Unite d States Preventi on, Pe sticides EPA739- R-06- 009
Enviro nmenta l Protection and T o xic Su b s tances August 20 06 Agenc y (751 0C)



# Reregistration Eligibility Decision for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)

### UNITE D S T AT ES E N VIRONME N TAL PROTECTIO N AGENCY WASHINGTON, D.C. 20460

OFFICE OF

PREVENTI ON, PESTICIDES

AND T OXI C SUB STANCES

CERTIFIED MAIL

Dear Registrant:

This is to inform you that the Environm enta l Protection Agency (her eafter referred to as EPA or the Agency) has com pleted its review of the available data and public comm e nts

rece ived re lated to the p r elim in ary risk assessm ents for the antim icrobial Alkyl Dim e thyl Benzyl

Ammonium Chloride (ADBAC). The Reregist ra tion Elig ibility Deci sion (RED) was approved

in the form of a decision m e m orandum which summarized the regulatory decision for ADBAC on August 3, 2006. Public comm ents and additional data received were considered in this

decision.

Based on its review, EPA is now publishing it s Reregis t ra tion Eligib ility Decision ( R ED)

and risk m a nagem e nt decision for A D BAC and its associated hum a n health and environm ental

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

The RED and supporting risk assessm e nts fo r 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, whic h provides opportunities for public involvem ent in the Agenc y ’s pestic ide tole rance re assessm en t and reregistration progr am s. Developed in partnership with USDA and with input from EP A’s advisory comm ittees and others, the public participation process encourages robust publ ic involvem e nt starting early and continuing throughout the pesticide risk as sessm ent and ri sk m itigation d ecis i on m aking process. The public participation process encom p asses full, m o dified, and stream lin ed v ersions tha t enable the Agency to ta ilor the level of review to the lev el of refinem e nt of the risk assessm ents, as well as

to the am ount of use, risk, public co ncern, and com p lexity associated with each pesticide. Using the public participation process, EP A is attain ing its strong comm it m e nt to both involve the public and m eet statutory deadlines.

Please no te that the ADBAC risk assessm en t and the attached RED document conce r n only this particular pesticide. This R E D pr esents the Agency’s conclus i on s on the dietary, drinking water, occupational and ecological ri sks posed by exposure to A D BAC alone. This

docum ent also contains both generi c and product-specific data that the A gency intends to require in Data Call-Ins (DCIs )

. Note that D C Is, with all pertinent in struc tions, w ill b e sent to registrants at a later date. Additionally, for pr odu ct-spe cific DCIs, the f i r s t set of req u ired

### 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. Summa ry of ADBAC Risk Assessments...

.................................... ... 10

A. Human Health Risk Assessmen t.............................................

... 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 Su mmary.....................

... 34

d. Occupation al 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 Treatme nt Scenarios (Handler and Post- 43

### Application)...................................................

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

.............................. 44

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

.. 45

1. Environmental Fate and Trans p ort.................................

... 45

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

a. Toxicity (Haz ard) As sessmen t

................................. 45

b. Exposure and Risk

.............................................. 46

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

IV. Risk Management, Reregistration, and Tolerance Rea ssessment Decision... 50

A. Determination of Reregistratio n Eligibility

.................................. 50

B. Public Comments and Respons e s.............................................

.. 50

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

1. Food Quality Protection Act Fin d ings..............................

... 50

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

b. Determin ation of Safety to U.S. Population...............

.. 51

c. Determin ation of Safety to Infan t s 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 Lab e l ...................... ..................................... 74

B. Table of Generic Data Requireme nts 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 A ll Registran t s Sent the Data Call-In..............................

.. 110

H. List of A vailable Forms .......................................................

... 111

### ADBAC Reregistration Team

Health Effects Risk Assessm ent
Jonathan Chen

Tim o thy Leighton

Tim McMahon Najm Sham im Matthew Lloyd

Ecological Risk Assessm e nt
Richard Petrie Kathryn Montague

Brian Kiernan

Marietta Echeverria

Environm ental Fate Risk Assessm ent
Srinivas Go wda

Che m istry Assessm ent Chris Jiang

Registration Support

Velm a Noble

Dennis Edwards

Risk Managem e nt Jacqueline Ca m pbell-McFarlane Tracy Lantz
Diane Isbell

iGLOSSARY OF TERMS AND ABBRE V IATIONS

a.i. Activ e Ing r ed i e n t
aPAD A c u te Popu latio n Adj u sted Do se APHIS Anim al and Pl ant Health Ins p ection Se rvice

ARTF Ag ricultu ral R e -entry Task F o rce BCF Bioconcentration Factor
CDC Cen t ers for Disease Con t ro l

CDPR Califo r n i a Departm en t o f Pest icid e Regu latio n C F R C ode o f Fe de r a l R e gul at i o ns Ch EI Ch o lin esterase Inh i b ition

CMBS Carbam ate Ma rket Bas k et Survey
cPA D C h r oni c Po p u l a t i on Ad j u st ed Dose
C SFII US DA C o nt i n ui n g S u rvey s f o r

Fo o d Int a ke by I n di vi d u al s C W S Co mm u n ity Water System

DCI Data Call-In

DEEM Di et ary Ex p o s u re Eval uat i o n M odel

D L D oub le layer clo t h i ng {i.e., co v e r a lls ov er SL}

D WLOC Dri nki ng W a t e r Le vel o f C o m p ari s on EC Em ul si fi abl e C once n t r at e Fo r m

ul at i on EDSP En doc ri ne Di sr upt or Scree n i n g P r o g r am EDST AC En doc ri ne Di sr upt or Scree n i n g a n d Test i n g Ad vi so ry C o m m i tt ee EEC Esti m a ted En v i ron m en tal Co ncen tration

. The esti m a ted p e sticid e con cen tratio n in an
envi ronm ent, such as a terrest rial ecosystem

. EP End-Use P r oduct

EPA U.S. Env iro nmen tal Pro tectio n Ag en cy EXAM S Tier II Surface Water C o m puter Model

FD A Fo od an d D r u g A d m i ni st rat i on FFDC A Fed e ral Fo od

, Dru g , and Cosmetic Act

FIFR A Fede ral I n sect i c i d e, F u ngi ci d e , an d R o dent i c i d e Act
FOB Fun c tio n a l Ob serv ation Battery FQPA Foo d Qu ality Pro t ection Act

F R F e d e r a l R e g i s t e r GL W i t h glo v es GPS Glob al Po sition i ng System
HIARC Hazard Ide n tifi cation Assess ment Review Committee

IDF S Inci dent Data Sy stem
IGR Insect Growth Regulator

IPM Int e grat ed Pest M a na gem e nt
RED Rereg i stration Elig ib ility Decisio n LAD D Lifetim e Avera g e Daily Do se LC 50 Med i an Let h al Co n c en tration

. Statistically d e ri ve d c once n t r ation of a subs tance expecte d to ca use deat h i n 50 % o f t e st ani m al s, usu a l l y exp r ess e d as t h e wei g ht o f s u bst a nce pe r wei g ht o r vol um e of

water

, air or fee d , e

. g., m g /l, m g /kg or ppm

. LCO Lawn Car e Oper ato r LD 50 Med i an Let h al Do se. Statistic ally d e riv e d si n g l e do se cau s i n g d eat h in 50% of th e test an im a l s whe n a d m i nistered by t h e route i ndi cat ed ( o r a l , de rm al , i nhal a t i on), ex p r e ssed as a wei g ht o f

su bstan ce p e r u n it weigh t of an im a l

, e.g., m g /kg

. LOAEC Lowest Obse rved Ad ve rse E f f ect C once n t r at i on LOAEL Lowest Obse rved Adve rse E f fect Level

LOC Level of C o nc ern LOEC Lowest Obse rved E ffect C o nc entration

m g /k g / d ay Millig ra m Per Kilo gram Per Day
MO E Mar g in of Expo sur e MP Man u f actur ing- U s e Prod uct
MRID Master Record Identifica t i o n (n um ber). EP A’s sy st em of r ecor d i n g a n d t r acki n g st udi es

su b m itted

. M R L M a xi m u m R e si due Level



### iiN/A No t Ap p licab le

NASS Natio n a l Ag ricu ltu ral Statistic al Serv ice NAWQA USGS Nation a l W ater Qu ality Assessm en t
NG No Gl oves NMFS Natio n a l Marine Fish eries Serv ice

NOAEC No Obse rve d Adve rse E ffect Concentrati o n NO AEL No O b se rve d Ad ve rse E ffect Level

NPIC Natio n al Pesticid e In form at io n Cen t er NR No res p irat or OP Or ga no p hos p h o r u s OPP EPA Office o f Pesticid e Prog ra m s ORETF Out d oor Residential Exposure Task F o rce PA D Po pul at i o n Ad j u st ed D o se PCA Perce n t Crop Area
PDCI Product Specific Data Call-In

PDP USDA Pesticide Data Pro g ram PF10 Pr o t ection s f a cto r 10 r e sp ir at or PF5 Protection fact or 5 res p irator

PHED Pesticid e Handler’s Exp o sure Data

PHI Pre-ha rvest Interval

p pb Parts Per Billio n PPE Pers onal Pr ot e c t i v e Eq ui pm ent
PRZM Pesticid e Roo t Zon e Mod e l

RBC Red Bloo d Cell

RED Rereg i stration Elig ib ility Decisio n REI Restricted E n try Interval
RfD Referen ce Do se RPA Reaso n a b l e and Prud en t Altern ativ es R P M R easona bl e a n d P r u d e n t M e a s ures RQ Risk Quo tien t
RTU ( R ead y- to -u se)

RUP Restricted Use Pesticide

SCI- GRO W Tier I G r o u n d Water C o m puter M o del

SF Safety Factor
SL Si ngl e l a y e r cl ot hi n g SLN Special L o cal Need (Re g istra t i ons U nde r Se ct i on 24C o f F I FR A)

STOR ET St ora g e a n d R e t r i e val

TEP Typical End-Use Product

TGAI Technical Gra d e Active Ingredient

TRAC Tolera nce Rea ssessm ent Advisory C o m m i ttee
TTRS Transfe r able T u rf Residues

UF Unce rtainty Fa ctor
US DA United States Depa rtm e nt of Ag ricultu re USFWS United States Fish a n d W i l d life Service
US GS United States Geol ogi cal S u r v ey WPS Wo r k er Pr ot ect i on St an dar d



### iii

### ABST RACT

The Environm ental Protection Agency (EPA or The Agency) has com pleted the hum an health and environm ental risk assessm ents fo r alkyl dim ethyl benzyl am monium chloride, ADBAC, and is issuing its risk m a nagem e nt d ecision and to lerance reass e ssm ent. The risk

assessm ents, which are s u mm arized below, are based on the review of the required target
databas e sup porting the u se patterns o f currently registered p r oducts and addition a l inf o rm ation received through the public docket. After considering the risks id entified in the revised risk

assessm ents, comments received, and m itigation s ugges tions f r om interested parties, the Agency developed its risk m a nagem e nt decision for uses of ADBAC that pose risks of concern. As a result of this review, EPA has determ ined th at ADBAC-containing products are eligible for

rereg i stratio n, provided that r i sk m itigation m easures ar e ado p ted and lab els ar e am ended
accord ingly. That decision is discu ss e d fully in this docum ent.

iv

### I. Introductio n

The Federal Insecticide, Fungicide, and R odenticide Act (FIF RA) was a m ended in 1988 to accelerate the reregistration of pro ducts with active ingred ient s reg i s t ered prior to Novem b er 1, 1984 and am ended again by the P e sticide Regi stration Improvem e nt Act of 2003 to set tim e f r am es f o r the issuanc e of Reregistr ation Eligib ility Dec i sio n s. The am ended Act calls f o r the developm ent and subm ission of data to support the reregistration of an active ingredient, as well

as a rev i ew of all subm itted data by the U.S. Environm ental Protec tion Ag ency (EPA or the Agency). Reregistration invol ves a thorough review of the sc ientific database underlying a pesticide’s registration. The purpose of the Agency’s review is to reassess the potential hazards
aris ing f r om the cur r ently regis t er ed uses of the p esticide ; to d eterm ine the need f o r ad dition al
data on health and environm ental effects; and to d eterm ine whether o r not the pes tic ide m eets the

“no unreaso nable advers e effects” criteria of FIFRA.

On August 3, 1996, the Food Quality Protecti on A c t of 1996 (FQPA) was signed in to law. This Act am ends FIFRA to require tole ra nce reassessment. The Agency has decided that,
for those chem icals that have tolerances a nd are undergoing reregist ration, the tolerance

reasse ssm ent will b e initiated throug h this r ereg i stra tion p r oc ess. The Act also requir es tha t by 2006, EPA must review all tolerances in effect on the day before th e date of the enactm ent of the FQPA. FQPA also am e nds the Federal Food, Drug, and Cosm etic Act (FFDCA) to require a safety finding in tolerance reassessment based on factors including cons ideration of cum u lative
effects of chem icals with a common m echanism of toxicity. This document presents the Agency’s revised hum an health and ecological risk assessm ents and th e Reregis t r ation Eligib ility Decision (R ED) for Alkyl Dim e thyl Benz yl Ammonium Chl oride (ADBAC).

ADBAC is an antim icrobial used in agricultural, food handling, commercial/ institutional/ industrial, reside ntial and public access, and m e di cal settings. Exam ples of registered uses for ADBAC in these settings include application to indoor and outdoor hard surfaces (e.g ., walls, floo rs, tab l es, toilets, a nd fixtures), eating utensils, lau ndry, carp e ts, agricultural tools and vehicles, egg shells, hands and gloves, s hoes, m ilking equipm e n t, and udders, humidifiers, RV tanks, m e dical instrum e nt s, hum an rem a ins, ultrasonic tanks, reverse

osm o sis units, and water storage tanks. There ar e also ADBAC end-use products that are used in
residential and commercial swimm i ng pools, in aquatic areas such as decorative ponds,
decorative f ountains, and agricultural watering lines, and in i ndustrial process and water system s such as once-through and re-circulating cooling water system s, cooling towers, evaporative condensers, pasteurizers, drilling m ud, packer fluids, oil well inje ction and wastewater system s, and in pulp and paper products, water, and chem icals. Additionally, ADBAC end-use products are used for wood preservation.

The Agency has concluded that the F Q PA Sa fety Factor for ADBAC should be rem oved (equivalent to 1X) based on: (1 ) there is no concern for develo pm ental neu r otoxicity re sulting
from exposure to ADBAC because th ere is no evidence ADBAC will ind u ce neuro t o x ic effects; (2) there is n o evidence o f increased s u sceptibility to the f etus f o llowing in utero exposure in the prenatal developm ental toxicity studies or to th e offspring when adults are exposed in the twogeneration reproductive study; a nd (3) the risk assessm ent does not underestim ate the potential exposure for infants and children.

1

### Risks summariz ed in th is docum ent are thos e tha t resu lt on ly f r om the use of the activ e ingredients ADBAC. The Food Quality Protection Act (FQPA) requires that the Agency
consider availab l e inform ation concerning the cu m u lative ef fects of a particular pesticide’s
residues and other substances that have a co mm on m echanism of toxicity. The reason for
consider atio n of other su bstances is d u e to the po s sibility that low-level ex posures to m u ltip le
chem ical substances that cause a co mmon toxic effect by a comm on toxic m echanism could lead
to the s a m e adverse h ealth effect that would o ccur at a higher level of exposure to any of the substances individually. Unlike other pesticides for which EPA has f o llowed a cum u lative risk approach based on a common m ech anism of toxicity, EPA has not m a de a common m echanis m of toxicity finding for ADBAC and any other su bstances. A D BAC does not appear to produce a
toxic m e tabolite produced by other substances. Fo r the purposes of this action, therefore, EPA
has not assum e d that ADBAC has a common mechanis m of toxicity with ot her substances. For
inform ation regarding E P A’s efforts to determ ine which chemicals have a common m e chanism of toxicity and to evaluate th e cum u l a tive effects of such chem icals, see the policy statem ents released by EPA’s Office of Pesticid e Program s concerning common m e chanism determ inations and procedures for cum u lating effects from s ubstances found to have a common m echanism on EPA’s website at http://www.epa.go v/pesticides/cum ulative.

This document pres ents the Agency’s decis i on re garding the r eregis t r ation elig ibility o f the registered uses of ADBAC. In an effort to simplif y the RED, the inf o rm ation pres ented
herein is summarized from m o re detailed info rmation that can be found in the technical supporting docum e nts for ADBAC referenced in th is RED. The revised risk assessm ents and
related addenda are not included in this docum ent, but are av ailab l e in th e Public Do cket at http://www.epa.gov/edocket

.

This document consists of six sections. Section I is the introduction. Section II provides
a chem ical overview, a p r ofile of the use and usage of ADBAC, and its regulatory history. Section III, Summ ary of ADBAC Ri sk Assessm ents, gives an overview of the hum an health and
environm ental assessm e n ts, based on the data av ailab l e to th e Agency. Section IV, Risk Managem e nt, Reregistration, and Tolerance Reas sessm ent Decision, presents the reregistration elig ibility an d risk m anagem ent decisions. Section V, W h at Regi strants Need to Do, summarizes
the nece ssar y label chan ges based on the r i sk m itigation m easures outline d in Section IV. Finally, the Appendices list all us e patterns eligible for reregist ration, bibliographic infor m ation,
related docu m ents and how to access them , and Data Call-In (DCI) inform ation.

2

### II. Chemical Overview

A. Regulatory Histo ry

The first product containing ADBAC was registered in 1947. The oldest active product containing an A D BAC was regist ered in 1956 under chem ical code 069105. These pesticides are clas sified as List A ch e m icals for which a registration standard w a s issued by E P A in 1985. W hen the list of ac tive ingredients under going reregistration was published in 1989, 43 addition al active ingred ie n t s were add e d to this cas e. Since

issuance of the lis t, one active ingred ient has been placed into a separate chem ical cas e , and 18 activ e ingred ients have been canceled thus resulting in 24 active ingredients in

this c ase.

The ADBAC Quat Steering Comm i ttee/Join t Venture com prised of Lonza, Inc.,

Mason Chem ical Com p any, and Stepan Com p any was for m e d to support the reregistgration activities of this chemical case. A l ong with the Quat Steering

Comm ittee/Joint Venture, Albem a rle Cor poration produces chem icals within the

ADB AC case. These chem icals are form ulated into countless products that are used in

residen t ial, comm ercial, industrial, in stitu tion al, and agricu ltu ral settings.

In 1988, EPA issued PR Notice 88-2 outlin ing “Clustering o f Quaternary
Ammonium Com pounds.” In this Notice, Quats were clustered into 4 groups as follows:

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

Group II: T he non-halogenated benz yl substituted Quats (including hydroxybenzyl, hydroxyethylbenzyl , naphylm e thyl, dodecyhlbenz hyl, and alkyl benzyl)

Group III: The di- and tri-chlo robenzyhl substituted Quats

Group IV: Quats with unusual substitu tes (charged heterocyclic com pounds).

The Agency agreed for d a ta develop m ent purposes that the p e sticide, alk y l (50%C 14 

### , 40% C 12 

### , 10% C 16 

### ) dim e thyl benzyl ammonium c hloride (PC code 069105),
would serve as the m odel com pound.

B. Chemical I d entificatio n

The alkyl dim e thyl benzyl amm onium chloride (ADBAC) chem ical case is

com p rised of 24 com pounds that are structurally sim ilar quaternary ammonium

com pounds (quats) that are characterized by having a positively charged nitrogen covalently bonded to thr ee alkyl group substituents and a be nzyl substituent. In finished
f o rm , these quats ar e sa lts with th e p o sitiv ely ch a r ged nitroge n (cation) ba lanced by a negatively charged m olecule (anion). The m ost c o mm on anion for the quats in this
cluster is chloride. However, oth e r anions, su ch as sacch arin e and brom ide are also u sed. Table 1 below provides the common chem i cal nam e , active ingredient code, CAS

num b er, and chem ical structure.

3

### Table 1: Active Ingredie nts in Group II Cluster

Pesticide

Code CAS RN Na me Structure Chain Length s

6910 4 5351 6- 76- 0 ADBAC N +

CH 3 CH 3 R Cl - R = C12 (5%) C14 ( 60%) C16 ( 30%) C 18 ( 5 %)

6910 5 6842 4- 85- 1 ADBAC N +

CH 3 CH 3 R Cl R = C12 ( 40%) C14 ( 50%) C16 ( 10%)

6910 6 8001- 5 4

- 5 ADBAC N +

CH 3 CH 3 R Cl - R = C12 ( 50%) C14 ( 30%) C16 ( 17%) C18 ( 3 %)

6910 7 139- 08- 2 ADBAC N +

CH 3 CH 3 R Cl R = C12 (1%) C14 ( 98%) C16 ( 1 %)

6911 9 7304 9- 75- 9 Dialky l M e thy l B A C N +

R CH 3 R Cl R = C12 (5%) C14 ( 60%) C16 ( 30%) C18 ( 5 %)

6913 7 6842 4- 85- 1 ADBAC N +

CH 3 CH 3 R Cl R = C12 ( 25%) C14 ( 60%) C16 ( 15%)

6914 0 6178 9- 71- 7 ADBAC N +

CH 3 CH 3 R Cl - R = C8-10 (2.5%) C14 ( 61%) C16 ( 23%) C18 ( 2

. 5 %)

6914 1 6842 4- 85- 1 ADBAC N +

CH 3 CH 3 R Cl R = C12 ( 14%) C14 ( 58%) C16 ( 28%)

6915 7 6842 4- 85- 1 ADBAC N +

CH 3 CH 3 R Cl R = C12 ( 65%) C14 ( 25%) C16 ( 10%)

6917 5 6839 1- 01- 5 ADBAC N +

CH 3 CH 3 R Cl - R = C12 ( 67%) C14 ( 25%) C16 ( 7 %) C18 ( 1 %)

6918 9 6839 1- 01- 5 ADBAC N +

CH 3 CH 3 R Cl - R = C12 ( 61%) C14 ( 23%) C16 ( 11%) C18 ( 5 %)

6918 4 6842 4- 85- 1 ADBAC N +

CH 3 CH 3 R Cl R = C12 (3%) C14 ( 95%) C16 ( 2 %)

6919 2 8540 9- 22- 9 ADBAC N +

CH 3 CH 3 R Cl R = C12 ( 70%) C14 ( 30%)



### 4

### Pesticide

Code CAS RN Na me Structure Chain Length s

6919 4 6842 4- 85- 1 ADBAC N +

CH 3 CH 3 R Cl R = C12 (5%) C14 ( 90%) C16 ( 5 %)

1289 28 6344 9- 41- 2 ADBAC N +

CH 3 CH 3 R Cl R = C8

– Not specif i ed C10 – Not specifie d C12 ( 67%) C14 ( 25%) C16 ( 7 %) C18 – Not specifie d

6917 1 6898 9- 01- 5 ADBA Sacchar inate N +

R CH 3 R O

- N

S

O

O R = C12 ( 40%) C14 ( 50%) C16 ( 10%)

6915 4 8540 9- 23- 0 ADE BAC
N +

CH 3 CH 3 R Cl H 3 C R = C12 ( 68%) C14 ( 32%)

6911 1 8045- 2 1

- 4 ADE BAC
N +

CH 3 CH 3 R Cl H 3 C R = C12 ( 50%) C14 ( 30%) C16 ( 17%) C18 ( 3 %)

0691 12 5351 6- 75- 9 n- Alky l di m e thy l 1

­ naphty l m e thy l

am m oniu m chlor i de R=C12 ( 98%) C14 ( 2 %)

0691 25 1330- 8 5- 4 Dodecy l benzy l

tri m eth y l a m m oni u m chloride

1691 59 N/A n- alky l dim e thy l

dim e thy l am m oniu m chloride R= C12 ( 68%) C14 ( 32%)

6912 2 121- 54- 0 Diisobuty l pheno xy

ethy oxy ethy l di m e thy l

benzy l a m m oniu m chloride [Benzethoni u m

Ch lo rid e] CH 3 H 3 C

O CH 3 H 3 C CH 3

O

N +

H 3 C CH 3 Cl 6912 9 1399- 8 0- 0 M e thy l dodecyl benzy l

tri m e thyl a m m oni u m chlor i de

- 80%

Methyl dodecyl xylene

bis tri m e thyl

am m oniu m chlor i de

– 20%



### 5

### Pesticide

Code CAS RN Na me Structure Chain Length s

6913 4 2515 5- 18- 4 Diisobuty l

cr esoxy ethoxy ethyl

dim e thy l benzy l

am m oniu m chlor i de

m onohy dr ate



### Common name: ADB AC

Chemical n ame: n-Alkyl dim e thyl benzyl ammonium chloride

Chemical f a mily : Quaternary am ines

Case number: 0350

Basic manufacturers: Albem a rle Corporation Lonza, Inc.
Mason Chem icals Company Stepan Company

Chemical p r operties: ADBAC is a clear yellow to straw colored liquid with an am ine
odor that is soluble in water and alco hols. ADBAC has a m e lting point of 241.02 o 

### C, vapor pressure of 3.53x 10 -1 2 

### mm HG, and a density of 0.9429 g/cm 2 

### at 25 o 

### C.

C. Use Profile

The following is information on the uses of ADBAC produc ts, currentl y registered as of April 26, 2006, and an overview of use sites and a pplication m e thods. A detailed table of the uses of ADBAC eligible for rereg i stra tion is contained in Appendix A.

Type of Pesticide: Algicide, bacteriocide, bacteriost at, wood preservative, fungicide, fungistat, virucide, tuberculocide, ins ecticide, m i crobiocide, microbiostat, molluscide, deodorant, disinfectant, and sanitizer

6

### Summary o f Uses:

Use Category Use Site Industrial processes and water
system s Industrial re-circu lating water system s, pulp and paper

f acilities, co oling wate r towers, dispo sal wate r, oil f i eld operations, and oilfield w a ter flood or saltwater disposal.

Swi m m i ng Pools Swi m m i ng Pools, Outsid e Spas, W h irlpools, and hot tubs Aquatic Areas Golf courses, recreational parks, am usem ent parks,

univers ities, cem eteries, and greenhouse/nurseries

Wood Treatm e nt Pressure T r eatm ent, Double vacuum , and dip/sp ray surface

trea tm ent Agricultural Prem ise and Equipm ent Hatcheries, swine/poultry/turk ey farm s, ani m al housing facilities, farrowing barns, dressing plants, m ushroom far m s, citrus farm , florist/flower shops, and greenhouses/nurseries

Residential and Public Access

Prem ises Hom e s, m o bile hom es, cars, boats, playgrounds, boats, public facilities, cam pgrounds, tra ilers, cam pers, trailers, and

trucks

Medical Prem ises and Equipm ent Hospitals, h ealth care f a ciliti es, m e dical/ dental offices, nursing homes, autopsy room s, funeral hom es, mortuaries,

m e dical research faci litie s, acute care institutions, alte rnative care institutions, newborn nurseri es, day-care facilities, and

sick room s Comm ercial, Institutional, and

Industrial Prem ise and Equipm ent Athletic/recr eation al f acilities, ex ercise facilities, health clubs, dressing/locker room s, sc hools, colleges, universities,
transpo r ta tio n term inals, libr aries, m o tels, ho tels, barber and beauty salons, convenience stores, offices, commercial/ institutional laundry m a ts, em ergency vehicles, factories,

commercial f l orist, and c o rrec tiona l f acilities Food Handling/Storage

Establishm e n ts Prem ises and Equipm ent Restaurants, food servic e establishm ents, food processing/storage/handling plan ts and facilities, beverage processing plants, superm arkets, breweries, bars, cafeterias, fishery/citru s/wine/ice cream / potato process i ng p l ants, egg processing plants, dairies, inst itutional kitchens, fast food operations, rendering plants, sc hool lunchroom s, and packing plants

Target Pests: Slim e-for m i ng bacteria, odor causing /staining bacteria, Gram -negative and

Gram -positive bacteria, Pseudomonas aeruginosa , pathogenic fungi ( Trichophyton mentagrophytes ), envelope and non-envelope viruses,
mold/m ildew, algae

Formulation Types : Form ulation inte rm ediate, aeroso l , s o luble concentrate/tablet, im pregnated wipes, ready-to-use solution, wettabl e powder, pressurized liquid, and water-soluble packaging.

7

### Method and Rates of Application :

Methods : ADBAC formulations are added dire ctly to water in swimm i ng pools, decorative ponds/fountains, spas, cooling water towe rs, oil field drilling muds and packing fluids, sm all proce ss water sy stem s, hum i di fiers, and cut flower applications. ADBAC f o rmulations a r e dilu ted in water to tre a t hard nonporous surfaces in institu tio na l, comm er cial, industrial, and residential settings by foggi ng, imm e rsion, wiping, m opping, aerosol/trigger spray, an d low pressure and high-pressure spray. Som e im pregnated wipes are dam p ened wi th water prior to use while others are

pre-m oistened. For the treatm e nt of wood, ADBAC is applied by a blender/spray system , diptank, spra y box, or pressure treatm e nt.

Application Rates : For details about specific use site s for ADBAC, refer to Appendix A. The following rates are a representati on of the maxim u m rate docum ented 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 s o lution f o r tr eatm ent of swi m m i ng pools and spas.

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

781.5 ppm active solution for treatm ent 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 fo r dip, brush, spray, and pressure

treatm ent for wood preservation.

• Use 9 oz of 3.2% end use product pe r gallon of water to achieve a 2250 ppm active solution for treatmen t of agricultural prem ises and equipm ent such as anim al housing f acilities, anim al life science laboratories, far m s, ornam e ntal nur series, and anim al 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 treatm ent in egg processing plants and hatcheries by fogging.

• Use 53.2 gram s of 40% end-use product per 2 gallons of water to achieve 2800 ppm active solution for treatm ent in ornam e ntal 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 treatm ent 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 form ulation for

treatm ent of m e dical prem ises and equipm ent such as hospitals, daycare centers, m ortuaries, 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 form ulation for

treatm ent of commercial and industr ial prem ises and equipment such

8

### as barber/beauty salons, athletic fa cilities, libraries, m a nufacturing 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

treatm ent of commercial and industrial prem ises by fogging.

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

ppm active solution or use Ready-to-U se for m ulation for treatm e nt of residential and public access prem ises such as hom e s, ca m pgr ounds,
and recreational facilities.

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

ppm active solution for f ood contac t sanitizing treatm e nt in food handling/storage establishm ents su ch as restaurants, food storage

areas, m eat, poultry, and vegeta ble processing facilities.

• Use 6 oz of 4.5% end-use product pe r gallon of water to achieve a 2100 ppm active solution for disinf ection in food handling/storage
establishm ents such as restaurant s, f ood storages areas, m e at, 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 treatm ent of carpets in m e dical, commercial, and resid ential s ettings.

• Use 8 oz of 20% end-use product per 100 pounds of dry laundry to achieve 1154 ppm active solution fro m treatm e nt of clothing/laundry
in m e dical and commercial settings.

Use Classification: General use.

9

### III. Summary o f ADBAC Risk Assessments

The purpose of this summ ary is to assist the read er by iden tif ying the key features and findings of these risk assessm ents and to help the reader better unde rstand the conclusions
reached in the assessm ents. The hu m an health and ecological risk asses s m ent documents and supporting infor m ation listed in Appendix C were used to form ulate the safety finding and regulatory decision for ADBAC. While the risk assessm ents and related addenda are not
included in this docum ent, they are av ailab l e fro m the OPP Public Dock et, http:/www.regulations.gov

. Hard copies of these docum ents m a y be found in the OPP public
docket under docket number OPP-2006-0339. The O PP public docket is located in RoomS4400, One Potom ac Yard (South Building), 2777 S outh Crystal Drive, Arlington, VA 22202 and is open Monday through Friday, excluding Fede ral 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 hum an studies in the ADBAC risk assessm ent is in accordan ce with the Agency’s Final Rule prom ulgated on January 26, 2006, related to P r otections for Subjects in

Hum a n Res earch, which is c odified in 40 CFR Part 26.

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

assessm ents are outlined below in Table 1. Furt her details on the toxicity of ADBAC can be found in the “Toxicology Disciplinary Chapte r for the Reregistration Eligibility Decision

Docum e nt on Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC),” dated February 27, 2006; “Draft Prelim inary Risk Assessm e nt for Alkyl Dim e thyl Amm onium Chloride (ADBAC),” dated April 20, 2006; and “ADBAC - Report of the Antim icrobials Division Toxicity En dpoint Comm ittee (ADTC) and the Hazard Identification A ssessm ent Review

Comm ittee (HIARC),” dated April 20, 2006. These docum ents are available at http://www.regulations.gov.

The Agency has reviewe d all toxic ity st udies sub m itted f o r ADBAC and has dete rm ined that the toxicological database is sufficient for reregistration. The acute toxicology data shows that ADBAC is toxicity category II by the oral a nd inhalation routes and t oxicity category III via
the derm al route. ADBAC is also considered to be highly irritating to the eyes and skin (toxicity category I) and is not a derm al sensitizer

. Major f eatures of the acu te toxicology profile are presented below

Table 1. Summary of Acute Toxicity Data for ADBAC

Guideline

Number Test Substance MRID Results Toxicity Category

870. 110 0 Acute oral, rat BQ451-8 Bio c ide (Pu r ity 82 .2 6%) 4510 920 4 LD50 =304. 5 m g /kg (co m bined)

LD50 =510. 9 m g/kg (m ales)

LD50 =280. 8 m g /kg (females) II



### 10

### Guideline

Number Test Substance MRID Results Toxicity Category

870. 120 0 Acute dermal, rat BQ451-8 Bio c ide (Pu r ity 82 .2 6%) 4510 920 2 LD50 =930 m g /kg (co m b i ned)

LD50 =1100 m g/kg (m ales)

LD50 =704 m g /kg (females) III

870. 130 0 Acute inhalation,

rat (Pu r ity 82 .26%) 4488 520 1 0.05 4 < LC5 0 < 0.51 m g /L II

870. 240 0 Pri m ary Ey e Irritation Waived N/A I

870. 250 0 Pri m ary Dermal Irritation, , ra bbit BQ451-8 Bio c ide (Pu r ity 82 .2 6%) 4510 920 1 Corrosive I

870. 260 0 Der m al sensitization, guinea pigs BQ451-8 Bio c ide (Pu r ity 82 .2 6%) 4510 920 1 Not a der m al sensitizer N/A



### The doses and toxicological endpoints selected for the dietary exposure scenarios are
summarized in Table 2 below.

Table 2. Summary of Toxicologi cal Endpoints for ADBAC (Dietary)

Ex pos u r e Scena r io Dose U s ed in

Risk As sessm e n t

(m g/ kg/ day ) Target M O E or UF, Special FQPA SF

fo r Risk As ses s m e nt St udy a n d T o x i col ogi cal E ffe ct s

Acute Dietary (ge n eral

p opu latio n ; fem a les 13+) An acu te d ietary en dpo in t was no t id en tified i n th e d a ta b a se.

Chronic Dietary NO AEL =4 4

m g / kg/ day FQP A SF = 1

UF = 100 (10x inter-species

extra polation, 10x i n tra-speci es vari at i o n) C h r oni c t oxi ci t y / carci no geni c i t y –rat

MRI D 4 194 750 1

LOA EL = 8 8 m g / kg/ day , b a s e d on decrease d b o d y wei g ht an d w e i ght gai n Chr o nic Rf D = 0. 4 4 m g / kg/ day

UF = unce rtainty factor, FQPA SF = FQ PA safet y fact o r , NO AEL = no obs er ved adve rse effect level, LOAEL =

l o west o b ser v e d a dve rse e ffec t l e vel , R f D = r e fere nce do se, M O E = m a rgi n o f e x p o s u re , L O C = Le vel of conce r n, NA = No t Ap plicab le.



### 11

### Dietary

Acute dietary risks were not assessed becau se an endpoint ap propriate for acute d i etary

assessm ent was not iden tif ied in th e available A D BAC database.

For ADBAC, a chronic toxicity/carcinogenic ity study was conducted in rats. This study
established the RfD of 0.44 m g/ kg/day based on decreased body wei ght and weight gain in m a le rats at 88 mg/kg/day. A n uncertainty factor of 100 (10X for interspecies extrapolation, 10X for intraspecies variation) was applied to the NOAEL to obtain the chronic RfD.

Inciden t al O r al

The short- and interm ediate-term incident al oral NOAE L is 10 m g /kg/day fro m a rat developm ental toxicity study that noted decrea sed body weight and decreased food consum ption

at 30 m g /kg/day.

Short-term Derm al

The short-term der m al NOAEL is 20 mg/ kg/day based on denuded non-vascularized epiderm al layer from a 21-day derm al toxicity study on a 4% active i ngredient form ulated product. The uncertainty factor or “target” MO E for ADBAC derm al exposures is 10 for occupational and residential scenarios. The target MOE was chosen becau se the es tab l ished endpoint is for derm al irritation, not a system ic toxic effect. In addition, derm al irritation is considered a reversible and short-term effect, thus supporting a 10x uncer tainty factor (3x for interspecies extrapolation and 3x for intraspeci es variation). It should be noted that the

determ ination to reduce the 100x UF to 10X UF for irritation endpoints is m a de on a c a se-bycase bas i s.

Interm ediate -Term Dermal

The inte rm ediate -te r m derm al NOAEL is 20 m g /kg/day since it was the highest dose

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

ADBAC derm al exposures are 10 for o ccupational and residential scenarios. The target MOE

was chosen because the estab lished endpoint is for derm al irritation, not a system ic to xic effect. The Agency has reev alu a ted th is value because th e estab lish ed endpoint is for derm al irritation, not a systemic toxic effect. In addition, derm al irritation is co nsidered a revers ib le and short- term effect, thus supporting a 10x uncertainty factor ( 3 x for intersp ecies extrap olation and 3x for

intr aspec i es varia tion )

. It should be noted that the determ ination to reduce the 100x UF to 10X UF for irritation endpoints is m a de on a case-by-case basis.

Short,- Interm ediate,- and Long-term Inhalation

The short-, interm ediate-, and long-term inhalation NOAE L is 3 m g/kg/day based on the hyperactivity and labored breathing at 9 m g/kg/da y in an oral developm ental study in rabbits

. In
the absen ce of route-specific da ta, it was conservatively assum e d that inhalation absorption is equivalent to oral absorption (i.e., 100%). Fo r inhalation exposures, th e target MOE is 100 for occupational and residential scenarios, (10x in terspecies extrapolati on and 10x interspecies

12

### variab ility). However, if the resu ltin g MOE is not at leas t 10 0, the Agency can reques t a rep eat dose inhalation study of at least 28 days in duration.

Carcinogenicity Classification

The database for carcinogencity is comple te, and ADBAC is not carcinogenic based on
studies in rats and m i ce.

Mutagenicity Potential

The data base for m utagenicity is consider ed adequate and indicates that ADBAC is not mutagenic or genotoxic.

Endocrine D i sruption Potential

EPA is required under the FFDCA, a s am e nded by FQPA, to develop a screening

program to determ ine whether certain substanc es (including all pes tic ide a ctive and other ingredients) “m ay have an effect in hum ans that is sim ilar to an effect produced by a naturally occurring estrogen, or other such endocrine e ffects as the Adm i nistrator m a y designate.” Following recomm endat i ons of its E ndocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined tha t the r e was a sc ie ntific basis for including, as part of the

program , the androgen and thyroid horm one syst em s, in addition to the estrogen hormone
system

. EPA also adopted EDSTAC’s recomm enda tion that the Program include evaluations of potential effects in wildlife. For pesticide chem icals, EPA will use FIFRA and, to the extent that

ef

f ects in wildlif e m ay help determ ine whether a substance m a y have an effect in humans, FFDCA authority to req u ire the wild lif e evalu ati ons. As the science de velops and resources allow, screening of additional horm one system s m a y be adde d to the Endocrine Disruptor Screening P r ogram (EDSP).

When the appropriate screening and/or te sting protocols being considered under the EDSP have been adopted, ADBAC m a y be subject to additional screening and/or testing to

better characterize effects rela ted to endocrine disruption.

2. FQPA Safety Factor

The FQPA Safety Facto r (as required by the Food Quality Protection Act of 1996) is intended to provide an a ddition al 10 -f old saf ety f actor (10X)

, to protect f o r special s e nsitiv ity in infants and children to specific pesticide resi dues in food, drinking wa ter, or residential
exposures, or to com pensate for an incom plete database. The FQPA Sa fety Factor has been

rem oved (i.e., reduced to 1X) for ADBAC ba sed on (1) the ex isten ce of a com p lete developm ental and reproductive t oxicity database, (2) the lack of evidence for increased susceptibility in these data, and (3) the risk assessm e nt does not underestim ate the potential riks

for infants and children. The FQPA Safety F actor assum e s that the exposure databases (food, drinking water, and residential) are com plete, th e risk assessm e nt for each potential exposure

scenario includes all m e tabolites and/or degrad ates of concern, and does not underestim ate the potential risk for infants and children. These cr iteria have been m e t for ADBAC. The Agency

13

### determ ined that no special FQPA Safety Facto r was needed s i nce there were no res i du al uncertainities for pre- an d/or postnatal toxicity.

3. Population Adjusted Dose (PAD)

Dietary risk is characterized in term s of the Population Adjusted Dose (P AD), which reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA Safety Factor (SF). This calcula tion is perform e d for each pop ulation subg roup. A
risk estim ate that is less than 100% of the acute or chronic PA D is not of concern.

a. Acute PAD

Acute dietary risks for A D BAC were not asse ssed because an endpoint ap propriate for
acute d i etary assessm ent was not for ADBAC.

b. Chronic PAD

Chronic dietary risk for ADBAC is asse ssed by com paring chr onic dietary exposure
estim ates (in m g/kg/day) to the chronic Populatio n Adjusted Dose (cPAD). Chronic dietary risk is expressed as a percent of th e cPAD. The cPAD is the chroni c reference dose (0.44 mg/kg/day) modified by the uncertainty factor. T he cP AD wa s derived from a chronic toxicity/ carcinogencity study in the rat, in which th e NOAEL (44 m g/k g/day) and the LOAEL ( 88 mg/kg/day) were determined based on decreased body weight and weight gain

. The ADBAC
cPAD is 0.44 m g/kg/day based on a reference dose of 0.44 m g /kg/day and a FQPA safe ty factor
of 1X.

4. Dietary Exposure Assumptions

The antim icrobial use of ADBAC on f ood contact surfaces, agricu ltural p r em ises, poultry prem ises including hatcheries and applica tion to food-grade eggs m ay result in pesticide
residues in hum a n food. Residues from the us e of ADBAC for food c ontact sanitization on
treated su rfaces, such as food utensils, counterto ps, equipm ent, and appliances, can m i grate to food com i ng into contact with the treated su rfaces and can be ingested by hum a ns.

In addition to food contact su rface sanitizer uses, this assessm ent also analyzed residues
from hard nonporous su rfaces that h a ve been trea ted with A D BAC as a disinfectant after rinsing with potab le water. In th e absence of transfer residue data for these ADBAC disinfectant uses, the Agency assum e d that rinsing with potable water cannot remove all residues deposited on the
treated su rfaces. Theref ore, residues from the treated and rinsed surf aces m a y m i grate to food

com i ng into contact with these su rfaces and then be inge sted by hum a ns.

In the absen ce of data for residues of ADBAC on treated food contact surf aces, th e Agency estim a ted residue levels that m a y o ccur in food from the a pplication rates on food
contact surf aces such as utensils and countertops. In addition

, the food packaging and beverage bottling uses have also been evaluated.

ADBAC products m a y be applie d to the shells of food gr ade-eggs in egg processing plants. Although it is po ssible that som e sanitizer/disinf ectant chem icals m ay penetrate egg

14

### shells, at this tim e, the Agency believes that th e amount of the chem ical transferred into eggs is likely to be m i ni m al because the egg s m u st be subj ected to a potable water ri ns e if they are to b e imm e diately broken for use in the manufacturing of egg products.

There is no evidence tha t ther e will b e resi du es of ADBAC in mushroom s f o llowing its

use as a m ushroom hous e disinfectant. Further, if dietary exposures from mushroom house uses occurred they would be expected to be m uch lo wer than the dietary exposures resulting from the
surface dis i n f ectant and s anitizing us es because th e la bel states that the pro duct is no t b e applied
to the m u shroom crop, com post or casing and treated surfaces are to be rinsed with potable water before contact with the crop, com pos t, or casing. Since these exposures are not likely to pose risks of concern, and the sanitizi ng u s es represen t a “worse-case” scen ario, these uses were not
assessed.

The Agency assessed the chronic dietary exposure due to ADBAC use as a disinfectant
and food contact sanitizer on di rect and indirect food-cont act surfaces. T h is assessm e n t calcu lated th e Daily Die t ary Dose (D DD) and the Estim ated Daily In take (EDI). The assessm ent considered: application rates, residual solution or quantity of solution rem aining on th e trea ted
surface with out rins ing with potab le water, surface area of the treated su rface which com e s into contact with food, pesticide m i gration fraction, and body weight. These assum ptions are based on FDA gui delines (FDA, 2003). However, in assessing dietary exposures from ADBAC in food packaging and beverage bottling, a num ber of assum p tions were m a de based on the EPA guidelines (2005) for the pesticide m i gration fracti on residual solution, daily food intake rates, application rate, and g r am s of food per surface area of container.

The EDI calculations presented in this assessm ent assum e s that food can contact 2,000cm 2 

### or 4,000 cm 2 

### ( 50% and 100% of the FDA worse cas e scen ario ) of treated s u rfaces, and that 10% of the pesticid e would m i grate to food. The use of th e 10% transfer rate instead of the
use of a 100% tran sfer rate was used for a ll ind i rect food con t act surfaces except for food packaging and bottling s urfaces. Th e 10% m i gr ation rate is b a sed on Agency Residen tial Standard Operation Procedures. These dail y estim a tes were conservatively used to assess chronic dietary risks (i.e ., percent chronic population adjusted dose or %cPAD).

5. Dietary Risk Assessment

A summ ary of the chronic risk estim a tes are shown in Table 4a and b. Based on a review of product labels containing ADBAC, food ha ndling establishm ents and food processing facilities, have been identified as having the potential to cause indirect dietary exposure due to
indirect foo d contact on the followin g surfaces:

1. Utensils

2. Countertops

3. Food bottling/Packaging

a. Dietary Risk from Food

A dietary risk assessm ent was conducted for three of the five dire ct and indirect food
contact surf aces listed above; as exp l ained p r ev iously exposures from poultry h a tcheries and
mushroom houses were not assess ed. Acute dietary risks were not as sess ed because an acute

15

### toxic ity va lu e was not id entif ied. However, the chronic dietary assessm ent concluded that for all
included u ses, the chron i c risk estim a tes are belo w the Agency’s level of concern for adults and
the m ost highly exposed population subgroup, chil dren (<4% of the cPAD). Any potential additional exposure as the result of the egg a nd mushroom house uses of ADBAC would not be expected to contribute signifi cantly to overall dietary exposure and would not im pact the %cPAD in a significant way.

Table 4a: Calculated EDIs and cPAD for Utensils a nd Countertops (The Aggregate represents
the to tal ch ronic population adjusted dose (cPAD) for both su rfaces)

Utensils Counter tops Ag gre g a t e Exposure

Grou p EDI (mg/day ) DDD (mg/kg/d) % cPAD a EDI (mg/day ) DDD (mg/kg/d) % cPAD a EDI (mg/day ) DDD (mg/kg/d) % cPAD a



### Adult

ma l e s 0. 08 1 5 0. 00 1 16 0. 26 5 0. 08 1 5 0. 00 2 43 0. 26 5 0. 25 2 0. 00 3 59 0. 53 0


### Adult

fe mal e s 0. 08 1 5 0. 00 1 36 0. 30 9 0. 08 1 5 0. 00 2 84 0. 30 9 0. 25 2 0. 00 4 19 0. 68 0


### Children 0. 08 1 5 0. 00 5 43 1. 23 0. 17 0 0. 01 1 3 1. 23 0. 25 2 0. 01 6 8 2. 46 

### a % PAD = exposure (D DD) /(cPAD) x 100.

EDI is the estim ated daily intake (m g/day). DDD is the dietary daily dose (m g/kg/day).

For food and beverage packaging/bottling, EDI va lues were calculated using an approach
sim ilar to that used for treated food contact surfaces and utensils. The m a xim u m application rate for ADBAC for bottling/packing of beverages an d food is 0.0103 lbs a.i. per gallon of treatm ent solution. Exposure was assum e d to occur through the ingestion of three food products that m i ght be packaged with treated m aterial: m ilk, e gg products, and bevera ges (alcoholic and nonalcoholic). None of the calcu lated % cPad valu es exceed ed 100% are no t of concern. The results of the EDI and %cPAD are presented in Table 4b.

16

### Table 4b. Calculated EDIs and cPAD for Repres entative Dairy and Beverage Consumption

Food Type Exposure Group EDI (mg/day) DDD % c P A D

Milk Adult Male

3.8 x 10 -3 

### 5.37 x 10 -5 

### (mg/kg/d )

1.2 x 10 -2



### Adult Fem ale 3.86 x 10 -4 

### 1.4 x 10 -2



### Child a 

### 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 Fem ale 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 Fem ale 1.96 x 10 -6 

### 1.2 x 10 -3



### Child a 

### 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 Fem ale 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 ornam e ntals and turf, and is used

for m osquito control in ponds and puddles and as an algaecide in decora tive pools. Since the

uses are ornam e ntal and periodic in nature, disc on nected from the larger w a tersh e d, the Agency believes exposures to drinking water sources from th ese uses are not exp ected to be s i gnifican t.
For the dr in king water a ssessm ent, only the turf and nursery uses for ADBAC were considered. Foliar spray, drench a nd “dribb le” ap plicati ons are allowed.

The Tier 1 surface water and ground water m odel was used to assess app l ication s to

ornam ental plants, this use repr esen ts the high est application rate of all labeled uses, of 302 lbs. a.i/Acre, an d a m a xi m u m of 3 application s per y ear

. Since the tier I m odels are not dependent on “crop” type, the Estim a ted Drinki ng Water Concentrations (EDWCs ) determ ined for the nurse ry

ornam ental use are also protective of all other uses with lower a pplication rates. Th e EDW C s f o r the hum an health risk as sessm ent are in Table 5.3 and are based on the nursery ornamental use
pattern. There were no m a jor degradates of ADBAC in the laboratory studies (EFE D Me m o by Marietta Echeverria to Jacque line Cam pbell-McFarlane: Tier I Drinking Water Assessm e nt for alkyl*dim ehtyl benzyl ammonium c h lori de (50%C14, 40%C12, 10%C10) (ADBAC) and Didecyl dim e thyl amm o nium chloride, (DDAC) , dated 2006).

An acute oral toxicologica l endpoint was not established for ADBAC. Therefore, only the chronic drinking water exposur e is calculated. The adult ch ronic drinking water dose is

0.009 m g/kg/day (i.e., average EDWC 331 ug/L x 2 L/day consum ption x 1/70 kg BW ). The chronic drinking water dose for children is 0.022 mg/kg/day (i.e., aver age EDWC 331 ug/L x 1 L/day consumption x 1/15 kg BW ). There are no drinking water concerns with ADBAC as the

concentratio ns are m u ch lower than level of concern.

17

### Table 5.3. Tier I Esti mate d Drinking Water Conc entrations (EDWC s ) Ba sed on Aeria l Application of ADBAC o n Nurse ry Ornamentals

Drinking Wat e r Source (Model) Use rat e (lbs ai/A/y ear) EDWC (ppb)

Surface wat e r (FIRST)

Acute (peak)

- Chronic (annual average) 906

13,1 29

331

Groundwater (SCIGROW) 906 5.4



### It should be noted that the Agency estim at ed concentrations for exposure to aquatic
anim als resulting from the antisapstain and cooling tower uses. These levels were not considered appropriate for use in the drinking water assessm en t due to the very conser vative nature of the models used, that the m o del estim ates runoff/ point source concentrations and not water body
concentratio ns, and the fact th at th e models does not account for dilution.

6. Residential Risk Assessment

The resid ential expo sure assessm ent considers all potential pesticide exposure, other than exposure due to residues in food or in drinki ng w a ter. Exposure m a y occur during and after application as a hard su rface disi nfectant o r non-food contact saniti zer (e. g., walls, flo o rs, tab l es, fixtures), to textiles (e.g. clot hing), and to carpets. Each route of exposure (oral, derm al, inhalation) is assessed, where appr opriate, and risk is expressed as a Margin of Exposure (MOE),
which is the ratio of estim a ted expos ure to an appropriate N OAEL.

a. Toxicity

A MOE of 100 for inhalation exposure and or al exposures and a 10 for derm al exposure are considered protective. The MOE of 100 is based on a 10x interspecies and 10x intraspecies variability w hile the MO E of 10 is based on a 3x interspecies and 3x intr aspecies variability. The toxicological endpoints and a ssociated uncertainty factors used for asse ssing the non-dietary,
residential risks for ADBAC are listed in Table 6a.

Table 6a. Toxicological Endpoints Selected fo r Residential and Occupa tional Toxicological
Risk s for ADBAC

Ex pos u r e Scena r io Risk As sessm e n t Dose U s ed in

(m g/ kg/ day ) Target M O E or UF, Special FQPA SF

fo r Risk As ses s m e nt St udy a n d T o x i col ogi cal E ffe ct s

Inci dental Oral

(sh o rt -term ) NO AEL = 10

m g / kg/ day FQP A SF = 1

UF = 100 (10x inter-species

extra polation, 10x i n tra-speci es vari at i o n) Devel opm ent a l To xi ci t y – R a t

, MRI D 4 235 150 1

LO AEL = 100 m g /k g /d a y, based

on dec rease d b ody wei g ht a n d

fo o d c ons um pt i on



### 18Ex pos u r e Scena r io Risk As sessm e n t Dose U s ed in

(m g/ kg/ day ) Target M O E or UF, Special FQPA SF

fo r Risk As ses s m e nt St udy a n d T o x i col ogi cal E ffe ct s

Inci dental Oral (interm e diate-term ) NO AEL = 10

m g / kg/ day FQP A SF = 1

UF = 100 (10x inter-species

extra polation, 10x i n tra-speci es vari at i o n) Devel opm ent a l To xi ci t y – R a t

, MRI D 4 235 150 1

LO AEL = 100 m g /k g /d a y, based

on dec rease d b ody wei g ht a n d

fo o d c ons um pt i on

Short-Term

Derm alNO AEL= 2 0 m g ai / kg/ day

( 333 μg /cm 2 ) FQP A SF = 1

UF = 1 0 (3 x i n ter-s pecies

ex trap o l ation

, 3 x in tra-sp ecies

vari at i o n) 21

- d ay de rm al t oxi ci t y - g u i n e a

p ig s MRI D 411 058 01

LO AEL = 1000 m g /k g /d a y,

base d on de n u d ed n o n

v a scu l arized ep id erm a l la yer

In term ed iate-Term

Derm al NO AEL= 2 0 m g ai / kg/ day

(8 0 u g /cm 2 ) UF = 1 0 (3 x i n ter-s pecies

ex trap o l ation

, 3 x in tra-sp ecies

vari at i o n) 9 0 -d ay d e rm al to x i city in rats

MRI D 4 149 960 1

20 m g / kg/ day i s t h e hi g h est d o se

tested be fore i r ritation became

si gni fi ca nt

Lo ng -Term De rm al (TG A I ) No ap p r o p ri at e en dp oi nt i d e n t i f i e d. N o sy st e m i c effect s o b s e rve d u p t o 2 0 m g / kg/ day , hi g h est
dos e of t e c hni c a l gra d e t h at co ul d be t e st e d w i t hout i rri t a t i o n effect s

.

In hal a t i ona (A ny t i m e poi n t ) NO AEL= 3

m g / kg/ day

MO E = 10 0 c UF = 100 (10x inter-species

extra polation, 10x i n tra-speci es vari at i o n)

No te: an add itio n a l 1 0 x is u s ed for

rou t e ex trapo l atio n to d e term i n e if a

co nfirm a to ry stu d y is n e ed ed Dev el o p m en tal Tox i city – rabb it,

MRI D 4 239 280 1

LOA EL = 9 m g / k g/ day

, base d on clin ical sig n s of tox i city in

m a ternal ra bbit s

UF = unce rtainty factor, FQPA SF = FQ PA safet y fact o r , NO AEL = no obs er ved adve rse effect level, LOAEL =

lo w e s t ob s e rv ed ad v e r s e ef f e ct le v e l, MO E = m a rg in of ex po sure, NA = No t App licab le.

aA n add itio nal un certain ty facto r o f 10x is ap p lied fo r us e o f an oral endpo in t for rou t -to-ro u t e ex trapo l atio n to
d eterm in e if con f irm ato ry inhalati o n tox i city stud y is warran t ed

. b De rm al endpoi nt = (2 0 m g / kg g u i n ea pi g x 0. 4 kg g u i n e a pi g x 1 0 0 0 u g / m g) / 2 5

. 8 μg / c m 2 area of guinea pig

dos ed = 33 3 μ g / c m 2

. c TG AI

- b ased derm al end poi nt = (2 0 m g / k g rat x 0. 2 kg rat x 1 0 0 0 u g / m g) / 1 00μ g/ cm 2 area of rat dose d = 40 μg/cm 2

.



### b. Residential Handlers

i. Exposure Scenarios, D ata and Assumptions

For antim icrobial uses, reside ntial exposure m a y occur during application of ADBAC as a

hard surface disinfectant or sani tizer (e.g. walls, f l oors, tables, fi xtures), to textiles, m usical

instrum ent mouthpieces , carpe ts, swimm i ng pools, a nd hum idifiers. In ad dition to the trad ition al

antim icrobial uses of ADBAC described above, it m a y also be used outdoors to treat ornam e ntal plants, lawns, and puddles/ponds /swimm ing pools. For this assessm ent, hom eowners are

assum e d to com p lete all elem ents of an appli cation (m ix/load/apply) wit hout the use of personal protective equipm ent.

19

### The following exposure scenarios were assessed for ADBAC:

• Indoor hard surfaces (e.g ., m opping, wiping, trig ger pum p sprays)

• Air deodorizers

• Carpets

• Swi m m i ng Pools (e.g., liquid pour)

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

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

• Musical ins t rum ent m o uthpieces; an d

• Hu m i difiers

• Ornam ental Plants

• Lawns

The antim icrobial residential handler scenar ios were assessed to determ ine derm al and inhalation exposures. S urrogate derm al and i nhalation unit exposure values were estim a ted using Pesticide Handler Exposure Database (PHED) data, the Chem ical Manufacturers

Association Antim icrobial Exposure Assessm ent Study (USEPA, 1999), Outdoor Residential Exposure Task Force data (ORETF).

The quantities handled/treated for the handler scenarios were estim a ted as indicated

below: For additional inform ation, please re view the Alkyl Dim e t hyl Benzyl Ammonium Chloride (A DBAC) Occupational and Residentia l Exposure Assessm ent (Antim icrobial Uses) dated July 27, 2006.

• For moppin g scenar ios, it is assum ed that 1 ga llon of diluted solution is used.

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

diluted solution is used.

• For aerosol sprays , it is assum e d that one can is use d. The net weight of the can was not provided on the label; therefore, it was assum e d that the can contained 16-oz of product.

• For low pressure hand wand

, it was assum e d that 2 gallons are used in all indoor applic ation s

.

• For liquid pour in swimming pool scenario, it w a s assum e d that a residential pool contains 20,000 gallons of water.

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

treated. The product label st ates a maxim u m application rate of 4 oz (0.031 gallons) product per tank.

• For m i xer/loader/applicators scenarios:

For agricultural exposures, residential exposures m a y occur during the application of

ADBAC to ornam e ntal plants, shrubs, trees as w e ll as seedlings, seeds, and cuttings,

residential/comm ercial turf, gol f courses, and fountains/wate r displays, sewage treatment
system s, standing water for m o squito control. As with the an tim icrobial use, hom eowners are

assum ed to com p lete ele m ents of an applic ation ( m ix/load/ap p ly) withou t the use of personal protective equipm ent.

20

### The quantitative exposure/risk a ssessm ent developed for reside ntial handlers is based on

these scenarios. For addition a l in for m ation, please rev i ew the Alkyl Dim e thyl Benzyl

Ammonium Chloride (ADBAC) Occupationa l and Residential Exposure Assessm e nt (Agricultural Uses) dated August 1, 2006

Mixer/Loader/Applicators: (1) Liquid Formulations: Low Pressure Handwand (PHED data for derm al and ORETF data for inhalation) (2) Dry Flowable Form ulations: Low Pre ssure Handwand (using liquid concentrate

PHED data for derm al and liquid con centr ate ORETF data f o r inhala tion ) (3) Liquid Concentrates: Hose-End Sprayer (PHED data for derm al and ORETF data

f o r inhala tio n) (4) Dry Flowable Form ulations: Hose-E nd Sprayer (no data) (5) Ready-to-Use Form ulations: Hose-E nd Sprayer (no data) (6) Liquid Concentrates: W a tering Can (using PHED hose-end sprayer data for

derm al and ORETF hos e-end data for inhalation) (7) Ready to Use Form ulations via Trig ger-Pum p Sprayer (PHED data for a e rosol can for dermal and ORETF data for inhalation), and (8) Dip or Soak Applications (no data)

Since no toxicological endpoint of concern was identified fo r derm al system ic adverse effects, both the handler and the post-appli cation derm al risks were assessed using the toxicological endpoint for derm al irritation. The duration of exposure for hom e owner handler exposures is believed to be the short-term duratio n (1 to 30 days). The short term duration was chosen because the handler and pos t- applic ation s cenar io s are assum e d to be episodic, not a daily

occurrence.

ii. Risk Assessment

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

derm al and inhalation exposure assessm e nts. As noted previously, MOEs greater than or equal to 100 for the inhalation route of exposure and 10 for derm al exposure are considered protective for the residential exposure assessment.

Antim icrobial Uses

A summ ary of the residentia l handler inhalation risks are presented in Table 6b. The

calcu lated in halation MO Es 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 Scen ar io
Application Method Application Method Applica tion R a te a Quantit y H a ndle d /

Treated per day b MOE c

(Target MOE = 100)

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

Wiping 0.025 lb ai/gal 0.13 gallon 820



### 21c Exposure Scen ar io
Application Method Application Method Applica tion R a te a Quantit y H a ndle d /

Treated per day b MOE c
(Target MOE = 100)

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

Air deodorizatio n Aerosol Spray 0.2% ai b y weig ht 1 can (1 lb) 38,000

Applica tion to C a rpets Low Pressure Spra y 0.014 lb ai/gal 2 gallons 9,200

Application to S w imming Pools Liquid Pour 0.000052 lb ai/g al 20,000 gallons 50,000

Application to R V holding tanks Liquid Pour 0.834 lb ai/gal 0.031 gal (1 tank

at 4 oz product/tank) 3,700

a Applica tion r a t e s are the m a xim u m applic ation r a tes d e te rm ined from EPA regist ered lab e ls for ADBAC.

b Amount handled per d a y v a lu es are es timates or labe l instructions

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

100.



### A summ ary of the residential handler derm al ri sks are presented in Table 6c. The derm al

MOEs for all form ulations assessed are above th e target MO E of 10, and therefore, are not of

concern.

Table 6c: Short-Term Resident ial Handler De rmal Ris k s

Exposure Scen ar io Applica tion

Method Applica tion

Rate a (lb ai/gal) Quantit y Handled/ Tr eat e d per day b Hand Unit Exposure Adjusted for

S u rface

Area
(m g/lb

ai/ cm 2 ) c Dermal Skin

Irrita tion Exposure d

(μg/cm 2 ) 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 in door

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 deodorizatio n Aerosol Spray 0.2% ai b y weight 1 can (1 lb) 0.129 0.259 1,300

Applica tion to Carpets Low Pre ssure Spray 0.014 lb ai/gal 2 gallons 0.161 4.615 72

Applica tion to R V 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

Applica tion to swimming pools Liquid Pour 0.000052 lb
ai/g al 20,000 gallons 0.000239 0.25 1,300

a Applica tion r a t e s are the m a xim u m applic ation r a tes d e te rm ined from EPA regist ered lab e ls for ADBAC.

b Amount handled per d a y v a lu es are estimates or label instructions

. Unit Exposure ( m g/lb ai/cm 2 ) = Unit Exposure fr om PHED or CMA (mg /lb ai) / surface area of h a nd (820 cm 2 ).

d Dermal Skin Irr itation Exposure (μg /lb ai/cm 2 ) = Unit Exposure ( m g/lb ai/cm 2 ) x Application R a te (lb ai/g al) x Quantity Treated (gal/day ) x 1

, 00 0 : g/mg

e MOE = NOAEL (μg /cm 2 )/ Surface R e sidue on S kin (μg/cm 2 ). [ W here short-ter m derm al form ul ated-b as ed NOAEL = 333 μg/cm 2 ]

. Ta rget MOE = 10

.



### 22 c

### Agricultural Uses

A summ ary of the agricu ltur al r eside ntia l ha ndler 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 In halati on Risks to Resid e ntial Handlers

S cenario Crop/Targ et Applica tion

Rate a Quantit y Handled/

Trea ted per day s Inhalation

Unit Exposure (ug/lb ai) c Inhalation Exposure d Inhalation

Dose e Inhalation

MOE f

Residential Turf

, Ornamental Bu lbs and

Orchids 0.0065 lb ai/g al wa ter 5 gal/day 30 0.000975 0.000016 180,000

M/L/A Liquid

Concentr ates w it h LP Handwand (1) Ornamental

Herbaceous P lan ts

, Ornamental Shr ubs, Ornamental Trees, Seedlings (p lant ed in garden), S eed lin gs ,

Seeds, Cuttings (preplan t or at plant) 0.0043 lb ai/g al wa ter 5 gal/day 30 0.00065 0.000011 280,000

M/L/A DF with Low
Pressure Handwand (liquid concentr ate
PHED data as surrogate) (3) Residential Turf

, Ornamental Bu lbs and

Orchids 0.0065 lb ai/g al wa ter 5 gal/day 30 0.000975 0.000016 180,000

Ornamental

Herbaceous P lan ts

, Ornamental Shr ubs, Ornamental Trees, Seedlings (p lant ed in garden), S eed lin gs ,

Seeds, Cuttings (preplan t or at plant) 0.0043 lb ai/g al wa ter 5 gal/day 30 0.00065 0.000011 280,000

Residential Turf 7 lb ai/A 0.5

acres /d a y 17 0.06 0.00099 3,000

M/L/A Liquid

Concentr ates w it h a Hose-end Sprayer (4) Ornamental

Herbaceous P lan ts

, Ornamental Shr ubs, Ornamental Trees, Seedlings (p lant ed in garden) 0.43 lb ai/A 0.25

acres /d a y 1.6 0.00017 2.9E-6 1,000,000

M/L/A Liquids with a Watering C a n (P HED Orna me nt a l Pa lms 0.013 lb ai/g al wa ter 5 gal/day 1.6 0.001 1.7E-6 1,700,000

residential hose- end data as surrogate) (8) S eedlings

, S eeds

, Cuttings (pr e plant or
at p lant) 0.0043 lb ai/g al wa ter 5 gal/day 1.6 0. 000034 5.7E-7 5,200,000

Apply i ng R ead y to

Us e F o rm ulation s via Trigger-Pump

Spray e r (9) Ornamental Shr ubs,

S eedlings

, S eeds

, Cuttings (pr e plant or
at p lant) 0.0043 lb ai/g allon 1 gal/day 19 0.000082 1.4E-6 2,200,000

a Application rates a r e the m a xi m u m a pplication rates deter m ined f r o m EP A registered l a bels f o r ADBAC

b Am ount handled p e r day valu es ar e based on E xposur e SAC SOP #12, and HE D estim a tes.
Baseline I nhalation: no r e spir ator

. d Baseline inhalation exposur e (m g/day ) = a pplication r a te ( l b ai/gal ) x a m o unt ha ndled per day ( g al/day ) x inhalation unit ex pos ur e ( μ g/lb ai) x conver s ion factor fr o m μ g to m g ( 0. 001)

e Baseline inhalation dose (m g / kg/day ) = ba seline inhalation expos ur e (m g/ day ) x inhalation absor p tion factor ( 100%) / fem a le body weight ( kg)



### 23 cf Inhalation MOE = inhalation NOAEL ( 3 m g /kg/day) / i nhalation dose ( m g / kg/day)



### A summ ary of the residential handler derm al ri sks are presented in Table 6c. The derm al

MOEs for all form ulations assessed are above th e target MO E of 10, and therefore, are not of

concern.

Table 6e: ADB AC S h ort-term Dermal Risks to Residential Handlers

S cenario Crop/Targ et

Residential Turf

, Ornamental Bu lbs

and Orchids Applica tion

Rate a

0.0065 lb ai/g al wa ter Quantit y Handled Per Day b

5 gal/day Unit Exposure for

Hands c (mg/lb ai)

102 Es tim ated

Residue

Trans f erred

to Skin on Hands (ug

ai/ cm 2 /da y ) d

4.0 Dermal

MOE (UF =

10 ) e

82

M/L/A Liquid

Concentr ates w it h LP Handwand (1) Ornamental

Herbaceous P lan ts

, Ornamental Shr ubs, Ornamental Trees, Seedlings (p lant ed in garden), S eed lin gs ,

Seeds, Cuttings (preplan t or at plant) 0.0043 lb ai/g al wa ter 5 gal/day 102 2.7 120

M/L/A DF with LP Handwand (liqu i d

concen trat e P H E D data as surrogate) (3) Residential Turf

, Ornamental Bu lbs

and Orchids 0.0065 lb ai/g al wa ter 5 gal/day 102 4.0 82

Ornamental

Herbaceous P lan ts

, Ornamental Shr ubs, Ornamental Trees, Seedlings (p lant ed in garden), S eed lin gs ,

Seeds, Cuttings (preplan t or at plant) 0.0043 lb ai/g al wa ter 5 gal/day 102 2.7 120

M/L/A Liquid

Concentr ates w it h a Hos e

end Spray e r (4) Residential Turf 0.0063 lb ai/g al wa ter 100 gal/day 27.5 21 16

Ornamental

Herbaceous P lan ts

, Ornamental Shr ubs, Ornamental Trees, Seedlings (p lant ed in garden) 0.0043 lb ai/g al wa ter 100 gal/day 27.5 14 23

M/L/A Liquids with a Watering C a n (P HED Orna me nt a l Pa lms 0.013 lb ai/g al wa ter 5 gal/day 27.5 0.7 460

residential hose- end data as surrogate) (8) S eedlings

, S eeds

, Cuttins (pr e plan t or at p lant) 0.0043 lb ai/g al wa ter 5 gal/day 27.5 0.1 2,300

Apply i ng R ead y to Use Formulations via Trigg e rPump Spra y e r (PHE D da ta

for aerosol can u s ed as surrogate) (9) Ornamental Shr ubs,

S eedlings

, S eeds

, Cuttings (pr e plant or
at p lant) 0.0043 lb ai/g allon 1 gal/day 106 2.8 120

Footnotes:

a Application rates a r e the m a xi m u m a pplication rates deter m ined f r o m EP A registered l a bels f o r ADBAC

b Am ount handled p e r day valu es ar e based on E xposur e SAC SOP #12 and HE D esti m a tes.

c Fr o m r e sidential PHE D unit exposur es va lues for hands for the scenar ios listed.

d Application r a te ( l b ai/gal) * a m ount handl ed per day ( g al/day ) * derm al u n it exposur es valu e ( m g/lb ai) * conver sion factor mg t o μ g (1000) / surface area of adult hands (820 c m 2 ) fr o m E x posur e Factor s Handbo ok.



### 24f Der m al M O E = E s tim a ted Residue transfer r e d to Skin of Hands ( μ g/cm 2 /d ay ) / Der m al E ndpoint ( 333 μ g/cm 2 /day)



### c. Residential Post-Applic ation

i. Exposure Assessment

Residential post application exposures resu lt when bystanders (adults and children) com e in contact w ith ADBAC in areas where products have been applied (e.g.. treated floors and carpets), or when children inadvertently ingest the pesticide residues through m outhing treated

item s (e.g., toys and fabric). The pos t-app lica tion scenar ios h ave been developed to represent a high end exposure scenario. Repres entative post-application scen arios for antim i crobial us es assessed include children crawling o n treated hard surfaces, carpets, and treated lum b er such as decks/play sets (derm a l and incidental oral exposure to children), w earing treated clothing (derm al exposure to adults and children and incidental oral e xposure to children), using air deodorizers (adult and child inhalation exposure) , using portable hum idifiers (adult and child inhalation exposure), sw imm i ng in treated pools (a dult and child incidental ingestion), and using

treated in strum ent m out hpieces and reeds (child and adult in cidental exp o sure). Derm al post application exposure to swimmers was not asse ssed because ADBAC is readily m i xed in the

water to a lo w concentra tion th at it d o es not pose any risk. R e presen tative post-application scenarios for agricultural uses as sess ed includ e adults contacting treated lawns and ornam e ntal plants (adult derm a exposure) and children’s incide ntal oral activities on treated lawns such as

hand-to-m outh activity, object to m o uth, and soil ingestion

. Data sources and m e thodologies include the HED Residential SOPs (USEPA 200 0, 2001), Residential and Residential Exposure Test Guidelines: Group B Post application Exposu re Monitoring Test Guidelines (1998), Hum a n and Environm ental Risk Assessm ent (HERA) Gu idance Docum e nt (2003 and 2005), the DDAC wood preservative task f orce study (MRID 455243- 04), the Multi-Chamber Concentration and Exposure Model (MCCEM), and the SW IMODEL.

Since no toxicological endpoint of concern wa s identified for derm al system ic adverse effects, post-application derm al risks were assessed using the t oxicological endpoint for derm al

irritation. T h e residential post- application derm al risks were assessed by com paring the surface residue on the skin (derm al irrita tion exposure) to the short-term der m al irritation endpoint. It

was assum e d that during the expos ure period the skin repeatedly c ontacts the treated surface until a steady

- state concentration of residu e is ach ieved on the skin

. Adults and children post application derm al risks were assessed for the antim icrobial uses; howev er, only adults were assessed for post-app lication derm al risks for th e agricu ltu ral uses becaus e the Agency believ es these are individuals that are expos ed to the chemical by engaging in activities at their residences previous ly treated with a pesticide.

ii. Risk Assessment

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

derm al, inhalation, incidental oral exposure assessm e nt for ADBAC. The inhalation and

inciden t al o r al target MOE of 100 is based on 10x interspecies and 10x intraspecies variability.

The derm al target MOE of 10 is based on 3x in terspecies and 3x intr aspecies variab ility.

25

### Antim cirobial Uses

The calcu lated derm al MOEs are abo v e the targ et 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 fr om the hum idifier. The inhalation MO Es for adults and children are 10 and 4, respectively. A summary of the resident ial post application are presented in Table 6d.

Table 6d. Residential Pos t-Application Risk Summary Exposure Scenario Der m al MOE Incidental Ing estion MOE Inhalation M O E Child pla y in g on flo o r 1,10 0 610 NA Child pla y in g on carpet 1,20 0 330 NA Clothing (1% residue transfer) 210 adu lts and

children 1900 NA Child pla y ing on decks/pla y sets (m axim u m exposure) 110 360 NA

Air deodorizer NA 5,70 0 adults

NA 1,80 0 childre n Swimm i ng NA Ranges fro m 500 t o 5, 600

for adults and children NA

Hu m i difiers

NA NA Adult 10 (24-hrs) Child 4 (24- hrs) Instrument mouthpiece/reed NA No data NA 

### NA = not assessed because negligible exposure is a ssum e d by that route for the exposure for the

scenario of concern.

Agricultural Uses

Table 6g presents the postappl ication MOE values calcu la ted f o r adults after hom e greenhouse, garden or turfglass applications of ADBAC for a short-term exposure duration. The

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

three s cena r ios with the dif f erent ap plica tion rate s. An MOE of less than 10 represents a risk of concern to the Agency.

Table 6g: ADBAC: Adult Residential Shor t-Term Dermal Risks for Postapplication Exposure

Exposure Scenario Route of Exposure Form ulation Application

Rate a 

### (lb a i/ac r e) Residue on

Skin b 

### MOE c 

### at Day 0

Exposure To Treated

Ornam ental Plants 0.43 0.96 350

Exposure to Treated Turf Derm al Spray 7 3.9 85

0.9 0.5 660

a Maximum application ra te on la bel ( l b ai/A).



### 26c b Residue concentration availa ble to be transferr e d on day 0 = app l ication rate in μ g/cm 2 (lb ai/g al * conversion f a cto r s (lb to μ g and A t o cm 2 ) * fr action of DFR or TTR availa ble on day 0 * per cen t of DFR or transf errable to skin (100 %).

Short-term Der m al MOE = der m al endpoin t (3 33 ug/cm 2 )/ residue con cen tratio n on skin



### A summ ary of the com bi ned risks from inci dental exposure for toddlers for applications

to hom e lawn for m a xi mum label application rate as well as the lower application rate (i.e. handto-m outh activity, object-to-m outh activities, and incidental soil ingestion and for hand-to-m outh

activ ity a t th e lower app l ication ra te) is rep r esen te d in tab l e 6h . An MOE of less than 1 00 represents a risk of concern to the Agency. For this scena r io, the m axim u m applicatio n rate (7 lb ai/A) resulted in a MOE of 76 while the lower con centration rate (0.9 lb ai /A) was not of concern

with a MOE of 590.

Table 6h: ADB AC: Combined Incident al Or al Risk Es timates - Toddlers

Postapplication Exposure Scenario Margins of Exposure (MOEs) (UF=100)

Short-Term Oral (Non-Dietary) Co m bined Short-Term Oral:

(Non-Dietary)

Turf application at 7 lb ai/acre Hand to Mouth 96

76 Object to Mouth 380

Inciden t al S o il Ingestion 29,000

Turf application at 0.9 lb ai/acre Hand to Mouth 740

590 Object to Mouth 3,000

Inciden t al S o il Ingestion 220,000

7. Aggregate Risk

The Food Quality P r otection Act (FQ P A) a m endm ents to the Federal Foo d, Drug, and

Cosm etic Act sec tion 40 8 (b)(2 )(A)(ii) requ ire “tha t there is reasonable ce rtainty that no harm

will result from aggregate exposure to pesticide chem ical residue, includ ing all an ticipated dietary exposures and other exposures for which there are reliable info rmation.” 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 id entified for ADBAC. Therefore, an acute aggregate risk assessm ent was not conducted. T h e chronic aggregate risk assessm ent includes only dietary and drinking water exposures because chronic expo sures are not expected from

residential uses. Chronic dietary risk estim ates from direct and indirect f ood uses are presented

in Section 5a

, and drinking water exposure estim ates ar e 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 indi rect food contact exposures) as we ll as a total dietary aggregate

27

### exposure estim a te (i.e., drinking water plus dire ct/indirect dietary exposures). Based on the

results of th e chronic ag gregate assessm ent, th e %cPAD for adults and children are 3.5% and 10.3%, respectively. Therefor e, the chronic dietary risks are not of concern (i.e., less then 100 % of cPAD).

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

Exposure Ro utes Chronic Dietary Ex posure s (m g/kg/da y )

Indirect Dietary Exposures a 

### Direct Food

Contact Dietary Exposures a 

### Drinking

Water Exposures Aggregate Dietary Exposures b 

### % cPA D c 

### (MOE)

Adults

Oral Ingestion 0.00 42 0.00 24 0.00 9 0.00 66 3.5% (2,800)

Children

Oral Ingestion 0.01 7 0.00 61 0.02 2 0.02 3 10.3 (980)

a Dietar y (indir e ct + direct food contact) e xposur es are presen ted in Tables 5.1 an d 5.2

. b Aggregate Dietar y Exposures = i ndir ect dietar y + dir ect food co ntact + drink i ng water exposures. c %cPAD (per cent chron i c population adjusted d ose) = (a ggreg ate exposures / cPAD) x 100. Where cPAD = NO AEL 44 mg/kg/day / 100 x uncer tain ty f a ctor = 0.44 mg/kg/day

. MO E = N OAEL of 44 mg/kg/day / aggregate d i etar y exposures mg/kg/day

.



### b. Short- and Intermed iate-Term Ag gregate Ris k
The short- and interm ediate-term aggregat e risks include pesticide exposures from dietary, drinking water, and re sid ential sou r ces. The f o llowing list summ arizes all o f the potential sources of ADBAC expos ures for adults and children.

Adult ADBAC exposure sources:

 

### handling of cleaning products containing ADBAC as an active ingredient during wiping, m opping, and spraying activities;

 

### applying products containing ADB AC to lawns/ornam e ntals;

 

### applying A D BAC as an air deodori z er using an a erosol sp ray ;

 

### applying A D BAC to carpets using a low pressure sprayer;

 

### applying A D BAC to swi m m i ng pools via open pouring;

 

### applying A D BAC to RV holdi ng tanks via open pouring;

 

### contacting pressure treated wood;

 

### wearing treated clothing;

 

### use of ADBAC in hum i difiers; and

 

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

Child ADBAC exposure sources:

 

### post-application exposures to cleaning pr oduct residues containing ADBAC that are

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

 

### breath i ng air treated with an ai r deodorizer or hum i difier;

 

### swimming in treated pools;

28 

### contacting pressure treated wood;

 

### wearing treated clothing/diapers;

 

### eating food having ADBAC residues from i ndirect or direct food contact.

The use patterns of the p r oducts and probabi lity of co-occurrence m u st be considered when selecting scenarios for incorporation in the aggregate as sessm ent. Table 6-2 su mmarizes

the scen ario s includ ed in the short- and interm ediate-term aggregate asses sm e nts.

Table 7b. Exposure Scenarios Incl uded in the Aggregate Assessments

Short-term (ST) Aggregate Interm ediate -Term (IT) Aggregate

Adults  chronic dietary (direct and i ndirect)

 han d l i n g cl ea ni ng p r od uct s (w i p e + t r i gge r

pum p s p ray )

 weari n g treate d clot hing

 h u m id ifier Oral: ST a n d IT endpoi nts are the sam e for

bot h du rat i o ns.

Derm al : ST en dp oi nt o n l y

.

In hal a t i on: Al l d u rat i o ns sam e en dp oi nt

.



### Children  chronic dietary

– (d irect and i ndi rect)

 post

- application to cleani n g product on

carpets (derm al and oral)

 weari n g treate d clot hing

 h u m id ifier Oral: ST a n d IT endpoi nts are the sam e for

bot h du rat i o ns.

Derm al : ST en dp oi nt o n l y

.

In hal a t i on: Al l d u rat i o ns sam e en dp oi nt

.



### The chronic dietary exposures were used in both the short- and interm ediate-term
aggregate assessm ent because ch ronic dietary ex posures occur nearly ev ery day (as opposed to acute dietary exposures occurring on a one-tim e basis). Therefore, short- or interm ediate-term non-dietary exposures have a m u ch higher probability to co-o ccur with the chronic dietary

intake.

Cleaning ac tivities in a r esiden tia l se tting o ccur on a short-term basis. However, the ADBAC-containing cleaning products ar e also labeled for use in institutional settings such as day-ca re f ac ilitie s where clean ing activities c an o ccur on an interm ediate-term basis. Therefore, children could have exposure to cleaning produc t residues on a m o re continuous basis in a day care facility, thus, thes e post-ap p lic a tion sc enar ios were inc l uded in the interm ediate- t erm aggregate as sessm ent.

Since the A D BAC toxicity endpoints for th e oral, derm al, and inhalation routes of exposure are based on different toxi c effects, these three routes of exposure are not aggregated together. In stead, the ag gregate assessm ent is ba sed sole ly o n the co-o ccurrence of the sam e route of exp o sure. Aggr egate risks were calcu la ted using the tota l MOE approach ou tlin ed in OPP guidance for aggregate risk assessm ent (A ugust 1, 1999, Updated “Interim Guidance for Incorporating Drinking Water Exposure in to Aggregate Risk Assessm ents”).

Table 7c presents a sum m a ry of the short- and interm ediate-term aggregate risks (i.e., MOEs). The short- and interm ediate-term a ggregate is identical because the endpoints for

inciden t al o r al as well as inhala tion a r e identica l f o r the sho r t- and inte rm ediate -te r m durations.

29

### Only a short-term derm a l endpoint was identified (i.e., no interm ediate- an d/or long-term derm al endpoints w e re identified). The ag gregate 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 derm al, and 630 for

inhala tion w h ich ar e gre ater than th e targe t MOE. For child ren, the agg r egate risk es tim ate for each of the routes of exposure are also above the target MOE (MOE=220 for the oral route, 180

for the derm al route) and thus are not of concern. It is im portant to note , however, that som e of the individual risks are of concern by th em selves (e.g., the hum i difier use).

Table 7c. Short- and I n termedia te-term Aggregate Ris k (MOE) Ass e ssment

Exposure

Routes Chronic Dietary

MOE Cleaning Pro duct MOEs (Adult Applic ators & Children Play ing) Hu m i difier

MOE Wearing

Treated Clothing

MOE RouteSpecific Aggregate

MOE

Adults
Oral Ingestion 2,80 0 NA NA NA 2,80 0

Der m al NA 210 (m op) 76 (wipe) 790 (spray ) NA 2,50 0 42

Inhalation NA 3,00 0 (m op) 820 (wipe) 23,0 00 (spray ) Not included,

risk of

concern NA 630

Children
Oral Ingestion 980 330 (han d-to- m outh carpets) NA 1,90 0 220

Der m al (ST onl y ) NA 1,20 0 (pla y in g on carpets) NA 210 (1% residue

transfer) 180

Inhalation NA NA Not included,

risk of

concern NA No cooccurrence

Aggregate M O E = 1 / ((1/M OE

sam e route ) + (1/ MOE same route ) + etc)



### 8. Occupation al Risk

Workers can be exposed to a pesticid e through m i xing, loading, and/or applying a pesticide or by entering tr eated sites. For ADBAC, potential occupational handler exposure can

occur from treatm e nt of the following uses: agri cultural prem ises, industrial processes and water
system s, f o od handling p r em ises, commercial/in stitu tion al/in dustrial p r e m ises, m edical pr em ises, swimming pools, and aquatic area s. In addition to the “antim icrobial” exposures scenarios,

ADBAC is used to treat ornam e ntal plants in nurseries and greenhouses, comm ercial turf and golf courses. Additionally, occupational expos ure can occur during the preservation of wood. For the preservation of wood, the procedure for treat m e nt can occur in different ways, such that multiple wo rker functio n s were analyzed. Due to the com p lexity of the w ood preserv a tive analysis, the results for handler and post-applic ation exposures are presented separately in

Section 8.e.

30

### Occupational risk for all poten tially exposed populations is m easured by a Margin of Exposure (MOE) which determ ines how close the occupational exposure com e s to a NO Observed Adverse Effect Level (NOAEL) from t oxi city studies. In th e case of ADAC, A MOE greater than or equal to 100 is considerably adequately pr otective for the occupational exposure

assessm ent for inhalation routes of exposure. The MOE of 100 includes 10x for interspecies extrapolation and 10x for intraspecies variati on. A MOE of 10 is considered adequately protective fo r the derm al route of con cern; it inclu d es 3x inters pecies extrapolation and 3x intraspecies variation.

Occupational risk is assessed for exposure at the tim e of applica tion (termed “handler” exposure) and is assessed for e xposure following application, or post-application exposure. Application param e ters are generally defined by the physical nature of the for m ulation (e.g.,

for m ula and packaging), by equipm e nt required to delive r the chem ical to the use s ite, and by the application rate required to achieve an efficaciou s dose.

For m o re inform ation on the assum p tions and calculations of potential risk of ADBAC to workers, see the Occupational Exposure Assessm en t (Section 8.0) in the Alkyl Dim e thyl Benzyl
Ammonium Chloride (ADBAC): Risk Assessm e n t for the Reregistration Eligibility Decision,” dated July 27,2006 and the “Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) Occupational/Residential Exposure Assessm ent,” dated August 3, 2006.

a. Occupation al Toxicity

The toxicological endpoints and associated uncertain ty factors used fo r 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 antim icrobial and agricu ltu ral use sites which includ e: agricu ltural p r em ises, ind u strial p r ocesses and water
system s, f o od handling p r em ises, commercial/in stitu tion al/in dustrial p r e m ises, m edical pr em ises, swimming pools, ornam e ntal greenhouses/nurse ries, golf courses, and aquatic areas. Additionally, occupational e xposure can occur during the pr eservation of wood. For the

preserv ation of wood, the procedu r e for treatm ent can occu r in different ways, such that m u ltiple worker functions were analyzed. Due to the co mplexity of the wood preservation analysis, the handler and post-application exposures are presented separately in section e.

The Agency has assessed exposures to ha ndlers m i xing/loading/applying antim icrobial and agricultural use products containing ADB AC. The following handler exposure scenarios represent high end exposure estim ates.

31

### Antimicrob i al Use - Mixer/Loader/Applicators :

• For the liquid pour scenarios, the unit exposure depe nds on the m a terial being treated. The following CMA unit exposures were available and used f o r the assessm e nt of the risk

associated w ith th e treatm e nt of the specified m a terials.

o Swimming pools, carpets, and oilfield operations ( drilling mud s 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

m i ni m a l replicates, the exposure value is sim ilar to the one f ound in PHED for a

sim ilar scen arios.

o Indoor hard surfaces (im m ersion, flo oding and circulation) and medical instruments in Use Site Categories II and V : The inhalation unit exposure value for disinfectant liquid pour (1.89 m g/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 mop p ing scenarios, the CMA inhalation unit exposure value for ungloved mopping was used (2.38 mg/lb a.i.). This va lue is based on data collected from six replicates in which the applicator m opped the floor and received exposure via contact

with the m op or with the bucket.

• For the wiping scenarios, the CMA inhalation un it exposure value for ungloved wiping was used (67.3 m g/lb a.i.). This value is ba sed on data collected from six replicates (dental technicians) who used a finger pum p sprayer to apply the product and then w i ped

the surf ace s with a pape r towel

• For the low pressure hand wand scenario, the CMA inhala ti on unit exposure value for low pressure spray was used (0.681 mg/lb a.i.). This value is based on data collected

f r om eight r eplic ates in which the ap plica t or hand sprayed carpet using 200 psi, then used a push broom rake to raise the carpet nap

• For the aero sol spray an d trigger pu mp spray sc enarios, the PHED inhalation un it exposure value for aerosol applications (P HED scenario 10) was used. The inhalation unit exposure is 1.3 m g /lb a.i.

• For the liquid/me tering pump scenarios, the unit exposure depends on the m a terial being

trea ted. The f o llowing CMA unit exp o sures were available an d used for th e assessm ent of

the risk asso ciated with the trea tm ent of the specified m a terials.

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

systems : C M A 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 sub j ects were wearin g a single la yer of clothing and chemical res i stan t gloves. This unit exposure was used for the once through cooling water
system because no representative data exis ts for the volum e of water treated in power plant f acilities.

o Small process water systems: CMA cooling tower data. The inhalation unit exposure is 0.00432 m g/lb a.i. a nd is based on 4 replicates.

• For the high -pressure/high volume spray and medium pressu re spray sc e n arios, the PHED inhalation unit exposure value for li quid/open pour/high pressure spray (PHED scenario 35) was used (0.12 m g/lb a.i.).

32

### • For the fogg ing, ULV/mist spra yer a n d automated syste m scenarios, it w as assum ed that most of the exposure to the handler will be due to preparing the fogger, and that the

handler leaves the room imm e diately after f ogging commences. Therefore, the available CMA disinfectant liquid pour i nhalation unit exposure value was used. The inhalation unit exposure value is 1.89 m g/lb a.i., respectively. This value is based on data collected

from two gloved replicates involving pouri ng a disinfectant product from a jug into sterilization trays design ed fo r dental instrum e nts, adding water and instrum e nts to the
tray, rem oving the instrum e nts, and discarding the old solution.

Agriculture Use - Mixer/Loader/A pplicators :

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

• Mixing/Loading Liquid Concentrates to Support LCO Handgun Applications (m ixing/loading supports 20 LCOs) (PHED) (1b)

• Mixing/Loading Liquids Concentrates for Airblas t Applica tio ns (PHED) (1c)

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

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

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

• Mixing/Loading Dry Flowables to S upport LCO Handgun Applications (m ixing/loading supports 20 LCOs) (PHED) (2c)

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

• Applying Sprays via Groundboom Equipm ent (PHED) (3)

• Applying Sprays via Airblast Equipm ent (PHED) (4)

• Applying Sprays via Handgun Equipm ent (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 wi th Low Pressure Handwand (using liquid concentrate ORETF data) (8)

• Mixing/Loading/Applying Liquid Concentrat es with a Handgun Sprayer (LCO ORETF data) (9)

• Mixing/Loading/Applying W a ter Soluble Bags with Handgun Sprayer (LCO ORETF data) (10)

• Mixing/Loading/Applying Dry Flowables C oncentrates with a Handgun Sprayer (LC O ORETF data) (11)

• Mixing/Loading/Applying Liquid Concentrates with a High Pressure Handwand (PHED) (12)

• Applying Ready to Use Form ulations vi a Trigger-Pum p Sprayer (ORETF) (13)

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

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

ADBAC derm al irritation exposures and risks were not estim ated fo r occupational handler

exposures. These risks are addressed using pe rsonal protective equipm ent (PPE) requirem ents

33

### already existing on labels. The level of PPE required is based on the tox i city of the end

- use product.

To m i nim i ze der m al exposures, the m i ni m u m PPE required for m i xers, loaders, and applicators exposed to end-use products containing concentrati ons off ADBAC that result in classification of toxicity category I, II, or III for skin irritati on potential will be long-sleeve shirt, long pants, shoes, socks, chem ical-resistan t gloves, and chem ical-resistant apron. For a diluted product, the classification of a toxi city category IV for skin irrita tion potential woul d result in the

elim ination of the required pers onal protective clothing and gloves; su ch as, chem ical-res i stan t gloves and chem ical-resistant apr on, for applicators and others e xposed to the end-use product.

Note that ch em ical-res i stant eyew ea r will be required if the en d- use produ ct is clas sif i ed as
catego r y I or II for eye ir ritation po te ntia l.

Inhalation exposures and risks were assessed based on the oral toxi city endpoint (i.e., route-specific inhalation study not available). The surrogate unit exposure values were taken

from the proprietary Che m ical Manufacturers Association (CMA) surr ogate exposure data (USEPA, 1999: DP Barcode D2 47642) or from the Pesticide Handler Exposure Database (USEPA, 1998). The specific inhalation unit exposures and qua ntity of ADBAC handled are provided in the Occupational and Residential Exposure Assessm ent for ADBAC dat e d July 27,

2006.

The inhalation MOEs were ca lcu l ate d f

o r the sh ort- and in te rm ediate-te r m

durations f o r occupational handlers.

c. Occupation al Handler Risk Summary

Based on toxicological criteria and the potential for exposure, the Agency has conducted inhalation exposure assessm e nts. As noted previously, MOEs great er than or equal to 100 for the inhalation route of exposure are cons idered protective for the occupational handler

exposure assessm ent.

Antim icrobial Uses

The resulting inhalation expos ures and MOEs for the repres entative occupational handler scenarios are presented in Ta ble 8.1. The calculated MOEs were above the target MO E of 100 for all scenarios, except those listed below.

• Agricultural fogging (m i xing and loading): ST/IT Inhalation MOE = 26

• Pulp and paper, liquid pu m p : ST/IT Inhala tion MOE = 33

• Once-through cooling w ater, m etering pum p : Using the average flow rate for high flow

stream s (153 MGD) the ST Inhalation MOE = 50

• Sm all process water system s, li quid pour: ST/IT Inhalation MOE = 6

.

34

### Table 8.1: Short- , Intermediate- and Long -Term Inhalation Risks A ssociated w i th Occupational Handlers

Exposure Scen ar io Method of Application Inhalation

Unit
Exposure

(m g/lb

a.i

. ) Applica tion R a te Quantit y Handled/

Treated per day Inhalation
Daily Dose (mg/kg/day ) a

Agr i c u ltur al P r e m ise s and Equipme n t (Use Site Cate gory 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 h a nd

wand 0.681 0.017 lb ai/gal 10 gallons 0.002

Trigger pump spray e r 1.3 0.017 lb ai/gal 0.26 gallons 0.000098 Applica tion to h a rd surfa ces,

equipment, and vehicles

Wipe 67.3 0.017 lb ai/gal 0.26 gallons 0.0051
Fogging (mix/lo ad only ) Liquid pour 1.89 2.46E-05 lb/ft 3 150,000 ft 3 0.12

F ood Handling/Stor age Establishme n ts P r e m is e s And Equipm e n t (Use Site Cate gor y II)

Low pressure h a nd

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 spray e r 1.3 0.025 lb ai/gal 0.26 gallons 0.00014 Application to in door hard

s u rfaces ( i nclud i ng dis h es , utensils, equipm ent)

Immersion, Flooding,

Circulation 1.89 0.00325 lb ai/gal 2 gallons 0.0002

Commercia l , Institutional and Industrial Prem ises and Equipment (Use Site Category III )

Low pressure h a nd

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 spray e r 1.3 0.0283 lb ai/gal 0.26 gallons 0.00016 Application to in door hard

s u rfaces

Immersion 1.89 0.025 lb ai/gal 2 gallons 0.0016

Air deodorizatio n Aerosol spray 1.3 0.20% a.i. b y weight 3.0 lbs 0.00013

Application to carpets Liquid pour 0.00346 0.141 lb ai/gal 32 gallons 0.00026

Med ica l P rem is es an d Eq u i p m en t (Us e S i te Categor y V)

Application to h a rd surfaces Mop 2.38 0.0176 lb ai/gal 45 gallons 0.031

Application to d e ntal

instrume nts Imme rsi on (Liquid pour) 1.89 0.0209 lb ai/gal 2 gallons 0.0013

Ind u str i al Pr oce sse s and Wate r S y ste m s (Use Site Cate gory V III)

Pulp and Pap e r Metering pump 0.000265 41.7 lb a i/ton

paper 500 tons 0.092

Papermaking Ch emicals Metering pump 0.000265 0.0019 lb ai/gal

additiv e 1,000 gallons 8.5E-6

Once-through C ooling Water

S y s t em - P o wer plant Metering pump 0.000265 Initia l Dose (ST): 8.86 E-5 lb ai/g al wa ter 5,900,000 gallons 0.0023 Inhalation

MOE b, 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



### 35c Exposure Scen ar io Method of Application Exposure (m g/lb

a.i

. ) Inhalation

Unit Applica tion R a te

Mainten a nce Dose (IT): 4.69E-5 lb ai/g al Handled/

Treated per day

5,900,000

gallons Quantit y

Daily Dose (mg/kg/day ) a

0.0012 Inhalation

(Target MOE = 100)

IT=2,500 MOE b, c Inhalation

Initia l Dose (ST): 8.86 E-5 lb ai/g al wa ter 153,000,000 gallons 0.06 ST = 50

Mainten a nce Dose (IT): 4.69E-5 lb ai/g al

6.67 lb ai/gal 153,000,000 gallons

10 gallons 0.032

0.5 IT= 95

6

Sma ll proc e ss w a te r s y ste m s: Recir c ulating co oling

tower/ev aporat iv e condenser/p asteurizers

Oil field op erations - drilling

mud and packin g fluids

Metal/wood cooling tower

surfa c e spray Metering pump Liquid pour

Liquid pour 0.00432 0.45

0.00346 Initia l Dose (ST): 3.34 E-4 lb ai/g al wa ter product

20,000 gallons 0.00048 ST=6,200

Mainten a nce Dose (IT): 1.25E-4 lb ai/g al

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

Applica tion to s w im m i ng pools Liquid pour Airle ss spray

0.00346 0.83

Winterizing Dose (ST):

0.000052 lb ai/g al ai/g al wa ter

Swimming Poo l s (Use Site Category X)

200,000 gallons

1,000 gallons

0.0006 0.0023

ST =5,000 1,300

Mainten a nce Dose (IT/L T):

0.0000098 lb ai/g al 200,000 gallons 0.00011 IT/LT =27

, 000

ST = shor t- ter m , IT = interm ediate- t erm , LT = long- term

, N/A= No data available

a Daily dose (m g/kg/day ) = [unit expos ure ( m g /lb a.i.) x a b sorption factor (1.0 for inhalation) x application rate x quantity t r eated / Body weight ( 60 kg for inhalati on)

. b M O E = NOAEL (m g/kg/day) / Absor b ed Da ily Dose [ W her e NOAE L = 3 m g /kg/day for al l inhalation exposu r e dur ations]

. T a rget M O E = 100.

The MO Es refer to short-ter m and int e rm ed iate- t erm du r a tion unless indicated other w ise.



### Agricultural Uses

In all occupational handler scen arios, the inhalation MOEs ar e above the level of concern of 100 at baseline PPE (i.e., no respirator).

36

### TABLE 8.2: ADBAC: Occupatio n al Handler Inhalation Risks

of water to be gallons of Exp o s u re S cen ario Crop or Ta rget Application

Rate a Treated Daily b Area MOEs c Inhalation

Baseline

Mixe r/Load er

Mixing/Load ing (M/L) Liquids f o r Groundboom Ap plications (1 a) Carnations (dren c h) 256 lb ai/acr e 1 acr es 590

Ornamental H e r b aceous Plants (dren c h) 72 lb ai/acr e 1 acr es 2100

Sodfarm Turf 0.9 lb ai/acre 1 acr es 170,000

Seedlings (p lanted in field) 0.43 lb ai/acre 1 acr es 350,000
Mosquito Contr o l in Decorative Ponds, Sewage

Trea tm ent S y s te m s , and Standing Water 0.0017 lb ai/gal

of water to be

trea ted 800,000 gallons of

water 110

Mosquito Contr o l in Decorative Ponds, Sewage

Trea tm ent S y s te m s , and Standing Water 0.0017 lb ai/gal

of water to be

trea ted 100,000 gallons of

water 880

Mosquito Contr o l in Decorative Ponds, Sewage

Trea tm ent S y s te m s , and Standing Water 0.0017 lb ai/gal

of water to be

trea ted 20,000 gallons of

water 4,400

ML Liqu id to Support LCO H a nd gun Applications (mixing/load ing sup ports 20 LCOs) (1b) Re si de nt ia l & Comme rc i a l

Turf 7 lb ai/acr e 1 acr es 21,000

Re si de nt ia l & Comme rc i a l

Turf 0.9 lb ai/acre 1 acr es 170,000

M/L Liquids for Airblast (1c) Ornament al Trees 0.65 lb ai/acre 2 acr es 120,000

M/L Liquid via Dip or Soak (1d ) Ornamental H e r b aceous Pla nts, 0.0065 lb ai/gal 100 gallons 230,000

Seedlings, Seeds

, Cuttings (preplan t or at plant) 0.0043 lb ai/gal 100 gallons 350,000

M/L DF for Gro undboom (2a) Carnations (dren c h) 256 lb ai/acr e 1 acr es 910

Ornamental H e r b aceous Plants (dren c h) 72 lb ai/acr e 1 acr es 3,200

Sodfarm Turf 0.9 lb ai/acre 1 acr es 260,000

Seedlings (p lanted in field) 0.43 lb ai/acre 1 acr es 540,000

M/L DF for Airb last (2b) Ornamental Trees 0.65 lb ai/acre 1 acr es 360,000
M/L DF to Supp ort LCO Handgu n Applications (mixing/load ing sup ports 20 LCOs) (2 c) Re si de nt ia l & Comme rc i a l

Turf 7 lb ai/acr e 1 acr es 33,000

Re si de nt ia l & Comme rc i a l

Turf 0.9 lb ai/acre 1 acr es 260,000

M/L DF via Dip or Soak (2d) Ornamental H e r b aceous Pla nts, 0.0065 lb ai/gal 100 gallons 360,000

Seedlings, Seeds

, Cuttings (preplan t or at plant) 0.0043 lb ai/gal 100 gallons 540,000

Applicator
Apply i ng Spray s via Groundboo m Equipment (3) Carnations (dren c h) 256 lb ai/acr e 1 acr es 950

Ornamental H e r b aceous Plants (dren c h) 72 lb ai/acr e 1 acr es 3,400

Sodfarm Turf 0.9 lb ai/acre 1 acr es 270,000

Seedlings (p lanted in field) 0.43 lb ai/acre 1 acr es 570,000

Mosquito Contr o l in 0.0017 lb ai/gal 800,000 180 Decorative Ponds, Sewage 

### 37Exp o s u re S cen ario Crop or Ta rget Application

Rate a Treated Daily b Area MOEs c Inhalation

Baseline

Trea tm ent S y s te m s , Swimming Pools and Standing Water trea ted water to b e

trea ted

Mosquito Contr o l in Decorative Ponds, Sewage

Trea tm ent S y s te m s , Swimming Pools and Standing Water 0.0017 lb ai/gal

of water to be

trea ted 100,000 gallons of

water to b e

trea ted 1,400

Mosquito Contr o l in Decorative Ponds, Sewage

Trea tm ent S y s te m s , Swimming Pools and Standing Water 0.0017 lb ai/gal

of water to be

trea ted 20,000 gallons of

water to b e

trea ted 7,200

Apply i ng Spray s via Airblast Equ i pment (4) Ornamental Trees 0.65 lb ai/acre 1 acr es 62,000

Apply i ng Spray s via Handgun (5) Re si de nt ia l a n d Comme rc i a l

Turf 7 lb ai/acr e 0.05 acres 370,000

0.9 lb ai/acre 0.05 acres 2,900,000

Mixer/Loader/Applicator

Mixing/Load ing / Apply i ng Liquid

Concentr ates w i th a H a ndgun Spr a y e r (LCO ORETF d a ta) (10) Carnations (dren c h) 256 lb ai/acr e 0.05 acres 2,000

Ornamental H e r b aceous Plants (dren c h) 72 lb ai/acr e 0.05 acres 6,900

Ornamental Trees and

Ornamental H e r b aceous Pla nts 0.65 lb ai/acre 0.05 acres 770,000

Ornamental Shr ubs, Seedlings (planted in field) 0.43 lb ai/acre 0.05 acres 1,200,000

Mixing/Load ing / Apply i ng Liquid

Concentr ates w i th a H a ndgun Spr a y e r (LCO ORETF d a ta) (7) Carnations (dren c h) 0.0235 lb ai/g allon 0.04 acres 71,000,000

Ornamental Trees and

Ornamental H e r b aceous Pla nts 0.0065 lb ai/g allon 0.04 acres 260,000,000

Ornamental Shr ubs, Seedlings (planted in field) 0.0043 lb ai/acre 0.04 acres 390,000,000

Mixing/Load ing / Apply i ng Water Soluble Bags with Hand gun Spray e r (LC O ORETF data) (1 0) Carnations (dren c h) 256 lb ai/acr e 0.05 acres 2,000

Ornamental H e r b aceous Plants (dren c h) 72 lb ai/acr e 0.05 acres 6,900

Ornamental Trees and

Ornamental H e r b aceous Pla nts 0.65 lb ai/acre 0.05 acres 770,000

Ornamental Shr ubs, Seedlings (planted in field) 0.43 lb ai/acre 0.05 acres 1,200,000

Mixing/Load ing / Apply i ng Dr y Flowables Concentrates with a H a ndgun Spray e r (LCO ORETF data) (11) Carnations (dren c h) 256 lb ai/acr e 0.05 acres 640

Ornamental H e r b aceous Plants (dren c h) 72 lb ai/acr e 0.05 acres 2,300

Ornamental Trees and

Ornamental H e r b aceous Pla nts 0.65 lb ai/acre 0.05 acres 250,000

Ornamental Shr ubs, Seedlings (planted in field) 0.43 lb ai/acre 0.05 acres 380,000

Mixing/Load ing / Apply i ng Liquid

Concentr ates w it h a High P r es s u re Handwand (PHED) (12) Ornamental H e r b aceous P l ants and Orna m e ntal Tre e s 0.0065 lb ai/g allon 1,000 gallons 230

Ornamental Shr ubs 0.0043 lb ai/g allon 1,000 gallons 350



### 38c Exp o s u re S cen ario Crop or Ta rget Application

Rate a Treated Daily b Area MOEs c Inhalation

Baseline

Apply i ng R ead y to Use Formulations

via Trigger -Pump Spray e r (ORETF) (13) Ornamental Shr ubs,

S eedlings

, S eeds

, Cut tins

(preplan t or at plant) 0.0043 lb ai/g allon 1 gallons 2,200,000

Ornamental P a lms 0.013 lb ai/gallo n 5 gallons 160,000

S eedlings

, S eeds

, Cut tins

(preplan t or at plant) 0.0043 lb ai/g allon 5 gallons 490,000

Mixing/Load ing / Apply i ng Liquids with a Watering C a n (u sing ORETF residential hose-end data) ( 14) Mosquito Contr o l in Decorative Ponds, Sewage

Trea tm ent S y s te m s , Swimming Pools, and Standing Water 0.0017 lb ai/g allon of wa te r to be tr eat ed 20,000 gallons to be

trea ted 310

Mosquito Contr o l in Fountains, Water Display s , Decorative Pools 0.0017 lb ai/g allon of wa te r to be tr eat ed 1,000 gallons

to be tr eat ed 6,200

a Application rates a r e the m a xi m u m a pplication rates deter m ined f r o m EP A registered l a bels f o r ADBAC

b Am ount handled p e r day values ar e HE D esti m a tes of gallons applied pe r day based on E x p o sur e SAC SOP #9 Standar d Values for Daily Acres T r eate d in Agriculture, in dustr y sour ces, an d HE D estim a tes.
Inhalation MOE = inhalation NOAE L (m g/kg/day ) / bas e line inhalation do se ( m g/kg/day ) , w h ere baseline inhal a tion exposure (m g/day) = application r a te ( l b ai/g al ) x a m ount handled per day ( g al/day ) x baseline inhalation unit expo sur e ( μ g/lb ai) x conver s ion

f actor f r o m μ g to m g ( 0

. 001) and the baseline inha lation dose (m g / kg/day ) = baseline inha lation expos ur e (m g/ day ) x inhalation

absor p tion factor ( 100%) / fem a le bo dy weight ( 60 kg)



### d. Occupational Post-Application Exposures

Post-Application exposure m a y occur from en tering food processing plants, hatcheries,

wood treatm e nt facilities, ornam e ntal greenho us e/nurs e ries, or from handling treated wood or

turf

. Except for the post-application scenarios asse ssed for fogging (food processing plants and hatcheries) in Section 8.2.2, occupational post-a pplication derm al and inhalation exposures are

assum e d 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 processi ng plants, because derm al post a pplication is presum ed to be negligible, it was not assessed. The inhalati on exposure assessm e nt was c onducted using the

Multi-Chamber Concentration and E xposur e Model (MCCEM v1.2). MCCEM estim a tes average and peak indoor air concen trations of chem icals released from products or m aterials in houses, apartm ents, townhouses, or other residen ces. Although the data libraries contained in

MCCEM are lim ited to residen t ial s ettings, the model can be used to assess other indoor

environm ents. MCCEM has the capability to estim a te inhalation exposures to chem icals,

calcu lated as single d ay doses, chron i c average d a ily dos es, o r lif etim e av erage daily doses. (All

dose estim a tes are potential dos es; they do not account for act ual absorption into the body.)

The fogging application to a food proce ssing plant was assessed using a m a xi m u m application rate of 0.011 lb ai /gal, one quart of the dilute d product per 1,000 cubic feet of the

trea ted a r ea

. For fogging applications, a two hour restrict ed entry interval is required on current

labels for this use. The inhalation MO E for fogging is 1 which is consider ably below the target

MOE of 100

. The risks of concern immediately af ter fogging are attributed to low air changes

39

### per hour assum e d (i.e., 0.18 ACH as a default para m e ter in MCCEM to represent low air flow).

The assessm ent for fogging in food processing pl ants could be refined if more accurate

ventilation rate inform ation could be obtained.

The fogging application to hatcheries a nd incubators was assessed using a m a xi m u m application rate of 0.24 lb ai/gal. For fogging a pplications, the Agency estim a ted risks from 0-8 hours and 2-10 hours following treatm ent. The 8-hr inhalation MOE from 0-8 hours (imm ediately after fogging) is below the target MOE of 100 at 0.5; how ever, 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 treatm ent m e thods and pressure treatm e nt m e thods. Section 1 presents the exposure analysis for the handler and post- application scenarios for non-pre ssure treatm e nt scenarios, and Section 2 p r esents the ex posure analy sis for the handler and post-application scenarios for

pressur e tr ea tm ent scenar ios. Derm al irr ita tion exposures from post-appli cation activities in the wood preservation treatm ent f acility will be m itigated us ing default pers onal pro t ective equipm ent requirem e nts based on the toxicity of the end-use product. Th erefore, only inhalation exposures and risks are presented.

i. Non-Pressure Treatmen t Scenarios (Handler an d Postapplica tion)

a. Scenarios Assessed by Worker Fu nction

A proprietary study, “ Measurement and Assessment of Derm al and Inhalation Exposures to Didecyl Dimethyl Am monium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase III) ” (Bestari et al., 1999, MRID 455243-04) wa s used to assess various worker functions/positions for individuals that ha ndle DDAC-containing wood preservatives for nonpressure treatm ent application m e thods and post-a pplication risk scenario s for individuals that could into contact with the preserved wood. The worker functions/positions identified in the DDAC study are presented below. It was assu m e d that sim ilar tasks are perform ed when handling A D BAC products and ADBAC treated-wood as , therefore, these sa m e funct i ons were assessed for ADBAC.

Handler:

• Blender/spray operators are workers that add the wood pres ervative into a blender/sprayer
system for c o m posite wood via closed-liquid pumping.

• Diptank Operators can be in reference to wood being lowered into the treating solution through an autom a ted process (i.e., elevator dipta nk, forklift diptank). This scenario can also

occur in a sm aller scale treatm ent fa cility in which the worker can m a nually dip the wood

into th e tr eatm ent solutio n.

40

### • Che m ical operators for spray box system consist of che m ical operators, chem ical assistants,

chem ical supervisors, and chem ical captains. These individuals m a intain a chem ical supply balance along with flushing and cleaning spray nozzles.

The post-application scenarios identif ied in the af orem entioned DDAC study are presented below based on the assum ption that th ese scen ario s are th e sam e for ADBAC.

Post-applic ation:

• Graders

, position e d righ t after the sp ray box, grade dry lum b er by hand (i.e., detect faults).

• Millwr i ghts repair all co nveyer cha i ns and gener al up-ke ep o f the m ill.

• Clean-up cr ews perf orm genera l cle a n ing duties a t the m ill.

• Trim saw operators operate the hula trim saw and cons ist of operato rs and strappers.

• Construction workers install treated plywood, oriented strand board, m edium density fiberboard, and others.

As very little chem ical specific data were availab l e reg arding typ i cal exposures to ADBAC as a wood preservative, su rrogate data were used to estim ate exposure risks. The

blender / spr a y opera tor p o sition was assessed using CMA unit expo sure data and the rem aining handler and post-applicati on positions were assessed using da ta from the DDAC study (Bestari et al., 1999).

Blender/Spray Operators

The inhalation exposures and risks to the com p osite wood blender/ spray operators are reported in Table 8.2. The inhalation MOE is below the target MOE of 100 for short-,

interm ediate-, and long-term inhalation exposures (MOE = 84 ).

Table 8.2: Short-, Intermediate-, and Long -Term Inhalation Exposures and MOEs for Blender/Spray Operator

Ex pos u r e Scena r io Inh a latio n Un it

Ex pos u re a
(m g /lb ai) App licatio n Rate
(% ai in so lu tion /
day ) W ood Sl u r r y Treated b
(l b/ day ) Daily Do se c (m g/ kg/ day ) ST/IT/LT

MO E d (Tar get M O E = 1 00) Occup ation al Hand ler

Blender/s p ray

ope rato r 0

. 0 004 03 3 17 8, 0 00 0. 03 6 84

ST = Shor t- ter m dur atio n; I T = I n term ediate- t erm dur ation; and L T = long- term

.

a. Inhalation unit exposure: Baseline.

b. W ood slur r y tr eated = ( 8 batches/day x 7, 000 gallon s /bat ch x 0. 0037 85 m 3 /gallon x 380 k g/m 3 x 2. 2 lb/kg)

c. Daily Dose = unit exposur e (m g/lb ai) x App Rate ( % ai/day ) x Quantit y treated ( l b/day ) x absor p tion factor ( 1 0 0 % for inhala tion) / B W ( 60 kg)

d. M O E = NOAEL (m g/kg/day) / Daily dose [W her e ST /IT / L T NOAE L = 3 m g /kg/day for inhalation. T a r g et M O E = 100.



### Chemical Operators, Graders, Millw r ights, Clean-up Crew s, and Trim Saw Ope r ators

The inhalation exposures (all durations ) to chem ical operato rs, g r aders, m illwrights, trim saw operators, and clean-up crews are presented in Table 8.3. The inhalation MO Es are above the target MOE of 100 for all worker functions. Any derm al irritation exposures from pos t41

### applic ation activ ities will be m itiga t ed using de f ault pe rsona l protective equipm ent requirem ents based on the toxicity of the end-use product.

Table 8.3: Short-, Intermediate, and Long -Term Inhalation Exposures and MOEs for

Wood Preservative C h emical Operators, Grad ers, Trim Saw Operators, an d Clean-Up

Crew s (Handler and Post-application Activities)

Expos ure Sce n ario a (n um ber o f v o luntee rs) Inh a latio n UE b

(m g/ day ) Co nv ersion Ratio c Daily Do se d

(m g/ kg/ day ) MO E e (Targ e t
MO E = 10 0)

Occup ation al Hand lers

Chem ica l Ope r ator (n= 1 1) 0. 02 8 1 0. 62 5 0. 00 0 29 2 10 ,0 0 0

Occup a tion a l Po st-App lication

Gra d er ( n = 1 3 ) 0. 02 9 5 0. 62 5 0. 00 0 30 7 9, 80 0

Trim Saw (n=2) 0. 06 1 0. 62 5 0. 00 0 63 4, 80 0

Millwrig h t (n =3 ) 0. 05 7 0. 62 5 0. 00 0 59 5, 10 0

Clean-U p ( n =6 ) 0. 60 0. 62 5 0. 00 6 3 48 0

ST = Short-term duration, I T = In termediate-term durati on, LT = Long- term duration

a. The exposure scenario repr esents a work er wearin g short-sleev ed s h ir ts, cotton wor k

trousers, and cotton glov e dosimeter glov es under ch emical resistant gloves

. Vol unteers were grouped according to tasks th ey conducted at the

m ill.

b. Inhalation un it exposures are fro m Best ari et. al. (1999). Refer to Tab l e E-1 in Ap pendix E for th e calculation of th e dermal and inh a lation exposures. Inha lation exposure (mg/day ) was calculated usin g the following equation: Air

concen trat ion ( μ g/m 3 ) x Inhalatio n rate (1 .0 m 3 /hr ) x Sample duration (8 hr /day ) x Unit conv ersion (1 mg/1000 μ g).

The inhalation r a te is from USEPA, 1997.

c. Conversion Ratio = 50% ADBAC / 80% DDAC

d. Daily dose (mg/kg/day ) = e xposure (mg/day ) x conversion ra tio ( 0 .625) x absorption factor (100% for inhalation)/b od y weight (60 kg).

e. MOE = NOAEL (mg/kg/day ) / D a ily dose [Wher e inh a lation NOAEL = 3 mg/kg/day ]

. Targ et MOE = 100.



### Diptank Op erators

Exposures to diptank operators were also as sessed using surrogate data from the DDAC study (Bestari et al., 1999). The diptank scenario assessm ent was conducted differently than for the other job functions because th e concentration of DDAC in the diptan k solution w a s provided. The exposure data for diptank operators were conve rted into unit exposures in term s of m g a.i. for each 1% of concentration of the product. T able 8.4 pro v ides the sh ort-, interm e d iate- and long-term inhalation dose and MOE s for diptan k 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 Op erator (Han dler Activ i ty)

Expos ure Sce n ario a
(n um ber o f rep licates) Inh a latio n Un it Expo sure b

(m g DDAC/1% so l u tio n) Ap p Rate (% a.i. in so l u tio n / d a y) Daily Do se c
(m g/ kg/ day ) MO E d

Occup ation al Hand ler

Di p pi n g, ( n=7 ) 0. 04 6 3 0. 00 2 3 1, 30 0



### 42a The e x pos ure s cenari o re prese n ts a wo rk er no t wearing a resp irator.

b I n h a latio n un it ex po su r e s ar e fr o m D D A C stud y ( M RID 45 52 43- 04 ). Ref e r to Tab le E-2 i n Ap pe ndi x E f o r t h e i n hal a t i o n u n i t ex po su re cal cul a t i ons. I n hal a t i on ex p o s u re (m g) was c a l c ul at ed

usi n g t h e f o l l o wi n g e quat i o n: Ai r co nce n t r at i on (m g/m 3 ) x In halation rate (1 .0 m 3 /h r) x Sa m p le

Duration (8 hr). Th e i n h a lation rate is fro m USEPA, 199 7.

c Daily d o se (m g / kg /d ay) = u n it ex po su re (mg / 1 % ai so l u tion ) x p e rcen t activ e in gred ien t in

so lu tion (3 % ai) x ab sorp tion facto r (10 0 % fo r inh a latio n) / bo d y weigh t (6 0 kg).

d M O E = N OAE L (m g/ kg/ d a y ) / Dai l y do se [ W he re i nhal a t i o n N O A EL = 3 m g / kg/ day

. T a rget
MO E = 10 0.



### ii. Pressure Treatment Scenarios (Ha ndler and PostApplication )

ADBAC m a y be used to treat wood and w ood products using pressurized application

m e thods such as double vacuum . According to the product labels, the m a xim u m retention rate is

0.6 lb/ft 3 

### . A n application rate was not provided on the produ ct lab els ; the r ef ore, an application

rate of 3% ai solution w a s used in this asse ssm ent, based on the m aster label. Since ADBACspecific exposure data are not available to assess pressure treatm ent exposure, surrogate
chrom a ted copper arsenate (CCA) data (ACC, 2002b) was utilized and using the approach described in a previous expos ure assessm ent (USEPA, 2003b).

The estim ated inhalation exposures and ri sks for ADBAC are presented in Table 8.6.

The calculated inhalation MOEs ar e 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

Expos ure Sce n ario Inh a latio n Un it

Ex pos u re a ( μ g As/ p pm ) App licatio n Rate (% ai so lu tion ) Daily Do ses b
(m g/ kg/ day ) Inh a latio n MO Es c (Tar get M O E = 1 00) Occup ation al Hand ler

Treat m e nt Ope rat or (T O ) 0. 00 2 57 3 0. 00 1 3 2, 30 0

Treat m e nt Assi st ant (T A) 0. 00 0 8 0 2 3 0. 00 0 40 7, 50 0

Occup a tion a l Po st-ap p lication

All (Tram sette r, stack er

ope rato r, l o ade r ope rato r,

sup erv isor, test bo rer, and tally man ) 0. 00 1 60 3 0. 00 0 80 3, 80 0

a. Unit exposure v a lues taken from CCA stud y and are shown in Table 6

. 11.

b. Daily Dose (mg/kg/ day ) = Unit Exposure ( μ g As/ppm) x [% ADBAC in solution ( 3) x 10 ,000 (p arts per million conversion)] x ( 0.001 mg/ μ g) x absorption f actor (100% for inhalation) / Bod y weight (60 kg).

c. MOE = NOAEL (mg/kg/day ) / D a ily dose [Where inhalation NOAEL = 3 mg/kg/ day for all durati ons. Target MOE =

100.



### 43

### 9. Human Incident Data

The Agency reviewed av ailab l e sou r ces of hu m a n incident data for incidents related to the use of the quaternar y ammonium chlorides

. As stated earlier, th e Agency clus tered the quaternary ammonium c hloride chem icals into f our groups. However, the available incident

inform ation does not differentiate between the specifi c groups; therefore, all the incident data are discussed together.

The Agency consulted the following sources of hum a n incidents related to the use of ADB AC:

(1) OPP Incident Data System (IDS) - The Office of Pesticide P r ogram s (OPP) Incident Data System contai ns reports of incidents fr om various sources, including registrants, other federal a nd state health and environm en tal agencies and individual

consum ers, subm itted to OPP since 1992. (2) California Departmen t of Pe sticide Regulation (1982-2004) - Since 1982, California’s Departm e nt of Pesticide Re gulation Pesticide Poisoning Surveillance Program consists of rep o rts f r om physicia ns who docum ent all illn esses they suspec t are related to pesticide exposure

. (3) National Pesticide In fo rmation Center(NPIC) - NPIC is a toll-free info rm ation service supported by OPP. The network provides inform ation on the top 200 active ingredients by answering telephone calls during cal endar years 1984-1991. (4) Published Incident Reports - Some incid e nt reports as sociated with Q u ats th at are
related to hu m a n health hazard are p ub lished in the scien tific literature.

There have been nearly 2700 in cidents reported to the OPP Incident Data System (IDS and the California Departm e nt of Pes ticide Regul ation (1982-2004) associat ed with exposure to end-use products containing Quats. Most of th e inciden t s a r e rela ted to derm al, ocular and

inhalation irritation. Allergic t ype reaction is also been report ed in som e incidents. A lthough risk associated with eye exposure is not assess ed in the risk assessm ent process, sym p tom s associated w ith eye are the m o st commonly reported associated with Quat exposure.

Incidents A ssociated w i th Quat Use Type of Incident Reported Most Common Symptom

Inhalation respiratory irritation/burning, irritation to mouth/throat/nose, coug hing/choking, chest pain, disorientation, dizziness, shortness of breath

Dermal irritation/burning, rash, itching, and blistering Allergic hives and a l lergic contac t derm atitis

Oral irr ita tion to mouth/throa t/nose, vom iting/ nausea/
abdom inal pain, dizziness, and headache

Ocular irritation / burning, eye pain, conjunctivitis, swelling of eye and eyelid

44

### B. Environmental Risk Assessment

A summ ary of the Agency’s environ m ental ri sk assessm ent is presented below. The
f o llowing risk chara cte rization is in te nded to describe the m a gnitude of the estim ated
environm ental risks for ADBAC use sites and an y associated uncertainties

. For detailed
inform ation on the environm ental risk assessm ent on ADBAC, see the following docum ents, “Environm ental Fate Assessm ent of Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC)” dated July 31, 2006, “Ecological Risk Assessm e n t on Antim icrobial Uses for Alkyl Dim e thyl Benzyl Ammonium Chl oride (ADBAC)” dated August 2, 2006, and “Ecological Risk

Assessm ent on Agricultural Uses for Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC)” dated February 3, 2006.

1. Environmental Fate an d Transport

The environm ental fate assessm ent for ADBAC is based on the available data subm itted
to fulfill th e rereg i stratio n data requirem e nts. However, the d ata set is incom p lete for the wood

preserv a tion use. An aqueous availablility study evaluating the leach ability of ADBAC from

trea ted woo d is requ ired

.

Based on the available data, ADBAC is hydrol ytically stable under abiotic and buffered conditions over the pH 5-9 range. T he calculate d 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. Ho wever, in th e presen ce o f a photosensitizer (e.g., acetone), ADBAC has been shown to degrade with an estim a ted half-life of 7.1 days.

Based on a biodegradation study, ADBAC readil y degrades into 60% carbon dioxide in 13 days. ADBAC is i mmobile in soil. The availa b l e soil m obility study sho w s that ADBAC has a strong tendency to bind to sedi m e nt/soil with F r eundlich K ads 

### values range from 5,123 to 32,429 depending on the soil type where as the corresponding K

oc 

### 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 contam inate surface and ground waters.

Although the estim a ted K

ow 

### is high, bioaccum ulation of ADBAC in freshwater fish n o r is bioconcentration in aquatic organism s expected to pose a concern because ADBAC has broken down into its’ degrades before it reaches the aqu a tic ecosys t em s.

2. Ecological Risk

The Agency’s ecological risk assessm e nt com pa r es toxicity e ndpoints from ecological
toxic ity s t ud ies to estim a te environmental concentrations based on environm ental fate characteristics and pesticide use data.

a. Toxicity (Haz ard) Assessment

ADBAC is categorized as highly toxic to fish (LC 50 

### = 280 μ g ai/L) and very highly toxic to aquatic invertebrates (LC 50 

### = 5.9 μ g ai/L) on an acute exposure ba s i s. Chronic effects were

seen in fish at a concentration of 32.2 μ g ai/L and a no observable a dverse effect concentration

45

### (NOAEC) o f 4.15 μ g ai/L was established for aquatic invert e b rates. Th e resu lts of the dietary avian studies categorized ADBAC a s m oderate ly toxic to birds on an acute basis (L C 50 

### = 136 mg/kg-bw, with no chronic data available. ADBAC is categ orized as slightly tox i c to m a mm als on an acute basis (LD50 = 430 m g/k g-bw) and a chronic NOAEC o f 44 mg/kg/day was

established.

b. Exposure and Risk

ADB AC INDOOR US ES

The m a jority of ADBAC uses are s p ray applic ations to indo or surf aces, truck interio r s, kennels, institutional areas, household areas, recirculating cooling towers, evaporative condensers, pulp/paper m ills, swimm i ng pools and sp as, an d oil field m ud treatm ents. The indoo r uses of ADBAC make it unlikely that any apprecia ble exposure to terrestria l or aquatic organism

would occur. However, the comm er cial/indus trial facilities usi ng ADBAC for indoor application s are required to have NPDES per m its prior to dis charging effluents into receiv i ng

waters.

ADB AC O U TDOOR USES

Risk Quotients (RQs) are calcu lated by dividing acute and chronic estim ated

environm ental concentrations (EECs), based on e nvironm ental fate characteristics and pesticide use data, ecotoxicity values for vario u s wildlif e a nd plant sp e cie s. RQs are then com pared to levels of concern (LOCs). W hen the RQ exceed s the LOC for a particular catego r y, th e Agency

presum es risks of concern for that category.

Ornam e ntal Nursery Plants

Expected en vironm ental concentratio ns (EECs) of ADBAC resulting from runoff following application to ornam e nt als in nurseries were calculated us ing availab l e eco toxicity data and the EPA aquatic exposure model PRZM/E XAMS. Risk quotients (RQs) for freshwater fish ranged from 1.99 to 5.26, RQs for freshw ater invertebrates ranged from 94.41 to 249.66, exceeding th e acute risk LOC by greater than 18 0- fold. The chronic risk LOC (1.0) is exceeded

m a ny- fold for freshwater fish ranging from RQ s 10-28 and for freshwater invertebrates ranging

from RQs 87-222. Using the EPA terrestrial an im al exposure m odel (TERX), acute avian RQs ranged from 19 to 2101, exceeding th e acute LOC up to 4000-fold. Chronic avian RQs could not

be calculated due to the lack of toxicity data, but chronic risk is presum ed. Mamm alian 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 E E Cs of ADBAC resultin g from r

unoff following application to turf and golf courses were calculated using av ailable ecotoxicity data and the EPA aquatic exposure m odel

PRZM/EXAMS. Risk quotien t s for freshwater fish range fro m 0.06 to 0.91, exceedin g the endangered species and acute risk L O Cs. Acute risk RQs for fr eshwater invertebrates range

46

### from 2.3 to 10.6, exceed ing the acute risk LOC. Using the E P A terrestrial anim al exposure model (TERX), acute av ian RQs ran g e from 0.11 to 12.35, exceeding the endangered species LOC for all size classes and forage item s. Chroni c RQs cannot be calculated, but chronic risk to avian species is presum e d. Acute risk m a mm a lian RQs from the turf/golf course use ranged

from 0.01 to 7.9, with ex ceedance of the endange red species LOC for all m a mmal size classes foraging on short grass, tall grass, broadleaf plan ts and sm all insects. Chronic RQs for m a mmals range from 0.07 to 77.2, and exceed the LOC for all m a mm al size classes foraging on short grass, tall grass, broadleaf plants and sm all insects. ( http ://www.epa.gov/op pefed1/m o dels/terres t rial/ind e x.htm ).

Ornam e ntal Ponds, Pools, and Puddles

Other outdoor uses of ADBAC on ornam e nt al ponds, pools and puddles are not expected to result in appreciable e xposure to aquatic ecosystem s due to their lim ited size and confined use

of ADBAC within the stru cture through the use of i m per m eable m a terials. ( http://www.epa.gov/oppefe d1/m o dels/water/index.htm ).

Algae Control and Mosquitocide

Although the algae control and m o squitocide uses are intended for waterbodies that are

disconnected from the larger watershed to redu ce nontarget environm ental exposure, these uses

m a y result in potential exposure to amphibians in tr eated water for a portion of their lifecycle and

to birds and m a mmals utilizing trea ted waterbodies for drinking water. T h e m o squito contro l use

has an initial concentration of 200 ppm ADBAC and represents the greatest risk to terrestrial

anim als. The algal control initial target con centration is 5 ppm ADBAC. At 200 ppm, RQs for

am phibians are 0.71 for acute risk and 6.2 for chroni c risk. RQs for birds drinking treated water range from 0.09 to 0.32. Sm aller birds face greater acu te risk

. Chronic risk to bird s is presum ed

due to lack of data. Neither acu te no r chroni c m a mmalian acute RQs exceed the LOCs at th e 200

ppm initia l c oncentr ation

.

Once-through Cooling Tower Use

Tier I once-through cooling tower m o deling i ndicates that ADBAC use wi ll result in

acute and chronic risk to non-e ndangered and endangered/threaten ed freshwater fish and acute risk to other aquatic anim als at all 3 dosag es m o deled: 2.0 ppm , 5.0 ppm, and 10.0ppm. High water flow, and interm ittent dos ing at 10.0 ppm had less acute and chronic impact on nonendangered freshwater fish than m e dium to low stream flow. However, LOC' s for all aquatic

anim als were triggered at the 2.0 ppm dosage using continuous dosing regardless of high,

m edium , or low stream flow. Green algae were only adversely affected from use of c ontinuous dosing in combination w ith low stream flow conditions. The con tinuous dosing, low flow nontarget plant LOC is triggered at all 3 dosages modeled. The a quatic plant risk assessm ent is

incom plete due to a number of outstanding stud ies. Dire ct ADBAC exposure to ter r estria l

anim als is not expected to occur from the once-through cooling tower use.

47

### Antisapstain W ood Treatm e nt Use

Terres t rial anim al species are not exp ected to be directly im pa cted by this ADBAC use

. Nontarget aquatic species (fish, invert eb rates, g r een algae) are not exp e cted to be at risk (acute or chronic) based on LOCs. Endangered/threatened fi sh and green algae specie s are not expected to be at risk from the ADBAC antisapstain use. Freshwater an d m arine aq uatic invertebrates are expected to be at risk from ADBAC antisapstain use unless m e t hods are used to prevent runoff

from the treatm ent site (Ex. store treated w ood indoors, cover treated wood and use berm s or plastic barriers in outdoor storage areas). However

, ADBAC is tigh tly adsorbed to clay and organic m a tter which greatly reduces potential for ADBAC to leach downward through soil to groundwater or m ove via surface run off. The Ti e r I screen ing m odel is on ly intended as a screening-level m odel, and, as such, has inherent uncertainties and lim itations which may result in inaccurate exposure estim ations.

c. Risk to End angered (Listed) Species

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536( a)(2), requires all

f ederal agen cies to cons ult with the National Ma rine Fish erie s Service (NMFS) for marine and

andronom us listed species, or the United States F i sh and W ildlife Services (FW S ) for listed wildlife and freshwater organism s, if they are proposing an "action" tha t m ay af f ect listed spec ies 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 c ontinued existence of a listed spec ie s or resu lt in the des t ruction or adverse m odification of designated critical habitat. To jeopard iz e the con tin ued exis tenc e of a liste d species m eans "to engage in an action that reasonably would be expected, dire ctly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by re ducing the reproduction, num bers, or distribution of the species." 50 C.F.R. § 402.02.

To f acilitate com p liance with the req u irem ents of the Endang ered Spec ies Act subsection (a)(2 ) th e Environm ental Protec tion A gency, Office of Pesticide Program s has established procedures to evaluate whether a proposed regi stration action m a y directly or indirectly reduce appreciably the likelihood of both the survival an d recove ry o f a listed spe cies in the w ild by reducing the reproduction, num bers, or distribution of any listed sp ecies (U.S. EPA 2004). After the Agency’s screen ing-level risk ass e ssm ent is pe rform e d, if any of the Agency’s Listed Species

LOC Criteria are ex ceed ed for either direct or in dire ct effects, a determ ination is m a de to iden tif y if any listed or candidate species m a y co-occur in the area of th e proposed pesticide use. If

determ ined that listed or candidate species m a y be present in the proposed use areas, further biological assessm ent is undertaken. The extent to which listed species m a y be at risk then

determ ines the need for the developm ent of a more com p rehensive consultation package as required by the Endangered Species Act.

The endang ered species Alte rnative Consultation Agreem ent (ACA) with NMFS, and

FW S will ta ke tim e to implem e nt f u lly, depend ing on availa ble resou r ce s. The Agency is

curren tly p r eparing risk assessm ents with the s er v ices on 9 high priority agricultural pesticides. Endangered species asse ssm ents of antim icrobial and additio n al agr i cultu r al pes t icide s will commence in 2008 under the Registration Review program

. 48

### For certain u se catego r ies, the Agency assum es there will be m i ni m al environm ental exposure, and only a m i nim al toxicity data set is required (Overview of the Ecological Risk

Assessm ent Process in th e Of f i ce of Pestic ide Pr ogram s U.S. Environm e ntal Protection Agency - Endangered and Threatened Species Effects De term inations, 1/23/04, Appendix A, Section IIB, pg.81). Chem icals in these categories therefor e do not undergo a full screening-level risk

assessm ent, and are considered to fall under a no effect determ ination. The active ingredient uses of ADBAC with the excepti on of the ornamental nurserie s, golf/turf/lawns, once-through cooling tow e r, and antisapstain wood preservati on uses, fall into this category. Using Tier I screening modeling to assess pot ential exposure from the ornam e nt al nurseries, golf/turf/lawns, once-through cooling tower, and antisapstain wo od preservation uses of ADBAC risks to Listed Species are indicated. S i nce the m o del is only intended as a screening-level m odel, and, as such,

has inherent uncertainties and lim itations which may result in inaccurate ex posure es timations,

further refinem e nt of the m odel is recommended before any regulatory ac tion is taken regarding

the ornam e ntal nurseries, golf/turf/lawns, once-th rough cooling tower, and antisapstain uses of

ADBAC. Additiona lly, impacts f r om the antisaps ta in use could potentially be m itigate d with precautions to preven t leaching and runoff when wood is stored outdoors and im pacts from the cooling tow er use cou l d potentially b e m itigated by the reduction of risk m itigation. Due to
these circum stances, the Agency defers m a king a determ ination for the ornam e ntal nurseries, golf/turf/law n s, once-th rough coolin g tower, an d antisap stain uses of ADBAC until additional

data and m o deling refinem e nts are available. At that tim e, the environm ental exposure

assessm ent of the ornamental nurseries, gol f/turf/lawns, once-through cooling tower, and antisap sta i n use of ADBAC will be r e vised, and th e risks to L i sted Spec ie s will be rec onsidered

.

49

### IV. Risk Management, Reregistratio n, and Tolerance Reassessment Decision

A. Determination of Rere gistra tion Eligib ility

Section 4(g)(2)(A) of FIFRA calls for the Agency to determ ine, after subm ission of relevant data concerning an active ingredient , whether or not products containing the active ingred ient a r e elig ible f o r

rereg i stration. The Agency has previ ously id entif ied and req u ired the
subm ission of the generic (i.e., act ive ingredient-specific) data required to support reregistration of products containing ADBAC as an active ingredient. The Agency has com pleted its review of these generic data and has determ ined that the da ta are sufficient to suppo rt reregistration of all supported products containing ADBAC.

The Agency has com pleted its assessm e nt of the dietary, occupational, drinking water, and ecolog i cal risks asso ciated with the use of pe stic ide prod ucts con t ain i ng the active ingredient

ADBAC. Based on a review of these data and on public comments on the Agency’s assessm ents for the activ e ingred ient, ADBAC, the Agency ha s sufficient infor m ation on the hum a n health and ecological effects of ADBAC to m a ke deci sions as part of the toleran ce reassessm e nt process under FFDCA a nd reregistration pro cess under FIFRA, as am ended by FQPA. The Agency has determ ined that ADBAC-containing produc ts are eligible for re registration provided that: (i) cur r ent data gap s and conf ir

m atory data needs ar e ad dressed ; (ii) the r i sk m itigation

m easure outlined in this docum ent is adopted; an d (i ii) label am endm ents are m ade to reflect this

m easure. Label chang e s are des c rib e d in Sectio n V. Appendix A summarizes the u s es of ADBAC that are eligible for rere gistration. Appendix B identifies the generic data requirem ents that the Agency reviewed as part of its determ ination of reregistration elig ibility of ADBAC and
lists the s u b m itted studies that the A g ency found accep table. Data gaps are iden tified as generic data requirem e nts that have not been satisfied with acceptable data.

Based on its evaluation of ADBAC, the Ag ency has determ ined that ADBAC produc ts, unless labeled and used as specified in this do cum ent, would present ri sk s inconsiste nt with

FIFRA. Ac cording l y, s hould a reg i stran t fail to im ple m ent the risk m itig ation m easure iden tified
in this docum e nt, the Agency m a y take regulatory action to addr ess the risk concerns from the
use of ADBAC. If all changes outlined in this do cum e nt are incorporated into the product labels,
then all cur r e nt r i sks f o r ADBAC will be subs tantially m itigated f or the pu rposes of this
determ ination. Once an Endangered Species asse ssm ent is completed, f u r t her ch anges to thes e registrations m a y be necessary as explai ned in S ection III of this docum ent.

B. Public Comments and Responses

Through the Agency’s public participation pr ocess, EPA worked with stakeholders and the public to reach the regulato r y decision fo r ADBAC. During the public comm ent period on

the risk assessm ents, which closed on June 26, 2006, the Agency received comments from the

ADBAC Consortium , Reckitt Benckiser, a nd The Clorox Company regarding the risk

assessm ents assum p tions. These comm ents in thei r 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 th e FQPA tolerance reass e ssm en t process, EPA assessed the risks associated
with ADBAC. The Age ncy has concluded that the ri sk from dietary exposure is within the “risk cup.” An aggregate assessm ent was conducted f or exposures through food, drinking water, and
residential uses. The Agency has determ ined th at the hum an health risk s from these com b ined exposures are within acceptable levels. In re aching this determ ination, EPA has considered the
available inf o rm ation on the spec ial s ensitivity 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 th e FQPA tolerance reass e ssm en t process, EPA assessed the risks associated
with ADBAC. The Age ncy has determ ined that food uses of ADBAC, meet the safety standards
under the F Q PA a m endm ents to section 408(b) (2)(D) of the FFDCA, a nd that there is a
reasonab l e certainty no h arm will res u lt to the general popu lation or any s ubgroup from the use
of ADBAC. In reaching this conclusion, the Ag ency has considered all available inform ation on the toxicity, use practices and e xposure scenarios, and the environm ental behavior of ADBAC.

As discusse d in Section III, the ch ro nic die t ar y a ggregate ris k s from direct and ind i re ct food contact as well as drinking water exposures for adults and children are below the Agency’s
level of con cern prov ided that m itigation m easures outlined in this docu m ent are adopted and
labels are am ended.

Since ADBAC toxicity endpoints for oral, derm al, and inhala tion routes of exposure are based on different toxic effects, these three routes of exposure are not aggr egated together for the
short- and in term ediate-term aggregate assessm ent. Instead, the short- an d inte rm ediate- t erm aggregate assessm ent is based sole ly on the co-occurrence of the sa m e route of exposures. Only
the short –term aggregate is presented because th e endpoints for inciden t al oral and in halation
are id entical f o r the shor t- and inte r m ediate -term durations, and only a short term derm al exposure duration was identified. T he aggregate ri sks are not of concern for adults and children for any of the three routes of exposure; the risk estim ates were a bove the target MOE.

c. Determination of Safety to Infants and Children

EPA has determ ined that the currently regi stered uses of ADBAC, with changes as specified in this docum ent, m eet the safety standards under the FQPA a m endments to section 408(b)(2)(C ) of the FFDCA, that there is a reas onable certainty of no harm for infants and
children. T h e safety determ ination for infants an d children considers factor s of the toxicity, use practices, and environm ental beha vior noted above for the genera l population, but also takes into account the possibility of increased susceptibility to the toxic eff ects of ADBAC residues in this population subgroup.

No Special FQPA Safety Factor is n ecessa ry to protec t the s a fety of infants and children.
In determ ining whether or not infants and children are particu l arly suscep tible to toxic effects
from ADBAC residues, the Agency consider ed th e com p leteness of the da tabase f o r developm ental and reproductive effects, the nature of th e effects observed, and other

51

### inform ation. The FQPA Safety Factor has been removed (i.e., reduced to 1X) for ADBAC based on (1) the ex isten ce of a com p le te developm ental and reproductiv e database (2) the lack of evidence for increased susceptibility in the da ta (3) the risk assessm ent does not underestim ate the potential exposure for infants and children.

d. Endocrine Disruptor Effects

EPA is required under the FFDCA, a s am e nded by FQPA, to develop a screening

program to determ ine whether certain substanc es (including all pes tic ide a ctive and other ingredients) “m ay have an effect in hum ans that is sim ilar to an effect produced by a naturally occurring estrogen, or other endocrine effects as the Adm i nistrator m a y designate.” Following

recomm endations of its Endocrine D i sruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined tha t the r e was a sc ie ntific basis for including, as part of the

program , the androgen and thyroid horm one syst em s, in addition to the estrogen hormone
system

. EPA also adopted EDSTAC’s recomm endation that EPA incl ude evaluations of potential effects in wildlife. For pesticides, EPA will use FIF R A and, to the exten t that effects in
wildlife m a y help determine whether a substa nce m a y have an effect in hum ans, FFDCA
author ity to requir e the wildlif e eva l uations. As the science develops and resources allow, screening of additional horm one system s m a y be added to the Endocrine Disruptor Screening Program (EDSP).

When the appropriate screening and/or te sting protocols being considered under the EDSP have been developed, ADBAC m a y be subject to additional screeni ng and/or testing to
better characterize effects relate d to endocrine disruption.

e. Cumulative Risks

Risks summarized in this docum ent are thos e tha t resu lt on ly f rom the use of ADBAC. The Food Quality Protection Act (FQPA) requi res that the Agency consider “available
inform ation” concern i n g the cum u lative effects of a particu l ar pesticide’s residu es an d “other
substances that have a comm on m e c hanism of toxicity.” The reason for consideration of other
substances is due to th e possibility that low-leve l exposures to m u ltiple chem ical substances that

cause a com m on toxic effect by a co mmon toxic m echanism could lead to the sam e 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 comm on

m echanis m of toxicity, EPA has not m a de a common m echanism of toxicity finding for

ADBAC. For inform ation regarding EPA’s effo r t s to determ ine which ch em icals have a

common m e chanism of t oxicity and to evaluate th e cum u lative effects of such chem icals, see the policy s t atem ents releas ed by EPA’s Office of Pesticide Program s concerning common

m echanis m determ inations and proc edures for cumulating effects from substances found to have

a common m echanism on EPA’s website at http://www.epa.gov/pest icides/cum ulative/

.

2. Tolerance S u mmary

Alkyl Dim e thyl Benz yl Ammonium Chloride, (ADBAC) has tolerance exem ptions in 40 CFR 180.940 (a) as a food contact sanitizer for use in public eating places, in dairies on processing equipm ent, and in food processing plants on equipm ent and utensi ls not to exceed the

52

### lim it of 200 ppm and (c) as a food contact sani tizer for use in food processing plants on equipm ent and utensils not to exceed the lim it of 400 ppm

.

Table 9: Tolerance Rea ssessment S u mmary fo r ADBAC

Tolerance Exem ption Listed Under 40 CFR 180.9 40 (a)

Use Site Current Limit (ppm) Tolerance

Reasse ss men t (ppm) Corre ct
Definition/Comment

Public eating places, dairie s on processing equipm ent and utensils, and f ood processing plants on equ ipment and

utensils Total quat

concentration

does not exceed

200 Total quat

concentration

does not exceed

200 No change

Tolerance Exem ption Listed Under 40 CFR 180.9 40 (c)

Use Site Current Limit (ppm) Tolerance

Reasse ss men t (ppm) Corre ct
Definition/Comment

Food processing plants on equipm ent an d utensils Specific quat

concentration

does not exceed 200; t o tal qua t
concentration

does not exceed

400 Specific quat

concentration

does not exceed 200; t o tal qua t
concentration

does not exceed

400 No change



### D. Regulatory Rationale

The Agency has dete rm ined that ADBAC is eligible f o r re reg i str a tion pro v ided tha t additional required data confirm this decis i on, the risk m itigation m easures outlin ed in this
docum ent are adopted, and label am e n dm ents are m ade to reflect these m easure.

The following is a summ ary of the rationale fo r m a naging risks associated with the use of

ADBAC. Where labeling revisions are warranted, specific language is set forth in the summ ary tables of Section V of this docum ent.

1. Human Health Risk Management

a. Dietary (Food) Risk Mitigation

The chronic dietary risks from ADBAC re sidues on food, estim ated using conservative

m easures, ar e below the Agency’s le vel of conce r n. Theref or e, no m itigation m easures are necessary at this tim e

.

b. Drinking Water Risk Mitigation

As an outdoor pesticide for use on nursery or nam e ntals, turf, and m o squito control in
decorative f ountain/ponds and puddl es, ADBAC is expected to im pact either surface or ground

53

### water resources. There are no drinking water concer ns since the risk estim a tes for children and
adults wer e below the le vel of conce r n. Theref or e, no m itigation m easures are ne cess a ry at this
tim e.

c. Residential Risk Mitigation

i. Handler Risk Mitigation

Residential handler risks we re calcu l ated for the short- term duration because it best
represents m o st hom eowner applications. The re sidential handler risks did exceeded the target
MOEs f o r all scena r ios. Theref ore, n o m itig ation m easures ar e needed a t this tim e.

ii. Post-Applic ation Ris k Mit i gation

As with the residen t ial h andler risk assessm ent, the post-app l ication risks were also
calcu lated f o r the sho r t-term duratio n because it be st rep r es ents m o st hom eowner applications. All residential post application risks were above the Agency’s level of concern except for inhalation exposures due to use in hum i difiers, based on the 24 hr inhalation MOEs for adults and children, 10 and 4, respectively and incidental oral exposure for children due to residential

treatm ent of lawns, MOE 76.

At this tim e, there a r e no availab l e mitiga ti on m easures for th e hum idifier use. Becaus e of

rem a ining residential exposure concerns, the re gistrants for ADBAC have a greed to conduct a inhalation exposure study that would allow the A gen cy to refine the risks associated w ith this

uses. However, this stu dy will not b e com p leted in tim e f o r inclusion in this RED. Until acceptab l e d a ta are submitted, the Ag ency has determ ined that the res i dential use of ADBAC in
hum i dif i ers is ine ligib le f o r reregistr ation and th is use m ust be deleted. Once the data has been
receiv ed and determ ined to be accep table, and if it is es tablish ed that the risks are no t o f concern, the registrants can request that this use be reinstated.

In order to m itigate the risks of conc ern s cena r io, the Agency is requ iring that the

m a xi mum a pplication rate for use on residential lawns m ust be re duced to 5.4 lb ai/A. The MOE at this application rate achieves the target of 100.

d. Occupation al Risk Mitigation

i. Handler Risk Mitigation

EPA determ ined that the grea test p o tential for handler exposure appe ars to be the shortand inte rm ediate -te r m inhalation ex posure scenarios. In order to reduce the occupational handler risk, th e following m itig ation m easures m u st be adopted:

Fogging in Agricultural Prem ises and Equipm ent: All labe ls m u st indi cate that a dust m i st respirator will be used when pouring the product into the fogging equipm e nt.

Pulp and Paper: In o r de r to m itigate the risks of c on cern f o r o ccupational handlers in pulp and

paper m ills, the Agency is requiring that the m a xi mum application rate m u st be redu c ed to 14 lbs ai/ton of paper for products coupled with the use of a m e tering pum p 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 stream s): In orde r to m itigate the risks of concern for occupationa l handlers in once-through cooli ng tower, the Agency believes
that the m axim u m num b er of appli cations per year for this use patte rn m us t be reduced to four. This reduction, together with the f act that application of these pr oducts utilizes m e tered pum p (a closed system ) addresses the inhalation risk of concern. (The reduction in the # of applications
should also be added to the eco risk m itigation p i ece for coo l ing towers. )

Sm all Process W ater System s: All labels m ust indicate that a dust m i st respirator will be used when applying the product to the water system

.

Blender/Spray Applicati on for W ood Preservation : Due to the conservative nature of the risk

assessm ent and the proxim ity of the MOE to the target of 100 (MOE = 84) the Agency believes that actual exposures do not exceed the Agency’s level of con cern.

Mopping in Medical Prem ises : Due to the conse r vative n atur e of the risk assessm ent and the proxim ity of the MOE to the target of 100 (M OE = 95) the Agency believes that actual exposures d o not exceed the Agency ’s level of concern.

ii. Post-Applic ation Ris k Mit i gation

Except for the post-application scenario assessed for fogging in hatcheries and food processing plants, the occupational post-applic ation derm al and inhalation exposures are

assum e d to be negligible. Based on the inhalati on risk estim a tes for fogging in hatcheries, a 2 hour re-entry interval m ust be pres cribed to all labels w ith this use to m itiga te the inhalation risk. In regard to food processing plan ts, the label m u s t indicate a 2 hour reentry interval as well as a

m i ni m u m requirem e nt of 4 air changes per hour (A CH). The registrants for ADBAC have agreed
to conduct air m onitorin g data and/o r provide ad ditional air exchange inform ation that would
allow the A g ency to f u rther ref i ne th e risks associated with this use.

2. Environmental Risk Management

There is m i nim a l environm ental exposure fr om the indoor uses of products containing

ADBAC theref ore no m itiga tion m easures a r e ne eded for these use patterns at this tim e.

Conversely, there is signifi cant environm ental exposure from t h e outdoor uses from products containing ADBAC; such as ornam e nt al nurseries, golf/turf , once-through cooling water towers, and antisapstain w ood treatm ent, each of which resu lted in RQs that ex ceeded th e Agency’s level of concern

. . In ord er to r educe the enviro n m ental risk, the f o llowin g m itigation

m easures must be adopted:

Ornam e ntal Nurseries : Application is lim ited to Spot Treat m e nt of diseased ornam e ntal plants
and flowers at a m a xi m u m rate of 800 ppm and total use of 5 lbs A.I/ acre. Treatm ent is
restricted to indoor uses or uses in w hich c ontrolled conditions prevent runoff and exposure to
the environm ent. In the case of diseased trees, the spot treatm ent of trees m ust be at least 100 feet
from any pond, lake, stream , or river to prevent possible runoff of the produc t into the waterway.

55

### The label m u st sta t e “ D o Not Apply by Aerial Spray.”

Golf /Turf : For comm er cial application to golf course s, trea tm ent is be lim ited to the “Greens
and Tees” at a rate of 0.8 lbs A.I./acre (200 ppm) not to exceed treatm ent of 10 acres (2000 gallons ) with retreatm e nt at 10 day interv als not to exceed 6 treatm e nts per year.

For resid ential app lic ation to turf /la w ns, applic a tion is lim ite d to Spot Tr eatm ent of diseased
areas of the lawn/tu rf only at a m aximum rate of 5.4 lbs A.I/acre no t to exceed 25 gallons per 1000 sq. ft. Treatm e nt must be repeated up to 6 tim es a year at 10 day intervals.

Mosquitocid e : The product labels suppor ting this use m u st state:

This product is not intended to be used for br oadcast m osquitocide app lication but rather is
lim ited to sm all residential ponds, decorative ponds, and si milar areas. T h e product labels m u st 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 am phibious organism s. This product controls mosquitoes where they breed (fountains, wate r displays, decorative pools, decorative ponds,
sewage treatm e nt systems, spas, hot tubs, swim m i ng pools and standing water in old tires, em pty tin cans, barrels, puddles, and wa ter drains around buildings). Do not exceed 10 applications at

a m i ni m u m of 10-day intervals per year. NOTE: Only out-of-season, not-in-service, or inactive spas, hot tubs, swimm i ng pools require treatm ent for m osquito control. Do not treat during the swimming season. Spray from fount ains treated with this product will not harm poolside plantings. DO NOT use when fish or other wild life (for example, am phibians) are pres ent

.



### Once-Through Cooling Water Tower: All labe ls m u st state “ D o Not Apply This Product m o re than 4 tim e s per year.” Also, all labels suppor ting this use must carry the NPDES s t atem ent per PR Notice 93-10 and 95-5 as well as directions fo r Bentonite Clay Treatm e nt, a m e thod to treat
the wate r be f o re it is re le ase.

Antisapstain W ood Treatm e nt: All product labels supporting this use m ust add the following

text:

Treated lumber m ust be stored under cover, or indoors, or at least 100 feet from any pond, lake, stream , wetland, or river to prevent possi ble runoff of the product into the water way.

Treated lumber stored outdoors within 100 feet of a pond, lake, stream , wetland, or river m ust be either covered with plastic or su rroun ded by berm to preven t surface water runoff into the nearby
waterway. If a berm is used around the site, it m ust consist of i m per m eable m a terial (clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events.

3. Labeling Requirements

In order to b e elig ible f o r

rereg i stratio n, various us e and saf ety inf o rm ation will be included in the labeling of all end-use products containing ADBAC

. For the specific labeling

statem ents and a list of outstanding data, refe r to Section V of this RED docum ent.

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

f ederal agen cies to cons ult with the National Ma rine Fish erie s Service (NMFS) for marine and

anadrom ous listed species, or the United States F i sh and W ildlif e Services (FW S ) f o r listed wildlife and freshwater organism s, if they are proposing an "action" tha t m ay af f ect listed spec ies 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 c ontinued existence of a listed spec ie s or resu lt in the des t ruction or adverse m odification of designated critical habitat. To jeopard iz e the con tin ued exis tenc e of a liste d species m eans "to engag e in an actio n that reasonably would be expected, dire ctly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by re ducing the reproduction, num bers, or distribution of the species." 50 C.F.R. § 402.02.

To f acilitate com p liance with the req u irem ents of the Endang ered Spec ies Act subsection (a)(2 ) th e Environm ental Protec tion A gency, Office of Pesticide Program s has established procedures to evaluate whether a proposed regi stration action m a y directly or indirectly reduce appreciably the likelihood of both the survival an d recove ry o f a listed spe cies in the w ild by reducing the reproduction, num bers, or distribution of any listed sp ecies (U.S. EPA 2004). After the Agency’s screen ing-level risk ass e ssm ent is pe rform e d, if any of the Agency’s Listed Species

LOC Criteria are ex ceed ed for either direct or in dire ct effects, a determ ination is m a de to iden tif y if any listed or candidate species m a y co-occur in the area of th e proposed pesticide use. If

determ ined that listed or candidate species m a y be present in the proposed use areas, further biological assessm ent is undertaken. The extent to which listed species m a y be at risk then

determ ines the need for the developm ent of a more com p rehensive consultation package as required by the Endangered Species Act.

For certain u se catego r ies, the Agency assum es there will be m i ni m al environm ental exposure, and only a m i nim al toxicity data set is required (Overview of the Ecological Risk

Assessm ent Process in th e Of f i ce of Pestic ide Pr ogram s U.S. Environm e ntal Protection Agency - Endangered and Threatened Species Effects De term inations, 1/23/04, Appendix A, Section IIB, pg.81). Chem icals in these categories therefor e do not undergo a full screening-level risk

assessm ent, and are considered to fall under a no effect determ ination. The active ingredient uses of ADBAC with the excepti on of the ornamental nurserie s, golf/turf/lawns, once-through cooling tow e r, and antisapstain wood preservati on uses, fall into this category. Using Tier I screening modeling to assess pot ential exposure from the ornam e nt al nurseries, golf/turf/lawns, once-through cooling tower, and antisapstain wo od preservation uses of ADBAC risks to Listed Species are indicated. S i nce the m o del is only intended as a screening-level m odel, and, as such,

has inherent uncertainties and lim itations which may result in inaccurate ex posure es timations,

further refinem e nt of the m odel is recommended before any regulatory ac tion is taken regarding

the ornam e ntal nurseries, golf/turf/lawns, once-th rough cooling tower, and antisapstain uses of

ADBAC. Additiona lly, impacts f r om the antisaps ta in use could potentially be m itigate d with precautions to preven t leaching and runoff when wood is stored outdoors and im pacts from the cooling tow er use cou l d potentially b e m itigated by the reduction of risk m itigation. Due to

57

### these circum stances, the Agency defers m a king a determ ination for the ornam e ntal nurseries, golf/turf/law n s, once-th rough coolin g tower, an d antisap stain uses of ADBAC until additional

data and m o deling refinem e nts are available. At that tim e, the environm ental exposure

assessm ent of the ornamental nurseries, gol f/turf/lawns, once-through cooling tower, and antisap sta i n use of ADBAC will be r e vised, and th e risks to L i sted Spec ie s will be rec onsidered

.

b. General Ris k Mitiga tio n

ADBAC end-use products (EPs) m a y also contai n other registered pesticides. Although the Agency is not propos ing any m itigation m easures for pro ducts con t aining ADBAC specific to federally listed sp ecies , the Agency needs to ad dress potential risks from other end

- u se products. T h erefore, th e Agency req u ires that u s ers adopt all listed species risk m itig ation

m easures for all active ingredien t s in the pr oduct. If a produ ct contains multiple active ingred ients with conf lic ting lis ted sp ecies ri sk m itiga tion m easures, th e more stringen t

m easure(s) should be adopted.

58

### V. What Registrants Need to Do

The Agency has determ ined that ADBAC is e ligible f o r re reg i str ation pro v ided tha t: (i)
additional d ata th at th e Agency inte nds to requ ir e conf irm this dec i sion ; ( ii) the r i sk m itigation

m easure outlined in this docum ent is adopted; an d (i ii) label am endm ents are m ade to reflect this

m easure. To im ple m ent the risk m itigation m easure, the registran t s m u st am end their product labeling to incorpora t e the labe l sta t em ent set forth in the Label Changes Summ ary Table in Section B below (Table 13). The additional data requirem e nts that the Ag ency intends to obtain
will in clude, am ong othe r things, sub m ission of the following :

For ADBAC technical grad e active ingredient products , the registrant needs to subm it the following item s:

Within 90 d ays from receipt of the generic data call-in (D CI):

1. com p leted response f o rm s to the generic DCI (i.e., DCI response form and requirem e nts status and regist rant’s response form ); and

2. subm it any tim e extension and/o r waiver r equ ests with a f u ll written justif ica tion.

Within the time limit s p eci fied in the generic DCI:

1. cite any existing generic data which addr ess data requirements or subm it new generic data responding to the DCI.

Please contact Jacqueline Cam pbell-McFarl ane at (703) 308-6416 with questions regarding generic reregistration.

By US m ail: By express or courier s e rvice : Docum e nt Processing Desk (DCI/AD) Docum e nt Processing Desk (DCI/AD) Jacqueline Ca m pbell-McFarlane Jacqueline Ca m pbell-McFarlane US EPA (7510P) Office of Pesticide Program s (7510P) 1200 Pennsylvania Ave., NW Room S-4900, 1 Potom a c Yard Washington, DC 20460 2777 South Crystal Drive Arlington, V A 22202

59

### For end-use products containi ng the active ingredient ADBAC , the registrant needs to subm it the following item s for each product.

Within 90 d ays from the receipt of th e product-specific da ta call-in (PDCI) :

1. com p leted response f o rm s to the PDCI (i.e., PDCI response form and requirem e nts status and registrant’s response form); and

2. subm it any tim e extension or waiver re quests with a full w r itten justification.

Within eight months fr om the re ce ipt of the P DCI:

1. two copies of the confidential st atem ent of formula (EPA Form 8570- 4);

2. a com pleted original application f or rere gistration (EPA Form 8570-1). Indicate on
the f o rm that it is an “ ap p lica tion f o r

rereg i stratio n ”;

3. f i ve copies of the dra f t label incor porat ing all label am endm ents outlin ed in Table 23
of this docum ent;

4. a com p leted form certifying compliance w ith data com p ensation requ irem ents (E PA

Form 8570- 34);

5. if applicable, a com p leted form cer tif ying com p lianc e with cost sha r e o f f er requirem e nts (EPA Form 8570-32); and

6. the product-specific data responding to the PDCI.

Please contact Velm a Noble at (703) 308-6233 with questions regarding product

rereg i stratio n and/or the PDCI. All m aterial s su bm itted in response to th e PDCI should be
addressed as follows:

By US m ail: By express or courier s e rvice : Docu m e nt Processing Desk (PDCI/AD) Docu m e nt Processing Desk (PDCI/AD)
Velm a Noble Velm a Noble US EPA (7510P) Office of Pesticide Program s (7510P) 1200 Pennsylvania Ave., NW Room S-4900, 1 Potom a c Yard Washington, DC 20460 2777 South Crystal Drive Arlington, V A 22202

60

### A. Manufacturing Use Products

1. Additional Generic Data Requirements

The generic database supporting the reregi stration of ADBAC has been reviewed and
determ ined to be substan tia lly com p lete. Howeve r, the following additional data requirem ents have been identified by the Agency as confirm a to ry and inc l u d ed in the g eneric DCI f o r this

RED.

The risk assessm ent noted deficiencies in the surrogate dermal and inhalation exposure
data availab l e from the Chem ical Manufacturers Association (CMA) data base. Therefore, the Agency is requiring confirm a tory data to suppor t the uses assessed with the CMA exposure data
within th is risk assessm ent. The risk assessm ent also noted that m a ny of t he use param e ters (e.g., am ount handled and duration of use) were based on professi onal judgm e nts. Therefore, descrip tion s of hum an activitie s asso ciated with the uses ass e ssed are req u ired as con f irm atory.

Table 11. Confirmato ry Data Requirements for Reregistration

Guideline Study Na me New OPPT S Guideline No

. Old Guideline No

.

D e r m al I n doo r Expo sur e 8 75

. 12 00 , 875 .1 600 2 33

, 236

I nh a latio n Ind oo r Expo su r e 8 75

. 14 00 , 875 .1 600 2 34

, 236

D e r m al O u tdoo r Expo su r e 8 75

. 11 00 , 875 .1 600 2 31

I nh a latio n Ou t d oor Ex po su r e 8 75

. 13 00 , 875 .1 600 2 32

Descri p tio ns o f Hu m an Activ ity (All Uses) 8 7 5

. 28 00 1 33-1

D i etar y- Residues in Food from Tr eatin g Co un ter top s w i th AD BA C ( F D A W i p e St u dy

Meth od o l o g y) ( F DA , 200 3 a an d 200 3b) Non

- Gu id elin e Non

- Gu id elin e

Surface -W i p e Press u re -T reated Wood St u dy Non

- Gu id elin e Non

- Gu id elin e
Special Aquat i c Leaching St udy on Wood Non-Guide line Non-Guideline

90 Day I nhal a t i on – R a t 87 0. 3 46 5 82

- 4

Non

- Targ et p lan t ph yto tox icity (Seed lin g Em ergency usi n g ri ce) 8 50

. 42 25 1 23- 1

V e g e tativ e V i go r u s i n g r ice 8 50

. 42 50 1 23- 1

Aq uat i c pl a n t gr owt h t o xi ci t y ( Lem n a gi b b a ) 8 50

. 44 00 1 23- 2

Chr onic A quat i c In verte b rate Life Cy cle -

D aph n i a m agna 85 0. 1 30 0 72

- 4

Acute e stuari n e/m a rine orga nis m (Eastern Oyster em bryo larvae ) 85 0. 1 05 5 72

- 3b

Aq uat i c pl a n t gr owt h (4 Al ga l t oxi ci t y – 4 species: gree n algal Selenast rum capri c o r nut um ( Pseu do kirsh n erierlla

su bcap ita ta )

, blu e -g r e en c y ano b a c t er ia ( Anab eana flo s- aqu a e ), fre sh water diatom ( Na vicu l a p e llicu lo s a ) , m a ri ne di at om ( S kel et one ma c o st at um ) 8 50

. 54 00 1 23- 2



### 61Guideline Study Na me New OPPT S Guideline No

. Old Guideline No

. Special Aquatic Field M onitoring (OnceThr o ug h C o oling W a te r T o w e rs) Non

- Gu id elin e Non

- Gu id elin e

A v ian r e pr oductio n st u d y –bo b wh ite qu ail 8 5 0

. 23 00

Ho ney b ee t o xi ci t y st udi es 85 0. 3 0 3 0 17 1

- 4



### 2. Labeling for Technical and Manufacturing Use Products

To ensure c o m p liance with FIFRA, tec hnical and m a nufacturi ng-use product (MP) labeling should be revised to com ply with all current EPA regulations, PR Notices and applicable policies. The Technical and MP labe ling should bear the labeling contained in Table 13, Label Changes Summ ary Table.

B. End-Use Products

1. Additional Product-Sp ecific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Ag ency to obtain any needed product-specific
data r egard ing the pes tic ide af ter a d eterm ination of eligibility has been m a de. The Registrant
must review previous data subm issions to ensure that they m e et curren t E P A acceptan ce criteria and if not, comm it to conduct new studies. If a regi strant b elieves that p r eviously sub m itted data

m eet current testing standards, then the study MRID num bers should be cited according to the instructions in the Requirem e nt Status and Registrants Response Form pr ovided for each product.

A product-s p ecific data call-in, ou tlining spec ific data requirem ents, will be sent to registrants at a later date. Pr oducts which include claim s for re sidual sanitizing activity as well

as res i dual claim s agains t certain non -public hea lth organism s, includ ing mold, will b e required
to subm it efficacy data to support th ese claim s. If a product label include s a sanitizing claim ; such as san i tizing carpets or laundry, the approp riate efficacy data m u st be subm itted to support
the claim

.

The efficacy studies the Agency intends to call-in are listed in Table 12 b e low.

Table 12. Efficacy Data Requirements for Reregistration

Claim Use P a ttern Guideline Study Name New OPPT S

Guideline No

. Old Guideline

No

.

Disinfecta n t Hard i n anim ate
surfaces AO AC Use Di lution Test ( H a r d

wat e r a n d or ga ni c s o i l )

or

AO AC Germ icidal Sp ray Test

or

AOAC Hard Surface Carrier Test (Distilled water o n l y) 81 0. 2 10 0 (c), ( d )

, (e) 9 1-2 (b)

, (c), ( d )



### 62Claim Use P a ttern Guideline Study Name New OPPT S

Guideline No

. Old Guideline

No

.

To ilet Bo wl

Di si nfect i o n To ilet bo wl and

uri n al ha rd s u rfaces AO AC Use Di lution Test ( H a r d

wat e r a n d or ga ni c s o i l )

or

AO AC Germ icidal Sp ray Test

or

AOAC Hard Surface Carrier Test (Distilled water o n l y) 81 0. 2 60 0 ( b) (1 ) 91

- 7 (a ) (1 )

Laun dr y Add itiv es Di si nfect i o n

(p re-s oa k) Laun dr y AOAC Hard Surface Carrier Test (Distilled water o n l y)

or

AO AC Use Di lution Test ( H a r d

wat e r a n d or ga ni c s o i l ) 8 10

. 23 00 (b )( 2) 9 1-4 ( a ) ( 1)

Laun dr y Add itiv es Di si nfect i o n (non -residu a l) Laun dr y Pet r occi a n d C l arke l a un dry

ad d itiv es (d isinfectan t lev e l ) or

act ual i n

- u se st udy 8 10

. 23 00 (b )( 3) 9 1-4 ( a ) ( 2)

Tu berc ul oci d al Hard i n anim ate
surfaces AO AC T u berc ul oci d al Act i v i t y Test m e tho d (s tanda rd )

or

AO AC T u berc ul oci d al

di si nfect a n t s t e st m e t hod (m odified)

or

Qu an titativ e Tu b e rcu lo c id al

Activ ity test meth od

or

AO AC Germ icidal Sp ray Test (m odified fo r s p ray pr o ducts ) 81 0. 2 10 0 ( h) 91

- 2 ( g )

Vir u cidal Hard i n anim ate
surfaces Viru cid a l Activ ity Meth od u s ed

in conj un ction with m o d i ficatio n of : AOAC Ha rd surface carrier

test (d istilled water on ly)

or

AO AC Germ icidal Sp ray Test 81 0. 2 10 0 ( g) 91

- 2 ( f)



### 63Claim Use P a ttern Guideline Study Name New OPPT S

Guideline No

. Old Guideline

No

.

Fu ngi ci dal Hard i n anim ate
surfaces AO AC F u ngi ci dal Test

or

AOAC Ha rd s u rface ca rrier test (d istilled water on ly)

or

AO AC Germ icidal Sp ray Test 81 0. 2 10 0 (f ) 91

- 2 (e )

San itizer N on -fo od con t actsurfaces (nonresid u al) Sanitizer Test for Ha rd Ina n imate

Non-Food C o ntact Surfaces 81 0. 2 10 0 (l ) 91

- 2 ( j )

Fo od C o nt act
San itizer Fi nal ri nse of

pre v i o usl y cl ea ned

food c ontact s u rface AO AC Germ icidal an d Deter g ent
San itizers Met h od 81 0. 2 10 0 (m )(2) 91

- 2 (l )( 2)

Laun dr y ad d itiv e, non

resid u al Laun dr y Pet r occi a n d C l arke l a un dry

ad d itiv es m e th o d (San itizin g lev el) 8 10

. 23 00 (b )( 4) 9 1-4 ( a ) ( 3)

Laun dr y ad d itiv e, resi du al

self san itizin g Laun dr y Pet r occi a n d C l arke l a un dry

ad d itiv es m e th o d or ATCC Test

m e t hod 1 00

- 19 74 8 10

. 23 00 (b )( 5) 9 1-4 ( a ) ( 4)

Laun dr y Add itiv es,

san itizin g presoa k Laun dr y San itizer test fo r h a rd in an imate

non-food c o ntact surfaces

m odi fi ed t o i n c l ude o rga ni c s o i l 81 0. 2 10 0

(b )( 2) N/A

R e si dual Sel f

San itizin g Hard s u rfaces (resi dual sel f

san itizin g activity o f

dri e d c h em i c al

r e sidu es on h a rd

inanim ate surfaces) C ont r o l l e d I n

- Use st udy o r sim u lated In-Use study 81 0. 2 10 0 ( o) 91

- 2 (m )

Carpet Sa nitizer Carpet EPA Ca rpet Sa n i t i zer Pr ot oco l 81 0. 2 3 0 0 (c) 91

- 4 ( b )

To ilet bo wl and

u r i n al san itizing To ilet bo wl and

uri n al ha rd s u rfaces Sanitizer Test for Ha rd Ina n imate

Non-Food C o ntact Surfaces 8 10

. 26 00 (b )( 2) 9 1-7 ( a ) ( 2)

Presaturated and

im preg nat e d

to welettes Hard Ina n im ate
Surfaces Si m u lated In -use Stud y 81 0. 2 10 0 (i ) N/ A

San itizin g Fab r ic

Treatm e nt Mattresses,

u pho lstered fu rn itu re,

p illo ws Si m u lated In -use Stud y 81 0. 2 30 0 ( d) 91

- 4 (c )

Term i ticid e Wood Pre v e n tive T r eatm e nt – wood

im preg nat i on N/A 95

- 1 2 ( b )(ii)



### 64

### 2. Labeling for End-Use Products

Labeling changes are necessary to implem e nt measures outlined in Section IV above. Specific language to incorporate thes e changes is specified in Table 13.

Registrants m ay generally dist ribute and sell products bear ing old labels/labeling for 26
months from the date of the issuance of this Rer egistration E ligib il ity Decision docum e nt. Persons other than the registrant m a y generally distribute or sell such products for 52 months
f r om the approval of labe ls ref l e cting the m itigatio n describ ed in this RED. However, existing
stocks tim e fram e s will be estab lish e d case-by -case, dependin g on the nu mber of products involved, the num ber of label change s, and other factors. Refer to “Existing Stocks of Pesticide Products; S t atem ent of Policy,” Federal Register , Volum e 56, No. 123, June 26, 1991.

a. Label Changes Summary Table

In order to be eligible for reregistration, am end all product labels to incorporate the risk

m itigation m easure outlined in Section IV. Th e following table describes how language on the
labels should be am ende d.

65Table 13.Labeling Changes Summary TableStatements noted with an * are not directlyrelated to risk mitigation but are reflective of Agency labeling requirements.DescriptionAmended Labeling LanguagePlacement on LabelManufacturingUseProductFor all ManufacturingUseProducts*“Onlyforformulation intoantimicrobialproducts for use in: agricultural/farmpremises,structures, buildings, andequipment; dairy farmmilkhandling facilities, equipment, storagerooms, houses,and sheds;foodprocessingplants,foodhandling,fooddistribution equipmentand premises;eatingestablishments premises andequipment; commercial, institutional,andindustrial premises andequipment (floors,walls, storage areas); domesticdwellings, foodhandling areas, bathroompremises (hardsurfaces), indoorpremises; andmedical institutionalcritical care andnoncriticalcarepremises and laundry.For Formulationintoantimicrobialproductsforuse ingolf/commercial turf/lawns,greenhouses/nurseries, fountains/waterdisplays/decorativeponds/standingwater,sewagetreatmentsystems, spas, air conditioner/refrigeration condensate watersystems, air washer andindustrial scrubbing systems,once- throughand recirculating industrial/commercial coolingwater systems, pulp/paper millwater systems,andswimmingpools.Gas/oil drillingmuds/packerfluids, mushroomhouses/emptypremises andequipment, woodpreservation, egghandlingequipment and rooms, egg washing treatment, poultry processing plantequipment/premises,meatprocessingplant/equipment, gas/oilrecoveryinjectionwatersystems.Directions for UsePPE Requirements1Corrosive. Causes irreversibleeye damage and skinburns.May befatal if swallowedorinhaled.Maybeharmful ifabsorbed throughthe skin.Donotget in eyes, onskin,oronclothing.Donot breathevapor or spray mist.Wear a dust/mist filteringrespirator(MSHA/NIOSH approvalnumber TC-21C)oraNIOSH approvedrespiratorwithanyN, R,P,or HE filter.Wear gogglesorfaceshield, rubbergloves, and protectiveclothing whenhandling.Washthoroughlywithsoapandwater afterhandling.Remove contaminated clothingandwashbeforereuse.PrecautionaryStatements66DescriptionAmended Labeling LanguagePlacement on LabelPulpandPaperApplications*Productlabelslisting usesfortreatmentofpulp/paperprocess components(eg.,paper machinewhitewater; catalase control indeinkingloops; starchandsizing;coatings;fillers; pigments;adhesives;etc.), andwhich containactive ingredientsnotclearedbyFDA for foodcontact,must state "For non-food useonly".Those cleared for foodcontact, may state "For food andnon-foodcontact".Directions for UseEcologicalEffects LanguageRequiredbythe RED and PRNotice93-10 and 95-1"Thisproductistoxic tofish,aquaticinvertebrates,oysters,and shrimp.Donotdischargeeffluent containingthis product intolakes,streams,ponds, estuaries,oceans, orotherwatersunless inaccordance with therequirementsof aNational PollutionDischarge EliminationSystem(NPDES)permit andthepermittingauthority has beennotifiedinwritingprior todischarge.Donotdischarge effluentcontainingthisproducttosewersystems withoutpreviously notifyingthe localsewagetreatment plant authority.Forguidance contact yourStateWater Board or RegionalOffice of theEPA."Environmental HazardStatementsPhysical and Chemical Hazards*Do notuseorstorenear heator openflame.Donotmixwithoxidizers, soap, or otheranionicmaterialsPhysical and ChemicalHazardsEnd-Use Productsfor Commercial,Industrial, Institutional UsesPPE Requirements1ThePrecautionary Statements/PPE aredependentonthe Acute Toxicity Data submittedtosupporttheend use productregistration(s).RefertoLabelManual,3rdEditionChapter 7 forlabeling.PrecautionaryStatementsFogginginHatcheries2 hourReentryIntervalfor foggingapplicationsDirections for UseFogginginFoodProcessingPlants2hourReentryIntervalforfoggingapplicationsanda minimumof 4 airexchanges(ACH)perhour in thefacilitySwimming Pools*Do not applywhenswimmersare inthe immediate vicinity (theAgencyrecommends a15minute reentryinterval)Directions for UseWoodPreservationLabel must includedilutionrate and retentionchart specific tothe typeofwoodused forpressure anddip treatmentIfregistranthas notsupportedHoneyBeeData, thefollowingstatementmustbe includedonthe Agency label as well as the end tag on the treated lumber:Woodtreated with ADBACshall notbeusedin the construction ofbeehives.Directions for Use67DescriptionAmended Labeling LanguagePlacement on LabelAgriculturalfogging(loading)Labels must indicate that adust mist respiratormust bewornwhenapplyingtheproducttothefogging equipment.Directions for UsePulp andPaperMaximumuse rateis14lbai/tonofpaper.Productlabelsinvolving treatmentofpulpandpaperprocesses (eg., treatmentofpapermachine whitewater; catalase control indeinkingloops; starch andsizing;coatings; fillers;pigments;adhesives;etc.),which resultinfinishedproductswhich mayhavedirectorindirectfoodcontact,must haveFDA clearancefor the entire formula via a foodadditivepetition,andmust state whether eachuse iscleared for "food contact" uses, and/orinvolves "non-foodcontact"uses.ProductswithoutFDA clearance muststate:Donotusetotreatpaperorpaperboard whichwill contact food.Directions for UseSmallProcessWater SystemsLabels must indicate that adust mist respiratormust bewornwhenapplyingtheproducttothewater system.Directions for UseHandSanitizerDeletethe UseDelete all claimsandDirections for UseUdders, Teats andFlanksDeletethe UsesDelete all claimsandDirections for UseTreatmentof HatchingEggsDelete theUseDelete all claimsandDirections for UseSanitizingIncubatorsandHatchers*Label must include thefollowingtext:Onlyfor treatmentof setters andhatchers afterpoultry/chicks/eggshavebeenremoved.Notfor treatmentofhatcherswhich containchicks/eggs.Directions for UseSanitizingHatcheryRooms*Label must includethefollowingtext:Removeall animalsandfeed frompremise, vehicles and enclosures.Directions for UseTreatmentof EggsinEggProcessingFacilities*Label must includethefollowingtext:Eggssanitizedwiththisproduct must besubjectedtoa potablewater rinseif they are tobebrokenimmediately foruse in the manufactureof eggproducts.Eggsmustbe reasonablydrybefore casingorbreaking.The solution mustnotbere-usedfor sanitizingeggs.Directions for UseAgricultural Premises andEquipment/Animalhousingfacilities*All animal viruses claimed onthe label mustimmediately precededirections foragriculturalpremises and equipment/animal housing facilities.Directions for Use68DescriptionAmended Labeling LanguagePlacement on LabelTreatmentofMushroomFarms*Labelmustinclude thefollowingtext:DONOT APPLYTO THEMUSHROOMCROP, COMPOSTOR CASING.Rinse treated surfaceswithpotablewater before theycontactthe crop, compostorcasing.Directions for UseInstitutional/ Medicalpremiseand equipment*If the labelindicates use ininstitutions, medical facilities/premises onmedical equipmentsuchas wheelchairs, hospitalbed frames,orunqualified metal, plastic, and stainless steel surfaces,the following statement, “This productisnotforuseonmedicaldevices andequipment” tothemustbe addedorthefollowingMOU languagefromPRNotice 94-4:Thisproduct is not tobeusedas a terminal sterilant/highlevel disinfectantonanysurfaceorinstrumentthat(1) is introduceddirectly into thehumanbody, either intoorincontact withthebloodstreamor normally sterileareasof thebody, or(2) contact intactmucousmembranes butwhichdoesnotordinarilypenetrate thebloodbarrierorotherwise enternormallysterileareasofthebody.Thisproductmaybeusedtopre-cleanor decontaminate critical or semi-criticalmedicaldevices prior tosterilizationorhighleveldisinfection.Directions for UseHardnonporous surfaces inInstitutional/Commercial FoodHandlingFacilities*After disinfection, apotablewater rinse isrequired. Donotusetodisinfectappliances,refrigeratorinteriors, and microwaveoven interiors.Donotuseondishes, glasses, andutensils.Directions for UseInstitutional/CommercialLaundry Treatment*Dilute____ozper_____gallonsofwaterper100 lbsoffabric(dryweight).Whenwashingthe clothes, amaximumof60gallonsofwater per100 lbs.of fabric(dryweight) mustbeinthemachine.Adduse solution tothe wash wheel at the beginning of the finalrinse cycle.Directions for UseDisinfection/SanitizingDrains/Disposals*Delete the claimbecause theAgencybelieves it isnot feasible todisinfect throughout adrainw/ orw/o adisposal system.Directions for UseAddition ofATCC number*All organisms testedtosupport bactericidal,virucidal, andfungicidal claimsmust list theATCCnumbertoidentifythespecific strainoforganismDirections for UseEnvironmental Hazards-forLabels for AntiSapstainTreatedlumbermust bestored undercover,orindoors, oratleast 100fromany pond, lake,stream,wetland, orrivertopreventpossible runoffofthe productintothe water way.Treatedlumberstoredoutdoors within100 feetofapond,lake, stream,wetland, orrivermustbe eithercoveredwithplasticor surroundedbybermtopreventsurface waterrunoffintothenearbywaterway.If a bermis usedaround the site,itmustconsistofimpermeable material (clay,asphalt, concrete) andbeofsufficientheighttopreventrunoffduringheavyrainfallevents.Environmental Hazards69DescriptionAmended Labeling LanguagePlacement on LabelEnvironmental HazardsforOnceThroughCoolingWaterTowersDONOTAPPLY THISPRODUCTMORE THAN4TIMES PERYEAR.DEACTIVATION: This productmustbe deactivatedprior todischarge ofthe NPDESoutfall.TODEACTIVATE:UseBentoniteClayata minimumratio5ppmclayto1ppmproduct.Deactivationmustoccurpriortodischargeof theNPDES outfall.Directions for UseOrnamentalUsesApplicationislimited toSpotTreatmentofdiseasedornamentalplantsandflowers atamaximumrateof800ppmand totaluseof5lbsA.I/acre.Treatment is restrictedtoindooruses orusesinwhich controlledconditions toprevent runoffand exposure totheenvironment.In thecase ofdiseased trees, thespottreatmentoftrees mustbe atleast100feetfromanypond,lake,stream, or river topreventpossiblerunoffoftheproduct intothe waterway.DoNotApply by Aerial Spray.Directions for UseGolf/Commercial Turf/LawnFor commercial applicationto golf courses, thetreatment is limitedtothe “Greens andTees”at a rateof0.8 lbsA.I./acre(200ppm)not toexceed treatment of 10 acres (2000gallons) withretreatment at 10 day intervals not to exceed 6 treatments per year.Directions for UseMosquitocideTheproductlabelsmuststate:Thisproductisnotintended tobeusedforbroadcastmosquitocideapplicationbutrather is limitedtosmall residential ponds, decorative ponds, andsimilar areas.This productisnottobeusedinopenwaterways connectedto largerwatershedsor in watersthatserve asnaturalhabitatsforaquaticandamphibiousorganisms.Thisproductcontrolsmosquitoes wherethey breed (fountains, water displays, decorativepools, decorative ponds,sewage treatmentsystems, spas,hottubs, swimming poolsandstandingwater inoldtires,empty tincans, barrels, puddles, and water drainsaroundbuildings).Donotexceed 10applications ata minimumof10-dayintervals per year.NOTE:Onlyout-of-season,not-inservice,orinactive spas,hottubs, swimming poolsrequire treatmentfor mosquitocontrol. Donot treat duringthe swimmingseason.Spray fromfountains treatedwiththis product will notharmpoolsideplantings.DONOTusewhenfishorotherwildlife (forexample, amphibians)are present.Directions for Use70DescriptionAmended Labeling LanguagePlacement on LabelMoldRemediation/Prevention(Water/Smokerestoration/Sewer backup/riverfloodcleanup/clean watersource)ForProfessional Use Only:ForusebyMoldRemediationWorkers, MoldRemediationContractors, Certified MoldRemediators,CertifiedMoldContractors, CertifiedMoldRemediation Contractors,Applied MicrobialRemediationTechnicians,Certified MoldProfessional,Certified Restorers, and MoldRemediation CompaniesRefer tohttp.//www.epa.gov/mold/mold_remediation Table 1 and2for RemediationDirectionsfor UseDirections for UseEnd Use Products IntendedforResidential UsePPE Requirements1ThePrecautionary Statements/PPE aredependentonthe Acute Toxicity Data submittedtosupporttheend use productregistration(s).RefertoLabelManual,3rdEditionChapter 7 forlabeling.PrecautionaryStatements:Hardnonporous foodcontactsurfaces *Donot use todisinfect appliances, refrigerator interiors, andmicrowaveoven interiors.Do notuse asadisinfectantondishes, glasses,orutensils.Directions for UseDisinfection/SanitizingDrains/Disposals*Delete the claimbecause theAgencybelieves it isnot feasible todisinfect throughout adrainw/ orw/o adisposal system.Directions for UseAddition ofATCC number*All organisms testedtosupport bactericidal,virucidal, andfungicidal claimsmust list theATCCnumbertoidentifythespecificstrainoforganismDirections for UseApplication Restrictions-ForProducts UsedinSwimmingPools/Spas*Do not applywhenswimmersare inthe immediate vicinity (theAgencyrecommends a15minute reentryinterval)Directions for Useunder GeneralPrecautionsandRestrictionsHumidifiersDeletetheUseResidentialTurf/LawnFor residential lawns/turf, applicationis limited to SpotTreatment ofdiseased areasof thelawn/turfata maximumuse rateof5.4lbs A.I/acre (800ppm)nottoexceed 25gallonsper1000 sq.ft.Treatmentmust be repeatedupto6 times a yearat10 day intervals.Directions for Use71DescriptionAmended Labeling LanguagePlacement on LabelResidentialMosquitocideTheproductlabelsmuststate:Thisproductisnotintended tobeusedforbroadcastmosquitocideapplicationbutrather is limitedtosmall residential ponds, decorative ponds, andsimilar areas.Theproduct labels must berevised toreflectthefollowing:This productisnottobeusedinopenwaterways connectedto largerwatershedsor in watersthatserve asnaturalhabitatsforaquaticandamphibiousorganisms.Thisproductcontrolsmosquitoes wherethey breed (fountains, water displays, decorativepools, decorative ponds,sewage treatmentsystems, spas,hottubs, swimming poolsandstandingwaterinold tires,emptytincans,barrels,puddles, andwaterdrains aroundbuildings).Donotexceed10applications ata minimumof10-day intervals per year.NOTE:Only out-of-season,not-inservice,orinactive spas,hottubs, swimming poolsrequire treatmentfor mosquitocontrol. Donot treat duringthe swimmingseason.Spray fromfountains treatedwiththis product will notharmpoolsideplantings.DONOTusewhenfishorotherwildlife (forexample, amphibians)are present.Directions for UseMoldRemediation/Prevention(Water/Smokerestoration/Sewer backup/riverfloodcleanup/clean watersource)ForProfessional Use Only:ForusebyMoldRemediationWorkers, MoldRemediationContractors, Certified MoldRemediators,CertifiedMoldContractors, CertifiedMoldRemediation Contractors,Applied MicrobialRemediationTechnicians,Certified MoldProfessional,Certified Restorers, and MoldRemediation Companies.Refer tohttp.//www.epa.gov/mold/mold_remediation Table 1 and2for RemediationDirectionsfor UseDirections for Use1PPE that isestablished onthe basis of Acute Toxicityofthe end-use product must be comparedtothe activeingredient PPE inthisdocument.Themore protectivePPE must beplaced inthe productlabeling.For guidance onwhich PPEisconsidered more protective, see PRNotice 93-7.72

# VI. APPENDICES

73

### APPE NDI X A: Master ADBAC Label

EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

Industrial proces ses and w a ter syst e m s

1032 4- 21 S m all Process Wat er Sy ste m s Re-circulating Cooling Tower Pour

Meter ed W e ar dust m i st respirator when apply i ng pr oduct to

sy ste m 795, 00 0 pp m Initial = 39.8 pp m
M a int. = 14. 9 pp m

1032 4- 102 S m all Process Wat er Sy ste m s Waste wate r tre at m e n t

E v apor ative condenser Pour

Meter ed W e ar dust m i st respirator when apply i ng pr oduct to

sy ste m 795, 00 0 pp m Initial = 39.8 pp m M a int. = 14. 9 pp m

6836- 5 8 I ndustr ial Recir c W a ter Sy ste m s Pulp/Paper Metered M a x appl. rate m u st
be r e duced to 14 lbs ai/ton of paper 226 ppm

1032 4- 21 I ndustr ial W a ter Sy stem s Once- thr ough Coo ling M e tered Do Not Apply This

Pr oduct M o r e T h an 4 T i m e s Per Year

Label m u st car ry NPDES state m ent Initial = 10.6 pp m
M a int. = 5. 6 pp m

Based on tr eatm e n t
of 15 3, 000, 0 00 gallons of water

6836- 2 34 S m all Process Wat er Sy ste m s Brewer y pasteuri z ers Pour

Meter ed W e ar dust m i st respirator when apply i ng pr oduct to

sy ste m 795, 00 0 pp m Initial = 39.8 pp m M a int. = 14. 9 pp m

1839- 1 79 Oil Field injection and wastewater packer f l uids drilling m uds continuo us injection

batch

treat m e nt 119, 00 0 pp m

Sw i mmi n g Po o l s

1839- 1 41 Swi m m i ng Pool/ Outside Spas/W hir l pools/Hot T ub Bath Pour Do not apply when

swi m m e rs are in the

i m m e di ate vicinity ( A llow 15 m i nute REI) Initial/Winte r. = 6. 2

pp m

M a int. = 1. 2 pp m

Aquatic A reas

5364 2- 1 fountains, water di splays,

decor a tive pools, decor a tive

ponds, sewage tr eatm ent

sy ste m s , spas, stan ding water spray Refer to T a ble 13.

L a beling Changes

Su m m ar y T a ble

p. 71 and 73 203 ppm for

M o squito Contr o l

499- 36 8 Gr eenhouse/Nur ser ies decor a tive pools, fountains, water displa ys pour Initial= 6.2 pp m

M a int. = 1. 2 pp m

499- 48 2 Gr eenhouse/Nur s er ies water i ng lines, water i ng tubes,

e m itte rs, drip lines , wate ring

nozzles and hoses pour , im m e r s e 6. 2 pp m

Wood Preservati v es

6836- 3 08 lu m ber Pressure

Treat m ent

Double

vacuu m Refer to T a ble 13.

L a beling Changes

Su m m ar y T a ble

p. 68 3% AI solution

1839- 1 84 lu m ber Dip/Br ush/S pray surf ace

treat m e nt Refer to T a ble 13.

L a beling Changes

Su m m ar y T a ble

p. 68 3% AI solution



### 74EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1839- 1 84 lu m ber dip, spr a y Refer to T a ble 13.

L a beling Changes

Su m m ar y T a ble

p. 70 3% AI solution fo r sapstsain contr o l

Agricultural Pre m ise and Equip m ent

1032 4- 118 Ani m al facilities

, hog/swine/p oultr y farm s Floors, walls, ceili ngs, feed

r acks, m a nger s , tr oughs,

auto m a t ic

feeders/fountains/ watere rs, other feeding and water i ng appliances, halter s, r opes and

other ty

pes of equip m ent used in handling an d r e str a ining

ani m als, as well as f o rks, shovels, and scr a per s used for

re m oving litter and m a nure, feeder s, fountains, dr inker s, blocks, chutes, incubator s, h a tch e rs, w a tere rs , f eed ers, fou n tains, hauling equip m ent, loading equi p m ent, kennels,

r uns, cages, coops, cr ates

, pens, tr ay s Fogging W e ar a dust m i st respirator when

pour ing pr o duct in to fog ging equi p m ent 0000 675 lb ai/ 100 0

ft 3

1839- 8 1 hatcher i es hatcher y r o o m s Fogging W e ar a dust m i st respirator when

pour ing pr o duct in to fog ging equi p m ent

2 hr reentry inte rval . 00006 75 lb ai/

1000 ft 3

1032 4- 81 hatcher i es incubator s , setter s , hatcher s Fogging W e ar a dust m i st respirator when

pour ing pr o duct in to fog ging equi p m ent

6751 7-15 hatcheries e gg shell sanitizing spray , im m e r s ion, 200 ppm

1839- 1 55 Ani m al facilities

, farm s ,

m

u shr o o m farm s, a n im a l

life science laborat ories,

anim al quar t er s, other

ani m al ca re faciliti es, hatcher i es, stables, catteries, stalls, anim a l

tr anspor tation vehi cles Dairy / equine/hog/ swine/ poultry/turkey farm s , bar n s, pens, egg r e ceiving

ar ea, egg holding a r ea, setter s, tra y s, chic k

holdin g r o o m , poultr y buildin gs, dr essing plants,

of

fal r o o m s , block s, cr eep

areas Floors, walls, ceili ngs, feed

r acks, m a nger s , tr oughs,

auto m a t ic

feeders/fountains/ watere rs, other feeding and water i ng appliances, halter s, r opes and

other ty

pes of equip m ent used in handling an d r e str a ining

ani m als, as well as f o rks, shovels, and scr a per s used for

re m oving litter and m a nure, feeder s, fountains, dr inker s, blocks, chutes, incubator s, h a tch e rs, w a tere rs , f eed ers, fou n tains, hauling equip m ent, loading equi p m ent, kennels,

r uns, cages, coops, cr ates

, pens, tr ay s , shoes, gloves m op, im m e r s ion, cloth,

sponge,

spray 2036 ppm

1032 4- 80 citr us gr ove or farm tr ucks, vehicles, equip m ent, trailers, field harve sting equip m ent, cargo a r ea, wheels,

tir es, under car r i ag e, hood,

r oof, fender s trig g e r sp ra y, im m e r s ion,

m opping 2036 p p m

Treat Citrus canke r



### 75EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1072- 1 6 stables, dair ies Dairy and Hoof tr im m i ng equip m ent cloth, m op,

sponge,

spray , im m e r s ion 2036 p p m

507- 3 gr eenhouses, nur se r i es or nam e ntal cr ops drench or

spray Do Not Apply b y Aerial Sp ra y.

Refer to T a ble 13.

L a beling Changes

Su m m ar y T a ble

p. 71 Spot T r eat m e nt

m a x. r a te of 800

pp m

Total Use = 5 lbs AI/ ac re

507- 3 gr eenhouses, nur se r i es gloves im m e r s ion 2036 p p m

5364 2- 1 gr eenhouses, nur se r i es wor k ar eas, benches, pots, flats, flower buckets, cutting tools, gr eenhouse glass, bir d baths, walkway s , h ouseplants Spray,

m opping, Swab,

im m e r s ion 2036 ppm

5364 2- 1 gr eenhouses, nur se r i es lawns, golf cour ses,

co mm e r cial turf Spray Co m m e r c ial = L im it

Treat m ent to

“ G reens and Tees”

Retreat m e nt at 10 day inter v als not to

exceed 6 treat m e nt s

per y e ar

Residential = Onl y Spot T r eat m e nt of

diseased areas.

Treat m ent repeate d up to 6x a year at 1 0 day intervals. C o mme r c i a l = 20 0

pp m not to exceed

tr eat m e nt of 10

acres

Residential = 800

pp m not to exceed 25 gallons per 100 0

sq . f t

.

499- 36 8 greenhouses, nurse ries cutting tools Im m e r s ion/ Spray/ Wipe 2036 p p m

499- 36 8 gr eenhouses, nur se r i es evaporative coolers, cooler pads Spray or

swab 2036 p p m

Medical pre m ises and equip m e nt

1032 4- 111 day-ca re c enters, h o spitals,

m e dical/dental offices,

nur sing hom es, other health care institutions,

m o rtu a ries, au to p s y ro o m s , EMS faciliti es, m e dical

research faciliti es, patient

care roo m s, recove ry anesthesia roo m s, operating

ro o m s Metal, stainless ste e l, glazed porcelain, glazed c era m i c tile

, plastic, granite, m a rble,

chro m e , vinyl, glas s, ena m el ed surfaces, painted woodwork,

Form ica, plastic u pholster y , floors, walls, toilet s , urinals,

lavator i es, bathtubs, sinks, sink tops, shower stalls,

shower door s/cur t ains, m i rr or s, ultr asonic bath, whir lpools,

counter tops, cabin ets, tables,

chair s , desks, bed spr i ngs, bed

fr am es, tr action devices, M R I, CAT, exa m ining tables, scales, paddles, wheelchairs, lif ts,
door kno bs, linen car ts,
ham p er s, telephon es, fixtur es, toy s , high chair s , cr ibs, changing tables m op, pour , im m e r s ion 2080 p p m



### 76EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1203- 4 1 hospitals, nur sing ho m e s, clinics tables,walls, cera m ic tiles,

m e tal surf aces , pla s tic, asphalt,

finished/ p ainted wood and glass spr a y , m op,

sponge 2080 p p m

1839- 8 1 Hospitals car pet Portable

extraction units, tr uck

m ounted

extraction

m a chines,

ro tary f l o o r

m a chines,

me t e r e d

, spray 16, 800 p p m

1839- 1 10 hospital L a undr y Pour @ final

rin s e in wash cycle 0. 10 lb AI / 100 lbs

dr

y laundr y

1839- 8 1 autopsy r o o m s , funer a l

ho m e s, hu m a n r e m a ins sponge, wash cloth, soft

br

ush 2080 p p m

6240 1- 6 nur sing hom es walls, telephones, chair s, tables, sinks, counter s, appliance exteriors

, garbage

cans, stovetops Presaturated wipe 2080 p p m

7211- 1 0 Medical P r e m ises &

E quip m ent critical instru m e nt s i m m e rsion Instru m e nts m u st b e sterilized af ter
disinfectio n 2490 p p m

Co m m e r c ial, ins t i t utional, and indu strial pre m ises an d equip m e nt

1032 4- 118 hair/nail salons, barber beauty shops, tanning salons, tattoo par l or s, veterinary clinics, locker facilities, shopping m a lls

,

m o tels, hotels, bookstor e s, dr essing r o o m s, photo copy centers, bic y cle sh ops, toy
f actories, co m pute r

m a nufactur ing sites, bur ial vaults, m a usoleu ms, jails, penitentiaries, transportation terminals, Cruise ships, airpl a nes, schools, univer siti es, churches, libraries

,

cos m etic m a nufactur ing facilities, m e dic a l device

m a nufacturing facilities, phar m aceutical

m a nufacturing facilities, bowling alley s , cr im e

scenes, pet shops,

gr oo m i ng and br eeding

establish m ents, zo os, tack shops, atheletic facilities, Sport Arenas, floors, walls, toilet s , urinals,

bathr o o m s, bathtubs, sinks,

counter tops, show er door s/cur t ains, toilet seats,

shower stalls, ultr asonic bath,

whir lpools, bar b er /salon

instr u m e nts/tools, tables,

chair s, shelves, telephones, cabinets, desks, tanning bed s, bed spr i ngs, door k

nobs, linen carts, ha m p ers, gar b age pails, telephones, r ecy cling equip m ent, exercis e equip m ent, per sonal safety equip m ent, auto mobile/truck interiors, garbage cans/pails,

m e tal, stainless ste e l, glazed porcelain, glazed c era m i c tile

, plastic, granite, m a rble,

chr o m e , vinyl, glas s, chr o m e

plated intakes, enam e l ed surfaces, painted woodwork,

Form ica, viny l and plastic upholster y , terr ar iu m s , cages, and cage f u rniture m op, wipe (cloth, swab)

, pour , im m e r s ion 2080 p p m



### 77EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1839- 8 1 m a nufactur ing

sites/facilities Floor s, walls, counter s, stainless steel, glaz ed

por celain, gr anite, viny l, glass,

chro m e fog ging W e ar a dust m i st respirator when

pour ing pr o duct in to fog ging equi p m ent 0000 246 lb ai/ 100 0

ft 3

6836- 1 93 hair/nail salons, barber beauty shops, tanning salons, tattoo par l or s, veterinary clinics, locker facilities, shopping m a lls

,

m o tels, hotels, bookstor e s, dr essing r o o m s, photo copy centers, bic y cle sh opes, toy
f actories, co m pute r

m a nufactur ing sites, bur ial vaults, m a usoleu ms, jails, penitentiaries, transportation terminals, Cruise ships, airpl a nes, schools, univer siti es, churches, libraries

,

cos m etic m a nufactur ing facilities, m e dic a l device

m a nufacturing facilities, phar m aceutical

m a nufacturing facilities,

bowling alley s , cr im e

scenes, pet shops,

gr oo m i ng and br eeding

establish m ents, zo os, tack shops, atheletic facilities, Sport Arenas, hair/nail salons, barber beauty shops, tannin g salo ns, tattoo

par l or s, veter i nar y clinics, locker facilities, sh oppin g

m a lls, m o tels, hotels,

bookst o r e s, dr essing r o o m s , photo copy center s, bicy cle shopes, toy factor ies, co m puter

m a nufactur ing sites, bur ial vaults, m a usoleu ms, jails, penitentiaries, tran sportation

term inals, Cruise s h ips, airplanes, schools, universities,

churches, libraries

, cos m etic

m a nufacturing facilities,

m e dical device m a nufactur ing

facilities, pharm a c e utical

m a nufacturing facilities, bowling alley s , cr im e scenes ,

pet shops, gr oo m i ng and

br eeding establish m ents, zoos, tack shops, atheletic facilities, Sport Arenas, sp ray (RTU

spray 2980 p p m

1839- 8 1 hotels, m o tels, dressing

r o m m s , bowling alley s , salons, libr a r i es, of fice

buildin gs, schools,

universities Carpet por table

extraction units, tr uck

m ounted

extraction

m a chines,

ro tary f l o o r

m a chines,

me t e r e d

,

spray 16, 800 p p m

6240 1- 6 schools, fo od ser v ice

establish m ents telephones, walls, chair s , tables, sinks, counter s, appliance exteriors

, garbage

cans, stovetops Presaturated wipe 2080 p p m

1839- 1 10 co m m er cial laundr y Pour @ final

rin s e in wash cycle 0. 10 lb AI / 100 lbs

dr

y laundr y

1839- 8 1 Flor ists/flower shops,

gr eenhouses, shipp e r s , packing areas flower buckets, cooler s, floor s and walls of cooler s, design and packing bench e s, gar b age pails M op/wipe, cloth, br ush,

sponge,

spray e r, RTU spra y 2036 p p m



### 78EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1839- 8 5 hair/nail salons, barber beauty shops, tanning salons, tattoo par l or s, veterinary clinics, locker facilities, shopping m a lls

,

m o tels, hotels, bookstor e s, dr essing r o o m s, photo copy centers, bic y cle sh opes, toy
f actories, co m pute r

m a nufactur ing sites, bur ial vaults, m a usoleu ms, jails, penitentiaries, transportation terminals, Cruise ships, airpl a nes, schools, univer siti es, churches, libraries

,

cos m etic m a nufactur ing facilities, m e dic a l device

m a nufacturing facilities, phar m aceutical

m a nufacturing facilities,

bowling alley s , cr im e

scenes, pet shops,

gr oo m i ng and br eeding

establish m ents, zo os, tack shops, atheletic facilities, Sport Arenas, air deodor izer /air fr eshener RT U spr a y 0. 2% ai by weight

3297 7- 1 schools and m u sic studios wi nd instr u m e nts Im m e r s ion 596 ppm

507- 3 industr ial pr em ises gloves Im m e r s ion 2036 p p m

Residential and p ublic access p r e m ises

1032 4- 111 RVs, m o tor ho m e s RV Holding T a nk Pour ing 0. 834 lb ai/gal

6836- 1 93 Households, cam p gr ounds, play gr ounds, picni c facilities, rec r eatio nal facilities, other public

facilities Floor s, walls, windows, toilets, bathtubs, whir lpoo ls, shower stalls, shower door/cur tain,

sin k s , m i rro rs , r e stro o m f ixtures, cabinets, tables,

chair s , desks, bed fr am es , door kn obs, gar b ag e cans/pails, picnic tables, outdoor

fur

n itur e , telephon es, countertops, external surfaces of appliances, tables, sinks, shelves, plastic choppin g blocks, m e tal, stainless steel, glazed porcelain, g lazed

cera m ic tile , plasti c, granite,

m a r b le, chr o m e , viny l, glass,

chro m e plated inta kes,

ena m eled surf aces, painted

woodwor k, Form ica, viny l, plastic upholster y , ter r a r i u m s, cages, and cage f u r n iture RTU

spr a y / m op 2980 p p m



### 79EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1839- 6 8 ho m e s Car p et por table

extraction units, tr uck

m ounted

extraction

m a chines,

ro tary f l o o r

m a chines,

me t e r e d

, spray 16, 680 p p m

1839- 8 5 ho m e s air deodor izer /air fr eshener RTU spra y 0. 2% a. i

. by w e i g ht

3 297 7-1 Ho m e s Musical instru m e n t

m outhpieces and r eeds im m e r s ion 596 ppm

1839- 1 10 Ho m e s L a undr y Pour @ final

rin s e in wash cycle 0. 10 lb AI / 100 lbs

dr

y laundr y

1839- 1 55 ho m e s water sof teners an d reverse

os m o sis units L i quid Pour 200 ppm

Food handling/st orage establish m e nts pre m ises and equip m ent

Disinfec t

2080 p p m

40 CF R 180. 940 (a )

200 ppm

Public Eating Places, Dair y Pr ocessing

E quip m ent, FoodPr ocessing

E quip m ent and

Utensils 1032 4- 111 restau ran t s, b a rs , superm ar ket, convenience stores, pizza pa rlor s, m e at and poultr y pr ocessing plants, r e nder i ng plants, fish, m ilk, wine, ci trus processing facilities,

institutional kitche ns, food
storage areas, tobacco processing facilities, ood

service establish m ents,
foo d pr ocessing plants/facilities, beverage

pr ocessing plants, Cafeterias, D a iries

, Egg

Pr ocessing plants, Federally inspecte d m eat and poultr y plants, Food Handling ar eas, Food

pr epar ation ar eas , Food
storage areas, U S DA inspected f o od processing facilities, brewe r ie s, fast

foo d oper a tions floor s, walls, counter tops, appliances (m ic rowaves,

r e fr iger ator s, stove tops,
f r eezers, coolers), chairs, tables, shelves, picnic tables,

outdo or fur n itur e , r acks, car t s, telephones, door k

nobs,
storage areas, potato storage

ar eas, food stor age ar eas, garbage storage ar eas, cutting

boar d s, tanks, exhaust fans,

ref

r igerator bins, r e f r igerated

stor age/display equip m ent,
coils and dr ain pans of air

conditioni ng/r e fr ig er ation equip m ent, heat pum ps , storage tanks, coolers, ic e chests, garbage ca ns/pails

m e tal, stainless ste e l, glazed porcelain, glazed c era m i c tile

, plastic, granite, m a rble,

chr o m e , vinyl, glas s, chr o m e plated intakes, enam e l ed surfaces, painted woodwork,

Form ica, viny l and plastic upholster y m op, wipe (cloth, swab)

, pour , im m e r s ion

m op, (cloth, swab)

, pour , im m e r s ion

40 CF R 180. 940 (c)

400 ppm

Food Pr ocessing

E quip m ent and

Utensils

507- 3 dair ies and food pr ocessing plants gloves Im m e r s ion 2036 p p m



### 80EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1839- 8 6 f e derally inspected m eat and poultr y plants, food processing facilities, dairies, tobacco pr ocessing facilities, beverage processing facilities Shoe im m e r s ion/

foam

gener a ting

m a chine/

aerator 2036 p p m

6836- 1 93 (Disinfect) restau ran t s, b a rs , superm ar ket, convenience stores, pizza pa rlor s, m e at and poultr y pr ocessing plants, r e nder i ng plants, fish, m ilk, wine, ci trus processing facilities,

institutional kitche ns, food
storage areas, tobacco processing facilities, ood

service establish m ents,
foo d pr ocessing plants/facilities, beverage

pr ocessing plants, Cafeterias, D a iries

, Egg

Pr ocessing plants, Federally inspecte d m eat and poultr y plants, Food Handling ar eas, Food

pr epar ation ar eas , Food
storage areas, U S DA inspected f o od processing facilities, brewe r ie s, fast

foo d oper a tions floor s, walls, counter tops, appliances (m ic rowaves,

r e fr iger ator s, stove tops,
f r eezers, coolers), chairs, tables, shelves, picnic tables,

outdo or fur n itur e , r acks, car t s, telephones, door k

nobs,
storage areas, potato storage

ar eas, food stor age ar eas, garbage storage ar eas, cutting

boar d s, tanks, exhaust fans,

ref

r igerator bins, r e f r igerated

stor age/display equip m ent,
coils and dr ain pans of air

conditioni ng/r e fr ig er ation equip m ent, heat pum ps , storage tanks, coolers, ic e chests, garbage ca ns/pails

m e tal, stainless ste e l, glazed porcelain, glazed c era m i c tile

, plastic, granite, m a rble,

chr o m e , vinyl, glas s, chr o m e plated intakes, enam e l ed surfaces, painted woodwork,

Form ica, viny l and plastic upholster y RT U Spr a y 2036 p p m

40 CF R 180. 940 (a )

200 ppm

Public Eating Places, Dair y Pr ocessing

E quip m ent, FoodPr ocessing

E quip m ent and

Utensils 1839- 1 55 Restaur a nts, Food Ser v ice

Establish m ents, B ars, Cafeter i a, Convenience

Stor es, Dair ies, Food Handling Ar eas, Food

Pr epar ation Ar eas, Food

Stor age Ar eas I n stitutional Kitchens, Fast Foo d Operations dair y equip m ent, dair y farm

bulk m ilk tanks, m ilking equip m ent, tanks, piping,
pasteur i zer s, cow udder s, dair y

pr oduct dispensi ng equip m ent,
dr inking glasses, eating utensils, cooking u t ensils,

silverware , glassw are, dishes,

ice m a chines, beve rage dispensin g equip m ent, counters, tables, cu tting boards, Slurrpy m a chines, ice

crea m dispensing equip m ent,
foo d dispensi ng eq uip m ent,
utensils and other f

ood contact

articles spr a y , flood,

im m e r s ion,

br

ushing, RTU spra y

40 CF R 180. 940 (c)

400 ppm

Food Pr ocessing

E quip m ent and

Utensils

1839- 1 55 Food pr ocessing pl ants,
f o od service establ ish m ents water sof teners an d reverse

os m o sis units 200 ppm



### 81EPA Reg

Nu m ber

used for

Max. Appl.

Rate Use Site Treat m ent Site/S urfaces Met h od of Application Mit i gat ion Maxim u m Application

Rate

1032 4- 118 dair ies, bever a ge and fo od

pr ocessing plants roo m surf aces f o gging W e ar a dust m i st respirator when

pour ing pr o duct in to fog ging equi p m ent

2 hr reentry inte rval

M i nim u m of 4 air exchanges per hou r . 00000 27 lb ai/

1000 ft 3

1203- 4 1 foo d pr ocessing pl ants,
f o od service are as, institutional kitche ns, industr ial/hospital

cafeter ias, school

lunchr oo m s , canning plants, dair ies, and packing plants tables, walls, ce ra m i c til es,

m e tal surf aces , pla s tic, asphalt,

finished/ p ainted wood and glass Spr a y , m op,

sponge 2080 p p m

Cleaning/ Deodor iz ing

1839- 8 1 W a ter / S m oke r e stor ation (institutional, industrial, hospital, nur sing h o m e ) car pets, car p et cus h ion, sub

floor s, dr y w all, tr im , far m lu m b e r , t ackless st rip and paneling M op, cloth,

br

ush,

sponge,

sp rayer Refer to T a ble 13 (Label Changes

Su m m ar y T a ble) for

appr opr iate label

restrictio n s 16, 800 p p m

1032 4- 118 Sewer backup/r i ver flood cleanup/clean water sour ce car pets, car p et cus h ion, sub

floor s, dr y w all, tr im , far m lu m b e r , t ackless st rip and paneling spray Refer to T a ble 13 (Label Changes

Su m m ar y T a ble) for

appr opr iate label

restrictio n s 16, 800 p p m

1032 4- 118 residential, co mm e r cial, institutional, indus trial, garbage cans, garb age trucks,

industr ial waste r e ceptacles,

gar

b age handling e quip m ent spray e r,

sponge, cloth, 2036 p p m



### 82

### Appendix B. Table of Generic Data Re quirements and Studies Used to Make the Reregistration Decision

Guide to A ppendix B Appendix B contains listing of data requi rem e nts which support the reregistration for active ingredients within case #035 0 (ADBAC) covered by this RED. It contains generic data requirem e nts that apply to ADBAC in all produc ts, including data requirem e nts for which a “typical formulation” is the test substance.

The data table is organized in the following for m ats:

1. Data Requirem e nt (Column 1). The data requirem e nts are lis ted in the or der in which they appear in 40 CFR part 158. The re ference num be rs accom p anying each test refer to
the te st pro t ocols se t in the Pesticide Assessm ent Guidance, which are available from the
National Technical Inform ation Service, 5285 P ort Royal R oad, Springfield, VA 22161 (703)

487-4650.

2. Use Pattern (Colum n 4). This colum n indica tes the use patterns for which the data requirem e nts apply. The following letter designa tions are used for the given use patterns.
(1) Agricultural prem ises and equipm ent (2) Food handling/ storage establishm ents, pre m ises, and equipm ent (3) Comm ercial, institu tional and in d u strial p r em ises and equipm ent (4) Residen t ial and pub lic acces s prem ises (5) Medical prem ises and equipm ent (6) Hum an water sys t e m s (7) Materials preservativ e s (8) Industrial proces ses and water system s (9) Antif ouling coating s (10) W ood preservatives (11) Swimming pools (12) Aquatic areas

3. Bibliographic Citation (Colum n 5). If th e Agency has accep table data in its files,
this co lum n list the identify num b er of each stud y. This norm a lly is the Master Reco rd
Identificatio n (MRID) n u m ber, but m a y be a “GS” num ber if no MRID num b er has been assigned. R e fer to the B i bliography appe ndix for a com plete citation of the study.

83APPENDIX BData Supporting Guideline Requirements for theReregistrationof ADBACPRODUCTCHEMISTRYNewGuidelineNumberOld GuidelineNumberUse PatternCitation830.155061-1Product Identity and CompositionAll4446702830.160061-2AStart. Mat. &Mnfg.ProcessAll4446702830.167061-2BFormationofImpuritiesAll44467401830.170062-1Preliminary AnalysisAll4446702830.175062-2CertificationoflimitsAll4446702830.180062-3Analytical MethodAll4446702830.630263-2ColorAll44467403830.630363-3Physical StateAll44467403830.630463-4OdorAll44467403830.7050NoneUV/Visable AbsorptionAll44467403830.720063-5MeltingPointAll44467403830.722063-6BoilingPointAll4446740384NewGuidelineNumberOld GuidelineNumberUse PatternCitation830.730063-7DensityAll44467403830.7840830.786063-8SolubilityAll44467403830.795063-9VaporPressureAll44467403830.737063-10Dissociation ConstantAllN/A830.755063-11Octanol/Water PartitionCoefficientAll44467403830.700063-12pHAll44467403830.631363-13StabilityAll44467403830.631463-14Oxidizing/ReducingActionAllN/A830.631563-15FlammabilityAll44467403830.631663-16ExplodabilityAllN/A830.631763-17Storage StabilityAll44467403830.710063-18ViscosityAll44467403830.631963-19MiscibilityAllN/A830.632063-20Corrosion characteristicsAll4446740385ECOLOGICAL EFFECTSNewGuidelineNumberOld GuidelineNumberUse PatternCitation850.210071-1Avian Acute OralToxicityAll42885901850.210071-1Avian Acute OralToxicityAll42885901850.220071-2BAvian DietaryToxicity–DuckWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWater850.2300AvianReproduction (Mallard orBobwhite)WoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWater850.240071-3WildMammalToxicityWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterRefer toToxicologyData850.107572-1AFishToxicity BluegillAll41947201850.107572-1CFishToxicity Rainbow TroutAll41947202850.101072-2AAquatic Invertebrate ToxicityAll41947203None72-3AEstuarine/Marine Toxicity - FishWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWater42479502850.105572-3BEstuarine/MarineToxicity -(EasternOyster embryo larvae)WoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterData GapNone72-3CEstuarine/Marine Toxicity- ShrimpWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWater42479501None72-4AFish- Early Life StageWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWater4230210286NewGuidelineNumberOld GuidelineNumberUse PatternCitation850.130072-4Aquatic Invertebrate Life Cycle- DaphniamagnaWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterData Gap850.440123-2AquaticPlantGrowth–Lemna gibbaWoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterData Gap850.5400123-2AquaticPlantGrowth(4species) Greenalga (Pseudokerschneria subcapitatum),blue-greenalga(Anabaena flos-aquae),freshwaterdiatom(Navicula sps.), andmarine diatom(Skeletonemacostatum)WoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterData Gap850.4225123-1Non-target TerrestrialPlant Phytotoxicity(seedling emergencetestusingrice)WoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterData Gap850.4250123-1Non-target TerrestrialPlant Phytotoxicity(Vegetative vigor using rice)WoodPreservation,Sapstain,OrnamentalNurseries, Turf, OnceThrough CoolingWaterData Gap850.3020141-1Honey BeeAcute ContactWood PreservativeData Gap850.1950AquaticField Monitoring(Once-ThroughCoolingWaterTowers)OnceThroughCoolingWaterData GapTOXICOLOGYNewGuidelineNumber870.1100Old GuidelineNumber81-1Acute OralToxicity-RatUse PatternAllCitation4510920487NewGuidelineNumberOld GuidelineNumberUse PatternCitation870.120081-2Acute DermalToxicity-Rabbit/RatAll45109202870.130081-3Acute InhalationToxicity-RatAll44885201870.240081-4Primary Eye Irritation-RabbitAll40919701, 44825001870.250081-5Primary SkinIrritationAll45109201870.260081-6Dermal/Photo-SensitizationAll45109203, 40958501,and44825002870.310082-1AOralSubchronic - RatAll40746601870.320082-221-Day Dermal–Guinea Pig?41105801870.325082-390-DayDermal – RatAll41499601870.346582-490-DayInhalation– RatAllData Gap870.3700(a)83-3ADevelopmental Toxicity - RatAll42351501870.3700 (b)83-3BDevelopmental Toxicity - RabbitSwimmingpool &WoodPreservative42392801870.380083-42-Generation Reproduction -RatIndirectFood41385001870.410083-1BChronicFeedingToxicity–NonRodentIndirectFood43221101870.4200(b)Oncogenicity–MouseSwimmingpool &Woodpreservative41765201870.430083-5CombinedChronicToxicity/ CarcinogenicitySwimmingpool &Woodpreservative4194750188NewGuidelineNumberOld GuidelineNumberUse PatternCitation870.5300870.538584-2A84-2BGeneMutation (Ames Test)Structural Chromosomal AberrationAllAll4101270140311101870.555084-4Unscheduled DNA SynthesisAll42290801, 42290802870.748585-1General MetabolismIndirectFood40990701OCCUPATIONAL and RESIDENTIAL EXPOSURENewGuidelineNumberOld GuidelineNumberUse PatternCitation875.2800133-1Description ofHumanActivityAllData Gap875.1100875.1200875.1600231233236Outdoor/IndoorDermal ExposureAll417426-01, 425875-01875.1300875.1400875.1600232234236Outdoor/IndoorInhalationExposureAll455021101, 455243-04Special StudySurface Wood Wipe StudyWoodPreservativeData Gap89ENVIRONMENTAL FATENewGuidelineNumberOld GuidelineNumberUse PatternCitation835.2120161-1HydrolysisAll408356-02835.2240161-2Photodegradation -WaterWood Preservative40835603835.4400162-3Anaerobic AquaticMetabolismOnce Through CoolingWaterWood Preservative41105501, 42415101835.4300162-4Aerobic Aquatic MetabolismOnceThroughCoolingWaterWood Preservative40835604835.1240163-1Leaching/Adsorption/DeadsorptionWood Preservative40835605, 42414801None165-4Bioaccumulation inFishWood Preservative41026801Special StudyBiodegradabilityNot Required46865601RESIDUE CHEMISTRYNewGuidelineNumberOld GuidelineNumber860.1480171-4JSpecial StudyMagnitude ofResidues­Meat/Milk/Poultry /EggDietary Residues inFoodfromTreatingCountertops withADBAC(FDAWipeStudyMethodology)Use PatternIndirectFoodIndirectFoodCitationFDA,2003. “SanitizingSolutions:Chemistry forfoodAdditives petitions.”Http://www.cfasan.fda.gov/-dms/opacg3aLastaccessed June9,2003Data Gap90

### Appendix C. Technical Support Documents

Additional docum e ntation in support of this RED is m a intained in the OPP docket,

located in R o om S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive, Arlington, V A 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 prelim inary risk assessm ent and the

related docum ents. EPA then considered comm e n ts on thes e risk as sessm ents (which are posted

to the e

- doc ket) and revised the r i sk assessm ents. The revis e d risk as sess m ents will be posted in

the docke t at the sam e tim e as the RED.

All docum e nts, in hard copy for m , m a y be viewed in the OP P docket room or

downloaded or viewed via the Inte rn et at the f o llowing sites :

http:// www. epa.gov/pesticides/antimicrobials http:/www.regulations.gov

These docu m ents include:

1. Alkyl Dim e thyl Benzyl Ammonium Chlo ride (ADBAC) Risk Assessm e nt, 8/1/06

2. Toxicology Disciplinary Chapter for th e Re-Registration Eligibility Decision (RED) Risk Assessm ent Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC),

8/10/06

3. Dietary Risk Assessm ent for Alkyl Di m e thyl Benzyl Ammonium Chloride (ADBAC) for Reregis t r ation Eligib ility Dec i sio n (RED) Process, 7/27 /0 6

4. Ecological Hazard and Environm ental Risk Ass e ssm ent of ADBAC for the Reregis t ra tion Eligib ility Docum ent (RED) – Antim icrobial Uses, 8/2/06

5. PDM4 Modeling of Alkyl Dim e thyl Be nzyl Ammonium Chl oride (ADBAC) in Once-Through Industrial W a ter System s, 8/2/06

6. Ecological Risk Assessm e nt in Sup port of the Antim icrobials Division’s Reregistration of Alkyl Di m e thyl Be nzyl Ammonium Chloride (ADBAC) & Didecyl Dim e thyl Ammoniu m Chl ori de (DDAC)-Agricultural Uses, 2/3/06

7. Tier 1 Drinking W a ter Assessm ent fo r Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) & Didecyl Dim e thyl Ammon i um Chloride (DDAC), 1/23/06

8. Environm ental Fate Assessm ent of Alkyl Dim ethyl Benzyl Ammonium Chloride (ADBAC) for the Rereg i stration Eligib ility Decision (RED) Docum e nt, 7/27/06

91

### 9. Incident Reports Associated with Q u aternary A mmonium Com pounds (Quats),

2/15/06

10. Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) Occupational and Residential Exposure Assessm ent – Antim icrobial Uses, 7/27/06

11. Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC): Occupational and Residential Exposure Assessm ent for th e Reregistration Eligibility Decision

Docum e nt – Agricultural Uses, 7/31/06

12. Appendix A Standard Methods for Ca lculating O ccupational Exposures to ADBAC, 7/ 31/06

13. Product Chem istry Science Chapter f or Alkyl Dim e thyl Benzyl Amm onium Chloride (ADBAC), 1/11/06

14. Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC)- Report of the

Antim icrobials Divis i on Toxicity En dpoi nt Comm ittee (ADTC) and the Hazard

Identification Assessm e nt Review Comm ittee (H IARC), 8/10/06

92

### Appendix D. CITATIONS CONSIDERE D TO BE PART OF THE DATA BAS E

SUPPORTI N G THE INTE RIM REREGIST RATION DECISION (BIBLIOGRAPHY)

GUIDE TO APPE NDI X D

1. CONTENTS OF BIBLI OGRAPHY. This biblio graphy contains citations of all studies considered relevant by EPA in arriving at th e positions and conclusi ons stated elsewhere

in the Rer e g i str a tion Eligibility Doc u m e nt

. Prim ary sources for studies in this bibliog r aphy have been the body of data subm itted to EPA and its predecessor agencies in support of past regulatory decisions. Selections from other sources including the published literatu re, in th ose instance s where they have been considered, are included.

2. UNITS OF ENTRY. The unit of entry in th is bibliography is called a "study". In the case of published m a terials, this corresponds cl osely to an article. In the case of unpublished m aterials su bm itted to th e Agen cy, th e Agency has sought to identify

docum ents at a lev el pa r alle l to the p ublishe d article f r om within the typic ally large r volum es in which they were subm itted. The re s u lting "stud i es" gene rally have a dis t inct title (o r at le ast a s i ngle s ubject), can stand alone for pur poses of review and can be described with a conventional bibliographic ci tation. The Agency has also attem pted to

unite basic docum e nts and commentaries upon them , treating them as a single study.

3. IDENTIFICATION OF ENTRIE S. The entries in this bibliography are sorted

num e rically by Master Record Identifier, or "MR I D @ num b er. This num ber is unique to the citation, and should be used whenever a sp ecif i c reference is required. It is not

rela ted to th e six-d i git " A ccession N u m b er" whic h has been used to identify volum es of

subm itted studies (s ee p aragr aph 4(d )(4) be low f o r f u rther ex planation). In a f ew cases, entries added to the b i bliogra phy late in the review m a y be preceded by a nine character

tem porary identifier. These en tries are listed afte r all MRID entries. This tem porary identifying num ber is also to be used whenever specific reference is needed.

4. FORM OF ENTRY. In addition to the Ma ster Record Id entifier (MRID), each entry consists of a citation containing standard el em ents f o llowed, in the c ase o f m aterial

subm itted to EPA, by a descrip tion of the earliest known subm ission. Bibliographic

convention s used reflect the standard of the Am erican National Standards Institu te (ANSI), expanded to provide for certain special needs.

a Author. W h enever the author cou l d c onfidently be identified, the Agency has chosen to show a personal author. When no individual was identified, the Agency has shown an identifiable laboratory or te sting facility as the author. W h en no author or lab o ratory could be identif i e d, the Agen cy has shown the f i rs t su bm itter

as the au thor.

93

### b. Docum e nt date. The date of the study is taken directly from t he

docum ent. When the date is followed by a question m a rk, the bibliographer has deduced the date from the evidence contained in the

docum ent. When the date appears as (1999), the Agency was unable to

determ ine or estim ate the date of the docum ent.

c. Title. In so m e cases, it has been ne c essary f o r th e Agency bibliogr aphers

to cre ate o r enhance a d o cum ent title. Any such edito ria l ins ertions ar e contained between square brackets.

d. Trailing par entheses. F o r studies su bm itted to th e Agency in the pas t , the trailing parentheses include (in additi on to any self-explanatory text) the following elem ents describing th e earliest known subm ission:

(1) Subm ission date. The date of the earliest known subm ission appears imm e diately following th e word "received."

(2) Adm i nistrative num ber. The next elem ent i m m e diately follow i ng the word "under" is the regist ration num b er, experim ental use

perm it number, petition num b er, or other adm i nistrative num ber

associated w ith the earliest known subm ission.

(3) Subm itter. The third ele m ent is the s u bm itter. W h en authors h ip is

def aulted to the subm itte r, this elem ent is om itted

.

(4) Volum e Identif ica tion ( A ccession N u m b ers). The f i nal ele m ent in the trailing p arenth eses identifie s the EPA accession num ber of the

volum e in which the original subm ission of the study appears. The six-digit accession num ber follows the sym bol "CDL," which

stands for "Com pany Data Lib r ary. " This access ion num ber is in turn followed by an alphabetic suffix which shows the relative position of the study within the volum e

.

94

# BIBLIOGRAPHY

MRID# CITATIONS

40311101 Kallersen, T . (1985) Assessm ent of the Mutagenic Activity of Hya m ine 3500 in the Mouse Micronucleus Test: Lab. No. 10753. Un- published study prepared by Scantox Labs Ltd. 17 p.

40746601 Van Miller, J.; W eaver, E. (1988) Ninety-day Dietary Toxicity Study with Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in Rats: Pro j ec t 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 Am ended Final Report # 35712. Unpublished study perform e d by Ana l yti cal Bio-Che m istry L a boratories, Inc., Columbia, MO, an d subm itted by Chem ical Specialtie s Manufacturers Association, W a shington, DC.

40835603 Carpenter, M. and M. Fennessey. 1988. Determination of the photolysis rate of ADBAC in pH 7 buffered so lution at 25° C. ABC Final Report

#35713. Unpublished study performed by Analytical Bio-Chem istry

Laborato r ies

, Inc., Colu mbia, MO, and subm itted by Chem ical Specialtie s Manufacturers Association, W a shington, DC.

40835604 Daly, D. and W . Cranor. 1988. Ae robic aquatic m e tabolism of alkyl

dim e thyl benzyl amm onium chloride. ABC Final Report #35715. Unpublished study perform e d by Ana l yti cal Bio-Che m istry L a boratories, Inc., Columbia, MO, an d subm itted by Chem ical Specialtie s Manufacturers Association, W a shington, DC.

40835605 Daly, D. and W . Cranor. 1992. So il/Sedim e nt Adsorption-Desorption of Alkyl Dim e thyl Amm oni um Chloride. Perform e d by ABC La boratories, Inc., Columbia, Mis sour i. Subm itted by ADBAC Joint Venture/Chem ical Specialties Manufacturers A ssociation, W a shington, DC.

40919701 Kreuzm ann, J. (1988) R e peated Eye Instillation Study in Rabbits: Alkyl

dim ethyl benzyl amm o nium chlori de (ADBAC): Study No.: 88- 3336-21. Unpublished study prepared by Hi ll Top Biolabs, Inc. 20 p

40958501 Kreuzm ann, J. (1989) Photoall ergy S t udy in Guinea Pigs: S t udy No. 88­ 3226-21. Unpublished s t udy prepared by Hill To p Biolabs, Inc. 63 p.

40990701 Selim , S. (1989) Absorption, Distribution, Metabolism and Excretion Studies of Alkyl Dim e thyl Benzyl A mmonium Chlorid e (ADBAC) in the

95

# BIBLIOGRAPHY

MRID# CITATIONS

Rat: BTC Study No. P01359. Unpublis hed study prepared by Biological Test Center. 247 p.

41012601 Cifone, M. (1989) Mutagenicity Test on Alkyl Dim e thyl Benzyl

Ammoniu m Chloride: In the Rat Pr imary Hepatocyte Unscheduled DNA Synthesis A ssay: HLA Study No. 10238-0-447. Unpublished study prepared by Hazleton Laborat ories A m erica, Inc. 56 p.

41012701 Young, R. (1989) Mutagenicity Test on Alkyl Dim e thyl Benzyl

Ammonium Chloride : In the CHO/ HGPRT Forward Mutation Assay: HLA Study No. 10238-0-435. Unpublishe d study prepared by Hazleton

Laboratories Am erica, Inc. 67 p.

41026801 Flacker, P. 1989. Bioconcentration and elim ination of 14 

### C-residues by bluegill ( Lepomis macrochirus ) exposed to alkyl dim e thyl benzyl

ammonium chloride (A DBAC ). Study No. 11572-0287-6103-140B, Report No. 89-1-2921. Unpublished st udy perform e d by Springborn Life Sciences, In c., W a reham, MA, a nd subm itted by ADBAC Quat Join t
Venture/Chem ical Specialties Ma nuf acturers Assoc., W a shington, DC.

41087701 Lin, P.; Selim, S. (1989) Adde ndum to Report Entitled "Absorption, Distribution, Metabolism and Excretion Studies of Alkyl Di methyl 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 T oxicology (EP): HS-Sanitizing Carpet Sham poo: Project ID: B6-27. Unpublished st udy prepared by Envirocon. 36 p.

41105501 Daly, D. and W . Cranor. 1989. An aerobic aquatic m e tabolism of alkyl

dim ethyl benzyl amm o nium chlo ride. ABC Am e nded Final Report

#35714. Unpublished study performed by Analytical Bio-Chem istry

Laborato r ies

, Inc., Colu mbia, MO, and subm itted by ADBAC Joint

Venture/Chem ical Specialties Ma nuf acturers Association, W a shington,

DC.

41385001 Neeper-Bradley, T. (1990) Two-generation Reproduction Study in Sprague-Dawley (CD) Rats with Al kyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) Adm i nistered in the Diet: P r oject Report 52- 52-254: Project Nos. 87-37-97105; 87-37-97 109. Unpublished study prepared by Bushy Run Research Center. 492 p.

96

# BIBLIOGRAPHY

MRID# CITATIONS

41499601 Gill, M.; W a gner, C. (19 90) Ninety-day Subchro n ic Derm al Toxicity Study with Alkyl Dim e t hyl Benzyl Ammonium Chloride (ABDAC) in Rats: Lab Project I.D.: 52-623. Unpub lished study prepared by Union Carbide Bushy Run Research Center. 264 p.

41765201 Gill, M.; Herm ansky, S.; W a gner, C. (1991) Chro nic Dietary Oncogenicity Study with Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in Mice: Lab Project Number: 53-515. Unpublished study prepared by Bushy Run Research Center. 1083 p.

41947501 Gill, M.; Herm ansky, S.; W a gner, C. (1991) Chro nic Dietary Toxicity/Oncogenicity S t udy with Al kyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in Rats: Lab P r oject Num ber: 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 Dim e thyl Benzyl Ammonium Chl o ride (ADBAC) to Bluegill Sunfish. St udy No. SC890050. Unpublished data. Conducted by Battelle C olum bus Di vision for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

41947202 Pate, H.O. and D.O. McIntyre. 1991. Daily Static-Renewal Acute 96­ Hour Toxicity Test of Alkyl Dim e thyl Benzyl Ammonium Chl o ride (ADBAC) to Rainbow Trout. Stud y No. SC890051. Unpublished data. Conducted by Battelle C olum bus Di vision for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

41947203 Pate, H.O. and D.O. McIntyre. 1991. Daily Static-Renewal Acute 48­ Hour Toxicity Test of Alkyl Dim e thyl Benzyl Ammonium Chl o ride (ADBAC) to Daphnia magna

. Study No. SC 890052. Unpublished data. Conducted by Battelle C olum bus Di vision for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

42290801 McKeon, M. (1992) Genotoxicity Test on Alkyl Di m e thyl Benzyl

Ammoniu m Chloride (ADBAC) in the Assay for Unscheduled DNA Synthesis in Rat Liver Prim ary Cell Cultures: Lab Project Number: 14778­ 0-447. Unpublished study prepared by Hazleton Washington, Inc. 51 p.

42290802 McKeon, M. (1989) Alkyl Dim e t hyl Benzyl Ammonium Chl o ride (ADBAC) in the Rat Prim ary Hepatocyte Unscheduled DNA Synthesis

97

# BIBLIOGRAPHY

MRID# CITATIONS

Assay: An Addendum : Lab Pr oject Num ber: 10238-0-447. Unpublished study prepared by Hazleton Laboratories Am erica, Inc. 11 p.

42302101 McIntyre, D.O. and H.O. Pate. 1992. Daily Static-Renewal Chronic 21­ Day Toxicity Test of Alkyl Dim e thyl Benzyl Ammonium Chl o ride (ADBAC) to Daphnia magna

. Study No. SC890056. Unpublished data. Conducted by Battelle C olum bus Di vision for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

42302102 McIntyre, D.O. and H.O. Pate. 1992. Daily Static-Renewal Early Life Stage Toxicity Test of Alkyl Dim e thyl Benzyl Ammonium Chl o ride (ADBAC) to Fathead Minnows. Project No. SC890057. Unpublished

data. Conducted by Battelle Colum bus Operations for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

42351501 Neeper-Bradley, T. (1992) Develo pm ental Toxicity Evaluation II of Alkyl

Di m e thyl Benzyl Ammonium Chlo ride (ADBAC) Adm i nistered by Gavage to CD Rats: Lab Projec t Number: 91N0031. Unpublished study prepared by Union Carbide Chem icals and Plastics Co., Inc. Bushy Run Research Center. 281 p

42392801 Neeper-Bradley, T.; Kubena, M. (1992) Developm ental Toxicity Evaluation of Alkyl Di methyl Benz yl Ammonium Chloride (ADBAC)

Adm i nistered by Gavage to New Z ealand W h ite Rabbits: Lab Project

Num ber: 91N0032. Unpublished study pr epared by Union Carbide. 179 p.

42414801 Daly, D. and W . Cranor. 1992. So il/Sedim e nt Adsorption-Desorption of Alkyl Dim e thyl Amm oni um Chloride. Supplem e nt in support of #

408356-05. Perform e d by ABC Laboratori es, Inc., Colum b ia, Missouri.

Subm itted b y ADBAC Joint Ventu r e / Chem ical Specia lties M anuf acture rs Association, W a shington, DC.

42414901 Daly, D. and W . Cranor. 1992. Ae robic m etabolism of alkyl dim ethyl benzyl ammonium chloride. Supplem ent in support of # 408356-04.

Perf orm ed by ABC Laborator i es, Inc. , Colum b ia, Missour i. Su bm itted by

ADB AC Joint Venture/Che m ical Speci alties M a nufacturers Association

, Washington, DC.

42415101 Daly, D. and W . Cranor. 1989. An aerobic aquatic m e tabolism of alkyl

dim ethyl benzyl amm o nium chlo ride. ABC Am e nded Final Report

#35714. Supplem ent in support of # 411055-01. Unpublished study

98

# BIBLIOGRAPHY

MRID# CITATIONS

perform e d by Analytical Bio-Chem is try Laboratories, Inc., Colum bia, MO, and subm itted by ADBAC Joint Venture / Chem ical Specia lties Manufacturers Association, W a shington, DC.

42415102 Daly, D. and W . Cranor. 1992. An aerobic m etabolism of alkyl dim ethyl benzyl ammonium chloride. Supplem ent in support of # 411055-01.

Perf orm ed by ABC Laborator i es, Inc. , Colum b ia, Missour i. S u bm itted by

ADB AC Joint Venture/Che m ical Speci alties M a nufacturers 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. Perform e d by A BC Laboratories, Inc., Colum bia,

Missour i. S u bm itted by ADBAC Joint Venture / Chem ical Specia lties Manufacturers Association, W a shington, DC.

42479502 Sved, D.W ., J.P. Swigert, and G.J. Sm ith. 1992. A 96-Hour StaticRenewal Acute Toxicity Test with Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in the Sheepshead Minnow ( Cyprinodon variegatus)

. Project No. 350A-102. Unpublished data. Conducted by W ildlife International Ltd. for ADBAC Quat Jo int Ventu r e / Chem ical Specia lties

Manufacturers Association.

42479503 Sved, D.W ., J.P. Swigert, and G. J. Sm ith. 1992. A 48- Hour Static Acute Toxicity Test with Alkyl Di m e t hyl Benzyl Ammonium Chloride (ADBAC) in Em bryo Larvae of the Eastern Oyster ( Crassostrea virgin ica)

. Unpublished data. Conducte d by W ildlife International Ltd.

for ADB AC Quat Joint Venture/Chem ical Specialties Manuf acturers
Association.

42479501 Sved, D.W ., J.P. Swigert, and G.J. Sm ith. 1992. A 96-Hour StaticRenewal Acute Toxicity Test with Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in the Saltwater Mysid ( Mysidopsis bahia) . Project No. 350A-101A. Unpublished data. Conduc ted by W ildlife International Ltd. for ADBAC Quat Joint Venture/ Chem ical Specialties M a nufacturers

Association.

42479502 Sved, D.W ., J.P. Swigert, and G.J. Sm ith. 1992. A 96-Hour StaticRenewal Acute Toxicity Test with Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in the Sheepshead Minnow ( Cyprinodon variegatus)

. Project No. 350A-102. Unpublished data. Conducted by W ildlife

99

# BIBLIOGRAPHY

MRID # CITATIONS

International Ltd. for ADBAC Quat Joint Ventu r e / Chem ical Specia lties

Manufacturers Association.

42645101 Chun, J.; Fisher, L. (1993) Deve lopm ental Toxicity Dose R a ng-Finding Study of Alkyl Dim e thyl Benzyl Ammonium Chl oride (ADBAC)

Adm i nistered by Gavage to CD Rats: Lab Project Num ber: 54-613. Unpublished study prepared by Bushy Run Research Center (BRRC). 104

p.

42734401 Chun, J.; Neeper-Bradley, T. (1993) Developm ental Toxicity Dose RangeFinding Study of ADBAC Adm i nis t er ed by Gavage to New Zealand White Rabbits: Lab Project Num ber: 54-603. Unpublished study prepared by Union Carbide. 118 p.

42885901 Ca m pbell, S.M. and M. Jaber. 1993. An Acute Oral Toxicity Study with Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) in the Northern Bobwhite Quail. Project No. 289- 109. Unpublished data. C onducted by

W ildlif e International L t d. f o r Lonza, Inc.

43037701 Schoenig, G. (1993) Response to EPA Data Evaluation Review for Study

Entitled: "Chrom osom e Aberrations in vivo--Mouse Micronucleus Test": Lab Project Num b er: 10753. Unpublis hed study prepared by SCANTOX Biologisk L a boratorium A/S. 7 p.

43221101 Goldenthal, E. (1994) Evaluati on of ADBAC in a One-Year Chronic Dietary Toxicity Study in Dogs: Lab Project Number: 638-004. Unpublished study prepared by International Research and D e velopm ent Corp. 355 p.

43731101 England, D.C. and T. Leak. 1995. Chronic Toxicity of Sedim e ntIncorporated ADBAC to Chironomus tentans

. Project No. 41004. Unpublished data. Conducted by A BC Laboratories, Inc. for ADBAC Quat Joint V e nture/Chem ical Speci alties Manuf acturers Association.

43740101 Sword, M.C. and L. Stuerm an. 1993. Static-Renewal Acute Toxicity of ADBAC to Fathead Minnow ( Pimephales promelas) in Dilution W ater
Am ended with 20 m g/L Hum i c Acid. Study No. 41235. Unpublished

data. Conducted by ABC Laboratorie s, Inc. for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

43740102 Sword, M.C. and L. Stuerm an. 1993. Static-Renewal Acute Toxicity of ADBAC to Fathead Minnow ( Pimephales promelas) in Dilution W ater

100

# BIBLIOGRAPHY

MRID# CITATIONS

Am ended with 10 m g/L Hum i c Acid. Study No. 41236. Unpublished

data. Conducted by ABC Laboratorie s, Inc. for ADBAC Quat Joint

Venture/Chem ical Specialties Manuf acturers Association.

43740103 Sword, M.C. and L. Stuerm an. 1993. Static-Renewal Acute Toxicity of ADBAC to Fathead Minnow ( Pimephales promelas)

. Study No. 41237. Unpublished data. Conducted by A BC Laboratories, Inc. for ADBAC Quat Joint V e nture/Chem ical Speci alties Manuf acturers Association.

44467401 Albem a rle BQ1416-8 Biocide--Pr oduct Chemistry, (1998) Albem a rle Corp., Lab Project Num b er 8382-141 Quat 6, Albem a rle Corporation.

44467402 Tolbert, A., Product Chem istry Chem ical Characterization for

Determ ining Identity and Purity of 80% n-Alkyl (60% C 14 

### , 30 % C 16 

### , 5 %

C 12 

### , 5% C 18 

### ) Di m e thyl Benzyl Ammonium Chloride, (1998), Lab Project

Num ber Quat 6B, Al bem a rle Corporation.

44467403 Tolbert, A

., Product Che m istry Che m ical Characterization for

Determ ining the Phys ical and Ch em ical Pro p erties, and Accelerated Storage Stability of 80% n-Alkyl (60% C 14 

### , 30 % C 16 

### ,5 % C 12 

### , 5% C 18 

### )

Di m e thyl Benzyl Ammonium Chloride , (1998), Lab Project Num ber Quat 6A, Albe m a rle Corporation.

44783401 Mazur, P. (1999) Absorption, Di stribution, Metabolism and Excretion (ADME) Studies of Alkyl Dim e t hyl Benzyl Ammonium Chl o ride (ADBAC) in the Rat and Addendum : Lab Project Num ber: P01359. Unpublished study prepared by ADBAC Quat Joint Venture/Che m ical Specialities Manufacturers Assoc. 4 p.

44825001 Kreuzm ann, J. (1999) R e peated Ey e Instillation Study in Rabbits of Alkyl

Di m e thyl Benzyl Ammonium Chlori de (ADBAC): Report Am endm ent : Lab Project Num b er: 88-3336-21. U npublished s t udy prepared by Hill Top Research, Inc. 4 p.

44825002 Kreuzm ann, J. (1999) Photoall ergy S t udy in Guinea Pigs with Alkyl

Di m e thyl Benzyl Ammonium Chlori de (ADBAC): Report Am endm ent : Lab Project Num b er: 88-3226-21. U npublished s t udy prepared by Hill Top Research, Inc. 4 p.

101

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MRID# CITATIONS

44885201 Wnorowski, G. (1999) Acute Inhalation Toxicity Study in Rats:

Albem a rle BQ451-8 Biocide: Lab P r oject Num b er: 7467: P330. Unpublished study prepared by Product Safety L a bs. 30 p.

45109201 Moore, G. (1999) Prim ary Skin Irritation Study in Rabbits: A l bem a rle BQ451-8 Biocide: Lab P r oject Num b er: 7468: P326. Unpublished study prepared by Product Safety Labs. 15 p.

45109202 Moore, G. (1999) Acute Derm al Toxicity Study in Rats: Albem a rle BQ451-8 Biocide: Lab P r oject Num b er: 7466: P322. Unpublished study prepared by Product Safety Labs. 25 p.

45109203 Moore, G. (1999) Dermal Sensi tization Study in Guinea Pigs (Buehler Method): Albem a rle BQ451-8 Biocide: Lab Project Num ber: 7469: P328. Unpublished study prepared by Product Safety L a bs. 24 p.

45109204 Bonnette, K. (1998) An Acute Oral T oxicity S t udy in Rats with BQ 451-8: Lab Project Num b er: 3192.32. Unpublishe d study prepared by Springborn Laboratories. 90 p.

455021101 Am erican Chem istry Council (A CC). 2002a.Assessm ent of Potential

Inhalation and Derm al Exposure Associ ated W ith Pressure T r eatm e nt of

Wood with Arsenical Wood Products

45524304 Bestari KT, Macey K, Solom a n KR, Tower N. 1999. Measu r em ent and

Assessm ent of Der m al and Inhalatio n Exposures to Didecyl Di m e thyl

Ammoniu m Chloride (DDAC) Used in the Protection of Cut Lu m ber (Phase III).

46865601 Van Dievoet, F. and V. Bouillon. 2 005. Biodegradability Test Report

accord ing to OECD 301 B – m odified (M odification: produ ct tested at a

concentration of ± 5 m g/L of TOC). Report No. ST49132.01.01. Unpublished study perform e d by BFB Oil Research S.A., Ge mbloux, Belgium

, and subm itted by ADBAC Issues

.

102

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Am erican Chem istry Council (ACC). 2002b. An Analys is of the Training Patterns and Practices

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Competitive Swimm e rs. Prepar ed by Richard Reiss. Scie nces Interna tiona l, Inc. Alexandria, Virginia. Decem ber 9, 2002.

Bryan, Elizabeth. 1988. Methods for Estim ating Re tention of Liquid on Hands. Volum e 13 of Methods for Assessing E xposure to C hem ical Substances. EP A 560/5-85-017

CEC, 2001. Residential Manual for Com p lian ce with California’s 2001 E nergy Efficiency

Standards. http://www.energy. ca.gov/title24/residential_m a n u al/index.htm l , viewed January

2005.

Dobbs, M.G., Cherry, D.S., Scott, J.C., Petrille, J.C. 1995

. 

### Environm ental Assessm ent of an Alkyl Dim e thyl Benzyl Ammonium Chloride (ADBAC) Ba sed Molluscicide Using Laboratory Tests. Virg inia Tech Un iversity Cen t er fo r Environm ental an d Hazardous Materials Studies Blacksburg, VA. Published data. Pro ceedings of the Fifth International Zebra Mussel and Other Aquatic Nuisance Organism s Conference, Toronto, Canada.

EpiSuite Computer Program

FDA. 2003. “Sanitizing Solutions: Chem istry Gu idelines for Food Additive Petitions.”

Freem an, N , Jim e nez M, Reed KJ,Gurunathan S, Edwards RD, Roy A, Adgate JL, Pellizzari ED, Quackenboss J, Sexton K, Lioy PJ, 2001. Quanti tative analysis of children’s m i croactivity
patterns: The Minnesota Childre n’s Pesticide Exposure Study. Journal of Exposure Analysis and Envi ronm ental Epidem iology. 11(6): 501-509.

Helwig, D. (2003) Personal Co mmunication between D. Helwig (Johnson Diversy, Inc) and K. Riley (Versar, Inc.), Novem ber 11, 2003.

. Jacobson, L a rry. 2005. Professor and Extension Engineer at University of Minnesota

Krahn, P.K. and R. Strub. 1990. Standard leachi ng test for antisapstain chem icals. Regional Program Re port 90-10. Environm ent Canada, Conservation and Protection, Environm ental Protection, Pacific and Yukon Re gion, North Vancouver, B.C.

Lee, C. 1992. Assessment of the Biodegradab ility of ADBAC and DDAC. Unpublished report prepared by Roy F. W e st on, Inc. Contractor’s Fate Summ ary Review. Docum e nt I m a ge No.

2011644.

103

# BIBLIOGRAPHY

OPEN LITERATURE CITATIONS

MCCEM V 1.2 The Multi-Cham ber Concentrat ion and Exposure Model (MCCEM) Model Version 1.2. Prepared for the US EPA Office of Pollution Prevention and Toxics. Prepared by Versar, Inc. and W ilkes Technologies, LLC.

Steering Committee/Jo int Ve nture, Washington, DC.

104

# BIBLIOGRAPHY

INTERNET CITATIONS

Am erican Chem ical Council (ACC), 2005. Slim icide Use in Paperm aking (Powerpoint Presentation). ACC Biocides Council, Septem be r 17, 2003. http://www.cfsan.fda.gov/~dm s /opa-cg3a.htm l

. Last accessed June 9, 2003.

DOE. 1997. Energy Inform ation Adm i nistration: Profile of Comm erci al Buildings in 1995. http://www.eia.doe.gov/em e u/ cbecs/char95/profile.htm l

HERA, 2003. Hum a n a nd Environm ental Risk Assessm ent, Guidance Docum e nt Methodology, April 22, 2002. http://w ww.heraproject.com /files/Guidancedocum ent.pdf

.

HERA, 2005. Hum a n a nd Environm ental Risk Assessm ent, Guidance Docum e nt Methodology, February 2005. http://w ww.heraproject.com

.

SIMetric. 2005. http://w ww.si m e tric.co.uk/si_m aterials.htm Last viewed Nove m ber 9, 2005.

USAID. 200 5. “ANNE X III: Recomm ended Ene r gy Allowance Tables.” Nove m ber 2005. http://www.usaid.gov/our_work/hum anita rian_assistance/ffp/crg/annex-3.htm

. Last viewed January 23, 2006.

USEPA. 2000. Office of Pesticide P r ogram s. 2000. Part A. Guidance for Use of the Index Reservoir in Drinking Water Assessm e nts. http://www.epa.gov/oppfead1/trac/science/reservoir.pdf

USEPA 2001a. Environ m ental Fate and Eff ects Division. 2 001a. FIRST (F)IFRA (I)ndex (R)eservoir (S)creening (T)ool . Tier 1 Model for Drinking Wa ter Exposure: User' s Manual. http://www.epa.gov/oppefed1/m odel s /water/first_users_m a nual.htm

USEPA 2001b. Environm ental Fate and Effect s Division. 2001b. SCI-GROW - (S)creening (C)oncentration (I)n (GRO)und (W )a ter: User' s Manual. http://www.epa.gov/oppefed1/m odel s /water/scigrow_users_manual.htm

USEPA 2002. Environmental Fate and Effects Di vision. 2002. Guidance for Selecting Input

Param eters in Modeling the Environ m ental Fate a nd Transport of Pesticides, Version II. U. S.

Environm ental Protection Ag ency. Washington, D.C. http://www.epa.go v/oppefed1/models water/input_guidance2_28_02.htm /

105

# BIBLIOGRAPHY

OTHE R SUPPORTING DOCUMENTS CITATIONS

USEPA. 1993. Environm ental Fate and Groundwater Branch (EFGB) review of alkyl dim e thyl benzyl ammonium chloride. Mem o from E. Rege lm an, EFGB, to J. Lee, Antim icrobial Program

Branch.

USEPA. 1996. Office of Research and Developm ent, Descriptive Statistics Tables from a Detailed Analysis of the National Hum a n Activity Pattern (NHAPS) Data; EPA/600/R-96/148, July 1996. Data Collection Pe riod O ctober 1992 - Septem ber 1994.

USEPA. 1997. Exposure Factors Handbook. Volum e I-II. Office of Research and Developm ent. 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. Estim ates of W orker Exposure from the Pesticide Handler Exposure Database Version 1.1. W a shington, DC: U.S. Environmental

Protection A gency.

USEPA. 1999. Evaluation of Che m i cal Manufac turers Association Antimicrobial Exposure

Assessm ent Study (Am e nded on 8 Decem ber 1992). Mem orandum from Siroos Mostaghim i

, PH.D., USEPA, to Julie Fairfax, USEPA. Dated Nove m ber, 4 1999. DP Barcode D247642.

USEPA (1999): Alkyl d i m e thyl benzyl amm oni um chloride (ADBAC) – Report of th e Hazard

Identification Assessm e nt Review Comm ittee, Office of Prevention, Pesticides, and T oxic

Substances.

USEPA (2000): Mem orandum on Sterilex ® Ultra-Kleen for Dental Un it W ater lin es: Request

for Risk Assessm ent. Subm ission S572183.

USEPA. 2000. Residential SOPs. EPA Office of Pesticide P r ogram s, Hum a n Health Effects Division. Dated April 5, 2000.

USEPA. 2001. HED Sc ience Advisory Council for Exposure. Policy Update, November 12. Recommended Revisions to the Standard Operati ng Procedures (SOPs) for Residential Exposure

Assessm ent, February 22, 2001.

USEPA. 2003. Assessm e nt of the Proposed Bard ac W ood Preservative Pressure T r eatm ent Use.

Mem o randum from Ti m Leighton and Si roos Mostaghim i

. February 11, 2003.

106

# BIBLIOGRAPHY

OTHE R SUPPORTING DOCUMENTS CITATIONS

USEPA. 2004. Occupational and Residentia l Exposure Assessm ent for Carboquat W P -50.

Mem o randum from Siroos Mostag him i , USEPA, to Velm a Noble, USEPA. Nove mber 4, 2004.

DP Barcodes D303714 and D303938.

USEPA. 2005. Dietary Assessm ent of Chlorine Dioxide, Sodium Chlorite from Thei r Use as
Indirect Foo d Contact Saniti zers / Disinfectants (Hard Surface Sanitizers ) . Mem o randum from Najm Sha m im, USEPA, to Melba Morrow and Jennifer Slotnick, USEPA. Dates August 15,

2005.

USEPA. 2006. Alkyl dim e thyl benzyl amm onium chloride (ADB AC) – Report of the

Antim icrobials Divis i on Toxicity En dpoint Co mm ittee (ADTC) and the Hazard Iden tification

Assessm ent Review Committee (HIARC). January 9, 2006.

USEPA. Undated. RIS K

. Version 1.9.27. Deve loped by Dr. Les Sparks of USEPA/NRMRL/

APPCD.

Versar. 2006. ADBAC Occupationa l and Residential Exposure Assessm ent. Mem o randum from Adria Diaz/Karie Riley/Kelly McAloon, Versar, In c., to Laura Bailey, USEPA dated January 16,

2006.

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### Appendix E

. GENERIC DAT A CALL-IN

The Agency intends to is sue a Generic Data Ca ll-In at a later date. See C hapter V of the

ADB AC R E D for a list of studies th at the Agency plans to req u ire.

108

### Appendix F

. PRODUCT SPECIFIC DAT A CALL-IN

The Agency intends to issue a Product Sp ecific D a ta Call-In at a later date.

109

### Appendix G. List of All Regi strants Sent the Data Call-In

A list of reg i stran t s sen t the data c all- i n will b e po sted a t a la te r date.

110

### Appendix H. List of Available Related Do cuments and Electronically Available Fo rms

Pestic ide Re gistr ation Form s are available at th e f o llowing EP A interne t site 

## : http://www.epa.gov/opprd001/form s /

Pesticide Registration Form s (These form s are in PDF for m at and require the Acrobat reader)

Instructions

1. Print out and com plete the for m s. (Not e: Form num b ers that are bolded can be
filled out on your com p uter then prin ted.)

2. The com p leted for m (s) s hould be sub m itted in hardcopy in accord with th e existing policy.

3. Mail the form s, along with any additional docum ents necessary to com ply with EPA regulations covering your request, to the address below for the Docum e nt Processing Desk.

DO NOT fa x or e-m a il any for m containing ' C onfi dential Business Inform ation' or ' S ensitive
Inform ation.'

If you have any problem s accessing these form s, please contact Nicole W i lliam s at (703) 308-5551 or by e-m a il at william s.nicole@epa.g ov.

The following Agency Pesticide Registration Form s are currently av ailable via the internet
at the f o llowing loca tion s:
8 570 -1 App licatio n fo r Pesticid e Reg i stratio n / Am en d m en t h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 1

. p d f

8 570 -4 Co nfid en tial State m en t o f Form u la h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 4

. p d f

85 7 0

- 5 Not i ce of S u p p l em ent a l R e gi st rat i on of Di st r i but i o n of a Registere d Pesticide Product h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 5

. p d f

85 7 0

- 1 7 Ap pl i cat i o n f o r

an Ex peri m e nt al Use Perm i t h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 1 7 .pdf

8 570 -25 App licatio n fo r/No tificatio n of State Reg i st ratio n o f
a Pesticide T o Meet a Special Local Nee d h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 2 5 .pdf

85 7 0

- 2 7 Form ul at or' s E x em pt i on St at e m ent h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 2 7 .pdf

8 570 -28 Certificatio n o f Co m p lian ce with Data Gap Procedure s h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 2 8 .pdf

8 570 -30 Pesticid e Reg i stratio n Mai n ten a n c e Fee Filin g h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 3 0 .pdf

8 570 -32 Certificatio n o f Attem p t to Enter in to an Ag ree m en t wi t h ot he r R e g i st rant s f o r De vel o pm ent of Dat a h ttp ://w ww .epa.go v / o pprd001 /fo r m s /8 5 7 0

- 3 2 .pdf

8 570 -34 Certificatio n with Resp ect t o Citatio n s of Data ( P R No tice 98- 5) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 5

. p d f

8 570 -35 Data Matrix (PR No tice 98 -5 ) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 5

. p d f

8 570 -36 Summ ary of the Physical/Che mical Prope rties (PR Notice 98

- 1 ) h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 1

. p d f

8 570 -37 Self-Certificatio n Statem en t fo r th e Ph y sical/ h ttp ://www.epa.go v / o ppp m s d 1 / PR_No tices/p r98

- 1

. p d f



### 111Ch em ica l Properties (PR No tice 98 -1 )



### Pestic ide Registra tion Kit www.epa.go v/pesticid es/registrationkit/

Dear Registrant:

For your convenience, we have assem bled an online registration kit which contains the following pertinent forms and info rmation needed to register a pesticide product with the U.S.
Environm ental Protection Agency' s Of fice of Pesticide Program s (OPP):

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIF RA) and the Federal Food, Drug and Cos m etic Act (FFDCA) as Am e nded by the Food Quality
Protection A c t (FQPA) of 1996.

2. Pesticide Registration (P R) Notices

a. 83-3 Label Improvem e nt Program --Sto rage and Disposal Statem ents b. 84-1 Clarification of Label Im provem e nt Program

c. 86-5 Standard Form at for Data Submitted under F I FRA d. 87-1 Label Improvem e nt Program for Pesticides Applied through Irrigation System s (Chem i gation)

e. 87-6 Inert Ingredients in Pes ticide Products Policy Statem ent f. 90-1 Inert Ingredients in Pesticid e Products; Revised Policy S t atem ent
g. 95-2 Notifications, Non-notific ations, and Minor Form ulation Am endm ent s h. 98-1 Self Certification of Product Chem istry Data with Attachm e nts (This docum ent is in PDF for m at and requires the Acrobat reader.)

Other PR Notices can be found at http://www.epa.gov/opppm s d1/PR_Notices

3. Pesticide Product Registration Application Forms (These form s are in PDF for m at and will req u ire the Acr obat re ader ).

a. EPA For m No. 8570-1, Application fo r Pesticide Registration/Am endm e n t b. EPA For m No. 8570-4, Confidential Statem ent of For m ula

c. EPA For m No. 8570-27, Form ulator' s Exe m ption Statem ent d. EPA For m No. 8570-34, Certif ication with Respect to Citations of Data

e. EPA For m No. 8570-35, Data Matrix

4. General Pes t icide Inf o rmation (Som e of these f o rm s are in PDF f o rm at and will require the Acrobat reader).

a. Registration Division Personnel Contact L i st b. Biopesticides and Pollution Preven tion Division (BPPD) Cont acts

c. Antim icrobials Division Organizatio nal Structure/Contact List d. 53 F.R. 15952, Pesticide Registra tion Procedures; Pesticide Data Requirem e nts (PDF form at)

e. 40 CFR Part 156, Labeling Requirem e nts for Pe sticides and Devices (PD F for m at ) f. 40 CFR Part 158, Data Requirem e nt s for Registration (PDF form at)

112

### g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (Novem ber 27, 1985)

Before subm itting your application for regi stration, you m a y wish to con s ult som e additional sources of inform ation. These include:

1. The Office of Pesticide P r ogram s' we bsite.

2. The booklet "General Inform ation on Applyi ng for Registration of Pesticides in
the United S t ates", PB92-221811, availabl e through the National Technical
Inform ation Service (NTIS) at the following address:

National Technical Inform ation Service (NTIS) 5285 Port Royal Road Springfield, VA 22161

The telephone num ber for NTIS is (703) 605-6000.

3. The National Pesticide Infor m ation Re trieval System (NPIRS) of Purdue University' s Center for E nvironm ental and Regulatory Inform ation System s. 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 T e lecomm uni cations Network (NPTN) can provide
inform ation on active ingredients, uses, t oxicology, 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 notic e of receip t of an applic ation f or registration or

am ended registration, experim e ntal use perm it, or am endm e n t to a petition if the applic ant or petitione r en closes with his subm ission a stam ped, self-addressed postcard. T h e postcard must contain th e f o llowing entr ies to be com p leted by
OPP:

· Date of rece ipt;

· EPA identifying num ber; and

· Product Manager assignm e nt.

113

### Other identifying information m a y be included by the applicant to link the acknowledg m e nt of receipt to the sp ecifi c app lication subm itted. EPA will stam p the date of receip t and p r ovide the E P A id entifying file sym b ol or petitio n num b er for the new subm ission. The identifying num ber should be used whenever you contact the Agency concerning an applica tion for registration, experim e ntal use

perm it, or tolerance petition.

To assist u s in ensuring that all data you have su bm itted for the chem ical are properly coded and assigned to your com p any, pl ease include a list of all

synonym s, c o mm on and trade nam e s, com p any experim e ntal codes, and other

nam es which identify the chem ical (inclu ding "blind" codes used when a sam ple

was subm itted f o r testin g by commercia l or a cad em ic f acilities). Plea se provide a

chem ical abstract sys t em (CAS) number if one has been assigned.

Documents Associated with this RED

The following docum ents are part of the Ad m i nistra tive Rec o rd f o r this RED document

and m a y be included in the EPA' s Office of Pestic ide Program s Public Docket. Copies of these

docum ents are not av ailable el ectronically, but may be obtaine d by contacting the person listed on the resp ective Chem ical Status S h eet.

1. Health Effects Division and Environm ental Fate and Effects Division Science Chapters, w hich include the com plete risk assessm e nts and supporting docum e nts. 2. Detailed Label Usage Infor m ation System (LUI S) Report.

114