United States Prevention, Pesticides EPA739-R-06-008
Environmental Protection and Toxic Substances August 2006
Agency (7510P)
Reregistration Eligibility Decision
for Aliphatic Alkyl Quaternaries
(DDAC)
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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 Didecyl Dimethyl
Ammonium Chloride (DDAC). The Reregi strati on Eligibility Decision (RED) was approved 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 DDAC 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 DDAC are available to the public in EPA's
Pesticide Docket EPA-HQ-OPP-2006-0338 at: http://www.regulations.gov.
The DDAC 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 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 DDAC risk assessment and the attached RED document concern only
this particular pesticide. This RED presents the Agency's conclusions on the dietary, drinking
water, residential, occupational and ecological risks posed by exposure to DDAC alone. This
document also contains both generic and product-specific data that the Agency intends to require
in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to
registrants at a later date. Additionally, for product-specific DCIs, the first set of required
responses will be due 90 days from the receipt of the DCI letter. The second set of required
responses will be due eight months from the receipt of the DCI letter.
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As part of the RED, the Agency has determined that DDAC will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measures outlined in Section IV of the document. Sections
IV and V of this RED document describe the labeling amendments for end-use products and data
requirements necessary to implement these mitigation measures. Instructions for registrants on
submitting the revised labeling can be found in the set of instructions for product-specific data
that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by DDAC. 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, Tracy Lantz, at (703) 308-6415. For
questions about product reregistration and/or the Product DCI that accompanies this document,
please contact Velma Noble at (703) 308-6233.
Sim
/ Frank T. Sanders
- Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
DDAC
CASE 3003
T. Sanders
Director, Antimicrobials Division
August 3, 2006
Attachment
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Table of Contents
DDAC Reregistration Team i
Glossary of Terms and Abbreviations ii
Executive Summary iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 5
III. Summary of DDAC Risk Assessments 8
A. Human Health Risk Assessment 8
1. Toxicity of DDAC 8
2. FQPA Safety Factor 11
3. Population Adjusted Dose (PAD) 11
a. Acute PAD 11
b. Chronic PAD 12
4. Dietary Exposure Assumptions 12
a. Dietary Risk from Food 13
b. Dietary Risk from Drinking Water 15
5. Residential Risk Assessment 16
a. Toxicity 16
b. Residential Handlers 17
i. Exposure Assessment 17
ii. Risk Assessment 18
c. Residential Post-Application 19
i. Exposure Assessment 19
ii. Risk Assessment 20
6. Aggregate Risk 21
a. Acute and Chronic Aggregate Risk 21
b. Short- and Intermediate-Term Aggregate Risk 22
7. Occupational Risk 25
a. Occupational Toxicity 25
b. Occupational Handler Exposure 25
c. Occupational Handler Risk Summary 26
d. Occupational Post-Application Exposure 28
8. Human Incident Data 32
B. Environmental Risk Assessment 34
1. Environmental Fate and Transport 34
2. Ecological Risk 35
a. Toxicity (Hazard) Assessment 35
b. Exposure and Risk 35
c. Risk to Listed Species 36
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 38
A. Determination of Reregistration Eligibility 38
B. Public Comments and Responses 38
C. Regulatory Position 39
1. Food Quality Protection Act Findings 39
a. "Risk Cup" Determination 39
b. Determination of Safety to U.S. Population 39
c. Determination of Safety to Infants and Children 39
d. Endocrine Disrupter Effects 40
e. Cumulative Risks 40
2. Tolerance Summary 41
D. Regulatory Rationale 41
1. Human Health Risk Management 42
a. Dietary (Food) Risk Mitigation 42
b. Drinking Water Risk Mitigation 42
c. Residential Risk Mitigation 42
i. Handler Risk Mitigation 42
ii. Post-Application Risk Mitigation 43
d. Occupational Risk Mitigation 44
i. Handler Risk Mitigation 44
ii. Post-Application Risk Mitigation 44
2. Environmental Risk Management 44
3. Other Labeling Requirements 45
4. Listed Species Considerations 45
a. The Endangered Species Act 45
b. General Risk Mitigation 46
V. What Registrants Need to Do 47
A. Manufacturing-Use Products 49
1. Additional Generic Data Requirements 49
2. Labeling for Technical and Manufacturing-Use Products 50
B. End-Use Products 50
1. Additional Product-Specific Data Requirements 50
2. Labeling for End-Use Products 52
a. Label Changes Summary Table 54
VI. Appendices 60
A. Table of Use Patterns for DDAC 61
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 73
C. Technical Support Documents 92
D. Bibliography Citations 93
E. Generic Data Call-In 109
F. Product Specific Data Call-In 110
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G. List of All Registrants Sent the Data Call-In Ill
H. List of Available Forms 112
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DDAC Reregistration Team
Health Effects Risk Assessment
Jonathan Chen
Timothy Leighton
Tim McMahon
Najm Shamim
Matthew Lloyd
Chemistry Assessment
Chris Jiang
Ecological Risk Assessment
David Bays
Brian Kiernan
Marietta Echeverria
Environmental Fate Risk Assessment
Srinivas Gowda
Registration Support
Velma Noble
Dennis Edwards
Risk Management
Diane Isbell
Tracy Lantz
Jacqueline Campbell-McFarlane
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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
WPS Worker Protection Standard
ill
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ABSTRACT
The Environmental Protection Agency (hereafter referred to as EPA or the Agency) has
completed the human health and environmental risk assessments for the aliphatic alkyl
quaternaries, DDAC, 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 DDAC that pose risks of
concern. As a result of this review, EPA has determined that DDAC-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 Didecyl Dimethyl Ammonium Chloride (DDAC).
DDAC is an antimicrobial used in several types of applications, such as indoor and
outdoor hard surfaces (e.g., walls, floors, tables, toilets, and fixtures), eating utensils, laundry,
carpets, agricultural tools and vehicles, egg shells, shoes, milking equipment and udders,
humidifiers, medical instruments, human remains, ultrasonic tanks, reverse osmosis units, and
water storage tanks. There are also DDAC-containing products that are used in residential and
commercial swimming pools, in aquatic areas such as decorative ponds and decorative fountains,
and in industrial process and water systems such as re-circulating cooling water systems, drilling
muds and packer fluids, oil well injection and wastewater systems. Additionally, DDAC-
containing products are used for wood preservation.
The Agency has concluded that the FQPA Safety Factor for DDAC should be removed
(equivalent to IX) 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 risk for infants and children.
Risks summarized in this document are those that result only from the use of the active
ingredients DDAC. 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
1
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based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding for DDAC and any other substances. DDAC does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this action, therefore, EPA has not
assumed that DDAC 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 DDAC. In an effort to simplify the RED, the information presented herein
is summarized from more detailed information which can be found in the technical supporting
documents for DDAC referenced in this RED. The revised risk assessments and related addenda
are not included in this document, but are available in the Public Docket at
http://www.regulations.gov.
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 DDAC, and its regulatory history. Section
III, Summary of DDAC 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 aliphatic alkyl quaternary chemical case is comprised of five compounds that are
structurally similar quaternary ammonium compounds characterized by having a positively
charged nitrogen covalently bonded to two alkyl group substituents (at least one C8 or longer)
and two methyl substituents. In finished form, these quats are salts with positively charged
nitrogen (cation) balanced by a negatively charged molecule (anion.). The anion for the quats in
this group is chlorine or bromine. Didecyl dimethyl ammonium chloride (DDAC) compound was
the first active ingredient registered in this group in 1962.
The Dialkyl Group Steering Committee/Joint Venture comprised of Lonza Inc, Mason
Chemical Company, and Stepan Company, was formed to support the reregi strati on activities of
Alkyl Dimethyl Ethyl Ammonium Bromide (PC 069146), Didecyl Dimethyl Ammonium
Chloride (PC 069149), Octyl Decyl Dimethyl Ammonium Chloride (PC 069165), and Dioctyl
Dimethyl Ammonium Chloride (PC 069166). These chemicals are formulated into numerous
products that are used in residential, commercial, industrial, institutional and agricultural
settings.
Oxydiethylenebis (aldyl*dimethyl ammonium chloride) was registered in 1963 (PC
069173). This chemical is registered for use in industrial processes and water systems such as
cooling towers, secondary oil recovery, and oil storage tank water. Petrolite Corporation and
Buckman Labs have registered five products containing this active ingredient.
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,
ethylbenzyl, hydroxyethylbenzyl, naphthylmethyl, dodecylbenzyl, and alkyl benzyl)
Group III: The di- and tri-chlorobenzyl substituted Quats
Group IV: Quats with unusual substitutes (charged heterocyclic compounds).
The Agency agreed that for data development purposes DDAC would serve as the
model compound.
B. Chemical Identification
Historically, the Agency has registered each distinct aliphatic alkyl quaternary compound
as a separate active ingredient. Table 1 below provides the common chemical name, active
ingredient code, CAS number, chemical structure and number of registered product for each
compound.
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Table 1: Active Ingredients in the Group I Quat Cluster
Pesticide
Code
69149
69166
69165
69146
69173
CASRN
7173-51-5
5538-94-3
32426-11-2
84540-07-8
68607-28-3
Name
Didecyl Dimethyl
Ammonium Chloride
(DDAC)
Dioctyl Dimethyl
Ammonium Chloride
Octyl Decyl
Dimethyl
Ammonium Chloride
Alkyl Dimethyl Ethyl
Ammonium Bromide
Oxydiethylenebis
(alkyl*) dimethyl
ammonium chloride
Structure
R CH3
X\H3Cr
\ /CH3
/\ CT
R XCH3
R-l ,CH3
^\ cr
R2 NCH3
\ /CH3
^X^v Bf
CH3
Chain Lengths
R = C10
R = C8
R1 =C8
(variable %)
R2 = C10
(variable %)
R = C12(5%)
C14(90%)
C16(5%)
R=C12 (40%)
C14(50%)
C16 (10%)
Molecular
Weight
332-361
332-361
332-361
350
561-681
Est. #
Products
396
211
206
4
5
Common name:
Chemical name:
Chemical family:
Case number:
DDAC
Didecyl Dimethyl Ammonium Chloride
Quaternary amines
3003
Basic manufacturers: Buckman Labs
Lonza, Inc.
Mason Chemical Company
Petrolite Corporation
Stepan Company
Chemical properties: DDAC is a clear yellow liquid with an ethanolic odor which is
completely soluble in water. DDAC has a melting point of
228.81°C, a density of 0.9216 g/cm3 at 25°C with a vapor
pressure of 2.33 x 10"11 mm Hg.
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c.
Use Profile
The following is information on the uses of DDAC products, currently registered as of
April 26, 2006, and an overview of use sites and application methods. A detailed table of the
uses of DDAC eligible for reregi strati on is contained in Appendix A.
Type of Pesticide:
Summary of Uses:
Algaecide, bacteriocide, fungicide, fungistat, microbiocide, microbiostat,
disinfectant, viricide, tuberculocide, molluscide, sanitizer, wood
preservative, deodorant, and insecticide
Use Category
Industrial Processes
and Water Systems
Swimming Pools
Aquatic Areas
Wood Treatment
Agricultural Premise
and Equipment
Residential and Public
Access Premise
Medical Premise and
Equipment
Commercial
Institutional and
Industrial Premise and
Equipment
Food Handling/Storage
Establishments
Premises and
Equipment
Use Sites
Industrial recirculating water systems, cooling water, disposal
water, oil field operations, oil field water flood or salt water
disposal
Swimming pools, outside spas, whirlpools, and hot tubs
Greenhouses/nurseries, golf courses, recreational parks,
amusement parks, universities, and cemeteries
Pressure treatment, double vacuum, and dip/spray surface
treatment
Hatcheries, swine/poultry/turkey farms, dressing plants,
farrowing barns, mushroom farm, citrus farm, animal housing
facilities, florists/flower shops, greenhouses, and nurseries
Homes, mobile homes, cars, trucks, campgrounds,
playgrounds, trailers, campers, boats, and public facilities
Hospitals, health care facilities, medical/dental offices,
nursing homes, medical research facilities, autopsy rooms,
newborn nurseries, acute care institutions, alternate care
institutions, funeral homes, mortuaries, day-care facilities,
sick rooms
Athletic/recreational facilities, exercise facilities, schools,
colleges, dressing/locker rooms, transportation terminals,
libraries, motel, hotels, barber/beauty salons, health clubs,
emergency vehicles, correctional facilities, factories,
commercial florists, conveniences stores, offices, commercial
and institutional laundry mats,
Restaurants, food service establishments, food storage,
handling, processing plants/facilities, beverage processing
plants, bars, cafeterias, supermarkets, dairies, egg processing
plants, institutional kitchens, breweries, fast food operations,
rendering plants, school lunchrooms, packing plants
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Target Pests:
Slime-forming bacteria, odor causing/staining bacteria, Gram negative and
Gram positive bacteria, Pseudomonas aeruginosa, pathogenic fungi
(Trichophyton mentagrophytes), viruses, mold/mildew, algae.
Formulation Types: Soluble concentrate/tablets, aerosol, impregnated wipes, ready-to-use
solution, pressurized liquid, and wettable powder.
Method and Rates of Application:
Method: DDAC formulations are added directly to water in swimming pools, spas,
humidifiers, fogging, and cut flower applications, as well as in oil field
drilling muds and packing fluids and small process water systems. DDAC
formulations are diluted in water to treat hard nonporous surfaces in
institutional, commercial, industrial and residential settings by fogging,
flood, immersion, wiping, mopping, aerosol/trigger spray, and low and
high-pressure spray. Wipes are typically pre-moistened. For treatment of
wood, DDAC is applied by a blender spray system, diptank, spray box or
pressure treatment.
Application Rates: For details about specific use sites for DDAC, refer to Appendix A.
• Use 1 gallon of a 50% end use product per 3000 barrels of water to 1
gallon of a 18% end use product to 100 gallons of water to achieve 32-
1800 ppm for treatment of industrial recirculating water systems,
cooling water, disposal water and oil field operation.
• Use enough 5 1A ounces of a 50% end use product to 10,000 gallon of
water to achieve a final concentration of 0.5-2 ppm in swimming pool
water.
• Use 1 ounce of a 12 % end use product per 1 gallon of irrigation water
to 1 teaspoon of a 12% end use product to 52 gallons of water in
decorative fountains, pools, ponds, water displays and standing water
to achieve a final concentration of 5-938 ppm.
• Use a 80% end use product to prepare a 3% active ingredient solution
to apply 0.6 pounds active ingredient per cubic foot of wood.
• Use 187 ounces of a 4.5% end use solution per 2.5 gallons water to
achieve 26,320 ppm for application by fog in hatcheries.
• Use 0.5 of a 7% end use product to 2 ounces of a 15.36% end use
solution per gallon water to achieve 234 to 2400 ppm for application to
porous and hard non porous surfaces in homes.
• Use 2.67 ounces of a 4.5% end use product per 4 gallons of water to 2
ounces of a 15.36% end use product per 1 gallon of water to achieve a
final concentration of 240-2,400 ppm for treatment of hard non-porous
surfaces in medical premise and equipment such as hospitals, day care
centers, mortuaries and EMS facilities.
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Use 12 ounces of a 13.02% end use product per 1 gallon of water to
achieve a final concentration of 12,207 ppm for treatment of carpets in
medical premise and commercial settings.
Use 0.5 ounces of a 50% end use product per 100 pounds of fabric to
1.75 ounces end use product per 100 pounds of fabric to achieve a
final concentration of 1935-8789 ppm for treatment of
clothing/laundry in commercial and institutional laundry mats.
Use ready to use end use product, at 0.08% active ingredient or 2
ounces of a 15.36% end use product per 1 gallon of water to achieve a
final concentration of 800-2,400 ppm for treatment of hard non-porous
surfaces in food handling/storage premise and equipment as well as
commercial establishments and a disinfectant/cleaner.
Use 0.5 ounces of a 7% end use product per 1 gallon of water to
achieve a final concentration of 234 ppm to sanitize food contact
surfaces in food handling/storage premise and equipment as well as
commercial establishments.
Use Classification: General use.
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III. Summary of DDAC 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 DDAC. While the risk assessments and related addenda are not included
in this document, they are available from the OPP Public Docket and may also be accessed on
the Agency's website at http://www.regulations.gov. Hard copies of these documents may be
found in the OPP public docket under docket number OPP-2006-0338. 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.
The Agency's use of human studies in the DDAC risk assessment is in accordance with
the Agency's Final Rule promulgated on January 26, 2006 related to Protections for Subjects in
Human Research, which is codified in 40 CFR Part 26.
A. Human Health Risk Assessment
1. ToxicityofDDAC
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 DDAC can be found
in the "Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision (RED) Risk
Assessment on Didecyl Dimethyl Ammonium Chloride (DDAC)," dated February 27, 2006; and
"Didecyl Dimethyl Ammonium Chloride (DDAC)-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 in the EPA Docket
at http://www.regulations.gov. Revised versions of these documents will be available when the
public docket opens.
The Agency has reviewed all toxicity studies submitted for DDAC and has determined
that the toxicological database is sufficient for reregi strati on. The studies have been submitted to
support guideline requirements. The acute toxicology data shows that DDAC is toxicity
category II by the oral and inhalation routes and toxicity category III via the dermal route.
DDAC 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 toxicology profile are presented below.
Table 1. Summary of Acute Toxicity Data for DDAC
Table 4.1 Acute Toxicity Data for DDAC
Guideline
No.
81-1
Study Type
Acute Oral
MRID #(S).
42296101
41394404
Results
LD50 (combined) = 238 mg/kg
LD50 (combined) = 262 mg/kg
Toxicity
Category
II
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Table 4.1 Acute Toxicity Data for DDAC
Guideline
No.
81-2
81-3
81-4
81-5
81-6
Study Type
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID #(S).
42053801
00145074
42161602
41394404
42160601
46367601
Results
LD50((?) = 3140mg/kg;
LD50(?) = 2730mg/kg;
LD50 (combined) = 2930 mg/kg
LC50= 0.07mg/L
Severe eye irritant
Severe dermal irritant
Not a sensitizer
Toxicity
Category
III
II
I
I
The doses and toxicological endpoints selected for the dietary exposure scenarios are
summarized in Table 2 below.
Table 2. Dietary Toxicological Endpoints for DDAC
Table 2. Summary of Toxicological Endpoints for DDAC (Dietary)
Exposure
Scenario
Acute Dietary
(Females 13-50)
Acute Dietary
(general population)
Chronic Dietary
(general population)
Dose Used in Risk
Assessment
(mg/kg/day)
NOAEL(developmental
) = 10 mg/kg/day
Target MOE/UF,
Special FQPA SF
for Risk Assessment
FQPA SF = 1
UF = 100 (lOx inter-species
extrapolation, lOx intra-species
variation)
Study and Toxicological Effects
Prenatal Developmental Toxicity -
Rat
MRID 41886701
LOAEL = 20 mg/kg/day based on
increased incidence of skeletal
variations.
aPAD = 0.1 mg/kg/day (for Females age 13-50)
An acute dietary endpoint was not identified in the data base.
NOAEL = 10
mg/kg/day
FQPA SF = 1
UF = 100 (lOx inter-species
extrapolation, lOx intra-species
variation
Chronic Toxicity Study - Dog
MRID 41970401
LOAEL = 20 mg/kg/day based on
increased incidence of clinical signs
in males and females and decreased
total cholesterol levels in females.
cPAD = 0.1 mg/kg/day
UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level,
LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD :
reference dose, MOE = margin of exposure, LOG = Level of concern, NA = Not Applicable.
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Dietary
The acute RfD is 0.1 mg/kg/day for females (13-50 years). This endpoint is based on a
developmental toxicity study in rats with a reported NOAEL of 10 mg/kg/day. This study
indicated increased incidence of skeletal variations at the LOAEL of 20 mg/kg/day. The chronic
RfD is 0.1 mg/kg/day. This is based on increased incidence of clinical observation signs in
males and females and decreased total cholesterol levels in females at 20 mg/kg/day in the
chronic toxicity study in dogs. An uncertainty factor of 100 (10X for interspecies extrapolation
and 10X for intraspecies variability) was applied to the NOAEL to obtain the acute and chronic
RfDs.
Incidental Oral
The short- and intermediate-term incidental oral NOAEL is 10 mg/kg/day from the dog
chronic toxicity study and rat prenatal developmental toxicity studies that noted increased
incidence of skeletal variations, increased incidence of clinical signs in males and females and
decreased total cholesterol levels in females. The target margin of exposure (MOE) is 100.
Short-term Dermal
The short-term dermal NOAEL is 2 mg/kg/day, which is based on increased clinical and
gross findings identified at a dose of 6 mg/kg/day in a 90-day rat dermal toxicity study. The
uncertainty factor or "target" MOE for DDAC 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.
Short- and Intermediate-term Inhalation
The short- intermediate- and long term inhalation NOAEL is 10 mg/kg/day based on the
oral endpoint. 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
uncertainty factor is 100 for occupational and residential scenarios. A lOx inter-species
extrapolation and lOx intraspecies variation was used to determine if a confirmatory study is
warranted. The target margin of exposure (MOE) is 100.
Carcinogenicity Classification
The Agency classified DDAC as not likely to be a human carcinogen based on the lack of
evidence of carcinogenicity in mice or rats.
Mutagenicity Potential
DDAC has been tested for mutagenic activity and the data base for mutagenicity is
considered adequate and indicates it is not mutagenic nor genotoxic. However, cytotoxic effects
were observed at concentrations as low as 4.0 ug/ml.
10
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Endocrine Disruption Potential
EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as amended
by FQPA, to develop a screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator
may designate." Following recommendations of its Endocrine Disrupter and Testing Advisory
Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP). When appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disruption Screening Program (EDSP) have been
developed, DDAC may be subjected to additional screening and/or testing to better characterize
effects related to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The FQPA Safety Factor has been
removed (i.e. reduced to IX) for DDAC 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 risk 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 DDAC. Based on the analysis of
submitted developmental toxicity studies, the Agency determined that no special FQPA Safety
Factor was needed since there were no residual uncertainties for pre- and/or postnatal toxicity.
3. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A
risk estimate that is less than 100% of the acute or chronic PAD is not of concern.
a. Acute PAD
Acute dietary risk for DDAC is assessed by comparing acute dietary exposure estimates
(in mg/kg/day) to the acute Population Adjusted Dose (aPAD). Acute dietary risk is expressed
as a percent of the aPAD. The aPAD is the acute reference dose (0.1 mg/kg/day) modified by
11
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the FQPA safety factor. The acute reference dose was derived from a developmental toxicity
study in rats in which both the NOAEL (10 mg/kg/day) and the LOAEL (20 mg/kg/day) were
determined based on increased incidence of skeletal variations. The DDAC aPAD is 0.1
mg/kg/day for the population subgroup females ages 13+ based on the acute RfD of 0.1
mg/kg/day, which incorporates the uncertainty factor of 100 (10X for interspecies extrapolation
and 10X for intraspecies variability) and which includes the incorporation of the FQPA safety
factor (IX).
b. Chronic PAD
Chronic dietary risk for DDAC is assessed by comparing chronic dietary exposure
estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic dietary risk
is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.1 mg/kg/day)
modified by the FQPA safety factor. The cPAD was derived from the chronic oral toxicity study
in the dog in which both the NOAEL (10 mg/kg/day) and the LOAEL (20 mg/kg/day) were
determined based on increased incidence of clinical signs in males and females and decreased
total cholesterol levels in females. The DDAC cPAD is 0.1 mg/kg/day based on a reference dose
of 0.1 mg/kg/day, which incorporates the uncertainty factor of 100 (10X for interspecies
extrapolation and 10X for intraspecies variability) and which includes the incorporation of the
FQPA safety factor (IX) for the overall U.S. population or any population subgroups.
4. Dietary Exposure Assumptions
The use of DDAC as an antimicrobial product on food contact surfaces, treatment of
mushroom houses, and application to food-grade eggs may result in pesticide residues in human
food. Residues from the use of DDAC 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 DDAC as a disinfectant after rinsing
with potable water. In the absence of transfer residue data on DDAC disinfectants, the Agency
assumed that rinsing with potable water cannot remove all residues deposited on the treated
surfaces from this use. Therefore, residues from the treated and rinsed surfaces may migrate to
food coming into contact with these surfaces and then be ingested by humans.
Exposure to DDAC may result from residues of DDAC on treated food contact surfaces.
For this assessment, the Agency estimated residue levels that may occur in food from the
application rates on food contact surfaces.
DDAC products may be applied to the shells of food grade eggs. Although it is possible
that some of the sanitizer/disinfectant chemicals may penetrate the egg shells, at this time the
Agency believes that the amount of chemical transferred into eggs is likely to be minimal. The
Agency believes this to be true since the labels of these products state that treated egg shells
must be subjected to a potable water rinse if they are to be immediately broken for use in the
manufacture of egg products. In addition, consumers generally do not ingest the egg shell.
Based on this analysis, the Agency did not assess exposures from this use pattern.
12
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There is no evidence that there will be residues of DDAC 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. The labels associated with mushroom house use state
that the product is not to be applied to the mushroom crop, compost or casing and that treated
surfaces are to be rinsed with potable water before contact with the crop, compost or casing.
Because any potential exposures would not likely pose risks of concern and the sanitizing uses
represent a worst-case scenario, these uses were not assessed.
Food packaging and beverage bottling uses have also been evaluated. For this use, 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 Agency assessed the acute and chronic dietary exposure assessment due to DDAC
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) using
an FDA model (2003). The assessment considered the following assumptions: application rates,
residual solution, surface area of the treated surface which comes into contact with food,
pesticide migration fraction, and body weight.
The EDI calculations presented in this assessment assumes that food can contact
2,000 cm2 or 4,000 cm2 (50% and 100% respectively of the FDA worst 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 100% transfer rate was used for all indirect food contact surfaces except for food
bottling and packaging surfaces. The 10% migration rate is based on Agency Residential
Standard Operation Procedures. These daily estimates were conservatively used to assess both
acute (i.e. percent acute population adjusted dose or %aPAD) and chronic dietary risks (i.e.
percent chronic population adjusted dose or %cPAD). When assessing the food
bottling/packaging use the 100% transfer rate is used because the food is in contact with the
treated surfaces for potentially very long periods of time.
A summary of acute and chronic risk estimates are shown in Tables 4a and 4b
respectively. Based on a review of product labels containing DDAC, three uses have been
identified as having the potential to cause indirect dietary exposure due to indirect food contact:
utensils; countertops; and food bottling/packaging. =
a. Acute and Chronic Dietary Risk from Food
Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does
not exceed the Agency's levels of concern. A summary of antimicrobial indirect food use acute
chronic risk estimates are shown below in Tables 4a-land 4a-2. Risk estimates are below the
Agency's level of concern. For adults, the acute, which is specific to adult females of child
bearing age (13-15) and chronic dietary risk estimate is 3.32% of the acute and chronic PAD.
For children, the most highly exposed population subgroup, the chronic dietary risk estimate is
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13.3% of the chronic PAD. Therefore, chronic dietary risk estimates are below the Agency's
level of concern for all population subgroups.
Table 4a-l. Calculated EDIs, aPAD, and cPAD for Utensils and Countertops
Exposure
Group
Adult
females
Utensils
EDI
(mg/p/d)
0.0959
DDD
(mg/kg/
d)
0.00160
% PADa
1.60
Countertops
EDI
(mg/p/d)
0.103
DDD
(mg/kg/
d)
0.00172
% PADa
1.72
Total
EDI
(mg/p/d)
0.199
DDD
(mg/kg/
d)
0.00332
% PAD"
(mg/kg/
d)
3.32
a.
Yo PAD = exposure (DDD) /(aPAD or cPAD) x 100. The acute and chronic population
average dose is the same; therefore the % PADs are the same.
EDI is estimated daily intake (mg/kg).
DDD is estimated dietary dose (mg/kg/day).
Table 4a-2. Calculated EDIs, aPAD, and cPAD for Utensils and Countertops
Exposure
Group
Adult
males
Adult
females
Children
Utensils
EDI
(mg/p/d)
0.0959
0.0959
0.0959
DDD
(mg/kg/
d)
0.00137
0.00160
0.00639
% PADa
1.37
1.60
6.39
Countertops
EDI
(mg/p/d)
0.103
0.103
0.103
DDD
(mg/kg/
d)
0.00147
0.00172
0.00687
% PADa
1.47
1.72
6.87
Total
EDI
(mg/p/d)
0.199
0.199
0.199
DDD
(mg/kg/
d)
0.00284
0.00332
0.0133
% PADa
(mg/kg/
d)
2.84
3.32
13.3
a. % PAD = exposure (DDD) /(aPAD or cPAD) x 100. The acute and chronic population
average dose is the same; therefore the % PADs are the same.
EDI is estimated daily intake (mg/kg).
DDD is estimated dietary dose (mg/kg/day).
The maximum application rate for DDAC for bottling/packing of food is 0.0020 Ibs a.i
per gallon of treatment solution. EDI values were calculated using an approach similar to that
used for treated food-contact surfaces and food utensils. 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). Neither the percent aPad or percent
cPad values exceeded 100% and are not of concern.
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Table 4b. Calculated EDIs, aPAD, and cPAD for Representative Dairy and Beverage
Consumption (Bottling/Packaging)
Food Type
Exposure Group
EDI
(mg/p/d)
ODD
(mg/kg/d)
% PAD
Acute
Milk
Egg product
Beverages, non-alcoholic
Beverages, alcoholic, beer
Adult Female (13-50years)
Childa
Adult Female(13-50years)
Child3
Adult Female(13-50years)
Child3
Adult Female(13-50years)
0.00451
0.00290
0.000034
0.000022
0.00038
0.00056
2.91xlO'4
6.44xlO'5
7.52xlO'5
1.94xlO'4
4.8xlO'7
5.6xlO'7
1.44xlO'6
5.6xlO'6
5.6xlO'6
1.60xlO'5
4.16xlO'6
4.85xlO'6
0.0644
0.0752
0.194
4.8xlO'4
5.6xlO'4
1.48xlO'3
0.0055
0.384
0.990
0.00416
0.00485
Chronic
Milk
Egg product
Beverages, non-alcoholic
Beverages, alcoholic, beer
Adults
Child3
Adults
Child3
Adults
Child3
Adults
0.00451
0.00290
0.000034
0.000022
0.00038
0.00056
2.91xlO'4
6.44xlO'5
7.52xlO'5
1.94xlO'4
4.8xlO'7
5.6xlO'7
1.44xlO'6
5.6xlO'6
5.6xlO'6
1.60xlO'5
4.16xlO'6
4.85xlO'6
0.0644
0.0752
0.194
4.8xlO'4
5.6xlO'4
1.48xlO'3
0.0055
0.384
0.990
0.00416
0.00485
a. Child EDI values are multiplied by a modification factor of 0.64
b. Dietary Risk from Drinking Water
The only DDAC outdoor uses are an algaecide in decorative pools, antisapstain wood
preservative treatment, once-through cooling tower treatment and oil field uses. The pond and
oil field uses are considered to be contained. The other uses are not expected to significantly
contaminate drinking water sources. Therefore, the DDAC contributions for drinking water
exposure are considered to be negligible and are not quantified.
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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.
5. Residential Risk Assessment
The residential exposure assessment considers all potential non-occupational pesticide
exposure, other than exposure due to residues in food or in drinking water. Exposures may occur
during and after application as a hard surfaces disinfectant (e.g., walls, floors, tables, fixtures), to
textiles (e.g., clothing, diapers) 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
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, residential risks for DDAC are listed in Table 5a.
MOEs greater than or equal to 100 for inhalation and oral exposures and 10 for dermal
exposures are considered protective. The MOE of 100 includes a 10X for interspecies
extrapolation, 10X for intraspecies variation. The MOE of 10 includes a 3X for interspecies
extrapolation, 3X for intraspecies variation.
Table 5a. Toxicological Endpoints Selected for Assessing Residential and Occupational
Risk for DDAC
Exposure
Scenario
Dose Used in Risk
Assessment
(mg/kg/day)
Target MOE/UF,
Special FQPA SF
for Risk Assessment
Study and Toxicological Effects
Incidental Oral
Short-Term
NOAEL
(developmental) =10
mg/kg/day
Target MOE = 100 (lOx inter-
species extrapolation, lOx intra-
species variation)
FQPA SF = 1
Prenatal Developmental Toxicity -
Rat
MRID 41886701
LOAEL = 20 mg/kg/day based on
increased incidence of skeletal
variations.
Incidental Oral
Intermediate-Term
NOAEL = 10
mg/kg/day
Target MOE = 100 (lOx inter-
species extrapolation, lOx intra-
species variation)
FQPA SF = 1
Chronic Toxicity Study - Dog
MRID 41970401
LOAEL = 20 mg/kg/day based on
increased incidence of clinical signs
in males and females and decreased
total cholesterol levels in females.
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Exposure
Scenario
Dose Used in Risk
Assessment
(mg/kg/day)
Target MOE/UF,
Special FQPA SF
for Risk Assessment
Study and Toxicological Effects
Dermal, Short-term
NOAEL(dermal) = 2
mg ai/kg/day
(8 ug ai/cm2)3
Target MOE = 10 (3x inter-
species extrapolation, 3x intra-
species variation)
90-day Dermal Toxicity - Rat
MRID 41305901
LOAEL = 6 mg ai/kg/day based on
increased clinical and gross findings
(erythema, edema, exfoliation,
excoriation, and ulceration)
Dermal, Intermediate-
and Long-term
No appropriate endpoint identified.
Inhalation, Short-
Term
NOAEL b = 10
mg/kg/day
Target MOE = 100 (lOx inter-
species extrapolation, lOx intra-
species variation)
FQPA SF = 1
Prenatal Developmental Toxicity -
Rat
MRID 41886701
LOAEL = 20 mg/kg/day based on
increased incidence of skeletal
variations.
Inhalation,
Intermediate- and
Long-Term
NOAEL b = 10
mg/kg/day
Target MOE = 100 (lOx inter-
species extrapolation, lOx intra-
species variation)
FQPA SF = 1
Chronic Toxicity Study - Dog
MRID 41970401
LOAEL = 20 mg/kg/day based on
increased incidence of clinical signs
in males and females and decreased
total cholesterol levels in females.
UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level,
LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD =
reference dose, MOE = margin of exposure, LOG = Level of concern, NA = Not Applicable.
a Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1000 ug/mg) / 50 cm2 area of rat dosed = 8 ug/cm2.
b An additional lOx is necessary for route extrapolation to determine the need for inhalation data. If results are
below a MOE of 1,000, a confirmatory inhalation study may be required
b.
Residential Handlers
i. Exposure Assessment, Data and Assumptions
Residential exposure may occur during the application of DDAC to indoor hard surfaces
(e.g., mopping, wiping, trigger pump sprays), carpets, swimming pools, wood as a preservative,
textiles (e.g., diaper treated during washing and clothes treated with fabric spray), and humidifiers.
The residential handler scenarios were assessed to determine dermal and inhalation exposures.
Surrogate dermal and inhalation unit exposure values were estimated using PHED data and the
Chemical Manufactures Association Antimicrobial Exposure Assessment Study (USEPA, 1999).
Note that 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 quantities handled/treated were estimated as indicated below.
•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 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 humidifier scenario, it was assumed that a humidifier with all gallon tank
would be treated, based on Holmes Model# FDVI4600-U-11. This humidifier releases 11
gallons/1,700 ft2/24 hours
(http://www.holmesproducts.com/estore/product.aspx?CatalogId=3&CategoryId=1120&Product
Id=582).
The duration for most homeowner exposures is believed to be best represented by the
short-term duration (1 to 30 days). The short-term duration was chosen for this assessment
because the residential handler and post-application scenarios are assumed to be performed on an
episodic, not daily basis.
11.
Residential Handler Risk Assessment
Based on toxicological criteria and the potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments for DDAC residential use. As noted previously,
MOEs greater than or equal to 100 for the inhalation route of exposure and 10 for dermal
exposure are considered adequately protective for the residential exposure assessment.
A summary of the residential handler inhalation risks are presented in Table 5b. The
calculated inhalation MOEs for all scenarios are above the target MOE of 100 and are not of
concern.
Table 5b. Short-Term Residential Handler Inhalation Exposures and MOEs
Exposure Scenario
Application Method
Application to
indoor hard surfaces
Application to
Carpets
Application to
Swimming Pools
Application to
Humidifiers
Application
Method
Mopping
Wiping
Trigger Spray
Low Pressure
Spray
Liquid Pour
Liquid Pour
Application Rate3
(Ib ai/gallon)
0.020
0.020
0.020
0.0088
0.0000244
0.0043
Quantity
Handled/ Treated
per dayb (gallons)
1
0.13
0.13
2
20,000
11
Unit
Exposure
(mg/lb a.i.)
2.38
67.3
2.4
0.681
0.00346
1.89
Daily Dose
(mg/kg/day) c
0.00079
0.0029
0.00010
0.012
0.00002
0.0015
MOEd
(Target
MOE = 100)
13,000
3,400
96,000
50,000
510,000
6,700
a Application rates are the maximum application rates determined from EPA registered labels for DDAC.
b Amount handled per day values are estimates or label instructions.
c Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x application rate (Ib ai/gal) x quantity treated (gal/day) x
absorption factor (1.0 for inhalation)]/ Body weight (60 kg for inhalation).
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MOE = NOAEL / Absorbed Daily Dose. [Where short-term NOAEL = 10 mg/kg/day for inhalation]. Target MOE =
100.
A summary of the residential handler risks from dermal exposures are presented in
Table 5c. The dermal MOEs were above the target MOE of 10 for all scenarios evaluated except
for the spray applications to carpets and the heavy duty cleaning rate (0.02 Ib ai/gallon) for
mopping and wiping.
Table 5c Short-Term Residential Handler Dermal Risks
Exposure Scenario
Application to indoor
hard surfaces
Application to
Carpets
Humidifier
Application to
swimming pools
Application
Method
Mopping
Wiping
Trigger Spray
Low Pressure
Spray
Liquid Pour
Liquid Pour
Application
Rate"
(Ib ai/gal)
0.0043
0.02
0.0043
0.02
0.0043
0.02
0.0088
0.0043
0.000017
Quantity
Handled/ Treated
per dayb (gallon)
1
0.13
0.13
2
11
20,000
Hand Unit
Exposure
Adjusted for
Surface
Area
(mg/lb
ai/cm )°
0.063
1.341
0.129
0.161
0.000239
0.000239
Dermal Skin
Irritation
Exposure d
(:g/cm2)
0.273
1.27
0.750
3.49
0.072
0.34
2.832
0.011
0.08
MOEe
(Target MOE =
100)
29
6
11
2
110
24
3
710
98
a Application rates are the maximum application rates determined from EPA registered labels for DDAC.
b Amount handled per day values are estimates or label instructions.
c Unit Exposure (mg/lb ai/cm2) = Hand unit exposure from PHED or CMA (mg/lb ai) / surface area of hand (820 cm2).
d Dermal Skin Irritation Exposure (:g/lb ai/cm2) = Unit Exposure (mg/lb ai/cm2) x Application Rate (Ib ai/gal) x Quantity
Treated (gal/day) x 1,000 :g/mg
e MOE = NOAEL (:g/cm2)/ Dermal Skin Irritation Exposure (:g/cm2). [Where short-term dermal NOAEL = 8 jig/cm2].
Target MOE = 10.
c. Residential Post-Application
i. Exposure Assessment
Residential post application exposures result when bystanders (adults and children) come
in contact with DDAC in areas where pesticide end-use products have recently been applied (e.g.
treated hard surfaces/floors), or when children incidentally ingest the pesticide residues through
mouthing the treated end products/treated articles (i.e. hand-to-mouth or object-to-mouth
contact.)
There is potential for dermal exposure to toddlers crawling on the floor. In addition to
dermal exposure, infants crawling on treated floors will also be exposed to DDAC via incidental
oral exposure from hand-to-mouth transfer. To calculate incidental ingestion exposure to DDAC
due to hand-to-mouth transfer the scenarios established in the Standard Operating Procedures
(SOPs)for Residential Exposure Assessments (USEPA 2000 and 2001) was used.
19
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Post-application scenarios have been developed that encompass multiple products, but
still represent high-end exposure scenarios. Post-application scenarios assessed include:
• crawling on treated hard surfaces, carpets, and treated lumber such as decks/play sets (dermal
and incidental oral exposure to children)
• wearing treated clothing from wash treatment and from a direct clothing spray treatment
(dermal exposure to adults and children and incidental oral exposure to children)
•mouthing/sucking on treated clothing (incidental oral exposure to children) and
•using portable humidifiers (adult and child inhalation exposure), and swimming in treated pools
(adult and child incidental ingestion).
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 skin 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 residues is achieved on the skin.
11.
Risk Assessment
Based on toxicological criteria and the potential for exposure, the Agency has conducted
dermal, inhalation, and incidental ingestion exposure assessments for DDAC. A MOE greater
than or equal to 100 is considered adequately protective for the residential exposure assessment
for the incidental oral and inhalation routes of exposure. The MOE of 100 includes 10X for
interspecies extrapolation, 10X for intraspecies variation. A MOE of 10 is considered
adequately protective for the dermal route of exposure.
A summary of the residential post-application scenarios are presented in Table 5d. The
calculated incidental oral MOEs are above the target MOE of 100 except for incidental ingestion
resulting from children mouthing/sucking on treated clothing. The dermal MOEs are above the
target MOE for all scenarios except for the adults and children wearing clothing treated with
DDAC and children playing on decks and play sets made of wood that has been treated with
DDAC. The inhalation MOEs are above the target MOE of 100 for all scenarios, except for the
humidifier use. The 24-hour inhalation MOEs for adults and children are 11 and 5, respectively.
Table 5d. Short-term Residential Post Application Risks for Adults and Children
Exposure Scenario
Child playing on floor
Child playing on carpet
Clothing
(Laundered - 1% transfer)
Clothing
(Fabric spray - 5% transfer)
Dermal MOE
(Target MOE=10)
33
45
690 adults and
children
8
Incidental Ingestion
(MOE Target MOE=100)
760
520
2,600
150
Inhalation MOE
(MOE Target
MOE=100)
NA
NA
NA
N/A
20
-------
Child playing on decks/play
sets
Swimming
Humidifiers
Range from
3 to 13
NA
NA
360
(high end)
Ranges from 330 to
4,000 for adults and
children
NA
NA
NA
Adult 11
(24-hrs)
Child 5
(24-hrs)
NA = not assessed because negligible exposure is assumed by that route for the exposure
scenario of concern.
6. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug and Cosmetic
Act (FFDCA, section 408(b)(2)(A)(ii) require "that there is 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. Acute and Chronic Aggregate Risks
The acute and chronic aggregate risk assessment includes dietary and drinking water
exposures. No drinking water exposures were identified for DDAC. Acute and chronic dietary
risk estimates from direct and indirect food uses are presented in Section 5. Table 6a presents a
summary of these exposures, including the aggregate indirect and direct dietary exposure (all
direct and indirect food contact exposures). Based on the results of the acute and chronic
aggregate assessment, the percent of aPAD and percent of the cPAD for adults and children are
3.8% and 14%, respectively. Therefore, the acute and chronic dietary risks are not of concern
(i.e., less then 100 percent of the aPAD and cPAD). Please note that for the acute duration of
exposure the only adult subpopulation for which a risk estimate was developed was females (13-
50).
21
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Table 6a. DDAC Acute and Chronic Aggregate Exposures and Risks (aPAD and cPAD)
Exposure Routes
Acute and Chronic Dietary Exposures (mg/kg/day)
Indirect
Dietary
Exposures3
Direct Food
Contact Dietary
Exposures3
Aggregate
Dietary
Exposures'3
% aPAD and cPAD
(MOE)
Adults
Oral Ingestion
0.0033
0.00046
0.00376
3.8
(2,700)
Children
Oral Ingestion
0.013
0.0012
0.0142
14
(700)
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 percent aPAD and cPAD (percent acute or chronic population adjusted dose) = aggregate exposures / (a PAD or cPAD) x 100.
Where aPAD and cPAD = NOAEL 10 mg/kg/day / lOOx uncertainty factor = 0.1 mg/kg/day. MOE = NOAEL of 10 mg/kg/day /
aggregate dietary exposures mg/kg/day.
b. Short- and Intermediate-Term Aggregate Risk
Short- and intermediate-term aggregate exposures and risks were assessed for adults and
children that could be exposed to DDAC residues from the use of products in non-occupational
environments. The following list summarizes all of the potential sources of DDAC exposures
for adults and children that have been aggregated in this assessment.
Adult DDAC exposure sources:
handling of cleaning products containing DDAC as an active ingredient during
wiping, mopping, and spraying activities;
applying DDAC as an air deodorizer using an aerosol spray;
applying DDAC to carpets using a low pressure sprayer;
applying DDAC to swimming pools via open pouring;
applying DDAC to humidifiers via open pouring;
contacting pressure treated wood;
wearing treated clothing;
use of DDAC in humidifiers; and
eating food having DDAC residues from indirect or direct food contact.
Child DDAC exposure sources:
post-application exposures to cleaning product residues containing DDAC that are
used on hard surfaces (e.g, floors/carpets);
breathing air treated with a humidifier;
swimming in treated pools;
contacting pressure treated wood;
wearing treated clothing/diapers;
eating food having DDAC residues from indirect or direct food contact.
The use patterns of the products and probability of co-occurrence must be considered
22
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when selecting scenarios for incorporation in the aggregate assessment. Table 6b summarizes
the scenarios included in the short- and intermediate-term aggregate assessments.
Table 6b. 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
DDAC-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.
The DDAC toxicity endpoints for the chronic dietary and the intermediate-term
incidental oral are based on the same toxic effect (and same study), and therefore, these two
dietary routes of exposure are aggregated. The dermal and inhalation routes of exposure are
based on different toxic effects, and therefore, these two routes of exposure are not aggregated.
However, the dermal route of exposure is aggregated among those dermal exposure scenarios
that are believed to co-occur. In addition, the inhalation route of exposure is also aggregated
among the inhalation exposure scenarios that are believed to co-occur.
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 6c presents a
summary of the short-term aggregate risks (i.e., MOEs). Only the short-term aggregate is
presented because the endpoints for incidental oral as well as inhalation are identical for the
short- and intermediate-term durations. Only a short-term dermal endpoint was identified (i.e.,
no intermediate- and/or long-term dermal endpoints were identified).
23
-------
The aggregate risks are not of concern for adults for the oral and inhalation routes of
exposure. The adult dermal MOE for the heavy duty cleaning product rate indicates that the
MOE is 1 which is less than the target MOE of 10. The general cleaning rate has an aggregate
MOE of 7 for the combined mopping, wiping, and spraying and wearing treated clothing. For
children, the oral aggregate (dietary and intermediate-term ingestion for children at day care
centers) is 270. The children aggregate MOE for the dermal route is 42 and therefore, not of
concern. No children aggregate inhalation scenarios were determined to co-occur. It is
important to note, however, that some of the individual risks for scenarios not included in the
aggregate are of concern by themselves (e.g., the humidifier use and the fabric spray for
clothing).
Table 6c. Short- and Intermediate-term Aggregate Risk (MOE) Assessment for DDAC
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
Dermal
(Heavy Duty
Cleaning)
Inhalation
2,700
NA
NA
NA
29
(mop)
6
(mop)
13,000
(mop)
11
(wipe)
2
(wipe)
3,400
(wipe)
110
(spray)
24
(spray)
96,000
(spray)
NA
NA
Not
included,
risk of
concern
NA
690
NA
2,700
7
1
2,600
Children
Oral Ingestion
Dermal
Inhalation
700
NA
NA
520
(IT hand-to-mouth carpets)
45 (playing on carpets, 5%
residue transfer)
NA
NA
NA
Not
included,
risk of
concern
2,600
(IT Laundered)
690
(Laundered)
NA
270
42
No co-
occurrence
Aggregate MOE = l/((l/MOEsameroute) + (1 /MOE same route) + etc)
24
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7. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Potential occupational handler exposure to DDAC can
occur from treatment of the following use sites: agricultural premises, industrial processes and
water systems, food handling premises, commercial/institutional/industrial premises, medical
premises, swimming pools, 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 preservative analysis, the results for handler and post-application
exposures are presented separately in Section S.d.e.
Occupational risk for all of these potentially exposed populations is measured by a
Margin of Exposure (MOE) which determines how close the occupational exposure comes to a
No Observed Adverse Effect Level (NOAEL) from toxicological studies. In the case of DDAC,
A MOE greater than or equal to 100 is considered adequately protective for the occupational
exposure assessment for the inhalation routes of exposure. The MOE of 100 includes lOx for
interspecies extrapolation, lOx for intraspecies variation. A MOE of 10 is considered adequately
protective for the dermal route of exposure.
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 the 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 DDAC to
workers, see the Occupational Exposure Assessment (Section 8.0) in the "Didecyl Dimethyl
Ammonium Chloride (DDAC): Risk Assessment," and the "Didecyl Dimethyl Ammonium
Chloride (DDAC): Occupational/Residential Exposure Assessment," dated July 27, 2006.
a. Occupational Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, occupational risks for DDAC were listed previously in Table 5a.
b. Occupational Handler Exposure
The Agency has assessed the following occupational exposure scenarios for handlers
mixing/loading/applying products containing DDAC. These scenarios represent high-end
exposure estimates.
• Agricultural Premises and Equipment: Application to hard surfaces, equipment, and
vehicles and Fogging (mix/load only)
• Food Handling/Storage Establishments Premises And Equipment: Application to indoor
hard surfaces
25
-------
• Commercial, Institutional and Industrial Premises and Equipment: Application to indoor
hard surfaces and Application to carpets
• Medical Premises and Equipment: Application to hard surfaces
• Industrial Processes and Water Systems: Small process water systems (Recirculating
cooling tower) and Oil field operations - drilling mud and packing fluids
• Application to swimming pools
DDAC dermal irritation exposures and risks were not estimated for occupational handler
exposures. These risks are addressed using personal protective equipment (PPE) requirements
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 who use products containing concentrations of DDAC that result in classification of
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. Once diluted, if the concentration of
DDAC in the diluted solution would result in classification of toxicity category IV for skin
irritation potential, then the chemical-resistant gloves and chemical-resistant apron can be
eliminated for applicators and others exposed to the dilute. Note that chemical-resistant eyewear
will be required if the end-use product is classified as category I or II for eye irritation potential.
These changes to product labels, if necessary, will occur during the product reregi strati on
process.
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) antimicrobial exposure data
(use actual title) (USEPA, 1999b: DP Barcode D247642) or from the Pesticide Handler Exposure
Database (USEPA, 1998). The specific inhalation unit exposures and quantity of DDAC
handled are provided in the Occupational and Residential Exposure assessment for DDAC dated
July 27, 2006.
The inhalation MOEs were calculated for the short- and intermediate-term durations for
occupational handlers using the oral endpoint.
c. Occupational Handler Risk Summary
The inhalation exposures and MOEs for the representative occupational handler scenarios
are presented in Table 8.a. The calculated MOEs were above the target MOE of 100 for all
scenarios, except for once-through cooling water, metering pump: using the average flow rate for
high flow streams (153 MGD) the ST inhalation MOE= 91 for initial applications.
26
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Table 7a. 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
handwand
Trigger pump sprayer
Wipe
Liquid pour
2.38
0.12
0.681
1.3
67.3
1.89
0.0094 Ib ai/gal
0.0094 Ib ai/gal
0.0094 Ib ai/gal
0.0094 Ib ai/gal
0.0094 Ib ai/gal
1.88E-051b/ft3
2 gallons
40 gallons
40 gallons
0.26 gallons
0.26 gallons
150,000ft3
0.0075
0.00075
0.0043
0.000052
0.0027
0.089
13,000
13,000
2,300
190,000
3,600
110
Food Handling/Storage Establishments Premises And Equipment (Use Site Category II)
Application to indoor hard
surfaces
Low pressure
handwand
Mop
Wipe
Trigger pump sprayer
Immersion, Flooding,
Circulation
0.681
2.38
67.3
1.3
1.89
0.0200 Ib ai/gal
0.0200 Ib ai/gal
0.0200 Ib ai/gal
0.0200 Ib ai/gal
0.00196 Ib ai/gal
2 gallons
2 gallons
0.26 gallons
0.26 gallons
2 gallons
0.00045
0.0016
0.0058
0.00011
0.00012
22,000
6,300
1,700
89,000
81,000
Commercial, Institutional and Industrial Premises and Equipment (Use Site Category III )
Application to indoor hard
surfaces
Application to carpets
Low pressure
handwand
Mop
Wipe
Trigger pump sprayer
Liquid pour
Liquid pour
0.681
2.38
67.3
1.3
1.89
0.00346
0.0200 Ib ai/gal
0.0200 Ib ai/gal
0.0200 Ib ai/gal
0.0200 Ib ai/gal
0.0043 Ib ai/gal
0.1 02 Ib ai/gal
2 gallons
2 gallons
0.26 gallons
0.26 gallons
2 gallons
32 gallons
0.00045
0.0016
0.0058
0.00011
0.00027
0.00019
22,000
6,300
1,700
89,000
37,000
53,000
Medical Premises and Equipment (Use Site Category V)
Application to hard surfaces
Mop
2.38
0.0200 Ib ai/gal
45 gallons
0.036
280
Industrial Processes and Water Systems (Use Site Category VIII)
Small process water systems:
Recirculation cooling tower
Liquid pour
Metering pump
0.45
0.00432
4.1 7 Ib ai/gal
product
Initial Dose
(ST): 1.50E-031b
ai/gal water
Maintenance
Dose (IT):
1.50E-041b
ai/gal water
2.5 gallons
20,000 gallons
20,000 gallons
0.078
0.0022
0.00022
130
ST = 4,600
IT =46,000
27
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Exposure Scenario
Oil field operations - drilling
mud and packing fluids
Once-through Cooling Water
System - Power plant
Method of Application
Liquid pour
Metering pump
Inhalation
Unit
Exposure
(mg/lb
a.i.)
0.00346
0.000265
Application Rate
1.501bai/gal
product
Slug Dose (ST):
4.89E-51bai/gal
water
Initial Dose
(ST): 4.89 E-5 Ib
ia/gal water
Quantity
Handled/
Treated per day
5.6 gallons
2.8 gallons
5,900,000
gallons
153,000,000
Inhalation
Daily Dose
(mg/kg/day)a
0.00048
0.00024
0.0013
0.033
Inhalation
MOEb'c
(Target MOE =
100)
ST = 21,000
IT = 4 1,000
ST=2300
ST=91
Swimming Pools (Use Category X)d
Application to swimming
pools
Liquid pour
0.00346
Heavy algae
Dose (ST):
0.000017 Ib
ai/gal
Maintenance
Dose (IT/LT):
0.00000417 Ib
ai/gal
200,000 gallons
200,000 gallons
0.00020
0.000048
ST= 15,000
IT=2 10,000
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 =10 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.
d. The swimming pool scenario also represents the decorative pond/fountain scenario in the aquatic area use site category because the application
rates are very similar.
d. Occupational Post-application Exposure
Post-Application exposure may occur from entering food processing plants, hatcheries, wood
treatment facilities, or from handling treated wood. Except for the post-application scenarios assessed
for fogging (food processing plant and hatchery) and wood preservatives (Section S.d.ii), occupational
post-application dermal and inhalation exposures are assumed to be negligible.
i. Fogging (Food Processing Plant and Hatchery)
There is potential for post-application exposure for workers reentering treated hatcheries
and food processing plants. Dermal post-application exposure is presumed to be negligible for
hatchery workers; therefore, these risks were 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. 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; the
model does not account for actual absorption into the body.
28
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The fogging application in a food processing plant was assessed using a maximum
application rate of 0.0065 Ib ai/gal, assuming one quart of the diluted product was used per 1,000
cubic feet of treated area. For fogging applications, a two hour restricted entry interval is
required on current labels. The MOE for fogging in the food processing plant with a 2-hr re-
entry interval MOE is 7, well below the target MOE of 100. The risks of concern for the food
processing plant are attributed to the low air changes per hour assumed (i.e., 0.18 ACH as a
default parameter in MCCEM to represent low air flow) in the assessment. This assessment can
be refined with additional information on air flows in food processing plants.
The fogging application in a hatchery was assessed using a maximum application rate of
0.181 Ib ai/gal, assuming 0.42 gallons of the diluted product was used per 4000 cubic feet of
treated area. Fogging in hatcheries is not of concern since the 8-hr MOE is well over 100 after a
2 hour REI.
ii. Wood Preservation
DDAC is used in products that are intended to preserve wood through both non-pressure
treatment methods and pressure treatment methods. Section 8.ii. 1 presents the exposure analysis
for the handler and post-application scenarios for non-pressure treatment scenarios and Section
8.ii.2 presents the exposure analysis for the handler and post-application scenarios for pressure
treatment scenarios.
DDAC dermal irritation exposures and risks were not estimated for occupational handler
exposures. These risks are addressed using PPE requirements already existing on labels. The
level of PPE required is based on the toxicity of the end-use product.
1. Non-Pressure Treatment Scenarios (Handler and Post-application)
There is potential for post- application exposure from DDAC for workers. 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, MRID 455243-04) identified various worker functions/positions for individuals that
handle DDAC-containing wood preservatives for non-pressure treatment application methods
and for individuals that could then come into contact with the preserved wood. The worker
functions/positions identified in the DDAC study are presented below.
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.
29
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• Chemical operators for a 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.
Post-application:
• Graders, positioned right after the spray box, grade dry lumber by hand (i.e. detect faults).
In the DDAC study, graders graded wet lumber; therefore, the exposures to graders using
DDAC are worst-case scenarios.
• 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. In the
DDAC study, hula trim saw operators handled dry lumber.
• Construction workers install treated plywood, oriented strand board, medium density
fiberboard, and others.
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
Table 7.b provides the inhalation doses and MOEs for the workers adding the
preservative to the wood slurry. The inhalation MOE is above the target MOE of 100 for short-,
intermediate-, and long-term inhalation exposures.
Table 7.b 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
280
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 nrVgallon 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 = 10 mg/kg/day for inhalation. Target MOE = 100.
Chemical Operators (post application): Graders, Millwrights, Clean-up Crews, and Trim
Saw Operators
Table 7.c provides the short-, intermediate-, and long-term inhalation doses and MOEs
for chemical operators, graders, millwrights, clean-up crews, and trim saw operators. The
inhalation MOEs are above the target MOE of 100 for all worker functions. Any dermal irritation
30
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exposures from post-application activities will be mitigated using default personal protective
equipment requirements based on the toxicity of the end-use product.
Table 7.c 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)
ST
a.
b.
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
NA
0.000468
21,000
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
NA
NA
NA
NA
0.000491
0.00101
0.00095
0.0101
20,000
9,900
11,000
990
= 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 the Occupational and Residential Exposure
Assessment for inhalation exposures. Inhalation exposure (mg/day) was calculated using the following equation: Air
c.
d.
e.
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.
A conversion ratio is not needed because the maximum % active ingredient in the product is the same as the % active
ingredient in the DDAC study.
Daily dose (mg/kg/day) = exposure (mg/day) x absorption factor (100% for inhalation)/body weight (60 kg).
MOE = NOAEL (mg/kg/day)/ Daily dose [Where inhalation NOAEL = 10 mg/kg/day]. Target MOE = 100.
Diptank Operators
These workers are exposed through automatic or manual dip of wood into treatment
tanks. Risk resulting form diptank use were assessed using the data from the DDAC study
(Bestari et al., 1999). The exposure data for diptank operators were converted into unit exposures
in terms of active ingredient, for each 1% of concentration of the product. Table 8.d 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 7.d 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
31
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Exposure Scenario3
(number of replicates)
Dipping, with gloves (n=7)
Inhalation Unit Exposure13
(mg DD AC/1% solution)
0.046
App Rate
(% a.i. in solution/ day)
3
Daily Dose0
(mg/kg/day)
0.0023
MOEd
4,300
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
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 = 10 mg/kg/day.] Target MOE =
100.
2. Pressure Treatment Scenarios (Handler and Post-Application)
DDAC 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 Ib/ft3. An application rate of 3% ai solution was used in this assessment, based on the master
label. DDAC-specific exposure data are not available for assessment of pressure treatment
exposure. Therefore, the assessment relies on surrogate chromated copper arsenate (CCA) data
(ACC, 2002b).
The estimated inhalation exposures and risks for DDAC are presented in Table 8.e. The
calculated inhalation MOEs are above the target MOE of 100 for all scenarios and are not of
concern.
Table 8e Short-, Intermediate-, and Long-Term Inhalation Exposures and MOEs for
Pressure Treatment Handler and Post-application Scenarios
Exposure Scenario
Inhalation Unit
Exposure3
(ug As/ppm)
Application Rate
(% ai solution)
Absorbed Daily Dosesb
(mg/kg/day)
Inhalation
MOEsc
(Target MOE =
100)
Occupational Handler
Treatment Operator (TO)
Treatment Assistant (TA)
0.00257
0.000802
3
3
0.0013
0.00040
7,800
25,000
Occupational Post-application
All (Tram setter, stacker
operator, loader operator,
supervisor, test borer, and
tallyman)
0.00160
o
J
0.00080
13,000
i. Unit exposure values taken from CCA study and are shown in Table 6.11.
3. Absorbed Daily Dose (mg/kg/day) = Unit Exposure (ug As/ppm) x [% DDAC 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).
32
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MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 10 mg/kg/day for all durations. Target MOE =
100.
8. Human Incident Data
The Agency reviewed available sources of human incident data for incidents relevant to
DDAC. The quaternary ammonium compounds (Quats) are clustered into four categories;
however, for the available incident information, it is difficult to differentiate the specific
members quaternary ammonium compounds associated with each incident. Therefore, all
incidents related to the these compounds are discussed together in this section.
The Agency consulted the following sources of information for human poisoning
incidents related to DDAC use:
(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) - The California
Department of Pesticide Regulation pesticide poisoning surveillance program consists of
reports from physicians of illness suspected of being related to pesticide exposure since
1982.
(3) National Pesticide Information Center (NPIC) - NPIC is a toll-free information
service supported by OPP that provides a ranking of the top 200 active ingredients for
which telephone calls were received during calendar years 1984-1991.
(4) Published Incident Reports - Some incident reports associated with Quat related
human health hazards 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
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
33
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Oral
Ocular
irritation to mouth/throat/nose,
vomiting/nausea/abdominal pain,
dizziness, and headache
irritation/burning, eye pain,
conjunctivitis,
swelling eye and swelling of eyelid
B. Environmental Risk Assessment
The Agency's ecological assessment compares toxicity endpoints from ecological
toxicity studies to estimate environmental concentrations based on environmental fate
characteristics and pesticide use data. A summary of the Agency's environmental risk
assessment is presented below. The following risk characterization is intended to describe the
potential for estimated environmental risks for DDAC use sites and any associated uncertainties.
For detailed information on the environmental risk assessment for DDAC please see the
following documents: "Environmental Fate Assessment for Didecyl Dimethyl Ammonium
Chloride (DDAC) for the Reregi strati on Eligibility Decision (RED) Document" ;"Ecological
Hazard and Environmental Risk Assessment Chapter on Didecyl Dimethyl Ammonium Chloride
(DDAC)-Antimicrobial Uses"; and 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" .
1. Environmental Fate and Transport
The environmental fate assessment for DDAC is based on the available data submitted to
fulfill the reregi strati on data requirements. The available data indicates that DDAC is
hydrolytically stable under abiotic and buffered conditions over the pH 5-9 range. The
calculated half-lives for DDAC were 368 days at pH 5, 194 days at pH 7 (TRIS), 175 days at pH
7 (HEPES), and 506 days at pH 9. DDAC is stable to photodegradation in pH 7 buffered
aqueous solutions; even in the presence of a photosensitizer (acetone), degradation is minimal
with a calculated half-life of 227 days. DDAC is photolytically stable in soil with a calculated
half-life of 132 days.
Aquatic metabolism studies under aerobic and anaerobic conditions indicate that DDAC
is stable to microbial degradation. The calculated aerobic and anaerobic half-lives of 14C-DDAC
in flooded river water are 180 days and 261 days, respectively. Similarly, DDAC was found to
be stable with very little degradation in aerobic soils during a year-long metabolism study. The
calculated half-life for aerobic soil degradation was 1,048 days. DDAC is not considered to be
degradable since it did not exhibit greater that 60% degredation within a ten-day window.
DDAC is immobile in soil. A soil mobility study reviewed by the Agency shows that
DDAC has a strong tendency to bind to sediment/soil with Freundlich Kads values ranging from
1,095 to 30,851 depending on the soil type. Because of its strong adsorption to soils, DDAC is
not expected to contaminate surface and ground waters.
Because DDAC is immobile in soil, and not subject to runoff contamination of water
bodies, bioaccumulation of DDAC in freshwater fish or aquatic organisms is not likely to occur.
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Information on the aqueous availability of DDAC from wood indicates that the use of DDAC as
a wood preservative may result in minimal releases to the environment.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics and pesticide use data.
a. Toxicity (Hazard) Assessment
DDAC Indoor Uses
The majority of DDAC uses are spray applications to indoor surfaces, truck interiors,
kennels, institutional areas, household areas, recirculating cooling towers, evaporative
condensers, swimming pools and spas, and oil field mud treatments. For the indoor uses of
DDAC, it is unlikely that any appreciable exposure to terrestrial or aquatic organisms would
occur. However, facilities using DDAC for indoor applications are required to have NPDES
permits prior to discharging effluents into receiving waters.
Once Through Cooling Tower Use:
Once through cooling tower use will result in a significant release of DDAC into the
nearby waterways. Tier I once-through cooling tower modeling indicates that DDAC use will
result in acute and chronic risk to all non-endangered and endangered/threatened aquatic
organisms at all dosages modeled: 32 ppm and 63 ppm for continuous dosing and 1000 ppm and
1800 ppm for intermittent dosing.
This scenario models a worst-case 10-year. Variables such as stream flow rate and
DDAC dissipation, degradation, and half-life were not considered in this Tier I model.
Wood Treatment Use:
DDAC wood treatment uses that have potential for direct release into the environment or
runoff to surface waters. The DDAC wood treatment use was modeled (Krahn and Strub, 1990)
to estimate the amount of DDAC that will runoff from treated wood when stored outdoors.
Modeled estimates range from 18.97ppb to 113ppb. Non-endangered/threatened aquatic species
(fish and invertebrates) are not expected to be adversely affected, all estimates are above the
LOC.
Endangered/threatened fish (freshwater warm water species) are not expected to be
adversely affected by the wood treatment use. However, endangered species LOCs are exceeded
based on Tier 1 modeling for many other aquatic organisms.
b. Exposure and Risk
The Agency has evaluated the outdoor use of the DDAC, being considered for
reregi strati on. Although primarily used as antimicrobial agents, DDAC is labeled for use in
puddles and decorative pools to control algae. This use is intended for waterbodies generally
35
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disconnected from the greater watershed and will not likely result in exposure to nontarget
aquatic species. It is possible these uses will result in exposure to amphibians utilizing these
waterbodies for some portion of their lifecycle (e.g. reproduction) and to birds and mammals
utilizing these waterbodies for drinking water. At the maximum label rate, 3 ppm initially
followed by weekly 1.5 ppm treatments, there are no LOG exceedances, assuming the toxicity of
DDAC is similar to that of ADBAC, another Quat compound. However, due to the persistence
of DDAC, it is possible that concentrations of DDAC in some waterbodies treated over time
could become harmful to animals utilizing these waterbodies.
Non-target Pests
Honeybees could potentially be exposed to pesticide residues if treated wood is used to
construct hives or hive components. These residues may be toxic to the bees or result in residues
in honey or other hive products intended for human use/consumption. Therefore, a special
honeybee study is required for all wood preservative uses unless a statement prohibiting the use
of treated wood in hive construction is added to the label such as, "Wood treated with TCMTB
shall not be used in the construction of beehives." This study is a combination of Guidelines
171-4 and 850.3030 (see information regarding residue data requirements for uses in beehives in
the residue chemistry section of 40 CFR part 158). Numbers of bees used in this study and
methods for collection/introduction of bees into hives, feeding, and observations for toxicity and
mortality should be consistent with those described in OPPTS Guideline 850.3030, "Honey Bee
Toxicity of Residues on Foliage." The toxicity portion of this study is in lieu of the honeybee
contact LD50 test.
c. Risk to Listed Species
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. Part 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
36
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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 DDAC, with the exception of the cooling tower and antisapstain wood preservation uses,
fall into this category. Using Tier I screening modeling to assess potential exposure from the
cooling tower and antisapstain wood preservation uses of DDAC risks to Listed Species are
indicated. Since the models are only intended as a screening-level model, and, as such, have
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 cooling tower and antisapstain uses of DDAC. 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 cooling tower and antisapstain uses of DDAC until additional data and
modeling refinements are available. At that time, the environmental exposure assessment of the
cooling tower and antisapstain use of DDAC 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 DDAC as an active ingredient. The Agency has completed its review of
these generic data and has determined that the data are sufficient to support reregistration of all
supported products containing DDAC.
The Agency has completed its assessment of the dietary, residential, occupational,
drinking water, and ecological risks associated with the use of pesticide products containing the
active ingredient DDAC. Based on a review of these data and on public comments on the
Agency's assessments for the active ingredient DDAC, the Agency has sufficient information on
the human health and ecological effects of DDAC 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 DDAC-containing products are eligible for
reregi strati on provided that: (i) current data gaps and confirmatory data needs are addressed; (ii)
the risk mitigation measures outlined in this document are adopted; and (iii) label amendments
are made to reflect these measures. Label changes are described in Section V. Appendix A
summarizes the uses of DDAC 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 DDAC 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 DDAC, the Agency has determined that DDAC 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 DDAC. If all changes outlined in this document are incorporated into the product labels,
then all current risks for DDAC 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 DDAC. During the public comment period on the
risk assessments, which closed on June 26, 2006, the Agency received comments from the
DDAC Consortium, Reckitt Benckiser, and The Clorox Company regarding the risk assessment
assumptions. These comments in their entirety are available in the public docket at
http://www.regulations.gov (OPP-2006-0338).
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C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with DDAC. The Agency has concluded that the risk from dietary exposure is within the "risk
cup." An aggregate assessment was conducted for exposures through food and residential uses.
The DDAC contributions for drinking water exposure are considered to be negligible; therefore,
Dietary exposure from drinking water was not assessed, as the uses of DDAC have been
determined to have no impact on surface or ground water. 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 DDAC. The Agency has determined that provided a safety finding can be made for DDAC,
the established tolerance exemptions for DDAC, with amendments and changes as specified in
this document, meet the safety standards under the FQPA amendments to section 408(b)(2)(D) of
the FFDCA, and that there is a reasonable certainty no harm will result to the general population
or any subgroup from the use of DDAC. In reaching this conclusion, the Agency has considered
all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of DDAC. As discussed in Section III, the acute and chronic dietary
(food and drinking water) risks from DDAC are below the Agency's level of concern, provided
that mitigation measures outlined in this document are adopted and labels are amended.
The chronic dietary aggregate risks from direct and indirect food contact exposures for
adults and children are 3.8 % and 14 % respectively. Therefore, the acute and chronic dietary
aggregate risks are not of concern.
The DDAC toxicity endpoints for the chronic dietary and the intermediate-term
incidental oral are based on the same toxic effect (and same study), and therefore, these two
dietary routes of exposure are aggregated. On the other hand, the dermal and inhalation routes of
exposure are based on different toxic effects, and therefore, these two routes of exposure are not
aggregated. In addition, the inhalation route of exposure is also aggregated among the inhalation
exposure scenarios that are believed to co-occur. The aggregate risks are not of concern for
adults for the oral and inhalation routes. However, the adult dermal MOE for the cleaning
products are all of concern by themselves. As an aggregate, the adult dermal MOE is less than
the target MOE of 10. The aggregate risks for children are above the target MOE.
c. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of DDAC, 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
39
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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 DDAC 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 DDAC residues, the Agency considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other
information. The FQPA Safety Factor has been removed (i.e., reduced to IX) for DDAC
based on (1) the existence of a complete developmental and reproductive database (2) the lack of
evidence for increased susceptibility in the data and (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, DDAC 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 DDAC.
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 DDAC.
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
40
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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 Reassessment Summary
Didecyl Dimethyl Ammonium Chloride, DDAC has a tolerance exemption in 40 CFR
180.940 (a) as a food contact sanitizer for use in public eating places, in dairy processing
equipment, and in food processing plants on equipment and utensils and (c) as a food contact
sanitizer for use in food processing plants on equipment and utensils.
Table 9: Tolerance Reassessment Summary for DDAC
Tolerance Exemption Listed Under 40 CFR 180.940 (a)
Use Site
public eating places, dairy
processing equipment,
and food processing
plants on equipment and
utensils
Current Limit
(ppm)
Total Quat
concentration
does not exceed
200
Reassessment
(ppm)
Total Quat
concentration
does not exceed
200 ppm
Correct Definition/Comment
No change in current definition
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 while total
Quat
concentration
does not exceed
400
Reassessment
(ppm)
Specific Quat
concentration
does not exceed
200 while total
Quat
concentration
does not exceed
400
Correct Definition/Comment
No change in current definition
D. Regulatory Rationale
The Agency has determined that DDAC 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 this measure.
The following is a summary of the rationale for managing risks associated with the use of
DDAC. Where labeling revisions are warranted, specific language is set forth in the summary
tables of Section V of this document.
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1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
The acute and chronic dietary risks from DDAC 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
The DDAC contributions for drinking water exposure are considered to be negligible,
thus no drinking water mitigation measures are necessary at this time.
c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler risks were considered for pouring DDAC into swimming pools and
humidifiers, mopping, wiping and trigger pump spray, and low pressure hand wand. All
exposure scenarios except carpet treatment by low pressure spray and indoor hard surface
mopping and wiping are below the level of Agency concern to residential handlers.
Mitigation of the treatment of carpet by low pressure spray is accomplished via labeling
and container size restrictions such that products with this use are not available to residential
applicators. Products with label directions for application by low pressure spray are only to be
marketed in 5 gallon or larger containers and will include the statement: "For Professional Use
Only" with appropriate PPE label statements.
The individual dermal MOEs at the treatment solution concentration of 0.0043 Ib
ai/gallon for hard surface cleaning includes mopping (MOE = 29), wipes (MOE =11), and
spraying (MOE = 110). The dermal aggregate MOE for the 0.0043 Ib ai/gallon hard surface
cleaning rate is 7 with a target MOE of 10. The aggregate MOE includes the three cleaning
scenarios plus the exposure to adults wearing treated laundered clothing (MOE = 690). The
individual dermal MOEs for all four scenarios are not of concern. Once aggregated, the MOE of
7 is less than the target MOE of 10. The assumption of the four scenarios co-occurring at the
highend assumptions used in the assessment for amount of treatment solution applied is very
conservative. Therefore, the dermal aggregate MOE of 7, based on a NOAEL for dermal
irritation, achieves a reasonable certainty of no harm.
However, the heavy duty cleaning rate of 0.02 Ib ai/gallon results in an aggregate dermal
MOE of 1. Mitigation of the treatment of indoor hard surfaces by mopping and wiping is
accomplished by reducing the application rate to 0.0066 Ib ai/gallon which results in individual
dermal MOEs for mopping, wiping, and spraying of 19, 7, and 72, respectively. The dermal
42
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aggregate MOE using these three individual MOEs plus the treated laundered clothing is 5.
While this rate does not result in an acceptable MOE, the Agency believes that the assessment is
conservative and that the actual exposures would not be of concern. The Agency recently
received extensive use and activity pattern information from industry. A preliminary review of
this data suggests that the assumptions used in the wiping and mopping scenarios may
overestimate actual use. Again, this rate (0.0066 Ib ai/gallon) and a dermal aggregate MOE of 5
based on a NOAEL for dermal irritation, achieves a reasonable certainty of no harm.
ii. Post-Application Risk Mitigation
Post-application scenarios have been developed that encompass multiple products, but
still represent a high end exposure scenario for all products represented. Post-application
scenarios assessed include crawling on treated hard surfaces, carpets, and treated lumber such as
decks/play sets (dermal and incidental oral exposure to children), wearing treated clothing from
wash treatment and from a direct clothing spray treatment (dermal exposure to adults and
children and incidental oral exposure to children), using portable humidifiers (adult and child
inhalation exposure), and swimming in treated pools (adult and child incidental ingestion).
All exposure scenarios except dermal exposure to clothing treated with fabric spray,
exposure of children to treated decks/play sets and inhalation exposures due to use in humidifiers
are below the level of Agency concern for residential post application exposure.
The assumptions used in developing the risk estimates for the fabric spray scenario are
considered to be very conservative. It was assumed that individuals would be exposed via oral
mouthing and dermal contact to fabrics that had wetness equivalent to freshly laundered clothing
removed from the washer following the final spin cycle. The Agency believes that it is unlikely
that people would actually be exposed to treated fabrics with this high level of dampness.
Therefore, the Agency has overestimated risks for this scenario.
Based on a screening level assessment, the MOEs for children playing on treated decks
and play sets ranged from 3 to 13. The Agency believes that actual exposures are most likely to
occur at the upper end of this range and, thus are not of concern. Further, these risk estimates
were derived from exposures from a study of workers exposed to DDAC following the
antisapstain treatment of freshly cut lumber. This scenario involves workers handling treated
wood shortly after a surface spray-on treatment of the lumber for an 8-hour work day where
residues on the wood would be relatively high. The residential exposure scenario is considerably
different in that children would be exposed to pressure-treated wood for a shorter duration at a
time that is much more distant from the actual treatment of the wood (time taken to treat, ship the
wood and construct the deck/playset as compared to minutes to hours post treatment.) Therefore,
the Agency believes that actual exposures would be at the upper end of the range and not of
concern. To confirm this finding the Agency will require confirmatory surface wipe data for
DDAC.
At this time, there are no available mitigation measures for the humidifier use. Because of
remaining residential exposure concerns, the registrants for DDAC 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 DDAC in
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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.
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
Occupational risks from handler and applicator exposures were calculated for short-,
intermediate- and long-term inhalation exposures. All exposure and risk estimates for
occupational handler scenarios are below the Agency's level of concern except for once-through
cooling water systems (MOE 91.) Due to the conservative nature of the risk assessment and the
proximity of the MOE to the target of 100, the Agency believes that actual exposures do not
exceed the Agency's level of concern. Therefore, no risk mitigation measures are required for
these handler scenarios.
ii. Post-Application Risk Mitigation
Except for the post-application scenario assessed for fogging in food processing plants
and hatcheries, the occupational post-application dermal and inhalation exposures are assumed to
be negligible. To mitigate the risk of concern for the fogging use the Agency is requiring that
labels to include a 2 hour reentry interval the fogger use in food processing plants and hatcheries.
In addition to the REI, food processing plants will be required to have a minimum four (4) ACH
(air exchanges) per hour in order to be treated with this chemical.
2. Environmental Risk Management
There is minimal environmental exposure from the indoor uses; such as commercial,
institutional, residential hard surfaces, re-circulating cooling water towers, pulp/paper mills, and
oil field mud treatments, of products containing DDAC because the amount that actually reaches
the environment is negligible and breakdown in the environment via sewage treatment is rapid.
Alternatively, there is the potential for environmental exposure from the outdoor uses
from products containing DDAC; once-through cooling water towers and antisapstain wood
treatment. In order to reduce the environmental risk, the following mitigation measures must be
adopted:
Once-Through Cooling Water Towers:
Reduce the maximum number of applications to 4 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 released.
The Agency will require monitoring data to confirm this decision.
Antisapstain Wood Treatment: All product labels supporting this use must carry the following
language:
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Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond, lake,
stream, wetland, or river to prevent possible runoff of the product into the waterway. Treated
lumber stored within 100 feet of a pond, lake, stream, or river must be either covered with plastic
or surrounded by a berm to prevent surface water runoff into the nearby waterway. If a berm or
curb 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. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing DDAC. For the specific labeling
statements and a list of outstanding data, refer to Section V of this RED document.
4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
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
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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 DDAC, with the exception of the cooling tower and antisapstain wood preservation uses,
fall into this category. Using Tier I screening modeling to assess potential exposure from the
cooling tower and antisapstain wood preservation uses of DDAC 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 cooling tower and antisapstain uses of DDAC. 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 (see General Risk Mitigation, below). Due to these circumstances,
the Agency defers making a determination for the cooling tower and antisapstain uses of DDAC
until additional data and modeling refinements are available. At that time, the environmental
exposure assessment of the cooling tower and antisapstain use of DDAC will be revised, and the
risks to Listed Species will be reconsidered.
b. General Risk Mitigation
DDAC end-use products (EPs) may also contain other registered pesticides. Although
the Agency is not proposing any mitigation measures for products containing DDAC 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 DDAC 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 DDAC 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 Tracy Lantz at (703) 308-6415 with questions regarding generic reregi strati on.
By US mail: By express or courier service:
Document Processing Desk (DCI/AD) Document Processing Desk (DCI/AD)
Tracy Lantz Tracy Lantz
US EPA (751 OP) Office of Pesticide Programs (751 OP)
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460 2777 South Crystal Drive
Arlington, VA 22202
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For end-use products containing the active ingredient DP AC, the registrant needs to submit the
following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (EPA Form 8570-4);
2. A completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. Five copies of the draft label incorporating all label amendments outlined in Table 13
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
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, One 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 DDAC 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
Descriptions of Human Activity (all uses)
Dietary -Residues in Food from Treating
Countertops with DDAC (FDA Wipe Study
Methodology) (FDA, 2003a and 2003b)
Surface Wood Wipe Study
Fabric Leaching Study
Dermal exposure outdoor
Inhalation Exposure outdoor
90-Day Inhalation Rat
Non-Target plant phytotoxicity (seedling
emergence test using rice)
Aquatic Field Monitoring (once through
cooling towers)
Fish-Early Life Stage
Aquatic Invertebrate Life Cycle
Vegetative Vigor using rice
Aquatic plant growth toxicity (Lemma gibba)
Aquatic plant growth (3 Algal toxicity
species) blue-green cyanobacteria (Anabeana
flos-aquae), freshwater diatom (Navicula
pelliculosa), marine diatom (Skeletonema
costatum)
Honey Bee Toxicity studies
New OPPTS Guideline No.
875.1200,875.1600
875.1400,875.1600
875.2800
Non-Guideline
Non-Guideline
Non-Guideline
875.1100,875.1600
875.1300,875.1600
870.3465
850.4225
Non-Guideline
850.1300
850.1400
850.4250
850.4400
850.5400
850.3030
Old Guideline No.
233,236
234, 236
133-1
Non-Guideline
Non-Guideline
Non-Guideline
231
232
82-4
123-1
Non-Guideline
72-4A
72-4B
123-1
123-2
123-2
141-1
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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
Toilet Bowl
Disinfection
Use Pattern
Hard inanimate
surfaces
Toilet bowl and
urinal hard 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 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)
810.2600 (b)(l)
Old Guideline
No.
91-2 (b),
(c), (d)
91-7 (a) (1)
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Claim
Laundry
Additives
Disinfection
(pre-soak)
Laundry
Additives
Disinfection
(non-residual)
Tuberculocidal
Virucidal
Fungicidal
Sanitizer
Use Pattern
Laundry
Laundry
Hard inanimate
surfaces
Hard inanimate
surfaces
Hard inanimate
surfaces
Non-food contact
surfaces (non-
residual)
Guideline Study Name
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
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
New OPPTS
Guideline No.
810.2300 (b)(2)
810.2300 (b)(3)
810.2100 (h)
810.2100 (g)
810.2100 (f)
810.2100 (1)
Old Guideline
No.
91-4 (a)(l)
91-4 (a)(2)
91-2 (g)
91-2 (f)
91-2 (e)
91-2 CJ)
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Claim
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
Termites
Use Pattern
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 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
Pesticide Assessment Guidelines
Subdivision G, Product
Performance, Preventative
treatment-wood impregnation
New OPPTS
Guideline No.
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 (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)
Section 95-
12(b)(ii)
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.
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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.
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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 Products
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 courses, greenhouses/nurseries,
fountains/water displays/decorative ponds/standing water, disposal water, spas, air
conditioner/refrigeration condensate water systems, air washer and industrial scrubbing
systems, once- through and recirculating industrial/commercial cooling 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
Precautionary Statements for all
Manufacturing Use Products
(based on concentration of
active ingredients)
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
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Description
Environmental Hazards
Language Required by the RED
and PR Notice 93-10 and 95-1
Amended Labeling Language
"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. "
Placement on Label
Environmental Hazard
Statements
End Use Products Intended for Commercial, Institutional, Industrial, and Agricultural Uses
PPE Requirements1
Hatcheries
Food Processing Plants
Wood Preservation
Application Restrictions-For
Products Used in Swimming
Pools/Spas
Environmental Hazards -for
Labels for AntiSapstain
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
Label must include dilution rate and retention chart specific to the type of wood 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 DDAC shall
not be used in the construction of bee hives.
Do not apply when swimmers are in the immediate vicinity (the Agency recommends a 15
minute reentry interval)
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 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.
Precautionary
Statements
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Environmental Hazards
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Description
Environmental Hazards for
Once Through Cooling Water
Towers
Humidifiers
Pulp and Paper Mill Water
Systems
Hard nonporous surfaces in
Institutional/Commercial Food
Handling Facilities *
Disinfection/Sanitizing
Drains/Disposals *
Institutional/Commercial
Laundry Treatment *
Addition of ATCC number *
Hand Sanitizer *
Udders, Teats and Flanks *
Treatment of Hatching Eggs *
Amended Labeling Language
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 minimum ratio 5 ppm clay to 1 ppm product.
Deactivation must occur prior to discharge of the NPDES outfall.
Delete the Use
Delete the Use. This use is not supported by this RED. There are no end use products for this
use, thus a risk assessment for this use was not completed.
After disinfection, a potable water rinse is required. Do not use on dishes, glasses, and
utensils. Do not use to disinfect appliances, refrigerator interiors, and microwave oven
interiors.
Delete the claim because the Agency believes it is not feasible to disinfect throughout a drain
w/ or w/out a disposal system.
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.
All organisms tested to support bactericidal, virucidal, and fungicidal claims must list the
ATCC number to identify the specific strain of organism.
Delete the Use. This use is regulated only by the Food and Drug Administration.
Delete the Uses. These uses are regulated only by the Food and Drug Administration.
Delete the Use. This use is regulated only by the Food and Drug Administration.
Placement on Label
Directions for Use
Delete all claims and
Directions for Use
Delete all claims
Directions for Use
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
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Description
Amended Labeling Language
Placement on Label
Sanitizing Incubators and
Hatchers
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.
Directions for Use
Carpet Restoration Treatment
(due to damage from flood, fire,
smoke other water damage)
This use only for commercial, industrial and institutional applicators: thus products with this
use are only to be marketed in 5 gallon or larger containers with statement: "For Professional
Use Only" with appropriate PPE statements listed on label including the use of gloves.
Refer to http://www.epa.gov/mold/mold remediatioahtml Table 1 & 2 for Remediation
Directions for Use.
Directions for Use and
Precautionary
Language
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 remediatioahtml Table 1 & 2 for Remediation
Directions for Use.
Directions for Use and
Precautionary
Language
Agricultural Premises and
Equipment/Animal housing
facilities *
All animal viruses claimed on the label must immediately precede directions for agricultural
premises and equipment/animal housing facilities.
Directions for Use
Institutional/ Medical premise
and equipment *
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" must
be added or the following MOU language from PR Notice 94-4 must be included in the label
text:
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.
Directions for Use
57
-------
Description
Treatment of Eggs in Egg
Processing Facilities *
Treatment of Mushroom Farms
Sanitizing Hatchery Rooms
Algae Treatment for Fountains,
Water Displays, Decorative
Pool/Ponds and Standing Water
Citrus Canker Control
Amended Labeling Language
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.
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.
Label must include the following text: Remove all animals and feed from premise, vehicles
and enclosures.
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. DO NOT use when fish
or other wildlife (for example, amphibians) are present.
Label must include the following text: After use, all surfaces which come in contact with food
or crop must be rinsed with potable water.
Placement on Label
Directions for Use
Directions for Use
Directions for Use
Direction for Use
End Use Products Intended for Residential Use
PPE Requirements1
Cleaning of hard surfaces by
Mopping and Wiping
Application Restrictions-For
Products Used in Swimming
Pools/Spas
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.
The use of products in this manner is limited to a final concentration (use solution) of no more
than 0.0066 Ib DDAC per gallon of water. This is equivalent to a final concentration (use
solution) of DDAC at no greater than 786 ppm. Revise labels such that this is the maximum
rate for any cleaning or heavy duty cleaning in which this product may be applied by mopping
or wiping.
Do not apply when swimmers are in the immediate vicinity (the Agency recommends a 15
minute reentry interval)
Immediately
following^elow
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Directions for Use
Directions for Use
under General
Precautions and
Restrictions
58
-------
Description
Disinfection/Sanitizing
Drains/Disposals *
Addition of ATCC number *
Carpet Restoration Treatment
(due to damage from flood, fire,
smoke other water damage)
Mold Remediation/Prevention
(Water/Smoke restoration/Sewer
backup/river flood cleanup/clean
water source)
Humidifiers
Algae Treatment for Fountains,
Water Displays, Decorative
Pool/Ponds and Standing Water
Hard, non-porous food contact
surfaces *
Amended Labeling Language
Delete the claim because the Agency believes it is not feasible to disinfect throughout a drain
w/ or w/out 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.
This use only for commercial, industrial and institutional applicators only. Delete this use from
residential products.
Refer to http://www.epa.gov/mold/mold remediatioahtml Table 1 & 2 for Remediation
Directions for Use.
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 remediatioahtml Table 1 & 2 for Remediation
Directions for Use.
Delete the Use
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. DO NOT use when fish
or other wildlife (for example, amphibians) are present.
Do not use to disinfect appliances, refrigerator interiors, and microwave oven interiors. Do not
use as a disinfectant on dishes, glasses, or utensils.
Placement on Label
Directions for Use
Directions for Use
Directions for Use
under General
Precautions and
Restrictions
Directions for Use and
Precautionary
Language
Delete all claims and
Directions for Use
Direction 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.
59
-------
VI. APPENDICES
60
-------
Appendix A. Master Label Table for DDAC
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
1839-129
1839-129
6836-235
1839-179
Small Process Water Systems
Small Process Water Systems
Industrial Water Systems
Oil Field Operations-Drilling
Mud and Packing Fluids
Cooling Towers
(recirculating only)
evaporative
condensers, dairy
sweetwater
systems, cooling
canals, pasteurizers,
tunnel coolers and
warmers
Cooling Towers
(recirculating only)
evaporative
condensers, dairy
sweetwater
systems, cooling
canals, pasteurizers,
tunnel coolers and
warmers
Once Through
Cooling
Oil Field Water
Disposal Systems,
Injection and
Wastewater, Packer
Fluids, Drilling
Muds
Pour
Metered
Metered
Pour/Metered,
Continuous
Injection, Batch
Treatment
Do Not Apply this
Product More Than 4
Times Per Year
Labels Must Carry
NPDES Statement
497,000 ppm
Initial: 178
ppm
Maintenance:
17.9 ppm
5.83 ppm
179,000 ppm
Swimming Pools
10324-69
1839-133
Swimming Pool
Swimming Pool
Swimming Pool
Outside
Spas/Whirlpools/
Hot Tub Bath
pour
pour
Do not apply when
swimmers are in the
immediate vicinity (the
Agency recommends a 1 5
minute reentry interval)
Do not apply when
swimmers are in the
immediate vicinity (the
Agency recommends a 1 5
minute reentry interval)
Initial/Winter
Treatment: 2
ppm
Maintenance
Dose: 0.5 ppm
2 ppm
Aquatic Areas
499-482
decorative
fountains,
decorative pools,
ponds, water
displays and
standing waters
associated with
greenhouse/
nurseries, golf
courses,
recreational parks,
amusement parks,
universities,
cemeteries
dribble, spray
ring
Refer to Table 13
(Labeling Changes
Summary Table) for
appropriate label
restriction
For Algae
control
Initial
Treatment: 3
ppm
Maintenance
Dose: 0.5 ppm
61
-------
EPA Reg
Number
used for
Max. Appl.
Rate
499-482
Use Site
Treatment
Site/Surfaces
irrigation system,
watering lines, drip
lines, emitters,
watering nozzles,
and hoses
associated with
greenhouses and
nurseries
Method of
Application
immersing or
running thru
system
Mitigation
Maximum
Application
Rate
For Algae and
Slime control
at 938 ppm
Wood Treatment
6836-212
10324-92
Lumber
Lumber
Pressure
Treatment,
Double Vacuum,
Dip/Spray
Surface
Treatment
Sapstain
Refer to Table 13
(Labeling Changes
Summary Table) for
appropriate label
restriction
Refer to Table 13
(Labeling Changes
Summary Table) for
appropriate label
restriction
3% AI
Solution
3% AI
Solution
Agricultural Premises and Equipment
10324-80
71240-5
10324-81
10324-81
hatcheries, swine/poultry/turkey
farms, egg receiving area, egg
holding area, setter room, tray
dumping area, chick holding
room, poultry buildings,
dressing plants, farrowing barns
and areas, blocks, creep areas,
chick holding area, hatchery
room, chick processing area,
and chick loading area
Greenhouses
hatchery rooms
incubators and hatchers
toilets, urinals,
portable toilets,
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, blocks,
chutes, incubators,
hatchers, glazed
porcelain, glazed
ceramic tile, glass,
shoes, gloves
Floors, carpets,
walls, ceilings,
counters, work
surfaces,
foundations
mop, wipe,
spray,
immersion
Mop, wipe,
spray
fogging
fogging
2 hour reentry interval
2 hour reentry interval
11 20 ppm
786 ppm
0.0000188
lb/AI/1000 ft. 3
0.0000188
lb/AI/1000 ft. 3
62
-------
EPA Reg
Number
used for
Max. Appl.
Rate
10324-108
1839-167
1839-167
10324-117
1839-167
499-482
48815-1
Use Site
Mushroom Farm
Mushroom Farm
Citrus Farm
Animal housing facilities
Florists/flower shops,
greenhouses, shippers, packing
areas
greenhouse/ nursuries
farms
Treatment
Site/Surfaces
breezeways and
track alleys before
spawning, inside
and outside walls of
mushroom houses,
lofts, floors, storage
sheds and casing
rings
breezeways and
track alleys before
spawning, inside
and outside walls of
mushroom houses,
lofts, floors, storage
sheds, casing rings,
and waterproof
footwear (shoe
bath)
trucks, vehicles,
equipment, trailers,
field harvesting
equipment, cargo
area, wheels, tires,
under carriage,
hood, roof, fenders
boots and shoes
flower buckets,
coolers, floors and
walls of coolers,
design and packing
benches, garbage
pails
work tables,
benches, pots, flats,
knives, pruning
tools, floors, plant
containers, carts,
transplant trays,
hanging baskets,
tray/ pot holders,
water collectors,
walkways,
windows
fish aquariums,
tanks, fish handling
equipment, nets,
seines, traps, filter
boxes, pumps, air
diffusers, shipping
boxes, feeding
equipment, floors,
countertops,
raceways, garbage
pails, other hard
nonporous surfaces,
holding tanks,
lavatories.
Method of
Application
mop, wipe,
cloth, mop,
sponge, spray,
immersion
cloth, mop,
sponge, spray,
immersion
spray, dip, brush
immersion
Mop/wipe, cloth,
brush, sponge,
sprayer
immersion,
spray, brush
immersion,
brush, mop or
cloth
Mitigation
Maximum
Application
Rate
1120ppm
1120ppm
1120ppm
1120ppm
1120ppm
1120ppm
1120ppm
63
-------
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment
Site/Surfaces
Method of
Application
Mitigation
Maximum
Application
Rate
Residential and Public Access Premises
10324-134
10324-108
3573-69
10324-117
Homes
homes
home
Homes
floors, walls,
windows, toilets,
bathtubs, shower
stalls, shower
door/curtain, sinks,
mirrors, restroom
fixtures, cabinets,
tables, chairs,
desks, bed frames,
doorknobs, garbage
cans/pails, outdoor
furniture,
telephones, glazed
porcelain, glazed
ceramic tile, glass,
Countertops
(kitchen/food prep);
Internal (external)
surfaces of
appliances
(refrigerator,
microwave,
freezer); stovetop;
table surfaces;
sinks, shelves,
racks
Carpets
Furniture
upholstery, window
treatments,
application to
clothing without
washing, plush
toys,
shoes/sneakers,
children mattresses,
pet bed, sports
bag/equipment,
carpet
cooking utensils;
coolers/ice chest;
cups; cutlery;
dishes; eating
utensils; glassware
mop, wipe,
(cloth), spray
Rotary Floor
Machine,
Portable
Extraction Units,
Truck Mounted
Extraction
Machines,
Metered
Spray (fabric
sanitizer)
Immersion
Disinfection at
512 ppm
Heavy Duty
Cleaning and
all other
applications
(excluding
disinfection,
sanitization,
carpets and
furniture) are
limited to 786
ppm
1050 ppm
1311 ppm
200 ppm
64
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1836-167
10324-117
48815-1
1677-109
Use Site
campgrounds, playgrounds,
Public facilites, mobile homes,
cars, campers, trailers, trucks
homes
homes
Homes
Treatment
Site/Surfaces
floors, walls,
toilets, urinals,
bathrooms,
bathtubs, sinks,
countertops, shower
doors/curtains,
toilet seats, shower
stalls, tables, chairs,
shelves, telephones,
cabinets, desks, bed
springs, door
knobs, linen carts,
hampers, exercise
equipment,
automobile/truck
interiors, garbage
cans/pails, fixtures,
metal, stainless
steel, glazed
porcelain, glazed
ceramic tile, plastic,
granite, marble,
chrome, vinyl,
glass, enameled
surfaces, painted
wood work,
Formica, vinyl and
plastic upholstery,
chrome plated
fixtures
water softners and
reverse osmosis
units
fish aquariums,
tanks, fish handling
equipment, nets,
seines, traps, filter
boxes, pumps, air
diffusers, shipping
boxes, feeding
equipment, floors,
countertops,
raceways, garbage
pails, other hard
nonporous surfaces,
holding tanks,
lavatories.
Clothing and
Diapers treated
during the final
rinse cycle of wash
Method of
Application
cloth, mop,
sponge, spray
pour
immersion,
brush, mop or
cloth
Immersion
Mitigation
Maximum
Application
Rate
512 ppm
200 ppm
512 ppm
0.000733 Ib
Al/lbs dry
fabric
65
-------
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment
Site/Surfaces
Method of
Application
Mitigation
Maximum
Application
Rate
Medical Premises and Equipment
1839-167
10324-134
1677-109
Hospitals, Health Care
facilities, Medical/Dental
offices, Nursing homes,
operating rooms, patient care
facilities, clinics, isolation
wards, medical research
facilities, autopsy rooms, ICU
areas, recovery anesthesia,
emergency rooms, X-ray cat
labs, newborn nurseries,
orthopedics, respiratory
therapy, acute care institutions,
alternate care institutions,
healthcare institutions, Funeral
Homes, mortuaries
Hospitals, medical/dental
offices, nursing homes
Hospitals
floors, walls,
toilets, urinals,
lavatories,
bathrooms, bathing
areas, bathtubs,
sinks, sink tops,
shower stalls,
shower
doors/curtains,
mirrors, ultrasonic
bath, whirlpools,
foot baths,
countertops,
cabinets, tables,
chairs, desks,
hospital beds, bed
springs, bed frames,
traction devices,
MRI, CAT,
examining tables,
scales, paddles,
wheelchairs, lifts,
door knobs, wheel
chairs, telephones,
garbage pails/cans,
fixtures, metal,
stainless steel.
glazed porcelain,
glazed ceramic tile,
plastic, granite,
marble, chrome,
vinyl, glass,
enameled surfaces,
painted wood work,
Floors, walls,
windows, toilets,
bathtubs, shower
stalls, shower
door/curtain, sinks,
mirrors, restroom
fixtures, cabinets,
tables, chairs,
desks, bed frames,
doorknobs, garbage
cans/pails,
telephones, glass,
glazed porcelain,
glazed ceramic tile,
table surfaces,
sinks, shelves,
racks
Clothing and
Diapers treated
during the final
rinse cycle of wash
Wipe, mop,
(cloth), swab,
brush, spray,
portable
extraction units,
truck mounted
extraction
machines,
metered
mop, wipe, spray
pour at final
rinse or sour to
washweel
2383 ppm
2383 ppm
0.000733 Ib
Al/lbs dry
fabric
66
-------
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment
Site/Surfaces
Method of
Application
Mitigation
Maximum
Application
Rate
71240-5
Nursing Homes
Floors, carpets,
walls, ceilings,
counters, work
surfaces,
foundations
Mop, wipe,
spray
786 ppm
1839-178
hospitals, day-care facilities,
sick rooms
counters, stovetops,
sinks, outside
microwaves,
refrigerator
exteriors, walls,
appliances, finished
wood, cabinets,
floors, exterior
toilet bowl surfaces,
trash cans, tubs,
shower walls,
bathrooms, door
knobs, closets,
phones, car
interiors,
computers, hand
rails, switch plates,
door frames,
urinals, desks,
cribs, changing
tables
RTU wipe
2383 ppm
1839-173
Morgues and Funeral homes
human remains
sponge, wash
cloth, soft brush
2383 ppm
Commercial, Institutional, and Industrial premises and equipment
10324-134 Athletic/recreational facilities,
exercise facilities, schools,
colleges, dressing rooms,
transportation terminals,
institutions
floors, walls,
windows, toilets,
bathtubs, shower
stalls, shower
door/curtain, sinks,
mirrors, restroom
fixtures, cabinets,
tables, chairs,
desks, bed frames,
doorknobs, garbage
cans/pails, outdoor
furniture,
telephones, glass,
glazed porcelain,
glazed ceramic tile,
chrome plated
intakes, enameled
surfaces,
countertops
(kitchen/food prep);
Internal (external)
surfaces of
appliances
(refrigerator,
microwave,
freezer); stovetop;
table surfaces;
sinks, shelves,
racks
mop, wipe,
(cloth), spray
2383 ppm
67
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1839-167
71240-5
1839-167
1839-175
6836-78
Use Site
Athletic/recreational facilities,
exercise facilites, locker rooms,
dressing rooms, schools,
colleges, transportation
terminals,
Hotels, restaurants (non-food
contact), kennels,
veterinary clinics, flower
shops, trailer and boat interiors
motels, hotels, schools
Hotels and schools
Barber and Beauty Salons
Treatment
Site/Surfaces
floors, walls,
toilets, urinals,
bathrooms,
bathtubs, sinks,
countertops, shower
doors/curtains,
toilet seats, shower
stalls, tables, chairs,
shelves, telephones,
cabinets, desks, bed
springs, door
knobs, garbage
cans/pails, fixtures,
metal, stainless
steel, glazed
porcelain, glazed
ceramic tile, plastic,
granite, marble,
chrome, vinyl,
glass, enameled
surfaces, painted
wood work,
Floors, carpets,
walls, ceilings,
counters, work
surfaces,
foundations
carpets
floors, walls, metal
surfaces, stainless
steel, glazed
porcelain, glazed
ceramic tile, shower
stalls, bathtubs,
cabinets, plastic
surfaces
Barber/ Beauty
Instruments and
Tools
Method of
Application
cloth, mop,
sponge, spray
Mop, wipe,
spray
portable
extraction units,
truck mounted
extraction
machines, rotary
floor machines,
metered, spray
RTU wipe/spray
immersion
Mitigation
Mitigation via labeling
and container size
restrictions such that
product is not available to
residential applicators.
Products with label
directions for low
pressure spray are only to
be marketed in 5 gallon
or larger containers and
will include: "For
Professional Use Only"
with appropriate PPE
label statements including
gloves.
Maximum
Application
Rate
2383 ppm
786 ppm
12, 150 ppm
2383 ppm
2383 ppm
68
-------
EPA Reg
Number
used for
Max. Appl.
Rate
1839-178
1839-167
3573-69
1677-109
6718-24
48815-1
Use Site
Barber and Beauty Salons,
Health clubs, hotels, motels,
emergency vehicles,
transportation terminals,
correctional facilities, factories,
commercial florists
Hotels, dorms, convenience
stores, recreational centers,
offices, motels
Commercial and institutional
laundry mats
industry and schools
Schools, Institutional, and
Industrial
Treatment
Site/Surfaces
counters, sinks,
walls, finished
wood, cabinets,
floors, exterior
toilet bowl surfaces,
trash cans, tubs,
shower walls,
bathrooms, door
knobs, closets,
phones, car
interiors,
computers, hand
rails, switch plates,
door frames,
urinals, desks,
flower buckets,
coolers, floors and
walls of coolers,
design and packing
benches, garbage
pails
floors, walls,
toilets, urinals,
bathrooms,
bathtubs, sinks,
countertops, shower
doors/curtains,
toilet seats, shower
stalls, tables, chairs,
shelves, telephones,
cabinets, desks, bed
springs, door
knobs, linen carts,
hampers, exercise
equipment, bidets,
fountains, synthetic
marble, vinyl,
linoleum , sealed
granite, glazed
porcelain,
microwave oven
exteriors, marlite,
plastic, outdoor
furniture, laundry
hampers
clothing
bedframes, tables,
sinks, walls,
countertops, chairs,
other hard
nonporous surfaces
fish aquariums,
tanks, fish handling
equipment, nets,
seines, traps, filter
boxes, pumps, air
diffusers, shipping
boxes, feeding
equipment, floors,
Method of
Application
RTU wipe
cloth, mop,
sponge, spray
spray
pour at final
rinse or sour to
washweel
cloth, mop,
spray
immersion,
brush, mop or
cloth
Mitigation
potable rinse for
children's toys and food
contact surfaces
Maximum
Application
Rate
2383 ppm
2383 ppm
2383 ppm
0.000733 Ib
Al/lbs dry
fabric
2383 ppm
2383 ppm
69
-------
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment
Site/Surfaces
countertops,
raceways, garbage
pails, other hard
nonporous surfaces,
holding tanks,
lavatories.
Method of
Application
Mitigation
Maximum
Application
Rate
Food Handling/Storage Establishments premises and equipment
1839-152
including
food
contact
surfaces
1839-175
10324-81
Restaurants, food service
establishments, food processing
plants/facilities, beverage
processing plants, Bars,
Cafeterias, Convenience stores,
supermarkets, Dairies, Egg
Processing plants, Federally
inspected meat and poultry
plants , Food Handling areas,
Food preparation areas, Food
storage areas, Institutional
kitchens, USDA inspected
food processing facilities,
breweries, fast food operations
Restaurants
Dairies and Food Processing
Facilities
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/refrige
ration equipment,
heat pumps, storage
tanks, coolers, ice
chests, garbage
cans/pails
floors, walls, tables,
shelves, garbage
disposal areas,
metal surfaces,
stainless steel,
glazed porcelain,
glazed ceramic tile,
shower stalls,
bathtubs, cabinets,
plastic surfaces
floors, walls, metal
surfaces, stainless
steel, glazed
porcelain, glazed
ceramic tile,
cabinets, plastic
surfaces
cloth, mop,
spray, flood,
immersion
RTU spray
fogging
2 Hour reentry interval
Minimum of 4 air
exchanges per hour
40CFR
180.940 (a)
200 ppm
Public Eating
Places, Dairy
Processing
Equipment,
Food
Processing
Equipment and
Utensils
40CFR
180.940 (c)
400 ppm
Food
Processing
Equipment and
Utensils
Disinfection
2383 ppm
2383 ppm
Need to talk to
Tim on rate:
0.0065 Ibs
Al/gal to ft3
70
-------
EPA Reg
Number
used for
Max. Appl.
Rate
10324-134
10324-117
including
food
contact
surfaces
10324-117
10324-117
Use Site
bottling and beverage plants,
breweries, tobacco, egg
processing plants, meat/poultry
processing plants, rendering
plants,
fishery/mi Ik/citrus/wine/ice
cream/ potato processing plants,
restaurants
bottling and beverage plants,
breweries, tobacco, egg
processing plants, meat/poultry
processing plants, rendering
plants,
fishery/mi Ik/citrus/wine/ice
cream/ potato processing plants,
restaurants
bottling and beverage plants,
breweries, tobacco, egg
processing plants, meat/poultry
processing plants, rendering
plants,
fishery/mi Ik/citrus/wine/ice
cream/ potato processing plants,
bottling and beverage plants,
breweries, tobacco, egg
processing plants, meat/poultry
processing plants, rendering
plants,
fishery/mi Ik/citrus/wine/ice
cream/ potato processing plants,
Treatment
Site/Surfaces
floors, walls, tables,
shelves, garbage
cans, garbage
disposal areas,
glazed porcelain,
glazed ceramic tile,
glass
ice machines, water
coolers, counters,
tables, food
processing
equipment, food
utensils, dairy
equipment, dishes,
silverware, eating
utensils, glasses,
sinks, counters,
refrigerated/storage
display equipment
water softners and
reverse osmosis
units
boots and shoes
Method of
Application
mop, wipe,
(cloth), spray
spray, wipe,
sponge,
immersion
pour
immersion
Mitigation
Maximum
Application
Rate
2383 ppm
40CFR
180.940 (a)
200 ppm
Public Eating
Places, Dairy
Processing
Equipment,
Food
Processing
Equipment and
Utensils
40CFR
180.940 (c)
400 ppm
Food
Processing
Equipment and
Utensils
Disinfection
2383 ppm
200 ppm
2382 ppm
Clean/Deodorization
1839-167
1839-167
1839-167
Water/Smoke restoration
(institutional, industrial,
hospital)
Sewer backup/river flood
cleanup, (clean water source)
garbage storage areas, pet areas
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 bins, cans
floors, walls, tables,
shelves, glazed
Pour, brush,
spray
spray
Spray, wipe,
sponge,
immersion
Refer to Table 13
(Labeling Changes
Summary Table) for
appropriate label
restriction
Refer to Table 13
(Labeling Changes
Summary Table) for
appropriate label
restriction
12, 154 ppm
12, 154 ppm
2383 ppm
71
-------
EPA Reg
Number
used for
Max. Appl.
Rate
Use Site
Treatment
Site/Surfaces
porcelain, glazed
ceramic tile, glass
Method of
Application
Mitigation
Maximum
Application
Rate
71814-1
hospitals
Medical waste
pour
Poured into
machine
72
-------
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 #3003
(DDAC) covered by this RED. It contains generic data requirements that apply to DDAC 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
73
-------
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.
74
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
USE PATTERN
CITATION(S)
CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1670
830.1700
Old
Guideline
Number
61-1
6 1-2 A
61-2B
62-1
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
All
All
All
All
44520301, 44520302
44520302, 44520301
44520302, 44520301
44520302, 44520301
75
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
62-2
62-3
63-2
63-3
63-4
None
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visable Absorption
USE PATTERN
All
All
All
All
All
All
CITATION(S)
44520302, 44520301
44520302,44520301
44520303
44520303
44520303
44520303
76
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
63-5
63-6
63-7
63-8
63-9
63-10
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
USE PATTERN
All
All
All
All
All
All
CITATION(S)
44520303
44520303
44520303
44520303
44520303
44520303
77
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
63-11
63-12
63-13
63-14
63-15
63-16
Octanol/Water Partition Coefficient
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
USE PATTERN
All
All
All
All
All
All
CITATION(S)
44520303
44520303
44520303
44520303
44520303
44520303
78
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
830.6317
830.7100
830.6319
830.6320
850.2100
63-17
63-18
63-19
63-20
Storage Stability
Viscosity
Miscibility
Corrosion characteristics
USE PATTERN
All
All
All
All
CITATION(S)
44520303
44520303
44520303
44520303
ECOLOGICAL EFFECTS
71-1
Avian Acute Oral Toxicity
All
41785803,258798
79
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
850.2200
850.2200
850.1075
850.1075
850.1010
850.1075
7 1-2 A
71-2B
72-1A
72-1C
72-2A
72-3A
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
USE PATTERN
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
ALL
ALL
ALL
Wood Preservation,
Sapstain, Once Through
Cooling Water
CITATION(S)
41785801,258798
41785802,258798
41578001,038901
038901, 40129801
41578002, 038901, 40129801, 40129802, 40129803
43620001
80
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
850. 1025 or
850.1055
850.1035 or
850.1045
850.1300
850.1400
850.1710
850.1730
850.1850
850.4400
72-3B
72-3 C
72-4A
72-4B
72-6
123-2
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
Fish- Early Life Stage
Aquatic Invertebrate Life Cycle
Aquatic organism bioaccumulation
Aquatic Plant Growth
USE PATTERN
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
CITATION(S)
249002, 43260003
249002, 41578004
Data Gap
Data Gap
45834101
Data Gap
81
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
850.5400
850.1950
850.4225
850.4250
850.3030
123-2
Non-
Guideline
123-1
123-1
141-1
Algal Toxicity
Aquatic Field Monitoring
Non-Target plant phytotoxicity
(seedling emergence test using rice)
Vegetative Vigor using rice
Honey Bee Toxicity Studies
USE PATTERN
Wood Preservation,
Sapstain, Once Through
Cooling Water
Wood Preservation,
Sapstain, Once Through
Cooling Water
Once Through Cooling
Water & Wood
Preservation
Once Through Cooling
Water & Wood
Preservation
Wood
Preservation
CITATION(S)
48596402, Data Gap for remaining species
Data Gap
Data Gap
Data Gap
Data Gap
82
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Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
870.1100
870.1200
870.1300
870.2400
870.2500
USE PATTERN
CITATION(S)
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
Acute Oral Toxicity-Rat
Acute Dermal Toxicity -Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
All
All
All
All
All
42296101, 41394494
00071158,42053801
00145074
41394404,42161602
42161601
83
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
870.2600
870.3100
870.3150
870.3200
870.3465
870.3250
81-6
82-1A
82-1B
82-2
82-4
82-3
Dermal Sensitization
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
90-Day Inhalation Rat
90-day Dermal- Rat
USE PATTERN
All
All
Indirect Food
Domestic dwelling
contents
All
All
CITATION(S)
42161603, 46367601
40966302
40262901
40565301, 41105801, 45656601
Data Gap
41305901
84
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
870.4100
870.4100
870.4200
870.4200
870.3700
870.3800
83-1A
83-1B
83 -2 A
83-2B
83-3B
83-4
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Carcinogenicity - Rat
Carcinogenicity - Mouse
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
USE PATTERN
Swimming Pool, Wood
Preservation
Swimming Pool, Wood
Preservation
Swimming Pool, Wood
Preservation
Swimming Pool, Wood
Preservation
Swimming Pool, Wood
Preservation
Indirect Food
CITATION(S)
41965101
41970401
41965101
41802301
41018701
41804501
85
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Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
870.4300
870.5140
870.5300
870.5375
870.5550
870.7485
83-5
84-2A
84-2B
84-4
84-4
85-1
Combined Chronic Toxicity/
Carcinogenicity-Rat
Gene Mutation (Ames Test)
Forward Gene Mutation
In vitro chromosome aberration
Unscheduled DNA synthesis
General Metabolism
USE PATTERN
Swimming Pool, Wood
Preservation
All
All
All
All
Indirect Food
CITATION(S)
41965101
40282201,44005801
40895202
41252601
40895201
41617101
86
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
USE PATTERN
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.1100
875.1100
875.1200
875.1300
875.1400
875.2800
Special
Studies
233,236
234, 236
133-1
Non-
Guideline
Wood Wipe Study
Dermal Indoor /Outdoor Exposure
Inhalation Indoor/Outdoor Exposure
Descriptions of Human Activity (all
uses)
Fabric Leaching Study
Handlers
Handlers
All
Domestic dwelling
contents
Find MRID
41742601,42587501
455021101,45524304
Data Gap
Data Gap
87
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
USE PATTERN
CITATION(S)
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4400
161-1
161-2
161-3
162-1
162-3
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
All
Wood Preservation
Not Required
Wood Preservation &
Once Through Cooling
Towers
Wood Preservation &
Once Through Cooling
Towers
41175801
41175802
42480801
42253801
42253801
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
835.4300
835.1240
None
162-4
163-1
165-4
AWPA
Ell-97
Special
Studies
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Bioaccumulation in Fish
Leachability of Wood Preservative
Biodegradability of DDAC
USE PATTERN
Wood Preservation &
Once Through Cooling
Towers
Wood Preservation
Wood Preservation
Wood Preservation
Not Required
CITATION(S)
42253803
41385301
45834101
45524305
46865701
89
-------
Data Supporting Guideline Requirements for the Reregistration of DDAC
REQUIREMENT
USE PATTERN
CITATION(S)
RESIDUE CHEMISTRY
860.1480
171-4J
Non-
Guideline
Magnitude of Residues -
Meat/Milk/Poultry /Egg
Dietary -Residues in Food from
Treating Countertops with DDAC
(FDA Wipe Study Methodology)
(FDA, 2003a and 2003b)
Indirect Food
Indirect Food
FDA, 2003. "Sanitizing Solutions: chemistry for food
Additives petitions." Http://www.cfsan.fda.gov/-dms/opa-
cg3a.html. Last accessed June 9, 2003
Data Gap
90
-------
91
-------
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, 2777 South Crystal Drive, Arlington, VA. 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. Sixty days later the first public comment period closed. 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 site: http ://www/regulations. gov, docket
ID # EPA-HQ-OPP-2006-0338
These documents include:
1. Risk Assessment on Didecyl Dimethyl Ammonium Chloride (DDAC), 7/31/06
2. Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision
(RED) Risk Assessment on Didecyl Dimethyl Ammonium Chloride (DDAC),
8/10/06
3. DDAC Dietary Risk Assessment, 7/27/06
4. Ecological Hazard and Environmental Risk Assessment Chapter on Didecyl
Dimethyl Ammonium Chloride (DDAC)-Antimicrobial Uses, 8/2/06
5. PDM4 Modeling of Didecyl Dimethyl Ammonium Chloride (DDAC) 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 Didecyl Dimethyl Ammonium Chloride
(DDAC) for the Reregi strati on Eligibility Decision (RED) Document, 7/31/06
9. Incident Reports Associated with Quaternary Ammonium Compounds (Quats),
2/15/06
10. Didecyl Dimethyl Ammonium Chloride (DDAC) Occupational and Residential
Exposure Assessment, 8/1/06
11. Product Chemistry Science Chapter for Didecyl Dimethyl Ammonium Chloride
(DDAC), 1/11/06
12. Didecyl Dimethyl Ammonium Chloride (DDAC)- 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
40129801 Henck, J.H. (1986) Avian Eight-day dietary toxicity test in bobwhite quail. TRL
Study No. 014-064. Toxicity Research Laboratories, Ltd.
40129802 Surprenant, D.C. (1986) Acute toxicity of Maquat MQ 416M: Report No. BW-
86-12-2263; Springborn Bionomics, Inc.
40129803 Surprenant, D.C. (1987) Acute Toxicity of Maquat MQ 416M to Daphnids
(Daphniapulex). Springborn Bionomics, Inc.
40262901 Bailey, D. (1975) 90-day Feeding Study in Dogs with a Quaternary Ammonium
Sanitizer: Bardac-22: Laboratory Project ID: 2224a. Unpublished study prepared
by Food & Drug Research Laboratories, Inc. 89 p.
40282201 Friederich, U.; Wurgler, F. (1982) Salmonella/Mammalian-Microsome Assay
with Bardac 22. Unpublished study prepared by Institute of Toxicology, Swiss
Federal Institute of Technology, and University of Zurich. 18 p.
40565301 Rose, G. (1988) Acute Toxicology (EP): HS-Sanitizing Carpet Shampoo:
Laboratory Project ID B 6-27. Unpublished study prepared by Envirocon. 21 p.
40895201 Cifone, M. (1988) Mutagenicity Test on Didecyldimethylammonium Chloride in
the Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: HLA Study No.
10141-0-447. Unpublished study prepared by Hazleton Laboratories America,
Inc. 60 p.
40895202 Young, R. (1988) Mutagenicity Test on Didecyldimethyl Ammonium Chloride
(DDAC) in the CHO/HGPRT Forward Mutation Assay: HLA Study No. 10141-0-
435. Unpublished study prepared by Hazleton Laboratories America, Inc. 68 p.
40966302 Van Miller, J. (1988) Ninety-day Dietary Subchronic Oral Toxicity Study with
Didecyldimethylammoniumchloride in Rats: Laboratory Project ID: 51-506.
Unpublished study prepared by Bushy Run Research Center, Union Carbide. 262
P-
41018701 Tyl, R. (1989) Developmental Toxicity Study of Didecyldimethylammonium
chloride Administered by Gavage to New Zealand White Rabbits: Project ID: 51-
590. Unpublished study prepared by Bushy Run Research Center. 164 p.
41105801 Rose, G. (1989) Acute Toxicology (EP): HS-Sanitizing Carpet Shampoo: Project
ID: B6-27. Unpublished study prepared by Envirocon. 36 p.
95
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BIBLIOGRAPHY
MRID#
CITATIONS
41175801 Dykes, J. and M. Fennessy. 1989. Hydrolysis of Didecyldimethylammonium
chloride (DDAC) as a function of pH at 25 °C. Final Report #37004.
Unpublished study prepared by Analytical Bio-chemistry Laboratories, Inc.
41175802 Dykes, J. and M. Fennessy. 1989. Determination of the Photolysis Rate of
Didecyldimethylammonium chloride (DDAC) in pH 7 Buffered solution at 25 °C.
Final Report #37005. Unpublished study prepared by Analytical Bio-chemistry
Laboratories, Inc.
41252601 Holmstrom, M.; Leftwich, D.; Leddy, I. (1986) PO151: Chromosomal
Aberrations Assay with Chinese Hamster Ovary Cells in vitro: Proj. No. 735717.
Unpublished study prepared by Lonza Inc. 36 p.
41305901 Gill, M; Van Miller, J. (1989) Ninety-day Subchronic Dermal Toxicity Study with
Didecyldimethylammonium chloride in Rats: Lab Project Number: 51-554.
Unpublished study prepared by Bush Run Research Center, Union Carbide. 244 p.
41385101 Lin, P.; Selim, S. (1989) Addendum to Report Entitled Absorption, Distribution,
Metabolism and Excretion Studies of Didecyldimethylammonium chloride
(DDAC) in the Rat: Lab Project Number: P01421. Unpublished study prepared by
Biological Test Center. 269 p.
41385301 Daly, D. 1989. Soil/Sediment Adsorption-desorption of
[14C]Didecyldimethylammonium chloride (14C-DDAC). Lab Project Number
37009. Unpublished study prepared by Analytical Bio-Chemistry Laboratories.
41394404 Myers, R.; Christopher, S. (1989) NP-1 Plus (Concentrate): Acute Toxicity and
Primary Irritation Studies: Lab Project Number: 52- 642. Unpublished study
prepared by Bushy Run Research Center. 31 p.
41578001 LeLievre, M.K. (1990a) Evaluation of Didecyldimethylammoniumchloride
(DDAC) in a static acute toxicity with bluegill sunfish, Lepomis macrochirus.
Springborn Laboratories, Inc.
41578002 LeLievre, M.K. (1990c) Evaluation of Didecyldimethylammoniumchloride
(DDAC) in a static acute toxicity test with daphnids, Daphnia magna. Springborn
Laboratories, Inc.
96
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BIBLIOGRAPHY
MRID#
CITATIONS
41578003 LeLievre, M.K. (1990b) Evaluation of Didecyldimethylammoniumchloride
(DDAC) in a static acute toxicity test with coho salmon, Oncorhynchus kisutch.
Springborn Laboratories, Inc.
41578004 LeLievre, M.K. (1990d) Evaluation of Didecyldimethylammoniumchloride
(DDAC) in a static acute toxicity test with mysid shrimp, Mysidopsis bahia.
Springborn Laboratories, Inc.
41592002 Rhodes, I.E. (2000a) Acute toxicity of PI 98 to the bluegill sunfish, Lepomis
macrochims, determined under static conditions. ABC Laboratories, Inc.
41617101 Selim, S. (1989) Absorption, Distribution, Metabolism and Excretion Studies of
Didecyldimethylammoniumchloride (DDAC): Lab Project Number: P01421.
Unpublished study prepared by Biological Test Center. 197 p.
41785801 Long, R.D., Hoxter, K.A. and Smith, GJ. (1991a)
Didecyldimethylammoniumchloride: A dietary LCso study with the northern
bobwhite. Wildlife International, Ltd.
41785802 Long, R.D., Hoxter, K.A. and Smith, GJ. (1991b)
Didecyldimethylammoniumchloride: A dietary LCso study with the mallard.
Wildlife International, Ltd.
41785803 Campbell, S., Hoxter, K.A., and Smith, GJ. (1991) Didecyldimenthyl ammonium
chloride: An acute oral toxicity study with the northern bobwhite. Wildlife
International Ltd.
41802301 Gill, M.; Hermansky, S.; Wagner, C. (1991) Chronic Dietary Oncogenicity Study
with Didecyldimethylammonium chloride in Mice: Lab Project Number: 53-528.
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41804501 Neeper-Bradley, T. (1991) Two-Generation Reproduction Study in Sprague-
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41886701 Neeper-Bradley, T. (1991) Development Toxicity Evaluation of
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97
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MRID#
CITATIONS
41965101 Gill, M.; Chun, J.; Wagner, C. (1991) Chronic Dietary Toxicity/On- cogenicity
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41970401 Schulze, G. (1991) Chronic Oral Toxicity Study of Didecyldimethylammonium
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42053801 Myers, R.; Christopher, S. (1991) Sapstain Control Chemical NP-1: Acute
Percutaneous Toxicity Study in the Rabbit: Lab Project Number: 54-588.
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42161601 Morris, T. (1991) Primary Skin Irritation Study in Rabbits with
Didecyldimethylammoniumchloride (DDAC): Lab Project Number: 91-8114-21
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42161602 Morris, T. (1991) Primary Eye Irritation Study in Rabbits with
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42161603 Morris, T. (1991) Photoallergy Study in Guinea Pigs with
Didecyldimethylammoniumchloride (DDAC): Lab Project Number: 91-8114-21
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4225303 Cranor, W. 1991. Aerobic Aquatic Metabolism of
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42253801 Cranor, W. 1991. Aerobic Soil Metabolism of
[14C]Didecyldimethylammonium chloride (14C-DDAC). Final Report. Lab
Project Number 37006. Unpublished study prepared by ABC Laboratories.
42253802 Cranor, W. 1991. Anaerobic Aquatic Metabolism of
[14C]Didecyldimethylammonium chloride (14C-DDAC). Final Report. Lab
Project Number 37007. Unpublished study prepared by ABC Laboratories.
42253803 Cranor, W. 1991. Aerobic Aquatic Metabolism of
[14C]Didecyldimethylammonium chloride (14C-DDAC). Final Report. Lab
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98
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BIBLIOGRAPHY
MRID#
CITATIONS
42296101 Morris, T. (1992) Acute Oral Toxicity in Rats-Median Lethal Dosage
Determination with Didecylammoniumchloride (DDAC): Lab Project Number:
91-8114-21 (A). Unpublished study prepared by Hill Top Biolabs, Inc. 153 p.
42480701 Schmidt, J. 1992. Determination of the Photolysis Rate of
Didecyldimethylammoniumchloride on the Surface of the Soil. Final Report #
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42746901 Neeper-Bradley, T. (1993) Developmental Toxicity Dose Range-Finding Study of
Didecyldimethylammoniumchloride Administered by Gavage to CD (Sprague-
Dawley) Rats: Lab Project Number: 53-533. Unpublished study prepared by
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43620001 Collins, M.K. (1994) Didecyldimethylammoniumchloride (DDAC): Evaluation in
a static acute toxicity test with the sheepshead minnow (Cyprinodon variegatus).
Springborn Laboratories, Inc.
44005801 Schoenig, G. (1996) Response to EPA Data Evaluation Report for Study Entitled:
"Salmonella/Mammalian-Microsome Assay with Bardac 22." Unpublished study
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44520301 Albemarle DAQ-1010-5 Biocide—Product Chemistry, (1998) Albemarle Corp.,
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45192001 Rhodes, I.E. (2000b) Acute toxicity of P198 to the rainbow trout, Onchorynchus
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455021101 American Chemistry Council (ACC). 2002a. Assessment of Potential Inhalation
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99
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CITATIONS
45524304 Bestari KT, Macey K, Soloman KR, Tower N. 1999. Measurement and
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45524305 Bestari, K. 2001. Determination of the Leachability of Bardac 22C from Treated
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45821701 England, D.C., and Leak, T. (1995) Chronic toxicity of sediment-incorporated
Didecyldimethylammonium Chloride (DDAC) to Chironomus tentans. ABC
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45834101 Fackler, P.H., E. Dionne, D.A. Hartley, and S.P. Shepherd. 1990.
Bioconcentration and Elimination of 14C- Residues by Bluegill (Lepomis
macrochirus) Exposed to Didecyldimethylammonium Chloride (DDAC). Final
Report. Study No. 11696.0887.6104.140. Unpublished study prepared by
Springborn Laboratories, Inc.
45896401 Krueger, H.O., Desjardins, D., Kendall, T., and Vanhoven, R. (2003) Bardac
2280: A 96-hour toxicity test with the freshwater alga (Selenastrum
capricortutum) using natural surface water. Wildlife International, Ltd.
45896402 Krueger, H.O., Desjardins, D., Kendall, T. andVanhoven, R. (2002) Bardac 2280:
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Wildlife International, Ltd.
46367601 Merkel, D. (2004) Dermal Sensitization Test in Guinea Pigs (Buehler Method):
Bardac 2280. Project Number: 15512, P328/TRS. Unpublished study prepared by
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100
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BIBLIOGRAPHY
MRID# CITATIONS
46865701 Gledhill, W. E. 2006. ETC® 1010-E and MAKON® NF-5 - Determination of the
Biodegradability of a Test Substance Based on OECD Method 301 B (CO2
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93014007 Schoenig, G. (1990) Lonza Inc Phase 3 Summary of MRID 40895201.
Mutagenicity Test on Didecyldimethylammoniumchloride in the Rat Hepatocyte
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93014008 Schoenig, G. (1990) Lonza Inc Phase 3 Summary of 40895202. Mutagenicity Test
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101
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BIBLIOGRAPHY
ACC#
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007958 Wells Labs. (1971a) Report on fish toxicity using Bardac 22 bluegill sunfish.
007958 Wells Labs. (1971b) Report on fish toxicity (rainbow trout) toxicity testing
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71158 Nitka, S.; Palanker, A.L.; Lally, E.; et al. (1980) Acute Dermal LD50 in Rabbits
(FIFRA): Experiment Reference No. 8044-10. Final rept. (Unpublished study
received Feb 2, 1981 under 6836-51; prepared by Consumer Product Testing Co.,
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132164 Cannon Lab. (1973) Report eight day dietary LC50 study of JJ-14 (BARDAC 22)
on bobwhite quail and mallard duck.
145074 Dudek, R. (1984) Four Hour Acute Aerosol Inhalation Toxicity Study in Rats of
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Unpublished study prepared by Toxigenics, Inc. 44 p.
225596 Cannon Lab. (1976) Report static 48 hour toxicity study of BARDAC 22 to
Daphnide.
225596 Cannon Lab. (1977) Report Acute oral LD50 toxicity study of BARDAC 22 to
Mallard Duck.
249002 Cannon Lab. (1974a) Report: 48 hour EC50 and 96 hour LC50 of Calgon JJ-14
(Bardac 22) on oyster eggs and straight-hinge larvae.
249002 Cannon Lab. (1974b) Report: 96 hour LC50 determination of Calgon JJ-14
(Bardac 22) in marine blue crab.
249002 Cannon Lab. (1974c) Report: 96 hour LC50 determination of Calgon JJ-14
(Bardac 22) in marine grass shrimp.
258798 Fink, R. and Beavers, J. (1982) Eight-day dietary LC50 - Bobwhite quail: 10-2D:
final report: project No. 183-104. Wildlife International, Ltd.
258798 Fink, R. and Beavers, J. (1985) Eight-day dietary LC50 - bobwhite quail: 10-2D:
final report: project no. 183-104. Wildlife International, Ltd.
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OPEN LITERATURE CITATIONS
American Chemistry Council (ACC). 2002b. An Analysis of the Training Patterns and Practices
of Competitive Swimmers. Prepared by Richard Reiss. Sciences International, Inc. Alexandria,
Virginia. December 9, 2002.
Bailey, H.C., Elphick, J.R., Potter, A., Chao, E. and Zak, B. (1999) Acute toxicity of the
antisapstain chemicals DDAC and IPBC, alone and in combination, to rainbow trout
(Oncorhynchusmykiss). Water Res. 33(10): 2410-2414.
Bennett, W.R. and Farrell, A.P. (1998) Acute toxicity testing with Juvenile white sturgeon
(Acipenser transmontanus). Water Qual. Res. Can. 33(1): 95-110.
DiToro, D. M. 1984. Probability Model of Stream Quality Due to Runoff. ASCE. Journal of
Environmental Engineering. 110(3):607-628.
EFAST Help, beta version, 2004.
EPISuite Property Assessment Program.
Freeman, N , Jimenez M, Reed KJ,Gurunathan S, Edwards RD, Roy A, Adgate JL, Pellizzari
ED, Quackenboss J, Sexton K, Lioy PJ, 2001. Quantitative analysis of chilren's microactivity
patterns: The Minnesota Children's Pesticide Exposure Study. Journal of Exposure Analysis
and Environmental Epidemiology. 11(6): 501-509.
Genest, Dan, Dominion Power. Telephone interview. June 14, 2004.
Helwig, D. (2003) Personal Communication between D. Helwig (Johnson Diversy, Inc) and K.
Riley (Versar, Inc.), November 11, 2003.
Jacobson, Larry. 2005. Professor and Extension Engineer at University of Minnesota.
Lee, C. 1992. Assessment of the Biodegradability of ADB AC and DDAC. Unpublished report
prepared by Roy F. Weston, Inc. Contractor's Fate Summary.
MCCEM V 1.2 The Multi-Chamber Concentration and Exposure Model (MCCEM) Model
Version 1.2. Prepared for the US EPA Office of Pollution Prevention and Toxics. Prepared by
Versar, Inc. and Wilkes Technologies, LLC.
No. 7E-6686: Roberts, S. (1977) Report: Static 48-hour toxicity study of Bardac 22 in daphnids.
Cannon Laboratories.
103
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BIBLIOGRAPHY
OPEN LITERATURE CITATIONS
Project # 03890-1: Onyx Chemical Co. (1982a) The acute toxicity of 10-2D (50% active
ingredient) to the bluegill sunfish.
Project # 03890-1: Onyx Chemical Co. (1982b) The acute toxicity of 10-2D (50% active
ingredient) to the rainbow trout.
Project # 03890-1: Onyx Chemical Co. (1982c) The acute toxicity of 10-2D (50% active
ingredient) to the Daphnia magna.
Tatarazako, N., Yamamota, K. and Iwasaki, K. (2000) Subacute toxicity of wood preservatives,
DDAC and BAAC, in several aquatic organisms. J. Health Sci. 48(4): 359-365.
Teh, S.J., Wong, C., Furtula, V. and Teh, F. (2003) Lethal and sublethal toxicity of
Dedecyldimethylammonoiumchloride in early life stages of white sturgeon, Acipenser
transmontanus. Environ. Toxicol. Chem. 22(9): 2152-2158.
Woods, A.W., Blair, D., Johnston, A.P., Farrell, P. and Kennedy, C.J. (1996) Effects of
idiecyldimethylammonium chloride (DDAC) on the swimming performance, gill morphology,
disease resistance, and biochemistry of rainbow trout (Oncorhynchus mykiss). Can. J. Aquat. Sci.
53:2424-2432
104
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BIBLIOGRAPHY
SUPPORTING DOCUMENTS CITATIONS
USEPA (2000): Didecyl Dimethyl Ammonium Chloride (DDAC) - Report of the Hazard
Identification Assessment Review Committee. HED document No. 014099.
USEPA (2000): Didecyl Dimethyl Ammonium Chloride: Toxicology Review. DP Barcode
D260952.
USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa. August 1997.
USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs, 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. Undated. RISK. Version 1.9.27. Developed by Dr. Les Sparks of USEPA/NRMRL/
APPCD.
USEPA. 1996. Office of Research and Development, Descriptive Statistics Tables from a
Detailed Analysis of the National Human Activity Pattern (NHAPS) Data; EPA/600/R-96/148,
July 1996. Data Collection Period October 1992 - September 1994 .
USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from the
Pesticide Handler Exposure Database Version 1.1. Washington, DC: U.S. Environmental
Protection Agency.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
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. 2003. Assessment of the Proposed Bardac Wood Preservative Pressure Treatment Use.
Memorandum from Tim Leighton and Siroos Mostaghimi. February 11, 2003.
USEPA. 2004. Occupational and Residential Exposure Assessment for Carboquat WP-50.
Memorandum from Siroos Mostaghimi, USEPA to Welma Noble, USEPA. Dated November 4,
2004. DP Barcodes D303714 and D303938.
105
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BIBLIOGRAPHY
SUPPORTING DOCUMENTS CITATIONS
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. Didecyl dimethyl benzyl ammonium chloride (DDAC) - Report of the
Antimicrobials Division Toxicity Endpoint Committee (ADTC) and the Hazard Identification
Assessment Review Committee (HIARC). January 9, 2006.
USEPA (2000): Didecyl Dimethyl Ammonium Chloride (DDAC) - Report of the Hazard
Identification Assessment Review Committee. HED document No. 014099.
USEPA (2000): Didecyl Dimethyl Ammonium Chloride: Toxicology Review. DP Barcode
D260952
Versar, 2005. Memorandum. Draft Environmental Fate Science Chapter for DDAC RED. From
Adria Diaz and Patricia Wood, Versar, Inc. to Srinivas Gowda, USEPA. Date: August 30, 2005.
Versar, 2006. DDAC Modeling (TAP 1-4-17, TAP CM 64). From Jignasha Patel/Adria Diaz
(Versar) to David Bays (USEPA).
Versar. 2006. DDAC Occupational and Residential Exposure Assessment. Memorandum from
Adria Diaz/Karie Riley/Kelly McAloon, Versar, Inc., to Laura Bailey, USEPA dated January 20,
2006.
106
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BIBLIOGRAPHY
INTERNET CITATIONS
CEC, 2001. Residential Manual for Compliance with California's 2001 Energy Efficiency
Standards. http://www.energy.ca.gov/title24/residential_manual/index.html, viewed January
2005.
Cloete TE, Smith Z, Saayman G. 1999. A Cooling Water System as a Biofilm Reactor for the
Treatment of Municipal Wastewater. Water SA Vol. 25 No. 3 July 1999. Available on website
http://www.wrc.org.za.
DOE. 1997. Energy Information Administration: Profile of Commercial Buildings in 1995.
http://www.eia.doe.gov/emeu/cbecs/char95/profile.html.
Environmental Fate and Effects Division. 200la. FIRST (F)IFRA (I)ndex (R)eservoir
(S)creening (T)ool. Tier 1 Model for Drinking Water Exposure: User's Manual.
http://www.epa.gov/oppefed 1 /model s/water/first users manual .htm.
Environmental Fate and Effects Division. 2001b. SCI-GROW - (S)creening (C)oncentration
(I)n (GRO)und (W)ater: User's Manual.
http://www.epa.gov/oppefedl/models/water/scigrow users manual.htm.
Environmental Fate and Effects Division. 2002. Guidance for Selecting Input Parameters in
Modeling the Environmental Fate and Transport of Pesticides, Version II. U. S. Environmental
Protection Agency. Washington, D.C. http://www.epa.gov/oppefedl/models
water/input_gui dance2_2 8_02. htm.
FDA. 2003. "Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions."
http://www.cfsan.fda.gov/~dms/opa-cg3a.html. Last accessed June 9, 2003.
HERA, 2003. Human and Environmental Risk Assessment, Guidance Document Methodology,
April 22, 2002 (http://www.heraproject.com/files/Guidancedocument.pdf).
HERA, 2005. Human and Environmental Risk Assessment, Guidance Document Methodology,
February 2005 (http://www.heraproiect.com).
Office of Pesticide Programs. 2000. Part A. Guidance for Use of the Index Reservoir in
Drinking Water Assessments, http://www.epa.gov/oppfeadl/trac/science/reservoir.pdf.
SEVIetric. 2005. http://www.simetric.co.ukysi_materials.htm Last viewed November 9, 2005.
US AID. 2005. "ANNEX III: Recommended Energy Allowance Tables." November 2005.
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Dibo, M. andBrasch, J. 2001. Occupational allergic contact dermatitis from N,N-bis93-
aminoprpyl)dodecylamine and dimethyldidecylammonium chloride in two hospital staff.
Contact Dermatitis. 45(1):40.
Mehler, L. 2005. Personal Communication. California Department of Pesticide Regulation.
Oriandini, A.; Viotti, G. Martinoli, C; and Magno, L. 1990. Allergic Contact Conjunctivities
from synthetic detergenets in nurse. Contact Dermatitis. 23: 376-377.
Preller, L.; Doekers, G.; Heederik, D.; Vermulen, R.; Vogelzang, P.F.J, and Boleij, J. S.M.
1996. Disinfinfectant use as a risk factor for atopic sensitization and symptoms consistent with
asthma: an epidemiological study. European Respiratory Journal: 9 (7) 1407-1413.
Shmunes, E. and Levy, EJ. 1972. Quaternary ammonium compound contact dermatitis from
deodorant. Arch Dermatol. 105(1)91-93.
108
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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 DDAC
RED for a list of studies that the Agency plans to require.
109
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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.
110
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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.
Ill
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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@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
112
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Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
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encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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