**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460**

**OFFICE OF**

**PREVENTION, PESTICIDES**

**AND TOXIC SUBSTANCES**

**[MEMORANDUM]{.underline}**

DATE: November 8, 2007

SUBJECT: **Flonicamid** Chronic Aggregate Dietary (Food and Drinking
Water) Exposure and Risk Assessments for an IR-4 Section 3 Registration
Action on Root Vegetables (Except Sugar Beet; Subgroup 1B), Tuberous and
Corm Vegetables (Subgroup 1C), Leafy *Brassica* Greens (Subgroup 5B),
Radish Tops, Turnip Greens, Hops, Dried Cones, and Okra. PP# 6E7081.

> PC Code: 128016 Decision Number: 368509
>
> DP Number: 343466
>
> Petition Number: 6E7081

REVIEWER: Amelia M. Acierto, Chemist

Registration Action Branch 3/HED (7509P)

THROUGH: Sheila Piper, Chemist

Douglas Dotson, Chemist

> Dietary Exposure Science Advisory Council (DESAC)
>
> Health Effects Division (7509P)
>
> Paula Deschamp, Chief
>
> Registration Action Branch 3
>
> Health Effects Division (7509P)

TO: Sheila Piper, Risk Assessor

> Chemistry & Exposure Branch
>
> Health Effects Division (7509P)

**Executive Summary**

Chronic aggregate dietary (food and drinking water) exposure and risk
assessments were conducted using the Dietary Exposure Evaluation Model
(DEEM-FCID, Version 2.03), which uses food consumption data from the
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998. In addition to residues in/on food items, the
assessment also addresses potential residues in drinking water. In this
analysis the chronic dietary exposure and risk estimates resulting from
food and water intake were determined for the general U.S. population
and various population subgroups. Flonicamid has no acute endpoint and
has been determined to be "not a carcinogen;" therefore only a chronic
analysis was performed to support a petition for tolerances in
conjunction with an IR-4 petition for a Section 3 registration for the
new uses of flonicamid in/on vegetable, root crop (except sugar beet,
subgroup 1B), radish, tops, tuberous and corm vegetable (subgroup 1C),
*Brassica*, leafy greens

(subgroup 5B), turnip (greens), hop, dried cones, and okra. Tolerances
have already been established under 40 CFR 180.613 on cotton, cucurbit
vegetables, fruiting vegetables, leafy vegetables (group 4 except
*Brassica*, except spinach), spinach, pome fruit (group 11), potato,
stone fruit (group 12), head and stem *Brassica* (subgroup 5A) and
mustard greens.

[Chronic Dietary Exposure Results and Characterization]{.underline}

A chronic dietary (food and drinking water) exposure assessment was
conducted for the proposed commodities, registered commodities and
drinking water. Except for water, a conservative unrefined assessment
was conducted. The residue levels used in the assessment were the
tolerance levels recommended by HED for the new commodities, the
tolerance levels established under 40 CFR.§180.613 for registered crops
(head and stem *Brassica*, cotton, cucurbit vegetable, fruiting
vegetable, leafy vegetable, mustard greens, potato, pome fruit, spinach
and stone fruit), and revised tolerance levels for livestock
commodities.

Estimated concentrations of 1.5 ppb (1.5 x 10**^-3^** ppm) for the 1 in
10 year annual mean concentration of flonicamid in drinking water from
the proposed uses were provided by EFED and incorporated directly into
the chronic assessment. A Tier II drinking water assessment for the
proposed uses was performed using PRZM/EXAMS modeling with index
reservoir (IR) scenarios and percent crop area (PCA) adjustment factors.

The chronic dietary (food and drinking water) exposure to flonicamid is
below HED's level of concern for the general U.S. population and all
population subgroups. The chronic dietary exposure estimates are 10%
cPAD for the general U.S. population, 15% cPAD for all infants (\<1 year
old), and 23% cPAD for children 1-2 years old, the most highly exposed
population subgroup.

[Acute Dietary Exposure Results and Characterization]{.underline}

An acute dietary risk assessment was not performed as flonicamid has no
acute toxicological endpoint.

[Cancer Dietary Exposure Results and Characterization]{.underline}

A cancer dietary assessment was not conducted as flonicamid has been
determined to be "not a carcinogen."

**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 point of departure (POD, NOAEL, LOAEL,
e.g.) divided by the required uncertainty or safety factors.

For non-cancer chronic exposures, HED is concerned when estimated
dietary risk exceeds 100% of the PAD. HED is generally concerned when
estimated cancer risk exceeds one in one million. References which
discuss the acute and chronic risk assessments in more detail are
available on the EPA/pesticides web site: "Available Information on
Assessing Exposure from Pesticides, A User's Guide," 21-JUN-2000, web
link: <http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf> ;
or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for flonicamid was conducted by
Amelia Acierto

(26-April-2005, DP Number 315611).

**II. Residue Information**

[Flonicamid Use:]{.underline}

Flonicamid is a Group 9C insecticide (selective feeding blocker)
registered for the control of a variety of aphid pests and the
suppression of a variety of non-aphid pests. Tolerances for registered
commodities can be found in 40 CFR.§180.613. The tolerances that are
currently being recommended are listed in Table 1, below. The residue of
concern for plants are parent flonicamid and its major metabolites
TFNA-AM, TFNA and TFNG; in ruminants are parent and its metabolites
TFNA-AM and TFNA.

[Residue Data used for Chronic Assessments:]{.underline}

The residue levels used in the chronic assessment were the established
tolerance levels for plant commodities established under 40 CFR §180.613
and the tolerance levels based on the crop trials for the proposed
crops. Most of the livestock commodity tolerances are being increased
because all regulated residues are going to be included in the
tolerances. See Table 1, below for the increased livestock commodity
tolerances.

Estimated concentrations of flonicamid in drinking water from the
proposed uses were provided by EFED and incorporated directly into the
chronic assessment.

The assessments used 100% crop treated.

+---------------+---------+---------+---------+----------------------+
| **Table 1.    |         |         |         |                      |
| Tolerance     |         |         |         |                      |
| Summary for   |         |         |         |                      |
| Flonicamid**  |         |         |         |                      |
+===============+=========+=========+=========+======================+
| Commodity or  | P       | Esta    | Reco    | Comments; *Correct   |
| Subgroup      | roposed | blished | mmended | Commodity            |
|               | To      | To      | To      | Definition*          |
|               | lerance | lerance | lerance |                      |
|               | (ppm)   | (ppm)   | (ppm)   |                      |
+---------------+---------+---------+---------+----------------------+
| **Tolerances  |         |         |         |                      |
| for combined  |         |         |         |                      |
| residues of   |         |         |         |                      |
| flonicamid    |         |         |         |                      |
| and its       |         |         |         |                      |
| metabolites   |         |         |         |                      |
| TFNA,         |         |         |         |                      |
| TFNA-AM, and  |         |         |         |                      |
| TFNG**        |         |         |         |                      |
|               |         |         |         |                      |
| **\[40 CFR    |         |         |         |                      |
| 180.6         |         |         |         |                      |
| 13(a)(1)\]:** |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| *Brassica*,   | 16      | \--     | 16      |                      |
| leafy greens, |         |         |         |                      |
| subgroup 5B   |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Hop, dried    | 7.0     | \--     | 7.0     |                      |
| cones         |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Mustard       | \--     | 11      | 16      | Residues in/on       |
| greens        |         |         |         | mustard greens will  |
|               |         |         |         | be covered by the    |
|               |         |         |         | tolerance for leafy  |
|               |         |         |         | *Brassica* green,    |
|               |         |         |         | subgroup 5B.         |
+---------------+---------+---------+---------+----------------------+
| Okra          | 0.4     | \--     | 0.40    |                      |
+---------------+---------+---------+---------+----------------------+
| Potato        |         | 0.20    | 0.20    | Residues in/on       |
|               |         |         |         | potato will be       |
|               |         |         |         | covered by the       |
|               |         |         |         | tolerance for        |
|               |         |         |         | tuberous and corm    |
|               |         |         |         | vegetables, subgroup |
|               |         |         |         | 1C.                  |
+---------------+---------+---------+---------+----------------------+
| Radish, tops  | 16      | \--     | 16      | Residues will be     |
|               |         |         |         | covered by the       |
|               |         |         |         | tolerance for leafy  |
|               |         |         |         | *Brassica* green,    |
|               |         |         |         | subgroup 5B.         |
+---------------+---------+---------+---------+----------------------+
| Turnip,       | 16      | \--     | 16      |                      |
| greens        |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Vegetable,    | 0.45    | \--     | 0.60    | Recommended          |
| root, except  |         |         |         | tolerance based on   |
| sugar beet,   |         |         |         | crop field trial     |
| subgroup 1B   |         |         |         | data                 |
+---------------+---------+---------+---------+----------------------+
| Vegetable,    | 0.2     | \--     | 0.20    |                      |
| tuberous and  |         |         |         |                      |
| corm,         |         |         |         |                      |
| subgroup 1C   |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| **Tolerances  |         |         |         |                      |
| for combined  |         |         |         |                      |
| residues of   |         |         |         |                      |
| flonicamid    |         |         |         |                      |
| and its       |         |         |         |                      |
| metabolites   |         |         |         |                      |
| TFNA-AM and   |         |         |         |                      |
| TFNA in/on    |         |         |         |                      |
| livestock     |         |         |         |                      |
| commodities   |         |         |         |                      |
| \[40 CFR      |         |         |         |                      |
| 180.6         |         |         |         |                      |
| 13(a)(2)\]:** |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Cattle, fat   | \--     | 0.02    | 0.03    | Increased tolerances |
|               |         |         |         | are needed to        |
|               |         |         |         | reflect combined     |
|               |         |         |         | limits of            |
|               |         |         |         | quantitation for all |
|               |         |         |         | regulated residues.  |
+---------------+---------+---------+---------+----------------------+
| Cattle, meat  | \--     | 0.05    | 0.08    |                      |
+---------------+---------+---------+---------+----------------------+
| Cattle, meat  | \--     | 0.08    | 0.08    | No change needed.    |
| byproducts    |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Egg           | \--     | 0.03    | 0.04    | An increased         |
|               |         |         |         | tolerance is needed  |
|               |         |         |         | to account for all   |
|               |         |         |         | regulated residues.  |
+---------------+---------+---------+---------+----------------------+
| Goat, fat     | \--     | 0.02    | 0.03    | Increased tolerances |
|               |         |         |         | are needed to        |
|               |         |         |         | reflect combined     |
|               |         |         |         | limits of            |
|               |         |         |         | quantitation for all |
|               |         |         |         | regulated residues.  |
+---------------+---------+---------+---------+----------------------+
| Goat, meat    | \--     | 0.05    | 0.08    |                      |
+---------------+---------+---------+---------+----------------------+
| Goat, meat    | \--     | 0.08    | 0.08    | No change needed.    |
| byproducts    |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Horse, fat    | \--     | 0.02    | 0.03    | Increased tolerances |
|               |         |         |         | are needed to        |
|               |         |         |         | reflect combined     |
|               |         |         |         | limits of            |
|               |         |         |         | quantitation for all |
|               |         |         |         | regulated residues.  |
+---------------+---------+---------+---------+----------------------+
| Horse, meat   | \--     | 0.05    | 0.08    |                      |
+---------------+---------+---------+---------+----------------------+
| Horse, meat   | \--     | 0.08    | 0.08    | No change needed.    |
| byproducts    |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Milk          | \--     | 0.02    | 0.03    | Increased tolerances |
|               |         |         |         | are needed to        |
|               |         |         |         | reflect combined     |
|               |         |         |         | limits of            |
|               |         |         |         | quantitation for all |
|               |         |         |         | regulated residues.  |
+---------------+---------+---------+---------+----------------------+
| Poultry, fat  | \--     | 0.02    | 0.03    |                      |
+---------------+---------+---------+---------+----------------------+
| Poultry, meat | \--     | 0.02    | 0.03    |                      |
+---------------+---------+---------+---------+----------------------+
| Poultry, meat | \--     | 0.02    | 0.03    |                      |
| byproducts    |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+
| Sheep, fat    | \--     | 0.02    | 0.03    |                      |
+---------------+---------+---------+---------+----------------------+
| Sheep, meat   | \--     | 0.05    | 0.08    |                      |
+---------------+---------+---------+---------+----------------------+
| Sheep, meat   | \--     | 0.08    | 0.08    | No change needed.    |
| byproducts    |         |         |         |                      |
+---------------+---------+---------+---------+----------------------+

[Processing Factors]{.underline}:

Separate tolerances were established for dried potatoes, tomato paste,
and tomato puree based on processing studies. The adjustment factor #1
was set to 1.0 for these commodities; the DEEM default processing
factors were used for the other processed commodities for which default
processing factors are available.

**III. Drinking Water**

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in the
following memorandum: **"**Drinking Water Assessment for the IR-4 New
Uses of Flonicamid on *Brassica*, Hops, Tubulars, and Okra. Including
The Flonicamid Degradation Products (TFNG, TFNA, TFNA-OH, TFNA-AM and
TFNG-AM)." Water residues were incorporated in the DEEM-FCID into the
food categories "water, direct, all sources" and "water, indirect, all
sources."

No monitoring data of flonicamid were available to the Environmental
Fate and Effects Division (EFED). The estimated drinking water
concentrations from surface water sources were calculated using the Tier
II PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis
Modeling System). PRIZM is used to simulate pesticide transport as a
result of runoff and erosion from an agricultural field and EXAMS
estimates environmental fate and transport of pesticides in surface
water. The values generated by the models for drinking water were
multiplied by a national crop area factor (PCA), which accounts for the
fact that it is unlikely for any basin to be completely planted to
agricultural crops. Ground water concentrations were estimated using the
Tier I SCI-GROW Model. Flonicamid may be applied by aerial or ground as
per the labels for this product. This memo only addresses the
estimations of parent flonicamid and its major metabolites, TFNG, TFNA,
TFNA-OH, TFNA-AM and TFNG-AM.

Based on modeling results, the estimated drinking water (surface water)
concentrations of combined residues of flonicamid and its degradation
products (based on three aerial applications at the rate of 0.089 lb
ai/acre and the values adjusted with PCA factor of 0.87) are:

> **9.8 µ**g /L for the 1 in 10 year annual peak concentration (acute) -
> Based on the Florida carrot scenario.
>
> **1.5 µ**g /L for the 1 in 10 year annual mean concentration
> (non-cancer chronic)- Based on the California lettuce and Maine potato
> scenario.
>
> **0.97µ**g /L for the 30 year annual mean concentration (cancer
> chronic) - Based on the Idaho potato scenario.

Both the acute and chronic estimated concentrations for flonicamid in
ground water using the SCIGROW (version 2.3) Model are 1.32 x 10^-3^
µg/L (ppb) for the combined residues.

In general, the linked PRZM/EXAMS Model produces estimated aquatic
concentrations that are expected to be exceeded once within a 10-year
period.

The model and its description are available at the EPA internet site:
<http://www.epa.gov/oppefed1/models/water/>.

**IV. DEEM-FCID™ Program and Consumption Information**

Flonicamid chronic dietary exposure assessment wase 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 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.

**V. Toxicological Information**

Toxicological Endpoints and Doses for Chronic Dietary Risk Assessment

The toxicity database for flonicamid was evaluated by HED\'s
Registration Action Branch III\'s Toxicology Team on 9/30/2004. The
Toxicology Team at that meeting selected endpoints and evaluated for
FQPA concerns the potential hazard and exposure data for flonicamid and
determined that there was no need for an additional safety factor for
the protection of infants and children. The Cancer Assessment Review
Committee met on 1/5/2005. The findings of those meetings, as related to
dietary exposure, are summarized in Table 2. Flonicamid is classified to
be category "Suggestive Evidence of Carcinogenicity, but Not Sufficient
to Assess Human Carcinogenic Potential," according to the EPA Draft
Guidelines for Carcinogen Risk Assessment dated July, 1999; therefore, a
cancer assessment is not necessary.

+--------------+----------------+----------------+--------------------+
| **Table 2.   |                |                |                    |
| Summary of   |                |                |                    |
| Dose and     |                |                |                    |
| T            |                |                |                    |
| oxicological |                |                |                    |
| Endpoint     |                |                |                    |
| Selection    |                |                |                    |
| Relative to  |                |                |                    |
| Use in       |                |                |                    |
| Dietary      |                |                |                    |
| Human Health |                |                |                    |
| Risk         |                |                |                    |
| Assessment   |                |                |                    |
| for          |                |                |                    |
| Flonicamid** |                |                |                    |
+==============+================+================+====================+
| **Exposure** | **Dose         | **FQPA Safety  | **Endpoint for     |
|              | (mg/kg/day)**  | Factor and     | Risk Assessment**  |
| **Scenario** |                | Level of       |                    |
|              | **UF**         | Concern for    |                    |
|              |                | Risk           |                    |
|              |                | Assessment**   |                    |
+--------------+----------------+----------------+--------------------+
| **Acute      | N/A            | N/A            | N/A.               |
| Dietary**    |                |                |                    |
|              |                |                |                    |
| [general     |                |                |                    |
| population   |                |                |                    |
| including    |                |                |                    |
| infants and  |                |                |                    |
| children]    |                |                |                    |
| {.underline} |                |                |                    |
+--------------+----------------+----------------+--------------------+
| **Chronic    | NOAEL= 4.0     | FQPA SF = 1x   | 2-Gen reproduction |
| Dietary**    | mg/kg/day      |                | study in the rat.  |
|              |                | **cPAD** =     | Parental LOAEL =   |
| (All         | UF = 100       | [Chronic       | 22 mg/kg/day based |
| populations) |                | Rf             | on increased       |
|              | **cPAD** =     | D]{.underline} | kidney weights,    |
|              | **0.04         |                | kidney hyaline     |
|              | mg/kg/day**    | FQPA SF        | deposition,        |
|              |                |                | increased blood    |
|              |                | = 0.04         | serum LH (F1       |
|              |                | mg/kg/day      | females).          |
+--------------+----------------+----------------+--------------------+
| **Cancer**   | Classified as  | N/A            | N/A                |
| (oral,       | \"Suggestive   |                |                    |
| dermal,      | Evidence of    |                |                    |
| inhalation)  | Ca             |                |                    |
|              | rcinogenicity, |                |                    |
|              | but Not        |                |                    |
|              | Sufficient to  |                |                    |
|              | Assess Human   |                |                    |
|              | Carcinogenic   |                |                    |
|              | Potential\"    |                |                    |
+--------------+----------------+----------------+--------------------+

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOEL = no
observed adverse effect level, LOAEL = lowest observed adverse effect
level, cPAD = chronic populatio, adjusted dose, Rfd = reference dose,
N/A = not applicable.

**VI. Results/Discussion**

As stated above, for chronic assessments, HED 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 results reported in Table 3 below 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 Chronic Dietary (Food and Drinking Water) Exposure
Analysis]{.underline}

The results of the chronic dietary (food and drinking water) exposure
analysis are reported in Table 3 below.

The chronic dietary (food and drinking water) exposure to flonicamid is
below HED's level of concern for the general U.S. population and all
population subgroups. The chronic dietary exposure estimates are 10%
cPAD for the general U.S. population and 15% cPAD for all infants (\<1
year old), and 23% cPAD for children 1-2 years old, the most highly
exposed population subgroup.

  -------------------------------------------------------------------------
  Table 3. Summary                                   
  of Dietary (Food                                   
  and Drinking                                       
  Water) Exposure                                    
  and Risk for                                       
  Flonicamid                                         
  ------------------ ------------- ----------------- ----------------------
  Population         cPAD          Exposure          \% cPAD
  Subgroup           (mg/kg/day)   (mg/kg/day)       

                                   DEEM-FCID         DEEM-FCID

  General U.S.       0.04          0.004095          10
  Population                                         

  All Infants (\< 1  0.04          0.006087          15
  year old)                                          

  Children 1-2 years 0.04          0.009070          **23**
  old                                                

  Children 3-5 years 0.04          0.007205          18
  old                                                

  Children 6-12      0.04          0.004483          11
  years old                                          

  Youth 13-19 years  0.04          0.003280          8
  old                                                

  Adults 20-49 years 0.04          0.003513          9
  old                                                

  Females 13-49      0.04          0.003504          9
  years old                                          

  Adults 50+ years   0.04          0.003978          10
  old                                                
  -------------------------------------------------------------------------

**VII. Characterization of Inputs/Outputs**

The chronic dietary exposure analysis is a conservative one. As a
result, HED is confident that exposure is not underestimated to the U.S.
population or any population subgroup. Further refinements could be
made; however, they are not necessary at the present time.

**VIII. Conclusions**

The chronic dietary exposure assessment was conducted for the proposed
uses on root vegetables (except sugar beet; subgroup 1B), tuberous and
corm vegetables (subgroup 1C), leafy Brassica greens (subgroup 5B),
turnip greens, hops, dried cones, and okra and drinking water. A
conservative assessment was conducted. Estimated concentrations of
flonicamid in drinking water from the proposed uses were provided by
EFED and incorporated directly into the chronic assessments.

The chronic dietary (food and drinking water) exposure to flonicamid is
below HED's level of concern for the general U.S. population and all
population subgroups. The chronic dietary exposure estimates are 10%
cPAD for the general U.S. population and 15% cPAD for all infants (\<1
year old), and 23% cPAD for children 1-2 years old, the most highly
exposed population subgroup.

**IX. List of Attachments**

#1: DEEM-FCID Chronic Residue Input File.

#2: DEEM-FCID Chronic Results.

**[Attachment 1. DEEM-FCID Chronic Residue Input File.]{.smallcaps}**

Filename: C:\\Documents and
Settings\\aacierto\\Desktop\\Flonicamid.DEEMr\\FLONICAMID.R98

Chemical: FLONICAMID

RfD(Chronic): .04 mg/kg bw/day NOEL(Chronic): 4 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 11-16-2007/14:10:38/8 Program ver. 2.03

Comment: CHRONIC ONLY

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

EPA Crop Def Res Adj.Factors Comment

Code Grp Commodity Name (ppm) #1 #2

\-\-\-\-\-\-\-- \-\-\--
\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
\-\-\-\-\-\-\-\-\-- \-\-\-\-\-- \-\-\-\-\-- \-\-\--

04010050 4A Amaranth, leafy 4.000000 1.000 1.000

11000070 11 Apple, fruit with peel 0.200000 1.000 1.000

11000080 11 Apple, peeled fruit 0.200000 1.000 1.000

11000081 11 Apple, peeled fruit-babyfood 0.200000 1.000 1.000

11000090 11 Apple, dried 0.200000 8.000 1.000

11000091 11 Apple, dried-babyfood 0.200000 8.000 1.000

11000100 11 Apple, juice 0.200000 1.300 1.000

11000101 11 Apple, juice-babyfood 0.200000 1.300 1.000

11000110 11 Apple, sauce 0.200000 1.000 1.000

11000111 11 Apple, sauce-babyfood 0.200000 1.000 1.000

12000120 12 Apricot 0.600000 1.000 1.000

12000121 12 Apricot-babyfood 0.600000 1.000 1.000

12000130 12 Apricot, dried 0.600000 6.000 1.000

12000140 12 Apricot, juice 0.600000 1.000 1.000

12000141 12 Apricot, juice-babyfood 0.600000 1.000 1.000

01030150 1CD Arrowroot, flour 0.200000 1.000 1.000

01030151 1CD Arrowroot, flour-babyfood 0.200000 1.000 1.000

01030170 1CD Artichoke, Jerusalem 0.200000 1.000 1.000

04010180 4A Arugula 4.000000 1.000 1.000

09020210 9B Balsam pear 0.400000 1.000 1.000

21000440 M Beef, meat 0.080000 1.000 1.000

21000441 M Beef, meat-babyfood 0.080000 1.000 1.000

21000450 M Beef, meat, dried 0.080000 1.920 1.000

21000460 M Beef, meat byproducts 0.080000 1.000 1.000

21000461 M Beef, meat byproducts-babyfood 0.080000 1.000 1.000

21000470 M Beef, fat 0.030000 1.000 1.000

21000471 M Beef,fat-babyfood 0.030000 1.000 1.000

21000480 M Beef, kidney 0.080000 1.000 1.000

21000490 M Beef, liver 0.080000 1.000 1.000

21000491 M Beef, liver-babyfood 0.080000 1.000 1.000

01010500 1AB Beet, garden, roots 0.600000 1.000 1.000

01010501 1AB Beet, garden, roots-babyfood 0.600000 1.000 1.000

05010610 5A Broccoli 1.500000 1.000 1.000

05010611 5A Broccoli-babyfood 1.500000 1.000 1.000

05010620 5A Broccoli, Chinese 1.500000 1.000 1.000

05020630 5B Broccoli raab 16.000000 1.000 1.000

05010640 5A Brussels sprouts 1.500000 1.000 1.000

01010670 1AB Burdock 0.600000 1.000 1.000

05010690 5A Cabbage 1.500000 1.000 1.000

05020700 5B Cabbage, Chinese, bok choy 16.000000 1.000 1.000

05010710 5A Cabbage, Chinese, napa 1.500000 1.000 1.000

05010720 5A Cabbage, Chinese, mustard 1.500000 1.000 1.000

09010750 9A Cantaloupe 0.400000 1.000 1.000

04020760 4B Cardoon 4.000000 1.000 1.000

01010780 1AB Carrot 0.600000 1.000 1.000

01010781 1AB Carrot-babyfood 0.600000 1.000 1.000

01010790 1AB Carrot, juice 0.600000 1.000 1.000

09010800 9A Casaba 0.400000 1.000 1.000

01030820 1CD Cassava 0.200000 1.000 1.000

01030821 1CD Cassava-babyfood 0.200000 1.000 1.000

05010830 5A Cauliflower 1.500000 1.000 1.000

01010840 1AB Celeriac 0.600000 1.000 1.000

04020850 4B Celery 4.000000 1.000 1.000

04020851 4B Celery-babyfood 4.000000 1.000 1.000

04020860 4B Celery, juice 4.000000 1.000 1.000

04020870 4B Celtuce 4.000000 1.000 1.000

09020880 9B Chayote, fruit 0.400000 1.000 1.000

12000900 12 Cherry 0.600000 1.000 1.000

12000901 12 Cherry-babyfood 0.600000 1.000 1.000

12000910 12 Cherry, juice 0.600000 1.500 1.000

12000911 12 Cherry, juice-babyfood 0.600000 1.500 1.000

40000930 P Chicken, meat 0.030000 1.000 1.000

40000931 P Chicken, meat-babyfood 0.030000 1.000 1.000

40000940 P Chicken, liver 0.030000 1.000 1.000

40000950 P Chicken, meat byproducts 0.030000 1.000 1.000

40000951 P Chicken, meat byproducts-babyfoo 0.030000 1.000 1.000

40000960 P Chicken, fat 0.030000 1.000 1.000

40000961 P Chicken, fat-babyfood 0.030000 1.000 1.000

40000970 P Chicken, skin 0.030000 1.000 1.000

40000971 P Chicken, skin-babyfood 0.030000 1.000 1.000

01011000 1AB Chicory, roots 0.600000 1.000 1.000

09021020 9B Chinese waxgourd 0.400000 1.000 1.000

04011040 4A Chrysanthemum, garland 4.000000 1.000 1.000

05021170 5B Collards 16.000000 1.000 1.000

95001280 O Cottonseed, oil 0.500000 1.000 1.000

95001281 O Cottonseed, oil-babyfood 0.500000 1.000 1.000

11001290 11 Crabapple 0.200000 1.000 1.000

04011330 4A Cress, garden 4.000000 1.000 1.000

04011340 4A Cress, upland 4.000000 1.000 1.000

09021350 9B Cucumber 0.400000 1.000 1.000

04011380 4A Dandelion, leaves 4.000000 1.000 1.000

01031390 1CD Dasheen, corm 0.200000 1.000 1.000

70001450 P Egg, whole 0.040000 1.000 1.000

70001451 P Egg, whole-babyfood 0.040000 1.000 1.000

70001460 P Egg, white 0.040000 1.000 1.000

70001461 P Egg, white (solids)-babyfood 0.040000 1.000 1.000

70001470 P Egg, yolk 0.040000 1.000 1.000

70001471 P Egg, yolk-babyfood 0.040000 1.000 1.000

08001480 8 Eggplant 0.400000 1.000 1.000

04011500 4A Endive 4.000000 1.000 1.000

04021520 4B Fennel, Florence 4.000000 1.000 1.000

01031660 1CD Ginger 0.200000 1.000 1.000

01031661 1CD Ginger-babyfood 0.200000 1.000 1.000

01031670 1CD Ginger, dried 0.200000 1.000 1.000

01011680 1AB Ginseng, dried 0.600000 1.000 1.000

23001690 M Goat, meat 0.080000 1.000 1.000

23001700 M Goat, meat byproducts 0.080000 1.000 1.000

23001710 M Goat, fat 0.030000 1.000 1.000

23001720 M Goat, kidney 0.080000 1.000 1.000

23001730 M Goat, liver 0.080000 1.000 1.000

09011870 9A Honeydew melon 0.400000 1.000 1.000

95001880 O Hop 7.000000 1.000 1.000

24001890 M Horse, meat 0.080000 1.000 1.000

01011900 1AB Horseradish 0.600000 1.000 1.000

05021940 5B Kale 16.000000 1.000 1.000

05011960 5A Kohlrabi 1.500000 1.000 1.000

04012040 4A Lettuce, head 4.000000 1.000 1.000

04012050 4A Lettuce, leaf 4.000000 1.000 1.000

11002100 11 Loquat 0.200000 1.000 1.000

27002220 D Milk, fat 0.030000 1.000 1.000

27002221 D Milk, fat - baby food/infant for 0.030000 1.000 1.000

27012230 D Milk, nonfat solids 0.030000 1.000 1.000

27012231 D Milk, nonfat solids-baby food/in 0.030000 1.000 1.000

27022240 D Milk, water 0.030000 1.000 1.000

27022241 D Milk, water-babyfood/infant form 0.030000 1.000 1.000

27032251 D Milk, sugar (lactose)-baby food/ 0.030000 1.000 1.000

05022290 5B Mustard greens 16.000000 1.000 1.000

12002300 12 Nectarine 0.600000 1.000 1.000

08002340 8 Okra 0.400000 1.000 1.000

04012480 4A Parsley, leaves 4.000000 1.000 1.000

01012500 1AB Parsley, turnip rooted 0.600000 1.000 1.000

01012510 1AB Parsnip 0.600000 1.000 1.000

01012511 1AB Parsnip-babyfood 0.600000 1.000 1.000

12002600 12 Peach 0.600000 1.000 1.000

12002601 12 Peach-babyfood 0.600000 1.000 1.000

12002610 12 Peach, dried 0.600000 7.000 1.000

12002611 12 Peach, dried-babyfood 0.600000 7.000 1.000

12002620 12 Peach, juice 0.600000 1.000 1.000

12002621 12 Peach, juice-babyfood 0.600000 1.000 1.000

11002660 11 Pear 0.200000 1.000 1.000

11002661 11 Pear-babyfood 0.200000 1.000 1.000

11002670 11 Pear, dried 0.200000 6.250 1.000

11002680 11 Pear, juice 0.200000 1.000 1.000

11002681 11 Pear, juice-babyfood 0.200000 1.000 1.000

08002700 8 Pepper, bell 0.400000 1.000 1.000

08002701 8 Pepper, bell-babyfood 0.400000 1.000 1.000

08002710 8 Pepper, bell, dried 0.400000 1.000 1.000

08002711 8 Pepper, bell, dried-babyfood 0.400000 1.000 1.000

08002720 8 Pepper, nonbell 0.400000 1.000 1.000

08002721 8 Pepper, nonbell-babyfood 0.400000 1.000 1.000

08002730 8 Pepper, nonbell, dried 0.400000 1.000 1.000

12002850 12 Plum 0.600000 1.000 1.000

12002851 12 Plum-babyfood 0.600000 1.000 1.000

12002860 12 Plum, prune, fresh 0.600000 1.000 1.000

12002861 12 Plum, prune, fresh-babyfood 0.600000 1.000 1.000

12002870 12 Plum, prune, dried 0.600000 5.000 1.000

12002871 12 Plum, prune, dried-babyfood 0.600000 5.000 1.000

12002880 12 Plum, prune, juice 0.600000 1.400 1.000

12002881 12 Plum, prune, juice-babyfood 0.600000 1.400 1.000

01032960 1C Potato, chips 0.200000 1.000 1.000

01032970 1C Potato, dry (granules/ flakes) 0.400000 1.000 1.000

01032971 1C Potato, dry (granules/ flakes)-b 0.400000 1.000 1.000

01032980 1C Potato, flour 0.200000 6.500 1.000

01032981 1C Potato, flour-babyfood 0.200000 6.500 1.000

01032990 1C Potato, tuber, w/peel 0.200000 1.000 1.000

01032991 1C Potato, tuber, w/peel-babyfood 0.200000 1.000 1.000

01033000 1C Potato, tuber, w/o peel 0.200000 1.000 1.000

01033001 1C Potato, tuber, w/o peel-babyfood 0.200000 1.000 1.000

60003010 P Poultry, other, meat 0.030000 1.000 1.000

60003020 P Poultry, other, liver 0.030000 1.000 1.000

60003030 P Poultry, other, meat byproducts 0.030000 1.000 1.000

60003040 P Poultry, other, fat 0.030000 1.000 1.000

60003050 P Poultry, other, skin 0.030000 1.000 1.000

09023080 9B Pumpkin 0.400000 1.000 1.000

09023090 9B Pumpkin, seed 0.400000 1.000 1.000

11003100 11 Quince 0.200000 1.000 1.000

04013130 4A Radicchio 4.000000 1.000 1.000

01013140 1AB Radish, roots 0.600000 1.000 1.000

02003150 2 Radish, tops 16.000000 1.000 1.000

01013160 1AB Radish, Oriental, roots 0.600000 1.000 1.000

05023180 5B Rape greens 16.000000 1.000 1.000

04023220 4B Rhubarb 4.000000 1.000 1.000

01013270 1AB Rutabaga 0.600000 1.000 1.000

01013310 1AB Salsify, roots 0.600000 1.000 1.000

26003390 M Sheep, meat 0.080000 1.000 1.000

26003391 M Sheep, meat-babyfood 0.080000 1.000 1.000

26003400 M Sheep, meat byproducts 0.080000 1.000 1.000

26003410 M Sheep, fat 0.030000 1.000 1.000

26003411 M Sheep, fat-babyfood 0.030000 1.000 1.000

26003420 M Sheep, kidney 0.080000 1.000 1.000

26003430 M Sheep, liver 0.080000 1.000 1.000

04013550 4A Spinach 9.000000 1.000 1.000

04013551 4A Spinach-babyfood 9.000000 1.000 1.000

09023560 9B Squash, summer 0.400000 1.000 1.000

09023561 9B Squash, summer-babyfood 0.400000 1.000 1.000

09023570 9B Squash, winter 0.400000 1.000 1.000

09023571 9B Squash, winter-babyfood 0.400000 1.000 1.000

01033660 1CD Sweet potato 0.200000 1.000 1.000

01033661 1CD Sweet potato-babyfood 0.200000 1.000 1.000

04023670 4B Swiss chard 4.000000 1.000 1.000

01033710 1CD Tanier, corm 0.200000 1.000 1.000

08003740 8 Tomatillo 0.400000 1.000 1.000

08003750 8 Tomato 0.400000 1.000 1.000

08003751 8 Tomato-babyfood 0.400000 1.000 1.000

08003760 8 Tomato, paste 2.000000 1.000 1.000

08003761 8 Tomato, paste-babyfood 2.000000 1.000 1.000

08003770 8 Tomato, puree 0.500000 1.000 1.000

08003771 8 Tomato, puree-babyfood 0.500000 1.000 1.000

08003780 8 Tomato, dried 0.400000 14.300 1.000

08003781 8 Tomato, dried-babyfood 0.400000 14.300 1.000

08003790 8 Tomato, juice 0.400000 1.500 1.000

50003820 P Turkey, meat 0.030000 1.000 1.000

50003821 P Turkey, meat-babyfood 0.030000 1.000 1.000

50003830 P Turkey, liver 0.030000 1.000 1.000

50003831 P Turkey, liver-babyfood 0.030000 1.000 1.000

50003840 P Turkey, meat byproducts 0.030000 1.000 1.000

50003841 P Turkey, meat byproducts-babyfood 0.030000 1.000 1.000

50003850 P Turkey, fat 0.030000 1.000 1.000

50003851 P Turkey, fat-babyfood 0.030000 1.000 1.000

50003860 P Turkey, skin 0.030000 1.000 1.000

50003861 P Turkey, skin-babyfood 0.030000 1.000 1.000

01033870 1CD Turmeric 0.200000 1.000 1.000

05023890 5B Turnip, greens 16.000000 1.000 1.000

01013880 1AB Turnip, roots 0.600000 1.000 1.000

86010000 O Water, direct, all sources

110-Uncooked; Fresh or N/S; Cook Meth N/S

0.001500 1.000 1.000

86020000 O Water, indirect, all sources 0.001500 1.000 1.000

09013990 9A Watermelon 0.400000 1.000 1.000

09014000 9A Watermelon, juice 0.400000 1.000 1.000

01034060 1CD Yam, true 0.200000 1.000 1.000

01034070 1CD Yam bean 0.200000 1.000 1.000

**Attachment 2: DEEM-FCID Chronic Results**

U.S. Environmental Protection Agency Ver. 2.00

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

Residue file name: C:\\Documents and
Settings\\aacierto\\Desktop\\Flonicamid.DEEMr\\FLONICAMID.R98

Adjustment factor #2 NOT used.

Analysis Date 11-16-2007/14:18:07 Residue file dated:
11-16-2007/14:10:38/8

Reference dose (RfD, Chronic) = .04 mg/kg bw/day

NOEL (Chronic) = 4 mg/kg bw/day

COMMENT 1: CHRONIC ONLY

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

Total exposure by population subgroup

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Total Exposure

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

Population mg/kg Margin of Percent

Subgroup body wt/day Exposure 1/ of RfD

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
\-\-\-\-\-\-\-\-\-\-\-\-- \-\-\-\-\-\-\-\-\-- \-\-\-\-\-\-\-\--

U.S. Population (total) 0.004095 977 10.2%

U.S. Population (spring season) 0.004096 976 10.2%

U.S. Population (summer season) 0.004141 966 10.4%

U.S. Population (autumn season) 0.004133 968 10.3%

U.S. Population (winter season) 0.004001 1,000 10.0%

Northeast region 0.004258 939 10.6%

Midwest region 0.003893 1,028 9.7%

Southern region 0.003940 1,015 9.8%

Western region 0.004410 907 11.0%

Hispanics 0.003861 1,036 9.7%

Non-hispanic whites 0.003770 1,061 9.4%

Non-hispanic blacks 0.005283 757 13.2%

Non-hisp/non-white/non-black 0.006604 606 16.5%

All infants (\< 1 year) 0.006087 657 15.2%

Nursing infants 0.003118 1,283 7.8%

Non-nursing infants 0.007214 554 18.0%

Children 1-6 yrs 0.007597 527 19.0%

Children 7-12 yrs 0.004241 943 10.6%

Females 13-19 (not preg or nursing) 0.003055 1,309 7.6%

Females 20+ (not preg or nursing) 0.003819 1,047 9.5%

Females 13-50 yrs 0.003587 1,115 9.0%

Females 13+ (preg/not nursing) 0.003024 1,323 7.6%

Females 13+ (nursing) 0.003991 1,002 10.0%

Males 13-19 yrs 0.003486 1,148 8.7%

Males 20+ yrs 0.003546 1,128 8.9%

Seniors 55+ 0.004002 999 10.0%

Children 1-2 yrs 0.009070 441 22.7%

Children 3-5 yrs 0.007205 555 18.0%

Children 6-12 yrs 0.004483 892 11.2%

Youth 13-19 yrs 0.003280 1,219 8.2%

Adults 20-49 yrs 0.003513 1,139 8.8%

Adults 50+ yrs 0.003978 1,005 9.9%

Females 13-49 yrs 0.003504 1,142 8.8%

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--