Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 1 of 8 **UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION** 

### MEMORANDUM **Date :**  March 21 , 201 3 **SUBJECT: Naphthalene Acetates**  **-** Chronic Dietary and Drinking Water Exposure and Risk Assessment for Section 3 New Use of Naphthalene Acetic Acid - ester on Avocado, Mango, Mamey Sapote, Rambuttan, and the Expansion to Pome Fruit Crop Subgroup 11 - 10.

. **PC Code:** 056003 (NAA potassium sa lt) **DP Barcode:** D 404399 **Decision No.:** 461439 **Registration No.:** 87320 - E **Petition No.:** 2F7991 **Regulatory Action:** Section 3 **Risk Assessment Type:** Dietary **Case No.:** 0379 **TXR No.:** NA **CAS No.:** 2122 - 70 - 5 **MRID No.:** NA **40 CFR:** §180.155 (a) & (b) 

### FROM: Thurston G. Morton, Chemist

Risk Assessment Branch IV Health Effects Division (7509P) **THROUGH:** Dennis McNeill y, Chemist

Meheret Negussie , Chemist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division (7509P) **TO:** Tony

Kish, Chemical Review Manager Fungicide Branch Registration Division (7505P) This document provides chronic dietary (food and drinking water) risk analy ses of exposures resulting from use of naphthalene acetates as plant activators on food crops.Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 2 of 8 **Executive Summary** C hronic dietary

risk assessment w as conducted for naphthalene acetates using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM - FCID, Version 3.16, which incorporates consumption data from USDA’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The anal ys i s w as performed to support a Section 3 request for use of naphthalene acetates (NAA) on avocado, mango, and mamey sapote and the expansion of the Crop Subgroup 11 - 10 . Acute Dietary

Exposure Results and Characterization There were no toxicological effects attributable to a single exposure (dose) of NAA observed in oral toxicity

studies in cluding the developmental toxicity studies in rats or rabbits. Therefore, a dose and an endpoint for acute dietary exposure w ere not identified for NAA and a quantitative acute dietary

exposure assessment was not conducted . Chronic Dietary

Exposure Result s and Characterization A conservative chronic dietary and drinking water exposure anal ys is was performed for the general U.S. population and various population subgroups. Tolerance level residues and 100 percent crop treated assumptions were used. DEEM default processing factors were used to modify the tolerance values. The chronic anal ys is incorporated the 10 ye ar average surface drinking water estimate from application of naphthalene acetates to olives . The chronic dietary exposure estimate for the h ighest exposed population subgroup, children 1 - 2 years of age, is 0.003 mg/kg/day

or 2% of the cPAD . The chronic dietary exposure estimate for the general population is 0.0005 mg/kg/day or <1% of the cPAD. **I. Introduction**  Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effec ts). This dose is referred to as the PAD. The PAD is equivalent to point of departure (POD, NOAEL, LOAE L, e.g.) divided by the required uncertainty or safet y factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary ri sk exceeds 100% of the PAD. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 21 - JUN - 2000, web link: http://www.epa.gov/fedrgstr/EPA - PEST/2000/July /Day - 12/6061.pdf ; or see SOP 99.6 (20 - AUG - 1999). The most recent dietary

risk assessment for NAA was conducted by B. Daiss **(** DP 397389, 1/31/12).Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 3 of 8 **II. Residue Information**  1 - Naphthaleneacetic acid (NAA), its salts, ester, and acetamide are plant growth regulators which are collectivel y referred to as naphthalene acetates. They are currently

registered for use on various orchard and fruit crops including apple, cherry , olive, orange, pear, tangelo, and tangerine. Naphthalene acetates are used to prevent preharvest drop of fruits, thin fruit trees, and delay flower induction. Tolerances for residues of naphthalene acetates in/on foo d and feed commodities are currently established under 40 CFR § 180.155, and are expressed in terms of 1 - naphthaleneacetic acid, [ ethyl ester of 1 - naphthaleneacetic acid, and naphthaleneacetamide ] . The petitioner has requested Section 3 for use of naphthalene acetates on avocado, mango, and mamey sapote and the expansion of the Crop Subgroup 11 - 10. Residues used in the acute and chronic dietary

anal ys es are provided in Table 1. **Table 1. Tolerance Values Used in Naphthalene Ace tates Dietary Exposure Analyses**  **RAC Tolerance (ppm)**  Pome Fruit Subgroup 11 - 10 0.15 Cherry, sweet 0.1 Olive 0. 7 Oranges 0.1 Pineapple 0.05 Tangerine 0.1 Avocado 0.05 Potato Seed Piece 0.01 **Proposed New Use Recommended Tolerance**  Avocado 0.05 Mango 0.05 Mamey Sapote 0.05 Rambuttan 2.0 

### III. **Drinking Water Data**  The Tier I Estimated Drinking Water Concentrations (EDWCs) for use in the human health risk assessment for 1 - naphthaleneacetic acid were calculated using FIRST (surface water) and SCI GROW (ground water) drinking water models (D293886, J.L . Melendez, 9/25/03). These values generall y represent upper - bound estimates of the concentrations of 1 - naphthaleneacetic acid equivalents that might be found in surface and ground water due to the use of 1 - naphthalenacetic acid on olives, which represents the highest use rate scenario. Both models provide estimates suitable for screening purposes. Modeled EDWCs are presented in Table 2.Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 4 of 8 **Table 2. Tier I Estimated Drinking Water Concentrations of 1**  **- Naphthaleneacetic acid**  **1 Chemical**  **Acute (peak) Surface Water**

**Concentration (ppb) Annual Average Surface**  **Water Concentration (ppb) Ground Water**  **Concentration (ppb)** NAA 22.3 2.99 0.0226 

### IV. **DEEM -**  **FCIDTM Program and Consumption Information** Naphthalene acetates chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM - FCID, Version 3.16, which incorporates consumption data from USDA’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The data are based on the reported consumption of more than 20,000 individuals over two non - consecutive survey day s. Foods “as co nsumed” (e.g., apple pie) are linked to EPA - defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicl y available recipe translation files developed jointly

by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events. Based on anal ys is of the 2003 - 2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 ye ar old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, adults 20 - 49, females 13 - 49, and adults 50 - 99 ye ars old. For chronic dietary

exposure assessment, an estimate of the residue level in each food or food form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average dail y consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food fo rms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup. **V. Toxicological Information**  HED evaluated the toxicology data base for naphthalene acetates and selected the following doses and endpoints for acute and chronic dietary and drinking water risk assessments.Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 5 of 8 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose - response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no ob served adverse effect level. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 

### VI. **Results/Discussion** As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM - FCIDTM anal ys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 4 are for the general U.S. Population, all infants (<1 year old), children 1 - 2, children 3 - 5, children 6 - 12, youth 13 - 19, females 13 - 49, adults 20 - 49, and adults 50 - 99 years. **Table 3. Summary of Toxicological Doses and Endpoints for Naphthalene acetates for Use in Dietary and Non**  **** **Occupational Hum an Health Risk Assessments**  **Exposure Scenario**  **Point of Departure Uncertainty/**  **FQPA Safety Factors**  **RfD, PAD,**

**LOC for Risk Assessment**  **Study and Toxicological Effects** Ac ute Dietary (General Population) An acute RfD for the general population or any population subgroups was not selected because no

effect attributable to a single (or few) day (s) oral exposure was observed in animal studies. Chronic Dietary (All Populations) NOAEL = 15

mg/kg/day UF A= 10x

UF H =10x FQPA SF= 1x Chronic RfD =

0.15 mg/kg/day cPAD = 0.15 mg/kg/day Chronic Toxicity - Dog

LOAEL = 75 mg/kg/day based on emesis, corpuscular regurgitation incidences, gross and histopathological changes in stomachs and sinusiodal histiocytosis in liv ers in males Cancer (all routes) Not a Human CarcinogenNaphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 6 of 8 Results of Chronic Dietary Exposure Analy sis **Table 4**  **. Summary of Chronic Dietary Exposure and Risk for NAA Population Subgroup**  **cPAD (m**  **g/kg/day) Chronic**  **Exposure (mg/kg/day) % cPAD**  General U.S. Population 0.15 0.0005 13 <1 All Infants (< 1 year old) 0.001 487 1 .0 Children 1 - 2 years old 0.00 2945 2 .0 Children 3 - 5 years old 0.001 868 1 .2 Children 6 - 12 years old 0.000 774 <1 Youth 13 - 19 years old 0.000 383 <1 Adults 20 - 49 years old 0.0003 0 5 <1 Adults 50 - 99 years old 0.0003 03 <1 Females 13 - 49 years old 0.0003 17 <1 

### VI. **Characterization of Inputs/Outputs** The chronic dietary

analy s i s is conservative. Tolerance level residues used in the anal ys is are expected to exceed the residues actuall y consumed. In addition, the 100% crop treated estimate used for all crops in the assessment will considerably overestimate the actual percent crop tr eated. **VII. Conclusions**  Based on screening level anal ys es of estimated dietary risks for the general U.S. population and various population subgroups, the chronic dietary exposure estimates for naphthalene acetates are significantl y below HED’s level o f concern for all supported commodities. The chronic dietary exposure estimate for the highest exposed population subgroup, children 1 - 2 years of age, is 0.003 mg/kg/day

or 2% of the cPAD . **VIII. List of Attachments**  1. Chronic DEEM - FCID Residue Input File. 2. Results of Chronic DEEM - FCID Dietary Exposure Anal ys is.Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 7 of 8 Attachment 1 Chronic DEEM - FCID Residue Input File Filename: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 056003 NAA \ 2E7991 \ 056003 Chronic 2F7991.R08 Chemical: NAA RfD( Chronic): .15 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 10 - 24 - 2012/10:08:49 Program ver. 3.16, 03 - 08 - d

------------------------------------------------------------ ----------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ----- - ------- 0103296000 1C Potato, chips 0.010000 1.000 1.000 0103297000 1C Potato, dry (granules/ flakes) 0.010000 6.500 1.000 0103297001 1C Potato, dry (granules/ flakes) - b 0.010000 6.500 1.000 0103298000 1C Potato, flour 0.010000 1.000 1.000 0103298001 1C Potato, flour - babyfood 0.010000 1.000 1.000 0103299000 1C Potato, tuber, w/peel 0.010000 1.000 1.000 0103299001 1C Potato, t uber, w/peel - babyfood 0.010000 1.000 1.000 0103300000 1C Potato, tuber, w/o peel 0.010000 1.000 1.000 0103300001 1C Potato, tuber, w/o peel - babyfood 0.010000 1.000 1.000 1001240000 10A Orange 0.100000 1.000 1.000 1001241000 10A Orange, juice 0.100000 1.800 1.000 1001241001 10A Orange, juice - babyfood 0.100000 1.800 1.000 1001242000 10A Orange, peel 0.100000 1.000 1.000 1001369000 10A Tangerine 0.100000 1.000 1.000 1001370000 10A Tangerine, juice 0.100000 2.300 1.000 1100007000 11 Apple, fruit with peel 0.150000 1.000 1.000 1100008000 11 Apple, peeled fruit 0.150000 1.000 1.000 1100008001 11 Apple, peeled fruit - babyfood 0.150000 1.000 1.000 1100009000 11 Apple, dried 0.150000 8.000 1.000 1100009001 11 Apple, dried - babyfood 0.150000 8.000 1.000 1100010000 11 Apple, juice 0.150000 1.300 1.000 1100010001 11 Apple, juice - babyfood 0.150000 1.300 1.000 1100011000 11 Apple, sauce 0.150000 1.000 1.00 0 1100011001 11 Apple, sauce - babyfood 0.150000 1.000 1.000 1100129000 11 Crabapple 0.150000 1.000 1.000 1100173500 11 Goji berry 0.150000 1.000 1.000 1100210000 11 Loqua t 0.150000 1.000 1.000 1100266000 11 Pear 0.150000 1.000 1.000 1100266001 11 Pear - babyfood 0.150000 1.000 1.000 1100267000 11 Pear, dried 0.150000 6.250 1.000 1100268000 11 Pear, juice 0.150000 1.000 1.000 1100268001 11 Pear, juice - babyfood 0.150000 1.000 1.000 1100310000 11 Quince 0.150000 1.000 1.000 1201090000 12A Cherry 0.100000 1.000 1.000 1201090001 12A Cherry - babyfood 0.100000 1.000 1.000 1201091000 12A Cherry, juice 0.100000 1.500 1.000 1201091001 12A C herry, juice - babyfood 0.100000 1.500 1.000 8601000000 86A Water, direct, all sources 0.003000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.003000 1.000 1.000 9500020000 O Avocado 0.050000 1.000 1.000 9500215000 O Mango 0.050000 1.000 1.000 9500215001 O Mango - babyfood 0.050000 1.000 1.000 9500216000 O Mango, dried 0.050000 1.000 1.000 9500217000 O Mango, juice 0.050000 1.000 1.000 9500217001 O Mango, juice - babyfood 0.050000 1.000 1.000 9500235000 O Olive 0.700000 1.000 1.000 9500236000 O Olive, oil 0.700000 1.000 1.000 9500279000 O Pineapple 0.050000 1.000 1.000 9500279001 O Pineapple - babyfood 0.050000 1.000 1.000 9500280000 O Pineapple, dried 0.050000 5.000 1.000 9500281000 O Pineapple, juice 0.050000 1.700 1.000 9500281001 O Pineapple, juice - babyfood 0.050000 1.700 1.000 9500333000 O Sapote, Mamey 0.050000 1.0 00 1.000Naphthalene acetates Dietary Exposure and Risk Assessment DP #: 404399



### Page 8 of 8 Attachment 2 Results of Chronic DEEM - FCID Dietary Exposure Anal ys is U.S. EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for NAA NHANES 2003 - 2008 2 - day Residue file name: C: \ Documents and Settings \ tmorton \ My Documents \ MyFiles \ DEEM Files \ 056003 NAA \ 2E7991 \ 056003 Chronic 2F7991.R08 Adjustment factor #2 NOT used. Analysis Date 10 - 24 - 2012/10:24:55 Residue file date d: 10 - 24 - 2012/10:12:06 Reference dose (RfD, Chronic) = .15 mg/kg bw/day

=============================================================================== Total exposure by population subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.000513 0.3% Hispanic 0.000735 0.5% Non - Hisp - White 0.000448 0.3% Non - Hisp - Black 0.000597 0.4% Non - Hisp - Other 0.000600 0.4% Nursing Infants 0.000880 0.6% Non - Nursing Infants 0.001757 1.2% Female 13+ PREG 0.000 544 0.4% Children 1 - 6 0.002154 1.4% Children 7 - 12 0.000682 0.5% Male 13 - 19 0.000396 0.3% Female 13 - 19/NP 0.000369 0.2% Male 20+ 0.000299 0.2% Female 20+/NP 0.000302 0.2% Seniors 55+ 0.000304 0.2% All Infants 0.001487 1.0% Female 13 - 50 0.000320 0.2% Children 1 - 2 0.002945 2.0% Chi ldren 3 - 5 0.001868 1.2% Children 6 - 12 0.000774 0.5% Youth 13 - 19 0.000383 0.3% Adults 20 - 49 0.000305 0.2% Adults 50 - 99 0.000303 0.2% Female 13 - 49 0.000317 0.2%

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