United States Prevention, Pesticides EPA739-R-06-009 

Environmental Protection and Toxic Substances August 2006 

Agency (7510C) 

Reregistration Eligibility Decision 

for Alkyl Dimethyl Benzyl 

Ammonium Chloride (ADBAC) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

CERTIFIED MAIL 

Dear Registrant: 

This is to inform you that the Environmental Protection Agency (hereafter referred to as 

EPA or the Agency) has completed its review of the available data and public comments 

received related to the preliminary risk assessments for the antimicrobial Alkyl Dimethyl Benzyl 

Ammonium Chloride (ADBAC). The Reregistration Eligibility Decision (RED) was approved 

in the form of a decision memorandum which summarized the regulatory decision for ADBAC 

on August 3, 2006. Public comments and additional data received were considered in this 

decision. 

Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED) 

and risk management decision for ADBAC and its associated human health and environmental 

risks. A Notice of Availability will be published in the Federal Register announcing the 

publication of the RED. 

The RED and supporting risk assessments for ADBAC are available to the public in 

EPA’s Pesticide Docket EPA-HQ-OPP-2006-0339 at: http://www.regulations.gov. 

The ADBAC RED was developed through EPA’s public participation process, published 

in the Federal Register on April 26, 2006, which provides opportunities for public involvement 

in the Agency’s pesticide tolerance reassessment and reregistration programs. Developed in 

partnership with USDA and with input from EPA’s advisory committees and others, the public 

participation process encourages robust public involvement starting early and continuing 

throughout the pesticide risk assessment and risk mitigation decision making process. The 

public participation process encompasses full, modified, and streamlined versions that enable the 

Agency to tailor the level of review to the level of refinement of the risk assessments, as well as 

to the amount of use, risk, public concern, and complexity associated with each pesticide. Using 

the public participation process, EPA is attaining its strong commitment to both involve the 

public and meet statutory deadlines. 

Please note that the ADBAC risk assessment and the attached RED document concern 

only this particular pesticide. This RED presents the Agency’s conclusions on the dietary, 

drinking water, occupational and ecological risks posed by exposure to ADBAC alone. This 

document also contains both generic and product-specific data that the Agency intends to require 

in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to 

registrants at a later date. Additionally, for product-specific DCIs, the first set of required 


Table of Contents 

ADBAC Reregistration Team............................................................ i 

Glossary of Terms and Abbreviations...................................................... ii 

Abstract............................................................................................ iv 

I. Introduction................................................................................... 1 

II. Chemical Overview...................................................................... ... 3 

A. Regulatory History.............................................................. ... 3 

B. Chemical Identification ......................................................... 3 

C. Use Profile........................................................................... 6 

III. Summary of ADBAC Risk Assessments.......................................... 10 

A. Human Health Risk Assessment................................................ 10 

1. Toxicity of ADBAC ...................................................... 10 

2. FQPA Safety Factor...................................................... 13 

3. Population Adjusted Dose (PAD)....................................... 14 

a. Acute PAD......................................................... 14 

b. Chronic PAD...................................................... 14 

4. Dietary Exposure Assumptions......................................... 14 

5. Dietary Risk Assessment................................................. 15 

 a. Dietary Risk from Food......................................... 15 

 b. Dietary Risk from Drinking Water .......................... 17 

6. Residential Risk Assessment............................................. 18 

 a. Residential Toxicity............................................... 18 

 b. Residential Handlers................................... .......... 19 

i. Exposure Scenarios, Data and Assumptions....... 19 

ii. Risk Assessment.......................................... 21 

 c. Residential Post-Application................................... 25 

i. Exposure Assessment.... ............................... 25 

ii. Risk Assessment.......................................... 25 

7. Aggregate Risk............................................................. 27 

 a. Chronic Aggregate Risk.......................................... 27 

b. Short-and Intermediate-Term Aggregate Risk............ 28 

8. Occupational Risk......................................................... 30 

a. Occupational Toxicity........................................... 31 

b. Occupational Handler Exposure.............................. 31 

c. Occupational Handler Risk Summary........................ 34 

d. Occupational Post Application Exposures.................. 39 

i. Fogging (Food Processing Plant and Hatchery)......... 39 

e. Wood Preservation .............................................. 40 

i. Non-Pressure Treatment Scenarios (Handler and 40 

Post-Application) ............................................ 

 a. Scenarios Assessed by Worker Function ............ 40 

ii. Pressure Treatment Scenarios (Handler and Post- 43 
 Application)................................................... 

9. Human Incident Data...................................................... 44 

B. Environmental Risk Assessment............................................... 45 

1. Environmental Fate and Transport.................................... 45 

2. Ecological Risk............................................................. 45 

 a. Toxicity (Hazard) Assessment ................................. 45 

b. Exposure and Risk .............................................. 46 

c. Risk to Listed Species............................................ 48 

IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 50 

A. Determination of Reregistration Eligibility.................................. 50 

B. Public Comments and Responses............................................... 50 

C. Regulatory Position............................................................... 50 

1. Food Quality Protection Act Findings................................. 50 

a. "Risk Cup" Determination..................................... 51 

b. Determination of Safety to U.S. Population................. 51 

c. Determination of Safety to Infants and Children.......... 51 

 d. Endocrine Disruptor Effects................................... 52 

e. Cumulative Risks................................................. 52 

2. Tolerance Summary...................................................... 52 

D. Regulatory Rationale.............................................................. 53 

1. Human Health Risk Management..................................... 53 

 a. Dietary (Food) Risk Mitigation................................ 53 

b. Drinking Water Risk Mitigation.............................. 53 

c. Residential Risk Mitigation.................................... 54 

i. Handler Risk Mitigation ............................... 54 

ii. Post-Application Risk Mitigation.................... 54 

d. Occupational Risk Mitigation................................. 54 

i. Handler Risk Mitigation ............................... 54 

ii. Post-Application Risk Mitigation.................... 55 

2. Environmental Risk Management...................................... 55 

3. Labeling Requirements................................................... 56 

4. Listed Species Considerations........................................... 57 

a. The Endangered Species Act................................... 57 

 b. General Risk Mitigation......................................... 58 

V. What Registrants Need to Do............................................................ 59 

A. Manufacturing-Use Products................................................... 61 

1. Additional Generic Data Requirements.............................. 61 

2. Labeling for Technical and Manufacturing-Use Products........ 62 

B. End-Use Products.................................................................. 62 

1. Additional Product-Specific Data Requirements..................... 62 

2. Labeling for End-Use Products......................................... 65 

a. Label Changes Summary Table............................... 65 

VI. Appendices.................................................................................. 73 
A. ADBAC Master Label ...................... ..................................... 74 

B. Table of Generic Data Requirements and Studies Used to Make the 

 Reregistration Decision............................................................... 83 

C. Technical Support Documents.................................................. 91 

D. Bibliography Citations............................................................ 93 

E. Generic Data Call-In.............................................................. 108

F. Product Specific Data Call-In................................................... 109

G. List of All Registrants Sent the Data Call-In................................ 110

H. List of Available Forms .......................................................... 111
ADBAC Reregistration Team 

Health Effects Risk Assessment 

Jonathan Chen 

Timothy Leighton 

Tim McMahon 

Najm Shamim 

Matthew Lloyd 

Ecological Risk Assessment 

Richard Petrie 

Kathryn Montague 

Brian Kiernan 

Marietta Echeverria 

Environmental Fate Risk Assessment 

Srinivas Gowda 

Chemistry Assessment 

Chris Jiang 

Registration Support 

Velma Noble 

Dennis Edwards 

Risk Management 

Jacqueline Campbell-McFarlane 

Tracy Lantz 

Diane Isbell 

i 
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 Disruptor Screening Program 

EDSTAC Endocrine Disruptor 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/l, 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 

LOC 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 
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 

PDP 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 

iii 
ABSTRACT 

The Environmental Protection Agency (EPA or The Agency) has completed the human 

health and environmental risk assessments for alkyl dimethyl benzyl ammonium chloride, 

ADBAC, and is issuing its risk management decision and tolerance reassessment. The risk 

assessments, which are summarized below, are based on the review of the required target 

database supporting the use patterns of currently registered products and additional information 

received through the public docket. After considering the risks identified in the revised risk 

assessments, comments received, and mitigation suggestions from interested parties, the Agency 

developed its risk management decision for uses of ADBAC that pose risks of concern. As a 

result of this review, EPA has determined that ADBAC-containing products are eligible for 

reregistration, provided that risk mitigation measures are adopted and labels are amended 

accordingly. That decision is discussed fully in this document. 

iv 
I. Introduction 

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 

to accelerate the reregistration of products with active ingredients registered prior to November 

1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time 

frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the 

development and submission of data to support the reregistration of an active ingredient, as well 

as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the 

Agency). Reregistration involves a thorough review of the scientific database underlying a 

pesticide’s registration. The purpose of the Agency’s review is to reassess the potential hazards 

arising from the currently registered uses of the pesticide; to determine the need for additional 

data on health and environmental effects; and to determine whether or not the pesticide meets the 

“no unreasonable adverse effects” criteria of FIFRA. 

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into 

law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that, 

for those chemicals that have tolerances and are undergoing reregistration, the tolerance 

reassessment will be initiated through this reregistration process. The Act also requires that by 

2006, EPA must review all tolerances in effect on the day before the date of the enactment of the 

FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a 

safety finding in tolerance reassessment based on factors including consideration of cumulative 

effects of chemicals with a common mechanism of toxicity. This document presents the 

Agency’s revised human health and ecological risk assessments and the Reregistration Eligibility 

Decision (RED) for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC). 

 ADBAC is an antimicrobial used in agricultural, food handling, commercial/ 

institutional/ industrial, residential and public access, and medical settings. Examples of 

registered uses for ADBAC in these settings include application to indoor and outdoor hard 

surfaces (e.g., walls, floors, tables, toilets, and fixtures), eating utensils, laundry, carpets, 

agricultural tools and vehicles, egg shells, hands and gloves, shoes, milking equipment, and 

udders, humidifiers, RV tanks, medical instruments, human remains, ultrasonic tanks, reverse 

osmosis units, and water storage tanks. There are also ADBAC end-use products that are used in 

residential and commercial swimming pools, in aquatic areas such as decorative ponds, 

decorative fountains, and agricultural watering lines, and in industrial process and water systems 

such as once-through and re-circulating cooling water systems, cooling towers, evaporative 

condensers, pasteurizers, drilling mud, packer fluids, oil well injection and wastewater systems, 

and in pulp and paper products, water, and chemicals. Additionally, ADBAC end-use products 

are used for wood preservation. 

The Agency has concluded that the FQPA Safety Factor for ADBAC should be removed 

(equivalent to 1X) based on: (1) there is no concern for developmental neurotoxicity resulting 

from exposure to ADBAC because there is no evidence ADBAC will induce neurotoxic effects; 

(2) there is no evidence of increased susceptibility to the fetus following in utero exposure in the 

prenatal developmental toxicity studies or to the offspring when adults are exposed in the twogeneration reproductive study; and (3) the risk assessment does not underestimate the potential 

exposure for infants and children. 

1
Risks summarized in this document are those that result only from the use of the active 

ingredients ADBAC. The Food Quality Protection Act (FQPA) requires that the Agency 

consider available information concerning the cumulative effects of a particular pesticide’s 

residues and other substances that have a common mechanism of toxicity. The reason for 

consideration of other substances is due to the possibility that low-level exposures to multiple 

chemical substances that cause a common toxic effect by a common toxic mechanism could lead 

to the same adverse health effect that would occur at a higher level of exposure to any of the 

substances individually. Unlike other pesticides for which EPA has followed a cumulative risk 

approach based on a common mechanism of toxicity, EPA has not made a common mechanism 

of toxicity finding for ADBAC and any other substances. ADBAC does not appear to produce a 

toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA 

has not assumed that ADBAC has a common mechanism of toxicity with other substances. For 

information regarding EPA’s efforts to determine which chemicals have a common mechanism 

of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements 

released by EPA’s Office of Pesticide Programs concerning common mechanism determinations 

and procedures for cumulating effects from substances found to have a common mechanism on 

EPA’s website at http://www.epa.gov/pesticides/cumulative. 

This document presents the Agency’s decision regarding the reregistration eligibility of 

the registered uses of ADBAC. In an effort to simplify the RED, the information presented 

herein is summarized from more detailed information that can be found in the technical 

supporting documents for ADBAC referenced in this RED. The revised risk assessments and 

related addenda are not included in this document, but are available in the Public Docket at 

http://www.epa.gov/edocket. 

This document consists of six sections. Section I is the introduction. Section II provides 

a chemical overview, a profile of the use and usage of ADBAC, and its regulatory history. 

Section III, Summary of ADBAC Risk Assessments, gives an overview of the human health and 

environmental assessments, based on the data available to the Agency. Section IV, Risk 

Management, Reregistration, and Tolerance Reassessment Decision, presents the reregistration 

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 reregistration, bibliographic information, 

related documents and how to access them, and Data Call-In (DCI) information. 

2
II. Chemical Overview 

A. Regulatory History 

The first product containing ADBAC was registered in 1947. The oldest active 

product containing an ADBAC was registered in 1956 under chemical code 069105. 

These pesticides are classified as List A chemicals for which a registration standard was 

issued by EPA in 1985. When the list of active ingredients undergoing reregistration was 

published in 1989, 43 additional active ingredients were added to this case. Since 

issuance of the list, one active ingredient has been placed into a separate chemical case, 

and 18 active ingredients have been canceled thus resulting in 24 active ingredients in 

this case. 

The ADBAC Quat Steering Committee/Joint Venture comprised of Lonza, Inc., 

Mason Chemical Company, and Stepan Company was formed to support the 

reregistgration activities of this chemical case. Along with the Quat Steering 

Committee/Joint Venture, Albemarle Corporation produces chemicals within the 

ADBAC case. These chemicals are formulated into countless products that are used in 

residential, commercial, industrial, institutional, and agricultural settings. 

In 1988, EPA issued PR Notice 88-2 outlining “Clustering of Quaternary 

Ammonium Compounds.” In this Notice, Quats were clustered into 4 groups as follows: 

Group I: The alkyl or hydroxyalkyl (straight chain) substituted Quats 

Group II: The non-halogenated benzyl substituted Quats (including 

hydroxybenzyl, hydroxyethylbenzyl, naphylmethyl, dodecyhlbenzhyl, and alkyl benzyl) 

Group III: The di- and tri-chlorobenzyhl substituted Quats 

Group IV: Quats with unusual substitutes (charged heterocyclic compounds). 

The Agency agreed for data development purposes that the pesticide, alkyl 

(50%C14, 40% C12, 10% C16) dimethyl benzyl ammonium chloride (PC code 069105), 

would serve as the model compound. 

B. Chemical Identification 

The alkyl dimethyl benzyl ammonium chloride (ADBAC) chemical case is 

comprised of 24 compounds that are structurally similar quaternary ammonium 

compounds (quats) that are characterized by having a positively charged nitrogen 

covalently bonded to three alkyl group substituents and a benzyl substituent. In finished 

form, these quats are salts with the positively charged nitrogen (cation) balanced by a 

negatively charged molecule (anion). The most common anion for the quats in this 

cluster is chloride. However, other anions, such as saccharine and bromide are also used. 

Table 1 below provides the common chemical name, active ingredient code, CAS 

number, and chemical structure. 

3
Table 1: Active Ingredients in Group II Cluster 

Pesticide 

Code CAS RN Name Structure Chain Lengths 

69104 53516-76-0 ADBAC N+ 

CH3 

CH3 

R Cl- R = C12 (5%) 

C14 (60%) 

C16 (30%) 

C 18 (5%) 

69105 68424-85-1 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (40%) 

C14 (50%) 

C16 (10%) 

69106 8001-54-5 ADBAC N+ 

CH3 

CH3 

R Cl- R = C12 (50%) 

C14 (30%) 

C16 (17%) 

C18 (3%) 

69107 139-08-2 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (1%) 

C14 (98%) 

C16 (1%) 

69119 73049-75-9 Dialkyl Methyl BAC N+ 

R 

CH3 

R ClR = C12 (5%) 

C14 (60%) 

C16 (30%) 

C18 (5%) 

69137 68424-85-1 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (25%) 

C14 (60%) 

C16 (15%) 

69140 61789-71-7 ADBAC N+ 

CH3 

CH3 

R Cl- R = C8-10 (2.5%) 

C14 (61%) 

C16 (23%) 

C18 (2.5%) 

69141 68424-85-1 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (14%) 

C14 (58%) 

C16 (28%) 

69157 68424-85-1 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (65%) 

C14 (25%) 

C16 (10%) 

69175 68391-01-5 ADBAC N+ 

CH3 

CH3 

R Cl- R = C12 (67%) 

C14 (25%) 

C16 (7%) 

C18 (1%) 

69189 68391-01-5 ADBAC N+ 

CH3 

CH3 

R Cl- R = C12 (61%) 

C14 (23%) 

C16 (11%) 

C18 (5%) 

69184 68424-85-1 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (3%) 

C14 (95%) 

C16 (2%) 

69192 85409-22-9 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (70%) 

C14 (30%) 

4
Pesticide 

Code CAS RN Name Structure Chain Lengths 

69194 68424-85-1 ADBAC N+ 

CH3 

CH3 

R ClR = C12 (5%) 

C14 (90%) 

C16 (5%) 

128928 63449-41-2 ADBAC N+ 

CH3 

CH3 

R ClR = C8 – Not specified 

C10 – Not specified 

C12 (67%) 

C14 (25%) 

C16 (7%) 

C18 – Not specified 

69171 68989-01-5 ADBA Saccharinate N+ 

R 

CH3 

R 

O 

-

N 

S 

O 

O 

R = C12 (40%) 

C14 (50%) 

C16 (10%) 

69154 85409-23-0 ADEBAC N+ 

CH3 

CH3 

R ClH3C 

R = C12 (68%) 

C14 (32%) 

69111 8045-21-4 ADEBAC N+ 

CH3 

CH3 

R ClH3C R = C12 (50%) 

C14 (30%) 

C16 (17%) 

C18 (3%) 

069112 53516-75-9 

n-Alkyl dimethyl 1­

naphtylmethyl 

ammonium chloride 

R=C12 (98%) 

C14 (2%) 

069125 1330-85-4 

Dodecyl benzyl 

trimethyl ammonium 

chloride 

169159 N/A 

n-alkyl dimethyl 

dimethyl ammonium 

chloride 

R= C12 (68%) 

C14 (32%) 

69122 121-54-0 

Diisobutylphenoxyethyoxyethyl dimethyl 

benzyl ammonium 

chloride 

[Benzethonium 

Chloride] 

CH3 

H3C 

O CH3 

H3C 

CH3 

O 

N+ 

H3C 

CH3 

Cl69129 1399-80-0 

Methyl dodecyl benzyl 

tri methyl ammonium 

chloride - 80% 

Methyl dodecyl xylene 

bis tri methyl 

ammonium chloride – 

20% 

5
Pesticide 

Code CAS RN Name Structure Chain Lengths 

69134 25155-18-4 

Diisobutyl 

cresoxyethoxyethyl 

dimethyl benzyl 

ammonium chloride 

monohydrate 

Common name: ADBAC 

Chemical name: n-Alkyl dimethyl benzyl ammonium chloride 

Chemical family: Quaternary amines 

Case number: 0350 

Basic manufacturers: Albemarle Corporation 

Lonza, Inc. 

Mason Chemicals Company 

 Stepan Company 

Chemical properties: ADBAC is a clear yellow to straw colored liquid with an amine 

odor that is soluble in water and alcohols. ADBAC has a melting 

point of 241.02oC, vapor pressure of 3.53x 10-12 mm HG, and a 

density of 0.9429 g/cm2

 at 25oC. 

C. Use Profile 

The following is information on the uses of ADBAC products, currently registered as of 

April 26, 2006, and an overview of use sites and application methods. A detailed table of the 

uses of ADBAC eligible for reregistration is contained in Appendix A. 

Type of Pesticide: Algicide, bacteriocide, bacteriostat, wood preservative, fungicide, 

fungistat, virucide, tuberculocide, insecticide, microbiocide, microbiostat, 

molluscide, deodorant, disinfectant, and sanitizer 

6
Summary of Uses: 

Use Category Use Site 

Industrial processes and water 

systems 

Industrial re-circulating water systems, pulp and paper 

facilities, cooling water towers, disposal water, oil field 

operations, and oilfield water flood or saltwater disposal. 

Swimming Pools Swimming Pools, Outside Spas, Whirlpools, and hot tubs 

Aquatic Areas Golf courses, recreational parks, amusement parks, 

universities, cemeteries, and greenhouse/nurseries 

Wood Treatment Pressure Treatment, Double vacuum, and dip/spray surface 

treatment 

Agricultural Premise and 

Equipment 

Hatcheries, swine/poultry/turkey farms, animal housing 

facilities, farrowing barns, dressing plants, mushroom farms, 

citrus farm, florist/flower shops, and greenhouses/nurseries 

Residential and Public Access 

Premises 

Homes, mobile homes, cars, boats, playgrounds, boats, 

public facilities, campgrounds, trailers, campers, trailers, and 

trucks 

Medical Premises and 

Equipment 

Hospitals, health care facilities, medical/ dental offices, 

nursing homes, autopsy rooms, funeral homes, mortuaries, 

medical research facilities, acute care institutions, alternative 

care institutions, newborn nurseries, day-care facilities, and 

sick rooms 

Commercial, Institutional, and 

Industrial Premise and 

Equipment 

Athletic/recreational facilities, exercise facilities, health 

clubs, dressing/locker rooms, schools, colleges, universities, 

transportation terminals, libraries, motels, hotels, barber and 

beauty salons, convenience stores, offices, commercial/ 

institutional laundry mats, emergency vehicles, factories, 

commercial florist, and correctional facilities 

Food Handling/Storage 

Establishments Premises and 

Equipment 

Restaurants, food service establishments, food 

processing/storage/handling plants and facilities, beverage 

processing plants, supermarkets, breweries, bars, cafeterias, 

fishery/citrus/wine/ice cream/ potato processing plants, egg 

processing plants, dairies, institutional kitchens, fast food 

operations, rendering plants, school lunchrooms, and packing 

plants 

Target Pests: Slime-forming bacteria, odor causing/staining bacteria, Gram-negative and 

Gram-positive bacteria, Pseudomonas aeruginosa, pathogenic fungi 

(Trichophyton mentagrophytes), envelope and non-envelope viruses, 

mold/mildew, algae 

Formulation Types: Formulation intermediate, aerosol, soluble concentrate/tablet, impregnated 

wipes, ready-to-use solution, wettable powder, pressurized liquid, and 

water-soluble packaging. 

7
Method and Rates of Application: 

Methods: ADBAC formulations are added directly to water in swimming pools, 

decorative ponds/fountains, spas, cooling water towers, oil field drilling 

muds and packing fluids, small process water systems, humidifiers, and 

cut flower applications. ADBAC formulations are diluted in water to treat 

hard nonporous surfaces in institutional, commercial, industrial, and 

residential settings by fogging, immersion, wiping, mopping, 

aerosol/trigger spray, and low pressure and high-pressure spray. Some 

impregnated wipes are dampened with water prior to use while others are 

pre-moistened. For the treatment of wood, ADBAC is applied by a 

blender/spray system, diptank, spray box, or pressure treatment. 

Application Rates: For details about specific use sites for ADBAC, refer to Appendix A. 

The following rates are a representation of the maximum rate documented 

in the label table by use category. 

• Use 14 oz of 50% end-use product per 10,000 of water to produce a 5 

ppm active solution for treatment of swimming pools and spas. 

• Use 1 oz of 20% end-use product per gallon of water to produce a 

781.5 ppm active solution for treatment of aquatic areas such as 

decorative ponds, fountains, and water displays. 

• Use 6 pounds of 50% end use product diluted to 3% active ingredient 

solution per cubic foot of wood for dip, brush, spray, and pressure 

treatment for wood preservation. 

• Use 9 oz of 3.2% end use product per gallon of water to achieve a 

2250 ppm active solution for treatment of agricultural premises and 

equipment such as animal housing facilities, animal life science 

laboratories, farms, ornamental nurseries, and animal transportation 

vehicles. 

• Use 115 oz of 9.0% end use product per 2.5 gallons of water to 

achieve 44,000 ppm active solution for treatment in egg processing 

plants and hatcheries by fogging. 

• Use 53.2 grams of 40% end-use product per 2 gallons of water to 

achieve 2800 ppm active solution for treatment in ornamental 

nurseries on plants and trees. 

• Use 0.5 oz of 20% end-use product per gallon of water every 40 sq. 

feet to achieve 781 ppm active solution for treatment of lawns, turf, 

and golf courses greens and tees. 

• Use 1 oz of 20% end-use product to one gallon of water to achieve 

1532 ppm active solution or use Ready-to-Use formulation for 

treatment of medical premises and equipment such as hospitals, daycare centers, mortuaries, and EMS facilities. 

• Use 9 oz of 3.2% end-use product to one gallon of water to achieve 

2250 ppm active solution or use Ready-to-Use formulation for 

treatment of commercial and industrial premises and equipment such 

8
as barber/beauty salons, athletic facilities, libraries, manufacturing 

facilities, and hotels. Also, use 155 oz of 9.0% end-use product per 

2.5 gallons of water to achieve 44,000 ppm active solution for 

treatment of commercial and industrial premises by fogging. 

• Use 2 oz of 10% end-use product per gallon of water to achieve 3000 

ppm active solution or use Ready-to-Use formulation for treatment of 

residential and public access premises such as homes, campgrounds, 

and recreational facilities. 

• Use 1 oz of 20% end-use product per gallon of water to achieve a 400 

ppm active solution for food contact sanitizing treatment in food 

handling/storage establishments such as restaurants, food storage 

areas, meat, poultry, and vegetable processing facilities. 

• Use 6 oz of 4.5% end-use product per gallon of water to achieve a 

2100 ppm active solution for disinfection in food handling/storage 

establishments such as restaurants, food storages areas, meat, poultry, 

and vegetable processing facilities. 

• Use 24 oz of 9.0% end-use product per gallon of water to achieve 

16,875 ppm active solution for treatment of carpets in medical, 

commercial, and residential settings. 

• Use 8 oz of 20% end-use product per 100 pounds of dry laundry to 

achieve 1154 ppm active solution from treatment of clothing/laundry 

in medical and commercial settings. 

Use Classification: General use. 

9
III. Summary of ADBAC Risk Assessments 

The purpose of this summary is to assist the reader by identifying the key features and 

findings of these risk assessments and to help the reader better understand the conclusions 

reached in the assessments. The human health and ecological risk assessment documents and 

supporting information listed in Appendix C were used to formulate the safety finding and 

regulatory decision for ADBAC. While the risk assessments and related addenda are not 

included in this document, they are available from the OPP Public Docket, 

http:/www.regulations.gov. Hard copies of these documents may be found in the OPP public 

docket under docket number OPP-2006-0339. The OPP public docket is located in Room S4400, One Potomac Yard (South Building), 2777 South Crystal Drive, Arlington, VA 22202 and 

is open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. 

A. Human Health Risk Assessment 

1. Toxicity of ADBAC 

The Agency’s use of human studies in the ADBAC risk assessment is in accordance with 

the Agency’s Final Rule promulgated on January 26, 2006, related to Protections for Subjects in 

Human Research, which is codified in 40 CFR Part 26. 

A brief overview of the toxicity studies used for determining endpoints in the risk 

assessments are outlined below in Table 1. Further details on the toxicity of ADBAC can be 

found in the “Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision 

Document on Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC),” dated February 27, 

2006; “Draft Preliminary Risk Assessment for Alkyl Dimethyl Ammonium Chloride 

(ADBAC),” dated April 20, 2006; and “ADBAC - Report of the Antimicrobials Division 

Toxicity Endpoint Committee (ADTC) and the Hazard Identification Assessment Review 

Committee (HIARC),” dated April 20, 2006. These documents are available at 

http://www.regulations.gov. 

The Agency has reviewed all toxicity studies submitted for ADBAC and has determined 

that the toxicological database is sufficient for reregistration. The acute toxicology data shows 

that ADBAC is toxicity category II by the oral and inhalation routes and toxicity category III via 

the dermal route. ADBAC is also considered to be highly irritating to the eyes and skin (toxicity 

category I) and is not a dermal sensitizer. Major features of the acute toxicology profile are 

presented below 

Table 1. Summary of Acute Toxicity Data for ADBAC 

Guideline 

Number 

Test Substance MRID Results Toxicity 

Category 

870.1100 Acute oral, rat 

BQ451-8 Biocide 

(Purity 82.26%) 

45109204 LD50 =304.5 mg/kg (combined) 

LD50 =510.9 mg/kg (males) 

LD50 =280.8 mg/kg (females) 

II 

10
Guideline 

Number 

Test Substance MRID Results Toxicity 

Category 

870.1200 Acute dermal, rat 

BQ451-8 Biocide 

(Purity 82.26%) 

45109202 LD50 =930 mg/kg (combined) 

LD50 =1100 mg/kg (males) 

LD50 =704 mg/kg (females) 

III 

870.1300 Acute inhalation, 

rat 

 (Purity 82.26%) 

44885201 0.054 < LC50 < 0.51 mg/L II 

870.2400 Primary Eye 

Irritation 

Waived N/A I 

870.2500 Primary Dermal 

Irritation, , rabbit 

BQ451-8 Biocide 

(Purity 82.26%) 

45109201 Corrosive I 

870.2600 Dermal 

sensitization, 

guinea pigs 

BQ451-8 Biocide 

(Purity 82.26%) 

45109201 Not a dermal sensitizer N/A 

The doses and toxicological endpoints selected for the dietary exposure scenarios are 

summarized in Table 2 below. 

Table 2. Summary of Toxicological Endpoints for ADBAC (Dietary) 

Exposure 

Scenario 

Dose Used in 

Risk Assessment 

(mg/kg/day) 

Target MOE or UF, 

Special FQPA SF 

for Risk Assessment 

Study and Toxicological Effects 

Acute Dietary 

(general 

population; 

females 13+) 

An acute dietary endpoint was not identified in the data base. 

Chronic Dietary 

NOAEL =44 

mg/kg/day 

FQPA SF = 1 

UF = 100 (10x inter-species 

extrapolation, 10x intra-species 

variation) 

Chronic toxicity/carcinogenicity –rat 

MRID 41947501 

LOAEL = 88 mg/kg/day, based on 

decreased body weight and weight gain 

Chronic RfD = 0.44 mg/kg/day 

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

lowest observed adverse effect level, RfD = reference dose, MOE = margin of exposure, LOC = Level of concern, 

NA = Not Applicable. 

11 
Dietary 

Acute dietary risks were not assessed because an endpoint appropriate for acute dietary 

assessment was not identified in the available ADBAC database. 

For ADBAC, a chronic toxicity/carcinogenicity study was conducted in rats. This study 

established the RfD of 0.44 mg/kg/day based on decreased body weight and weight gain in male 

rats at 88 mg/kg/day. An uncertainty factor of 100 (10X for interspecies extrapolation, 10X for 

intraspecies variation) was applied to the NOAEL to obtain the chronic RfD. 

Incidental Oral 

The short- and intermediate-term incidental oral NOAEL is 10 mg/kg/day from a rat 

developmental toxicity study that noted decreased body weight and decreased food consumption 

at 30 mg/kg/day. 

Short-term Dermal 

The short-term dermal NOAEL is 20 mg/kg/day based on denuded non-vascularized 

epidermal layer from a 21-day dermal toxicity study on a 4% active ingredient formulated 

product. The uncertainty factor or “target” MOE for ADBAC dermal exposures is 10 for 

occupational and residential scenarios. The target MOE was chosen because the established 

endpoint is for dermal irritation, not a systemic toxic effect. In addition, dermal irritation is 

considered a reversible and short-term effect, thus supporting a 10x uncertainty factor (3x for 

interspecies extrapolation and 3x for intraspecies variation). It should be noted that the 

determination to reduce the 100x UF to 10X UF for irritation endpoints is made on a case-bycase basis. 

Intermediate-Term Dermal 

The intermediate-term dermal NOAEL is 20 mg/kg/day since it was the highest dose 

tested before irritation became significant at day 43. The uncertainty factor or “target” MOE for 

ADBAC dermal exposures are 10 for occupational and residential scenarios. The target MOE 

was chosen because the established endpoint is for dermal irritation, not a systemic toxic effect. 

The Agency has reevaluated this value because the established endpoint is for dermal irritation, 

not a systemic toxic effect. In addition, dermal irritation is considered a reversible and short-term 

effect, thus supporting a 10x uncertainty factor (3x for interspecies extrapolation and 3x for 

intraspecies variation). It should be noted that the determination to reduce the 100x UF to 10X 

UF for irritation endpoints is made on a case-by-case basis. 

Short,- Intermediate,- and Long-term Inhalation 

The short-, intermediate-, and long-term inhalation NOAEL is 3 mg/kg/day based on the 

hyperactivity and labored breathing at 9 mg/kg/day in an oral developmental study in rabbits. In 

the absence of route-specific data, it was conservatively assumed that inhalation absorption is 

equivalent to oral absorption (i.e., 100%). For inhalation exposures, the target MOE is 100 for 

occupational and residential scenarios, (10x interspecies extrapolation and 10x interspecies 

12
variability). However, if the resulting MOE is not at least 100, the Agency can request a repeat 

dose inhalation study of at least 28 days in duration. 

Carcinogenicity Classification 

The database for carcinogencity is complete, and ADBAC is not carcinogenic based on 

studies in rats and mice. 

Mutagenicity Potential 

The data base for mutagenicity is considered adequate and indicates that ADBAC is not 

mutagenic or genotoxic. 

Endocrine Disruption Potential 

EPA is required under the FFDCA, as amended by FQPA, to develop a screening 

program to determine whether certain substances (including all pesticide active and other 

ingredients) “may have an effect in humans that is similar to an effect produced by a naturally 

occurring estrogen, or other such endocrine effects as the Administrator may designate.” 

Following recommendations of its Endocrine Disruptor 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 Disruptor 

Screening Program (EDSP). 

When the appropriate screening and/or testing protocols being considered under the 

EDSP have been adopted, ADBAC may be subject to additional screening and/or testing to 

better characterize effects related to endocrine disruption. 

2. FQPA Safety Factor 

The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is 

intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in 

infants and children to specific pesticide residues in food, drinking water, or residential 

exposures, or to compensate for an incomplete database. The FQPA Safety Factor has been 

removed (i.e., reduced to 1X) for ADBAC based on (1) the existence of a complete 

developmental and reproductive toxicity database, (2) the lack of evidence for increased 

susceptibility in these data, and (3) the risk assessment does not underestimate the potential riks 

for infants and children. The FQPA Safety Factor assumes that the exposure databases (food, 

drinking water, and residential) are complete, the risk assessment for each potential exposure 

scenario includes all metabolites and/or degradates of concern, and does not underestimate the 

potential risk for infants and children. These criteria have been met for ADBAC. The Agency 

13
determined that no special FQPA Safety Factor was needed since there were no residual 

uncertainities for pre- and/or postnatal toxicity. 

3. Population Adjusted Dose (PAD) 

Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which 

reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for 

the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A 

risk estimate that is less than 100% of the acute or chronic PAD is not of concern. 

a. Acute PAD 

Acute dietary risks for ADBAC were not assessed because an endpoint appropriate for 

acute dietary assessment was not for ADBAC. 

b. Chronic PAD 

Chronic dietary risk for ADBAC is assessed by comparing chronic dietary exposure 

estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic dietary risk 

is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.44 mg/kg/day) 

modified by the uncertainty factor. The cPAD was derived from a chronic toxicity/ 

carcinogencity study in the rat, in which the NOAEL (44 mg/kg/day) and the LOAEL (88 

mg/kg/day) were determined based on decreased body weight and weight gain. The ADBAC 

cPAD is 0.44 mg/kg/day based on a reference dose of 0.44 mg/kg/day and a FQPA safety factor 

of 1X. 

4. Dietary Exposure Assumptions 

 The antimicrobial use of ADBAC on food contact surfaces, agricultural premises, 

poultry premises including hatcheries and application to food-grade eggs may result in pesticide 

residues in human food. Residues from the use of ADBAC for food contact sanitization on 

treated surfaces, such as food utensils, countertops, equipment, and appliances, can migrate to 

food coming into contact with the treated surfaces and can be ingested by humans. 

In addition to food contact surface sanitizer uses, this assessment also analyzed residues 

from hard nonporous surfaces that have been treated with ADBAC as a disinfectant after rinsing 

with potable water. In the absence of transfer residue data for these ADBAC disinfectant uses, 

the Agency assumed that rinsing with potable water cannot remove all residues deposited on the 

treated surfaces. Therefore, residues from the treated and rinsed surfaces may migrate to food 

coming into contact with these surfaces and then be ingested by humans. 

In the absence of data for residues of ADBAC on treated food contact surfaces, the 

Agency estimated residue levels that may occur in food from the application rates on food 

contact surfaces such as utensils and countertops. In addition, the food packaging and beverage 

bottling uses have also been evaluated. 

ADBAC products may be applied to the shells of food grade-eggs in egg processing 

plants. Although it is possible that some sanitizer/disinfectant chemicals may penetrate egg 

14
shells, at this time, the Agency believes that the amount of the chemical transferred into eggs is 

likely to be minimal because the eggs must be subjected to a potable water rinse if they are to be 

immediately broken for use in the manufacturing of egg products. 

There is no evidence that there will be residues of ADBAC in mushrooms following its 

use as a mushroom house disinfectant. Further, if dietary exposures from mushroom house uses 

occurred they would be expected to be much lower than the dietary exposures resulting from the 

surface disinfectant and sanitizing uses because the label states that the product is not be applied 

to the mushroom crop, compost or casing and treated surfaces are to be rinsed with potable water 

before contact with the crop, compost, or casing. Since these exposures are not likely to pose 

risks of concern, and the sanitizing uses represent a “worse-case” scenario, these uses were not 

assessed. 

The Agency assessed the chronic dietary exposure due to ADBAC use as a disinfectant 

and food contact sanitizer on direct and indirect food-contact surfaces. This assessment 

calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI). The assessment 

considered: application rates, residual solution or quantity of solution remaining on the treated 

surface without rinsing with potable water, surface area of the treated surface which comes into 

contact with food, pesticide migration fraction, and body weight. These assumptions are based 

on FDA guidelines (FDA, 2003). However, in assessing dietary exposures from ADBAC in 

food packaging and beverage bottling, a number of assumptions were made based on the EPA 

guidelines (2005) for the pesticide migration fraction residual solution, daily food intake rates, 

application rate, and grams of food per surface area of container. 

The EDI calculations presented in this assessment assumes that food can contact 

2,000cm2 or 4,000 cm2 (50% and 100% of the FDA worse case scenario) of treated surfaces, and 

that 10% of the pesticide would migrate to food. The use of the 10% transfer rate instead of the 

use of a 100% transfer rate was used for all indirect food contact surfaces except for food 

packaging and bottling surfaces. The 10% migration rate is based on Agency Residential 

Standard Operation Procedures. These daily estimates were conservatively used to assess 

chronic dietary risks (i.e., percent chronic population adjusted dose or %cPAD). 

5. Dietary Risk Assessment 

A summary of the chronic risk estimates are shown in Table 4a and b. Based on a review 

of product labels containing ADBAC, food handling establishments and food processing 

facilities, have been identified as having the potential to cause indirect dietary exposure due to 

indirect food contact on the following surfaces: 

1. Utensils 

2. Countertops 

3. Food bottling/Packaging 

a. Dietary Risk from Food 

A dietary risk assessment was conducted for three of the five direct and indirect food 

contact surfaces listed above; as explained previously exposures from poultry hatcheries and 

mushroom houses were not assessed. Acute dietary risks were not assessed because an acute 

15
toxicity value was not identified. However, the chronic dietary assessment concluded that for all 

included uses, the chronic risk estimates are below the Agency’s level of concern for adults and 

the most highly exposed population subgroup, children (<4% of the cPAD). Any potential 

additional exposure as the result of the egg and mushroom house uses of ADBAC would not be 

expected to contribute significantly to overall dietary exposure and would not impact the 

%cPAD in a significant way. 

Table 4a: Calculated EDIs and cPAD for Utensils and Countertops (The Aggregate represents 

the total chronic population adjusted dose (cPAD) for both surfaces) 

Utensils Countertops Aggregate 

Exposure 

Group 

EDI 

(mg/day) 

DDD 

(mg/kg/d) % cPADa EDI (mg/day) 

DDD 

(mg/kg/d) % cPADa EDI (mg/day) 

DDD 

(mg/kg/d) % cPADa 

Adult 

males 0.0815 0.00116 0.265 0.0815 0.00243 0.265 0.252 0.00359 0.530 

Adult 

females 0.0815 0.00136 0.309 0.0815 0.00284 0.309 0.252 0.00419 0.680 

Children 0.0815 0.00543 1.23 0.170 0.0113 1.23 0.252 0.0168 2.46 

a % PAD = exposure (DDD) /(cPAD) x 100. 

EDI is the estimated daily intake (mg/day). 

DDD is the dietary daily dose (mg/kg/day). 

For food and beverage packaging/bottling, EDI values were calculated using an approach 

similar to that used for treated food contact surfaces and utensils. The maximum application rate 

for ADBAC for bottling/packing of beverages and food is 0.0103 lbs a.i. per gallon of treatment 

solution. Exposure was assumed to occur through the ingestion of three food products that might 

be packaged with treated material: milk, egg products, and beverages (alcoholic and nonalcoholic). None of the calculated % cPad values exceeded 100% are not of concern. The 

results of the EDI and %cPAD are presented in Table 4b. 

16
Table 4b. Calculated EDIs and cPAD for Representative Dairy and Beverage Consumption 

Food Type Exposure 

Group EDI (mg/day) DDD % cPAD 

Milk 

Adult Male 

3.8 x 10-3 

5.37 x 10-5

(mg/kg/d) 

1.2 x 10-2 

Adult Female 3.86 x 10-4 1.4 x 10-2 

Childa 2.4 x 10-3 1.66 x 10-4 3.6 x 10-2 

Egg product 

Adult Male 

2.8 x 10-5 

4.06 x 10-7 9.1 x 10-5 

Adult Female 4.69 x 10-7 1.1 x 10-4 

Child a 1.58 x 10-5 1.20 x 10-6 2.7 x 10-4 

Beverages, nonalcoholic 

Adult Male 

3.2 x 10-4 

4.57 x 10-6 1.0 x 10-3 

Adult Female 1.96 x 10-6 1.2 x 10-3 

Childa 2.0 x 10-4 1.37 x 10-5 3.1 x 10-3 

Beverages, 

alcoholic, beer 

Adult Male 

2.4 x 10-5 

3.47 x 10-6 7.9 x 10-4 

Adult Female 4.04 x 10-6 9.0 x 10-4 

b. Dietary Risk from Drinking Water 

As an outdoor pesticide, ADBAC is applied to nursery ornamentals and turf, and is used 

for mosquito control in ponds and puddles and as an algaecide in decorative pools. Since the 

uses are ornamental and periodic in nature, disconnected from the larger watershed, the Agency 

believes exposures to drinking water sources from these uses are not expected to be significant. 

For the drinking water assessment, only the turf and nursery uses for ADBAC were considered. 

Foliar spray, drench and “dribble” applications are allowed. 

The Tier 1 surface water and groundwater model was used to assess applications to 

ornamental plants, this use represents the highest application rate of all labeled uses, of 302 lbs. 

a.i/Acre, and a maximum of 3 applications per year. Since the tier I models are not dependent on 

“crop” type, the Estimated Drinking Water Concentrations (EDWCs) determined for the nursery 

ornamental use are also protective of all other uses with lower application rates. The EDWCs for 

the human health risk assessment are in Table 5.3 and are based on the nursery ornamental use 

pattern. There were no major degradates of ADBAC in the laboratory studies (EFED Memo by 

Marietta Echeverria to Jacqueline Campbell-McFarlane: Tier I Drinking Water Assessment for 

alkyl*dimehtyl benzyl ammonium chloride (50%C14, 40%C12, 10%C10) (ADBAC) and 

Didecyl dimethyl ammonium chloride, (DDAC), dated 2006). 

An acute oral toxicological endpoint was not established for ADBAC. Therefore, only 

the chronic drinking water exposure is calculated. The adult chronic drinking water dose is 

0.009 mg/kg/day (i.e., average EDWC 331 ug/L x 2 L/day consumption x 1/70 kg BW). The 

chronic drinking water dose for children is 0.022 mg/kg/day (i.e., average EDWC 331 ug/L x 1 

L/day consumption x 1/15 kg BW). There are no drinking water concerns with ADBAC as the 

concentrations are much lower than level of concern. 

17
Table 5.3. Tier I Estimated Drinking Water Concentrations (EDWCs) Based on Aerial 

Application of ADBAC on Nursery Ornamentals 

Drinking Water Source (Model) Use rate (lbs ai/A/year) EDWC (ppb) 

Surface water (FIRST) 

Acute (peak) 

- Chronic (annual average) 

906 

13,129 

331 

Groundwater (SCIGROW) 906 5.4 

It should be noted that the Agency estimated concentrations for exposure to aquatic 

animals resulting from the antisapstain and cooling tower uses. These levels were not considered 

appropriate for use in the drinking water assessment due to the very conservative nature of the 

models used, that the model estimates runoff/point source concentrations and not water body 

concentrations, and the fact that the models does not account for dilution. 

6. Residential Risk Assessment 

The residential exposure assessment considers all potential pesticide exposure, other than 

exposure due to residues in food or in drinking water. Exposure may occur during and after 

application as a hard surface disinfectant or non-food contact sanitizer (e.g., walls, floors, tables, 

fixtures), to textiles (e.g. clothing), and to carpets. Each route of exposure (oral, dermal, 

inhalation) is assessed, where appropriate, and risk is expressed as a Margin of Exposure (MOE), 

which is the ratio of estimated exposure to an appropriate NOAEL. 

a. Toxicity 

A MOE of 100 for inhalation exposure and oral exposures and a 10 for dermal exposure 

are considered protective. The MOE of 100 is based on a 10x interspecies and 10x intraspecies 

variability while the MOE of 10 is based on a 3x interspecies and 3x intraspecies variability. 

The toxicological endpoints and associated uncertainty factors used for assessing the non-dietary, 

residential risks for ADBAC are listed in Table 6a. 

Table 6a. Toxicological Endpoints Selected for Residential and Occupational Toxicological 

Risks for ADBAC 

Exposure 

Scenario Risk Assessment 

Dose Used in 

(mg/kg/day) 

Target MOE or UF, 

Special FQPA SF 

for Risk Assessment 

Study and Toxicological Effects 

Incidental Oral 

(short-term) 

NOAEL = 10 

mg/kg/day 

FQPA SF = 1 

UF = 100 (10x inter-species 

extrapolation, 10x intra-species 

variation) 

Developmental Toxicity – Rat, 

MRID 42351501 

LOAEL = 100 mg/kg/day, based 

on decreased body weight and 

food consumption 

18
Exposure 

Scenario Risk Assessment 

Dose Used in 

(mg/kg/day) 

Target MOE or UF, 

Special FQPA SF 

for Risk Assessment 

Study and Toxicological Effects 

Incidental Oral 

(intermediate-term) 

NOAEL = 10 

mg/kg/day 

FQPA SF = 1 

UF = 100 (10x inter-species 

extrapolation, 10x intra-species 

variation) 

Developmental Toxicity – Rat, 

MRID 42351501 

LOAEL = 100 mg/kg/day, based 

on decreased body weight and 

food consumption 

Short-Term 

DermalNOAEL= 20 mg 

ai/kg/day 

(333 μg/cm2

) 

FQPA SF = 1 

UF = 10 (3x inter-species 

extrapolation, 3x intra-species 

variation) 

21-day dermal toxicity- guinea 

pigs MRID 41105801 

LOAEL = 1000 mg/kg/day, 

based on denuded nonvascularized epidermal layer 

Intermediate-Term 

Dermal 

NOAEL=20 mg 

ai/kg/day 

(80 ug/cm2

) 

UF = 10 (3x inter-species 

extrapolation, 3x intra-species 

variation) 

90-day dermal toxicity in rats 

MRID 41499601 

20 mg/kg/day is the highest dose 

tested before irritation became 

significant 

Long-Term Dermal 

(TGAI) 

No appropriate endpoint identified. No systemic effects observed up to 20 mg/kg/day, highest 

dose of technical grade that could be tested without irritation effects. 

Inhalationa 

(Any time point) 

NOAEL= 3 

mg/kg/day 

MOE = 100c 

UF = 100 (10x inter-species 

extrapolation, 10x intra-species 

variation) 

Note: an additional 10x is used for 

route extrapolation to determine if a 

confirmatory study is needed 

Developmental Toxicity – rabbit, 

MRID 42392801 

LOAEL = 9 mg/kg/day, based on 

clinical signs of toxicity in 

maternal rabbits 

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

lowest observed adverse effect level, MOE = margin of exposure, NA = Not Applicable. 

aAn additional uncertainty factor of 10x is applied for use of an oral endpoint for rout-to-route extrapolation to 

determine if confirmatory inhalation toxicity study is warranted. 

b Dermal endpoint = (20 mg/kg guinea pig x 0.4 kg guinea pig x 1000 ug/mg) / 25.8μg/cm2

 area of guinea pig 

dosed = 333 μg/cm2

 . 

c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1000 ug/mg) / 100μg/cm2 area of rat dosed = 40 

μg/cm2 . 

b. Residential Handlers 

i. Exposure Scenarios, Data and Assumptions 

For antimicrobial uses, residential exposure may occur during application of ADBAC as a 

hard surface disinfectant or sanitizer (e.g. walls, floors, tables, fixtures), to textiles, musical 

instrument mouthpieces, carpets, swimming pools, and humidifiers. In addition to the traditional 

antimicrobial uses of ADBAC described above, it may also be used outdoors to treat ornamental 

plants, lawns, and puddles/ponds/swimming pools. For this assessment, homeowners are 

assumed to complete all elements of an application (mix/load/apply) without the use of personal 

protective equipment. 

19
 The following exposure scenarios were assessed for ADBAC: 

• Indoor hard surfaces (e.g., mopping, wiping, trigger pump sprays) 

• Air deodorizers 

• Carpets 

• Swimming Pools (e.g., liquid pour) 

• RV holding tanks (e.g., liquid pour) 

• Textiles (e.g. clothing, treated during washing); 

• Musical instrument mouthpieces; and 

• Humidifiers 

• Ornamental Plants 

• Lawns 

The antimicrobial residential handler scenarios were assessed to determine dermal and 

inhalation exposures. Surrogate dermal and inhalation unit exposure values were estimated 

using Pesticide Handler Exposure Database (PHED) data, the Chemical Manufacturers 

Association Antimicrobial Exposure Assessment Study (USEPA, 1999), Outdoor Residential 

Exposure Task Force data (ORETF). 

The quantities handled/treated for the handler scenarios were estimated as indicated 

below: For additional information, please review the Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) Occupational and Residential Exposure Assessment (Antimicrobial Uses) 

dated July 27, 2006. 

• For mopping scenarios, it is assumed that 1 gallon of diluted solution is used. 

• For wiping and trigger pump spray scenarios, it is assumed that 0.5 liter (0.13 gal) of 

diluted solution is used. 

• For aerosol sprays, it is assumed that one can is used. The net weight of the can was not 

provided on the label; therefore, it was assumed that the can contained 16-oz of product. 

• For low pressure hand wand, it was assumed that 2 gallons are used in all indoor 

applications. 

• For liquid pour in swimming pool scenario, it was assumed that a residential pool 

contains 20,000 gallons of water. 

• For liquid pour in RV holding tank scenario, it was assumed that one tank would be 

treated. The product label states a maximum application rate of 4 oz (0.031 gallons) 

product per tank. 

• For mixer/loader/applicators scenarios: 

 For agricultural exposures, residential exposures may occur during the application of 

ADBAC to ornamental plants, shrubs, trees as well as seedlings, seeds, and cuttings, 

residential/commercial turf, golf courses, and fountains/water displays, sewage treatment 

systems, standing water for mosquito control. As with the antimicrobial use, homeowners are 

assumed to complete elements of an application (mix/load/apply) without the use of personal 

protective equipment. 

20
 The quantitative exposure/risk assessment developed for residential handlers is based on 

these scenarios. For additional information, please review the Alkyl Dimethyl Benzyl 

Ammonium Chloride (ADBAC) Occupational and Residential Exposure Assessment 

(Agricultural Uses) dated August 1, 2006 

Mixer/Loader/Applicators: 

(1) Liquid Formulations: Low Pressure Handwand (PHED data for dermal and 

ORETF data for inhalation) 

(2) Dry Flowable Formulations: Low Pressure Handwand (using liquid concentrate 

PHED data for dermal and liquid concentrate ORETF data for inhalation) 

(3) Liquid Concentrates: Hose-End Sprayer (PHED data for dermal and ORETF data 

for inhalation) 

(4) Dry Flowable Formulations: Hose-End Sprayer (no data) 

(5) Ready-to-Use Formulations: Hose-End Sprayer (no data) 

(6) Liquid Concentrates: Watering Can (using PHED hose-end sprayer data for 

dermal and ORETF hose-end data for inhalation) 

(7) Ready to Use Formulations via Trigger-Pump Sprayer (PHED data for aerosol 

can for dermal and ORETF data for inhalation), and 

(8) Dip or Soak Applications (no data) 

Since no toxicological endpoint of concern was identified for dermal systemic adverse 

effects, both the handler and the post-application dermal risks were assessed using the 

toxicological endpoint for dermal irritation. The duration of exposure for homeowner handler 

exposures is believed to be the short-term duration (1 to 30 days). The short term duration was 

chosen because the handler and post-application scenarios are assumed to be episodic, not a daily 

occurrence. 

ii. Risk Assessment 

Based on toxicological criteria and the potential for exposure, the Agency has conducted 

dermal and inhalation exposure assessments. As noted previously, MOEs greater than or equal 

to 100 for the inhalation route of exposure and 10 for dermal exposure are considered protective 

for the residential exposure assessment. 

Antimicrobial Uses 

A summary of the residential handler inhalation risks are presented in Table 6b. The 

calculated inhalation MOEs for all scenarios are above the target MOE of 100, and not of 

concern. 

Table 6b Short-Term Residential Handler Inhalation Exposures and MOEs 

Exposure Scenario 

Application Method Application Method Application Ratea Quantity Handled/ 

Treated per dayb 

MOE c 

(Target MOE = 100) 

Application to indoor hard surfaces Mopping 0.025 lb ai/gal 1 gallon 3,000 

Wiping 0.025 lb ai/gal 0.13 gallon 820 

21
c 

Exposure Scenario 

Application Method Application Method Application Ratea Quantity Handled/ 

Treated per dayb 

MOE c 

(Target MOE = 100) 

Trigger Spray 0.025 lb ai/gal 0.13 gallon 23,000 

Air deodorization Aerosol Spray 0.2% ai by weight 1 can (1 lb) 38,000 

Application to Carpets Low Pressure Spray 0.014 lb ai/gal 2 gallons 9,200 

Application to Swimming Pools Liquid Pour 0.000052 lb ai/gal 20,000 gallons 50,000 

Application to RV holding tanks Liquid Pour 0.834 lb ai/gal 

0.031 gal (1 tank 

at 4 oz 

product/tank) 

3,700 

a Application rates are the maximum application rates determined from EPA registered labels for ADBAC. 

b Amount handled per day values are estimates or label instructions. 

MOE = NOAEL / Absorbed Daily Dose. [Where short-term NOAEL = 3 mg/kg/day for inhalation]. Target MOE = 

100. 

A summary of the residential handler dermal risks are presented in Table 6c. The dermal 

MOEs for all formulations assessed are above the target MOE of 10, and therefore, are not of 

concern. 

Table 6c: Short-Term Residential Handler Dermal Risks 

Exposure Scenario Application 

Method 

Application 

Ratea 

(lb ai/gal) 

Quantity 

Handled/ Treated 

per dayb 

Hand Unit 

Exposure 

Adjusted for 

Surface 

Area 

(mg/lb 

ai/cm2)

c 

Dermal Skin 

Irritation 

Exposure d 

(μg/cm2) 

MOE e 

(Target MOE = 

10) 

0.025 lb ai/gal 1 gallon 0.063 1.587 210 Mopping 0.0070 lb ai/gal 0.44 760 

Application to indoor 

hard surfaces Wiping 0.025 lb ai/gal 0.13 gallon 1.341 4.363 76 

0.0070 lb ai/gal 1.22 270 

0.025 lb ai/gal 0.13 gallon 0.129 0.420 790 Trigger Spray 0.014 lb ai/gal 0.24 1,400 

Air deodorization Aerosol Spray 0.2% ai by 

weight 

1 can (1 lb) 0.129 0.259 1,300 

Application to 

Carpets 

Low Pressure 

Spray 0.014 lb ai/gal 2 gallons 0.161 4.615 72 

Application to RV 

holding tanks Liquid Pour 0.834 lb ai/gal 

0.031 gal (1 tank 

at 4 oz 

product/tank) 

0.000239 0.0062 54,000 

Application to 

swimming pools Liquid Pour 0.000052 lb 

ai/gal 20,000 gallons 0.000239 0.25 1,300 

a Application rates are the maximum application rates determined from EPA registered labels for ADBAC. 

b Amount handled per day values are estimates or label instructions. 

Unit Exposure (mg/lb ai/cm2) = Unit Exposure from PHED or CMA (mg/lb ai) / surface area of hand (820 cm2). 

d Dermal Skin Irritation Exposure (μg /lb ai/cm2

) = Unit Exposure (mg/lb ai/cm2) x Application Rate (lb ai/gal) x 

Quantity Treated (gal/day) x 1,000 :g/mg 

e MOE = NOAEL (μg /cm2

)/ Surface Residue on Skin (μg/cm2). [Where short-term dermal formulated-based NOAEL = 

333 μg/cm2

]. Target MOE = 10. 

22

c 
Agricultural Uses 

A summary of the agricultural residential handler inhalation risks are presented in Table 

6d. The calculated inhalation MOEs for all scenarios are above the target MOE of 100, and not 

of concern. 

Table 6d: ADBAC Short-term Inhalation Risks to Residential Handlers 

Scenario Crop/Target Application 

Rate a 

Quantity 

Handled/ 

Treated 

per days 

Inhalation 

Unit 

Exposure 

(ug/lb ai)c 

Inhalation 

Exposured

 Inhalation 

Dosee 

Inhalation 

MOEf 

Residential Turf, 

Ornamental Bulbs and 

Orchids 

0.0065 lb 

ai/gal water 5 gal/day 30 0.000975 0.000016 180,000 

M/L/A Liquid 

Concentrates with LP 

Handwand (1) 

Ornamental 

Herbaceous Plants, 

Ornamental Shrubs, 

Ornamental Trees, 

Seedlings (planted in 

garden), Seedlings, 

Seeds, Cuttings 

(preplant or at plant) 

0.0043 lb 

ai/gal water 5 gal/day 30 0.00065 0.000011 280,000 

M/L/A DF with Low 

Pressure Handwand 

(liquid concentrate 

PHED data as 

surrogate) (3) 

Residential Turf, 

Ornamental Bulbs and 

Orchids 

0.0065 lb 

ai/gal water 5 gal/day 30 0.000975 0.000016 180,000 

Ornamental 

Herbaceous Plants, 

Ornamental Shrubs, 

Ornamental Trees, 

Seedlings (planted in 

garden), Seedlings, 

Seeds, Cuttings 

(preplant or at plant) 

0.0043 lb 

ai/gal water 5 gal/day 30 0.00065 0.000011 280,000 

Residential Turf 7 lb ai/A 0.5 

acres/day 

17 0.06 0.00099 3,000 

M/L/A Liquid 

Concentrates with a 

Hose-end Sprayer (4) 

Ornamental 

Herbaceous Plants, 

Ornamental Shrubs, 

Ornamental Trees, 

Seedlings (planted in 

garden) 

0.43 lb ai/A 0.25 

acres/day 

1.6 0.00017 2.9E-6 1,000,000 

M/L/A Liquids with a 

Watering Can (PHED Ornamental Palms 0.013 lb 

ai/gal water 5 gal/day 1.6 0.001 1.7E-6 1,700,000 

residential hose-end 

data as surrogate) (8) 

Seedlings, Seeds, 

Cuttings (preplant or 

at plant) 

0.0043 lb 

ai/gal water 5 gal/day 1.6 0.000034 5.7E-7 5,200,000 

Applying Ready to 

Use Formulations via 

Trigger-Pump 

Sprayer (9) 

Ornamental Shrubs, 

Seedlings, Seeds, 

Cuttings (preplant or 

at plant) 

0.0043 lb 

ai/gallon 1 gal/day 19 0.000082 1.4E-6 2,200,000 

a Application rates are the maximum application rates determined from EPA registered labels for ADBAC 

b Amount handled per day values are based on Exposure SAC SOP #12, and HED estimates. 

Baseline Inhalation: no respirator. 

d Baseline inhalation exposure (mg/day) = application rate (lb ai/gal ) x amount handled per day (gal/day) x inhalation unit exposure 

(μg/lb ai) x conversion factor from μg to mg (0.001) 

e Baseline inhalation dose (mg/kg/day) = baseline inhalation exposure (mg/day) x inhalation absorption factor (100%) / female 

bodyweight (kg) 

23 

c 
f Inhalation MOE = inhalation NOAEL ( 3 mg/kg/day) / inhalation dose (mg/kg/day) 

A summary of the residential handler dermal risks are presented in Table 6c. The dermal 

MOEs for all formulations assessed are above the target MOE of 10, and therefore, are not of 

concern. 

Table 6e: ADBAC Short-term Dermal Risks to Residential Handlers 

Scenario Crop/Target 

Residential Turf, 

Ornamental Bulbs 

and Orchids 

Application 

Ratea 

0.0065 lb 

ai/gal water 

Quantity 

Handled Per 

Dayb 

5 gal/day 

Unit 

Exposure for 

Handsc 

(mg/lb ai) 

102 

Estimated 

Residue 

Transferred 

to Skin on 

Hands (ug 

ai/cm2/day)

d 

4.0 

Dermal 

MOE 

(UF = 

10)

e 

82 

M/L/A Liquid 

Concentrates with LP 

Handwand (1) 

Ornamental 

Herbaceous Plants, 

Ornamental Shrubs, 

Ornamental Trees, 

Seedlings (planted in 

garden), Seedlings, 

Seeds, Cuttings 

(preplant or at plant) 

0.0043 lb 

ai/gal water 5 gal/day 102 2.7 120 

M/L/A DF with LP 

Handwand (liquid 

concentrate PHED data as 

surrogate) (3) 

Residential Turf, 

Ornamental Bulbs 

and Orchids 

0.0065 lb 

ai/gal water 5 gal/day 102 4.0 82 

Ornamental 

Herbaceous Plants, 

Ornamental Shrubs, 

Ornamental Trees, 

Seedlings (planted in 

garden), Seedlings, 

Seeds, Cuttings 

(preplant or at plant) 

0.0043 lb 

ai/gal water 5 gal/day 102 2.7 120 

M/L/A Liquid 

Concentrates with a Hoseend Sprayer (4) 

Residential Turf 0.0063 lb 

ai/gal water 100 gal/day 27.5 21 16 

Ornamental 

Herbaceous Plants, 

Ornamental Shrubs, 

Ornamental Trees, 

Seedlings (planted in 

garden) 

0.0043 lb 

ai/gal water 100 gal/day 27.5 14 23 

M/L/A Liquids with a 

Watering Can (PHED Ornamental Palms 0.013 lb 

ai/gal water 5 gal/day 27.5 0.7 460 

residential hose-end data 

as surrogate) (8) 

Seedlings, Seeds, 

Cuttins (preplant or 

at plant) 

0.0043 lb 

ai/gal water 5 gal/day 27.5 0.1 2,300 

Applying Ready to Use 

Formulations via TriggerPump Sprayer (PHED data 

for aerosol can used as 

surrogate) (9) 

Ornamental Shrubs, 

Seedlings, Seeds, 

Cuttings (preplant or 

at plant) 

0.0043 lb 

ai/gallon 1 gal/day 106 2.8 120 

Footnotes: 

a Application rates are the maximum application rates determined from EPA registered labels for ADBAC 

b Amount handled per day values are based on Exposure SAC SOP #12 and HED estimates. 

c From residential PHED unit exposures values for hands for the scenarios listed. 

d Application rate (lb ai/gal) * amount handled per day (gal/day) * dermal unit exposures value (mg/lb ai) * conversion factor mg to μg 

(1000) / surface area of adult hands (820 cm2 ) from Exposure Factors Handbook. 

24 
f Dermal MOE = Estimated Residue transferred to Skin of Hands (μg/cm2

/day)/ Dermal Endpoint (333 μg/cm2/day) 

c. Residential Post-Application 

i. Exposure Assessment 

Residential post application exposures result when bystanders (adults and children) come 

in contact with ADBAC in areas where products have been applied (e.g.. treated floors and 

carpets), or when children inadvertently ingest the pesticide residues through mouthing treated 

items (e.g., toys and fabric). The post-application scenarios have been developed to represent a 

high end exposure scenario. Representative post-application scenarios for antimicrobial uses 

assessed include children crawling on treated hard surfaces, carpets, and treated lumber such as 

decks/play sets (dermal and incidental oral exposure to children), wearing treated clothing 

(dermal exposure to adults and children and incidental oral exposure to children), using air 

deodorizers (adult and child inhalation exposure), using portable humidifiers (adult and child 

inhalation exposure), swimming in treated pools (adult and child incidental ingestion), and using 

treated instrument mouthpieces and reeds (child and adult incidental exposure). Dermal post 

application exposure to swimmers was not assessed because ADBAC is readily mixed in the 

water to a low concentration that it does not pose any risk. Representative post-application 

scenarios for agricultural uses assessed include adults contacting treated lawns and ornamental 

plants (adult derma exposure) and children’s incidental oral activities on treated lawns such as 

hand-to-mouth activity, object to mouth, and soil ingestion. Data sources and methodologies 

include the HED Residential SOPs (USEPA 2000, 2001), Residential and Residential Exposure 

Test Guidelines: Group B Post application Exposure Monitoring Test Guidelines (1998), Human 

and Environmental Risk Assessment (HERA) Guidance Document (2003 and 2005), the DDAC 

wood preservative task force study (MRID 455243-04), the Multi-Chamber Concentration and 

Exposure Model (MCCEM), and the SWIMODEL. 

Since no toxicological endpoint of concern was identified for dermal systemic adverse 

effects, post-application dermal risks were assessed using the toxicological endpoint for dermal 

irritation. The residential post-application dermal risks were assessed by comparing the surface 

residue on the skin (dermal irritation exposure) to the short-term dermal irritation endpoint. It 

was assumed that during the exposure period the skin repeatedly contacts the treated surface until 

a steady-state concentration of residue is achieved on the skin. Adults and children post 

application dermal risks were assessed for the antimicrobial uses; however, only adults were 

assessed for post-application dermal risks for the agricultural uses because the Agency believes 

these are individuals that are exposed to the chemical by engaging in activities at their residences 

previously treated with a pesticide. 

ii. Risk Assessment 

Based on toxicological criteria and the potential for exposure, the Agency has conducted 

dermal, inhalation, incidental oral exposure assessment for ADBAC. The inhalation and 

incidental oral target MOE of 100 is based on 10x interspecies and 10x intraspecies variability. 

The dermal target MOE of 10 is based on 3x interspecies and 3x intraspecies variability. 

25
Antimcirobial Uses 

The calculated dermal MOEs are above the target MOE of 10 and are, therefore, not of 

concern. The inhalation and incidental oral MOEs are above the target MOE of 100 for all 

scenarios, except for the inhalation exposure from the humidifier. The inhalation MOEs for 

adults and children are 10 and 4, respectively. A summary of the residential post application are 

presented in Table 6d. 

Table 6d. Residential Post-Application Risk Summary 

Exposure Scenario Dermal MOE Incidental Ingestion MOE Inhalation MOE 

Child playing on floor 1,100 610 NA 

Child playing on carpet 1,200 330 NA 

Clothing 

(1% residue transfer) 

210 adults and 

children 1900 NA 

Child playing on decks/play sets 

(maximum exposure) 110 360 NA 

Air deodorizer NA 5,700 adults 

NA 1,800 children 

Swimming 

NA 

Ranges from 500 to 5,600 

for adults and children NA 

Humidifiers 

NA 

NA Adult 10 (24-hrs) 

Child 4 (24-hrs) 

Instrument mouthpiece/reed NA No data NA 

NA = not assessed because negligible exposure is assumed by that route for the exposure for the 

scenario of concern. 

Agricultural Uses 

Table 6g presents the postapplication MOE values calculated for adults after home 

greenhouse, garden or turfglass applications of ADBAC for a short-term exposure duration. The 

dermal MOEs were not of concern (i.e., MOEs <10) on the day of application for any of the 

three scenarios with the different application rates. An MOE of less than 10 represents a risk of 

concern to the Agency. 

Table 6g: ADBAC: Adult Residential Short-Term Dermal Risks for Postapplication 

Exposure 

Exposure Scenario Route of 

Exposure Formulation 

Application 

Ratea 

(lb ai/acre) 

Residue on 

Skinb 

MOEc 

at Day 0 

Exposure To Treated 

Ornamental Plants 0.43 0.96 350 

Exposure to Treated Turf 

Dermal Spray 7 3.9 85 

0.9 0.5 660 

a Maximum application rate on label (lb ai/A). 

26 
c 

b Residue concentration available to be transferred on day 0 = application rate in μg/cm2 (lb ai/gal * conversion factors 

(lb to μg and A to cm2

) * fraction of DFR or TTR available on day 0 * percent of DFR or transferrable to skin (100%). 

Short-term Dermal MOE = dermal endpoint (333 ug/cm2

)/ residue concentration on skin 

A summary of the combined risks from incidental exposure for toddlers for applications 

to home lawn for maximum label application rate as well as the lower application rate (i.e. handto-mouth activity, object-to-mouth activities, and incidental soil ingestion and for hand-to-mouth 

activity at the lower application rate) is represented in table 6h. An MOE of less than 100 

represents a risk of concern to the Agency. For this scenario, the maximum application rate (7 lb 

ai/A) resulted in a MOE of 76 while the lower concentration rate (0.9 lb ai/A) was not of concern 

with a MOE of 590. 

Table 6h: ADBAC: Combined Incidental Oral Risk Estimates - Toddlers 

Postapplication Exposure Scenario 

Margins of Exposure (MOEs) 

(UF=100) 

Short-Term Oral 

(Non-Dietary) Combined 

Short-Term Oral: 

(Non-Dietary) 

Turf application at 7 lb ai/acre 

Hand to Mouth 96 

76 Object to Mouth 380 

Incidental Soil 

Ingestion 29,000 

Turf application at 0.9 lb ai/acre 

Hand to Mouth 740 

590 Object to Mouth 3,000 

Incidental Soil 

Ingestion 220,000 

7. Aggregate Risk 

The Food Quality Protection Act (FQPA) amendments to the Federal Food, Drug, and 

Cosmetic Act section 408 (b)(2)(A)(ii) require “that there is reasonable certainty that no harm 

will result from aggregate exposure to pesticide chemical residue, including all anticipated 

dietary exposures and other exposures for which there are reliable information.” Aggregate 

exposure will typically include exposures from food, drinking water, residential uses of a 

pesticide, and other non-occupational sources of exposure. 

a. Chronic Aggregate Risks 

An acute toxicological endpoint was not identified for ADBAC. Therefore, an acute 

aggregate risk assessment was not conducted. The chronic aggregate risk assessment includes 

only dietary and drinking water exposures because chronic exposures are not expected from 

residential uses. Chronic dietary risk estimates from direct and indirect food uses are presented 

in Section 5a, and drinking water exposure estimates are presented in Section 5b. Table 7a 

presents a summary of these exposures, including the aggregate indirect and direct dietary 

exposure (i.e., all direct and indirect food contact exposures) as well as a total dietary aggregate 

27
exposure estimate (i.e., drinking water plus direct/indirect dietary exposures). Based on the 

results of the chronic aggregate assessment, the %cPAD for adults and children are 3.5% and 

10.3%, respectively. Therefore, the chronic dietary risks are not of concern (i.e., less then 100 % 

of cPAD). 

Table 7a. ADBAC Chronic Aggregate Exposures and Risks (cPAD) 

Exposure Routes 

Chronic Dietary Exposures (mg/kg/day) 

Indirect 

Dietary 

Exposuresa 

Direct Food 

Contact 

Dietary 

Exposuresa 

Drinking 

Water 

Exposures 

Aggregate 

Dietary 

Exposuresb 

% cPADc 

(MOE) 

Adults 

Oral Ingestion 0.0042 0.0024 0.009 0.0066 3.5% 

(2,800) 

Children 

Oral Ingestion 0.017 0.0061 0.022 0.023 10.3 

(980) 

a Dietary (indirect + direct food contact) exposures are presented in Tables 5.1 and 5.2.

b Aggregate Dietary Exposures = indirect dietary + direct food contact + drinking water exposures. 

c %cPAD (percent chronic population adjusted dose) = (aggregate exposures / cPAD) x 100. Where cPAD = NOAEL 44 

mg/kg/day / 100x uncertainty factor = 0.44 mg/kg/day. MOE = NOAEL of 44 mg/kg/day / aggregate dietary exposures 

mg/kg/day.

b. Short- and Intermediate-Term Aggregate Risk

 The short- and intermediate-term aggregate risks include pesticide exposures from 

dietary, drinking water, and residential sources. The following list summarizes all of the 

potential sources of ADBAC exposures for adults and children. 

Adult ADBAC exposure sources: 

 handling of cleaning products containing ADBAC as an active ingredient during 

wiping, mopping, and spraying activities; 

 applying products containing ADBAC to lawns/ornamentals; 

 applying ADBAC as an air deodorizer using an aerosol spray; 

 applying ADBAC to carpets using a low pressure sprayer; 

 applying ADBAC to swimming pools via open pouring; 

 applying ADBAC to RV holding tanks via open pouring; 

 contacting pressure treated wood; 

 wearing treated clothing; 

 use of ADBAC in humidifiers; and 

 eating food having ADBAC residues from indirect or direct food contact. 

Child ADBAC exposure sources: 

 post-application exposures to cleaning product residues containing ADBAC that are 

used on hard surfaces (e.g, floors/carpets); 

 breathing air treated with an air deodorizer or humidifier; 

 swimming in treated pools; 

28
 contacting pressure treated wood; 

 wearing treated clothing/diapers; 

 eating food having ADBAC residues from indirect or direct food contact. 

The use patterns of the products and probability of co-occurrence must be considered 

when selecting scenarios for incorporation in the aggregate assessment. Table 6-2 summarizes 

the scenarios included in the short- and intermediate-term aggregate assessments. 

Table 7b. Exposure Scenarios Included in the Aggregate Assessments 

Short-term (ST) Aggregate Intermediate-Term (IT) Aggregate 

Adults 

 chronic dietary (direct and indirect) 

 handling cleaning products (wipe + trigger 

pump spray) 

 wearing treated clothing 

 humidifier 

Oral: ST and IT endpoints are the same for 

both durations. 

Dermal: ST endpoint only. 

Inhalation: All durations same endpoint. 

Children 

 chronic dietary – (direct and indirect) 

 post-application to cleaning product on 

carpets (dermal and oral) 

 wearing treated clothing 

 humidifier 

Oral: ST and IT endpoints are the same for 

both durations. 

Dermal: ST endpoint only. 

Inhalation: All durations same endpoint. 

The chronic dietary exposures were used in both the short- and intermediate-term 

aggregate assessment because chronic dietary exposures occur nearly every day (as opposed to 

acute dietary exposures occurring on a one-time basis). Therefore, short- or intermediate-term 

non-dietary exposures have a much higher probability to co-occur with the chronic dietary 

intake. 

Cleaning activities in a residential setting occur on a short-term basis. However, the 

ADBAC-containing cleaning products are also labeled for use in institutional settings such as 

day-care facilities where cleaning activities can occur on an intermediate-term basis. Therefore, 

children could have exposure to cleaning product residues on a more continuous basis in a day 

care facility, thus, these post-application scenarios were included in the intermediate-term 

aggregate assessment. 

Since the ADBAC toxicity endpoints for the oral, dermal, and inhalation routes of 

exposure are based on different toxic effects, these three routes of exposure are not aggregated 

together. Instead, the aggregate assessment is based solely on the co-occurrence of the same 

route of exposure. Aggregate risks were calculated using the total MOE approach outlined in 

OPP guidance for aggregate risk assessment (August 1, 1999, Updated “Interim Guidance for 

Incorporating Drinking Water Exposure into Aggregate Risk Assessments”). 

Table 7c presents a summary of the short- and intermediate-term aggregate risks (i.e., 

MOEs). The short- and intermediate-term aggregate is identical because the endpoints for 

incidental oral as well as inhalation are identical for the short- and intermediate-term durations. 

29
Only a short-term dermal endpoint was identified (i.e., no intermediate- and/or long-term dermal 

endpoints were identified). The aggregate risks are not of concern for adults for any of the three 

routes of exposure as the total aggregate MOE is 2,800 for oral, 42 dermal, and 630 for 

inhalation which are greater than the target MOE. For children, the aggregate risk estimate for 

each of the routes of exposure are also above the target MOE (MOE=220 for the oral route, 180 

for the dermal route) and thus are not of concern. It is important to note, however, that some of 

the individual risks are of concern by themselves (e.g., the humidifier use). 

Table 7c. Short- and Intermediate-term Aggregate Risk (MOE) Assessment 

Exposure 

Routes 

Chronic 

Dietary 

MOE 

Cleaning Product MOEs 

(Adult Applicators & Children 

Playing) 

Humidifier 

MOE 

Wearing 

Treated 

Clothing 

MOE 

RouteSpecific 

Aggregate 

MOE 

Adults 

Oral Ingestion 2,800 NA NA NA 2,800 

Dermal NA 210 

(mop) 

76 

(wipe) 

790 

(spray) NA 2,500 42 

Inhalation NA 3,000 

(mop) 

820 

(wipe) 

23,000 

(spray) 

Not 

included, 

risk of 

concern 

NA 630 

Children 

Oral Ingestion 980 330 (hand-to-mouth carpets) NA 1,900 220 

Dermal 

(ST only) NA 1,200 (playing on carpets) NA 

210 

(1% residue 

transfer) 

180 

Inhalation NA NA 

Not 

included, 

risk of 

concern 

NA No cooccurrence 

Aggregate MOE = 1/((1/MOEsame route) + (1/MOE same route) + etc) 

8. Occupational Risk 

Workers can be exposed to a pesticide through mixing, loading, and/or applying a 

pesticide or by entering treated sites. For ADBAC, potential occupational handler exposure can 

occur from treatment of the following uses: agricultural premises, industrial processes and water 

systems, food handling premises, commercial/institutional/industrial premises, medical premises, 

swimming pools, and aquatic areas. In addition to the “antimicrobial” exposures scenarios, 

ADBAC is used to treat ornamental plants in nurseries and greenhouses, commercial turf and 

golf courses. Additionally, occupational exposure can occur during the preservation of wood. 

For the preservation of wood, the procedure for treatment can occur in different ways, such that 

multiple worker functions were analyzed. Due to the complexity of the wood preservative 

analysis, the results for handler and post-application exposures are presented separately in 

Section 8.e. 

30
Occupational risk for all potentially exposed populations is measured by a Margin of 

Exposure (MOE) which determines how close the occupational exposure comes to a NO 

Observed Adverse Effect Level (NOAEL) from toxicity studies. In the case of ADAC, A MOE 

greater than or equal to 100 is considerably adequately protective for the occupational exposure 

assessment for inhalation routes of exposure. The MOE of 100 includes 10x for interspecies 

extrapolation and 10x for intraspecies variation. A MOE of 10 is considered adequately 

protective for the dermal route of concern; it includes 3x interspecies extrapolation and 3x 

intraspecies variation. 

Occupational risk is assessed for exposure at the time of application (termed “handler” 

exposure) and is assessed for exposure following application, or post-application exposure. 

Application parameters are generally defined by the physical nature of the formulation (e.g., 

formula and packaging), by equipment required to deliver the chemical to the use site, and by the 

application rate required to achieve an efficacious dose. 

For more information on the assumptions and calculations of potential risk of ADBAC to 

workers, see the Occupational Exposure Assessment (Section 8.0) in the Alkyl Dimethyl Benzyl 

Ammonium Chloride (ADBAC): Risk Assessment for the Reregistration Eligibility Decision,” 

dated July 27,2006 and the “Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) 

Occupational/Residential Exposure Assessment,” dated August 3, 2006. 

a. Occupational Toxicity 

The toxicological endpoints and associated uncertainty factors used for assessing the nondietary, residential risks for ADBAC were listed previously in Table 6a. 

b. Occupational Handler Exposure 

Potential occupational handler exposure can occur in various antimicrobial and 

agricultural use sites which include: agricultural premises, industrial processes and water 

systems, food handling premises, commercial/institutional/industrial premises, medical premises, 

swimming pools, ornamental greenhouses/nurseries, golf courses, and aquatic areas. 

Additionally, occupational exposure can occur during the preservation of wood. For the 

preservation of wood, the procedure for treatment can occur in different ways, such that multiple 

worker functions were analyzed. Due to the complexity of the wood preservation analysis, the 

handler and post-application exposures are presented separately in section e. 

The Agency has assessed exposures to handlers mixing/loading/applying antimicrobial 

and agricultural use products containing ADBAC. The following handler exposure scenarios 

represent high end exposure estimates. 

31
Antimicrobial Use - Mixer/Loader/Applicators: 

• For the liquid pour scenarios, the unit exposure depends on the material being treated. 

The following CMA unit exposures were available and used for the assessment of the risk 

associated with the treatment of the specified materials. 

o Swimming pools, carpets, and oilfield operations (drilling muds and packer 

fluids): CMA preservative data (gloved). The inhalation unit exposure is 0.00346 

mg/lb a.i. and is based on 2 replicates. Although this unit exposure is based on 

minimal replicates, the exposure value is similar to the one found in PHED for a 

similar scenarios. 

o Indoor hard surfaces (immersion, flooding and circulation) and medical 

instruments in Use Site Categories II and V: The inhalation unit exposure value 

for disinfectant liquid pour (1.89 mg/lb a.i.) was used. 

o Small process water systems: CMA cooling tower data (gloved). The inhalation 

unit exposure is 0.450 mg/lb a.i. and is based on 5 replicates. 

• For the mopping scenarios, the CMA inhalation unit exposure value for ungloved 

mopping was used (2.38 mg/lb a.i.). This value is based on data collected from six 

replicates in which the applicator mopped the floor and received exposure via contact 

with the mop or with the bucket. 

• For the wiping scenarios, the CMA inhalation unit exposure value for ungloved wiping 

was used (67.3 mg/lb a.i.). This value is based on data collected from six replicates 

(dental technicians) who used a finger pump sprayer to apply the product and then wiped 

the surfaces with a paper towel 

• For the low pressure hand wand scenario, the CMA inhalation unit exposure value for 

low pressure spray was used (0.681 mg/lb a.i.). This value is based on data collected 

from eight replicates in which the applicator hand sprayed carpet using 200 psi, then used 

a push broom rake to raise the carpet nap 

• For the aerosol spray and trigger pump spray scenarios, the PHED inhalation unit 

exposure value for aerosol applications (PHED scenario 10) was used. The inhalation 

unit exposure is 1.3 mg/lb a.i. 

• For the liquid/metering pump scenarios, the unit exposure depends on the material being 

treated. The following CMA unit exposures were available and used for the assessment of 

the risk associated with the treatment of the specified materials. 

o Pulp and paper, Papermaking chemicals, and Once-through cooling water 

systems: CMA pulp and paper gloved data were used. The inhalation unit 

exposure is 0.000265 mg/lb a.i. The value is based on 7 replicates where the 

test subjects were wearing a single layer of clothing and chemical resistant 

gloves. This unit exposure was used for the once through cooling water 

system because no representative data exists for the volume of water treated in 

power plant facilities. 

o Small process water systems: CMA cooling tower data. The inhalation unit 

exposure is 0.00432 mg/lb a.i. and is based on 4 replicates. 

• For the high-pressure/high volume spray and medium pressure spray scenarios, the 

PHED inhalation unit exposure value for liquid/open pour/high pressure spray (PHED 

scenario 35) was used (0.12 mg/lb a.i.). 

32
• For the fogging, ULV/mist sprayer and automated system scenarios, it was assumed that 

most of the exposure to the handler will be due to preparing the fogger, and that the 

handler leaves the room immediately after fogging commences. Therefore, the available 

CMA disinfectant liquid pour inhalation unit exposure value was used. The inhalation 

unit exposure value is 1.89 mg/lb a.i., respectively. This value is based on data collected 

from two gloved replicates involving pouring a disinfectant product from a jug into 

sterilization trays designed for dental instruments, adding water and instruments to the 

tray, removing the instruments, and discarding the old solution. 

Agriculture Use - Mixer/Loader/Applicators: 

• Mixing/Loading Liquids Concentrates for Groundboom Applications (PHED) (1a) 

• Mixing/Loading Liquid Concentrates to Support LCO Handgun Applications 

(mixing/loading supports 20 LCOs) (PHED) (1b) 

• Mixing/Loading Liquids Concentrates for Airblast Applications (PHED) (1c) 

• Mixing/Loading Liquid Concentrates via Dip or Soak (PHED) (1d) 

• Mixing/Loading Dry Flowables for Groundboom Applications (PHED) (2a) 

• Mixing/Loading Dry Flowables for Airblast Applications (PHED) (2b) 

• Mixing/Loading Dry Flowables to Support LCO Handgun Applications (mixing/loading 

supports 20 LCOs) (PHED) (2c) 

• Mixing/Loading Dry Flowables via Dip or Soak (PHED) (2d) 

• Applying Sprays via Groundboom Equipment (PHED) (3) 

• Applying Sprays via Airblast Equipment (PHED) (4) 

• Applying Sprays via Handgun Equipment (PHED) (5) 

• Applying as a Soak or Dip (no data) (6) 

• Mixing/Loading/Applying Liquid Concentrates with Low Pressure Handwand (ORETF 

data) (7) 

• Mixing/Loading/Applying Dry Flowables with Low Pressure Handwand (using liquid 

concentrate ORETF data) (8) 

• Mixing/Loading/Applying Liquid Concentrates with a Handgun Sprayer (LCO ORETF 

data) (9) 

• Mixing/Loading/Applying Water Soluble Bags with Handgun Sprayer (LCO ORETF 

data) (10) 

• Mixing/Loading/Applying Dry Flowables Concentrates with a Handgun Sprayer (LCO 

ORETF data) (11) 

• Mixing/Loading/Applying Liquid Concentrates with a High Pressure Handwand (PHED) 

(12) 

• Applying Ready to Use Formulations via Trigger-Pump Sprayer (ORETF) (13) 

• Mixing/Loading/Applying Liquids with a Watering Can (using ORETF residential hoseend data) (14) 

• Mixing/Loading/Applying Dip or Soak (no data) (15) 

ADBAC dermal irritation exposures and risks were not estimated for occupational handler 

exposures. These risks are addressed using personal protective equipment (PPE) requirements 

33
already existing on labels. The level of PPE required is based on the toxicity of the end-use 

product. 

 To minimize dermal exposures, the minimum PPE required for mixers, loaders, and 

applicators exposed to end-use products containing concentrations off ADBAC that result in 

classification of toxicity category I, II, or III for skin irritation potential will be long-sleeve shirt, 

long pants, shoes, socks, chemical-resistant gloves, and chemical-resistant apron. For a diluted 

product, the classification of a toxicity category IV for skin irritation potential would result in the 

elimination of the required personal protective clothing and gloves; such as, chemical-resistant 

gloves and chemical-resistant apron, for applicators and others exposed to the end-use product. 

Note that chemical-resistant eyewear will be required if the end-use product is classified as 

category I or II for eye irritation potential. 

Inhalation exposures and risks were assessed based on the oral toxicity endpoint (i.e., 

route-specific inhalation study not available). The surrogate unit exposure values were taken 

from the proprietary Chemical Manufacturers Association (CMA) surrogate exposure data 

(USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database 

(USEPA, 1998). The specific inhalation unit exposures and quantity of ADBAC handled are 

provided in the Occupational and Residential Exposure Assessment for ADBAC dated July 27, 

2006. 

The inhalation MOEs were calculated for the short- and intermediate-term durations for 

occupational handlers. 

c. Occupational Handler Risk Summary 

Based on toxicological criteria and the potential for exposure, the Agency has 

conducted inhalation exposure assessments. As noted previously, MOEs greater than or equal to 

100 for the inhalation route of exposure are considered protective for the occupational handler 

exposure assessment. 

Antimicrobial Uses 

The resulting inhalation exposures and MOEs for the representative occupational handler 

scenarios are presented in Table 8.1. The calculated MOEs were above the target MOE of 100 

for all scenarios, except those listed below. 

• Agricultural fogging (mixing and loading): ST/IT Inhalation MOE = 26 

• Pulp and paper, liquid pump: ST/IT Inhalation MOE = 33 

• Once-through cooling water, metering pump: Using the average flow rate for high flow 

streams (153 MGD) the ST Inhalation MOE = 50 

• Small process water systems, liquid pour: ST/IT Inhalation MOE = 6. 

34
Table 8.1: Short- , Intermediate- and Long-Term Inhalation Risks Associated with 

Occupational Handlers 

Exposure Scenario Method of Application 

Inhalation 

Unit 

Exposure 

(mg/lb 

a.i.) 

Application Rate 

Quantity 

Handled/ 

Treated per day 

Inhalation 

Daily Dose 

(mg/kg/day)

a 

Agricultural Premises and Equipment (Use Site Category I) 

Mop 2.38 0.012 lb ai/gal 2 gallons 0.00091 

High pressure/high 

volume spray 0.12 0.017 lb ai/gal 40 gallons 0.0014 

Low pressure hand 

wand 0.681 0.017 lb ai/gal 10 gallons 0.002 

Trigger pump sprayer 1.3 0.017 lb ai/gal 0.26 gallons 0.000098 

Application to hard surfaces, 

equipment, and vehicles 

Wipe 67.3 0.017 lb ai/gal 0.26 gallons 0.0051 

Fogging (mix/load only) Liquid pour 1.89 2.46E-05 lb/ft3 150,000 ft3

 0.12 

Food Handling/Storage Establishments Premises And Equipment (Use Site Category II) 

Low pressure hand 

wand 0.681 0.0176 lb ai/gal 2 gallons 0.0004 

Mop 2.38 0.0176 lb ai/gal 2 gallons 0.0014 

Wipe 67.3 0.0176 lb ai/gal 0.26 gallons 0.0051 

Trigger pump sprayer 1.3 0.025 lb ai/gal 0.26 gallons 0.00014 

Application to indoor hard 

surfaces (including dishes, 

utensils, equipment) 

Immersion, Flooding, 

Circulation 1.89 0.00325 lb ai/gal 2 gallons 0.0002 

Commercial, Institutional and Industrial Premises and Equipment (Use Site Category III ) 

Low pressure hand 

wand 0.681 0.0283 lb ai/gal 2 gallons 0.00064 

Mop 2.38 0.0283 lb ai/gal 2 gallons 0.0022 

Wipe 67.3 0.0283 lb ai/gal 0.26 gallons 0.0083 

Trigger pump sprayer 1.3 0.0283 lb ai/gal 0.26 gallons 0.00016 

Application to indoor hard 

surfaces 

Immersion 1.89 0.025 lb ai/gal 2 gallons 0.0016 

Air deodorization Aerosol spray 1.3 0.20% a.i. by 

weight 3.0 lbs 0.00013 

Application to carpets Liquid pour 0.00346 0.141 lb ai/gal 32 gallons 0.00026 

Medical Premises and Equipment (Use Site Category V) 

Application to hard surfaces Mop 2.38 0.0176 lb ai/gal 45 gallons 0.031 

Application to dental 

instruments 

Immersion 

(Liquid pour) 1.89 0.0209 lb ai/gal 2 gallons 0.0013 

Industrial Processes and Water Systems (Use Site Category VIII) 

Pulp and Paper Metering pump 0.000265 41.7 lb ai/ton 

paper 

500 tons 0.092 

Papermaking Chemicals Metering pump 0.000265 0.0019 lb ai/gal 

additive 1,000 gallons 8.5E-6 

Once-through Cooling Water 

System - Power plant Metering pump 0.000265 

Initial Dose 

(ST): 8.86E-5 lb 

ai/gal water 

5,900,000 

gallons 0.0023 

Inhalation 

MOEb, c 

(Target MOE 

= 100) 

3,300 

2,200 

1,500 

31,000 

590 

26 

7,500 

2,100 

580 

21,000 

15,000 

4,700 

1,300 

360 

19,000 

1,900 

23,000 

12,000 

95 

2,300 

33 

350,000 

ST=1300 

35
c 

Exposure Scenario Method of Application Exposure 

(mg/lb 

a.i.) 

Inhalation 

Unit 

Application Rate 

Maintenance 

Dose (IT): 

4.69E-5 lb ai/gal 

Handled/ 

Treated per day 

5,900,000 

gallons 

Quantity 

Daily Dose 

(mg/kg/day)

a 

0.0012 

Inhalation 

(Target MOE 

= 100) 

IT=2,500 

MOEb, c 

Inhalation 

Initial Dose 

(ST): 8.86E-5 lb 

ai/gal water 

153,000,000 

gallons 0.06 ST =50 

Maintenance 

Dose (IT): 

4.69E-5 lb ai/gal 

6.67 lb ai/gal 

153,000,000 

gallons 

10 gallons 

0.032 

0.5 

IT=95 

6 

Small process water systems: 

Recirculating cooling 

tower/evaporative 

condenser/pasteurizers 

Oil field operations - drilling 

mud and packing fluids 

Metal/wood cooling tower 

surface spray 

Metering pump 

Liquid pour 

Liquid pour 

0.00432 

0.45 

0.00346 

Initial Dose 

(ST): 3.34E-4 lb 

ai/gal water 

product 

20,000 gallons 0.00048 ST=6,200 

Maintenance 

Dose (IT): 

1.25E-4 lb ai/gal 

water 

1.00 lb ai/gal 

product 

0.000168 lb 

20,000 gallons 

5.6 gallons 

2.8 gallons 

100 gallons 

0.00018 

ST = 0.00032 

IT = 0.00016 

0.00023 

IT=17,000 

ST = 9,300 

IT = 19,000 

13,000 

Application to swimming 

pools Liquid pour 

Airless spray 

0.00346 

0.83 

Winterizing 

Dose (ST): 

0.000052 lb 

ai/gal 

ai/gal water 

Swimming Pools (Use Site Category X) 

200,000 gallons 

1,000 gallons 

0.0006 

0.0023 

ST =5,000 

1,300 

Maintenance 

Dose (IT/LT): 

0.0000098 lb 

ai/gal 

200,000 gallons 0.00011 IT/LT =27,000 

ST = short-term, IT = intermediate-term, LT = long-term, N/A= No data available 

a Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x absorption factor (1.0 for inhalation) x application rate x quantity treated / Body weight 

(60 kg for inhalation). 

b MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where NOAEL = 3 mg/kg/day for all inhalation exposure durations]. Target MOE = 100. 

The MOEs refer to short-term and intermediate-term duration unless indicated otherwise. 

Agricultural Uses 

In all occupational handler scenarios, the inhalation MOEs are above the level of concern 

of 100 at baseline PPE (i.e., no respirator). 

36
TABLE 8.2: ADBAC: Occupational Handler Inhalation Risks 

of water to be gallons of 

Exposure Scenario Crop or Target Application 

Rate a Treated 

Daily b 

Area 

MOEsc 

Inhalation 

Baseline 

Mixer/Loader 

Mixing/Loading (M/L) Liquids for 

Groundboom Applications (1a) 

Carnations (drench) 256 lb ai/acre 1 acres 590 

Ornamental Herbaceous 

Plants (drench) 72 lb ai/acre 1 acres 2100 

Sodfarm Turf 0.9 lb ai/acre 1 acres 170,000 

Seedlings (planted in field) 0.43 lb ai/acre 1 acres 350,000 

Mosquito Control in 

Decorative Ponds, Sewage 

Treatment Systems, and 

Standing Water 

0.0017 lb ai/gal 

of water to be 

treated 

800,000 

gallons of 

water 

110 

Mosquito Control in 

Decorative Ponds, Sewage 

Treatment Systems, and 

Standing Water 

0.0017 lb ai/gal 

of water to be 

treated 

100,000 

gallons of 

water 

880 

Mosquito Control in 

Decorative Ponds, Sewage 

Treatment Systems, and 

Standing Water 

0.0017 lb ai/gal 

of water to be 

treated 

20,000 

gallons of 

water 

4,400 

ML Liquid to Support LCO Handgun 

Applications (mixing/loading supports 

20 LCOs) (1b) 

Residential & Commercial 

Turf 7 lb ai/acre 1 acres 21,000 

Residential & Commercial 

Turf 0.9 lb ai/acre 1 acres 170,000 

M/L Liquids for Airblast (1c) Ornamental Trees 0.65 lb ai/acre 2 acres 120,000 

M/L Liquid via Dip or Soak (1d) 

Ornamental Herbaceous 

Plants, 0.0065 lb ai/gal 100 gallons 230,000 

Seedlings, Seeds, Cuttings 

(preplant or at plant) 0.0043 lb ai/gal 100 gallons 350,000 

M/L DF for Groundboom (2a) 

Carnations (drench) 256 lb ai/acre 1 acres 910 

Ornamental Herbaceous 

Plants (drench) 72 lb ai/acre 1 acres 3,200 

Sodfarm Turf 0.9 lb ai/acre 1 acres 260,000 

Seedlings (planted in field) 0.43 lb ai/acre 1 acres 540,000 

M/L DF for Airblast (2b) Ornamental Trees 0.65 lb ai/acre 1 acres 360,000 

M/L DF to Support LCO Handgun 

Applications (mixing/loading supports 

20 LCOs) (2c) 

Residential & Commercial 

Turf 7 lb ai/acre 1 acres 33,000 

Residential & Commercial 

Turf 0.9 lb ai/acre 1 acres 260,000 

M/L DF via Dip or Soak (2d) 

Ornamental Herbaceous 

Plants, 0.0065 lb ai/gal 100 gallons 360,000 

Seedlings, Seeds, Cuttings 

(preplant or at plant) 0.0043 lb ai/gal 100 gallons 540,000 

Applicator 

Applying Sprays via Groundboom 

Equipment (3) 

Carnations (drench) 256 lb ai/acre 1 acres 950 

Ornamental Herbaceous 

Plants (drench) 72 lb ai/acre 1 acres 3,400 

Sodfarm Turf 0.9 lb ai/acre 1 acres 270,000 

Seedlings (planted in field) 0.43 lb ai/acre 1 acres 570,000 

Mosquito Control in 0.0017 lb ai/gal 800,000 180 

Decorative Ponds, Sewage

37 
Exposure Scenario Crop or Target Application 

Rate a Treated 

Daily b 

Area 

MOEsc 

Inhalation 

Baseline 

Treatment Systems, 

Swimming Pools and 

Standing Water 

treated water to be 

treated 

Mosquito Control in 

Decorative Ponds, Sewage 

Treatment Systems, 

Swimming Pools and 

Standing Water 

0.0017 lb ai/gal 

of water to be 

treated 

100,000 

gallons of 

water to be 

treated 

1,400 

Mosquito Control in 

Decorative Ponds, Sewage 

Treatment Systems, 

Swimming Pools and 

Standing Water 

0.0017 lb ai/gal 

of water to be 

treated 

20,000 

gallons of 

water to be 

treated 

7,200 

Applying Sprays via Airblast Equipment 

(4) Ornamental Trees 0.65 lb ai/acre 1 acres 62,000 

Applying Sprays via Handgun (5) Residential and Commercial 

Turf 

7 lb ai/acre 0.05 acres 370,000 

0.9 lb ai/acre 0.05 acres 2,900,000 

Mixer/Loader/Applicator 

Mixing/Loading/Applying Liquid 

Concentrates with a Handgun Sprayer 

(LCO ORETF data) (10) 

Carnations (drench) 256 lb ai/acre 0.05 acres 2,000 

Ornamental Herbaceous 

Plants (drench) 72 lb ai/acre 0.05 acres 6,900 

Ornamental Trees and 

Ornamental Herbaceous 

Plants 

0.65 lb ai/acre 0.05 acres 770,000 

Ornamental Shrubs, Seedlings 

(planted in field) 0.43 lb ai/acre 0.05 acres 1,200,000 

Mixing/Loading/Applying Liquid 

Concentrates with a Handgun Sprayer 

(LCO ORETF data) (7) 

Carnations (drench) 0.0235 lb 

ai/gallon 0.04 acres 71,000,000 

Ornamental Trees and 

Ornamental Herbaceous 

Plants 

0.0065 lb 

ai/gallon 0.04 acres 260,000,000 

Ornamental Shrubs, Seedlings 

(planted in field) 0.0043 lb ai/acre 0.04 acres 390,000,000 

Mixing/Loading/Applying Water Soluble 

Bags with Handgun Sprayer (LCO 

ORETF data) (10) 

Carnations (drench) 256 lb ai/acre 0.05 acres 2,000 

Ornamental Herbaceous 

Plants (drench) 72 lb ai/acre 0.05 acres 6,900 

Ornamental Trees and 

Ornamental Herbaceous 

Plants 

0.65 lb ai/acre 0.05 acres 770,000 

Ornamental Shrubs, Seedlings 

(planted in field) 0.43 lb ai/acre 0.05 acres 1,200,000 

Mixing/Loading/Applying Dry 

Flowables Concentrates with a Handgun 

Sprayer (LCO ORETF data) (11) 

Carnations (drench) 256 lb ai/acre 0.05 acres 640 

Ornamental Herbaceous 

Plants (drench) 72 lb ai/acre 0.05 acres 2,300 

Ornamental Trees and 

Ornamental Herbaceous 

Plants 

0.65 lb ai/acre 0.05 acres 250,000 

Ornamental Shrubs, Seedlings 

(planted in field) 0.43 lb ai/acre 0.05 acres 380,000 

Mixing/Loading/Applying Liquid 

Concentrates with a High Pressure 

Handwand (PHED) (12) 

Ornamental Herbaceous 

Plants and Ornamental Trees 

0.0065 lb 

ai/gallon 1,000 gallons 230 

Ornamental Shrubs 0.0043 lb 

ai/gallon 1,000 gallons 350 

38
c 

Exposure Scenario Crop or Target Application 

Rate a Treated 

Daily b 

Area 

MOEsc 

Inhalation 

Baseline 

Applying Ready to Use Formulations 

via Trigger-Pump Sprayer (ORETF) (13) 

Ornamental Shrubs, 

Seedlings, Seeds, Cuttins 

(preplant or at plant) 

0.0043 lb 

ai/gallon 1 gallons 2,200,000 

Ornamental Palms 0.013 lb ai/gallon 5 gallons 160,000 

Seedlings, Seeds, Cuttins 

(preplant or at plant) 

0.0043 lb 

ai/gallon 5 gallons 490,000 

Mixing/Loading/Applying Liquids with a 

Watering Can (using ORETF residential 

hose-end data) (14) 

Mosquito Control in 

Decorative Ponds, Sewage 

Treatment Systems, 

Swimming Pools, and 

Standing Water 

0.0017 lb 

ai/gallon of water 

to be treated 

20,000 

gallons to be 

treated 

310 

Mosquito Control in 

Fountains, Water Displays, 

Decorative Pools 

0.0017 lb 

ai/gallon of water 

to be treated 

1,000 gallons 

to be treated 6,200 

a Application rates are the maximum application rates determined from EPA registered labels for ADBAC 

b Amount handled per day values are HED estimates of gallons applied per day based on Exposure SAC SOP #9 Standard Values for 

Daily Acres Treated in Agriculture, industry sources, and HED estimates. 

Inhalation MOE = inhalation NOAEL (mg/kg/day) / baseline inhalation dose (mg/kg/day), where baseline inhalation exposure 

(mg/day) = application rate (lb ai/gal ) x amount handled per day (gal/day) x baseline inhalation unit exposure (μg/lb ai) x conversion 

factor from μg to mg (0.001) and the baseline inhalation dose (mg/kg/day) = baseline inhalation exposure (mg/day) x inhalation 

absorption factor (100%) / female bodyweight (60 kg) 

d. Occupational Post-Application Exposures 

Post-Application exposure may occur from entering food processing plants, hatcheries, 

wood treatment facilities, ornamental greenhouse/nurseries, or from handling treated wood or 

turf. Except for the post-application scenarios assessed for fogging (food processing plants and 

hatcheries) in Section 8.2.2, occupational post-application dermal and inhalation exposures are 

assumed to be negligible. 

i. Fogging (Food Processing Plant and Hatchery) 

There is a potential for post-application inhalation exposure for workers re-entering a 

treated hatchery or food processing plants, because dermal post application is presumed to be 

negligible, it was not assessed. The inhalation exposure assessment was conducted using the 

Multi-Chamber Concentration and Exposure Model (MCCEM v1.2). MCCEM estimates 

average and peak indoor air concentrations of chemicals released from products or materials in 

houses, apartments, townhouses, or other residences. Although the data libraries contained in 

MCCEM are limited to residential settings, the model can be used to assess other indoor 

environments. MCCEM has the capability to estimate inhalation exposures to chemicals, 

calculated as single day doses, chronic average daily doses, or lifetime average daily doses. (All 

dose estimates are potential doses; they do not account for actual absorption into the body.) 

The fogging application to a food processing plant was assessed using a maximum 

application rate of 0.011 lb ai/gal, one quart of the diluted product per 1,000 cubic feet of the 

treated area. For fogging applications, a two hour restricted entry interval is required on current 

labels for this use. The inhalation MOE for fogging is 1 which is considerably below the target 

MOE of 100. The risks of concern immediately after fogging are attributed to low air changes 

39
per hour assumed (i.e., 0.18 ACH as a default parameter in MCCEM to represent low air flow). 

The assessment for fogging in food processing plants could be refined if more accurate 

ventilation rate information could be obtained. 

The fogging application to hatcheries and incubators was assessed using a maximum 

application rate of 0.24 lb ai/gal. For fogging applications, the Agency estimated risks from 0-8 

hours and 2-10 hours following treatment. The 8-hr inhalation MOE from 0-8 hours 

(immediately after fogging) is below the target MOE of 100 at 0.5; however, the 8-hr MOE from 

2 to 10 hours was above the target MOE of 100. 

e. Wood Preservation 

ADBAC is used in products that are intended to preserve wood through both nonpressure treatment methods and pressure treatment methods. Section 1 presents the exposure 

analysis for the handler and post-application scenarios for non-pressure treatment scenarios, and 

Section 2 presents the exposure analysis for the handler and post-application scenarios for 

pressure treatment scenarios. Dermal irritation exposures from post-application activities in the 

wood preservation treatment facility will be mitigated using default personal protective 

equipment requirements based on the toxicity of the end-use product. Therefore, only inhalation 

exposures and risks are presented. 

i. Non-Pressure Treatment Scenarios (Handler and Postapplication)

 a. Scenarios Assessed by Worker Function 

A proprietary study, “Measurement and Assessment of Dermal and Inhalation Exposures 

to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase 

III)” (Bestari et al., 1999, MRID 455243-04) was used to assess various worker 

functions/positions for individuals that handle DDAC-containing wood preservatives for nonpressure treatment application methods and post-application risk scenarios for individuals that 

could into contact with the preserved wood. The worker functions/positions identified in the 

DDAC study are presented below. It was assumed that similar tasks are performed when 

handling ADBAC products and ADBAC treated-wood as, therefore, these same functions were 

assessed for ADBAC. 

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. 

40
• Chemical operators for spray box system consist of chemical operators, chemical assistants, 

chemical supervisors, and chemical captains. These individuals maintain a chemical supply 

balance along with flushing and cleaning spray nozzles. 

The post-application scenarios identified in the aforementioned DDAC study are 

presented below based on the assumption that these scenarios are the same for ADBAC. 

Post-application: 

• Graders, positioned right after the spray box, grade dry lumber by hand (i.e., detect faults). 

• Millwrights repair all conveyer chains and general up-keep of the mill. 

• Clean-up crews perform general cleaning duties at the mill. 

• Trim saw operators operate the hula trim saw and consist of operators and strappers. 

• Construction workers install treated plywood, oriented strand board, medium density 

fiberboard, and others. 

As very little chemical specific data were available regarding typical exposures to 

ADBAC as a wood preservative, surrogate data were used to estimate exposure risks. The 

blender/spray operator position was assessed using CMA unit exposure data and the remaining 

handler and post-application positions were assessed using data from the DDAC study (Bestari et 

al., 1999). 

Blender/Spray Operators 

The inhalation exposures and risks to the composite wood blender/spray operators are 

reported in Table 8.2. The inhalation MOE is below the target MOE of 100 for short-, 

intermediate-, and long-term inhalation exposures (MOE = 84). 

Table 8.2: Short-, Intermediate-, and Long-Term Inhalation Exposures and MOEs for 

Blender/Spray Operator 

Exposure 

Scenario 

Inhalation Unit 

Exposurea 

(mg/lb ai) 

Application Rate 

(% ai in solution/ 

day) 

Wood Slurry 

Treatedb 

(lb/day) 

Daily Dosec 

(mg/kg/day) 

ST/IT/LT 

MOEd 

(Target MOE = 

100) 

Occupational Handler 

Blender/spray 

operator 

0.000403 3 178,000 0.036 84 

ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term. 

a. Inhalation unit exposure: Baseline. 

b. Wood slurry treated = (8 batches/day x 7,000 gallons/batch x 0.003785 m3

/gallon x 380 kg/m3 x 2.2 lb/kg) 

c. Daily Dose = unit exposure (mg/lb ai) x App Rate (% ai/day) x Quantity treated (lb/day) x absorption factor (100% for inhalation) / BW 

(60 kg) 

d. MOE = NOAEL (mg/kg/day)/ Daily dose [Where ST/IT/LT NOAEL = 3 mg/kg/day for inhalation. Target MOE = 100. 

Chemical Operators, Graders, Millwrights, Clean-up Crews, and Trim Saw Operators

 The inhalation exposures (all durations) to chemical operators, graders, millwrights, trim 

saw operators, and clean-up crews are presented in Table 8.3. The inhalation MOEs are above 

the target MOE of 100 for all worker functions. Any dermal irritation exposures from post41
application activities will be mitigated using default personal protective equipment requirements 

based on the toxicity of the end-use product. 

Table 8.3: Short-, Intermediate, and Long-Term Inhalation Exposures and MOEs for 

Wood Preservative Chemical Operators, Graders, Trim Saw Operators, and Clean-Up 

Crews (Handler and Post-application Activities) 

Exposure Scenarioa 

(number of volunteers) 

Inhalation UEb 

(mg/day) Conversion Ratioc Daily Dosed (mg/kg/day) 

MOEe (Target 

MOE = 100) 

Occupational Handlers 

Chemical Operator (n=11) 0.0281 0.625 0.000292 10,000 

Occupational Post-Application 

Grader (n=13) 0.0295 0.625 0.000307 9,800 

Trim Saw (n=2) 0.061 0.625 0.00063 4,800 

Millwright (n=3) 0.057 0.625 0.00059 5,100 

Clean-Up (n=6) 0.60 0.625 0.0063 480 

ST = Short-term duration, IT = Intermediate-term duration, LT = Long-term duration 

a. 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. 

b. Inhalation unit exposures are from Bestari et. al. (1999). Refer to Table E-1 in Appendix E for the calculation of the 

dermal and inhalation exposures. Inhalation exposure (mg/day) was calculated using the following equation: Air 

concentration (μg/m3) x Inhalation rate (1.0 m3/hr) x Sample duration (8 hr/day) x Unit conversion (1 mg/1000 μg). 

The inhalation rate is from USEPA, 1997. 

c. Conversion Ratio = 50% ADBAC / 80% DDAC 

d. Daily dose (mg/kg/day) = exposure (mg/day) x conversion ratio (0.625) x absorption factor (100% for inhalation)/body 

weight (60 kg). 

e. MOE = NOAEL (mg/kg/day)/ Daily dose [Where inhalation NOAEL = 3 mg/kg/day]. Target MOE = 100. 

Diptank Operators 

Exposures to diptank operators were also assessed using surrogate data from the DDAC 

study (Bestari et al., 1999). The diptank scenario assessment was conducted differently than for 

the other job functions because the concentration of DDAC in the diptank solution was provided. 

The exposure data for diptank operators were converted into unit exposures in terms of mg a.i. 

for each 1% of concentration of the product. Table 8.4 provides the short-, intermediate- and 

long-term inhalation dose and MOEs for diptank operators. The inhalation MOE is above the 

target MOE of 100 and, therefore, is not of concern. 

Table 8.4: Short-, Intermediate-, and Long-Term Inhalation Exposures and MOEs for 

Diptank Operator (Handler Activity) 

Exposure Scenarioa 

(number of replicates) 

Inhalation Unit Exposureb 

(mg DDAC/1% solution) 

App Rate 

(% a.i. in solution/ day) 

Daily Dosec 

(mg/kg/day) MOEd 

Occupational Handler 

Dipping, (n=7) 0.046 3 0.0023 1,300 

42
a The exposure scenario represents a worker not wearing a respirator. 

b Inhalation unit exposures are from DDAC study (MRID 455243-04). Refer to Table E-2 in 

Appendix E for the inhalation unit exposure calculations. Inhalation exposure (mg) was calculated 

using the following equation: Air concentration (mg/m3

) x Inhalation rate (1.0 m3/hr) x Sample 

Duration (8 hr). The inhalation rate is from USEPA, 1997. 

c Daily dose (mg/kg/day) = unit exposure (mg/1% ai solution) x percent active ingredient in 

solution (3% ai) x absorption factor (100% for inhalation) / body weight (60 kg). 

d MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 3 mg/kg/day. Target 

MOE = 100. 

ii. Pressure Treatment Scenarios (Handler and PostApplication) 

ADBAC may be used to treat wood and wood products using pressurized application 

methods such as double vacuum. According to the product labels, the maximum retention rate is 

0.6 lb/ft3

. An application rate was not provided on the product labels; therefore, an application 

rate of 3% ai solution was used in this assessment, based on the master label. Since ADBACspecific exposure data are not available to assess pressure treatment exposure, surrogate 

chromated copper arsenate (CCA) data (ACC, 2002b) was utilized and using the approach 

described in a previous exposure assessment (USEPA, 2003b). 

The estimated inhalation exposures and risks for ADBAC are presented in Table 8.6. 

The calculated inhalation MOEs are above the target MOE of 100 for all scenarios and not of 

concern. 

Table 8.6: Short-, Intermediate-, and Long-Term Inhalation Exposures and MOEs for 

Pressure Treatment Handler and Post-application Scenarios 

Exposure Scenario 

Inhalation Unit 

Exposurea 

(μg As/ppm) 

Application Rate 

(% ai solution) 

Daily Dosesb 

(mg/kg/day) 

Inhalation 

MOEsc 

(Target MOE = 

100) 

Occupational Handler 

Treatment Operator (TO) 0.00257 3 0.0013 2,300 

Treatment Assistant (TA) 0.000802 3 0.00040 7,500 

Occupational Post-application 

All (Tram setter, stacker 

operator, loader operator, 

supervisor, test borer, and 

tallyman) 

0.00160 3 0.00080 3,800 

a. Unit exposure values taken from CCA study and are shown in Table 6.11. 

b. Daily Dose (mg/kg/day) = Unit Exposure (μg As/ppm) x [% ADBAC in solution (3) x 10,000 (parts per million 

conversion)] x (0.001 mg/μg) x absorption factor (100% for inhalation) / Body weight (60 kg). 

c. MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 3 mg/kg/day for all durations. Target MOE = 

100. 

43 
9. Human Incident Data 

The Agency reviewed available sources of human incident data for incidents related to 

the use of the quaternary ammonium chlorides. As stated earlier, the Agency clustered the 

quaternary ammonium chloride chemicals into four groups. However, the available incident 

information does not differentiate between the specific groups; therefore, all the incident data are 

discussed together. 

The Agency consulted the following sources of human incidents related to the use of ADBAC: 

(1) OPP Incident Data System (IDS) - The Office of Pesticide Programs (OPP) 

Incident Data System contains reports of incidents from various sources, including 

registrants, other federal and state health and environmental agencies and individual 

consumers, submitted to OPP since 1992. 

(2) California Department of Pesticide Regulation (1982-2004) - Since 1982, 

California’s Department of Pesticide Regulation Pesticide Poisoning Surveillance 

Program consists of reports from physicians who document all illnesses they suspect 

are related to pesticide exposure. 

(3) National Pesticide Information Center(NPIC) - NPIC is a toll-free information 

service supported by OPP. The network provides information on the top 200 active 

ingredients by answering telephone calls during calendar years 1984-1991. 

(4) Published Incident Reports - Some incident reports associated with Quats that are 

related to human health hazard are published in the scientific literature. 

There have been nearly 2700 incidents reported to the OPP Incident Data System (IDS 

and the California Department of Pesticide Regulation (1982-2004) associated with exposure to 

end-use products containing Quats. Most of the incidents are related to dermal, ocular and 

inhalation irritation. Allergic type reaction is also been reported in some incidents. Although 

risk associated with eye exposure is not assessed in the risk assessment process, symptoms 

associated with eye are the most commonly reported associated with Quat exposure. 

Incidents Associated with Quat Use 

Type of Incident Reported Most Common Symptom 

Inhalation respiratory irritation/burning, irritation to 

mouth/throat/nose, coughing/choking, chest pain, 

disorientation, dizziness, shortness of breath 

Dermal irritation/burning, rash, itching, and blistering 

Allergic hives and allergic contact dermatitis 

Oral irritation to mouth/throat/nose, vomiting/ nausea/ 

abdominal pain, dizziness, and headache 

Ocular irritation/burning, eye pain, conjunctivitis, 

swelling of eye and eyelid 

44
B. Environmental Risk Assessment 

A summary of the Agency’s environmental risk assessment is presented below. The 

following risk characterization is intended to describe the magnitude of the estimated 

environmental risks for ADBAC use sites and any associated uncertainties. For detailed 

information on the environmental risk assessment on ADBAC, see the following documents, 

“Environmental Fate Assessment of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)” 

dated July 31, 2006, “Ecological Risk Assessment on Antimicrobial Uses for Alkyl Dimethyl 

Benzyl Ammonium Chloride (ADBAC)” dated August 2, 2006, and “Ecological Risk 

Assessment on Agricultural Uses for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)” 

dated February 3, 2006. 

1. Environmental Fate and Transport 

The environmental fate assessment for ADBAC is based on the available data submitted 

to fulfill the reregistration data requirements. However, the data set is incomplete for the wood 

preservation use. An aqueous availablility study evaluating the leachability of ADBAC from 

treated wood is required. 

Based on the available data, ADBAC is hydrolytically stable under abiotic and buffered 

conditions over the pH 5-9 range. The calculated half-lives for ADBAC were 379 days at pH 9, 

150-183 days at pH 5 and pH 7. ADBAC is also stable to photodegradation in pH 7 buffered 

aqueous solutions. However, in the presence of a photosensitizer (e.g., acetone), ADBAC has 

been shown to degrade with an estimated half-life of 7.1 days. 

Based on a biodegradation study, ADBAC readily degrades into 60% carbon dioxide in 

13 days. ADBAC is immobile in soil. The available soil mobility study shows that ADBAC has a 

strong tendency to bind to sediment/soil with Freundlich Kads values range from 5,123 to 32,429 

depending on the soil type where as the corresponding Koc values range from 640,389 to 

6,171,657 depending on the soil type. Due to its strong adsorption to soils, ADBAC is not 

expected to contaminate surface and ground waters. 

Although the estimated Kow is high, bioaccumulation of ADBAC in freshwater fish nor is 

bioconcentration in aquatic organisms expected to pose a concern because ADBAC has broken 

down into its’ degrades before it reaches the aquatic ecosystems. 

2. Ecological Risk 

The Agency’s ecological risk assessment compares toxicity endpoints from ecological 

toxicity studies to estimate environmental concentrations based on environmental fate 

characteristics and pesticide use data. 

a. Toxicity (Hazard) Assessment 

ADBAC is categorized as highly toxic to fish (LC50 = 280 μg ai/L) and very highly toxic 

to aquatic invertebrates (LC50 = 5.9 μg ai/L) on an acute exposure basis. Chronic effects were 

seen in fish at a concentration of 32.2 μg ai/L and a no observable adverse effect concentration 

45
(NOAEC) of 4.15 μg ai/L was established for aquatic invertebrates. The results of the dietary 

avian studies categorized ADBAC as moderately toxic to birds on an acute basis (LC50 = 136 

mg/kg-bw, with no chronic data available. ADBAC is categorized as slightly toxic to mammals 

on an acute basis (LD50 = 430 mg/kg-bw) and a chronic NOAEC of 44 mg/kg/day was 

established. 

b. Exposure and Risk 

ADBAC INDOOR USES 

The majority of ADBAC uses are spray applications to indoor surfaces, truck interiors, 

kennels, institutional areas, household areas, recirculating cooling towers, evaporative 

condensers, pulp/paper mills, swimming pools and spas, and oil field mud treatments. The indoor 

uses of ADBAC make it unlikely that any appreciable exposure to terrestrial or aquatic organism 

would occur. However, the commercial/industrial facilities using ADBAC for indoor 

applications are required to have NPDES permits prior to discharging effluents into receiving 

waters. 

ADBAC OUTDOOR USES 

Risk Quotients (RQs) are calculated by dividing acute and chronic estimated 

environmental concentrations (EECs), based on environmental fate characteristics and pesticide 

use data, ecotoxicity values for various wildlife and plant species. RQs are then compared to 

levels of concern (LOCs). When the RQ exceeds the LOC for a particular category, the Agency 

presumes risks of concern for that category. 

Ornamental Nursery Plants 

Expected environmental concentrations (EECs) of ADBAC resulting from runoff 

following application to ornamentals in nurseries were calculated using available ecotoxicity 

data and the EPA aquatic exposure model PRZM/EXAMS. Risk quotients (RQs) for freshwater 

fish ranged from 1.99 to 5.26, RQs for freshwater invertebrates ranged from 94.41 to 249.66, 

exceeding the acute risk LOC by greater than 180-fold. The chronic risk LOC (1.0) is exceeded 

many-fold for freshwater fish ranging from RQs 10-28 and for freshwater invertebrates ranging 

from RQs 87-222. Using the EPA terrestrial animal exposure model (TERX), acute avian RQs 

ranged from 19 to 2101, exceeding the acute LOC up to 4000-fold. Chronic avian RQs could not 

be calculated due to the lack of toxicity data, but chronic risk is presumed. Mammalian acute 

RQs for the nursery use range from 1.2 to 182 and chronic RQs range from 11 to 1782. 

Turf and Golf Courses 

Expected EECs of ADBAC resulting from runoff following application to turf and golf 

courses were calculated using available ecotoxicity data and the EPA aquatic exposure model 

PRZM/EXAMS. Risk quotients for freshwater fish range from 0.06 to 0.91, exceeding the 

endangered species and acute risk LOCs. Acute risk RQs for freshwater invertebrates range 

46
from 2.3 to 10.6, exceeding the acute risk LOC. Using the EPA terrestrial animal exposure 

model (TERX), acute avian RQs range from 0.11 to 12.35, exceeding the endangered species 

LOC for all size classes and forage items. Chronic RQs cannot be calculated, but chronic risk to 

avian species is presumed. Acute risk mammalian RQs from the turf/golf course use ranged 

from 0.01 to 7.9, with exceedance of the endangered species LOC for all mammal size classes 

foraging on short grass, tall grass, broadleaf plants and small insects. Chronic RQs for mammals 

range from 0.07 to 77.2, and exceed the LOC for all mammal size classes foraging on short 

grass, tall grass, broadleaf plants and small insects. 

(http://www.epa.gov/oppefed1/models/terrestrial/index.htm). 

Ornamental Ponds, Pools, and Puddles 

Other outdoor uses of ADBAC on ornamental ponds, pools and puddles are not expected 

to result in appreciable exposure to aquatic ecosystems due to their limited size and confined use 

of ADBAC within the structure through the use of impermeable materials. 

(http://www.epa.gov/oppefed1/models/water/index.htm). 

Algae Control and Mosquitocide 

Although the algae control and mosquitocide uses are intended for waterbodies that are 

disconnected from the larger watershed to reduce nontarget environmental exposure, these uses 

may result in potential exposure to amphibians in treated water for a portion of their lifecycle and 

to birds and mammals utilizing treated waterbodies for drinking water. The mosquito control use 

has an initial concentration of 200 ppm ADBAC and represents the greatest risk to terrestrial 

animals. The algal control initial target concentration is 5 ppm ADBAC. At 200 ppm, RQs for 

amphibians are 0.71 for acute risk and 6.2 for chronic risk. RQs for birds drinking treated water 

range from 0.09 to 0.32. Smaller birds face greater acute risk. Chronic risk to birds is presumed 

due to lack of data. Neither acute nor chronic mammalian acute RQs exceed the LOCs at the 200 

ppm initial concentration. 

Once-through Cooling Tower Use 

Tier I once-through cooling tower modeling indicates that ADBAC use will result in 

acute and chronic risk to non-endangered and endangered/threatened freshwater fish and acute 

risk to other aquatic animals at all 3 dosages modeled: 2.0 ppm, 5.0 ppm, and 10.0ppm. High 

water flow, and intermittent dosing at 10.0 ppm had less acute and chronic impact on nonendangered freshwater fish than medium to low stream flow. However, LOC's for all aquatic 

animals were triggered at the 2.0 ppm dosage using continuous dosing regardless of high, 

medium, or low stream flow. Green algae were only adversely affected from use of continuous 

dosing in combination with low stream flow conditions. The continuous dosing, low flow 

nontarget plant LOC is triggered at all 3 dosages modeled. The aquatic plant risk assessment is 

incomplete due to a number of outstanding studies. Direct ADBAC exposure to terrestrial 

animals is not expected to occur from the once-through cooling tower use. 

47
Antisapstain Wood Treatment Use 

Terrestrial animal species are not expected to be directly impacted by this ADBAC use. 

Nontarget aquatic species (fish, invertebrates, green algae) are not expected to be at risk (acute or 

chronic) based on LOCs. Endangered/threatened fish and green algae species are not expected to 

be at risk from the ADBAC antisapstain use. Freshwater and marine aquatic invertebrates are 

expected to be at risk from ADBAC antisapstain use unless methods are used to prevent runoff 

from the treatment site (Ex. store treated wood indoors, cover treated wood and use berms or 

plastic barriers in outdoor storage areas). However, ADBAC is tightly adsorbed to clay and 

organic matter which greatly reduces potential for ADBAC to leach downward through soil to 

groundwater or move via surface runoff. The Tier I screening model is only intended as a 

screening-level model, and, as such, has inherent uncertainties and limitations which may result 

in inaccurate exposure estimations. 

c. Risk to Endangered (Listed) Species 

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all 

federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and 

andronomus listed species, or the United States Fish and Wildlife Services (FWS) for listed 

wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species 

or their designated habitat. Each federal agency is required under the Act to insure that any 

action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a 

listed species or result in the destruction or adverse modification of designated critical habitat. 

To jeopardize the continued existence of a listed species means "to engage in an action that 

reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both 

the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, 

or distribution of the species." 50 C.F.R. § 402.02. 

To facilitate compliance with the requirements of the Endangered Species Act subsection 

(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established 

procedures to evaluate whether a proposed registration action may directly or indirectly reduce 

appreciably the likelihood of both the survival and recovery of a listed species in the wild by 

reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After 

the Agency’s screening-level risk assessment is performed, if any of the Agency’s Listed Species 

LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify 

if any listed or candidate species may co-occur in the area of the proposed pesticide use. If 

determined that listed or candidate species may be present in the proposed use areas, further 

biological assessment is undertaken. The extent to which listed species may be at risk then 

determines the need for the development of a more comprehensive consultation package as 

required by the Endangered Species Act. 

The endangered species Alternative Consultation Agreement (ACA) with NMFS, and 

FWS will take time to implement fully, depending on available resources. The Agency is 

currently preparing risk assessments with the services on 9 high priority agricultural pesticides. 

Endangered species assessments of antimicrobial and additional agricultural pesticides will 

commence in 2008 under the Registration Review program. 

48
For certain use categories, the Agency assumes there will be minimal environmental 

exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk 

Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - 

Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, 

pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk 

assessment, and are considered to fall under a no effect determination. The active ingredient 

uses of ADBAC with the exception of the ornamental nurseries, golf/turf/lawns, once-through 

cooling tower, and antisapstain wood preservation uses, fall into this category. Using Tier I 

screening modeling to assess potential exposure from the ornamental nurseries, golf/turf/lawns, 

once-through cooling tower, and antisapstain wood preservation uses of ADBAC risks to Listed 

Species are indicated. Since the model is only intended as a screening-level model, and, as such, 

has inherent uncertainties and limitations which may result in inaccurate exposure estimations, 

further refinement of the model is recommended before any regulatory action is taken regarding 

the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and antisapstain uses of 

ADBAC. Additionally, impacts from the antisapstain use could potentially be mitigated with 

precautions to prevent leaching and runoff when wood is stored outdoors and impacts from the 

cooling tower use could potentially be mitigated by the reduction of risk mitigation. Due to 

these circumstances, the Agency defers making a determination for the ornamental nurseries, 

golf/turf/lawns, once-through cooling tower, and antisapstain uses of ADBAC until additional 

data and modeling refinements are available. At that time, the environmental exposure 

assessment of the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and 

antisapstain use of ADBAC will be revised, and the risks to Listed Species will be reconsidered. 

49
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 reregistration. The Agency has previously identified and required the 

submission of the generic (i.e., active ingredient-specific) data required to support reregistration 

of products containing ADBAC as an active ingredient. The Agency has completed its review of 

these generic data and has determined that the data are sufficient to support reregistration of all 

supported products containing ADBAC. 

The Agency has completed its assessment of the dietary, occupational, drinking water, 

and ecological risks associated with the use of pesticide products containing the active ingredient 

ADBAC. Based on a review of these data and on public comments on the Agency’s assessments 

for the active ingredient, ADBAC, the Agency has sufficient information on the human health 

and ecological effects of ADBAC to make decisions as part of the tolerance reassessment 

process under FFDCA and reregistration process under FIFRA, as amended by FQPA. The 

Agency has determined that ADBAC-containing products are eligible for reregistration provided 

that: (i) current data gaps and confirmatory data needs are addressed; (ii) the risk mitigation 

measure outlined in this document is adopted; and (iii) label amendments are made to reflect this 

measure. Label changes are described in Section V. Appendix A summarizes the uses of 

ADBAC that are eligible for reregistration. Appendix B identifies the generic data requirements 

that the Agency reviewed as part of its determination of reregistration eligibility of ADBAC and 

lists the submitted studies that the Agency found acceptable. Data gaps are identified as generic 

data requirements that have not been satisfied with acceptable data. 

Based on its evaluation of ADBAC, the Agency has determined that ADBAC products, 

unless labeled and used as specified in this document, would present risks inconsistent with 

FIFRA. Accordingly, should a registrant fail to implement the risk mitigation measure identified 

in this document, the Agency may take regulatory action to address the risk concerns from the 

use of ADBAC. If all changes outlined in this document are incorporated into the product labels, 

then all current risks for ADBAC will be substantially mitigated for the purposes of this 

determination. Once an Endangered Species assessment is completed, further changes to these 

registrations may be necessary as explained in Section III of this document. 

B. Public Comments and Responses 

Through the Agency’s public participation process, EPA worked with stakeholders and 

the public to reach the regulatory decision for ADBAC. During the public comment period on 

the risk assessments, which closed on June 26, 2006, the Agency received comments from the 

ADBAC Consortium, Reckitt Benckiser, and The Clorox Company regarding the risk 

assessments assumptions. These comments in their entirety are available in the public docket, at 

http://www.regulations.gov (OPP-2006-0339). 

C. Regulatory Position 

1. Food Quality Protection Act Findings 

50
a. “Risk Cup” Determination 

As part of the FQPA tolerance reassessment process, EPA assessed the risks associated 

with ADBAC. The Agency has concluded that the risk from dietary exposure is within the “risk 

cup.” An aggregate assessment was conducted for exposures through food, drinking water, and 

residential uses. The Agency has determined that the human health risks from these combined 

exposures are within acceptable levels. In reaching this determination, EPA has considered the 

available information on the special sensitivity of infants and children, as well as aggregate 

exposure from food and residential uses. 

b. Determination of Safety to U.S. Population 

As part of the FQPA tolerance reassessment process, EPA assessed the risks associated 

with ADBAC. The Agency has determined that food uses of ADBAC, meet the safety standards 

under the FQPA amendments to section 408(b)(2)(D) of the FFDCA, and that there is a 

reasonable certainty no harm will result to the general population or any subgroup from the use 

of ADBAC. In reaching this conclusion, the Agency has considered all available information on 

the toxicity, use practices and exposure scenarios, and the environmental behavior of ADBAC. 

As discussed in Section III, the chronic dietary aggregate risks from direct and indirect 

food contact as well as drinking water exposures for adults and children are below the Agency’s 

level of concern provided that mitigation measures outlined in this document are adopted and 

labels are amended. 

Since ADBAC toxicity endpoints for oral, dermal, and inhalation routes of exposure are 

based on different toxic effects, these three routes of exposure are not aggregated together for the 

short- and intermediate-term aggregate assessment. Instead, the short- and intermediate-term 

aggregate assessment is based solely on the co-occurrence of the same route of exposures. Only 

the short –term aggregate is presented because the endpoints for incidental oral and inhalation 

are identical for the short- and intermediate-term durations, and only a short term dermal 

exposure duration was identified. The aggregate risks are not of concern for adults and children 

for any of the three routes of exposure; the risk estimates were above the target MOE. 

c. Determination of Safety to Infants and Children 

EPA has determined that the currently registered uses of ADBAC, with changes as 

specified in this document, meet the safety standards under the FQPA amendments to section 

408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and 

children. The safety determination for infants and children considers factors of the toxicity, use 

practices, and environmental behavior noted above for the general population, but also takes into 

account the possibility of increased susceptibility to the toxic effects of ADBAC residues in this 

population subgroup. 

No Special FQPA Safety Factor is necessary to protect the safety of infants and children. 

In determining whether or not infants and children are particularly susceptible to toxic effects 

from ADBAC residues, the Agency considered the completeness of the database for 

developmental and reproductive effects, the nature of the effects observed, and other 

51
information. The FQPA Safety Factor has been removed (i.e., reduced to 1X) for ADBAC based 

on (1) the existence of a complete developmental and reproductive database (2) the lack of 

evidence for increased susceptibility in the data (3) the risk assessment does not underestimate 

the potential exposure for infants and children. 

d. Endocrine Disruptor 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 Disruptor 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 Disruptor Screening 

Program (EDSP). 

When the appropriate screening and/or testing protocols being considered under the 

EDSP have been developed, ADBAC may be subject to additional screening and/or testing to 

better characterize effects related to endocrine disruption. 

e. Cumulative Risks 

Risks summarized in this document are those that result only from the use of ADBAC. 

The Food Quality Protection Act (FQPA) requires that the Agency consider “available 

information” concerning the cumulative effects of a particular pesticide’s residues and “other 

substances that have a common mechanism of toxicity.” The reason for consideration of other 

substances is due to the possibility that low-level exposures to multiple chemical substances that 

cause a common toxic effect by a common toxic mechanism could lead to the same adverse 

health effect as would a higher level of exposure to any of the substances individually. Unlike 

other pesticides for which EPA has followed a cumulative risk approach based on a common 

mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for 

ADBAC. For information regarding EPA’s efforts to determine which chemicals have a 

common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the 

policy statements released by EPA’s Office of Pesticide Programs concerning common 

mechanism determinations and procedures for cumulating effects from substances found to have 

a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/. 

2. Tolerance Summary 

Alkyl Dimethyl Benzyl Ammonium Chloride, (ADBAC) has tolerance exemptions in 40 

CFR 180.940 (a) as a food contact sanitizer for use in public eating places, in dairies on 

processing equipment, and in food processing plants on equipment and utensils not to exceed the 

52
limit of 200 ppm and (c) as a food contact sanitizer for use in food processing plants on 

equipment and utensils not to exceed the limit of 400 ppm. 

Table 9: Tolerance Reassessment Summary for ADBAC 

Tolerance Exemption Listed Under 40 CFR 180.940 (a) 

Use Site Current Limit 

(ppm) 

Tolerance 

Reassessment 

(ppm) 

Correct 

Definition/Comment 

Public eating places, dairies on 

processing equipment and 

utensils, and food processing 

plants on equipment and 

utensils 

Total quat 

concentration 

does not exceed 

200 

Total quat 

concentration 

does not exceed 

200 

No change 

Tolerance Exemption Listed Under 40 CFR 180.940 (c) 

Use Site Current Limit 

(ppm) 

Tolerance 

Reassessment 

(ppm) 

Correct 

Definition/Comment 

Food processing plants on 

equipment and utensils 

Specific quat 

concentration 

does not exceed 

200; total quat 

concentration 

does not exceed 

400 

Specific quat 

concentration 

does not exceed 

200; total quat 

concentration 

does not exceed 

400 

No change 

D. Regulatory Rationale 

The Agency has determined that ADBAC is eligible for reregistration provided that 

additional required data confirm this decision, the risk mitigation measures outlined in this 

document are adopted, and label amendments are made to reflect these measure. 

The following is a summary of the rationale for managing risks associated with the use of 

ADBAC. Where labeling revisions are warranted, specific language is set forth in the summary 

tables of Section V of this document. 

1. Human Health Risk Management 

a. Dietary (Food) Risk Mitigation 

The chronic dietary risks from ADBAC residues on food, estimated using conservative 

measures, are below the Agency’s level of concern. Therefore, no mitigation measures are 

necessary at this time. 

b. Drinking Water Risk Mitigation 

As an outdoor pesticide for use on nursery ornamentals, turf, and mosquito control in 

decorative fountain/ponds and puddles, ADBAC is expected to impact either surface or ground 

53
water resources. There are no drinking water concerns since the risk estimates for children and 

adults were below the level of concern. Therefore, no mitigation measures are necessary at this 

time. 

c. Residential Risk Mitigation 

i. Handler Risk Mitigation 

 Residential handler risks were calculated for the short-term duration because it best 

represents most homeowner applications. The residential handler risks did exceeded the target 

MOEs for all scenarios. Therefore, no mitigation measures are needed at this time. 

ii. Post-Application Risk Mitigation 

As with the residential handler risk assessment, the post-application risks were also 

calculated for the short-term duration because it best represents most homeowner applications. 

All residential post application risks were above the Agency’s level of concern except for 

inhalation exposures due to use in humidifiers, based on the 24 hr inhalation MOEs for adults 

and children, 10 and 4, respectively and incidental oral exposure for children due to residential 

treatment of lawns, MOE 76. 

At this time, there are no available mitigation measures for the humidifier use. Because of 

remaining residential exposure concerns, the registrants for ADBAC have agreed to conduct a 

inhalation exposure study that would allow the Agency to refine the risks associated with this 

uses. However, this study will not be completed in time for inclusion in this RED. Until 

acceptable data are submitted, the Agency has determined that the residential use of ADBAC in 

humidifiers is ineligible for reregistration and this use must be deleted. Once the data has been 

received and determined to be acceptable, and if it is established that the risks are not of concern, 

the registrants can request that this use be reinstated. 

In order to mitigate the risks of concern scenario, the Agency is requiring that the 

maximum application rate for use on residential lawns must be reduced to 5.4 lb ai/A. The MOE 

at this application rate achieves the target of 100. 

d. Occupational Risk Mitigation 

i. Handler Risk Mitigation

 EPA determined that the greatest potential for handler exposure appears to be the shortand intermediate-term inhalation exposure scenarios. In order to reduce the occupational handler 

risk, the following mitigation measures must be adopted: 

Fogging in Agricultural Premises and Equipment: All labels must indicate that a dust mist 

respirator will be used when pouring the product into the fogging equipment. 

Pulp and Paper: In order to mitigate the risks of concern for occupational handlers in pulp and 

paper mills, the Agency is requiring that the maximum application rate must be reduced to 14 lbs 

ai/ton of paper for products coupled with the use of a metering pump system (a closed system). 

54
The MOE at this application rate achieves the target of 100, and thus addresses the inhalation 

risk of concern. 

Once-through Cooling Water (average flow rate for high flow streams): In order to mitigate the 

risks of concern for occupational handlers in once-through cooling tower, the Agency believes 

that the maximum number of applications per year for this use pattern must be reduced to four. 

This reduction, together with the fact that application of these products utilizes metered pump (a 

closed system) addresses the inhalation risk of concern. (The reduction in the # of applications 

should also be added to the eco risk mitigation piece for cooling towers.) 

Small Process Water Systems: All labels must indicate that a dust mist respirator will be used 

when applying the product to the water system. 

Blender/Spray Application for Wood Preservation: Due to the conservative nature of the risk 

assessment and the proximity of the MOE to the target of 100 (MOE = 84) the Agency believes 

that actual exposures do not exceed the Agency’s level of concern. 

Mopping in Medical Premises: Due to the conservative nature of the risk assessment and the 

proximity of the MOE to the target of 100 (MOE = 95) the Agency believes that actual 

exposures do not exceed the Agency’s level of concern.

 ii. Post-Application Risk Mitigation 

Except for the post-application scenario assessed for fogging in hatcheries and food 

processing plants, the occupational post-application dermal and inhalation exposures are 

assumed to be negligible. Based on the inhalation risk estimates for fogging in hatcheries, a 2 

hour re-entry interval must be prescribed to all labels with this use to mitigate the inhalation risk. 

In regard to food processing plants, the label must indicate a 2 hour reentry interval as well as a 

minimum requirement of 4 air changes per hour (ACH). The registrants for ADBAC have agreed 

to conduct air monitoring data and/or provide additional air exchange information that would 

allow the Agency to further refine the risks associated with this use. 

2. Environmental Risk Management 

There is minimal environmental exposure from the indoor uses of products containing 

ADBAC therefore no mitigation measures are needed for these use patterns at this time. 

Conversely, there is significant environmental exposure from the outdoor uses from 

products containing ADBAC; such as ornamental nurseries, golf/turf, once-through cooling 

water towers, and antisapstain wood treatment, each of which resulted in RQs that exceeded the 

Agency’s level of concern. . In order to reduce the environmental risk, the following mitigation 

measures must be adopted: 

Ornamental Nurseries: Application is limited to Spot Treatment of diseased ornamental plants 

and flowers at a maximum rate of 800 ppm and total use of 5 lbs A.I/ acre. Treatment is 

restricted to indoor uses or uses in which controlled conditions prevent runoff and exposure to 

the environment. In the case of diseased trees, the spot treatment of trees must be at least 100 feet 

from any pond, lake, stream, or river to prevent possible runoff of the product into the waterway. 

55
The label must state “Do Not Apply by Aerial Spray.” 

Golf/Turf: For commercial application to golf courses, treatment is be limited to the “Greens 

and Tees” at a rate of 0.8 lbs A.I./acre (200 ppm) not to exceed treatment of 10 acres (2000 

gallons) with retreatment at 10 day intervals not to exceed 6 treatments per year. 

 For residential application to turf/lawns, application is limited to Spot Treatment of diseased 

areas of the lawn/turf only at a maximum rate of 5.4 lbs A.I/acre not to exceed 25 gallons per 

1000 sq. ft. Treatment must be repeated up to 6 times a year at 10 day intervals. 

Mosquitocide: The product labels supporting this use must state: 

This product is not intended to be used for broadcast mosquitocide application but rather is 

limited to small residential ponds, decorative ponds, and similar areas. The product labels must 

be revised to reflect the following: 

This product is not to be used in open waterways connected to larger watersheds or in waters that 

serve as natural habitats for aquatic and amphibious organisms. This product controls 

mosquitoes where they breed (fountains, water displays, decorative pools, decorative ponds, 

sewage treatment systems, spas, hot tubs, swimming pools and standing water in old tires, empty 

tin cans, barrels, puddles, and water drains around buildings). Do not exceed 10 applications at 

a minimum of 10-day intervals per year. NOTE: Only out-of-season, not-in-service, or inactive 

spas, hot tubs, swimming pools require treatment for mosquito control. Do not treat during the 

swimming season. Spray from fountains treated with this product will not harm poolside 

plantings. DO NOT use when fish or other wildlife (for example, amphibians) are present. 

Once-Through Cooling Water Tower: All labels must state “Do Not Apply This Product more 

than 4 times per year.” Also, all labels supporting this use must carry the NPDES statement per 

PR Notice 93-10 and 95-5 as well as directions for Bentonite Clay Treatment, a method to treat 

the water before it is release. 

Antisapstain Wood Treatment: All product labels supporting this use must add the following 

text: 

Treated lumber must be stored under cover, or indoors, or at least 100 feet from any 

pond, lake, stream, wetland, or river to prevent possible runoff of the product into the water way. 

Treated lumber stored outdoors within 100 feet of a pond, lake, stream, wetland, or river must be 

either covered with plastic or surrounded by berm to prevent surface water runoff into the nearby 

waterway. If a berm is used around the site, it must consist of impermeable material (clay, 

asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events. 

3. Labeling Requirements 

In order to be eligible for reregistration, various use and safety information will be 

included in the labeling of all end-use products containing ADBAC. For the specific labeling 

statements and a list of outstanding data, refer to Section V of this RED document. 

56
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 

LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify 

if any listed or candidate species may co-occur in the area of the proposed pesticide use. If 

determined that listed or candidate species may be present in the proposed use areas, further 

biological assessment is undertaken. The extent to which listed species may be at risk then 

determines the need for the development of a more comprehensive consultation package as 

required by the Endangered Species Act. 

For certain use categories, the Agency assumes there will be minimal environmental 

exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk 

Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - 

Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, 

pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk 

assessment, and are considered to fall under a no effect determination. The active ingredient 

uses of ADBAC with the exception of the ornamental nurseries, golf/turf/lawns, once-through 

cooling tower, and antisapstain wood preservation uses, fall into this category. Using Tier I 

screening modeling to assess potential exposure from the ornamental nurseries, golf/turf/lawns, 

once-through cooling tower, and antisapstain wood preservation uses of ADBAC risks to Listed 

Species are indicated. Since the model is only intended as a screening-level model, and, as such, 

has inherent uncertainties and limitations which may result in inaccurate exposure estimations, 

further refinement of the model is recommended before any regulatory action is taken regarding 

the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and antisapstain uses of 

ADBAC. Additionally, impacts from the antisapstain use could potentially be mitigated with 

precautions to prevent leaching and runoff when wood is stored outdoors and impacts from the 

cooling tower use could potentially be mitigated by the reduction of risk mitigation. Due to 

57
these circumstances, the Agency defers making a determination for the ornamental nurseries, 

golf/turf/lawns, once-through cooling tower, and antisapstain uses of ADBAC until additional 

data and modeling refinements are available. At that time, the environmental exposure 

assessment of the ornamental nurseries, golf/turf/lawns, once-through cooling tower, and 

antisapstain use of ADBAC will be revised, and the risks to Listed Species will be reconsidered. 

b. General Risk Mitigation 

ADBAC end-use products (EPs) may also contain other registered pesticides. Although 

the Agency is not proposing any mitigation measures for products containing ADBAC specific 

to federally listed species, the Agency needs to address potential risks from other end-use 

products. Therefore, the Agency requires that users adopt all listed species risk mitigation 

measures for all active ingredients in the product. If a product contains multiple active 

ingredients with conflicting listed species risk mitigation measures, the more stringent 

measure(s) should be adopted. 

58
V. What Registrants Need to Do 

The Agency has determined that ADBAC is eligible for reregistration provided that: (i) 

additional data that the Agency intends to require confirm this decision; (ii) the risk mitigation 

measure outlined in this document is adopted; and (iii) label amendments are made to reflect this 

measure. To implement the risk mitigation measure, the registrants must amend their product 

labeling to incorporate the label statement set forth in the Label Changes Summary Table in 

Section B below (Table 13). The additional data requirements that the Agency intends to obtain 

will include, among other things, submission of the following: 

For ADBAC technical grade active ingredient products, the registrant needs to submit the 

following items: 

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

1. completed response forms to the generic DCI (i.e., DCI response form and 

requirements status and registrant’s response form); and 

2. submit any time extension and/or waiver requests with a full written justification. 

Within the time limit specified in the generic DCI: 

1. cite any existing generic data which address data requirements or submit new generic 

data responding to the DCI. 

Please contact Jacqueline Campbell-McFarlane at (703) 308-6416 with questions 

regarding generic reregistration. 

By US mail: By express or courier service:

Document Processing Desk (DCI/AD) Document Processing Desk (DCI/AD) 

Jacqueline Campbell-McFarlane Jacqueline Campbell-McFarlane 

US EPA (7510P) Office of Pesticide Programs (7510P)

1200 Pennsylvania Ave., NW Room S-4900, 1 Potomac Yard 

Washington, DC 20460 2777 South Crystal Drive 

Arlington, VA 22202 

59
For end-use products containing the active ingredient ADBAC, the registrant needs to submit the 

following items for each product. 

Within 90 days from the receipt of the product-specific data call-in (PDCI): 

1. completed response forms to the PDCI (i.e., PDCI response form and requirements 

status and registrant’s response form); and 

2. submit any time extension or waiver requests with a full written justification. 

Within eight months from the receipt of the PDCI: 

1. two copies of the confidential statement of formula (EPA Form 8570-4); 

2. a completed original application for reregistration (EPA Form 8570-1). Indicate on 

the form that it is an “application for reregistration”; 

3. five copies of the draft label incorporating all label amendments outlined in Table 23 

of this document; 

4. a completed form certifying compliance with data compensation requirements (EPA 

Form 8570-34); 

5. if applicable, a completed form certifying compliance with cost share offer 

requirements (EPA Form 8570-32); and 

6. the product-specific data responding to the PDCI. 

Please contact Velma Noble at (703) 308-6233 with questions regarding product 

reregistration 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 (7510P) Office of Pesticide Programs (7510P)

1200 Pennsylvania Ave., NW Room S-4900, 1 Potomac Yard 

Washington, DC 20460 2777 South Crystal Drive 

 Arlington, VA 22202 

60
A. Manufacturing Use Products 

1. Additional Generic Data Requirements 

The generic database supporting the reregistration of ADBAC has been reviewed and 

determined to be substantially complete. However, the following additional data requirements 

have been identified by the Agency as confirmatory and included in the generic DCI for this 

RED. 

The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure 

data available from the Chemical Manufacturers Association (CMA) data base. Therefore, the 

Agency is requiring confirmatory data to support the uses assessed with the CMA exposure data 

within this risk assessment. The risk assessment also noted that many of the use parameters 

(e.g., amount handled and duration of use) were based on professional judgments. Therefore, 

descriptions of human activities associated with the uses assessed are required as confirmatory. 

Table 11. Confirmatory Data Requirements for Reregistration 

Guideline Study Name New OPPTS Guideline No. Old Guideline No. 

Dermal Indoor Exposure 875.1200, 875.1600 233, 236 

Inhalation Indoor Exposure 875.1400, 875.1600 234, 236 

Dermal Outdoor Exposure 875.1100, 875.1600 231 

Inhalation Outdoor Exposure 875.1300, 875.1600 232 

Descriptions of Human Activity (All Uses) 875.2800 133-1 

Dietary-Residues in Food from Treating 

Countertops with ADBAC (FDA Wipe Study 

Methodology) (FDA, 2003a and 2003b) 

Non-Guideline Non-Guideline 

Surface-Wipe Pressure-Treated Wood Study Non-Guideline Non-Guideline 

 Special Aquatic Leaching Study on Wood Non-Guideline Non-Guideline 

90 Day Inhalation – Rat 870.3465 82-4 

Non-Target plant phytotoxicity (Seedling 

Emergency using rice) 850.4225 123-1 

Vegetative Vigor using rice 850.4250 123-1 

Aquatic plant growth toxicity (Lemna gibba) 850.4400 123-2 

Chronic Aquatic Invertebrate Life Cycle - 

Daphnia magna 

850.1300 72-4 

Acute estuarine/marine organism (Eastern 

Oyster embryo larvae) 850.1055 72-3b 

Aquatic plant growth (4 Algal toxicity – 4 

species: green algal Selenastrum 

capricornutum (Pseudokirshnerierlla 

subcapitata), blue-green cyanobacteria 

(Anabeana flos-aquae), freshwater diatom 

(Navicula pelliculosa), marine diatom 

(Skeletonema costatum) 

850.5400 123-2 

61
Guideline Study Name New OPPTS Guideline No. Old Guideline No. 

Special Aquatic Field Monitoring (OnceThrough Cooling Water Towers) Non-Guideline Non-Guideline 

Avian reproduction study –bob white quail 850.2300 

Honeybee toxicity studies 850.3030 171-4 

2. Labeling for Technical and Manufacturing Use Products 

To ensure compliance with FIFRA, technical and manufacturing-use product (MP) 

labeling should be revised to comply with all current EPA regulations, PR Notices and 

applicable policies. The Technical and MP labeling should bear the labeling contained in Table 

13, Label Changes Summary Table. 

B. End-Use Products 

1. Additional Product-Specific Data Requirements 

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific 

data regarding the pesticide after a determination of eligibility has been made. The Registrant 

must review previous data submissions to ensure that they meet current EPA acceptance criteria 

and if not, commit to conduct new studies. If a registrant believes that previously submitted data 

meet current testing standards, then the study MRID numbers should be cited according to the 

instructions in the Requirement Status and Registrants Response Form provided for each 

product. 

A product-specific data call-in, outlining specific data requirements, will be sent to 

registrants at a later date. Products which include claims for residual sanitizing activity as well 

as residual claims against certain non-public health organisms, including mold, will be required 

to submit efficacy data to support these claims. If a product label includes a sanitizing claim; 

such as sanitizing carpets or laundry, the appropriate efficacy data must be submitted to support 

the claim. 

The efficacy studies the Agency intends to call-in are listed in Table 12 below. 

Table 12. Efficacy Data Requirements for Reregistration 

Claim Use Pattern Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline 

No. 

Disinfectant Hard inanimate 

surfaces 

AOAC Use Dilution Test (Hard 

water and organic soil) 

or 

AOAC Germicidal Spray Test 

or 

AOAC Hard Surface Carrier Test 

(Distilled water only) 

810.2100 

(c), (d), (e) 

91-2 (b), 

(c), (d) 

62
Claim Use Pattern Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline 

No. 

Toilet Bowl 

Disinfection 

Toilet bowl and 

urinal hard surfaces 

AOAC Use Dilution Test (Hard 

water and organic soil) 

or 

AOAC Germicidal Spray Test 

or 

AOAC Hard Surface Carrier Test 

(Distilled water only) 

810.2600 (b)(1) 91-7 (a) (1) 

Laundry 

Additives 

Disinfection 

(pre-soak) 

Laundry 

AOAC Hard Surface Carrier Test 

(Distilled water only) 

or 

AOAC Use Dilution Test (Hard 

water and organic soil) 

810.2300 (b)(2) 91-4 (a)(1) 

Laundry 

Additives 

Disinfection 

(non-residual) 

Laundry 

Petrocci and Clarke laundry 

additives (disinfectant level) or 

actual in-use study 

810.2300 (b)(3) 91-4 (a)(2) 

Tuberculocidal Hard inanimate 

surfaces 

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) 

810.2100 (h) 91-2 (g) 

Virucidal Hard inanimate 

surfaces 

Virucidal Activity Method used 

in conjunction with modification 

of : AOAC Hard surface carrier 

test (distilled water only) 

or 

AOAC Germicidal Spray Test 

810.2100 (g) 91-2 (f) 

63
Claim Use Pattern Guideline Study Name New OPPTS 

Guideline No. 

Old Guideline 

No. 

Fungicidal Hard inanimate 

surfaces 

AOAC Fungicidal Test 

or 

 AOAC Hard surface carrier test 

(distilled water only) 

or 

AOAC Germicidal Spray Test 

810.2100 (f) 91-2 (e) 

Sanitizer 

Non-food contact 

surfaces (nonresidual) 

Sanitizer Test for Hard Inanimate 

Non-Food Contact Surfaces 810.2100 (l) 91-2 (j) 

Food Contact 

Sanitizer 

Final rinse of 

previously cleaned 

food contact surface 

AOAC Germicidal and Detergent 

Sanitizers Method 810.2100 (m)(2) 91-2 (l)(2) 

Laundry 

additive, non 

residual 

Laundry 

Petrocci and Clarke laundry 

additives method (Sanitizing 

level) 

810.2300 (b)(4) 91-4 (a)(3) 

Laundry 

additive, residual 

self sanitizing 

Laundry 

Petrocci and Clarke laundry 

additives method or ATCC Test 

method 100-1974 

810.2300 (b)(5) 91-4 (a)(4) 

Laundry 

Additives, 

sanitizing presoak 

Laundry 

Sanitizer test for hard inanimate 

non-food contact surfaces 

modified to include organic soil 

810.2100 

(b)(2) 

N/A 

Residual Self 

Sanitizing 

Hard surfaces 

(residual selfsanitizing activity of 

dried chemical 

residues on hard 

inanimate surfaces) 

Controlled In-Use study or 

simulated In-Use study 810.2100 (o) 91-2 (m) 

Carpet Sanitizer Carpet EPA Carpet Sanitizer Protocol 810.2300 (c) 91-4 (b) 

Toilet bowl and 

urinal sanitizing 

Toilet bowl and 

urinal hard surfaces 

Sanitizer Test for Hard Inanimate 

Non-Food Contact Surfaces 810.2600 (b)(2) 91-7 (a)(2) 

Presaturated and 

impregnated 

towelettes 

Hard Inanimate 

Surfaces Simulated In-use Study 810.2100 (i) N/A 

Sanitizing Fabric 

Treatment 

Mattresses, 

upholstered furniture, 

pillows 

Simulated In-use Study 810.2300 (d) 91-4 (c) 

Termiticide Wood Preventive Treatment – wood 

impregnation 

N/A 95-12(b)(ii) 

64
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 Reregistration Eligibility Decision document. 

Persons other than the registrant may generally distribute or sell such products for 52 months 

from the approval of labels reflecting the mitigation described in this RED. However, existing 

stocks time frames will be established case-by-case, depending on the number of products 

involved, the number of label changes, and other factors. Refer to “Existing Stocks of Pesticide 

Products; Statement of Policy,” Federal Register, Volume 56, No. 123, June 26, 1991. 

a. Label Changes Summary Table 

In order to be eligible for reregistration, amend all product labels to incorporate the risk 

mitigation measure outlined in Section IV. The following table describes how language on the 

labels should be amended. 

65
Table 13. Labeling Changes Summary Table 

Statements noted with an * are not directly related to risk mitigation but are reflective of Agency labeling 

Description Amended Labeling Language 

Manufacturing Use Product 

For all Manufacturing Use Products * 

“Only for formulation into antimicrobial products for use in: agricultural/farm premises, structures, buildings, and equipment; dairy farm milk handling facilities, equipment, storage rooms, houses, and sheds; food processing plants, food handling, food distribution equipment and premises; eating establishments premises and equipment; commercial, institutional, and industrial premises and equipment (floors, walls, storage areas); domestic dwellings, food handling areas, bathroom premises (hard surfaces), indoor premises; and medical institutional critical care and noncritical care premises and laundry. For Formulation into antimicrobial products for use in golf/commercial turf/lawns, greenhouses/nurseries, fountains/water displays/decorative ponds/standing water, sewage treatment systems, spas, air conditioner/refrigeration condensate water systems, air washer and industrial scrubbing systems, once- through and recirculating industrial/commercial cooling water systems, pulp/paper mill water systems, and swimming pools. Gas/oil drilling muds/packer fluids, mushroom houses/empty premises and equipment, wood preservation, egg handling equipment and rooms, egg washing treatment, poultry processing plant equipment/premises, meat processing plant/equipment, gas/oil recovery injection water systems. 

PPE Requirements1 Corrosive. Causes irreversible eye damage and skin burns. May be fatal if swallowed or 

inhaled. May be harmful if absorbed through the skin. Do not get in eyes, on skin, or on clothing. Do not breathe vapor or spray mist. Wear a dust/mist filtering respirator (MSHA/NIOSH approval number TC-21C) or a NIOSH approved respirator with any N, R, P, or HE filter. Wear goggles or faceshield, rubber gloves, and protective clothing when handling. Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash before reuse. 

66
Description Amended Labeling Language 

Pulp and Paper Applications * Product labels listing uses for treatment of pulp/paper process components (eg., paper machine 

white water; catalase control in deinking loops; starch and sizing; coatings; fillers; pigments; adhesives; etc.), and which contain active ingredients not cleared by FDA for food contact, must state "For non-food use only". Those cleared for food contact, may state "For food and non-food contact". 

Ecological Effects Language Required by the RED and PR Notice 93-10 and 95-1 

"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." 

Physical and Chemical Hazards* Do not use or store near heat or open flame. Do not mix with oxidizers, soap, or other anionic 

materials 

End-Use Products for Commercial, Industrial, Institutional Uses 

PPE Requirements1 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. 

Fogging in Hatcheries 2 hour Reentry Interval for fogging applications Fogging in Food Processing Plants 

2 hour Reentry Interval for fogging applications and a minimum of 4 air exchanges (ACH) per hour in the facility 

Swimming Pools* Do not apply when swimmers are in the immediate vicinity (the Agency recommends a 15 minute reentry interval) Wood Preservation Label must include dilution rate and retention chart specific to the type of wood used for 

pressure and dip treatment If registrant has not supported Honey Bee Data, the following statement must be included on the Agency label as well as the end tag on the treated lumber: Wood treated with ADBAC shall not be used in the construction of bee hives. 

67
Description Amended Labeling Language 

Agricultural fogging (loading) Labels must indicate that a dust mist respirator must be worn when applying the product to the fogging equipment. Pulp and Paper Maximum use rate is 14 lb ai/ton of paper. 

Product labels involving treatment of pulp and paper processes (eg., treatment of paper machine white water; catalase control in deinking loops; starch and sizing; coatings; fillers; pigments; adhesives; etc.), which result in finished products which may have direct or indirect food contact, must have FDA clearance for the entire formula via a food additive petition, and must state whether each use is cleared for "food contact" uses, and/or involves "non-food contact" uses. Products without FDA clearance must state: Do not use to treat paper or paperboard which will contact food. 

Small Process Water Systems Labels must indicate that a dust mist respirator must be worn when applying the product to the water system. Hand Sanitizer Delete the Use Udders, Teats and Flanks Delete the Uses Treatment of Hatching Eggs Delete the Use 

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. 

Sanitizing Hatchery Rooms* Label must include the following text: Remove all animals and feed from premise, vehicles and enclosures. 

Treatment of Eggs in Egg Processing Facilities* 

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. 

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. 

68
Description Amended Labeling Language 

Treatment of Mushroom Farms* 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. 

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 ” to the must be added or the following MOU language from PR Notice 94-4: This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contact intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to pre-clean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection. 

Hard nonporous surfaces in Institutional/Commercial Food Handling Facilities* 

After disinfection, a potable water rinse is required. Do not use to disinfect appliances, refrigerator interiors, and microwave oven interiors. Do not use on dishes, glasses, and utensils. 

Institutional/Commercial Laundry Treatment* 

Dilute ____ oz per _____ gallons of water per 100 lbs of fabric (dry weight). When washing the clothes, a maximum of 60 gallons of water per 100 lbs. of fabric (dry weight) must be in the machine. Add use solution to the wash wheel at the beginning of the final rinse cycle. 

Disinfection/Sanitizing Drains/Disposals* 

Delete the claim because the Agency believes it is not feasible to disinfect throughout a drain w/ or w/o a disposal system. 

Addition of ATCC number* All organisms tested to support bactericidal, virucidal, and fungicidal claims must list the ATCC number to identify the specific strain of organism Environmental Hazards -for Labels for AntiSapstain 

Treated lumber must be stored under cover, or indoors, or at least 100 from any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the water way. Treated lumber stored outdoors within 100 feet of a pond, lake, stream, wetland, or river must be either covered with plastic or surrounded by berm to prevent surface water runoff into the nearby waterway. If a berm is used around the site, it must consist of impermeable material (clay, 

asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events. 

69
Description Amended Labeling Language 

Environmental Hazards for Once Through Cooling Water Towers 

DO NOT APPLY THIS PRODUCT MORE THAN 4 TIMES PER YEAR. DEACTIVATION: This product must be deactivated prior to discharge of the NPDES outfall. TO DEACTIVATE: Use Bentonite Clay at a minimum ratio 5 ppm clay to 1 ppm product. Deactivation must occur prior to discharge of the NPDES outfall. 

Ornamental Uses Application is limited to Spot Treatment of diseased ornamental plants and flowers at a maximum rate of 800 ppm and total use of 5 lbs A.I/ acre. 

Treatment is restricted to indoor uses or uses in which controlled conditions to prevent runoff and exposure to the environment. In the case of diseased trees, the spot treatment of trees must be at least 100 feet from any pond, lake, stream, or river to prevent possible runoff of the product into the waterway. Do Not Apply by Aerial Spray. 

Golf/Commercial Turf/Lawn For commercial application to golf courses, the treatment is limited to the “Greens and Tees” at a rate of 0.8 lbs A.I./acre (200 ppm) not to exceed treatment of 10 acres (2000 gallons) with 

retreatment at 10 day intervals not to exceed 6 treatments per year. 

Mosquitocide The product labels must state: This product is not intended to be used for broadcast mosquitocide application but rather is limited to small residential ponds, decorative ponds, and 

similar areas. This product is not to be used in open waterways connected to larger watersheds or in waters that serve as natural habitats for aquatic and amphibious organisms. This product controls mosquitoes where they breed (fountains, water displays, decorative pools, decorative ponds, sewage treatment systems, spas, hot tubs, swimming pools and standing water in old tires, empty tin cans, barrels, puddles, and water drains around buildings). Do not exceed 10 applications at a minimum of 10-day intervals per year. NOTE: Only out-of-season, not-inservice, or inactive spas, hot tubs, swimming pools require treatment for mosquito control. Do not treat during the swimming season. Spray from fountains treated with this product will not harm poolside plantings. DO NOT use when fish or other wildlife (for example, amphibians) are present. 

70
Description Amended Labeling 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_remediation Table 1 and 2 for Remediation Directions for Use 

End Use Products Intended for Residential Use 

PPE Requirements1 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. 

Hard nonporous food contact surfaces * 

 Do not use to disinfect appliances, refrigerator interiors, and microwave oven interiors. Do not use as a disinfectant on dishes, glasses, or utensils. 

Disinfection/Sanitizing Drains/Disposals* 

Delete the claim because the Agency believes it is not feasible to disinfect throughout a drain w/ or w/o a disposal system. 

Addition of ATCC number* All organisms tested to support bactericidal, virucidal, and fungicidal claims must list the ATCC number to identify the specific strain of organism Application Restrictions-For Products Used in Swimming Pools/Spas* 

Do not apply when swimmers are in the immediate vicinity (the Agency recommends a 15 minute reentry interval) 

Humidifiers Delete the Use Residential Turf/Lawn For residential lawns/turf, application is limited to Spot Treatment of diseased areas of the lawn/turf at a maximum use rate of 5.4 lbs A.I/acre (800 ppm) not to exceed 25 gallons per 

1000 sq. ft. Treatment must be repeated up to 6 times a year at 10 day intervals. 

71
Description Amended Labeling Language 

Residential Mosquitocide The product labels must state: This product is not intended to be used for broadcast mosquitocide application but rather is limited to small residential ponds, decorative ponds, and 

similar areas. The product labels must be revised to reflect the following: This product is not to be used in open waterways connected to larger watersheds or in waters that serve as natural habitats for aquatic and amphibious organisms. This product controls mosquitoes where they breed (fountains, water displays, decorative pools, decorative ponds, sewage treatment systems, spas, hot tubs, swimming pools and standing water in old tires, empty tin cans, barrels, puddles, and water drains around buildings). Do not exceed 10 applications at a minimum of 10-day intervals per year. NOTE: Only out-of-season, not-inservice, or inactive spas, hot tubs, swimming pools require treatment for mosquito control. Do not treat during the swimming season. Spray from fountains treated with this product will not harm poolside plantings. DO NOT use when fish or other wildlife (for example, amphibians) are present. 

Mold Remediation/Prevention (Water/Smoke restoration/ Sewer backup/river flood cleanup/clean water source) 

For Professional Use Only: For use by Mold Remediation Workers, Mold Remediation Contractors, Certified Mold Remediators, Certified Mold Contractors, Certified Mold Remediation Contractors, Applied Microbial Remediation Technicians, Certified Mold Professional, Certified Restorers, and Mold Remediation Companies. Refer to http.//www.epa.gov/mold/mold_remediation Table 1 and 2 for Remediation Directions for Use 

1 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 m

placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7. 

72
VI. APPENDICES 

73
APPENDIX A: Master ADBAC Label 

EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

Industrial processes and water systems 

10324-21 Small Process Water 

Systems Re-circulating Cooling Tower Pour Metered 

Wear dust mist 

respirator when 

applying product to 

system 

795,000 ppm 

Initial = 39.8 ppm 

Maint.= 14.9 ppm 

10324-102 Small Process Water 

Systems 

Waste water treatment 

Evaporative condenser 

Pour 

Metered 

Wear dust mist 

respirator when 

applying product to 

system 

795,000 ppm 

Initial = 39.8 ppm 

Maint.= 14.9 ppm 

6836-58 Industrial Recirc Water 

Systems Pulp/Paper Metered 

Max appl. rate must 

be reduced to 14 lbs 

ai/ton of paper 

226 ppm 

10324-21 Industrial Water Systems Once-through Cooling Metered 

Do Not Apply This 

Product More Than 

4 Times Per Year 

Label must carry 

NPDES statement 

Initial = 10.6 ppm 

Maint.= 5.6 ppm 

Based on treatment 

of 153,000,000 

gallons of water 

6836-234 Small Process Water 

Systems Brewery pasteurizers Pour Metered 

Wear dust mist 

respirator when 

applying product to 

system 

795,000 ppm 

Initial = 39.8 ppm 

Maint.= 14.9 ppm 

1839-179 Oil Field 

injection and wastewater 

packer fluids 

drilling muds 

continuous 

injection 

batch 

treatment 

 119,000 ppm 

Swimming Pools 

1839-141 Swimming Pool/ Outside 

Spas/Whirlpools/Hot Tub Bath Pour 

Do not apply when 

swimmers are in the 

immediate vicinity 

(Allow 15 minute 

REI) 

Initial/Winter. = 6.2 

ppm 

Maint. = 1.2 ppm 

Aquatic Areas 

53642-1 

fountains, water displays, 

decorative pools, decorative 

ponds, sewage treatment 

systems, spas, standing water 

spray 

Refer to Table 13. 

Labeling Changes 

Summary Table 

p. 71 and 73 

203 ppm for 

Mosquito Control 

499-368 Greenhouse/Nurseries decorative pools, fountains, 

water displays pour 

Initial= 6.2 ppm 

Maint. = 1.2 ppm 

499-482 Greenhouse/Nurseries 

watering lines, watering tubes, 

emitters, drip lines, watering 

nozzles and hoses 

pour, 

immerse 

6.2 ppm 

Wood Preservatives 

6836-308 lumber 

Pressure 

Treatment 

Double 

vacuum 

Refer to Table 13. 

Labeling Changes 

Summary Table 

p. 68 

3% AI solution 

1839-184 lumber 

Dip/Brush/S 

pray surface 

treatment 

Refer to Table 13. 

Labeling Changes 

Summary Table 

p. 68 

3% AI solution 

74
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1839-184 lumber dip, spray 

Refer to Table 13. 

Labeling Changes 

Summary Table 

p.70 

3% AI solution for 

sapstsain control 

Agricultural Premise and Equipment 

10324-118 Animal facilities, 

hog/swine/poultry farms 

Floors, walls, ceilings, feed 

racks, mangers, troughs, 

automatic 

feeders/fountains/waterers, 

other feeding and watering 

appliances, halters, ropes and 

other types of equipment used 

in handling and restraining 

animals, as well as forks, 

shovels, and scrapers used for 

removing litter and manure, 

feeders, fountains, drinkers, 

blocks, chutes, incubators, 

hatchers, waterers, feeders, 

fountains, hauling equipment, 

loading equipment, kennels, 

runs, cages, coops, crates, 

pens, trays 

Fogging 

Wear a dust mist 

respirator when 

pouring product into 

fogging equipment 

0000675 lb ai/ 1000 

ft3 

1839-81 hatcheries hatchery rooms Fogging 

Wear a dust mist 

respirator when 

pouring product into 

fogging equipment 

2 hr reentry interval 

.0000675 lb ai/ 

1000 ft3 

10324-81 hatcheries incubators, setters, hatchers Fogging 

Wear a dust mist 

respirator when 

pouring product into 

fogging equipment 

67517-15 hatcheries egg shell sanitizing spray, 

immersion, 200 ppm 

1839-155 

Animal facilities, farms, 

mushroom farms, animal 

life science laboratories, 

animal quarters, other 

animal care facilities, 

hatcheries, stables, 

catteries, stalls, animal 

transportation vehicles 

Dairy/equine/hog/ swine/ 

poultry/turkey farms, 

barns, pens, egg receiving 

area, egg holding area, 

setter s, trays, chick 

holding room, poultry 

buildings, dressing plants, 

offal rooms, blocks, creep 

areas 

Floors, walls, ceilings, feed 

racks, mangers, troughs, 

automatic 

feeders/fountains/waterers, 

other feeding and watering 

appliances, halters, ropes and 

other types of equipment used 

in handling and restraining 

animals, as well as forks, 

shovels, and scrapers used for 

removing litter and manure, 

feeders, fountains, drinkers, 

blocks, chutes, incubators, 

hatchers, waterers, feeders, 

fountains, hauling equipment, 

loading equipment, kennels, 

runs, cages, coops, crates, 

pens, trays, shoes, gloves 

mop, 

immersion, 

cloth, 

sponge, 

spray

 2036 ppm 

10324-80 citrus grove or farm 

trucks, vehicles, equipment, 

trailers, field harvesting 

equipment, cargo area, wheels, 

tires, under carriage, hood, 

roof, fenders 

trigger spray, 

immersion, 

mopping 

2036 ppm 

Treat Citrus canker 

75
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1072-16 stables, dairies Dairy and Hoof trimming 

equipment 

cloth, mop, 

sponge, 

spray, 

immersion 

2036 ppm 

507-3 greenhouses, nurseries ornamental crops 

drench or 

spray 

Do Not Apply by 

Aerial Spray. 

Refer to Table 13. 

Labeling Changes 

Summary Table 

p. 71 

Spot Treatment 

max. rate of 800 

ppm 

Total Use = 

5 lbs AI/ acre 

507-3 greenhouses, nurseries gloves immersion 2036 ppm 

53642-1 greenhouses, nurseries 

work areas, benches, pots, 

flats, flower buckets, cutting 

tools, greenhouse glass, bird 

baths, walkways, houseplants 

Spray, 

mopping, 

Swab, 

immersion 

2036 ppm 

53642-1 greenhouses, nurseries lawns, golf courses, 

commercial turf Spray 

Commercial =Limit 

Treatment to 

“Greens and Tees” 

Retreatment at 10 

day intervals not to 

exceed 6 treatments 

per year 

Residential = Only 

Spot Treatment of 

diseased areas. 

Treatment repeated 

up to 6x a year at 10 

day intervals. 

Commercial = 200 

ppm not to exceed 

treatment of 10 

acres 

Residential = 800 

ppm not to exceed 

25 gallons per 1000 

sq. ft. 

499-368 greenhouses, nurseries cutting tools Immersion/ 

Spray/Wipe 2036 ppm 

499-368 greenhouses, nurseries evaporative coolers, cooler 

pads 

Spray or 

swab 2036 ppm 

Medical premises and equipment 

10324-111 

day-care centers, hospitals, 

medical/dental offices, 

nursing homes, other health 

care institutions, 

mortuaries, autopsy rooms, 

EMS facilities, medical 

research facilities, patient 

care rooms, recovery 

anesthesia rooms, operating 

rooms 

Metal, stainless steel, glazed 

porcelain, glazed ceramic tile, 

plastic, granite, marble, 

chrome, vinyl, glass, enameled 

surfaces, painted woodwork, 

Formica, plastic upholstery, 

floors, walls, toilets, urinals, 

lavatories, bathtubs, sinks, 

sink tops, shower stalls, 

shower doors/curtains, mirrors, 

ultrasonic bath, whirlpools, 

countertops, cabinets, tables, 

chairs, desks, bed springs, bed 

frames, traction devices, MRI, 

CAT, examining tables, scales, 

paddles, wheelchairs, lifts, 

door knobs, linen carts, 

hampers, telephones, fixtures, 

toys, high chairs, cribs, 

changing tables 

mop, pour, 

immersion 2080 ppm 

76
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1203-41 hospitals, nursing homes, 

clinics 

tables,walls, ceramic tiles, 

metal surfaces, plastic, asphalt, 

finished/painted wood and 

glass 

spray, mop, 

sponge 2080 ppm 

1839-81 Hospitals carpet 

Portable 

extraction 

units, truck 

mounted 

extraction 

machines, 

rotary floor 

machines, 

metered, 

spray 

16,800 ppm 

1839-110 hospital Laundry 

Pour @ final 

rinse in wash 

cycle 

0.10 lb AI/ 100 lbs 

dry laundry 

1839-81 autopsy rooms, funeral 

homes, 

human remains 

sponge, wash 

cloth, soft 

brush 

 2080 ppm 

62401-6 nursing homes 

walls, telephones, chairs, 

tables, sinks, counters, 

appliance exteriors, garbage 

cans, stovetops 

Presaturated 

wipe 2080 ppm 

7211-10 Medical Premises & 

Equipment critical instruments immersion 

Instruments must be 

sterilized after 

disinfection 

2490 ppm 

Commercial, institutional, and industrial premises and equipment 

10324-118 

hair/nail salons, barber 

beauty shops, tanning 

salons, tattoo parlors, 

veterinary clinics, locker 

facilities, shopping malls, 

motels, hotels, bookstores, 

dressing rooms, photo copy 

centers, bicycle shops, toy 

factories, computer 

manufacturing sites, burial 

vaults, mausoleums, jails, 

penitentiaries, 

transportation terminals, 

Cruise ships, airplanes, 

schools, universities, 

churches, libraries, 

cosmetic manufacturing 

facilities, medical device 

manufacturing facilities, 

pharmaceutical 

manufacturing facilities, 

bowling alleys, crime 

scenes, pet shops, 

grooming and breeding 

establishments, zoos, tack 

shops, atheletic facilities, 

Sport Arenas, 

floors, walls, toilets, urinals, 

bathrooms, bathtubs, sinks, 

countertops, shower 

doors/curtains, toilet seats, 

shower stalls, ultrasonic bath, 

whirlpools, barber/salon 

instruments/tools, tables, 

chairs, shelves, telephones, 

cabinets, desks, tanning beds, 

bed springs, door knobs, linen 

carts, hampers, garbage pails, 

telephones, recycling 

equipment, exercise 

equipment, personal safety 

equipment, automobile/truck 

interiors, garbage cans/pails, 

metal, stainless steel, glazed 

porcelain, glazed ceramic tile, 

plastic, granite, marble, 

chrome, vinyl, glass, chrome 

plated intakes, enameled 

surfaces, painted woodwork, 

Formica, vinyl and plastic 

upholstery, terrariums, cages, 

and cage furniture 

mop, wipe 

(cloth, 

swab), pour, 

immersion 

 2080 ppm 

77
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1839-81 manufacturing 

sites/facilities 

Floors, walls, counters, 

stainless steel, glazed 

porcelain, granite, vinyl, glass, 

chrome 

fogging 

Wear a dust mist 

respirator when 

pouring product into 

fogging equipment 

0000246 lb ai/ 1000 

ft3 

6836-193 

hair/nail salons, barber 

beauty shops, tanning 

salons, tattoo parlors, 

veterinary clinics, locker 

facilities, shopping malls, 

motels, hotels, bookstores, 

dressing rooms, photo copy 

centers, bicycle shopes, toy 

factories, computer 

manufacturing sites, burial 

vaults, mausoleums, jails, 

penitentiaries, 

transportation terminals, 

Cruise ships, airplanes, 

schools, universities, 

churches, libraries, 

cosmetic manufacturing 

facilities, medical device 

manufacturing facilities, 

pharmaceutical 

manufacturing facilities, 

bowling alleys, crime 

scenes, pet shops, 

grooming and breeding 

establishments, zoos, tack 

shops, atheletic facilities, 

Sport Arenas, 

hair/nail salons, barber beauty 

shops, tanning salons, tattoo 

parlors, veterinary clinics, 

locker facilities, shopping 

malls, motels, hotels, 

bookstores, dressing rooms, 

photo copy centers, bicycle 

shopes, toy factories, computer 

manufacturing sites, burial 

vaults, mausoleums, jails, 

penitentiaries, transportation 

terminals, Cruise ships, 

airplanes, schools, universities, 

churches, libraries, cosmetic 

manufacturing facilities, 

medical device manufacturing 

facilities, pharmaceutical 

manufacturing facilities, 

bowling alleys, crime scenes, 

pet shops, grooming and 

breeding establishments, zoos, 

tack shops, atheletic facilities, 

Sport Arenas, 

spray (RTU 

spray 2980 ppm 

1839-81 

hotels, motels, dressing 

romms, bowling alleys, 

salons, libraries, office 

buildings, schools, 

universities 

Carpet 

portable 

extraction 

units, truck 

mounted 

extraction 

machines, 

rotary floor 

machines, 

metered, 

spray 

16,800 ppm 

62401-6 schools, food service 

establishments 

telephones, walls, chairs, 

tables, sinks, counters, 

appliance exteriors, garbage 

cans, stovetops 

Presaturated 

wipe 2080 ppm 

1839-110 commercial laundry 

Pour @ final 

rinse in wash 

cycle 

0.10 lb AI/ 100 lbs 

dry laundry 

1839-81 

Florists/flower shops, 

greenhouses, shippers, 

packing areas 

flower buckets, coolers, floors 

and walls of coolers, design 

and packing benches, garbage 

pails 

Mop/wipe, 

cloth, brush, 

sponge, 

sprayer, 

RTU spray

 2036 ppm 

78
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1839-85 

hair/nail salons, barber 

beauty shops, tanning 

salons, tattoo parlors, 

veterinary clinics, locker 

facilities, shopping malls, 

motels, hotels, bookstores, 

dressing rooms, photo copy 

centers, bicycle shopes, toy 

factories, computer 

manufacturing sites, burial 

vaults, mausoleums, jails, 

penitentiaries, 

transportation terminals, 

Cruise ships, airplanes, 

schools, universities, 

churches, libraries, 

cosmetic manufacturing 

facilities, medical device 

manufacturing facilities, 

pharmaceutical 

manufacturing facilities, 

bowling alleys, crime 

scenes, pet shops, 

grooming and breeding 

establishments, zoos, tack 

shops, atheletic facilities, 

Sport Arenas, 

air deodorizer/air freshener RTU spray 0.2% ai by weight 

32977-1 schools and music studios wind instruments Immersion 596 ppm 

507-3 industrial premises gloves Immersion 2036 ppm 

Residential and public access premises 

10324-111 RVs, motor homes RV Holding Tank Pouring 0.834 lb ai/gal 

6836-193 

Households, campgrounds, 

playgrounds, picnic 

facilities, recreational 

facilities, other public 

facilities 

Floors, walls, windows, toilets, 

bathtubs, whirlpools, shower 

stalls, shower door/curtain, 

sinks, mirrors, restroom 

fixtures, cabinets, tables, 

chairs, desks, bed frames, 

doorknobs, garbage cans/pails, 

picnic tables, outdoor 

furniture, telephones, 

countertops, external surfaces 

of appliances, tables, sinks, 

shelves, plastic chopping 

blocks, metal, stainless steel, 

glazed porcelain, glazed 

ceramic tile, plastic, granite, 

marble, chrome, vinyl, glass, 

chrome plated intakes, 

enameled surfaces, painted 

woodwork, Formica, vinyl, 

plastic upholstery, terrariums, 

cages, and cage furniture 

RTU 

spray/mop 2980 ppm 

79
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1839-68 homes Carpet 

portable 

extraction 

units, truck 

mounted 

extraction 

machines, 

rotary floor 

machines, 

metered, 

spray 

16,680 ppm 

1839-85 homes air deodorizer/air freshener RTU spray 0.2% a.i. by weight 

32977-1 Homes Musical instrument 

mouthpieces and reeds immersion 596 ppm 

1839-110 Homes Laundry 

Pour @ final 

rinse in wash 

cycle 

0.10 lb AI/ 100 lbs 

dry laundry 

1839-155 homes water softeners and reverse 

osmosis units Liquid Pour 200 ppm 

Food handling/storage establishments premises and equipment 

Disinfect 

2080 ppm 

40 CFR 180.940 

(a) 

200 ppm 

Public Eating 

Places, Dairy 

Processing 

Equipment, FoodProcessing 

Equipment and 

Utensils 

10324-111 

restaurants, bars, 

supermarket, convenience 

stores, pizza parlors, meat 

and poultry processing 

plants, rendering plants, 

fish, milk, wine, citrus 

processing facilities, 

institutional kitchens, food 

storage areas, tobacco 

processing facilities, ood 

service establishments, 

food processing 

plants/facilities, beverage 

processing plants, 

Cafeterias, Dairies, Egg 

Processing plants, 

Federally inspected meat 

and poultry plants, Food 

Handling areas, Food 

preparation areas, Food 

storage areas, USDA 

inspected food processing 

facilities, breweries, fast 

food operations 

floors, walls, countertops, 

appliances (microwaves, 

refrigerators, stove tops, 

freezers, coolers), chairs, 

tables, shelves, picnic tables, 

outdoor furniture, racks, carts, 

telephones, door knobs, 

storage areas, potato storage 

areas, food storage areas, 

garbage storage areas, cutting 

boards, tanks, exhaust fans, 

refrigerator bins, refrigerated 

storage/display equipment, 

coils and drain pans of air 

conditioning/refrigeration 

equipment, heat pumps, 

storage tanks, coolers, ice 

chests, garbage cans/pails 

metal, stainless steel, glazed 

porcelain, glazed ceramic tile, 

plastic, granite, marble, 

chrome, vinyl, glass, chrome 

plated intakes, enameled 

surfaces, painted woodwork, 

Formica, vinyl and plastic 

upholstery 

mop, wipe 

(cloth, 

swab), pour, 

immersion 

mop, (cloth, 

swab), pour, 

immersion 

40 CFR 180.940 

(c) 

400 ppm 

Food Processing 

Equipment and 

Utensils 

507-3 dairies and food processing 

plants gloves Immersion 2036 ppm 

80
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

1839-86 

federally inspected meat 

and poultry plants, food 

processing facilities, 

dairies, tobacco processing 

facilities, beverage 

processing facilities 

Shoe 

immersion/ 

foam 

generating 

machine/ 

aerator 

 2036 ppm 

6836-193 

(Disinfect) 

restaurants, bars, 

supermarket, convenience 

stores, pizza parlors, meat 

and poultry processing 

plants, rendering plants, 

fish, milk, wine, citrus 

processing facilities, 

institutional kitchens, food 

storage areas, tobacco 

processing facilities, ood 

service establishments, 

food processing 

plants/facilities, beverage 

processing plants, 

Cafeterias, Dairies, Egg 

Processing plants, 

Federally inspected meat 

and poultry plants, Food 

Handling areas, Food 

preparation areas, Food 

storage areas, USDA 

inspected food processing 

facilities, breweries, fast 

food operations 

floors, walls, countertops, 

appliances (microwaves, 

refrigerators, stove tops, 

freezers, coolers), chairs, 

tables, shelves, picnic tables, 

outdoor furniture, racks, carts, 

telephones, door knobs, 

storage areas, potato storage 

areas, food storage areas, 

garbage storage areas, cutting 

boards, tanks, exhaust fans, 

refrigerator bins, refrigerated 

storage/display equipment, 

coils and drain pans of air 

conditioning/refrigeration 

equipment, heat pumps, 

storage tanks, coolers, ice 

chests, garbage cans/pails 

metal, stainless steel, glazed 

porcelain, glazed ceramic tile, 

plastic, granite, marble, 

chrome, vinyl, glass, chrome 

plated intakes, enameled 

surfaces, painted woodwork, 

Formica, vinyl and plastic 

upholstery 

RTU Spray 2036 ppm 

40 CFR 180.940 

(a) 

200 ppm 

Public Eating 

Places, Dairy 

Processing 

Equipment, FoodProcessing 

Equipment and 

Utensils 

1839-155 

Restaurants, Food Service 

Establishments, Bars, 

Cafeteria, Convenience 

Stores, Dairies, Food 

Handling Areas, Food 

Preparation Areas, Food 

Storage Areas Institutional 

Kitchens, Fast Food 

Operations 

dairy equipment, dairy farm 

bulk milk tanks, milking 

equipment, tanks, piping, 

pasteurizers, cow udders, dairy 

product dispensing equipment, 

drinking glasses, eating 

utensils, cooking utensils, 

silverware, glassware, dishes, 

ice machines, beverage 

dispensing equipment, 

counters, tables, cutting 

boards, Slurrpy machines, ice 

cream dispensing equipment, 

food dispensing equipment, 

utensils and other food contact 

articles 

spray, flood, 

immersion, 

brushing, 

RTU spray 

40 CFR 180.940 

(c) 

400 ppm 

Food Processing 

Equipment and 

Utensils 

1839-155 Food processing plants, 

food service establishments 

water softeners and reverse 

osmosis units 200 ppm 

81
EPA Reg 

Number 

used for 

Max. Appl. 

Rate 

Use Site Treatment Site/Surfaces Method of 

Application Mitigation 

Maximum 

Application 

Rate 

10324-118 dairies, beverage and food 

processing plants room surfaces fogging 

Wear a dust mist 

respirator when 

pouring product into 

fogging equipment 

2 hr reentry interval 

Minimum of 4 air 

exchanges per hour 

.0000027 lb ai/ 

1000 ft3 

1203-41 

food processing plants, 

food service areas, 

institutional kitchens, 

industrial/hospital 

cafeterias, school 

lunchrooms, canning 

plants, dairies, and packing 

plants 

tables, walls, ceramic tiles, 

metal surfaces, plastic, asphalt, 

finished/painted wood and 

glass 

Spray, mop, 

sponge 

 2080 ppm 

Cleaning/ Deodorizing 

1839-81 

Water/Smoke restoration 

(institutional, industrial, 

hospital, nursing home) 

carpets, carpet cushion, sub 

floors, drywall, trim, farm 

lumber, tackless strip and 

paneling 

Mop, cloth, 

brush, 

sponge, 

sprayer 

Refer to Table 13 

(Label Changes 

Summary Table) for 

appropriate label 

restrictions 

16,800 ppm 

10324-118 Sewer backup/river flood 

cleanup/clean water source 

carpets, carpet cushion, sub 

floors, drywall, trim, farm 

lumber, tackless strip and 

paneling 

spray 

Refer to Table 13 

(Label Changes 

Summary Table) for 

appropriate label 

restrictions 

16,800 ppm 

10324-118 residential, commercial, 

institutional, industrial, 

garbage cans, garbage trucks, 

industrial waste receptacles, 

garbage handling equipment 

sprayer, 

sponge, 

cloth,

 2036 ppm 

82
Appendix B. Table of Generic Data Requirements and Studies Used to Make the 

Reregistration Decision 

Guide to Appendix B 

Appendix B contains listing of data requirements which support the reregistration for 

active ingredients within case #0350 (ADBAC) covered by this RED. It contains generic data 

requirements that apply to ADBAC in all products, including data requirements for which a 

“typical formulation” is the test substance. 

The data table is organized in the following formats: 

1. Data Requirement (Column 1). The data requirements are listed in the order in 

which they appear in 40 CFR part 158. The reference numbers accompanying each test refer to 

the test protocols set in the Pesticide Assessment Guidance, which are available from the 

National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 

487-4650. 

2. Use Pattern (Column 4). This column indicates the use patterns for which the 

data requirements apply. The following letter designations are used for the given use patterns. 

(1) Agricultural premises and equipment 

(2) Food handling/ storage establishments, premises, and equipment 

(3) Commercial, institutional and industrial premises and equipment 

(4) Residential and public access premises 

(5) Medical premises and equipment 

(6) Human water systems 

(7) Materials preservatives 

(8) Industrial processes and water systems 

(9) Antifouling coatings 

(10) Wood preservatives 

(11) Swimming pools 

(12) Aquatic areas 

3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, 

this column list the identify number of each study. This normally is the Master Record 

Identification (MRID) number, but may be a “GS” number if no MRID number has been 

assigned. Refer to the Bibliography appendix for a complete citation of the study. 

83
APPENDIX B 

Data Supporting Guideline Requirements for the Reregistration of ADBAC 

PRODUCT CHEMISTRY New Guideline Number 

Old Guideline Number 

Use Pattern Citation 

830.1550 61-1 Product Identity and Composition All 4446702 830.1600 61-2A Start. Mat. & Mnfg. Process All 4446702 830.1670 61-2B Formation of Impurities All 44467401 830.1700 62-1 Preliminary Analysis All 4446702 830.1750 62-2 Certification of limits All 4446702 830.1800 62-3 Analytical Method All 4446702 830.6302 63-2 Color All 44467403 830.6303 63-3 Physical State All 44467403 830.6304 63-4 Odor All 44467403 830.7050 None UV/Visable Absorption All 44467403 830.7200 63-5 Melting Point All 44467403 830.7220 63-6 Boiling Point All 44467403 

84
New 

Guideline Number 

Old Guideline Number 

Use Pattern Citation 

830.7300 63-7 Density All 44467403 830.7840 830.7860 63-8 Solubility All 44467403 830.7950 63-9 Vapor Pressure All 44467403 830.7370 63-10 Dissociation Constant All N/A 830.7550 63-11 Octanol/Water Partition Coefficient All 44467403 830.7000 63-12 pH All 44467403 830.6313 63-13 Stability All 44467403 830.6314 63-14 Oxidizing/Reducing Action All N/A 830.6315 63-15 Flammability All 44467403 830.6316 63-16 Explodability All N/A 830.6317 63-17 Storage Stability All 44467403 830.7100 63-18 Viscosity All 44467403 830.6319 63-19 Miscibility All N/A 830.6320 63-20 Corrosion characteristics All 44467403 

85
ECOLOGICAL EFFECTS

New Guideline Number 

Old Guideline Number 

Use Pattern Citation 

850.2100 71-1 Avian Acute Oral Toxicity All 42885901 850.2100 71-1 Avian Acute Oral Toxicity All 42885901 850.2200 71-2B Avian Dietary Toxicity – Duck Wood Preservation, Sapstain, 

Ornamental Nurseries, Turf, Once Through Cooling Water 

850.2300 

Avian Reproduction (Mallard or 

Bobwhite) 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

850.2400 71-3 Wild Mammal Toxicity Wood Preservation, Sapstain, 

Ornamental Nurseries, Turf, Once Through Cooling Water 

Refer to Tox

850.1075 72-1A Fish Toxicity Bluegill All 41947201 850.1075 72-1C Fish Toxicity Rainbow Trout All 41947202 850.1010 72-2A Aquatic Invertebrate Toxicity All 41947203 None 72-3A Estuarine/Marine Toxicity - Fish 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

42479502 

850.1055 72-3B

 Estuarine/Marine Toxicity - (Eastern Oyster embryo larvae) 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water Data Gap 

None 72-3C Estuarine/Marine Toxicity - Shrimp 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

42479501 

None 72-4A Fish- Early Life Stage 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

42302102 

86
New 

Guideline Number 

Old Guideline Number 

Use Pattern Citation 

850.1300 72-4 Aquatic Invertebrate Life Cycle- Daphnia 

magna 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

Data Gap 

850.440 123-2 Aquatic Plant Growth – Lemna gibba 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

Data Gap 

850.5400 123-2 Aquatic Plant Growth (4 species) Green 

alga (Pseudokerschneria subcapitatum), blue-green alga (Anabaena flos-aquae), freshwater diatom (Navicula sps.), and marine diatom (Skeletonema costatum) 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

Data Gap 

850.4225 123-1 Non-target Terrestrial Plant Phytotoxicity 

(seedling emergence test using rice) 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

Data Gap 

850.4250 123-1 Non-target Terrestrial Plant Phytotoxicity 

(Vegetative vigor using rice) 

Wood Preservation, Sapstain, Ornamental Nurseries, Turf, Once Through Cooling Water 

Data Gap 

850.3020 141-1 Honey Bee Acute Contact Wood Preservative Data Gap 850.1950 Aquatic Field Monitoring (Once-Through 

Cooling Water Towers) 

Once Through Cooling Water Data Gap 

TOXICOLOGYNew Guideline Number 870.1100 

Old Guideline Number 

81-1 Acute Oral Toxicity-Rat 

Use Pattern 

All 

Citation 

45109204 

87
New 

Guideline Number 

Old Guideline Number 

Use Pattern Citation 

870.1200 81-2 Acute Dermal Toxicity-Rabbit/Rat All 45109202 870.1300 81-3 Acute Inhalation Toxicity-Rat All 44885201 870.2400 81-4 Primary Eye Irritation-Rabbit All 40919701, 44825870.2500 81-5 Primary Skin Irritation All 45109201 870.2600 81-6 Dermal/Photo- Sensitization All 45109203, 40958

44825002 

870.3100 82-1A Oral Subchronic - Rat All 40746601 870.3200 82-2 21-Day Dermal – Guinea Pig ? 41105801 870.3250 82-3 90-Day Dermal – Rat All 41499601 870.3465 82-4 90-Day Inhalation – Rat All Data Gap 870.3700 (a) 83-3A Developmental Toxicity - Rat All 42351501 870.3700 (b) 83-3B Developmental Toxicity - Rabbit Swimming pool & Wood 

Preservative 

42392801 

870.3800 83-4 2-Generation Reproduction - Rat Indirect Food 41385001 870.4100 83-1B Chronic Feeding Toxicity –Non Rodent Indirect Food 43221101 870.4200(b) Oncogenicity –Mouse Swimming pool & Wood 

preservative 

41765201 

870.4300 83-5 Combined Chronic Toxicity/ Carcinogenicity Swimming pool & Wood 

preservative 

41947501 

88
New 

Guideline Number 

Old Guideline Number 

Use Pattern Citation 

870.5300 870.5385 

84-2A 84-2B 

Gene Mutation (Ames Test) Structural Chromosomal Aberration 

All All 

41012701 40311101 

870.5550 84-4 Unscheduled DNA Synthesis All 42290801, 42290870.7485 85-1 General Metabolism Indirect Food 40990701 OCCUPATIONAL and RESIDENTIAL EXPOSURE New Guideline Number 

Old Guideline Number 

Use Pattern Citation 

875.2800 133-1 Description of Human Activity All Data Gap 875.1100 875.1200 875.1600 

231 233 236 

Outdoor/Indoor Dermal Exposure All 417426-01, 425875-01 

875.1300 875.1400 875.1600 

232 234 236 

Outdoor/Indoor Inhalation Exposure All 455021101, 455243-04 

Special Study Surface Wood Wipe Study Wood 

Preservative 

Data Gap 

89
ENVIRONMENTAL FATE

New Guideline Number 

Old Guideline Number 

Use Pattern Citation 

835.2120 161-1 Hydrolysis All 408356-02 835.2240 161-2 Photodegradation - Water Wood Preservative 40835603 835.4400 162-3 Anaerobic Aquatic Metabolism 

 Once Through Cooling Water Wood Preservative 41105501, 42415

835.4300 162-4 Aerobic Aquatic Metabolism 

Once Through Cooling Water Wood Preservative 40835604 

835.1240 163-1 Leaching/Adsorption/Deadsorption Wood Preservative 40835605, 42414None 165-4 Bioaccumulation in Fish Wood Preservative 41026801 Special Study Biodegradability Not Required 46865601 RESIDUE CHEMISTRYNew Guideline Number 

Old Guideline Number 

860.1480 171-4J Special Study 

Magnitude of Residues ­Meat/Milk/Poultry /Egg Dietary Residues in Food from Treating Countertops with ADBAC (FDA Wipe Study Methodology) 

Use Pattern 

Indirect Food Indirect Food 

Citation 

FDA, 2003. “Sanitizing Chemistry for food Add

Http://www.cfasan.fda.cg3a Last accessed Jun

Data Gap 

90
Appendix C. Technical Support Documents 

Additional documentation in support of this RED is maintained in the OPP docket, 

located in Room S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive, 

Arlington, VA 22202. It is open Monday through Friday, excluding legal holidays, from 8:30 

am to 4 pm. 

The docket initially contained the April 18, 2006 preliminary risk assessment and the 

related documents. EPA then considered comments on these risk assessments (which are posted 

to the e-docket) and revised the risk assessments. The revised risk assessments will be posted in 

the docket at the same time as the RED. 

All documents, in hard copy form, may be viewed in the OPP docket room or 

downloaded or viewed via the Internet at the following sites: 

http://www.epa.gov/pesticides/antimicrobials 

http:/www.regulations.gov 

These documents include: 

1. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Risk Assessment, 8/1/06 

2. Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision 

(RED) Risk Assessment Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC), 

8/10/06 

3. Dietary Risk Assessment for Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) for Reregistration Eligibility Decision (RED) Process, 7/27/06 

4. Ecological Hazard and Environmental Risk Assessment of ADBAC for the 

Reregistration Eligibility Document (RED) – Antimicrobial Uses, 8/2/06 

5. PDM4 Modeling of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in 

Once-Through Industrial Water Systems, 8/2/06 

6. Ecological Risk Assessment in Support of the Antimicrobials Division’s 

Reregistration of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) & 

Didecyl Dimethyl Ammonium Chloride (DDAC)-Agricultural Uses, 2/3/06 

7. Tier 1 Drinking Water Assessment for Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) & Didecyl Dimethyl Ammonium Chloride (DDAC), 1/23/06 

8. Environmental Fate Assessment of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) for the Reregistration Eligibility Decision (RED) Document, 7/27/06 

91
9. Incident Reports Associated with Quaternary Ammonium Compounds (Quats), 

2/15/06 

10. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Occupational and 

Residential Exposure Assessment – Antimicrobial Uses, 7/27/06 

11. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC): Occupational and 

Residential Exposure Assessment for the Reregistration Eligibility Decision 

Document – Agricultural Uses, 7/31/06 

12. Appendix A Standard Methods for Calculating Occupational Exposures to 

ADBAC, 7/31/06 

13. Product Chemistry Science Chapter for Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC), 1/11/06 

14. Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)- Report of the 

Antimicrobials Division Toxicity Endpoint Committee (ADTC) and the Hazard 

Identification Assessment Review Committee (HIARC), 8/10/06 

92
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 Reregistration 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
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
BIBLIOGRAPHY 

MRID# CITATIONS 

40311101 Kallersen, T. (1985) Assessment of the Mutagenic Activity of Hyamine 

3500 in the Mouse Micronucleus Test: Lab. No. 10753. Un- published 

study prepared by Scantox Labs Ltd. 17 p. 

40746601 Van Miller, J.; Weaver, E. (1988) Ninety-day Dietary Toxicity Study with 

Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in Rats: Project 

ID: 51-503. Unpublished study prepared by Bushy Run Re- search Center. 

300 p. 

40835602 Carpenter, M. and M. Fennessey. 1988. Hydrolysis of ADBAC as a 

function of pH at 25°. ABC Amended Final Report # 35712. 

Unpublished study performed by Analytical Bio-Chemistry Laboratories, 

Inc., Columbia, MO, and submitted by Chemical Specialties 

Manufacturers Association, Washington, DC. 

40835603 Carpenter, M. and M. Fennessey. 1988. Determination of the photolysis 

rate of ADBAC in pH 7 buffered solution at 25° C. ABC Final Report 

#35713. Unpublished study performed by Analytical Bio-Chemistry 

Laboratories, Inc., Columbia, MO, and submitted by Chemical Specialties 

Manufacturers Association, Washington, DC. 

40835604 Daly, D. and W. Cranor. 1988. Aerobic aquatic metabolism of alkyl 

dimethyl benzyl ammonium chloride. ABC Final Report #35715. 

Unpublished study performed by Analytical Bio-Chemistry Laboratories, 

Inc., Columbia, MO, and submitted by Chemical Specialties 

Manufacturers Association, Washington, DC. 

40835605 Daly, D. and W. Cranor. 1992. Soil/Sediment Adsorption-Desorption of 

Alkyl Dimethyl Ammonium Chloride. Performed by ABC Laboratories, 

Inc., Columbia, Missouri. Submitted by ADBAC Joint Venture/Chemical 

Specialties Manufacturers Association, Washington, DC. 

40919701 Kreuzmann, J. (1988) Repeated Eye Instillation Study in Rabbits: Alkyl 

dimethyl benzyl ammonium chloride (ADBAC): Study No.: 88- 3336-21. 

Unpublished study prepared by Hill Top Biolabs, Inc. 20 p 

40958501 Kreuzmann, J. (1989) Photoallergy Study in Guinea Pigs: Study No. 88­

3226-21. Unpublished study prepared by Hill Top Biolabs, Inc. 63 p. 

40990701 Selim, S. (1989) Absorption, Distribution, Metabolism and Excretion 

Studies of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in the 

95
BIBLIOGRAPHY 

MRID# CITATIONS 

Rat: BTC Study No. P01359. Unpublished study prepared by Biological 

Test Center. 247 p. 

41012601 Cifone, M. (1989) Mutagenicity Test on Alkyl Dimethyl Benzyl 

Ammonium Chloride: In the Rat Primary Hepatocyte Unscheduled DNA 

Synthesis Assay: HLA Study No. 10238-0-447. Unpublished study 

prepared by Hazleton Laboratories America, Inc. 56 p. 

41012701 Young, R. (1989) Mutagenicity Test on Alkyl Dimethyl Benzyl 

Ammonium Chloride: In the CHO/HGPRT Forward Mutation Assay: 

HLA Study No. 10238-0-435. Unpublished study prepared by Hazleton 

Laboratories America, Inc. 67 p. 

41026801 Flacker, P. 1989. Bioconcentration and elimination of 14C-residues by 

bluegill (Lepomis macrochirus) exposed to alkyl dimethyl benzyl 

ammonium chloride (ADBAC). Study No. 11572-0287-6103-140B, 

Report No. 89-1-2921. Unpublished study performed by Springborn Life 

Sciences, Inc., Wareham, MA, and submitted by ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Assoc., Washington, DC. 

41087701 Lin, P.; Selim, S. (1989) Addendum to Report Entitled "Absorption, 

Distribution, Metabolism and Excretion Studies of Alkyl Dimethyl Benzyl 

Ammonium Chloride (ADBAC) in the Rat" 40990701: Study No. 

P01359. Unpublished study prepared by Biological Test Center. 44 p. 

41105801 Rose, G. (1989) Acute Toxicology (EP): HS-Sanitizing Carpet Shampoo: 

Project ID: B6-27. Unpublished study prepared by Envirocon. 36 p. 

41105501 Daly, D. and W. Cranor. 1989. Anaerobic aquatic metabolism of alkyl 

dimethyl benzyl ammonium chloride. ABC Amended Final Report 

#35714. Unpublished study performed by Analytical Bio-Chemistry 

Laboratories, Inc., Columbia, MO, and submitted by ADBAC Joint 

Venture/Chemical Specialties Manufacturers Association, Washington, 

DC. 

41385001 Neeper-Bradley, T. (1990) Two-generation Reproduction Study in 

Sprague-Dawley (CD) Rats with Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) Administered in the Diet: Project Report 52- 52-254: 

Project Nos. 87-37-97105; 87-37-97109. Unpublished study prepared by 

Bushy Run Research Center. 492 p. 

96
BIBLIOGRAPHY 

MRID# CITATIONS 

41499601 Gill, M.; Wagner, C. (1990) Ninety-day Subchronic Dermal Toxicity 

Study with Alkyl Dimethyl Benzyl Ammonium Chloride (ABDAC) in 

Rats: Lab Project I.D.: 52-623. Unpublished study prepared by Union 

Carbide Bushy Run Research Center. 264 p. 

41765201 Gill, M.; Hermansky, S.; Wagner, C. (1991) Chronic Dietary 

Oncogenicity Study with Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) in Mice: Lab Project Number: 53-515. Unpublished study 

prepared by Bushy Run Research Center. 1083 p. 

41947501 Gill, M.; Hermansky, S.; Wagner, C. (1991) Chronic Dietary 

Toxicity/Oncogenicity Study with Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) in Rats: Lab Project Number: 53-543. Unpublished 

Study prepared by Bushy Run Research Center. 1671 p. 

41947201 Pate, H.O. and D.O. McIntyre. 1991. Daily Static-Renewal Acute 96­

Hour Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) to Bluegill Sunfish. Study No. SC890050. Unpublished data. 

Conducted by Battelle Columbus Division for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

41947202 Pate, H.O. and D.O. McIntyre. 1991. Daily Static-Renewal Acute 96­

Hour Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) to Rainbow Trout. Study No. SC890051. Unpublished data. 

Conducted by Battelle Columbus Division for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

41947203 Pate, H.O. and D.O. McIntyre. 1991. Daily Static-Renewal Acute 48­

Hour Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) to Daphnia magna. Study No. SC 890052. Unpublished data. 

Conducted by Battelle Columbus Division for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

42290801 McKeon, M. (1992) Genotoxicity Test on Alkyl Dimethyl Benzyl 

Ammonium Chloride (ADBAC) in the Assay for Unscheduled DNA 

Synthesis in Rat Liver Primary Cell Cultures: Lab Project Number: 14778­

0-447. Unpublished study prepared by Hazleton Washington, Inc. 51 p. 

42290802 McKeon, M. (1989) Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) in the Rat Primary Hepatocyte Unscheduled DNA Synthesis 

97
BIBLIOGRAPHY 

MRID# CITATIONS 

Assay: An Addendum: Lab Project Number: 10238-0-447. Unpublished 

study prepared by Hazleton Laboratories America, Inc. 11 p. 

42302101 McIntyre, D.O. and H.O. Pate. 1992. Daily Static-Renewal Chronic 21­

Day Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) to Daphnia magna. Study No. SC890056. Unpublished data. 

Conducted by Battelle Columbus Division for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

42302102 McIntyre, D.O. and H.O. Pate. 1992. Daily Static-Renewal Early Life 

Stage Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) to Fathead Minnows. Project No. SC890057. Unpublished 

data. Conducted by Battelle Columbus Operations for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

42351501 Neeper-Bradley, T. (1992) Developmental Toxicity Evaluation II of Alkyl 

Dimethyl Benzyl Ammonium Chloride (ADBAC) Administered by 

Gavage to CD Rats: Lab Project Number: 91N0031. Unpublished study 

prepared by Union Carbide Chemicals and Plastics Co., Inc. Bushy Run 

Research Center. 281 p 

42392801 Neeper-Bradley, T.; Kubena, M. (1992) Developmental Toxicity 

Evaluation of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) 

Administered by Gavage to New Zealand White Rabbits: Lab Project 

Number: 91N0032. Unpublished study prepared by Union Carbide. 179 p. 

42414801 Daly, D. and W. Cranor. 1992. Soil/Sediment Adsorption-Desorption of 

Alkyl Dimethyl Ammonium Chloride. Supplement in support of # 

408356-05. Performed by ABC Laboratories, Inc., Columbia, Missouri. 

Submitted by ADBAC Joint Venture/Chemical Specialties Manufacturers 

Association, Washington, DC. 

42414901 Daly, D. and W. Cranor. 1992. Aerobic metabolism of alkyl dimethyl 

benzyl ammonium chloride. Supplement in support of # 408356-04. 

Performed by ABC Laboratories, Inc., Columbia, Missouri. Submitted by 

ADBAC Joint Venture/Chemical Specialties Manufacturers Association, 

Washington, DC. 

42415101 Daly, D. and W. Cranor. 1989. Anaerobic aquatic metabolism of alkyl 

dimethyl benzyl ammonium chloride. ABC Amended Final Report 

#35714. Supplement in support of # 411055-01. Unpublished study 

98
BIBLIOGRAPHY 

MRID# CITATIONS 

performed by Analytical Bio-Chemistry Laboratories, Inc., Columbia, 

MO, and submitted by ADBAC Joint Venture/Chemical Specialties 

Manufacturers Association, Washington, DC. 

42415102 Daly, D. and W. Cranor. 1992. Anaerobic metabolism of alkyl dimethyl 

benzyl ammonium chloride. Supplement in support of # 411055-01. 

Performed by ABC Laboratories, Inc., Columbia, Missouri. Submitted by 

ADBAC Joint Venture/Chemical Specialties Manufacturers Association, 

Washington, DC. 

42415201 Carpenter, M. and M. Fennessey. 1992. Determination of the photolysis 

rate of ADBAC in pH 7 buffered solution at 25° C. Supplement in 

support of # 408356-03. Performed by ABC Laboratories, Inc., Columbia, 

Missouri. Submitted by ADBAC Joint Venture/Chemical Specialties 

Manufacturers Association, Washington, DC. 

42479502 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 96-Hour StaticRenewal Acute Toxicity Test with Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) in the Sheepshead Minnow (Cyprinodon variegatus). 

Project No. 350A-102. Unpublished data. Conducted by Wildlife 

International Ltd. for ADBAC Quat Joint Venture/Chemical Specialties 

Manufacturers Association. 

42479503 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 48-Hour Static Acute 

Toxicity Test with Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) in Embryo Larvae of the Eastern Oyster (Crassostrea 

virginica). Unpublished data. Conducted by Wildlife International Ltd. 

for ADBAC Quat Joint Venture/Chemical Specialties Manufacturers 

Association. 

42479501 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 96-Hour StaticRenewal Acute Toxicity Test with Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) in the Saltwater Mysid (Mysidopsis bahia). Project 

No. 350A-101A. Unpublished data. Conducted by Wildlife International 

Ltd. for ADBAC Quat Joint Venture/Chemical Specialties Manufacturers 

Association. 

42479502 Sved, D.W., J.P. Swigert, and G.J. Smith. 1992. A 96-Hour StaticRenewal Acute Toxicity Test with Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) in the Sheepshead Minnow (Cyprinodon variegatus). 

Project No. 350A-102. Unpublished data. Conducted by Wildlife 

99
BIBLIOGRAPHY 

MRID # CITATIONS 

International Ltd. for ADBAC Quat Joint Venture/Chemical Specialties 

Manufacturers Association. 

42645101 Chun, J.; Fisher, L. (1993) Developmental Toxicity Dose Rang-Finding 

Study of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) 

Administered by Gavage to CD Rats: Lab Project Number: 54-613. 

Unpublished study prepared by Bushy Run Research Center (BRRC). 104 

p. 

42734401 Chun, J.; Neeper-Bradley, T. (1993) Developmental Toxicity Dose RangeFinding Study of ADBAC Administered by Gavage to New Zealand 

White Rabbits: Lab Project Number: 54-603. Unpublished study prepared 

by Union Carbide. 118 p. 

42885901 Campbell, S.M. and M. Jaber. 1993. An Acute Oral Toxicity Study with 

Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) in the Northern 

Bobwhite Quail. Project No. 289-109. Unpublished data. Conducted by 

Wildlife International Ltd. for Lonza, Inc. 

43037701 Schoenig, G. (1993) Response to EPA Data Evaluation Review for Study 

Entitled: "Chromosome Aberrations in vivo--Mouse Micronucleus Test": 

Lab Project Number: 10753. Unpublished study prepared by SCANTOX 

Biologisk Laboratorium A/S. 7 p. 

43221101 Goldenthal, E. (1994) Evaluation of ADBAC in a One-Year Chronic 

Dietary Toxicity Study in Dogs: Lab Project Number: 638-004. 

Unpublished study prepared by International Research and Development 

Corp. 355 p. 

43731101 England, D.C. and T. Leak. 1995. Chronic Toxicity of SedimentIncorporated ADBAC to Chironomus tentans. Project No. 41004. 

Unpublished data. Conducted by ABC Laboratories, Inc. for ADBAC 

Quat Joint Venture/Chemical Specialties Manufacturers Association. 

43740101 Sword, M.C. and L. Stuerman. 1993. Static-Renewal Acute Toxicity of 

ADBAC to Fathead Minnow (Pimephales promelas) in Dilution Water 

Amended with 20 mg/L Humic Acid. Study No. 41235. Unpublished 

data. Conducted by ABC Laboratories, Inc. for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

43740102 Sword, M.C. and L. Stuerman. 1993. Static-Renewal Acute Toxicity of 

ADBAC to Fathead Minnow (Pimephales promelas) in Dilution Water 

100
BIBLIOGRAPHY 

MRID# CITATIONS 

Amended with 10 mg/L Humic Acid. Study No. 41236. Unpublished 

data. Conducted by ABC Laboratories, Inc. for ADBAC Quat Joint 

Venture/Chemical Specialties Manufacturers Association. 

43740103 Sword, M.C. and L. Stuerman. 1993. Static-Renewal Acute Toxicity of 

ADBAC to Fathead Minnow (Pimephales promelas). Study No. 41237. 

Unpublished data. Conducted by ABC Laboratories, Inc. for ADBAC 

Quat Joint Venture/Chemical Specialties Manufacturers Association. 

44467401 Albemarle BQ1416-8 Biocide--Product Chemistry, (1998) Albemarle 

Corp., Lab Project Number 8382-141 Quat 6, Albemarle Corporation. 

44467402 Tolbert, A., Product Chemistry Chemical Characterization for 

Determining Identity and Purity of 80% n-Alkyl (60% C14, 30 % C16, 5 % 

C12, 5% C18) Dimethyl Benzyl Ammonium Chloride, (1998), Lab Project 

Number Quat 6B, Albemarle Corporation. 

44467403 Tolbert, A., Product Chemistry Chemical Characterization for 

Determining the Physical and Chemical Properties, and Accelerated 

Storage Stability of 80% n-Alkyl (60% C14, 30 % C16,5 % C12, 5% C18) 

Dimethyl Benzyl Ammonium Chloride, (1998), Lab Project Number Quat 

6A, Albemarle Corporation. 

44783401 Mazur, P. (1999) Absorption, Distribution, Metabolism and Excretion 

(ADME) Studies of Alkyl Dimethyl Benzyl Ammonium Chloride 

(ADBAC) in the Rat and Addendum: Lab Project Number: P01359. 

Unpublished study prepared by ADBAC Quat Joint Venture/Chemical 

Specialities Manufacturers Assoc. 4 p. 

44825001 Kreuzmann, J. (1999) Repeated Eye Instillation Study in Rabbits of Alkyl 

Dimethyl Benzyl Ammonium Chloride (ADBAC): Report Amendment: 

Lab Project Number: 88-3336-21. Unpublished study prepared by Hill 

Top Research, Inc. 4 p. 

44825002 Kreuzmann, J. (1999) Photoallergy Study in Guinea Pigs with Alkyl 

Dimethyl Benzyl Ammonium Chloride (ADBAC): Report Amendment: 

Lab Project Number: 88-3226-21. Unpublished study prepared by Hill 

Top Research, Inc. 4 p. 

101
BIBLIOGRAPHY 

MRID# CITATIONS 

44885201 Wnorowski, G. (1999) Acute Inhalation Toxicity Study in Rats: 

Albemarle BQ451-8 Biocide: Lab Project Number: 7467: P330. 

Unpublished study prepared by Product Safety Labs. 30 p. 

45109201 Moore, G. (1999) Primary Skin Irritation Study in Rabbits: Albemarle 

BQ451-8 Biocide: Lab Project Number: 7468: P326. Unpublished study 

prepared by Product Safety Labs. 15 p. 

45109202 Moore, G. (1999) Acute Dermal Toxicity Study in Rats: Albemarle 

BQ451-8 Biocide: Lab Project Number: 7466: P322. Unpublished study 

prepared by Product Safety Labs. 25 p. 

45109203 Moore, G. (1999) Dermal Sensitization Study in Guinea Pigs (Buehler 

Method): Albemarle BQ451-8 Biocide: Lab Project Number: 7469: P328. 

Unpublished study prepared by Product Safety Labs. 24 p. 

45109204 Bonnette, K. (1998) An Acute Oral Toxicity Study in Rats with BQ 451-8: 

Lab Project Number: 3192.32. Unpublished study prepared by Springborn 

Laboratories. 90 p. 

455021101 American Chemistry Council (ACC). 2002a.Assessment of Potential 

Inhalation and Dermal Exposure Associated With Pressure Treatment of 

Wood with Arsenical Wood Products 

45524304 Bestari KT, Macey K, Soloman KR, Tower N. 1999. Measurement and 

Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl 

Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber 

(Phase III). 

46865601 Van Dievoet, F. and V. Bouillon. 2005. Biodegradability Test Report 

according to OECD 301 B – modified (Modification: product tested at a 

concentration of ± 5 mg/L of TOC). Report No. ST49132.01.01. 

Unpublished study performed by BFB Oil Research S.A., Gembloux, 

Belgium, and submitted by ADBAC Issues 

. 

102
BIBLIOGRAPHY 

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. 

Bryan, Elizabeth. 1988. Methods for Estimating Retention of Liquid on Hands. Volume 13 of 

Methods for Assessing Exposure to Chemical Substances. EPA 560/5-85-017 

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. 

Dobbs, M.G., Cherry, D.S., Scott, J.C., Petrille, J.C. 1995. Environmental Assessment of an 

Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) Based Molluscicide Using Laboratory 

Tests. Virginia Tech University Center for Environmental and Hazardous Materials Studies 

Blacksburg, VA. Published data. Proceedings of the Fifth International Zebra Mussel and Other 

Aquatic Nuisance Organisms Conference, Toronto, Canada. 

EpiSuite Computer Program

FDA. 2003. “Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions.” 

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 children’s microactivity 

patterns: The Minnesota Children’s Pesticide Exposure Study. 

Journal of Exposure Analysis and Environmental Epidemiology. 11(6): 501-509. 

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 

Krahn, P.K. and R. Strub. 1990. Standard leaching test for antisapstain chemicals. Regional 

Program Report 90-10. Environment Canada, Conservation and Protection, Environmental 

Protection, Pacific and Yukon Region, North Vancouver, B.C. 

Lee, C. 1992. Assessment of the Biodegradability of ADBAC and DDAC. Unpublished report 

prepared by Roy F. Weston, Inc. Contractor’s Fate Summary Review. Document Image No. 

2011644. 

103
BIBLIOGRAPHY 

OPEN LITERATURE CITATIONS 

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. 

Steering Committee/Joint Venture, Washington, DC. 

104
BIBLIOGRAPHY 

INTERNET CITATIONS 

American Chemical Council (ACC), 2005. Slimicide Use in Papermaking (Powerpoint 

Presentation). ACC Biocides Council, September 17, 2003. 

http://www.cfsan.fda.gov/~dms/opa-cg3a.html. Last accessed June 9, 2003. 

DOE. 1997. Energy Information Administration: Profile of Commercial Buildings in 1995. 

http://www.eia.doe.gov/emeu/cbecs/char95/profile.html 

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.heraproject.com. 

SIMetric. 2005. http://www.simetric.co.uk/si_materials.htm Last viewed November 9, 2005. 

USAID. 2005. “ANNEX III: Recommended Energy Allowance Tables.” November 2005. 

http://www.usaid.gov/our_work/humanitarian_assistance/ffp/crg/annex-3.htm. Last viewed 

January 23, 2006. 

USEPA. 2000. Office of Pesticide Programs. 2000. Part A. Guidance for Use of the Index 

Reservoir in Drinking Water Assessments. 

http://www.epa.gov/oppfead1/trac/science/reservoir.pdf 

USEPA 2001a. Environmental Fate and Effects Division. 2001a. 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/oppefed1/models/water/first_users_manual.htm 

USEPA 2001b. 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/oppefed1/models/water/scigrow_users_manual.htm 

USEPA 2002. 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/oppefed1/models 

water/input_guidance2_28_02.htm/ 

105
BIBLIOGRAPHY 

OTHER SUPPORTING DOCUMENTS CITATIONS 

USEPA. 1993. Environmental Fate and Groundwater Branch (EFGB) review of alkyl dimethyl 

benzyl ammonium chloride. Memo from E. Regelman, EFGB, to J. Lee, Antimicrobial Program 

Branch. 

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. 1997. Exposure Factors Handbook. Volume I-II. Office of Research and Development. 

Washington, D.C. EPA/600/P-95/002Fa. August 1997. 

USEPA. 1998. Occupational and Residential Exposure Test Guidelines, Group B – Post 

Application Exposure Monitoring Test Guidelines, Series 875. 

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 (1999): Alkyl dimethyl benzyl ammonium chloride (ADBAC) – Report of the Hazard 

Identification Assessment Review Committee, Office of Prevention, Pesticides, and Toxic 

Substances. 

USEPA (2000): Memorandum on Sterilex ® Ultra-Kleen for Dental Unit Water lines: Request 

for Risk Assessment. Submission S572183. 

USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs, Human Health Effects 

Division. Dated April 5, 2000. 

USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update, November 12. 

Recommended Revisions to the Standard Operating Procedures (SOPs) for Residential Exposure 

Assessment, February 22, 2001. 

USEPA. 2003. Assessment of the Proposed Bardac Wood Preservative Pressure Treatment Use. 

Memorandum from Tim Leighton and Siroos Mostaghimi. February 11, 2003. 

106
BIBLIOGRAPHY 

OTHER SUPPORTING DOCUMENTS CITATIONS 

USEPA. 2004. Occupational and Residential Exposure Assessment for Carboquat WP-50. 

Memorandum from Siroos Mostaghimi, USEPA, to Velma Noble, USEPA. November 4, 2004. 

DP Barcodes D303714 and D303938. 

USEPA. 2005. Dietary Assessment of Chlorine Dioxide, Sodium Chlorite from Their Use as 

Indirect Food Contact Sanitizers/Disinfectants (Hard Surface Sanitizers). Memorandum from 

Najm Shamim, USEPA, to Melba Morrow and Jennifer Slotnick, USEPA. Dates August 15, 

2005. 

USEPA. 2006. Alkyl dimethyl benzyl ammonium chloride (ADBAC) – Report of the 

Antimicrobials Division Toxicity Endpoint Committee (ADTC) and the Hazard Identification 

Assessment Review Committee (HIARC). January 9, 2006. 

USEPA. Undated. RISK. Version 1.9.27. Developed by Dr. Les Sparks of USEPA/NRMRL/ 

APPCD. 

Versar. 2006. ADBAC Occupational and Residential Exposure Assessment. Memorandum from 

Adria Diaz/Karie Riley/Kelly McAloon, Versar, Inc., to Laura Bailey, USEPA dated January 16, 

2006. 

107
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 

ADBAC RED for a list of studies that the Agency plans to require. 

108
Appendix F. PRODUCT SPECIFIC DATA CALL-IN 

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

109
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. 

110
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 at williams.nicole@epa.gov. 

The following Agency Pesticide Registration Forms are currently available via the internet 

at the following locations: 

8570-1 Application for Pesticide Registration/ Amendment http://www.epa.gov/opprd001/forms/8570-1.pdf 

8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf 

8570-5 Notice of Supplemental Registration of Distribution 

of a Registered Pesticide Product http://www.epa.gov/opprd001/forms/8570-5.pdf 

8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf 

8570-25 Application for/Notification of State Registration of

a Pesticide To Meet a Special Local Need http://www.epa.gov/opprd001/forms/8570-25.pdf 

8570-27 Formulator's Exemption Statement http://www.epa.gov/opprd001/forms/8570-27.pdf 

8570-28 Certification of Compliance with Data Gap 

Procedures 

http://www.epa.gov/opprd001/forms/8570-28.pdf 

8570-30 Pesticide Registration Maintenance Fee Filing http://www.epa.gov/opprd001/forms/8570-30.pdf 

8570-32 Certification of Attempt to Enter into an Agreement 

with other Registrants for Development of Data 

http://www.epa.gov/opprd001/forms/8570-32.pdf 

8570-34 Certification with Respect to Citations of Data 

 (PR Notice 98-5) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf 

8570-35 Data Matrix (PR Notice 98-5) http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf 

8570-36 Summary of the Physical/Chemical Properties 

(PR Notice 98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf 

8570-37 Self-Certification Statement for the Physical/ http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf 

111
Chemical Properties (PR Notice 98-1) 

Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/ 

Dear Registrant: 

For your convenience, we have assembled an online registration kit which contains the 

following pertinent forms and information needed to register a pesticide product with the U.S. 

Environmental Protection Agency's Office of Pesticide Programs (OPP): 

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal 

Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality 

Protection Act (FQPA) of 1996. 

2. Pesticide Registration (PR) Notices 

a. 83-3 Label Improvement Program--Storage and Disposal Statements 

b. 84-1 Clarification of Label Improvement Program 

c. 86-5 Standard Format for Data Submitted under FIFRA 

d. 87-1 Label Improvement Program for Pesticides Applied through 

Irrigation Systems (Chemigation) 

e. 87-6 Inert Ingredients in Pesticide Products Policy Statement 

f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement 

g. 95-2 Notifications, Non-notifications, and Minor Formulation 

Amendments 

h. 98-1 Self Certification of Product Chemistry Data with Attachments (This

document is in PDF format and requires the Acrobat reader.) 

Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices 

3. Pesticide Product Registration Application Forms (These forms are in PDF format 

and will require the Acrobat reader). 

a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment 

b. EPA Form No. 8570-4, Confidential Statement of Formula 

c. EPA Form No. 8570-27, Formulator's Exemption Statement 

d. EPA Form No. 8570-34, Certification with Respect to Citations of Data 

e. EPA Form No. 8570-35, Data Matrix 

4. General Pesticide Information (Some of these forms are in PDF format and will 

require the Acrobat reader). 

a. Registration Division Personnel Contact List 

b. Biopesticides and Pollution Prevention Division (BPPD) Contacts 

c. Antimicrobials Division Organizational Structure/Contact List 

d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data 

Requirements (PDF format) 

e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF

format) 

f. 40 CFR Part 158, Data Requirements for Registration (PDF format) 

112
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 

1985) 

Before submitting your application for registration, you may wish to consult some

additional sources of information. These include: 

1. The Office of Pesticide Programs' website. 

2. The booklet "General Information on Applying for Registration of Pesticides in 

the United States", PB92-221811, available through the National Technical 

Information Service (NTIS) at the following address: 

National Technical Information Service (NTIS) 

5285 Port Royal Road

Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000. 

3. The National Pesticide Information Retrieval System (NPIRS) of Purdue 

University's Center for Environmental and Regulatory Information Systems. This 

service does charge a fee for subscriptions and custom searches. You can contact 

NPIRS by telephone at (765) 494-6614 or through their website. 

4. The National Pesticide Telecommunications Network (NPTN) can provide 

information on active ingredients, uses, toxicology, and chemistry of pesticides. 

You can contact NPTN by telephone at (800) 858-7378 or through their website: 

ace.orst.edu/info/nptn. 

The Agency will return a notice of receipt of an application for registration or 

amended registration, experimental use permit, or amendment to a petition if the 

applicant or petitioner encloses with his submission a stamped, self-addressed 

postcard. The postcard must contain the following entries to be completed by 

OPP: 

· Date of receipt; 

· EPA identifying number; and 

· Product Manager assignment. 

113
Other identifying information may be included by the applicant to link the 

acknowledgment of receipt to the specific application submitted. EPA will stamp 

the date of receipt and provide the EPA identifying file symbol or petition number 

for the new submission. The identifying number should be used whenever you 

contact the Agency concerning an application for registration, experimental use 

permit, or tolerance petition. 

To assist us in ensuring that all data you have submitted for the chemical are 

properly coded and assigned to your company, please include a list of all 

synonyms, common and trade names, company experimental codes, and other 

names which identify the chemical (including "blind" codes used when a sample 

was submitted for testing by commercial or academic facilities). Please provide a 

chemical abstract system (CAS) number if one has been assigned. 

Documents Associated with this RED 

The following documents are part of the Administrative Record for this RED document 

and may be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these 

documents are not available electronically, but may be obtained by contacting the person listed 

on the respective Chemical Status Sheet. 

1. Health Effects Division and Environmental Fate and Effects Division Science 

Chapters, which include the complete risk assessments and supporting documents. 

2. Detailed Label Usage Information System (LUIS) Report. 

114