UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

                                                                                AND POLLUTION PREVENTION

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  Aug 27, 2013

SUBJECT:  Mandipropamid:  Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Fresh Basil, Dried Basil, Ginseng, Fruiting Vegetable (Crop Group 8-10); Small Fruit, Vine Climbing (Crop Subgroup 13-07F), except Fuzzy Kiwifruit; Snap Bean, Bulb Onion (Crop Subgroup 3-07A), and Green Onion (Crop Subgroup 3-07B).

PC Code:  036602	DP Number:  412238

Decision No.:  472747	Registration No.:   100-1254

Petition No.:  2E8126	Regulatory Action:  Section 3

Risk Assessment Type:  Dietary 	Case No.:   7058

TXR No.:  None	CAS No.:  374726-62-2

MRID No.:   None	40 CFR:  §180.637

FROM:  	Dennis McNeilly, Chemist

	Registration Action Branch 2

	Health Effects Division (7509P)  SEQ CHAPTER \h \r 1

THROUGH:	Sheila Piper, Chemist

		Jennifer Tyler, Chemist

Michael Doherty, Ph.D., Senior Scientist

	Registration Action Branch 2

Health Effects Division (7509P)  SEQ CHATER \h \r 1

TO:		Laura Nollen/Barbara Madden, RM 05

Risk Integration, Minor Use, Emergency Response Branch

		Registration Division (7505P)

Executive Summary

A chronic dietary [food and drinking water] exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16.  This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  The analysis was performed to evaluate a Section 3 request for the establishment of tolerances for residues of mandipropamid in/on fresh basil, dried basil, ginseng, fruiting vegetable (crop group 8-10); small fruit, vine climbing (crop subgroup 13-07F), except fuzzy kiwifruit; snap bean, bulb onion (crop subgroup 3-07A), and green onion (crop subgroup 3-07B).  This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

No acute dietary toxicity endpoint could be identified based on the toxicology data currently available for mandipropamid; therefore, no acute dietary exposure assessment for mandipropamid was conducted.  The Cancer Assessment Review Committee (CARC) classified mandipropamid as “Not likely to be a human carcinogen;” therefore a cancer assessment was not performed.

Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization

A chronic dietary exposure assessment was performed for mandipropamid.  The assumptions underlying this unrefined assessment were 100% crop treated (CT), HED-recommended tolerance levels or tolerance level residues (with the exception of vegetable, tuberous and corm, crop subgroup 1C (which includes the SYN 500003 metabolite)), and default DEEM-FCID( (ver. 7.81) processing factors (with the exception of chemical-specific empirical processing factors (PF) described in Table 1).  The mean (i.e., relevant to chronic exposure) drinking water estimate of 79 ppb was provided by the Environmental Fate and Effects Division (EFED) and directly incorporated into the chronic assessment.  The estimated drinking water concentration (EDWC) of 79 µg/L reflects ground water exposure, and was used for chronic exposure.

For the general U.S. population, the exposure from food and drinking water utilizes 27% of the chronic population adjusted dose (cPAD).  The chronic dietary risk estimate for the most highly exposed population subgroup, children 1-2 years old, is 46% of the cPAD.  The chronic dietary risk assessment shows that for all included commodities, the chronic dietary risk estimates are below the Agency’s level of concern (i.e. <100% 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 effects).  This dose is referred to as the population-adjusted dose (PAD).  The PAD is equivalent to the point of departure (e.g., NOAEL, LOAEL) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides website:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (8/20/1999).

The most recent dietary risk assessment for mandipropamid was conducted (D376967, R. Chesser, 27-APR-2010) for a Section 18 Emergency Exemption request for use on fresh and dried basil.

II.	Residue Information

Tolerances:  Permanent tolerances for residues of mandipropamid are listed in 40 CFR §180.637 and are expressed in terms of mandipropamid [4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]- α-(2-propynyloxy)-benzeneacetamide] in/on a variety of raw agricultural commodities (RACs), ranging from 0.01 ppm to 50 ppm.

Residue Data used for the Chronic Dietary Assessment:

Residues of Concern (residues included in dietary exposure analysis):  Tolerances are for the parent only, but for exposure/risk assessment purposes the metabolite SYN 500003 has been included for the vegetable, tuberous and corm, subgroup 1C (Residue chemistry memoranda D333121 & D328534; D. McNeilly; 28-Aug-2007).  For drinking water, the parent plus the metabolites SYN 500003 and SYN 504851 are included in the exposure/risk assessment.

Current Tolerances:  The chronic dietary risk assessment was based on the assumption of tolerance-level residues for all commodities with existing tolerances except for vegetable, tuberous and corm, subgroup 1C, which was assessed at 0.026 ppm (DP Num 333121 & 328534; D. McNeilly; 28-Aug-2007), which includes the metabolites discussed for subgroup 1C.

Recommended Tolerance:  The chronic dietary risk assessment was based on the assumption of the following HED-recommended tolerance-level residues for the proposed new uses (D409363, W. Drew, Aug 27, 2013).

Commodity        	   HED-Recommended

        Tolerance  (ppm)

Basil, fresh                                     	30

Basil, dried                                   	200

Ginseng   	0.30

Bean, Snap	0.90

Vegetable, fruiting, group 8-10    	1.0

Fruit, small, vine climbing,

subgroup 13-07F, except fuzzy kiwifruit

(Note:  Grape, raisin remains at 3.0 ppm,)	2.0

Onion, bulb, subgroup 3-07A  	0.10

Onion, green, subgroup 3-07B	7.0

Percent Crop Treated:  100 % crop treated was assumed for all commodities.

Processing Factors:  The chemical-specific empirical processing factors in Table 1 have been used in this assessment.  Otherwise DEEM-FCID( (ver. 7.81) default processing factors are assumed.

Table 1.  Mandipropamid Processing Factors.

Commodity	Processing Factors  (ppm)

Grape

	       Raisin	Not used, raisin tolerance value was used

       Wine/Sherry	1.5  (empirical value)

III.   Percent Crop Treated Information

The chronic assessments are based on 100% crop treated assumptions for all commodities.

IV.   Drinking Water Data

Drinking Water Exposure Assessment for Proposed Section 3 New Uses on: Basil, Ginseng and Succulent Beans; and Expanded Uses on Bulb Vegetables, Cucurbits, Grapes, and Fruiting Vegetables including Tomatoes., D409108, R. Shamblen, 7/9/2013.

EFED conducted a Tier 1 drinking water exposure assessment for the fungicide mandipropamid.  PRZM-GW was used to estimate mandipropamid exposure in ground water. Maximum estimated drinking water concentrations (EDWCs) in ground water are 87 and 79 µg/L for acute and chronic exposures, respectively. These values are as much as 480 times higher than SCI-GROW model results. Maximum acute and chronic EDWCs in surface waters are 79 and 9.0 µg/L, respectively.

Previous exposure assessments evaluated maximum single application rates of 0.13 lbs a.i./A, four times per season.  The registrant seeks to increase the total annual application rate to 2.08 lbs a.i./A for tomato and basil by allowing for up to four crop production seasons per year.  This proposed multi-season total annual application rate exceeds those assessed in previous d楲歮湩慷整⁲硥潰畳敲愠獳獥浳湥獴ഠ名扡敬㈠ 楔牥ㄠ䔠瑳浩瑡摥䐠楲歮湩慗整⁲潃据湥牴瑡潩獮 ⠠䑅䍗
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(μg/L)	Chronic (μg/L)

Surface Water (FIRST, 1.1.1)	91	Tomato & Basil

(2.08 lbs a.i./A)	79	9.0

Ground Water (PRZM-GW, 1.01)	N/A	Tomato & Basil

(2.08 lbs a.i./A)	87	79

Ground Water (SCI-GROW, 2.3)	N/A	Tomato & Basil

(2.08 lbs a.i./A)	0.18

Abbreviations: A= acre; a.i. = active ingredient; μg = micrograms; lbs = pounds (US); N/A = not applicable

The Total Residue (TR) modeling approach (USEPA, 2013) was used to estimate aerobic aquatic half-lives, and estimate drinking water concentrations in surface waters. Previous drinking water assessments calculated separate half-lives for the parent compound and two degradates of concern, for which exposure was estimated with separate model runs. Simple addition of the exposure estimates for mandipropamid and it’s degradates of concern was used to generate estimated drinking water concentrations. Previous authors acknowledge this approach is conservative because the exposure estimates may not be temporally coincident. The TR method, however, tallies the parent compound and it’s degradates of concern prior to calculating a Total Residue half-life using PestDF.

The PRZM-GW chronic ground water value was higher than the surface water value.  As a result, the ground water value was incorporated directly into these dietary assessments under the DEEM-FCID food categories “water, all sources” and “water, indirect, all sources.”  The FIRST model and its description are available at the EPA internet site:  HYPERLINK "http://www.epa.gov/oppefed1/models/water/" http://www.epa.gov/oppefed1/models/water/ .

V.	DEEM-FCID™ Program and Consumption Information

The mandipropamid 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 2003-2008 consumption data from USDA’s NHANES/WWEIA.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (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 publicly 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.  Based on analysis 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 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For a 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 daily 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 forms 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.

VI.	Toxicological Information

HED evaluated the toxicology data base of mandipropamid and selected a dose and endpoint for chronic dietary risk assessment based on evidence of liver toxicity.  No acute dietary exposure assessment for mandipropamid has been conducted because no appropriate endpoint attributable to a single dose was identified.  There were no treatment-related tumors observed in carcinogenicity studies in rats and mice and mandipropamid is classified as “Not likely to be a human carcinogen.”  Therefore, cancer risk is not a concern for this chemical.  Doses and toxicological endpoints selected for the chronic dietary exposure scenario are summarized in Table 3.

Table 3.  Summary of Toxicological Doses and Endpoints for Use in Dietary Human Health Risk Assessments for Mandipropamid

Exposure

Scenario	Dose Used in Risk Assessment, UF

POD	FQPA SF and Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary (All populations, including infants and children)	None

	None	Not selected.

No appropriate dose and endpoint could be identified for any population group.

Chronic Dietary

(All populations)	NOAEL= 5 mg/kg/day

UFA= 10x

UFH= 10x

Chronic RfD = 0.05 mg/kg/day	FQPA SF =1

cPAD = chronic RfD

                FQPA SF

= 0.05 mg/kg/day	Chronic toxicity – dogs

LOAEL = 40 mg/kg/day, based on  evidence of liver toxicity (increased incidence and severity of microscopic pigment in the liver and increased alkaline phosphatase activity in both sexes as well as increased alanine aminotransferase activity in males).

Cancer (oral, dermal, inhalation)	There were no treatment-related tumors observed in carcinogenicity studies in rats and mice. Classified as “Not likely to be a human carcinogen.”

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 observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = 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.

VII.	Results/Discussion

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analysis estimates the dietary exposure of the general U.S. population and various population subgroups.  Table 4 lists the results of the chronic dietary exposure analyses 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 old.

Results of Chronic Dietary Exposure Analysis

In the chronic dietary exposure analysis, the most highly exposed population subgroup is children 1-2 years old which utilizes 47% of the cPAD (Table 4).  The general U.S. population utilizes 27% of the cPAD.

Table 4.  Summary of Dietary Exposure and Risk for Mandipropamid (Food and Drinking Water)

Population Subgroup	Acute Dietary	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	N/A	N/A	0.013475	27	N/A	N/A

All Infants (< 1 year old)

	0.011653	23

Children 1-2 years old

	0.022893	46

Children 3-5 years old

	0.020342	41

Children 6-12 years old

	0.012364	25

Youth 13-19 years old

	0.009617	19

Adults 20-49 years old

	0.013459	27

Adults 50-99 years old

	0.013425	27

Females 13-49 years old

	0.013293	27

N/A = Not applicable.

VIII.	Characterization of Inputs/Outputs

DEEM-FCID™.  Tolerance-level residues for all commodities, except vegetable, tuberous and corm, subgroup 1C, DEEM (ver. 7.81) default processing factors (except grape, wine and sherry, 1.5X) and 100% crop treated were assumed for this assessment.  Further refinement to the analyses could be made through the use of anticipated residues, incorporation of percent crop treated information with mandipropamid, and/or monitoring data that better reflect residues at the time of consumption.  Since risk estimates are below HED’s level of concern, a more highly refined analysis is not needed at this time.

IX. Conclusions

Based on the conservative assumptions noted above, chronic dietary risk estimates for mandipropamid do not exceed HED’s level of concern for the general U.S. population, or any of the population subgroups, including those comprised of infants and children.

X.  List of Attachments:

Attachment 1:  Residue Input File for Chronic Analysis

Attachment 2:  Results of Chronic Dietary Exposure Analysis

Attachment 1:   Residue Input File for Chronic (Non-Cancer) Analysis

US EPA                                                          Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for MANDIPROPAMID

Residue file: J:\Mandy\deem\036602C.R08                    Adjust. #2 NOT used

Analysis Date 07-25-2013             Residue file dated: 07-25-2013/13:59:50

Reference dose (RfD) = 0.05 mg/kg bw/day

------------------------------------------------------------------------ ----------

 Food      Crop                                   Residue       Adj.Factors

EPA Code    Grp  Food Name                        (ppm)        #1         #2

---------- ---- -------------------------------   ---------- ------     ------

0401005000 4A   Amaranth, leafy                   20.000000   1.000      1.000

0103015000 1CD  Arrowroot, flour                   0.026000   1.000      1.000

0103015001 1CD  Arrowroot, flour-babyfood          0.026000   1.000      1.000

0103017000 1CD  Artichoke, Jerusalem               0.026000   1.000      1.000

0401018000 4A   Arugula                           20.000000   1.000      1.000

0902021000 9B   Balsam pear                        0.600000   1.000      1.000

1901028000 19A  Basil, fresh leaves               30.000000   1.000      1.000

1901028001 19A  Basil, fresh leaves-babyfood      30.000000   1.000      1.000

1901029000 19A  Basil, dried leaves              200.000000   1.000      1.000

1901029001 19A  Basil, dried leaves-babyfood     200.000000   1.000      1.000

0601043000 6A   Bean, snap, succulent              0.900000   1.000      1.000

0601043001 6A   Bean, snap, succulent-babyfood     0.900000   1.000      1.000

0501061000 5A   Broccoli                           3.000000   1.000      1.000

0501061001 5A   Broccoli-babyfood                  3.000000   1.000      1.000

0501062000 5A   Broccoli, Chinese                  3.000000   1.000      1.000

0502063000 5B   Broccoli raab                     25.000000   1.000      1.000

0501064000 5A   Brussels sprouts                   3.000000   1.000      1.000

0501069000 5A   Cabbage                            3.000000   1.000      1.000

0502070000 5B   Cabbage, Chinese, bok choy        25.000000   1.000      1.000

0501071000 5A   Cabbage, Chinese, napa             3.000000   1.000      1.000

0501072000 5A   Cabbage, Chinese, mustard          3.000000   1.000      1.000

0901075000 9A   Cantaloupe                         0.600000   1.000      1.000

0402076000 4B   Cardoon                           20.000000   1.000      1.000

0103082000 1CD  Cassava                            0.026000   1.000      1.000

0103082001 1CD  Cassava-babyfood                   0.026000   1.000      1.000

0501083000 5A   Cauliflower                        3.000000   1.000      1.000

0402085000 4B   Celery                            20.000000   1.000      1.000

0402085001 4B   Celery-babyfood                   20.000000   1.000      1.000

0402086000 4B   Celery, juice                     20.000000   1.000      1.000

0402087000 4B   Celtuce                           20.000000   1.000      1.000

0902088000 9B   Chayote, fruit                     0.600000   1.000      1.000

0902102000 9B   Chinese waxgourd                   0.600000   1.000      1.000

0302103000 3B   Chive, fresh leaves                7.000000   1.000      1.000

0401104000 4A   Chrysanthemum, garland            20.000000   1.000      1.000

0502117000 5B   Collards                          25.000000   1.000      1.000

0401133000 4A   Cress, garden                     20.000000   1.000      1.000

0401134000 4A   Cress, upland                     20.000000   1.000      1.000

0902135000 9B   Cucumber                           0.600000   1.000      1.000

0401138000 4A   Dandelion, leaves                 20.000000   1.000      1.000

0103139000 1CD  Dasheen, corm                      0.026000   1.000      1.000

0802148000 8BC  Eggplant                           1.000000   1.000      1.000

0401150000 4A   Endive                            20.000000   1.000      1.000

0402152000 4B   Fennel, Florence                  20.000000   1.000      1.000

0301165000 3A   Garlic, bulb                       0.100000   1.000      1.000

0301165001 3A   Garlic, bulb-babyfood              0.100000   1.000      1.000

0103166000 1CD  Ginger                             0.026000   1.000      1.000

0103166001 1CD  Ginger-babyfood                    0.026000   1.000      1.000

0103167000 1CD  Ginger, dried                      0.026000   1.000      1.000

0101168000 1AB  Ginseng, dried                     0.300000   1.000      1.000

1302174000 13B  Gooseberry                         2.000000   1.000      1.000

1304175000 13D  Grape                              2.000000   1.000      1.000

1304176000 13D  Grape, juice                       2.000000   1.200      1.000

1304176001 13D  Grape, juice-babyfood              2.000000   1.200      1.000

9500177000 O    Grape, leaves                      2.000000   1.000      1.000

9500178000 O    Grape, raisin                      3.000000   1.000      1.000

1304179000 13D  Grape, wine and sherry             2.000000   1.500      1.000

0901187000 9A   Honeydew melon                     0.600000   1.000      1.000

9500188000 O    Hop                               50.000000   1.000      1.000

0502194000 5B   Kale                              25.000000   1.000      1.000

0501196000 5A   Kohlrabi                           3.000000   1.000      1.000

0302198000 3B   Leek                               7.000000   1.000      1.000

0401204000 4A   Lettuce, head                     20.000000   1.000      1.000

0401205000 4A   Lettuce, leaf                     20.000000   1.000      1.000

0502229000 5B   Mustard greens                    25.000000   1.000      1.000

0802234000 8BC  Okra                               1.000000   1.000      1.000

0301237000 3A   Onion, bulb                        0.100000   1.000      1.000

0301237001 3A   Onion, bulb-babyfood               0.100000   1.000      1.000

0301238000 3A   Onion, bulb, dried                 0.100000   9.000      1.000

0301238001 3A   Onion, bulb, dried-babyfood        0.100000   9.000      1.000

0302239000 3B   Onion, green                       7.000000   1.000      1.000

0401248000 4A   Parsley, leaves                   20.000000   1.000      1.000

0802270000 8B   Pepper, bell                       1.000000   1.000      1.000

0802270001 8B   Pepper, bell-babyfood              1.000000   1.000      1.000

0802271000 8B   Pepper, bell, dried                1.000000   1.000      1.000

0802271001 8B   Pepper, bell, dried-babyfood       1.000000   1.000      1.000

0802272000 8BC  Pepper, nonbell                    1.000000   1.000      1.000

0802272001 8BC  Pepper, nonbell-babyfood           1.000000   1.000      1.000

0802273000 8BC  Pepper, nonbell, dried             1.000000   1.000      1.000

0103296000 1C   Potato, chips                      0.026000   1.000      1.000

0103297000 1C   Potato, dry (granules/ flakes)     0.026000   6.500      1.000

0103297001 1C   Potato, dry (granules/ flakes)-b   0.026000   6.500      1.000

0103298000 1C   Potato, flour                      0.026000   6.500      1.000

0103298001 1C   Potato, flour-babyfood             0.026000   6.500      1.000

0103299000 1C   Potato, tuber, w/peel              0.026000   1.000      1.000

0103299001 1C   Potato, tuber, w/peel-babyfood     0.026000   1.000      1.000

0103300000 1C   Potato, tuber, w/o peel            0.026000   1.000      1.000

0103300001 1C   Potato, tuber, w/o peel-babyfood   0.026000   1.000      1.000

0902308000 9B   Pumpkin                            0.600000   1.000      1.000

0902309000 9B   Pumpkin, seed                      0.600000   1.000      1.000

0401313000 4A   Radicchio                         20.000000   1.000      1.000

0502318000 5B   Rape greens                       25.000000   1.000      1.000

0402322000 4B   Rhubarb                           20.000000   1.000      1.000

0302338500 3B   Shallot, fresh leaves              7.000000   1.000      1.000

0401355000 4A   Spinach                           20.000000   1.000      1.000

0401355001 4A   Spinach-babyfood                  20.000000   1.000      1.000

0902356000 9B   Squash, summer                     0.600000   1.000      1.000

0902356001 9B   Squash, summer-babyfood            0.600000   1.000      1.000

0902357000 9B   Squash, winter                     0.600000   1.000      1.000

0902357001 9B   Squash, winter-babyfood            0.600000   1.000      1.000

0103366000 1CD  Sweet potato                       0.026000   1.000      1.000

0103366001 1CD  Sweet potato-babyfood              0.026000   1.000      1.000

0402367000 4B   Swiss chard                       20.000000   1.000      1.000

0103371000 1CD  Tanier, corm                       0.026000   1.000      1.000

0801374000 8A   Tomatillo                          1.000000   1.000      1.000

0801375000 8A   Tomato                             1.000000   1.000      1.000

0801375001 8A   Tomato-babyfood                    1.000000   1.000      1.000

0801376000 8A   Tomato, paste                      1.000000   5.400      1.000

0801376001 8A   Tomato, paste-babyfood             1.000000   5.400      1.000

0801377000 8A   Tomato, puree                      1.000000   3.300      1.000

0801377001 8A   Tomato, puree-babyfood             1.000000   3.300      1.000

0801378000 8A   Tomato, dried                      1.000000  14.300      1.000

0801378001 8A   Tomato, dried-babyfood             1.000000  14.300      1.000

0801379000 8A   Tomato, juice                      1.000000   1.500      1.000

0801380000 8A   Tomato, Tree                       1.000000   1.000      1.000

0103387000 1CD  Turmeric                           0.026000   1.000      1.000

0502389000 5B   Turnip, greens                    25.000000   1.000      1.000

8601000000 86A  Water, direct, all sources         0.079000   1.000      1.000

8602000000 86B  Water, indirect, all sources       0.079000   1.000      1.000

0901399000 9A   Watermelon                         0.600000   1.000      1.000

0901400000 9A   Watermelon, juice                  0.600000   1.000      1.000

0103406000 1CD  Yam, true                          0.026000   1.000      1.000

0103407000 1CD  Yam bean                           0.026000   1.000      1.000

0301338000 3A   Shallot, bulb                      0.100000   1.000      1.000

Attachment 2:  Results of Chronic Dietary Exposure Analysis

US EPA                                                          Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for MANDIPROPAMID               NHANES 2003-2008 2-day

Residue file name: J:\Mandy\deem\036602C.R08     Adjustment factor #2 NOT used.

Analysis Date 07-25-2013/14:00:17     Residue file dated: 07-25-2013/13:59:50

Reference dose (RfD, Chronic) = .05 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

------------------------------------------------------------------------ -------

                                                    Total Exposure

                                         -----------------------------------

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

--------------------------------------   -------------       ----------------

Total US Population                         0.013475                27.0%

Hispanic                                    0.011932                23.9%

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Non-Hisp-Black                              0.012226                24.5%

Non-Hisp-Other                              0.014678                29.4%

Nursing Infants                             0.005723                11.4%

Non-Nursing Infants                         0.014302                28.6%

Female 13+ PREG                             0.011797                23.6%

Children 1-6                                0.020727                41.5%

Children 7-12                               0.011523                23.0%

Male 13-19                                  0.009229                18.5%

Female 13-19/NP                             0.010005                20.0%

Male 20+                                    0.012668                25.3%

Female 20+/NP                               0.014206                28.4%

Seniors 55+                                 0.013238                26.5%

All Infants                                 0.011653                23.3%

Female 13-50                                0.013273                26.5%

Children 1-2                                0.022893                45.8%

Children 3-5                                0.020342                40.7%

Children 6-12                               0.012364                24.7%

Youth 13-19                                 0.009617                19.2%

Adults 20-49                                0.013459                26.9%

Adults 50-99                                0.013425                26.9%

Female 13-49                                0.013293                26.6%

------------------------------------------------------------------------ -------

Mandipropamid	Dietary Exposure and Risk Assessment	           DP Number: 412238

Page   PAGE  1  of   NUMPAGES  2


[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Rules and Regulations]
[Pages 27271-27273]
[FR Doc No: 2021-10608]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0105; Project Identifier MCAI-2020-01422-R;
Amendment 39-21543; AD 2021-10-10]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus Helicopters Model SA330J helicopters. This AD was prompted by
the failure of a second stage planet gear installed in the main gearbox
(MGB). This AD requires repetitively inspecting the MGB particle
detector and the MGB bottom housing (oil sump) for metal particles,
analyzing any metal particles that are found, and replacement of the
MGB if necessary, as specified in a European Aviation Safety Agency
(now European Union Aviation Safety Agency) (EASA) AD, which is
incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective June 24, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 24,
2021.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +49 221 8999 000; email<EMAIL_ADDRESS>internet:
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0105.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0105; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Mahmood G. Shah, Aviation Safety
Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0272, dated December 13, 2018
(EASA AD 2018-0272) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus Helicopters Model SA330J helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus Helicopters
Model SA330J helicopters. The NPRM published in the Federal Register on
March 2, 2021 (86 FR 12127). The NPRM was prompted by the failure of a
second stage planet gear installed in the MGB. The NPRM proposed to
require repetitively inspecting the MGB particle detector and the MGB
bottom housing (oil sump) for metal particles, analyzing any metal
particles that are found, and replacement of the MGB if necessary, as
specified in an EASA AD.
    The FAA is issuing this AD to address failure of an MGB second
stage planet gear, which could result in failure of the MGB and
subsequent loss of control of the helicopter. See the MCAI for
additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2018-0272 specifies procedures for repetitively inspecting
the MGB particle detector and the MGB bottom housing (oil sump) for
metal particles, analyzing any metal particles that are found, and
replacement of the MGB if necessary. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

Interim Action

    The FAA considers this AD interim action. If final action is later
identified, the FAA might consider further rulemaking then.

Costs of Compliance

    The FAA estimates that this AD affects 15 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
5 work-hours x $85 per hour = $425...........................              $0             $425           $6,375
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition replacements that would be required based on the results of
any required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition replacements:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
           Labor cost                   Parts cost            product
------------------------------------------------------------------------
40 work-hours x $85 per hour =   $600,000 (overhauled)..        $603,400
 $3,400.
------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-10-10 Airbus Helicopters: Amendment 39-21543; Docket No. FAA-
2021-0105; Project Identifier MCAI-2020-01422-R.

(a) Effective Date

    This airworthiness directive (AD) is effective June 24, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

 (c) Applicability

    This AD applies to all Airbus Helicopters Model SA330J
helicopters, certificated in any category.

 (d) Subject

    Joint Aircraft System Component (JASC) Code 6320, Main Rotor
Gearbox.

 (e) Reason

    This AD was prompted by a failure of a second stage planet gear
installed in the main gearbox (MGB). The FAA is issuing this AD to
address failure of an MGB second stage planet gear, which could
result in failure of the MGB and subsequent loss of control of the
helicopter.

 (f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

 (g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2018-0272, dated December 13, 2018
(EASA AD 2018-0272).

 (h) Exceptions to EASA AD 2018-0272

    (1) Where EASA AD 2018-0272 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2018-0272 refers to March 30, 2018 (the
effective date of EASA AD 2018-0065, dated March 23, 2018), this AD
requires using the effective date of this AD.
    (3) The ``Remarks'' section of EASA AD 2018-0272 does not apply
to this AD.
    (4) Where EASA AD 2018-0272 refers to flight hours (FH), this AD
requires using hours time-in-service.
    (5) Where paragraph (1) of EASA AD 2018-0272 specifies to
inspect the MGB particle detector ``in accordance with the
instructions of Section 3 of the ASB'' for this AD use ``in
accordance with the instructions in step 3.B.2.a. of the ASB.''
    (6) Where paragraph (2) of EASA AD 2018-0272 specifies to
inspect the MGB bottom housing (oil sump) ``in accordance with the
instructions of Section 3 of the ASB'' for this AD use ``in
accordance with the instructions in step 3.B.2.b. of the ASB.''

    (7) Where the service information referenced in EASA AD 2018-
0272 specifies to perform a metallurgical analysis and contact the
manufacturer if unsure about the characterization of the particles
collected, this AD does not require contacting the manufacturer to
determine the characterization of the particles collected.
    (8) Although the service information referenced in EASA AD 2018-
0272 specifies that if any 16NCD13 particles are found to contact
the manufacturer and send a 1-liter sample of oil to the
manufacturer, this AD does not require that action.
    (9) Although the service information referenced in EASA AD 2018-
0272 specifies returning certain parts to the manufacturer, this AD
does not require that action.
    (10) Where EASA AD 2018-0272 specifies actions be done after the
last flight of the day or ``ALF,'' this AD requires doing those
actions before the first flight of the day.
    (11) Although the service information referenced in EASA AD
2018-0272 specifies discarding certain parts, this AD requires
removing the parts from service.

 (i) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the helicopter to a location where the
helicopter can be modified (if the operator elects to do so),
provided that the helicopter is operated during the day, under
visual flight rules, and with no passengers onboard.

 (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

 (k) Related Information

    For more information about this AD, contact Mahmood G. Shah,
Aviation Safety Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
 (l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Aviation Safety Agency (EASA) AD 2018-0272, dated
December 13, 2018.
    (ii) [Reserved]
    (3) For EASA AD 2018-0272, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; phone: +49 221 8999 000; email:
<EMAIL_ADDRESS>Internet: www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0105.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 3, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-10608 Filed 5-19-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4461-4462]
[FR Doc No: 2019-02499]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG19-55-000.
    Applicants: Long Ridge Energy Generation LLC.
    Description: Self-Certification of EG of Long Ridge Energy
Generation LLC.
    Filed Date: 2/8/19.
    Accession Number: 20190208-5135.
    Comments Due: 5 p.m. ET 3/1/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-1481-002.
    Applicants: Duke Energy Florida, LLC.
    Description: Compliance filing: DEF Interchange Compliance Filing
to be effective 1/1/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5117.
    Comments Due: 5 p.m. ET 3/4/19.

    Docket Numbers: ER19-356-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: Deficiency Response--Require All
VERs to Register and Convert to DVERs to be effective 1/16/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5098.
    Comments Due: 5 p.m. ET 3/4/19.

    Docket Numbers: ER19-601-001.
    Applicants: AEP Energy Partners, Inc.
    Description: Tariff Amendment: MBR Tariff, FERC Electric Tariff for
Market Bases Sales to be effective 3/1/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5000.
    Comments Due: 5 p.m. ET 2/21/19.

    Docket Numbers: ER19-606-001.
    Applicants: AEP Generation Resources Inc.
    Description: Tariff Amendment: MBR Tariff, FERC Electric Tariff For
Market-Based Sales to be effective 3/1/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5002.
    Comments Due: 5 p.m. ET 2/21/19.

    Docket Numbers: ER19-936-001.
    Applicants: New England Power Pool Participants Committee.
    Description: Tariff Amendment: Feb 2019 Membership Filing
(Corrected) to be effective 1/1/2019.
    Filed Date: 2/8/19.
    Accession Number: 20190208-5150.
    Comments Due: 5 p.m. ET 3/1/19.

    Docket Numbers: ER19-1021-000.
    Applicants: Appalachian Power Company.
    Description: Sec.  205(d) Rate Filing: OATT--Revise Attachment K,
AEP Texas Inc. Rate Update to be effective 12/31/9998.
    Filed Date: 2/8/19.
    Accession Number: 20190208-5114.
    Comments Due: 5 p.m. ET 3/1/19.

    Docket Numbers: ER19-1022-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised WMPA Service
Agreement No. 2033; Queue No. N07 to be effective 1/12/2019.
    Filed Date: 2/8/19.
    Accession Number: 20190208-5125.
    Comments Due: 5 p.m. ET 3/1/19.

    Docket Numbers: ER19-1023-000.
    Applicants: Spruance Operating Services, LLC.
    Description: Baseline eTariff Filing: MBR Application to be
effective 3/25/2019.
    Filed Date: 2/8/19.
    Accession Number: 20190208-5136.
    Comments Due: 5 p.m. ET 3/1/19.

    Docket Numbers: ER19-1024-000.
    Applicants: AEP Generation Resources Inc.
    Description: Sec.  205(d) Rate Filing: MBR Tariff, FERC Electric
Tariff For Market-Based Sales to be effective 3/1/2019.
    Filed Date: 2/8/19.
    Accession Number: 20190208-5151.
    Comments Due: 5 p.m. ET 3/1/19.

    Docket Numbers: ER19-1025-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-02-11_SA 3239 Kossuth
Wind-MidAmerican GIA (J534) to be effective 1/28/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5060.
    Comments Due: 5 p.m. ET 3/4/19.

    Docket Numbers: ER19-1026-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-02-11_SA 3238 EDF
Renewables-MidAmerican FCA (J495) to be effective 1/28/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5069.
    Comments Due: 5 p.m. ET 3/4/19.

    Docket Numbers: ER19-1027-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-02-11_SA 2988
MidAmerican-MidAmerican 2nd Rev GIA (J500) to be effective 1/28/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5073.
    Comments Due: 5 p.m. ET 3/4/19.

    Docket Numbers: ER19-1028-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1534R9 Kansas Municipal
Energy Agency NITSA NOA to be effective 2/1/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5080.
    Comments Due: 5 p.m. ET 3/4/19.

    Docket Numbers: ER19-1029-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) Rate Filing: SPS-GSEC-SPEC-T-IA-Yuma-2-
707-0.0.0 to be effective 4/13/2019.
    Filed Date: 2/11/19.
    Accession Number: 20190211-5094.
    Comments Due: 5 p.m. ET 3/4/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-02499 Filed 2-14-19; 8:45 am]
 BILLING CODE 6717-01-P