202
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of ADBAC has been reviewed and
determined to be substantially complete. However, the following additional data requirements
have been identified by the Agency as confirmatory and included in the generic DCI for this
RED.
The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure
data available from the Chemical Manufacturers Association (CMA) data base. Therefore, the
Agency is requiring confirmatory data to support the uses assessed with the CMA exposure data
within this risk assessment. The risk assessment also noted that many of the use parameters
(e.g., amount handled and duration of use) were based on professional judgments. Therefore,
descriptions of human activities associated with the uses assessed are required as confirmatory.
Table 11. Confirmatory Data Requirements for Reregistration
Guideline Study Name
Dermal Indoor Exposure
Inhalation Indoor Exposure
Dermal Outdoor Exposure
Inhalation Outdoor Exposure
Descriptions of Human Activity (All Uses)
Dietary -Residues in Food from Treating
Countertops with ADBAC (FDA Wipe Study
Methodology) (FDA, 2003a and 2003b)
Surface-Wipe Pressure-Treated Wood Study
Special Aquatic Leaching Study on Wood
90 Day Inhalation - Rat
Non-Target plant phytotoxicity (Seedling
Emergency using rice)
Vegetative Vigor using rice
Aquatic plant growth toxicity (Lemna gibba)
Chronic Aquatic Invertebrate Life Cycle -
Daphnia magna
Acute estuarine/marine organism (Eastern
Oyster embryo larvae)
Aquatic plant growth (4 Algal toxicity - 4
species: green algal Selenastrum
capncomut\im(Pseudokirshnerierlla
subcapitata), blue-green cyanobacteria
(Anabeanaflos-aquae), freshwater diatom
(Navicula pelliculosd), marine diatom
(Skeletonema costatum)
New OPPTS Guideline No.
875.1200,875.1600
875.1400,875.1600
875.1100,875.1600
875.1300,875.1600
875.2800
Non-Guideline
Non-Guideline
Non-Guideline
870.3465
850.4225
850.4250
850.4400
850.1300
850.1055
850.5400
Old Guideline No.
233,236
234, 236
231
232
133-1
Non-Guideline
Non-Guideline
Non-Guideline
82-4
123-1
123-1
123-2
72-4
72-3b
123-2
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Guideline Study Name
Special Aquatic Field Monitoring (Once-
Through Cooling Water Towers)
Avian reproduction study -bob white quail
Honeybee toxicity studies
New OPPTS Guideline No.
Non-Guideline
850.2300
850.3030
Old Guideline No.
Non-Guideline
171-4
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
13, Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product.
A product-specific data call-in, outlining specific data requirements, will be sent to
registrants at a later date. Products which include claims for residual sanitizing activity as well
as residual claims against certain non-public health organisms, including mold, will be required
to submit efficacy data to support these claims. If a product label includes a sanitizing claim;
such as sanitizing carpets or laundry, the appropriate efficacy data must be submitted to support
the claim.
The efficacy studies the Agency intends to call-in are listed in Table 12 below.
Table 12. Efficacy Data Requirements for Reregistration
Claim
Disinfectant
Use Pattern
Hard inanimate
surfaces
Guideline Study Name
AOAC Use Dilution Test (Hard
water and organic soil)
or
AOAC Germicidal Spray Test
or
AOAC Hard Surface Carrier Test
(Distilled water only)
New OPPTS
Guideline No.
810.2100
(c), (d), (e)
Old Guideline
No.
91-2 (b),
(c), (d)
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Claim
Toilet Bowl
Disinfection
Laundry
Additives
Disinfection
(pre-soak)
Laundry
Additives
Disinfection
(non-residual)
Tuberculocidal
Virucidal
Use Pattern
Toilet bowl and
urinal hard surfaces
Laundry
Laundry
Hard inanimate
surfaces
Hard inanimate
surfaces
Guideline Study Name
AOAC Use Dilution Test (Hard
water and organic soil)
or
AOAC Germicidal Spray Test
or
AOAC Hard Surface Carrier Test
(Distilled water only)
AOAC Hard Surface Carrier Test
(Distilled water only)
or
AOAC Use Dilution Test (Hard
water and organic soil)
Petrocci and Clarke laundry
additives (disinfectant level) or
actual in-use study
AOAC Tuberculocidal Activity
Test method (standard)
or
AOAC Tuberculocidal
disinfectants test method
(modified)
or
Quantitative Tuberculocidal
Activity test method
or
AOAC Germicidal Spray Test
(modified for spray products)
Virucidal Activity Method used
in conjunction with modification
of : AOAC Hard surface carrier
test (distilled water only)
or
AOAC Germicidal Spray Test
New OPPTS
Guideline No.
810.2600 (b)(l)
810.2300 (b)(2)
810.2300 (b)(3)
810.2100 (h)
810.2100 (g)
Old Guideline
No.
91-7 (a) (1)
91-4 (a)(l)
91-4 (a)(2)
91-2 (g)
91-2 (f)
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Claim
Fungicidal
Sanitizer
Food Contact
Sanitizer
Laundry
additive, non
residual
Laundry
additive, residual
self sanitizing
Laundry
Additives,
sanitizing pre-
soak
Residual Self
Sanitizing
Carpet Sanitizer
Toilet bowl and
urinal sanitizing
Presaturated and
impregnated
towelettes
Sanitizing Fabric
Treatment
Termiticide
Use Pattern
Hard inanimate
surfaces
Non-food contact
surfaces (non-
residual)
Final rinse of
previously cleaned
food contact surface
Laundry
Laundry
Laundry
Hard surfaces
(residual self-
sanitizing activity of
dried chemical
residues on hard
inanimate surfaces)
Carpet
Toilet bowl and
urinal hard surfaces
Hard Inanimate
Surfaces
Mattresses,
upholstered furniture,
pillows
Wood
Guideline Study Name
AOAC Fungicidal Test
or
AOAC Hard surface carrier test
(distilled water only)
or
AOAC Germicidal Spray Test
Sanitizer Test for Hard Inanimate
Non-Food Contact Surfaces
AOAC Germicidal and Detergent
Sanitizers Method
Petrocci and Clarke laundry
additives method (Sanitizing
level)
Petrocci and Clarke laundry
additives method or ATCC Test
method 100-1974
Sanitizer test for hard inanimate
non-food contact surfaces
modified to include organic soil
Controlled In-Use study or
simulated In-Use study
EPA Carpet Sanitizer Protocol
Sanitizer Test for Hard Inanimate
Non-Food Contact Surfaces
Simulated In-use Study
Simulated In-use Study
Preventive Treatment - wood
impregnation
New OPPTS
Guideline No.
810.2100 (f)
810.2100 (1)
810.2100 (m)(2)
810.2300 (b)(4)
810.2300 (b)(5)
810.2100
(b)(2)
810.2100 (o)
810.2300 (c)
810.2600 (b)(2)
810.2100 (i)
810.2300 (d)
N/A
Old Guideline
No.
91-2 (e)
91-2 (j)
91-2 (1)(2)
91-4 (a)(3)
91-4 (a)(4)
N/A
91-2 (m)
91-4 (b)
91-7 (a)(2)
N/A
91-4 (c)
95-12(b)(ii)
64
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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 13.
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this RED. However, existing
stocks time frames will be established case-by-case, depending on the number of products
involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy," Federal Register, Volume 56, No. 123, June 26, 1991.
a. Label Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk
mitigation measure outlined in Section IV. The following table describes how language on the
labels should be amended.
65
-------
Table 13. Labeling Changes Summary Table
Statements noted with an * are not directly related to risk mitigation but are reflective of Agency labeling requirements.
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Product
For all Manufacturing Use
Products *
"Only for formulation into antimicrobial products for use in: agricultural/farm premises,
structures, buildings, and equipment; dairy farm milk handling facilities, equipment, storage
rooms, houses, and sheds; food processing plants, food handling, food distribution equipment
and premises; eating establishments premises and equipment; commercial, institutional, and
industrial premises and equipment (floors, walls, storage areas); domestic dwellings, food
handling areas, bathroom premises (hard surfaces), indoor premises; and medical institutional
critical care and noncritical care premises and laundry.
For Formulation into antimicrobial products for use in golf/commercial turf/lawns,
greenhouses/nurseries, fountains/water displays/decorative ponds/standing water, sewage
treatment systems, spas, air conditioner/refrigeration condensate water systems, air washer and
industrial scrubbing systems, once- through and recirculating industrial/commercial cooling
water systems, pulp/paper mill water systems, and swimming pools. Gas/oil drilling
muds/packer fluids, mushroom houses/empty premises and equipment, wood preservation, egg
handling equipment and rooms, egg washing treatment, poultry processing plant
equipment/premises, meat processing plant/equipment, gas/oil recovery injection water
systems.
Directions for Use
PPE Requirements1
Corrosive. Causes irreversible eye damage and skin burns. May be fatal if swallowed or
inhaled. May be harmful if absorbed through the skin. Do not get in eyes, on skin, or on
clothing. Do not breathe vapor or spray mist. Wear a dust/mist filtering respirator
(MSHA/NIOSH approval number TC-21C) or a NIOSH approved respirator with any N, R, P,
or HE filter. Wear goggles or faceshield, rubber gloves, and protective clothing when handling.
Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash
before reuse.
Precautionary
Statements
66
-------
Description
Pulp and Paper Applications *
Ecological Effects Language
Required by the RED and PR
Notice 93-10 and 95-1
Physical and Chemical Hazards*
Amended Labeling Language
Product labels listing uses for treatment of pulp/paper process components (eg., paper machine
white water; catalase control in deinking loops; starch and sizing; coatings; fillers; pigments;
adhesives; etc.), and which contain active ingredients not cleared by FDA for food contact,
must state "For non-food use only". Those cleared for food contact, may state "For food and
non-food contact".
"This product is toxic to fish, aquatic invertebrates, oysters, and shrimp. 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. "
Do not use or store near heat or open flame. Do not mix with oxidizers, soap, or other anionic
materials
Placement on Label
Directions for Use
Environmental Hazard
Statements
Physical and Chemical
Hazards
End-Use Products for Commercial, Industrial, Institutional Uses
PPE Requirements1
Fogging in Hatcheries
Fogging in Food Processing
Plants
Swimming Pools*
Wood Preservation
The Precautionary Statements/PPE are dependent on the Acute Toxicity Data submitted to
support the end use product registration(s). Refer to Label Manual, 3rd Edition Chapter 7 for
labeling.
2 hour Reentry Interval for fogging applications
2 hour Reentry Interval for fogging applications and a minimum of 4 air exchanges (ACH) per
hour in the facility
Do not apply when swimmers are in the immediate vicinity (the Agency recommends a 15
minute reentry interval)
Label must include dilution rate and retention chart specific to the type of wood used for
pressure and dip treatment
If registrant has not supported Honey Bee Data, the following statement must be included on
the Agency label as well as the end tag on the treated lumber: Wood treated with ADB AC
shall not be used in the construction of bee hives.
Precautionary
Statements
Directions for Use
Directions for Use
Directions for Use
67
-------
Description
Agricultural fogging (loading)
Pulp and Paper
Small Process Water Systems
Hand Sanitizer
Udders, Teats and Flanks
Treatment of Hatching Eggs
Sanitizing Incubators and
Hatchers*
Sanitizing Hatchery Rooms*
Treatment of Eggs in Egg
Processing Facilities*
Agricultural Premises and
Equipment/Animal housing
facilities*
Amended Labeling Language
Labels must indicate that a dust mist respirator must be worn when applying the product to the
fogging equipment.
Maximum use rate is 14 Ib ai/ton of paper.
Product labels involving treatment of pulp and paper processes (eg., treatment of paper
machine white water; catalase control in deinking loops; starch and sizing; coatings; fillers;
pigments; adhesives; etc.), which result in finished products which may have direct or indirect
food contact, must have FDA clearance for the entire formula via a food additive petition, and
must state whether each use is cleared for "food contact" uses, and/or involves "non-food
contact" uses. Products without FDA clearance must state: Do not use to treat paper or
paperboard which will contact food.
Labels must indicate that a dust mist respirator must be worn when applying the product to the
water system.
Delete the Use
Delete the Uses
Delete the Use
Label must include the following text: Only for treatment of setters and hatchers after
poultry/chicks/eggs have been removed. Not for treatment of hatchers which contain
chicks/eggs.
Label must include the following text: Remove all animals and feed from
premise, vehicles and enclosures.
Label must include the following text: Eggs sanitized with this product must be subjected to
a potable water rinse if they are to be broken immediately for use in the manufacture of egg
products. Eggs must be reasonably dry before casing or breaking. The solution must not be
re-used for sanitizing eggs.
All animal viruses claimed on the label must immediately precede directions for agricultural
premises and equipment/animal housing facilities.
Placement on Label
Directions for Use
Directions for Use
Directions for Use
Delete all claims and
Directions for Use
Delete all claims and
Directions for Use
Delete all claims and
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
68
-------
Description
Treatment of Mushroom Farms*
Institutional/ Medical premise
and equipment*
Hard nonporous surfaces in
Institutional/Commercial Food
Handling Facilities*
Institutional/Commercial
Laundry Treatment*
Disinfection/Sanitizing
Drains/Disposals*
Addition of ATCC number*
Environmental Hazards -for
Labels for AntiSapstain
Amended Labeling Language
Label must include the following text: DO NOT APPLY TO THE
MUSHROOM CROP, COMPOST OR CASING. Rinse treated surfaces
with potable water before they contact the crop, compost or casing.
If the label indicates use in institutions, medical facilities/premises on medical equipment such
as wheelchairs, hospital bed frames, or unqualified metal, plastic, and stainless steel surfaces,
the following statement, "This product is not for use on medical devices and equipment " to the
must be added or the following MOU language from PR Notice 94-4:
This product is not to be used as a terminal sterilant/high level disinfectant on any surface or
instrument that (1) is introduced directly into the human body, either into or in contact with the
bloodstream or normally sterile areas of the body, or (2) contact intact mucous membranes but
which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas
of the body. This product may be used to pre-clean or decontaminate critical or semi-critical
medical devices prior to sterilization or high level disinfection.
After disinfection, a potable water rinse is required. Do not use to disinfect appliances,
refrigerator interiors, and microwave oven interiors. Do not use on dishes, glasses, and
utensils.
Dilute oz per gallons of water per 100 Ibs of fabric (dry weight). When washing
the clothes, a maximum of 60 gallons of water per 100 Ibs. of fabric (dry weight) must be in the
machine. Add use solution to the wash wheel at the beginning of the final rinse cycle.
Delete the claim because the Agency believes it is not feasible to disinfect throughout a drain
w/ or w/o a disposal system.
All organisms tested to support bactericidal, virucidal, and fungicidal claims must list the
ATCC number to identify the specific strain of organism
Treated lumber must be stored under cover, or indoors, or at least 100 from any pond, lake,
stream, wetland, or river to prevent possible runoff of the product into the water way. Treated
lumber stored outdoors within 100 feet of a pond, lake, stream, wetland, or river must be either
covered with plastic or surrounded by berm to prevent surface water runoff into the nearby
waterway. If a berm is used around the site, it must consist of impermeable material (clay,
asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events.
Placement on Label
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Environmental Hazards
69
-------
Description
Amended Labeling Language
Placement on Label
Environmental Hazards for
Once Through Cooling Water
Towers
DO NOT APPLY THIS PRODUCT MORE THAN 4 TIMES PER YEAR
DEACTIVATION: This product must be deactivated prior to discharge of the NPDES outfall.
TO DEACTIVATE: Use Bentonite Clay at a minimum ratio 5 ppm clay to 1 ppm product.
Deactivation must occur prior to discharge of the NPDES outfall.
Directions for Use
Ornamental Uses
Application is limited to Spot Treatment of diseased ornamental plants and flowers at a
maximum rate of 800 ppm and total use of 5 Ibs A.I/ acre.
Treatment is restricted to indoor uses or uses in which controlled conditions to prevent runoff
and exposure to the environment. In the case of diseased trees, the spot treatment of trees must
be at least 100 feet from any pond, lake, stream, or river to prevent possible runoff of the
product into the waterway.
Do Not Apply by Aerial Spray.
Directions for Use
Golf/Commercial Turf/Lawn
For commercial application to golf courses, the treatment is limited to the "Greens and Tees"
at a rate of 0.8 Ibs A.I./acre (200 ppm) not to exceed treatment of 10 acres (2000 gallons) with
retreatment at 10 day intervals not to exceed 6 treatments per year.
Directions for Use
Mosquitocide
The product labels must state: This product is not intended to be used for broadcast
mosquitocide application but rather is limited to small residential ponds, decorative ponds, and
similar areas.
This product is not to be used in open waterways connected to larger watersheds or in waters
that serve as natural habitats for aquatic and amphibious organisms. This product controls
mosquitoes where they breed (fountains, water displays, decorative pools, decorative ponds,
sewage treatment systems, spas, hot tubs, swimming pools and standing water in old tires,
empty tin cans, barrels, puddles, and water drains around buildings). Do not exceed 10
applications at a minimum of 10-day intervals per year. NOTE: Only out-of-season, not-in-
service, or inactive spas, hot tubs, swimming pools require treatment for mosquito control. Do
not treat during the swimming season. Spray from fountains treated with this product will not
harm poolside plantings. DO NOT use when fish or other wildlife (for example, amphibians)
are present.
Directions for Use
70
-------
Description
Mold Remediation/Prevention
(Water/Smoke restoration/
Sewer backup/river flood
cleanup/clean water source)
Amended Labeling Language
For Professional Use Only: For use by Mold Remediation Workers, Mold Remediation
Contractors, Certified Mold Remediators, Certified Mold Contractors, Certified Mold
Remediation Contractors, Applied Microbial Remediation Technicians, Certified Mold
Professional, Certified Restorers, and Mold Remediation Companies
Refer to http.//www.epa.gov/mold/mold_remediation Table 1 and 2 for Remediation Directions
for Use
Placement on Label
Directions for Use
End Use Products Intended for Residential Use
PPE Requirements1
Hard nonporous food contact
surfaces *
Disinfection/Sanitizing
Drains/Disposals*
Addition of ATCC number*
Application Restrictions-For
Products Used in Swimming
Pools/Spas*
Humidifiers
Residential Turf/Lawn
The Precautionary Statements/PPE are dependent on the Acute Toxicity Data submitted to
support the end use product registration(s). Refer to Label Manual, 3rd Edition Chapter 7 for
labeling.
Do not use to disinfect appliances, refrigerator interiors, and microwave oven interiors. Do not
use as a disinfectant on dishes, glasses, or utensils.
Delete the claim because the Agency believes it is not feasible to disinfect throughout a drain
w/ or w/o a disposal system.
All organisms tested to support bactericidal, virucidal, and fungicidal claims must list the
ATCC number to identify the specific strain of organism
Do not apply when swimmers are in the immediate vicinity (the Agency recommends a 15
minute reentry interval)
Delete the Use
For residential lawns/turf, application is limited to Spot Treatment of diseased areas of the
lawn/turf at a maximum use rate of 5.4 Ibs A.I/acre (800 ppm) not to exceed 25 gallons per
1000 sq. ft. Treatment must be repeated up to 6 times a year at 10 day intervals.
Precautionary
Statements:
Directions for Use
Directions for Use
Directions for Use
Directions for Use
under General
Precautions and
Restrictions
Directions for Use
71
-------
Description
Amended Labeling Language
Placement on Label
Residential Mosquitocide
The product labels must state: This product is not intended to be used for broadcast
mosquitocide application but rather is limited to small residential ponds, decorative ponds, and
similar areas. The product labels must be revised to reflect the following:
This product is not to be used in open waterways connected to larger watersheds or in waters
that serve as natural habitats for aquatic and amphibious organisms. This product controls
mosquitoes where they breed (fountains, water displays, decorative pools, decorative ponds,
sewage treatment systems, spas, hot tubs, swimming pools and standing water in old tires,
empty tin cans, barrels, puddles, and water drains around buildings). Do not exceed 10
applications at a minimum of 10-day intervals per year. NOTE: Only out-of-season, not-in-
service, or inactive spas, hot tubs, swimming pools require treatment for mosquito control. Do
not treat during the swimming season. Spray from fountains treated with this product will not
harm poolside plantings. DO NOT use when fish or other wildlife (for example, amphibians)
are present.
Directions for Use
Mold Remediation/Prevention
(Water/Smoke restoration/
Sewer backup/river flood
cleanup/clean water source)
For Professional Use Only: For use by Mold Remediation Workers, Mold Remediation
Contractors, Certified Mold Remediators, Certified Mold Contractors, Certified Mold
Remediation Contractors, Applied Microbial Remediation Technicians, Certified Mold
Professional, Certified Restorers, and Mold Remediation Companies.
Refer to http.//www.epa.gov/mold/mold_remediation Table 1 and 2 for Remediation Directions
for Use
Directions for Use
PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be
placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
72
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VI. APPENDICES
73
-------
APPENDIX A: Master ADBAC Label
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment Site/Surfaces
Method of
Application
Mitigation
Maximum
Application
Rate
Industrial processes and water systems
10324-21
10324-102
6836-58
10324-21
6836-234
1839-179
Small Process Water
Systems
Small Process Water
Systems
Industrial Recirc Water
Systems
Industrial Water Systems
Small Process Water
Systems
Oil Field
Re-circulating Cooling Tower
Waste water treatment
Evaporative condenser
Pulp/Paper
Once-through Cooling
Brewery pasteurizers
injection and wastewater
packer fluids
drilling muds
Pour
Metered
Pour
Metered
Metered
Metered
Pour
Metered
continuous
injection
batch
treatment
Wear dust mist
respirator when
applying product to
system
Wear dust mist
respirator when
applying product to
system
Max appl. rate must
be reduced to 14 Ibs
ai/ton of paper
Do Not Apply This
Product More Than
4 Times Per Year
Label must carry
NPDES statement
Wear dust mist
respirator when
applying product to
system
795,000 ppm
Initial = 39.8 ppm
Maint.= 14.9 ppm
795,000 ppm
Initial = 39.8 ppm
Maint.= 14.9 ppm
226 ppm
Initial =10.6 ppm
Maint.= 5.6 ppm
Based on treatment
of 153,000,000
gallons of water
795,000 ppm
Initial = 39.8 ppm
Maint.= 14.9 ppm
11 9,000 ppm
Swimming Pools
1839-141
Swimming Pool/ Outside
Spas/Whirlpools/Hot Tub Bath
Pour
Do not apply when
swimmers are in the
immediate vicinity
(Allow 1 5 minute
REI)
Initial/Winter. = 6.2
ppm
Maint. = 1.2 ppm
Aquatic Areas
53642-1
499-368
499-482
Greenhouse/Nurseries
Greenhouse/Nurseries
fountains, water displays,
decorative pools, decorative
ponds, sewage treatment
systems, spas, standing water
decorative pools, fountains,
water displays
watering lines, watering tubes,
emitters, drip lines, watering
nozzles and hoses
spray
pour
pour,
immerse
Refer to Table 13.
Labeling Changes
Summary Table
p. 71 and 73
203 ppm for
Mosquito Control
Initial= 6.2 ppm
Maint. = 1.2 ppm
6.2 ppm
Wood Preservatives
6836-308
1839-184
lumber
lumber
Pressure
Treatment
Double
vacuum
Dip/Brush/S
pray surface
treatment
Refer to Table 13.
Labeling Changes
Summary Table
p. 68
Refer to Table 13.
Labeling Changes
Summary Table
p. 68
3% AI solution
3% AI solution
74
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1839-184
Use Site
Treatment Site/Surfaces
lumber
Method of
Application
dip, spray
Mitigation
Refer to Table 13.
Labeling Changes
Summary Table
p.70
Maximum
Application
Rate
3% AI solution for
sapstsain control
Agricultural Premise and Equipment
10324-118
1839-81
10324-81
67517-15
1839-155
10324-80
Animal facilities,
hog/swine/poultry farms
hatcheries
hatcheries
hatcheries
Animal facilities, farms,
mushroom farms, animal
life science laboratories,
animal quarters, other
animal care facilities,
hatcheries, stables,
catteries, stalls, animal
transportation vehicles
Dairy/equine/hog/ swine/
poultry /turkey farms,
barns, pens, egg receiving
area, egg holding area,
setter s, trays, chick
holding room, poultry
buildings, dressing plants,
offal rooms, blocks, creep
areas
citrus grove or farm
Floors, walls, ceilings, feed
racks, mangers, troughs,
automatic
feeders/fountains/waterers,
other feeding and watering
appliances, halters, ropes and
other types of equipment used
in handling and restraining
animals, as well as forks,
shovels, and scrapers used for
removing litter and manure,
feeders, fountains, drinkers,
blocks, chutes, incubators,
hatchers, waterers, feeders,
fountains, hauling equipment,
loading equipment, kennels,
runs, cages, coops, crates,
pens, trays
hatchery rooms
incubators, setters, hatchers
egg shell sanitizing
Floors, walls, ceilings, feed
racks, mangers, troughs,
automatic
feeders/fountains/waterers,
other feeding and watering
appliances, halters, ropes and
other types of equipment used
in handling and restraining
animals, as well as forks,
shovels, and scrapers used for
removing litter and manure,
feeders, fountains, drinkers,
blocks, chutes, incubators,
hatchers, waterers, feeders,
fountains, hauling equipment,
loading equipment, kennels,
runs, cages, coops, crates,
pens, trays, shoes, gloves
trucks, vehicles, equipment,
trailers, field harvesting
equipment, cargo area, wheels,
tires, under carriage, hood,
roof, fenders
Fogging
Fogging
Fogging
spray,
immersion,
mop,
immersion,
cloth,
sponge,
spray
trigger spray,
immersion,
mopping
Wear a dust mist
respirator when
pouring product into
fogging equipment
Wear a dust mist
respirator when
pouring product into
fogging equipment
2 hr reentry interval
Wear a dust mist
respirator when
pouring product into
fogging equipment
0000675 Ib ai/ 1000
ft3
.0000675 Ib ai/
1000 ft3
200 ppm
2036 ppm
2036 ppm
Treat Citrus canker
75
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1072-16
507-3
507-3
53642-1
53642-1
499-368
499-368
Use Site
stables, dairies
greenhouses, nurseries
greenhouses, nurseries
greenhouses, nurseries
greenhouses, nurseries
greenhouses, nurseries
greenhouses, nurseries
Treatment Site/Surfaces
Dairy and Hoof trimming
equipment
ornamental crops
gloves
work areas, benches, pots,
flats, flower buckets, cutting
tools, greenhouse glass, bird
baths, walkways, houseplants
lawns, golf courses,
commercial turf
cutting tools
evaporative coolers, cooler
pads
Method of
Application
cloth, mop,
sponge,
spray,
immersion
drench or
spray
immersion
Spray,
mopping,
Swab,
immersion
Spray
Immersion/
Spray/Wipe
Spray or
swab
Mitigation
Do Not Apply by
Aerial Spray.
Refer to Table 13.
Labeling Changes
Summary Table
p. 71
Commercial =Limit
Treatment to
"Greens and Tees"
Retreatment at 10
day intervals not to
exceed 6 treatments
per year
Residential = Only
Spot Treatment of
diseased areas.
Treatment repeated
up to 6x a year at 10
day intervals.
Maximum
Application
Rate
2036 ppm
Spot Treatment
max. rate of 800
ppm
Total Use =
5 Ibs All acre
2036 ppm
2036 ppm
Commercial = 200
ppm not to exceed
treatment of 10
acres
Residential = 800
ppm not to exceed
25 gallons per 1000
sq.ft.
2036 ppm
2036 ppm
Medical premises and equipment
10324-111
day-care centers, hospitals,
medical/dental offices,
nursing homes, other health
care institutions,
mortuaries, autopsy rooms,
EMS facilities, medical
research facilities, patient
care rooms, recovery
anesthesia rooms, operating
rooms
Metal, stainless steel, glazed
porcelain, glazed ceramic tile,
plastic, granite, marble,
chrome, vinyl, glass, enameled
surfaces, painted woodwork,
Formica, plastic upholstery,
floors, walls, toilets, urinals,
lavatories, bathtubs, sinks,
sink tops, shower stalls,
shower doors/curtains, mirrors,
ultrasonic bath, whirlpools,
countertops, cabinets, tables,
chairs, desks, bed springs, bed
frames, traction devices, MRI,
CAT, examining tables, scales,
paddles, wheelchairs, lifts,
door knobs, linen carts,
hampers, telephones, fixtures,
toys, high chairs, cribs,
changing tables
mop, pour,
immersion
2080 ppm
76
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1203-41
1839-81
1839-110
1839-81
62401-6
7211-10
Use Site
hospitals, nursing homes,
clinics
Hospitals
hospital
autopsy rooms, funeral
homes,
nursing homes
Medical Premises &
Equipment
Treatment Site/Surfaces
tables, walls, ceramic tiles,
metal surfaces, plastic, asphalt,
finished/painted wood and
glass
carpet
Laundry
human remains
walls, telephones, chairs,
tables, sinks, counters,
appliance exteriors, garbage
cans, stovetops
critical instruments
Method of
Application
spray, mop,
sponge
Portable
extraction
units, truck
mounted
extraction
machines,
rotary floor
machines,
metered,
spray
Pour @ final
rinse in wash
cycle
sponge, wash
cloth, soft
brush
Presaturated
wipe
immersion
Mitigation
Instruments must be
sterilized after
disinfection
Maximum
Application
Rate
2080 ppm
16,800 ppm
O.lOlb AI/ lOOlbs
dry laundry
2080 ppm
2080 ppm
2490 ppm
Commercial, institutional, and industrial premises and equipment
10324-118
hair/nail salons, barber
beauty shops, tanning
salons, tattoo parlors,
veterinary clinics, locker
facilities, shopping malls,
motels, hotels, bookstores,
dressing rooms, photo copy
centers, bicycle shops, toy
factories, computer
manufacturing sites, burial
vaults, mausoleums, jails,
penitentiaries,
transportation terminals,
Cruise ships, airplanes,
schools, universities,
churches, libraries,
cosmetic manufacturing
facilities, medical device
manufacturing facilities,
pharmaceutical
manufacturing facilities,
bowling alleys, crime
scenes, pet shops,
grooming and breeding
establishments, zoos, tack
shops, atheletic facilities,
Sport Arenas,
floors, walls, toilets, urinals,
bathrooms, bathtubs, sinks,
countertops, shower
doors/curtains, toilet seats,
shower stalls, ultrasonic bath,
whirlpools, barber/salon
instruments/tools, tables,
chairs, shelves, telephones,
cabinets, desks, tanning beds,
bed springs, door knobs, linen
carts, hampers, garbage pails,
telephones, recycling
equipment, exercise
equipment, personal safety
equipment, automobile/truck
interiors, garbage cans/pails,
metal, stainless steel, glazed
porcelain, glazed ceramic tile,
plastic, granite, marble,
chrome, vinyl, glass, chrome
plated intakes, enameled
surfaces, painted woodwork,
Formica, vinyl and plastic
upholstery, terrariums, cages,
and cage furniture
mop, wipe
(cloth,
swab), pour,
immersion
2080 ppm
77
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1839-81
6836-193
1839-81
62401-6
1839-110
1839-81
Use Site
manufacturing
sites/facilities
hair/nail salons, barber
beauty shops, tanning
salons, tattoo parlors,
veterinary clinics, locker
facilities, shopping malls,
motels, hotels, bookstores,
dressing rooms, photo copy
centers, bicycle shopes, toy
factories, computer
manufacturing sites, burial
vaults, mausoleums, jails,
penitentiaries,
transportation terminals,
Cruise ships, airplanes,
schools, universities,
churches, libraries,
cosmetic manufacturing
facilities, medical device
manufacturing facilities,
pharmaceutical
manufacturing facilities,
bowling alleys, crime
scenes, pet shops,
grooming and breeding
establishments, zoos, tack
shops, atheletic facilities,
Sport Arenas,
hotels, motels, dressing
romms, bowling alleys,
salons, libraries, office
buildings, schools,
universities
schools, food service
establishments
commercial
Florists/flower shops,
greenhouses, shippers,
packing areas
Treatment Site/Surfaces
Floors, walls, counters,
stainless steel, glazed
porcelain, granite, vinyl, glass,
chrome
hair/nail salons, barber beauty
shops, tanning salons, tattoo
parlors, veterinary clinics,
locker facilities, shopping
malls, motels, hotels,
bookstores, dressing rooms,
photo copy centers, bicycle
shopes, toy factories, computer
manufacturing sites, burial
vaults, mausoleums, jails,
penitentiaries, transportation
terminals, Cruise ships,
airplanes, schools, universities,
churches, libraries, cosmetic
manufacturing facilities,
medical device manufacturing
facilities, pharmaceutical
manufacturing facilities,
bowling alleys, crime scenes,
pet shops, grooming and
breeding establishments, zoos,
tack shops, atheletic facilities,
Sport Arenas,
Carpet
telephones, walls, chairs,
tables, sinks, counters,
appliance exteriors, garbage
cans, stovetops
laundry
flower buckets, coolers, floors
and walls of coolers, design
and packing benches, garbage
pails
Method of
Application
fogging
spray (RTU
spray
portable
extraction
•j tmrk
mounted
extraction
machines
rotary floor
machines,
metered,
spray
Presaturated
wipe
Pour (G) final
rinse in wash
cycle
Mop/wipe,
cloth, brush,
sponge,
sprayer,
RTU spray
Mitigation
Wear a dust mist
respirator when
pouring product into
fogging equipment
Maximum
Application
Rate
0000246 Ib ai/ 1000
ft3
2980 ppm
16,800 ppm
2080 ppm
0.10 Ib AI/ 100 Ibs
dry laundry
2036 ppm
78
-------
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment Site/Surfaces
Method of
Application
Mitigation
Maximum
Application
Rate
1839-85
hair/nail salons, barber
beauty shops, tanning
salons, tattoo parlors,
veterinary clinics, locker
facilities, shopping malls,
motels, hotels, bookstores,
dressing rooms, photo copy
centers, bicycle shopes, toy
factories, computer
manufacturing sites, burial
vaults, mausoleums, jails,
penitentiaries,
transportation terminals,
Cruise ships, airplanes,
schools, universities,
churches, libraries,
cosmetic manufacturing
facilities, medical device
manufacturing facilities,
pharmaceutical
manufacturing facilities,
bowling alleys, crime
scenes, pet shops,
grooming and breeding
establishments, zoos, tack
shops, atheletic facilities,
Sport Arenas,
air deodorizer/air freshener
RTU spray
0.2%ai by weight
32977-1
schools and music studios
wind instruments
Immersion
596 ppm
507-3
industrial premises
gloves
Immersion
2036 ppm
Residential and public access premises
10324-111
RVs, motor homes
RV Holding Tank
Pouring
0.834 Ib ai/gal
6836-193
Households, campgrounds,
playgrounds, picnic
facilities, recreational
facilities, other public
facilities
Floors, walls, windows, toilets,
bathtubs, whirlpools, shower
stalls, shower door/curtain,
sinks, mirrors, restroom
fixtures, cabinets, tables,
chairs, desks, bed frames,
doorknobs, garbage cans/pails,
picnic tables, outdoor
furniture, telephones,
countertops, external surfaces
of appliances, tables, sinks,
shelves, plastic chopping
blocks, metal, stainless steel,
glazed porcelain, glazed
ceramic tile, plastic, granite,
marble, chrome, vinyl, glass,
chrome plated intakes,
enameled surfaces, painted
woodwork, Formica, vinyl,
plastic upholstery, terrariums,
cages, and cage furniture
RTU
spray/mop
2980 ppm
79
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1839-68
1839-85
32977-1
1839-110
1839-155
Use Site
homes
homes
Homes
Homes
homes
Treatment Site/Surfaces
Carpet
air deodorizer/air freshener
Musical instrument
mouthpieces and reeds
Laundry
water softeners and reverse
osmosis units
Method of
Application
portable
extraction
units, truck
mounted
extraction
machines,
rotary floor
machines,
metered,
spray
RTU spray
immersion
Pour @ final
rinse in wash
cycle
Liquid Pour
Mitigation
Maximum
Application
Rate
16,680 ppm
0.2% a.i. by weight
596 ppm
0.10 Ib AI/ 100 Ibs
dry laundry
200 ppm
Food handling/storage establishments premises and equipment
10324-111
507-3
restaurants, bars,
supermarket, convenience
stores, pizza parlors, meat
and poultry processing
plants, rendering plants,
fish, milk, wine, citrus
processing facilities,
institutional kitchens, food
storage areas, tobacco
processing facilities, ood
service establishments,
food processing
plants/facilities, beverage
processing plants,
Cafeterias, Dairies, Egg
Processing plants,
Federally inspected meat
and poultry plants, Food
Handling areas, Food
preparation areas, Food
storage areas, USDA
inspected food processing
facilities, breweries, fast
food operations
dairies and food processing
plants
floors, walls, countertops,
appliances (microwaves,
refrigerators, stove tops,
freezers, coolers), chairs,
tables, shelves, picnic tables,
outdoor furniture, racks, carts,
telephones, door knobs,
storage areas, potato storage
areas, food storage areas,
garbage storage areas, cutting
boards, tanks, exhaust fans,
refrigerator bins, refrigerated
storage/display equipment,
coils and drain pans of air
conditioning/refrigeration
equipment, heat pumps,
storage tanks, coolers, ice
chests, garbage cans/pails
metal, stainless steel, glazed
porcelain, glazed ceramic tile,
plastic, granite, marble,
chrome, vinyl, glass, chrome
plated intakes, enameled
surfaces, painted woodwork,
Formica, vinyl and plastic
upholstery
gloves
mop, wipe
swab), pour,
immersion
mop, (cloth,
swab), pour,
immersion
Immersion
Disinfect
2080 ppm
40 CFR 180.940
(a)
200 ppm
Public Eating
Places, Dairy
Processing
Equipment, Food-
Processing
Equipment and
Utensils
40 CFR 180.940
(c)
400 ppm
Food Processing
Equipment and
Utensils
2036 ppm
80
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1839-86
6836-193
(Disinfect)
1839-155
1839-155
Use Site
federally inspected meat
and poultry plants, food
processing facilities,
dairies, tobacco processing
facilities, beverage
processing facilities
restaurants, bars,
supermarket, convenience
stores, pizza parlors, meat
and poultry processing
plants, rendering plants,
fish, milk, wine, citrus
processing facilities,
institutional kitchens, food
storage areas, tobacco
processing facilities, ood
service establishments,
food processing
plants/facilities, beverage
processing plants,
Cafeterias, Dairies, Egg
Processing plants,
Federally inspected meat
and poultry plants, Food
Handling areas, Food
preparation areas, Food
storage areas, USDA
inspected food processing
facilities, breweries, fast
food operations
Restaurants, Food Service
Establishments, Bars,
Cafeteria, Convenience
Stores, Dairies, Food
Handling Areas, Food
Preparation Areas, Food
Storage Areas Institutional
Kitchens, Fast Food
Operations
Food processing plants,
food service establishments
Treatment Site/Surfaces
Shoe
floors, walls, countertops,
appliances (microwaves,
refrigerators, stove tops,
freezers, coolers), chairs,
tables, shelves, picnic tables,
outdoor furniture, racks, carts,
telephones, door knobs,
storage areas, potato storage
areas, food storage areas,
garbage storage areas, cutting
boards, tanks, exhaust fans,
refrigerator bins, refrigerated
storage/display equipment,
coils and drain pans of air
conditioning/refrigeration
equipment, heat pumps,
storage tanks, coolers, ice
chests, garbage cans/pails
metal, stainless steel, glazed
porcelain, glazed ceramic tile,
plastic, granite, marble,
chrome, vinyl, glass, chrome
plated intakes, enameled
surfaces, painted woodwork,
Formica, vinyl and plastic
upholstery
dairy equipment, dairy farm
bulk milk tanks, milking
equipment, tanks, piping,
pasteurizers, cow udders, dairy
product dispensing equipment,
drinking glasses, eating
utensils, cooking utensils,
silverware, glassware, dishes,
ice machines, beverage
dispensing equipment,
counters, tables, cutting
boards, Slurrpy machines, ice
cream dispensing equipment,
food dispensing equipment,
utensils and other food contact
articles
water softeners and reverse
osmosis units
Method of
Application
.
foam
generating
machine/
aerator
RTU Spray
spray, flood,
immersion,
brushing,
RTU spray
Mitigation
Maximum
Application
Rate
2036 ppm
2036 ppm
40 CFR 180.940
(a)
200 ppm
Public Eating
Places, Dairy
Processing
Equipment, Food-
Processing
Equipment and
Utensils
40 CFR 180.940
(c)
400 ppm
Food Processing
Equipment and
Utensils
200 ppm
81
-------
EPA Reg
Number
used for
Max. Appl.
Rate
10324-118
1203-41
Use Site
dairies, beverage and food
processing plants
food processing plants,
food service areas,
institutional kitchens,
industrial/hospital
cafeterias, school
lunchrooms, canning
plants, dairies, and packing
plants
Treatment Site/Surfaces
room surfaces
tables, walls, ceramic tiles,
metal surfaces, plastic, asphalt,
finished/painted wood and
glass
Method of
Application
fogging
Spray, mop,
sponge
Mitigation
Wear a dust mist
respirator when
pouring product into
fogging equipment
2 hr reentry interval
Minimum of 4 air
exchanges per hour
Maximum
Application
Rate
.0000027 Ib ail
1000 ft3
2080 ppm
Cleaning/ Deodorizing
1839-81
10324-118
10324-118
Water/Smoke restoration
(institutional, industrial,
hospital, nursing home)
Sewer backup/river flood
cleanup/clean water source
residential, commercial,
institutional, industrial,
carpets, carpet cushion, sub
floors, drywall, trim, farm
lumber, tackless strip and
paneling
carpets, carpet cushion, sub
floors, drywall, trim, farm
lumber, tackless strip and
paneling
garbage cans, garbage trucks,
industrial waste receptacles,
garbage handling equipment
Mop, cloth,
brush,
sponge,
sprayer
spray
sprayer,
sponge,
cloth,
Refer to Table 13
(Label Changes
Summary Table) for
appropriate label
restrictions
Refer to Table 13
(Label Changes
Summary Table) for
appropriate label
restrictions
16,800 ppm
16,800 ppm
2036 ppm
82
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregi strati on for
active ingredients within case #0350 (ADBAC) covered by this RED. It contains generic data
requirements that apply to ADBAC in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR part 158. The reference numbers accompanying each test refer to
the test protocols set in the Pesticide Assessment Guidance, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use patterns.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments, premises, and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files,
this column list the identify number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
83
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of ADBAC
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
Old Guideline
Number
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-6
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visable Absorption
Melting Point
Boiling Point
Use Pattern
All
All
All
All
All
All
All
All
All
All
All
All
Citation
4446702
4446702
44467401
4446702
4446702
4446702
44467403
44467403
44467403
44467403
44467403
44467403
84
-------
New
Guideline
Number
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
Old Guideline
Number
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion characteristics
Use Pattern
All
All
All
All
All
All
All
All
All
All
All
All
All
All
Citation
44467403
44467403
44467403
N/A
44467403
44467403
44467403
N/A
44467403
N/A
44467403
44467403
N/A
44467403
85
-------
ECOLOGICAL EFFECTS
New
Guideline
Number
850.2100
850.2100
850.2200
850.2300
850.2400
850.1075
850.1075
850.1010
None
850.1055
None
None
Old Guideline
Number
71-1
71-1
71-2B
71-3
72-1A
72-1C
72-2A
72-3A
72-3B
72-3 C
72-4A
Avian Acute Oral Toxicity
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Duck
Avian Reproduction (Mallard or
Bobwhite)
Wild Mammal Toxicity
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Aquatic Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - (Eastern
Oyster embryo larvae)
Estuarine/Marine Toxicity - Shrimp
Fish- Early Life Stage
Use Pattern
All
All
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
All
All
All
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Citation
42885901
42885901
Refer to Toxicology Data
41947201
41947202
41947203
42479502
Data Gap
42479501
42302102
86
-------
New
Guideline
Number
850.1300
850.440
850.5400
850.4225
850.4250
850.3020
850.1950
Old Guideline
Number
72-4
123-2
123-2
123-1
123-1
141-1
Aquatic Invertebrate Life Cycle- Daphnia
magna
Aquatic Plant Growth - Lemna gibba
Aquatic Plant Growth (4 species) Green
alga (Pseudokerschneria subcapitatum),
blue-green alga (Anabaena flos-aquae),
freshwater diatom (Navicula sps.), and
marine diatom (Skeletonema costatum)
Non-target Terrestrial Plant Phytotoxicity
(seedling emergence test using rice)
Non-target Terrestrial Plant Phytotoxicity
(Vegetative vigor using rice)
Honey Bee Acute Contact
Aquatic Field Monitoring (Once-Through
Cooling Water Towers)
Use Pattern
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservation, Sapstain,
Ornamental Nurseries, Turf, Once
Through Cooling Water
Wood Preservative
Once Through Cooling Water
Citation
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
TOXICOLOGY
New
Guideline
Number
870.1100
Old Guideline
Number
81-1
Acute Oral Toxicity-Rat
Use Pattern
All
Citation
45109204
87
-------
New
Guideline
Number
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3200
870.3250
870.3465
870.3700 (a)
870.3700 (b)
870.3800
870.4100
870.4200(b)
870.4300
Old Guideline
Number
81-2
81-3
81-4
81-5
81-6
82-1A
82-2
82-3
82-4
83-3A
83-3B
83-4
83-1B
83-5
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal/Photo- Sensitization
Oral Subchronic - Rat
21 -Day Dermal - Guinea Pig
90-Day Dermal - Rat
90-Day Inhalation - Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Chronic Feeding Toxicity -Non Rodent
Oncogenicity -Mouse
Combined Chronic Toxicity/ Carcinogenicity
Use Pattern
All
All
All
All
All
All
?
All
All
All
Swimming pool & Wood
Preservative
Indirect Food
Indirect Food
Swimming pool & Wood
preservative
Swimming pool & Wood
preservative
Citation
45109202
44885201
40919701, 44825001
45109201
45109203, 40958501, and
44825002
40746601
41105801
41499601
Data Gap
42351501
42392801
41385001
43221101
41765201
41947501
-------
New
Guideline
Number
870.5300
870.5385
870.5550
870.7485
Old Guideline
Number
84-2A
84-2B
84-4
85-1
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Unscheduled DNA Synthesis
General Metabolism
Use Pattern
All
All
All
Indirect Food
Citation
41012701
40311101
42290801, 42290802
40990701
OCCUPATIONAL and RESIDENTIAL EXPOSURE
New
Guideline
Number
875.2800
875.1100
875.1200
875.1600
875.1300
875.1400
875.1600
Special Study
Old Guideline
Number
133-1
231
233
236
232
234
236
Description of Human Activity
Outdoor/Indoor Dermal Exposure
Outdoor/Indoor Inhalation Exposure
Surface Wood Wipe Study
Use Pattern
All
All
All
Wood
Preservative
Citation
Data Gap
417426-01, 425875-01
455021101,455243-04
Data Gap
89
-------
ENVIRONMENTAL FATE
New
Guideline
Number
835.2120
835.2240
835.4400
835.4300
835.1240
None
Special Study
Old Guideline
Number
161-1
161-2
162-3
162-4
163-1
165-4
Hydrolysis
Photodegradation - Water
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/ Adsorption/Deadsorption
Bioaccumulation in Fish
Biodegradability
Use Pattern
All
Wood Preservative
Once Through Cooling Water
Wood Preservative
Once Through Cooling Water
Wood Preservative
Wood Preservative
Wood Preservative
Not Required
Citation
408356-02
40835603
41105501,42415101
40835604
40835605, 42414801
41026801
46865601
RESIDUE CHEMISTRY
New
Guideline
Number
860.1480
Special Study
Old Guideline
Number
171-4J
Magnitude of Residues -
Meat/Milk/Poultry /Egg
Dietary Residues in Food from Treating
Countertops with ADBAC (FDA Wipe
Study Methodology)
Use Pattern
Indirect Food
Indirect Food
Citation
FDA, 2003. "Sanitizing Solutions:
Chemistry for food Additives petitions."
Http://www.cfasan.fda.gov/-dms/opa-
cs3a Last accessed June 9, 2003
Data Gap
90
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive,
Arlington, VA 22202. It is open Monday through Friday, excluding legal holidays, from 8:30
am to 4 pm.
The docket initially contained the April 18, 2006 preliminary risk assessment and the
related documents. EPA then considered comments on these risk assessments (which are posted
to the e-docket) and revised the risk assessments. The revised risk assessments will be posted in
the docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following sites:
http://www.epa.gov/pesticides/antimicrobials
http:/www.regulati ons.gov
These documents include:
1. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Risk Assessment, 8/1/06
2. Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision
(RED) Risk Assessment Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC),
8/10/06
3. Dietary Risk Assessment for Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) for Reregi strati on Eligibility Decision (RED) Process, 7/27/06
4. Ecological Hazard and Environmental Risk Assessment of ADBAC for the
Reregi strati on Eligibility Document (RED) - Antimicrobial Uses, 8/2/06
5. PDM4 Modeling of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in
Once-Through Industrial Water Systems, 8/2/06
6. Ecological Risk Assessment in Support of the Antimicrobials Division's
Reregi strati on of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) &
Didecyl Dimethyl Ammonium Chloride (DDAC)-Agricultural Uses, 2/3/06
7. Tier 1 Drinking Water Assessment for Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) & Didecyl Dimethyl Ammonium Chloride (DDAC), 1/23/06
8. Environmental Fate Assessment of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) for the Reregi strati on Eligibility Decision (RED) Document, 7/27/06
91
-------
9. Incident Reports Associated with Quaternary Ammonium Compounds (Quats),
2/15/06
10. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Occupational and
Residential Exposure Assessment - Antimicrobial Uses, 7/27/06
11. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC): Occupational and
Residential Exposure Assessment for the Reregistration Eligibility Decision
Document - Agricultural Uses, 7/31/06
12. Appendix A Standard Methods for Calculating Occupational Exposures to
ADBAC, 7/31/06
13. Product Chemistry Science Chapter for Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC), 1/11/06
14. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)-Report of the
Antimicrobials Division Toxicity Endpoint Committee (ADTC) and the Hazard
Identification Assessment Review Committee (HIARC), 8/10/06
92
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Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE INTERIM REREGISTRATION DECISION
(BIBLIOGRAPHY)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregi strati on Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID@ number. This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
93
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b. Document date. The date of the study is taken directly from the
document. When the date is followed by a question mark, the
bibliographer has deduced the date from the evidence contained in the
document. When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers
to create or enhance a document title. Any such editorial insertions are
contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission
appears immediately following the word "received."
(2) Administrative number. The next element immediately following
the word "under" is the registration number, experimental use
permit number, petition number, or other administrative number
associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in
the trailing parentheses identifies the EPA accession number of the
volume in which the original submission of the study appears. The
six-digit accession number follows the symbol "CDL," which
stands for "Company Data Library." This accession number is in
turn followed by an alphabetic suffix which shows the relative
position of the study within the volume.
94
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BIBLIOGRAPHY
MRID#
CITATIONS
40311101 Kallersen, T. (1985) Assessment of the Mutagenic Activity of Hyamine
3500 in the Mouse Micronucleus Test: Lab. No. 10753. Un- published
study prepared by Scantox Labs Ltd. 17 p.
40746601 Van Miller, I; Weaver, E. (1988) Ninety-day Dietary Toxicity Study with
Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in Rats: Project
ID: 51-503. Unpublished study prepared by Bushy Run Re- search Center.
300 p.
40835602 Carpenter, M. and M. Fennessey. 1988. Hydrolysis of ADBAC as a
function of pH at 25°. ABC Amended Final Report # 35712.
Unpublished study performed by Analytical Bio-Chemistry Laboratories,
Inc., Columbia, MO, and submitted by Chemical Specialties
Manufacturers Association, Washington, DC.
40835603 Carpenter, M. and M. Fennessey. 1988. Determination of the photolysis
rate of ADBAC in pH 7 buffered solution at 25° C. ABC Final Report
#35713. Unpublished study performed by Analytical Bio-Chemistry
Laboratories, Inc., Columbia, MO, and submitted by Chemical Specialties
Manufacturers Association, Washington, DC.
40835604 Daly, D. and W. Cranor. 1988. Aerobic aquatic metabolism of alkyl
dimethyl benzyl ammonium chloride. ABC Final Report #35715.
Unpublished study performed by Analytical Bio-Chemistry Laboratories,
Inc., Columbia, MO, and submitted by Chemical Specialties
Manufacturers Association, Washington, DC.
40835605 Daly, D. and W. Cranor. 1992. Soil/Sediment Adsorption-Desorption of
Alkyl Dimethyl Ammonium Chloride. Performed by ABC Laboratories,
Inc., Columbia, Missouri. Submitted by ADBAC Joint Venture/Chemical
Specialties Manufacturers Association, Washington, DC.
40919701 Kreuzmann, J. (1988) Repeated Eye Instillation Study in Rabbits: Alkyl
dimethyl benzyl ammonium chloride (ADBAC): Study No.: 88- 3336-21.
Unpublished study prepared by Hill Top Biolabs, Inc. 20 p
40958501 Kreuzmann, J. (1989) Photoallergy Study in Guinea Pigs: Study No. 88-
3226-21. Unpublished study prepared by Hill Top Biolabs, Inc. 63 p.
40990701 Selim, S. (1989) Absorption, Distribution, Metabolism and Excretion
Studies of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in the
95
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BIBLIOGRAPHY
MRID#
CITATIONS
Rat: ETC Study No. P01359. Unpublished study prepared by Biological
Test Center. 247 p.
41012601 Cifone, M. (1989) Mutagenicity Test on Alkyl Dimethyl Benzyl
Ammonium Chloride: In the Rat Primary Hepatocyte Unscheduled DNA
Synthesis Assay: HLA Study No. 10238-0-447. Unpublished study
prepared by Hazleton Laboratories America, Inc. 56 p.
41012701 Young, R. (1989) Mutagenicity Test on Alkyl Dimethyl Benzyl
Ammonium Chloride: In the CHO/HGPRT Forward Mutation Assay:
HLA Study No. 10238-0-435. Unpublished study prepared by Hazleton
Laboratories America, Inc. 67 p.
41026801 Flacker, P. 1989. Bioconcentration and elimination of 14C-residues by
bluegill (Lepomis macrochirus) exposed to alkyl dimethyl benzyl
ammonium chloride (ADBAC). Study No. 11572-0287-6103-140B,
Report No. 89-1-2921. Unpublished study performed by Springborn Life
Sciences, Inc., Wareham, MA, and submitted by ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Assoc., Washington, DC.
41087701 Lin, P.; Selim, S. (1989) Addendum to Report Entitled "Absorption,
Distribution, Metabolism and Excretion Studies of Alkyl Dimethyl Benzyl
Ammonium Chloride (ADBAC) in the Rat" 40990701: Study No.
P01359. Unpublished study prepared by Biological Test Center. 44 p.
41105801 Rose, G. (1989) Acute Toxicology (EP): HS-Sanitizing Carpet Shampoo:
Project ID: B6-27. Unpublished study prepared by Envirocon. 36 p.
41105501 Daly, D. and W. Cranor. 1989. Anaerobic aquatic metabolism of alkyl
dimethyl benzyl ammonium chloride. ABC Amended Final Report
#35714. Unpublished study performed by Analytical Bio-Chemistry
Laboratories, Inc., Columbia, MO, and submitted by ADBAC Joint
Venture/Chemical Specialties Manufacturers Association, Washington,
DC.
41385001 Neeper-Bradley, T. (1990) Two-generation Reproduction Study in
Sprague-Dawley (CD) Rats with Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) Administered in the Diet: Project Report 52- 52-254:
Project Nos. 87-37-97105; 87-37-97109. Unpublished study prepared by
Bushy Run Research Center. 492 p.
96
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BIBLIOGRAPHY
MRID#
CITATIONS
41499601 Gill, M.; Wagner, C. (1990) Ninety-day Subchronic Dermal Toxicity
Study with Alkyl Dimethyl Benzyl Ammonium Chloride (ABDAC) in
Rats: Lab Project ID.: 52-623. Unpublished study prepared by Union
Carbide Bushy Run Research Center. 264 p.
41765201 Gill, M.; Hermansky, S.; Wagner, C. (1991) Chronic Dietary
Oncogenicity Study with Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) in Mice: Lab Project Number: 53-515. Unpublished study
prepared by Bushy Run Research Center. 1083 p.
41947501 Gill, M.; Hermansky, S.; Wagner, C. (1991) Chronic Dietary
Toxicity/Oncogenicity Study with Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) in Rats: Lab Project Number: 53-543. Unpublished
Study prepared by Bushy Run Research Center. 1671 p.
41947201 Pate, H.O. and D.O. Mclntyre. 1991. Daily Static-Renewal Acute 96-
Hour Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) to Bluegill Sunfish. Study No. SC890050. Unpublished data.
Conducted by Battelle Columbus Division for ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
41947202 Pate, H.O. and D.O. Mclntyre. 1991. Daily Static-Renewal Acute 96-
Hour Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) to Rainbow Trout. Study No. SC890051. Unpublished data.
Conducted by Battelle Columbus Division for ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
41947203 Pate, H.O. and D.O. Mclntyre. 1991. Daily Static-Renewal Acute 48-
Hour Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) to Daphniamagna. Study No. SC 890052. Unpublished data.
Conducted by Battelle Columbus Division for ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
42290801 McKeon, M. (1992) Genotoxicity Test on Alkyl Dimethyl Benzyl
Ammonium Chloride (ADBAC) in the Assay for Unscheduled DNA
Synthesis in Rat Liver Primary Cell Cultures: Lab Project Number: 14778-
0-447. Unpublished study prepared by Hazleton Washington, Inc. 51 p.
42290802 McKeon, M. (1989) Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) in the Rat Primary Hepatocyte Unscheduled DNA Synthesis
97
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BIBLIOGRAPHY
MRID#
CITATIONS
Assay: An Addendum: Lab Project Number: 10238-0-447. Unpublished
study prepared by Hazleton Laboratories America, Inc. lip.
42302101 Mclntyre, D.O. and H.O. Pate. 1992. Daily Static-Renewal Chronic 21-
Day Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) to Daphnia magna. Study No. SC890056. Unpublished data.
Conducted by Battelle Columbus Division for ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
42302102 Mclntyre, D.O. and H.O. Pate. 1992. Daily Static-Renewal Early Life
Stage Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) to Fathead Minnows. Project No. SC890057. Unpublished
data. Conducted by Battelle Columbus Operations for ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
42351501 Neeper-Bradley, T. (1992) Developmental Toxicity Evaluation II of Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC) Administered by
Gavage to CD Rats: Lab Project Number: 91N0031. Unpublished study
prepared by Union Carbide Chemicals and Plastics Co., Inc. Bushy Run
Research Center. 281 p
42392801 Neeper-Bradley, T.; Kubena, M. (1992) Developmental Toxicity
Evaluation of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)
Administered by Gavage to New Zealand White Rabbits: Lab Project
Number: 91N0032. Unpublished study prepared by Union Carbide. 179 p.
42414801 Daly, D. and W. Cranor. 1992. Soil/Sediment Adsorption-Desorption of
Alkyl Dimethyl Ammonium Chloride. Supplement in support of #
408356-05. Performed by ABC Laboratories, Inc., Columbia, Missouri.
Submitted by ADBAC Joint Venture/Chemical Specialties Manufacturers
Association, Washington, DC.
42414901 Daly, D. and W. Cranor. 1992. Aerobic metabolism of alkyl dimethyl
benzyl ammonium chloride. Supplement in support of # 408356-04.
Performed by ABC Laboratories, Inc., Columbia, Missouri. Submitted by
ADBAC Joint Venture/Chemical Specialties Manufacturers Association,
Washington, DC.
42415101 Daly, D. and W. Cranor. 1989. Anaerobic aquatic metabolism of alkyl
dimethyl benzyl ammonium chloride. ABC Amended Final Report
#35714. Supplement in support of # 411055-01. Unpublished study
98
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BIBLIOGRAPHY
MRID#
CITATIONS
performed by Analytical Bio-Chemistry Laboratories, Inc., Columbia,
MO, and submitted by ADBAC Joint Venture/Chemical Specialties
Manufacturers Association, Washington, DC.
42415102 Daly, D. and W. Cranor. 1992. Anaerobic metabolism of alkyl dimethyl
benzyl ammonium chloride. Supplement in support of # 411055-01.
Performed by ABC Laboratories, Inc., Columbia, Missouri. Submitted by
ADBAC Joint Venture/Chemical Specialties Manufacturers Association,
Washington, DC.
42415201 Carpenter, M. and M. Fennessey. 1992. Determination of the photolysis
rate of ADBAC in pH 7 buffered solution at 25° C. Supplement in
support of # 408356-03. Performed by ABC Laboratories, Inc., Columbia,
Missouri. Submitted by ADBAC Joint Venture/Chemical Specialties
Manufacturers Association, Washington, DC.
42479502 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 96-Hour Static-
Renewal Acute Toxicity Test with Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) in the Sheepshead Minnow (Cyprinodon variegatus).
Project No. 350A-102. Unpublished data. Conducted by Wildlife
International Ltd. for ADBAC Quat Joint Venture/Chemical Specialties
Manufacturers Association.
42479503 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 48-Hour Static Acute
Toxicity Test with Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) in Embryo Larvae of the Eastern Oyster (Crassostrea
virginica). Unpublished data. Conducted by Wildlife International Ltd.
for ADBAC Quat Joint Venture/Chemical Specialties Manufacturers
Association.
42479501 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 96-Hour Static-
Renewal Acute Toxicity Test with Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) in the Saltwater Mysid (Mysidopsis bahia). Project
No. 350A-101A. Unpublished data. Conducted by Wildlife International
Ltd. for ADBAC Quat Joint Venture/Chemical Specialties Manufacturers
Association.
42479502 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 96-Hour Static-
Renewal Acute Toxicity Test with Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) in the Sheepshead Minnow (Cyprinodon variegatus).
Project No. 350A-102. Unpublished data. Conducted by Wildlife
99
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BIBLIOGRAPHY
MRID#
CITATIONS
International Ltd. for ADB AC Quat Joint Venture/Chemical Specialties
Manufacturers Association.
42645101 Chun, J.; Fisher, L. (1993) Developmental Toxicity Dose Rang-Finding
Study of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)
Administered by Gavage to CD Rats: Lab Project Number: 54-613.
Unpublished study prepared by Bushy Run Research Center (BRRC). 104
P-
42734401 Chun, J.; Neeper-Bradley, T. (1993) Developmental Toxicity Dose Range-
Finding Study of ADB AC Administered by Gavage to New Zealand
White Rabbits: Lab Project Number: 54-603. Unpublished study prepared
by Union Carbide. 118 p.
42885901 Campbell, S.M. and M. Jaber. 1993. An Acute Oral Toxicity Study with
Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in the Northern
Bobwhite Quail. Project No. 289-109. Unpublished data. Conducted by
Wildlife International Ltd. for Lonza, Inc.
43037701 Schoenig, G. (1993) Response to EPA Data Evaluation Review for Study
Entitled: "Chromosome Aberrations in vivo—Mouse Micronucleus Test":
Lab Project Number: 10753. Unpublished study prepared by SCANTOX
Biologisk Laboratorium A/S. 7 p.
43221101 Goldenthal, E. (1994) Evaluation of ADB AC in a One-Year Chronic
Dietary Toxicity Study in Dogs: Lab Project Number: 638-004.
Unpublished study prepared by International Research and Development
Corp. 355 p.
43731101 England, D.C. and T. Leak. 1995. Chronic Toxicity of Sediment-
Incorporated ADB AC to Chironomus tentans. Project No. 41004.
Unpublished data. Conducted by ABC Laboratories, Inc. for ADBAC
Quat Joint Venture/Chemical Specialties Manufacturers Association.
43740101 Sword, M.C. and L. Stuerman. 1993. Static-Renewal Acute Toxicity of
ADBAC to Fathead Minnow (Pimephalespromelas) in Dilution Water
Amended with 20 mg/L Humic Acid. Study No. 41235. Unpublished
data. Conducted by ABC Laboratories, Inc. for ADBAC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
43740102 Sword, M.C. and L. Stuerman. 1993. Static-Renewal Acute Toxicity of
ADBAC to Fathead Minnow (Pimephalespromelas) in Dilution Water
100
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BIBLIOGRAPHY
MRID#
CITATIONS
Amended with 10 mg/L Humic Acid. Study No. 41236. Unpublished
data. Conducted by ABC Laboratories, Inc. for ADB AC Quat Joint
Venture/Chemical Specialties Manufacturers Association.
43740103 Sword, M.C. and L. Stuerman. 1993. Static-Renewal Acute Toxicity of
ADBAC to Fathead Minnow (Pimephalespromelas). Study No. 41237.
Unpublished data. Conducted by ABC Laboratories, Inc. for ADBAC
Quat Joint Venture/Chemical Specialties Manufacturers Association.
44467401 Albemarle BQ1416-8 Biocide-Product Chemistry, (1998) Albemarle
Corp., Lab Project Number 8382-141 Quat 6, Albemarle Corporation.
44467402 Tolbert, A., Product Chemistry Chemical Characterization for
Determining Identity and Purity of 80% n-Alkyl (60% CM, 30 % Ci6, 5 %
Ci2, 5% Ci8) Dimethyl Benzyl Ammonium Chloride, (1998), Lab Project
Number Quat 6B, Albemarle Corporation.
44467403 Tolbert, A., Product Chemistry Chemical Characterization for
Determining the Physical and Chemical Properties, and Accelerated
Storage Stability of 80% n-Alkyl (60% CM, 30 % Ci6,5 % Ci2, 5% Ci8)
Dimethyl Benzyl Ammonium Chloride, (1998), Lab Project Number Quat
6A, Albemarle Corporation.
44783401 Mazur, P. (1999) Absorption, Distribution, Metabolism and Excretion
(ADME) Studies of Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC) in the Rat and Addendum: Lab Project Number: P01359.
Unpublished study prepared by ADBAC Quat Joint Venture/Chemical
Specialities Manufacturers Assoc. 4 p.
44825001 Kreuzmann, J. (1999) Repeated Eye Instillation Study in Rabbits of Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC): Report Amendment:
Lab Project Number: 88-3336-21. Unpublished study prepared by Hill
Top Research, Inc. 4 p.
44825002 Kreuzmann, J. (1999) Photoallergy Study in Guinea Pigs with Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC): Report Amendment:
Lab Project Number: 88-3226-21. Unpublished study prepared by Hill
Top Research, Inc. 4 p.
101
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BIBLIOGRAPHY
MRID#
CITATIONS
44885201 Wnorowski, G. (1999) Acute Inhalation Toxicity Study in Rats:
AlbemarleBQ451-8 Biocide: Lab Project Number: 7467: P330.
Unpublished study prepared by Product Safety Labs. 30 p.
45109201 Moore, G. (1999) Primary Skin Irritation Study in Rabbits: Albemarle
BQ451-8 Biocide: Lab Project Number: 7468: P326. Unpublished study
prepared by Product Safety Labs. 15 p.
45109202 Moore, G. (1999) Acute Dermal Toxicity Study in Rats: Albemarle
BQ451-8 Biocide: Lab Project Number: 7466: P322. Unpublished study
prepared by Product Safety Labs. 25 p.
45109203 Moore, G. (1999) Dermal Sensitization Study in Guinea Pigs (Buehler
Method): Albemarle BQ451-8 Biocide: Lab Project Number: 7469: P328.
Unpublished study prepared by Product Safety Labs. 24 p.
45109204 Bonnette, K. (1998) An Acute Oral Toxicity Study in Rats with BQ 451-8:
Lab Project Number: 3192.32. Unpublished study prepared by Springborn
Laboratories. 90 p.
455021101 American Chemistry Council (ACC). 2002a.Assessment of Potential
Inhalation and Dermal Exposure Associated With Pressure Treatment of
Wood with Arsenical Wood Products
45524304 Bestari KT, Macey K, Soloman KR, Tower N. 1999. Measurement and
Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl
Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber
(Phase III).
46865601 Van Dievoet, F. and V. Bouillon. 2005. Biodegradability Test Report
according to OECD 301 B - modified (Modification: product tested at a
concentration of ± 5 mg/L of TOC). Report No. ST49132.01.01.
Unpublished study performed by BFB Oil Research S.A., Gembloux,
Belgium, and submitted by ADBAC Issues
102
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Assessment Study (Amended on 8 December 1992). Memorandum from Siroos Mostaghimi,
PH.D., USEPA, to Julie Fairfax, USEPA. Dated November, 4 1999. DP Barcode D247642.
USEPA (1999): Alkyl dimethyl benzyl ammonium chloride (ADBAC) - Report of the Hazard
Identification Assessment Review Committee, Office of Prevention, Pesticides, and Toxic
Substances.
USEPA (2000): Memorandum on Sterilex ® Ultra-Kleen for Dental Unit Water lines: Request
for Risk Assessment. Submission S572183.
USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs, Human Health Effects
Division. Dated April 5, 2000.
USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update, November 12.
Recommended Revisions to the Standard Operating Procedures (SOPs) for Residential Exposure
Assessment, February 22, 2001.
USEPA. 2003. Assessment of the Proposed Bardac Wood Preservative Pressure Treatment Use.
Memorandum from Tim Leighton and Siroos Mostaghimi. February 11, 2003.
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BIBLIOGRAPHY
OTHER SUPPORTING DOCUMENTS CITATIONS
USEPA. 2004. Occupational and Residential Exposure Assessment for Carboquat WP-50.
Memorandum from Siroos Mostaghimi, USEPA, to Velma Noble, USEPA. November 4, 2004.
DP Barcodes D303714 and D303938.
USEPA. 2005. Dietary Assessment of Chlorine Dioxide, Sodium Chlorite from Their Use as
Indirect Food Contact Sanitizers/Disinfectants (Hard Surface Sanitizers). Memorandum from
Najm Shamim, USEPA, to Melba Morrow and Jennifer Slotnick, USEPA. Dates August 15,
2005.
USEPA. 2006. Alkyl dimethyl benzyl ammonium chloride (ADBAC) - Report of the
Antimicrobials Division Toxicity Endpoint Committee (ADTC) and the Hazard Identification
Assessment Review Committee (HIARC). January 9, 2006.
USEPA. Undated. RISK. Version 1.9.27. Developed by Dr. Les Sparks of USEPA/NRMRL/
APPCD.
Versar. 2006. ADBAC Occupational and Residential Exposure Assessment. Memorandum from
Adria Diaz/Karie Riley/Kelly McAloon, Versar, Inc., to Laura Bailey, USEPA dated January 16,
2006.
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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
ADB AC RED for a list of studies that the Agency plans to require.
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Appendix F. PRODUCT SPECIFIC DATA CALL-IN
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G. 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 H. 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@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
(PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties
(PR Notice 98-1)
Self-Certification Statement for the Physical/
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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I Chemical Properties (PR Notice 98-1)
Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which 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/opppmsdI/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
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)
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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' website.
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.
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 website.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their website:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner 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; and
Product Manager assignment.
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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
chemical abstract system (CAS) number if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document
and may be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed
on the respective Chemical Status Sheet.
1. Health Effects Division and Environmental Fate and Effects Division Science
Chapters, which include the complete risk assessments and supporting documents.
2. Detailed Label Usage Information System (LUIS) Report.
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