[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46614]
[DOCID:fr11au08-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13092-000]

Rhode Island Energy Group, LLC; Notice of Preliminary Permit
Applications Accepted for Filing and Soliciting Comment, Motions To
Intervene, and Competing Applications

August 5, 2008.
    On December 31, 2007, Rhode Island Energy Group, LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Sakonnet River Project, to be
located on the Sakonnet River in Newport County, Rhode Island.
    The proposed Sakonnet River Project consists of: (1) A proposed
shrouded tidal turbin generating unit having an installed capacity of
500 kilowatts, (2) a proposed transmission line, and (3) appurtenant
facilities. The Rhode Island Energy Group, LLC, project would have an
average annual generation of 2 gigawatt-hours and be sold to a local
utility.
    Applicant Contact: Mr. John J. Callahan, Rhode Island Energy Group,
LLC, P.O. Box 130, Portsmouth, RI 02871, phone<PHONE_NUMBER>.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13092) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-18462 Filed 8-8-08; 8:45 am]

BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

                                                                                OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:   	05/DEC/2006

SUBJECT:	Cymoxanil: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure Assessment for the Proposed IR-4 Uses on Grapes, Hops (PP # 5E7000) and Caneberries (PP # 6E7100).

PC Code:	129106			Decision Number: 369731

DP Num: 	333189

REVIEWER:	Eugenia McAndrew, Biologist

Risk Integration, Minor Use and Emergency Response Branch

Registration Division (7505P)

THROUGH:	Amelia Acierto

		Thurston Morton

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

TO:		Shaja Brothers

		Risk Integration, Minor Use and Emergency Response Branch

Registration Division (7505P)

Executive Summary

ion Model (DEEM-FCID™), Version 2.03, which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of  Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support the proposed IR-4 tolerance petitions for the use of cymoxanil on grapes, hops and caneberries.

The unrefined acute analysis (females 13-49 years old only) assumed that cymoxanil residues are present in all registered food commodities at tolerance levels and that 100% of all commodities are treated.  DEEM version 7.81 default processing factors were used for all registered and proposed commodities except for grape juice and raisins where the default concentration factors were set to 1 (see memo S. Chun; DP Num: 248603; 02/SEPT/1998). For risk assessment purposes for lettuce and hops, the metabolite IN-KQ960 was included, along with the parent, based on the ratio of IN-KQ960 to the parent (3.5) in the lettuce metabolism study (i.e., the recommended tolerance level was multiplied by 3.5 to account for IN-KQ960).

The partially refined chronic analysis was conducted for the general U.S. population and all population subgroups using mean tolerance level residues for all commodities except lettuce and residues for lettuce field trials conducted at the highest application rate (1.3125 lb. ai/A) (MRID 44946430, S. Levy, 20/NOV/2002). Exposure estimates were further refined based on screening-level percent crop treated (% CT) data for several registered commodities and projected % crop treated data for grapes.

Drinking water was incorporated directly into the dietary assessment using the estimated drinking water concentrations (EDWC).  EDWCs were generated using the FIRST (version 1.0) model for surface water.  For the acute assessment, a concentration of 0.019 ppm was used; for the chronic assessment, the value of 0.0001 ppm was used.

Acute Dietary Exposure Results

The unrefined acute dietary exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general U.S. population.  Based on the assumptions described above, acute dietary exposure of females 13-49 years old is below ARIA’s level of concern at the 95th percentile of exposure.  Combined dietary exposure from food and drinking water is estimated at 0.028791 mg/kg/day, equivalent to 72 % of the acute Population Adjusted Dose (aPAD).

Chronic Dietary Exposure Results

™ software, dietary exposure is estimated at 0.000414 mg/kg/day for the general U.S. population (52% of the chronic Population Adjusted Dose (cPAD)) and 0.000560 mg/kg/day (70% of the cPAD) for adults 20-49 years, the population subgroup with the highest estimated chronic dietary exposure to cymoxanil.

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 reference dose (RfD) divided by the special Food Quality Protection Act (FQPA) Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 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,” 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 (8/20/99).

The most recent HED dietary risk assessment for cymoxanil (S. Levy, DP Num: 276292, 04/DEC/2002) was conducted to support the FIFRA §3 food uses on hops, lychee, fruiting vegetables, head lettuce and cucurbits. The current assessment incorporates drinking water directly into the dietary analyses using the EDWCs calculated for the proposed tolerances on grapes, hops and caneberries.

Food Residue Information

A. Tolerance Expression and Residues of Concern for the Registered/Proposed Crops

An ad hoc MARC met on 21/JAN/1998 and decided that parent only is of regulatory concern (G. Kramer, et. al., DP Num: 242321, 26/JAN/1998) in tomatoes, potatoes, grapes, livestock, rotational crops and drinking water. Subsequent to the initial MARC meeting, the petitioner submitted a lettuce metabolism study (MRID 44944605). Metabolites IN-KQ960 and IN-KP533 are present in the lettuce metabolism study which were not present in the tomato, grape, potato or rat metabolism studies. The lettuce metabolism results were presented to the HED MARC to assess the toxicological significance of these metabolites and to determine which additional residues, if any, to regulate in lettuce.

The MARC concluded (S. Levy, DP Num: 276796, 30/AUG/2001) that for the tolerance expression the residue of concern in/on hops is cymoxanil per se. For risk assessment purposes for hops and lettuce, the metabolite IN-KQ960 must be included, along with the parent, based on the ratio of IN-KQ960 to the parent in the lettuce 14C metabolism study. For any future petitions for tolerance on leafy vegetables, the petitioner was instructed to include residue data for IN-KQ960. The final decision concerning the tolerance expression in lettuce and other leafy vegetables is deferred pending results of the residue studies.

Tolerances are currently established under 40 CFR 180.503 for grape (0.1 ppm, imports only), hop, dried cones (1.0 ppm), lettuce, head (4.0 ppm), lychee (1.0 ppm), potato, (0.05 ppm), vegetable, cucurbit, group 9 (0.05 ppm) and vegetable, fruiting, group 8 (0.2 ppm). IR-4 has proposed adding caneberries (4 ppm) and increasing the grape tolerance to 1 ppm and the dried hop tolerance to 5 ppm. The increased tolerance for grapes is being requested to support domestic use of cymoxanil on grapes. The increased tolerance for dried hop is being requested to support a different formulation which results in higher field trials. ARIA has reviewed the residue chemistry data associated with the current request. These data do not support increasing the tolerance for grapes from 0.1 to 1.0 ppm.  The data indicate that the tolerance for hop should be increased from 1.0 to 7.0 ppm. ARIA concludes that the following tolerances for residues of cymoxanil are appropriate (D. Rate, DP Num: 324447)

Grape 			0.1 ppm

Hop, dried cones	7.0 ppm

Caneberries		4.0 ppm

B. Residue Data used in the Acute and Chronic Dietary Analyses

Acute:  Tolerance level residues and 100% CT were assumed for all plant commodities. DEEM (ver.7.81) default processing factors were assumed for all registered and proposed commodities except for grape juice and raisins where the default concentration factors were set to 1 (see S. Chun, DP Num: 248603, 02/SEPT/1998 for details). For risk assessment purposes for lettuce and hops, the metabolite IN-KQ960 was included, along with the parent, based on the ratio of IN-KQ960 to the parent (3.5) in the lettuce metabolism study (i.e., the recommended tolerance level was multiplied by 3.5 to account for IN-KQ960).

Table # 1.  Residue Data used in the Acute Dietary Analysis for Cymoxanil

Commodity	Tolerance

(Tolerance + Metabolite)	Percent Crop Treated	Processing Factors

Grape	0.1  ppm	100	Juice (1x)

Raisins (1x)

Hop, dried cones	           7.0  ppm

        (31.5  ppm)	100	1x

Lettuce, head	           4.0 ppm

(18  ppm)	100	1x

Lychee	          1.0   ppm	100	Dried  1.85

Potato	          0.05 ppm	100	Dried  6.5

Cucurbit Vegetables (Group 9)	          0.05 ppm	100	1x

Fruiting vegetables

(Group 8)	          0.2  ppm	100	Tomato paste  5.4

Tomato puree 3.3

Tomato dried 14.3

Tomato juice  1.5

Caneberries

(Subgroup 13A)	           4    ppm	100	1x

Chronic:

The partially refined chronic dietary exposure analysis incorporated mean field trial residues of cymoxanil for lettuce (with wrapper leaves) from trials conducted at the highest application rate (1.3125 lb. ai/A) (MRID 44946430, S. Levy, 20/NOV/2002).  Tolerance level residues were used for all other commodities. Exposure estimates were further refined based on screening-level percent crop treated (% CT) data provided by BEAD for cucumbers, lettuce, peppers, potatoes, pumpkins, squash, tomatoes and watermelons [Cymoxanil Screening- level Usage Analysis (SLUA),  J. Carter, 02/NOV/2006].  A conservative projected % crop treated estimate of 10% was used for grapes. Cymoxanil is proposed for use only on grapes grown east of the Rocky Mountains. USDA production statistics for grapes indicate that in 2003, 2004 and 2005 more than 93% of U.S. grapes were produced in two West Coast states (California and Washington) [USDA NASS Non-Citrus Fruits and Nuts; 2005 Summary; FrNt 1-3 (06)].  Therefore, ARIA conservatively estimates that even if all of the grapes grown east of the Rockies were treated with cymoxanil, less than 10% of the grapes would be treated.

Table # 2.  Residue Data used in the Chronic Dietary Analysis for Cymoxanil

Commodity	Residue	Percent Crop Treated	Processing Factors

Grape	0.1  ppm

(tolerance)	             10	Juice (1x)

Raisins (1x)

Hop, dried cones1	31.5 ppm

(tolerance + metabolite)	            100	1x

Lettuce, head 2	 3.15 ppm

(average field trial + metabolite)	              10	1x

Lychee	 1.0   ppm (tolerance)	             100	Dried  1.85

Potato	 0.05 ppm (tolerance)	               10	Dried  6.5

Cucurbit Vegetables (Group 9)	 0.05 ppm (tolerance)	Cucumber       10

Pumpkin           1

Squash              1

Watermelon      1

All others      100	1x

Fruiting vegetables

(Group 8)	 0.2  ppm (tolerance)	Tomatoes        10

Peppers           10

All others      100

	Tomato paste  5.4

Tomato puree 3.3

Tomato dried 14.3

Tomato juice  1.5

Caneberries

(Subgroup 13A)	  4.0 ppm (tolerance)	              100	1x

1 Tolerance + (3.5 x Tolerance) = 7 ppm + ( 3.5 x 7) = 31.5 ppm

2 Average FT + (3.5 x Average FT) = 0,7 ppm + (3.5 x 0.7 ppm) = 3.15 ppm

 Drinking Water Data

References: IR-4 Tolerance Petition for Cymoxanil (Tanos) Use on Grapes, Hops: DW Assessment; D.Young and T. Steeger, 20/SEPT/2006, DP Num: 323681 and IR-4 Tolerance Petition for Cymoxanil (Tanos) Use on Caneberries: DW Assessment; D.Young and T. Steeger,  21/SEPT/2006, DP Num: 331978

The Environmental Fate and Effects Division (EFED) calculated screening level surface water and ground water estimates for cymoxanil using FIRST (version 1.0) model and the SCI-GROW model, respectively. The drinking water models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .  The newly proposed application rate for caneberries is less than the rates evaluated for the new use of cymoxanil on grapes and hops. Therefore no new drinking water concentrations are needed for the proposed use. The newly proposed application rates for use on grapes and hops are higher than the rates evaluated in the previous Section 3 registration for the use of cymoxanil on potatoes (DP Num: 233366) and for the initial IR-4 tolerance petition for use of cymoxanil (Curzate 60 DF) on hops (DP Num: 271572).  Therefore new drinking water concentrations were determined for the proposed uses. Tier 1 drinking water concentrations (EDWCs) based on the newly proposed application rate for grapes appear in Table 3 as follows:

Table #3.  Estimated drinking water concentrations for Cymoxanil1

	Acute  (ppm)	Chronic  (ppm)

Groundwater	0.000003	0.000003

Surface Water	0.019	0.0001

1 Concentrations determined from the grape application (0.25 lbs per acre, 10 times), which was the highest application rate reported for the new proposed uses.

For the purpose of these dietary assessments, ARIA used 0. 019 ppm for the acute analysis and 0.0001 ppm for the chronic analysis.  For both the acute and chronic analyses, the drinking water EDWC was incorporated directly as a point estimate in the 䕄䵅愠慮祬楳⁳潴愠獳獥⁳硥潰畳敲琠祣潭慸楮牦 浯搠楲歮湩慷整⹲഍

IV.	DEEM-FCID™ Program and Consumption Information

Cymoxanil acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 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, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII 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+ years old.

For chronic dietary exposure assessments, 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.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for Tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

Toxicological Information

This memo updates the previous memo with a new toxicological endpoint for the chronic assessment.

.

Table # 4.  Summary of Cymoxanil Toxicological Doses and Endpoints for Dietary Risk Assessment

Exposure

Scenario

Dose Used in Risk Assessment, UF

Special FQPA SF* and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

(Females 13-50 years of age)

NOAEL = 4 mg/kg

UF = 100

Acute RfD = 0.04 mg/kg

FQPA SF = 1X

aPAD = acute RfD

              FQPA SF

= 0.04 mg/kg

Developmental Toxicity (rabbit)

Offspring LOAEL = 8 mg/kg/day  based on increased skeletal malformations of he cervical and thoracic vertebrae and ribs

Acute Dietary

(General population including infants and children)

NOAEL = NA

UF = NA

Acute RfD = NA

FQPA SF =  NA

aPAD = acute RfD

              FQPA SF

= NA

Not Required.  An endpoint of concern (effect) attributable to a single dose was not identified in the database.

Chronic Dietary

(All populations)

NOAEL< 0.8 mg/kg/day

UF = 100

Chronic RfD = 0.008

 mg/kg/day

FQPA SF1 = 10X

(includes UFL =  10X

cPAD = chronic RfD

               FQPA SF

= 0.0008 mg/kg/day

Chronic toxicity (dog; 2003)

LOAEL = 1.3/0.8 mg/kg/day (M/F), based on decreased absolute and relative thymus weights and histopathology of the thymus (thymic atrophy/involution) in males and decreased thymus weights in females

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, NA = Not Applicable

1  The 10X FQPA SF has been retained in the form of UFL to account for the use of a LOAEL to extrapolate a NOAEL

VI.	Results/Discussion

As stated above, for acute and chronic assessments, ARIA is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The acute exposure results are reported in Table # 5 for females 13-49 only.  The chronic results reported in Table # 6 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+ years.

Results of Acute Dietary Exposure Analysis

The unrefined acute dietary (food + drinking water) exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general population.  Based on the assumptions described above in sections II and III, acute dietary exposure of females 13-49 years old is below ARIA’s level of concern (i.e., <100% of the aPAD of 0.04 mg/kg).  The combined dietary exposure from food and drinking water is estimated at 0.028791 mg/kg/day (72% of the aPAD), at the 95th percentile of exposure, the appropriate regulatory statistic for Tier 1 dietary assessments.

Table # 5.  Results of Acute Dietary Exposure Analysis Using DEEM FCID

Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile 99.9th Percentile

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

Females 13-49 years old 	0.04	0 .028791	72	0.051094	128	0.108653	272

Results of Chronic Dietary Exposure Analysis

-FCID™ software are below ARIA’s level of concern for the general U.S. population and each of the population subgroups.  Dietary exposure was estimated at 0.000414 mg/kg/day for the U.S. population         (52% of the cPAD) and 0.000560 mg/kg/day (70% of the cPAD) for the most highly exposed population subgroup (adults 20-49 years).  The estimated exposures/risks for food, drinking water and combined food and water are summarized in Table # 6 for all populations.

Table # 6.  Results of Chronic Dietary Exposure Analysis

Population Subgroup

cPAD

(mg/kg/day)

Exposure (mg/kg/day)

% cPAD

General U.S. Population	0.0008	0.000414	52

All Infants (< 1 year old)	0.0008	0.000122	15

Children 1-2 years old	0.0008	         0.000327	41

Children 3-5 years old	0.0008	0.000342	43

Children 6-12 years old	0.0008	0.000246	31

Youth 13-19 years old	0.0008	0.000253	32

Adults 20-49 years old	0.0008	0.000560	701

Females 13-49 years old	0.0008	0.000304	38

Adults 50+ years old	0.0008	0.000328	41

1The population subgroup with the highest estimated chronic dietary (food + drinking water) exposure and risk is indicated by bold text.

VII.	Characterization of Inputs/Outputs

The acute dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with cymoxanil and that residues are present at tolerance levels.  In addition, drinking water exposure estimates were based on screening level estimates generated by the model.  Dietary exposure estimates could be refined through the use of anticipated residues and percent crop treated data, as well as refined estimated drinking water concentrations.  However, since estimated exposures and risks using conservative assumptions are below ARIA’s level of concern, such refinement is not warranted.

This chronic dietary exposure for cymoxanil is a partially refined assessment which incorporates average field trial residues for lettuce, a screening level % CT data for several registered commodities and projected % CT for grapes.  Dietary exposure estimates could be further refined through the use of additional anticipated residues as well as refined EDWCs. As with the acute assessment, such refinements are not warranted at this time.

VIII.	Conclusions

The unrefined acute dietary exposure analysis using DEEM-FCID™ indicates that dietary exposures to cymoxanil from food and drinking water are below ARIA’s level of concern for this pesticide.  The estimated acute exposure of females 13-49 years old, the only population subgroup of concern for acute exposure, represents 72% of the aPAD at the 95th percentile of exposure.

The partially refined chronic dietary exposure analysis using DEEM-FCID™ indicates that dietary exposure to cymoxanil from food and drinking water are below ARIA’s level of concern for this pesticide. Estimated chronic dietary exposures are less than or equal to 70% of the cPAD for the general U.S. population and all population subgroups.

IX.		List of Attachments

Acute Food + Drinking Water Input File

Acute Food + Drinking Water Results File

Chronic Food + Drinking Water Input File

Chronic Food + Drinking Water Results File

Acute Food + Drinking Water Input File

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for CYMOXANIL

Residue file name: E:\Cymoxanil Oct.2006\acute129106.r98

Analysis Date 11-09-2006             Residue file dated: 11-09-2006/09:06:14/8

Reference dose (aRfD) = 0.04 mg/kg bw/day

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

09020210 9B   Balsam pear                        0.050000   1.000  1.000

13010550 13A  Blackberry                         4.000000   1.000  1.000

13010560 13A  Blackberry, juice                  4.000000   1.000  1.000

13010561 13A  Blackberry, juice-babyfood         4.000000   1.000  1.000

13010580 13A  Boysenberry                        4.000000   1.000  1.000

09010750 9A   Cantaloupe                         0.050000   1.000  1.000

09010800 9A   Casaba                             0.050000   1.000  1.000

09020880 9B   Chayote, fruit                     0.050000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.050000   1.000  1.000

09021350 9B   Cucumber                           0.050000   1.000  1.000

13011420 13A  Dewberry                           4.000000   1.000  1.000

08001480 8    Eggplant                           0.200000   1.000  1.000

95001750 O    Grape                              0.100000   1.000  1.000

95001760 O    Grape, juice                       0.100000   1.000  1.000

95001761 O    Grape, juice-babyfood              0.100000   1.000  1.000

95001770 O    Grape, leaves                      0.100000   1.000  1.000

95001780 O    Grape, raisin                      0.100000   1.000  1.000

95001790 O    Grape, wine and sherry             0.100000   1.000  1.000

09011870 9A   Honeydew melon                     0.050000   1.000  1.000

95001880 O    Hop                               31.500000   1.000  1.000

04012040 4A   Lettuce, head                     18.000000   1.000  1.000

13012080 13A  Loganberry                         4.000000   1.000  1.000

95002110 O    Lychee                             1.000000   1.000  1.000

95002120 O    Lychee, dried                      1.000000   1.850  1.000

08002340 8    Okra                               0.200000   1.000  1.000

08002700 8    Pepper, bell                       0.200000   1.000  1.000

08002701 8    Pepper, bell-babyfood              0.200000   1.000  1.000

08002710 8    Pepper, bell, dried                0.200000   1.000  1.000

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000  1.000

08002720 8    Pepper, nonbell                    0.200000   1.000  1.000

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000  1.000

08002730 8    Pepper, nonbell, dried             0.200000   1.000  1.000

01032960 1C   Potato, chips                      0.050000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000

01032980 1C   Potato, flour                      0.050000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000

09023080 9B   Pumpkin                            0.050000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.050000   1.000  1.000

13013200 13A  Raspberry                          4.000000   1.000  1.000

13013201 13A  Raspberry-babyfood                 4.000000   1.000  1.000

13013210 13A  Raspberry, juice                   4.000000   1.000  1.000

13013211 13A  Raspberry, juice-babyfood          4.000000   1.000  1.000

09023560 9B   Squash, summer                     0.050000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.050000   1.000  1.000

09023570 9B   Squash, winter                     0.050000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.050000   1.000  1.000

08003740 8    Tomatillo                          0.200000   1.000  1.000

08003750 8    Tomato                             0.200000   1.000  1.000

08003751 8    Tomato-babyfood                    0.200000   1.000  1.000

08003760 8    Tomato, paste                      0.200000   5.400  1.000

08003761 8    Tomato, paste-babyfood             0.200000   5.400  1.000

08003770 8    Tomato, puree                      0.200000   3.300  1.000

08003771 8    Tomato, puree-babyfood             0.200000   3.300  1.000

08003780 8    Tomato, dried                      0.200000  14.300  1.000

08003781 8    Tomato, dried-babyfood             0.200000  14.300  1.000

08003790 8    Tomato, juice                      0.200000   1.500  1.000

86010000 O    Water, direct, all sources         0.019000   1.000  1.000

86020000 O    Water, indirect, all sources       0.019000   1.000  1.000

09013990 9A   Watermelon                         0.050000   1.000  1.000

09014000 9A   Watermelon, juice                  0.050000   1.000  1.000

Acute Food + Drinking Water Results File

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for CYMOXANIL                           (1994-98 data)

Residue file: acute129106.r98                     Adjustment factor #2 NOT used.

Analysis Date: 11-09-2006/09:24:05    Residue file dated: 11-09-2006/09:06:14/8

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

Females 13-49 yrs:

                    0.028791    71.98    0.051094   127.74    0.108653   271.63

Chronic Food + Water Input File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for CYMOXANIL                          1994-98 data

Residue file: E:\Cymoxanil Oct.2006\chronic129106%CT.R98       Adjust. #2 used

Analysis Date 11-07-2006             Residue file dated: 11-07-2006/11:14:45/8

Reference dose (RfD) = 0.0008 mg/kg bw/day

Comment:Cymoxanil chronic food + water using mean FT for lettuce; SLUA %CT for registered uses and 10%CT for Grapes.

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

09020210 9B   Balsam pear                        0.050000   1.000      1.000

13010550 13A  Blackberry                         4.000000   1.000      1.000

13010560 13A  Blackberry, juice                  4.000000   1.000      1.000

13010561 13A  Blackberry, juice-babyfood         4.000000   1.000      1.000

13010580 13A  Boysenberry                        4.000000   1.000      1.000

09010750 9A   Cantaloupe                         0.050000   1.000      1.000

09010800 9A   Casaba                             0.050000   1.000      1.000

09020880 9B   Chayote, fruit                     0.050000   1.000      1.000

09021020 9B   Chinese waxgourd                   0.050000   1.000      1.000

09021350 9B   Cucumber                           0.050000   1.000      0.100

13011420 13A  Dewberry                           4.000000   1.000      1.000

08001480 8    Eggplant                           0.200000   1.000      1.000

95001750 O    Grape                              0.100000   1.000      0.100

95001760 O    Grape, juice                       0.100000   1.000      0.100

95001761 O    Grape, juice-babyfood              0.100000   1.000      0.100

95001770 O    Grape, leaves                      0.100000   1.000      0.100

95001780 O    Grape, raisin                      0.100000   1.000      0.100

95001790 O    Grape, wine and sherry             0.100000   1.000      0.100

09011870 9A   Honeydew melon                     0.050000   1.000      1.000

95001880 O    Hop                               31.500000   1.000      1.000

04012040 4A   Lettuce, head                      3.150000   1.000      0.100

13012080 13A  Loganberry                         4.000000   1.000      1.000

95002110 O    Lychee                             1.000000   1.000      1.000

95002120 O    Lychee, dried                      1.000000   1.850      1.000

08002340 8    Okra                               0.200000   1.000      1.000

08002700 8    Pepper, bell                       0.200000   1.000      0.100

08002701 8    Pepper, bell-babyfood              0.200000   1.000      0.100

08002710 8    Pepper, bell, dried                0.200000   1.000      0.100

08002711 8    Pepper, bell, dried-babyfood       0.200000   1.000      0.100

08002720 8    Pepper, nonbell                    0.200000   1.000      0.100

08002721 8    Pepper, nonbell-babyfood           0.200000   1.000      0.100

08002730 8    Pepper, nonbell, dried             0.200000   1.000      0.100

01032960 1C   Potato, chips                      0.050000   1.000      0.100

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500      0.100

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500      0.100

01032980 1C   Potato, flour                      0.050000   1.000      0.100

01032981 1C   Potato, flour-babyfood             0.050000   1.000      0.100

01032990 1C   Potato, tuber, w/peel              0.050000   1.000      0.100

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000      0.100

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000      0.100

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000      0.100

09023080 9B   Pumpkin                            0.050000   1.000      0.010

09023090 9B   Pumpkin, seed                      0.050000   1.000      0.010

13013200 13A  Raspberry                          4.000000   1.000      1.000

13013201 13A  Raspberry-babyfood                 4.000000   1.000      1.000

13013210 13A  Raspberry, juice                   4.000000   1.000      1.000

13013211 13A  Raspberry, juice-babyfood          4.000000   1.000      1.000

09023560 9B   Squash, summer                     0.050000   1.000      0.010

09023561 9B   Squash, summer-babyfood            0.050000   1.000      0.010

09023570 9B   Squash, winter                     0.050000   1.000      0.010

09023571 9B   Squash, winter-babyfood            0.050000   1.000      0.010

08003740 8    Tomatillo                          0.200000   1.000      1.000

08003750 8    Tomato                             0.200000   1.000      0.100

08003751 8    Tomato-babyfood                    0.200000   1.000      0.100

08003760 8    Tomato, paste                      0.200000   5.400      0.100

08003761 8    Tomato, paste-babyfood             0.200000   5.400      0.100

08003770 8    Tomato, puree                      0.200000   3.300      0.100

08003771 8    Tomato, puree-babyfood             0.200000   3.300      0.100

08003780 8    Tomato, dried                      0.200000  14.300      0.100

08003781 8    Tomato, dried-babyfood             0.200000  14.300      0.100

08003790 8    Tomato, juice                      0.200000   1.500      0.100

86010000 O    Water, direct, all sources         0.000100   1.000      1.000

86020000 O    Water, indirect, all sources       0.000100   1.000      1.000

09013990 9A   Watermelon                         0.050000   1.000      0.010

09014000 9A   Watermelon, juice                  0.050000   1.000      0.010

Chronic Food + Water Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for CYMOXANIL                        (1994-98 data)

Residue file name: E:\Cymoxanil Oct.2006\chronic129106%CT.R98

                                                     Adjustment factor #2 used.

Analysis Date 11-07-2006/11:15:48     Residue file dated: 11-07-2006/11:14:45/8

Reference dose (RfD, Chronic) = .0008 mg/kg bw/day

COMMENT 1: Cymoxanil chronic food + water using mean FT for lettuce; SLUA %CT for registered uses and 10%CT for Grapes.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000414                51.7%

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Northeast region                            0.000366                45.8%

Midwest region                              0.000451                56.3%

Southern region                             0.000355                44.4%

Western region                              0.000509                63.7%

Hispanics                                   0.000361                45.1%

Non-hispanic whites                         0.000453                56.6%

Non-hispanic blacks                         0.000265                33.2%

Non-hisp/non-white/non-black                0.000323                40.4%

All infants (< 1 year)                      0.000122                15.2%

Nursing infants                             0.000080                10.1%

Non-nursing infants                         0.000137                17.2%

Children 1-6  yrs                           0.000334                41.7%

Children 7-12 yrs                           0.000232                29.0%

Females 13-19 (not preg or nursing)         0.000185                23.1%

Females 20+ (not preg or nursing)           0.000300                37.5%

Females 13-50 yrs                           0.000322                40.3%

Females 13+ (preg/not nursing)              0.000148                18.6%

Females 13+ (nursing)                       0.000226                28.2%

Males 13-19 yrs                             0.000320                40.0%

Males 20+ yrs                               0.000670                83.8%

Seniors 55+                                 0.000288                36.0%

Children 1-2 yrs                            0.000327                40.8%

Children 3-5 yrs                            0.000342                42.8%

Children 6-12 yrs                           0.000246                30.7%

Youth 13-19 yrs                             0.000253                31.7%

Adults 20-49 yrs                            0.000560                70.0%

Adults 50+ yrs                              0.000328                41.0%

Females 13-49 yrs                           0.000304                38.0%

Cymoxanil                       Dietary Exposure Assessment                         DP Num: 333189	                PC Code: 129106

Page   PAGE  1  of   NUMPAGES  15


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2233-2235]
[FR Doc No: 2019-01232]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0060]

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee
and the Drug Safety and Risk Management Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Psychopharmacologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee. The general function of the committees is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document. Consistent with FDA's regulation, notice is being
published with less than 15 days prior to the date of the meeting based
on a determination that an immediate meeting of the Psychopharmacologic
Drugs Advisory Committee and the Drug Safety and Risk Management
Advisory Committee is needed. This Federal Register notice could not be
published 15 days prior to

the date of the meeting due to the lapse of appropriations that began
on December 22, 2018. Notice was provided on the Agency website on
February 1, 2019, at https://www.fda.gov/AdvisoryCommittees/Calendar/ucm630167.htm.

DATES: The meeting will be held on February 12, 2019, from 8 a.m. to 5
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-0060. The docket will close on February
11, 2019. Submit either electronic or written comments on this public
meeting by February 11, 2019. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
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Time at the end of February 11, 2019. Comments received by mail/hand
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timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before February 11, 2019, will be provided
to the committees.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
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Follow the instructions for submitting comments. Comments submitted
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    Submit written/paper submissions as follows:
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     Confidential Submissions--To submit a comment with
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Any information marked as ``confidential'' will not be disclosed except
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For more information about FDA's posting of comments to public dockets,
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FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
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SUPPLEMENTARY INFORMATION:
    Agenda: The committees will discuss the efficacy, safety, and risk-
benefit profile of new drug application (NDA) 211243, esketamine 28 mg
single-use nasal spray device, submitted by Janssen Pharmaceuticals,
Inc., for the treatment of treatment-resistant depression.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the

appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before February 11, 2019, will be provided to the
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making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
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requesting to speak is greater than can be reasonably accommodated
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lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by February 8, 2019.
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that FDA is not responsible for providing access to electrical outlets.
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<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
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meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 1, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01232 Filed 2-5-19; 8:45 am]
 BILLING CODE 4164-01-P