UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

  OFFICE OF PREVENTION, PESTICIDES

                                                                                AND TOXIC SUBSTANCES

February 20, 2008

MEMORANDUM

SUBJECT: 	Risk Assessment and Science Support Branch’s (RASSB’s) Review of Petition Submission to Amend 27 CFR § 178.1010 (b)41 and (c)36, and 40 CFR § 180.940 for Steramine 1G Tablets.

FROM:		Sherrie L. Kinard, Chemist, Team 1

Risk Assessment and Science Support Branch

Antimicrobials Division (7510P)

THROUGH:  Norm Cook, Branch Chief

Risk Assessment and Science Support Branch

Antimicrobials Division (7510P)

TO:			Dennis Edwards, Branch Chief

				Regulatory Management Branch I

Antimicrobials Division (7510P)

Chemical:		N-alkyl (C12-14) dimethyl benzyl ammonium chloride (ADBAC compounds)

PC Code:		069105

CAS #:	1225-02-9 and 8001-54-5

DP Barcodes:	  D340428 and D340759

 I.	INTRODUCTION AND BACKGROUND

	1.	Introduction

A petition has been submitted to the Agency which requests that the 40 CFR § 180.940 (a) be amended to increase the end use solution concentration permitted for the quaternary sanitizer, ADBAC.  The proposed amendment requests that the tolerance exemption for ADBAC be increased from 200 ppm to 400 ppm when it is used as an active ingredient in food-contact surface sanitizing products.   Approval of this petition to increase the tolerance exemption level from 200 ppm to 400 ppm will eliminate restrictions placed on this product and allow its usage throughout the USA along with those quaternary sanitizers that are approved under 21 CFR 178.1010 for use up to 400 ppm level.  The label being considered for this tolerance exemption increase is currently registered with the Agency (EPA registration number 1561-11) at a use rate of 200 ppm.  Supplementary to the review of the proposed tolerance exemption increase, the residential and occupational risks associated with the labeled uses were also evaluated.   A proposed RED was completed for the ADBAC quaternary ammonium chloride chemicals for uses in food handling establishments, food processing establishments, and bottling/packaging establishments.  Additionally, data that has been collected by and reported by the Quats Residue Group (QRG) Joint Venture and Consumer Specialty Products Association (CSPA) have been considered for this review.

	2.	Petition

	Edwards-Councilor CO., Inc. has submitted this petition which requests that the Agency amend 40 CFR § 180.940 (a) by increasing the end-use concentration of the quaternary ammonium compound n-alkyl (C12-16) dimethylbenzylammonium chloride in the sanitizing solution from 200 to 400 ppm of active ingredient (a.i.).  The use sites covered under § 180.940 (a) are:  food-contact surfaces in public eating places, dairy processing equipment, and food-processing equipment and utensils.

Section F of the petition reads as follows:

Pesticide Chemical	CAS Reg. No.	Limits

Quaternary Ammonium Compounds n-alkyl (C14-16) benzyldimethyl ammonium chloride, average molecular weight (in amu) 351-380	1225-02-9 in 21 CFR

and

8001-54-5 in 40 CFR	When ready for use, the end-use concentration of the n-alkyl benzyldimethyl ammonium chloride is not to exceed 400 ppm of the sanitizing solution in food handling establishments.

Note:  Pending approval of this petition, the 8001-54-5 in 40 CFR should read, “When ready for use, the end-use concentration of all quaternary chemicals in the solution is not to exceed 400 ppm of active quaternary compound.

		2.1. Reference ADBAC Label and Chemical Identity

	The registrant has submitted a reference product label:  STERAMINE™ 1-G TABLETS (EPA Reg. No. 1561-11), which contains the following product ingredients:

n-alkyl dimethyl benzyl ammonium chloride 	50% a.i.

	The alkyl (C14, 95%; C12, 3%; C16, 2%) dimethyl benzyl ammonium chloride (ADBAC) compounds comprise 50% of the formulation. The alkyl groups contain 12 to 16 carbons and not more than 1% each of the groups with 8 to 10 carbon atoms, in or on all foods, when residues are the result of the lawful application of a registered pesticide containing not more than 400 ppm of the n-alkyl benzyldimethyl ammonium chloride as a sanitizing solution in food handling establishments.  The alkyl benzyl quaternary compound falls into cluster 2 of PR Notice 88-2.

		2.2. Proposed ADBAC Uses and Rates

	The representative product label claims uses as a multi-purpose sanitizer and claims that the product “kills HIV-1 (AIDS Virus) when used as directed for sanitizing.”   The label states that the uses for this product are intended for institutional and commercial sites only.  The sanitizer maximum application rate for food contact surfaces is currently 1 tablet per 1 gallon of water which results in the diluted solution concentrations of 200 ppm total a.i.; however, pending approval of this petition, the maximum application rate for food contact surfaces will be 1 to 2 tablets per 1 gallon of water resulting in diluted solution concentrations of 200 to 400 ppm total a.i..  Also pending approval of this petition for a tolerance exemption increase, the following “statement of compliance” will be added to the label:

™ sanitizing solutions of 200 to 400 ppm concentration may be safely used on food processing equipment, utensils, and other food contact articles and surface as specified under 40 CFR 180.940 of the U.S. Environmental Protection Agency.”

		2.3. Residue Analytical Method (860.1340) and Residue Data (860.1500)

	The registrant did not submit an analytical method (860.1340).  However, the use is regulated as an exemption from the requirement of a tolerance and an analytical method is not required.  Also, no residue data (860.1500) were submitted.  These ammonium compounds presently have clearances under 40 CFR CFR § 180.940 (a) at lower application rates.

II.	RASSB Comments and Conclusions

		RASSB has performed an evaluation of ADBAC at the proposed increase in n-alkyl benzyldimethyl ammonium chloride residues from 200 ppm total a.i. to 400 ppm total a.i. which is not covered by existing tolerance exemptions under 40 CFR § 180.940 (a).

The proposed petition results in an increase in potential ADBAC residues in food-contact settings.  The petition proposes an increase to the tolerance exemption level from 200 ppm to 400 ppm and also an increase in the maximum application rate to 200 to 400 ppm.

		It is noted that in the proposed RED for ADBAC (see Public Docket under EPA-HQ-OPP-2006-0339) the rate of 200 ppm a.i. is evaluated for food-contact settings.  Essentially, the ADBAC petition’s proposed use rate has not been evaluated under the ADBAC RED.  Considering this, RASSB has completed the following evaluation of the proposed ADBAC petition using surface residues resulting from an application of 0.0033 lbs a.i./gal (400 ppm a.i).  The findings are as follows:

Dietary: 			No risks of concern resulting from an increase in potential residues in food-contact settings.

Drinking Water:  	A drinking water assessment is not warranted based on the uses proposed on this label; however, the drinking water assessment that was performed in the ADBAC RED was used to aggregate risks from this proposed use with those currently allowed on other labels.  The drinking water assessment demonstrated no risks of concern.

Residential: 		No risks of concern resulting from an increase in potential residues in food-contact settings.

Aggregate: 		No risks of concern resulting from an increase in potential residues in food-contact settings.

Occupational: 		No risks of concern.

		1. Toxicology

	In assessing the proposed petition, RASSB used appropriate toxicological end-points, which are taken from the ADBAC RED (see Public Docket under EPA-HQ-OPP-2006-0339):

Table 1.  Summary of Toxicological Endpoints for ADBAC

Exposure

Scenario	Dose Used in Risk Assessment

(mg/kg/day)	Target MOE or UF,

Special FQPA SF

for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(general population; females 13+)	An acute dietary endpoint was not identified in the data base.  This risk assessment is not required.

Chronic Dietary

NOAEL =44 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation) Chronic toxicity/carcinogenicity –rat MRID 41947501

LOAEL = 88 mg/kg/day, based on decreased body weight and weight gain

Chronic RfD = 0.44 mg/kg/day

Incidental Oral (Short-term)	NOAEL = 10 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation) Developmental Toxicity – Rat,

MRID 42351501

LOAEL = 30 mg/kg/day, based on decreased body weight and food consumption

Incidental Oral (Intermediate-term)	NOAEL = 10 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation) Developmental Toxicity – Rat,

MRID 42351501

LOAEL = 30 mg/kg/day, based on decreased body weight and food consumption

Short-term

Dermal 	NOAEL= 20 mg a.i./kg/day

(333 µg/cm2)a	FQPA SF = 1

UF = 10 (3x inter-species extrapolation, 3x intra-species variation) 21-day dermal toxicity- guinea pigs MRID 41105801

LOAEL = 40 mg a.i./kg/day, based on denuded non-vascularized epidermal layer

Short-term dermal 	NOAEL = 20 mg ai/kg/day

 (80 µg ai/cm2) b	UF = 10 (3x inter-species extrapolation, 3x intra-species variation)	21-day dermal toxicity in rats MRID 41499601

20 mg ai/kg/day is the highest dose tested before irritation became significant at day 43.

Short-term Dermal (technical grade a.i.)

	No endpoint identified from the available data on dermal irritation. Dermal irritation in the 90-day dermal toxicity study was not evident until day 43 (MRID 41499601).

Long-term Dermal (TGAI)	No appropriate endpoint identified.  No systemic effects observed up to 20 mg/kg/day, highest dose of technical grade that could be tested without irritation effects.

Inhalationc

(Any time point)	NOAEL= 3 mg/kg/day

MOE = 100c

	UF = 100 (10x inter-species extrapolation, 10x intra-species variation)

Note:  an additional 10x is used for route extrapolation to determine if a confirmatory study is needed	Developmental Toxicity – rabbit, MRID 42392801

LOAEL = 9 mg/kg/day, based on clinical signs of toxicity in maternal rabbits

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RfD = reference dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable.

a  Formulated-based dermal endpoint = (20 mg a.i./kg guinea pig x 0.43 kg guinea pig x 1000 ug/mg) / 25.8cm2  area of guinea pig dosed = 333 µg ai/cm2 .

b  TGAI-based dermal endpoint = (20 mg ai/kg rat x 0.2 kg rat x 1000 ug/mg) / 50cm2  area of rat dosed = 80 µg ai/cm2  .

c  SEQ CHAPTER \h \r 1 aAn additional uncertainty factor of 10x is applied for use of an oral endpoint for route-to-route extrapolation to determine if a confirmatory inhalation toxicity study is warranted.

2. Endocrine Disruption

	  SEQ CHAPTER \h \r 1 EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.”  Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potential effects in wildlife.  For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.  As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

		3. Dietary Assessment

	In the absence of data for residues of ADBAC on treated food contact surfaces, the Agency estimated residue levels that may occur in food from the application rates on food contact surfaces.  In addition, the food processing and dairy equipment uses of ADBAC have also been addressed.

Utensils

To calculate the Estimated Daily Intake (EDI) for dietary exposures resulting from sanitizing utensils, a number of assumptions were made based on the FDA guidelines (FDA, 2003).

When a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface (Residual Solution).  The FDA recommended worst-case concentration for this quantity is 1 mg of solution per square centimeter of treated surface area.  In the absence of any other data, this value has been used.

The FDA suggests that, as a worst-case scenario, all food that an individual consumes will come into contact with 4,000 cm2 of sanitized non-porous food-contact surfaces.  This contact area represents all the surface area from silverware, china, and glass used by a person who regularly eats three meals per day at an institutional or public facility.

The value for the amount of active material present on food contact surfaces that is expected to migrate to is based on the standard assumption of 100%.  This is a conservative estimate assumes that 100% of the residues available on the surface will be transferred to the food and subsequently ingested.

The body weights used for this assessment are: adult man = 70 kg; adult woman = 60 kg, and an infant = 10 kg (USEPA, 1997).

The above assumptions and the following equations were used to calculate EDI and Dietary Daily Dose (DDD):

EDI (mg/p/day) = AR x RS x SA x F x 10-6	 			(1)

DDD (mg/kg/day) = EDI/BW 						(2)

Table 2:  Input Parameters for Utensil Sanitization

Parameter	Value	Rationale

Residual Solution on Surface (RS)	1 mg/cm2	FDA worst-case assumption

Area of Treated Surface (SA)	4,000 cm2	100% FDA worst case assumption

ADBAC concentration in diluted Solution (AR)	400 ppm	Diluted Solution concentration, based on maximum concentration in Stearamine 1-G Tablets.

Fraction Transferred(F)	100%	Standard Assumption

Body Weight (kg) (BW)

Adult man =

Adult woman =

Child =	70

60

10	EPA, 1997

The calculated dietary risks resulting from utensil contact are provided below.  These risks are not of concern since the % PAD values are less than 100%.

Table 3:  Calculated EDIs and PADs for Chronic Indirect Dietary Exposures from Utensils

Population	Utensils

	EDI (mg/p/d)a	DDD (mg/kg/d)b	% PADc

Adult males	1.60	0.023	5.2

Adult females

0.027	6.1

Children

0.16	36.4

a.	EDI (mg/p/day) = AR x RS x SA x F x 10-6

b.	DDD (mg/kg/day) = EDI (mg/p/day) / BW (kg)

c.	% PAD = exposure (DDD) /(cPAD, both 0.44 mg/kg/day) x 100.

3.2. 	Countertops

To calculate the Estimated Daily Intake (EDI) from treated countertops, the Indirect Dietary Residue Exposure Model (IDREAM) (Exponent 2006) along with the new residue data that has been submitted by QRG and CSPA were utilized.  There are currently two levels of refinement for assessing dietary exposure to antimicrobial pesticide products on countertops and for purposes of this assessment; a Tier 2 approach was used.

A Tier 1 assessment is a two-dimensional approach using default assumptions based on AD’s current standard operating procedures (SOP), which are considered to be conservative.  These assessments assume 1 mg/cm2 of product residue on countertops and that 100% of the residues are transferred from the 2000 cm2 of countertop into the food consumed by each individual daily.  A Tier 1 estimate would be made as follows:

1 mg/ cm2 × 1000 ppm active concentration = 0.001 mg a.i./ cm2

0.001 mg a.i./ cm2  × (2000) × 100% ÷ (15 or 60 or 70 kg bw) = exposure in mg/kg/d

A Tier 2 assessment is a three-dimensional approach which is still conservative, yet provides a refined exposure estimate compared to that from a Tier 1.  For Tier 2 assessment, potential residues are estimated in foods that are prepared on treated countertops.  Tier 2 uses food consumption and preparation patterns as well as data and assumptions that are not chemical specific.  Foods ingredients are separated into nine categories based on food preparation, food physical properties, and the potential, or likelihood of contact with treated countertops.  The nine categories are liquids, fruit, bread, cheese, vegetable, meat, purees (e.g., pudding, oatmeal), pieces (foods normally consumed in small pieces), and powders (foods normally used in powder/granular forms).  Assumed countertop residues are converted to estimated residues contacting the countertops using a translation factor for each food category, and default residue transfer efficiency for a representative food.  Therefore, IDREAM™ combines estimated countertop residues for surface treatment products, CSFII consumption data, food-specific conversion factors that relate the surface area contacting a countertop to the corresponding weight of the food item, and the transfer efficiency of residues from countertops to food.  Conservative assumptions for these analyses include: all disinfectants registered uses to clean kitchen countertops and subsequently prepare foods on those countertops; all foods prepared contact the treated countertop with maximum active ingredient residues and that residues do not diminish over time; there is a 100% likelihood of contact to account for both commercial and residential scenarios; all commercial and households use the same disinfectant product; all foods are prepared and consumed; all foods are prepared on the countertops, and no reduction of residues in food result from cooking or other preparation processes.  Tier 2 estimates are calculated as follows:

Ingestion (mg/kg/d) = CSR (mg/ cm2) × [CSA (cm2) ÷ FW (g)] × LC (%) × RT (%)× ConR (g/kg bw/d)

Where:

	CSR:	Countertop surface residue (mg/ cm2)

	CSA:  	Contact Surface area from CSFII (cm2)

	FW:  	Weight of a piece/serving of food from CSFII (g)

	LC:  	Likelihood of contact (%)

	RTE:  	Residue transfer efficiency (%)

IDREAM™ such to incorporate the new data that has been generated and submitted by QRG and CSPA.  The residue values provided by these constituents were generated by collecting data on the residual levels of ADBAC found on three food types: apple, bread, and bologna.  The value for the amount of active material present on food contact surfaces that is expected to migrate to is based on the information that is provided in MRID #468707-03. Study to Demonstrate Transferability Equivalence Among Quats and Measure Food Surrogate Transfer Efficiency.  Three food types were sampled n this study; bologna, apple, and bread, with bologna yielding the highest average percent transfer rate.  The residue data from QRG and CSPA are reported in Table 4.

The detailed IDREAM output tables are provided in Appendix A.  All of the calculated indirect dietary exposures are not of a concern.

Table 4. Food categories and QRG data utilized with IDREAM parameters

Food Category as Identified in IDREAM™	QRGa food equivalence	Residue Transfer Efficiency

(%)

Liquid	NA	100

Fruit	Apple	39

Bread	Bread	0.86

Cheese	Bologna	47

Vegetable	Apple	39

Meat	Bologna	47

Purees	Apple	39

Pieces	Bread	0.86

Powders	Bread	0.86

Table 5:  Calculated DDDs and PADs for Chronic Indirect Dietary Exposures

Exposure Group	Countertops

	DDD (mg/kg/d)	% cPADa

Adult males (13+)	0.00059	0.13

Adult females (13-49)	0.00055	0.12

Children (1-2)	0.0019	0.43

a.	DDD (mg/kg/day) was provided from the IDREAM model

b.	% PAD = exposure (DDD) /(cPAD, 0.44 mg/kg/day) x 100.

	3.3.	Food Processing/Dairy Equipment

ADBAC may also be used as a sanitizer or disinfectant in for food processing equipment as well as dairy equipment.  The sanitization of food processing and dairy equipment permits product contact with the interior of equipment.  FDA utilizes the milk truck model (described in the FDA document, “Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions”, pages 9-10) (FDA 2003) for these types of uses and this was performed in order to estimate residues that could transfer from treated surfaces to food such as milk.  The risks calculated for these uses are not of a concern.

This guidance states on page 9, “For applications limited to use of the food sanitizer on food processing equipment and utensils, the Agency has determined that estimates of sanitary exposure from use in dairy processing plants significantly exceed estimates based on other uses with food processing equipment and utensils.  Depending on the available safety data, the petitioner may either submit a petition for the broader use of its sanitizer on ‘food processing equipment and utensils including dairy processing plants’ or for the more limited use on ‘food processing equipment and utensils excepting use in dairy processing plants.’”

Although in practice, consideration of all of the components of a milk handling system should be included as sources of sanitizer residue in milk, for purposes of this assessment, the Agency assumes the sanitized tank truck which transports the milk is the primary source of residue.  It is conservatively assumed that the milk undergoes no additional dilution prior to reaching the consumer.   The calculation of the estimated daily intake (EDI) of residual sanitizer solution in milk from use in a dairy processing plant utilized the following equation and assumptions:

EDI = SA x CT x R x AR x CF1 x CF2 x CF3

EDI:	Estimated Daily Intake (µg /L milk)

SA:	Internal surface area of 413 ft2 is calculated for the tank (413 ft2/truck).

CT:	Assuming a cylindrical model for the tank truck, it is assumed to have a 4,000 gal capacity (1 truck/4,000 gallons).

R:		When a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface.  The FDA recommended worst-case concentration for this quantity is 1 mg of solution per square centimeter of treated surface area.  In the absence of data, this value has been used.

AR:	Application rate based on label direction to use an undiluted product, which contains 0.005% silver (or 50 ppm)

CF1:	Conversion factor (929 cm2/1 ft2)

CF2:	Conversion factor (0.264 gal/1L)

CF3:	Conversion factor (1000ug = 1mg)

Table 3.   Estimated Dietary Consumption of Adults and Children from the use of ADBAC in Dairy Processing Plants

Exposure Scenario

Application Rate (% a.i.)

	Estimated Daily Intake

(µg /L milk) a	Adult dietary consumption (µg/day)b	Child dietary consumption (µg/day)c	Total Dietary Dose (mg/kg/day)d	c% PAD (mg/kg/day)e

Food processing equipment	0.004	1.13 	0.15	0.38	Male: 2.1 x 10-6	4.8 x 10-4

	Female: 2.5 x 10-6	5.7 x 10-4

	Child: 3.8 x 10-5	9.0 x 10-3

a  Estimated Daily Intake (ug/L milk) = 413ft2/ truck x 1truck/4000gal x 1mg/cm2 x (0.004%) x 929cm2/ft2 x 0.264gal/1L x  1,000µg/1mg = 1.13µg /L milk ~ 1.13 ppb.

b  If an adult (male or female) were to consume 125g of food per day, assumed to be containing 1.13 µg/L of ADBAC, utilizing the following equation: 125g/day x kg/1000g x 1.13µg/L x L/0.96kg, then the person would ingest 0.15µg of ADBAC per day.

c  If an child were to consume 320g of food per day, assumed to be containing 1.13µg/L of ADBAC, utilizing the following equation: 320g/day x kg/1000g x 1.13µg/L x L/0.96kg, then the child would ingest 0.38µg of ADBAC per day.

d  Dietary exposure (mg/kg/day) = Dietary Consumption (mg/day) / Body weight (Where male body weight is 70 kg, female is 60 kg and children is 10 kg and a conversion factor of 1,000ug = 1mg is applied).

e  % PAD (population adjusted dose) = exposure (total dietary dose)/ PAD) x 100.  The PAD is assumed to be equivalent to the chronic dietary RfD value of 0.44mg/kg/day.

Combined Dietary Exposures and Risks

Combined exposures were calculated for the use of ADBAC in food handling establishments, and risks were not of concern.  ADBAC treatments of food processing equipment and dairy equipment are considered to be negligible and were not included in the combined dietary assessment.  Therefore, the combined dietary assessment includes utensils and countertop dietary exposures only.  The combined dietary exposures from indirect food exposure are not of concern.

Table 9:  Cumulative DDDs and PADs for Chronic Indirect Dietary Exposures

Exposure Group	Countertops and Utensils

	DDD (mg/kg/d)	% cPADa

Adult males (13+)	0.024	5.4

Adult females (13-69)	0.028	6.4

Children (1-2)	0.16	36.4

a.	Aggregate DDD = Utensil DDD + Countertop DDD

b.	% PAD = exposure (DDD) /(cPAD, 0.44 mg/kg/day) x 100.

3.5. 	Drinking Water Assessment  tc "5.4	Drinking Water Exposures and Risks " \l 2

	A drinking water assessment is not warranted based on the uses proposed on this label.  The indoor hard surface applications are anticipated to result in minimal, if any, runoff of silver into the groundwater.  However, ADBAC is also used as an outdoor pesticide on nursery ornamentals, turf, and for mosquito control in ponds and puddles and as an algaecide in decorative pools.  Therefore, for the purposes of this assessment, the labeled turf and nursery uses for ADBAC were included in the aggregate dietary assessment.  Details of these assessments may be found in the ADBAC RED (see Public Docket under EPA-HQ-OPP-2006-0339).

	An acute oral toxicological endpoint was not established for ADBAC.  Therefore, only the chronic drinking water exposure was calculated.  The adult chronic drinking water dose is 0.009 mg/kg/day (i.e., average EDWC 331 ug/L x 2 L/day consumption x 1/70 kg BW).  The children chronic drinking water dose is 0.022 mg/kg/day (i.e., average EDWC 331 ug/L x 1 L/day consumption x 1/15 kg BW). There are no drinking water concerns with ADBAC as the concentrations are much lower than the level of concern.

Table 10. Tier I Estimated Drinking Water Concentrations (EDWCs) Based on Aerial Application of ADBAC on Nursery Ornamentals

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

Surface water (FIRST)

Acute (peak)

Chronic (annual average)	906

13,129

331

Groundwater (SCIGROW)	906	5.4

4. Residential Exposure/Risk Pathway

	There are no residential uses associated with this petition; however, since the request is also for an increase in the tolerance exemption, certain residential uses were assessed.  The exposure scenarios assessed in this document for the representative antimicrobial uses selected by the Agency to represent the residential risks include:

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

Exposure Data and Assumptions

	The residential handler scenarios were assessed to determine dermal and inhalation exposures.  Surrogate dermal and inhalation unit exposure values were taken from the PHED data presented in HED’s Residential SOPs (USEPA, 1997) and from the CMA data from the EPA memorandum Evaluation of Chemical Manufacturers Association Antimicrobial Exposure Assessment Study (USEPA, 1999).  Specific surrogate data used in determining the dermal and inhalation exposures are reported below:

For the mopping and wiping, the CMA data were used; and

For trigger pump scenarios the PHED data were used.

The quantities handled/treated for the handler scenarios were estimated based on information from various sources, including Antimicrobial Division estimates.

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

For wiping and trigger pump spray scenarios, it is assumed that 0.5 liter (0.13 gal) of diluted solution is used.

As with the antimicrobial use, homeowners are assumed to complete elements of an application (mix/load/apply) without the use of personal protective equipment.

	Post-application scenarios have been developed that encompass multiple products, but still represent a high end exposure scenario for all products represented.  Representative post-application scenarios assessed include crawling on treated hard surfaces.  Data sources and methodologies include the HED Residential SOPs (USEPA 2000, 2001), Human and Environmental Risk Assessment (HERA) Guidance Document (2003 and 2005), Pesticide Handlers Exposure Database (PHED), and Outdoor Residential Exposure Task Force (ORETF) studies.

Since no toxicological endpoint of concern was identified for dermal systemic adverse effects, both the handler and the post-application dermal risks were assessed using the short-term toxicological endpoint for dermal irritation.  The duration of exposure for most homeowner handler exposures is believed to be best represented by the short-term duration (1 to 30 days).  The reason that short-term duration was chosen to be assessed is because the different handler and post-application scenarios are assumed to be episodic, not daily.

		4.1. 	Risk Characterization of Antimicrobial Uses

	A summary of the residential handler inhalation risks are presented in Table 11.  Although the inhalation endpoint represents short, intermediate, and long-term durations, the exposure duration of most homeowner applications of cleaning products is believed to be best represented by the short-term duration.  The inhalation toxicological endpoint is based on an oral study because a route-specific inhalation study is not available.  The calculated inhalation MOEs are above the target MOE of 100.  The dermal MOEs are presented in Table 12.  The dermal MOEs are above the target MOE of 10.

Table 11. Short-term Residential Handler Inhalation Exposures and MOEs

Exposure Scenario

Application Method	Application Method	Application Ratea	Quantity Handled/

Treated per dayb	Unit Exposure

(mg/lb ai)c	MOE d

(Target MOE = 100)

Application to indoor hard surfaces	Mopping	0.0033 lb ai/gal	1 gallon 2.38	23,000

	Wiping	0.0033 lb ai/gal	0.13 gallon	67.3	6,200

	Trigger Spray	0.0033 lb ai/gal	0.13 gallon	2.4	170,000

a	Application rates used for mopping, wiping, and trigger spray are the equal to the proposed application rate of 400 ppm of ADBAC.

b	Amount handled per day values are AD standards.

c	Unit Exposure (mg/lb ai) = Unit Exposure from PHED or CMA (mg/lb ai).

d	MOE = NOAEL / Absorbed Daily Dose.  [Where short-term NOAEL = 3 mg/kg/day for inhalation]. Target MOE = 100.

Table 12.  ADBAC Short-term Residential Handler Dermal Risks

Exposure Scenario	Application Method	Application Ratea 	Quantity Handled/ Treated per dayb	Hand Unit Exposure Adjusted for Surface Area

(mg/lb ai/cm2)c

Dermal Skin Irritation Exposure d

(µg/cm2)	MOE e

(Target MOE = 10)

Application to indoor hard surfaces	Mopping	0.0033 lb ai/gal	1 gallon 0.063	0.208	1,600

	Wiping	0.0033 lb ai/gal	0.13 gallon	1.341	0.575	580

	Trigger Spray	0.0033 lb ai/gal	0.13 gallon	0.129	0.055	6,100

a	Application rates used for mopping, wiping, and trigger spray are the equal to the proposed application rate of 400 ppm of ADBAC.  For all other methods, application rates are the maximum application rates determined from EPA registered labels for ADBAC.

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

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

μg/mg

e 	MOE = NOAEL (µg /cm2)/ Surface Residue on Skin (µg/cm2).  [Where short-term dermal formulated-based NOAEL = 333 µg/cm2]. Target MOE = 10.

	A summary of the residential post application risks are presented in Table 13.  Although the inhalation endpoint represents short, intermediate, and long-term durations, the exposure duration of most homeowner applications of cleaning products is believed to be best represented by the short-term duration.  The inhalation toxicological endpoint is based on an oral study because a route-specific inhalation study is not available.  The calculated dermal and incidental oral MOEs are above the target MOE of 10 and 100, respectively. The inhalation MOEs are above the target MOE of 100 for both scenarios.

Table 13.  Short-term Residential Post Application Risks for Children.

Exposure Scenario	Dermal MOE	Incidental Ingestion MOE	Inhalation MOE

Child playing on floora	1,100	610	NA

Child playing on carpeta	1,200	330	NA

NA = not assessed because negligible exposure is assumed by that route for the exposure for the scenario of concern.

a.	These exposures are not resulting from the proposed use associated with this petition; however, are included in the aggregate.  For details on the assessment for uses resulting in these exposures, please refer to the ADBAC RED.

		 tc \l2 "4.4	Residential Exposure/Risk Pathway 5. Aggregate Assessment

	In order for a pesticide registration to continue, it must be shown that the use does not result in “unreasonable adverse effects on the environment”. Section 2 (bb) of FIFRA defines this term to include “a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with standard under section 408...” of FFDCA.  Consequently, even though no pesticide tolerances have been established for ADBAC, the standards of FQPA must still be met, including “that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information.”   Aggregate exposure is the total exposure to a single chemical (or its residues) that may occur from dietary (i.e., food and drinking water), residential, and other non-occupational sources, and from all known or plausible exposure routes (oral, dermal, and inhalation).  Aggregate risk assessment were conducted for short-term (1-30 days), intermediate-term (1-6 months) and chronic (several months to lifetime) exposures.  An acute endpoint was not identified for ADBAC, and therefore, an acute aggregate dietary assessment was not necessary.

	In performing aggregate exposure and risk assessments, the Office of Pesticide Programs has published guidance outlining the necessary steps to perform such assessments (General Principles for Performing Aggregate Exposure and Risk Assessments, November 28, 2001; available at http://www.epa.gov/pesticides/trac/science/aggregate.pdf).  Steps for deciding whether to perform aggregate exposure and risk assessments are listed, which include: identification of toxicological endpoints for each exposure route and duration; identification of potential exposures for each pathway (food, water, and/or residential);  reconciliation of durations and pathways of exposure with durations and pathways of health effects; determination of which possible residential exposure scenarios are likely to occur together within a given time frame; determination of magnitude and duration of exposure for all exposure combinations; determination of the appropriate technique (deterministic or probabilistic) for exposure assessment; and determination of the appropriate risk metric to estimate aggregate risk.

5.1. Acute and Chronic Aggregate Dietary Risks tc "6.1	Acute and Chronic Aggregate Risks " \l 2

	An acute toxicological endpoint was not identified for ADBAC.  Therefore, an acute aggregate risk assessment was not conducted.  The chronic aggregate risk assessment includes dietary and drinking water exposures.  Chronic dietary risk estimates from indirect food uses are presented in Section 3.3.  Drinking water exposure estimates are presented in Section 3.5.  Table 14 presents a summary of these exposures, including the combined dietary exposures (i.e., all indirect food contact exposures), as well as a total dietary aggregate exposure estimate (i.e., drinking water plus indirect dietary exposures).  Based on the results of the chronic aggregate assessment, the %cPAD for adults and children are 5.0% and 22.0%, respectively.  Therefore, the chronic dietary risks are not of concern (i.e., less then 100 % of cPAD).

Table 14.  ADBAC Chronic Aggregate Exposures and Risks (cPAD)

Exposure Routes	Chronic Dietary Exposures (mg/kg/day)

	Countertop Dietary  Exposuresa	Utensil Dietary Exposuresa	Drinking Water Exposures 	Aggregate Dietary Exposuresb	% cPADc

(MOE)c

Adultsd

Oral Ingestion	0.00059	0.027	0.009	0.037	8.4

(1,200)

Childrene

Oral Ingestion	0.0019	0.16	0.022	0.18	40.9

(240)

a 	Dietary (countertops and utensil food contact) exposures are presented in Tables 3 and 5.

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

c 		%cPAD (percent chronic population adjusted dose) = (aggregate exposures / cPAD) x 100.  Where cPAD = NOAEL 44 mg/kg/day ÷ 100x uncertainty factor = 0.44 mg/kg/day.  MOE = NOAEL of 44 mg/kg/day ÷ aggregate dietary exposures mg/kg/day.

d 	Adult population used is the highest exposed adult population, adult females 13-69 years of age.

e 	Children population used is the highest exposed children population, children 1-2 years of age.

 		5.2. Short and Intermediate-term Aggregate Exposures and Risks  tc "6.2	Short- and Intermediate-Term Aggregate Exposures and Risks " \l 2

	Short and intermediate-term aggregate exposures and risks were assessed for adults and children that could be exposed to ADBAC residues from the use of products in non-occupational environments.  The short and intermediate-term aggregate risks account for pesticide exposures from the diet, drinking water, and residential uses.  The following list summarizes all of the potential sources of ADBAC exposures for adults and children related to the label and increased tolerance exemption considered for this petition.

Adult ADBAC exposure sources:

handling of cleaning products containing ADBAC as an a.i. during wiping, mopping, and spraying activities;

and, eating food having ADBAC residues from indirect food contact.

Child ADBAC exposure sources:

post-application exposures to cleaning product residues containing ADBAC that are used on hard surfaces (e.g, floors);

and, eating food having ADBAC residues from indirect food contact.

	The use patterns of the products and probability of co-occurrence must be considered when selecting scenarios for incorporation in the aggregate assessment.  Table 15 summarizes the scenarios from this petition included in the short and intermediate-term aggregate assessments.

	Short-term (ST) Aggregate

Adults	chronic dietary (indirect)

handling cleaning products (wipe + trigger pump spray)

Children	chronic dietary – (indirect)

post-application to cleaning product on carpets (dermal and oral) from the ADBAC RED

The chronic dietary exposures were used in both the short and intermediate-term aggregate assessment because chronic dietary exposures occur nearly every day (as opposed to acute dietary exposures occurring on a one-time basis).  Therefore, short or intermediate-term non-dietary exposures have a high probability to co-occur with the chronic dietary intake.

	Since the ADBAC toxicity endpoints for the oral, dermal, and inhalation routes of exposure are based on different toxic effects, these three routes of exposure are not aggregated together.  Instead, the aggregate assessment is based solely on the co-occurrence of the same route of exposures.  Aggregate risks were calculated using the total MOE approach outlined in OPP guidance for aggregate risk assessment (August 1, 1999, Updated “Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments”).  The aggregate MOE for adults is 2,000 for oral, 480 for dermal with a target MOE of 10, and 2,000 for inhalation with a target MOE of 100.  These aggregate MOEs demonstrate risks that are not of concern for adults.  For children, the aggregate risk estimate for each of the routes of exposure are above the target MOE of 100 for oral and inhalation, and a target MOE of 10 for dermal (MOE=454 for the oral route, 1,200 for the dermal route, and no co-occurrence for the inhalation route); and thus, are not of concern.

Table 16.  Short and Intermediate-term Aggregate Risk (MOE) Assessment

Exposure Routes	Chronic Dietary

MOE	Cleaning Product MOEs(Adult Applicators & Children Playing) Route-Specific Aggregate MOE

Adults

Oral Ingestion	1,200	NA	1,200

Dermal

	NA	1,600 (mop)	580 (wipe)	6,100 (spray)	480

Inhalation	NA	27,000

(mop)	7,300 (wipe)	200,000 (spray)	2,000

Children

Oral Ingestion	240	 330	140

Dermal

(ST only)	NA	1,200	1,200

Inhalation	NA	NA	NA

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

6. Cumulative Exposure and Risk

		Another standard of section 408 of the FFDCA which must be considered in making an unreasonable adverse effect determination is that the Agency considers "available information” concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity.”

		Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ADBAC and any other substances and ADBAC does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, EPA has not assumed that ADBAC has a common mechanism of toxicity with other substances.  For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at   HYPERLINK "http://www.epa.gov/pesticides/cumulative/"  http://www.epa.gov/pesticides/cumulative/ .

7. Occupational Exposure Assessment tc \l1 "6.0	OCCUPATIONAL EXPOSURE AND RISK

	Potential occupational handler exposure can occur in food handling premises, dairy processing premises, and in food processing premises.

7.1. Occupational Handler Exposures

ADBAC dermal irritation exposures and risks were not estimated for occupational handler exposures.  Instead, dermal irritation exposures and risks will be mitigated using default personal protective equipment requirements based on the toxicity of the end-use product.  To minimize dermal  exposures, the minimum PPE required for those exposed to end-use products containing concentrations of ADBAC that result in classification of category I, II, or III for skin irritation potential will be long-sleeve shirt, long pants, shoes, socks,  chemical-resistant gloves, and chemical-resistant apron.  Once diluted, if the concentration of ADBAC in the diluted solution would result in classification of toxicity category IV for skin irritation potential, then the chemical-resistant gloves and chemical-resistant apron can be eliminated for applicators and others exposed to the dilute. Note that chemical-resistant eyewear will be required if the end-use product is classified as category I or II for eye irritation potential.

	Inhalation exposures and risks were presented based on the oral toxicity endpoint (i.e., route-specific inhalation study not available).  The surrogate unit exposure values were taken from the proprietary Chemical Manufacturers Association (CMA) antimicrobial exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database (USEPA, 1998).   The specific inhalation unit exposures and quantity of ADBAC handled are provided in the Occupational and Residential Exposure chapter for ADBAC.

The inhalation MOEs were calculated for the short and intermediate-term durations for occupational handlers using the oral endpoint.

 Risk Characterization for Antimicroibal Uses

	The resulting inhalation exposures and MOEs for the representative occupational handler scenarios are presented in Table 17. The calculated MOEs were above the target MOE of 100 for all scenarios, except those listed below.

Table 17. Short , Intermediate, and Long-term Inhalation Risks Associated with Occupational Handlers

Exposure Scenario

Method of Application

Inhalation Unit Exposure

(mg/lb a.i.) 	Application Rate a	Quantity Handled/ Treated per day Inhalation  Daily Dose (mg/kg/day) b	Inhalation

MOEc,d

(Target MOE = 100)

  SEQ CHAPTER \h \r 1 Food Handling/Storage Establishments Premises And Equipment	 (Use Site Category II)

Application to indoor hard surfaces (including dishes, utensils, equipment)	Low pressure hand wand	0.681	0.0033 lb ai/gal	2 gallons 0.00007	40,000

	Mop	2.38	0.0033 lb ai/gal	2 gallons	0.0003	11,000

	Wipe	67.3	0.0033 lb ai/gal	0.26 gallons	0.0010	3,100

	Trigger pump sprayer	1.3	0.0033 lb ai/gal	0.26 gallons	0.00002	160,000

	Immersion, Flooding, Circulation	1.89	0.0033 lb ai/gal	2 gallons	0.0002 14,000

	ST = short-term,  IT = intermediate-term, LT = long-term, N/A= No data available

a	Application rate used is the proposed application rate of 400 ppm of ADBAC.

b	Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x absorption factor (1.0 for inhalation) x application rate x quantity treated / Body weight (60 kg for inhalation).

	c	MOE = NOAEL  (mg/kg/day) / Absorbed Daily Dose [Where NOAEL = 3 mg/kg/day for all inhalation exposure durations].  Target MOE = 100.

	d	The MOEs refer to short-term and intermediate-term duration unless indicated otherwise.

7.2. Occupational Post-application Exposures

	The occupational post-application dermal and inhalation exposures are assumed to be negligible for the use sites listed under 40 CFR § 180.940 (a).  The use sites covered under 40 CFR § 180.940 (a) are:  food-contact surfaces in public eating places, dairy processing equipment, and food-processing equipment and utensils.

8.  Conclusions

In conclusion, the above represents RASSB’s evaluation of the proposed petition for the increased application rate and tolerance exemption from 200 ppm to 400 ppm for ADBAC.  There appear to be no dietary, residential, or occupational risks of concern resulting from an increase in the tolerance exemption or from an increase in the end use solution concentration permitted for the quaternary sanitizer, ADBAC, to food-contact surfaces in public eating places, dairy processing equipment, and food-processing equipment and utensils.

	If there are questions on the above, please contact RASSB.

Appendix A

IDREAM Inputs and Results:

IDREAM Tier 2 - Incidental Ingestion Exposure

Subject active ingredient	400 ppm ADBAC

	Product residue	1	mg/cm²

In-use active conc (%)	0.040%

	Active surface residue	0.0004	mg/cm²

CHRONIC ASSESSMENT

Subpopulation	Tier 2 Chronic Exposure (mg/kg/d)	%cPAD

Children 1-2	0.00189	0.429

Children 3-5	0.00150	0.341

Adults 13+	0.00059	0.134

Females 13-49	0.00055	0.125

TIER 2 MODEL - Children aged 1-2

Active ingredient:	400 ppm ADBAC

	modified to match the first section of the children 1-2 years old and includes the quat residue data for the % residue transfer, as well as 100% likelihood

CHRONIC EXPOSURE ASSESSMENT

Food Category	Contact Surface Area	Weight of Serving/ Piece	Likelihood of Contact	Residue Transfer Efficiency	Residue Translation Factor	Quat Surface Residue	Residue in Food	Mean Food Consumption Rate	Ingestion Exposure

	(cm²)	(g)	(%)	(%)	(cm²/g)	(mg/cm²)	(mg/g)	(g/kg bw)	(mg/kg/d)

Liquid	250	240	0%	100%	0	0.0004	0	70.80	0

Solid

Fruit	28	97	100%	39%	0.11	0.0004	0.000045	6.30	0.00028

Bread	94	56	100%	0.86%	0.01	0.0004	0.000006	8.77	0.00005

Cheese	65	49	100%	47%	0.62	0.0004	0.000249	1.05	0.00026

Vegetable	34	99	100%	39%	0.13	0.0004	0.000054	6.39	0.00034

Meat	103	138	100%	47%	0.35	0.0004	0.000140	5.11	0.00072

Purees	46	107	100%	39%	0.17	0.0004	0.000067	3.17	0.00021

Pieces	0.8	1.2	100%	0.86%	0.01	0.0004	0.000002	1.27	0.00000

Powders	123	30	100%	0.86%	0.04	0.0004	0.000014	1.32	0.00002

	 	Total Ingestion Exposure:	0.00189

TIER 2 MODEL - Children aged 3-5

Active ingredient:	400 ppm ADBAC

	modified to match the first section of the children 3-5 years old and includes the quat residue data for the % residue transfer, as well as 100% likelihood

CHRONIC EXPOSURE ASSESSMENT

Food Category	Contact Surface Area	Weight of Serving/ Piece	Likelihood of Contact	Residue Transfer Efficiency	Residue Translation Factor	Quat Surface Residue	Residue in Food	Mean Food Consumption Rate	Ingestion Exposure

	(cm²)	(g)	(%)	(%)	(cm²/g)	(mg/cm²)	(mg/g)	(g/kg bw)	(mg/kg/d)

Liquid	250	240	0%	100%	0	0.0004	 	50.07	0

Solid

Fruit	28	97	100%	39%	0.113	0.0004	0.000045	3.59	0.00016

Bread	94	56	100%	0.86%	0.014	0.0004	0.000006	4.17	0.00002

Cheese	65	49	100%	47%	0.623	0.0004	0.000249	0.89	0.00022

Vegetable	34	99	100%	39%	0.134	0.0004	0.000054	2.80	0.00015

Meat	103	138	100%	47%	0.351	0.0004	0.000140	4.88	0.00068

Purees	46	107	100%	39%	0.168	0.0004	0.000067	3.19	0.00021

Pieces	0.8	1.2	100%	0.86%	0.006	0.0004	0.000002	9.22	0.00002

Powders	123	30	100%	0.86%	0.035	0.0004	0.000014	1.65	0.00002

 	 	 	 	 	 	Total Ingestion Exposure:	0.00150

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Purees	46	107	100%	39%	0.168	0.0004	0.000067	0.83	0.00006

Pieces	0.8	1.2	100%	0.86%	0.006	0.0004	0.000002	2.72	0.00001

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 	 	 	 	 	 	Total Ingestion Exposure:	0.00059

TIER 2 MODEL – Females aged 13-49

Active ingredient:	400 ppm ADBAC

	modified to match the first section of the females 13-49 years old and includes the quat residue data for the % residue transfer, as well as 100% likelihood

CHRONIC EXPOSURE ASSESSMENT

Food Category	Contact Surface Area	Weight of Serving/ Piece	Likelihood of Contact	Residue Transfer Efficiency	Residue Translation Factor	Quat Surface Residue	Residue in Food	Mean Food Consumption Rate	Ingestion Exposure

	(cm²)	(g)	(%)	(%)	(cm²/g)	(mg/cm²)	(mg/g)	(g/kg bw)	(mg/kg/d)

Liquid	250	240	0%	100%	0	0.0004	0	19.94	0

Solid

Fruit	28	97	100%	39%	0.113	0.0004	0.000045	0.89	0.00004

Bread	94	56	100%	0.86%	0.014	0.0004	0.000006	1.30	0.00001

Cheese	65	49	100%	47%	0.623	0.0004	0.000249	0.30	0.00007

Vegetable	34	99	100%	39%	0.134	0.0004	0.000054	1.72	0.00009

Meat	103	138	100%	47%	0.351	0.0004	0.000140	1.87	0.00026

Purees	46	107	100%	39%	0.168	0.0004	0.000067	0.84	0.00006

Pieces	0.8	1.2	100%	0.86%	0.006	0.0004	0.000002	2.78	0.00001

Powders	123	30	100%	0.86%	0.035	0.0004	0.000014	0.64	0.00001

 	 	 	 	 	 	Total Ingestion Exposure:	0.00055

  Note:  for a full discussion of toxicology, exposure, etc. the reader should consult with the RED science chapters available in the Public Docket for ADBAC under EPA-HQ-OPP-2006-0339.

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