![](media/image1.wmf)

**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460**

**OFFICE OF**

**PREVENTION, PESTICIDES**

**AND TOXIC SUBSTANCES**

**[MEMORANDUM]{.underline}**

**Date:** 04/15/08

**SUBJECT: Linuron.** Acute Probabilistic and Chronic Aggregate (Food
and Drinking Water) Dietary Exposure and Risk Assessments to Support a
Section 18 Emergency Exemption for Use on Lentils in Washington and
Idaho.

  ----------------------------------- -----------------------------------
  **PC Code: 035506**                 **DP Barcode: D350545**

  **Decision No.: 388493**            **Registration No.: 352-686**

  **Petition No.: 08WA05**            **Regulatory Action: Section 18**

  **Risk Assessment Type: Dietary**   **Case No.: N/A**

  **TXR No.: N/A**                    **CAS No.: 330-55-2**

  **MRID No.: N/A**                   **40 CFR: 180.184**
  ----------------------------------- -----------------------------------

**FROM:** Donna S. Davis, Chemist

> Reregistration Branch 1
>
> Health Effects Division (7509P)

Number range CHAPTER

**THROUGH:** Toiya Goodlow, Chemist

> Thurston Morton, Chemist
>
> Dietary Exposure Science Advisory Council (DESAC)
>
> Health Effects Division (7509P)
>
> Michael S. Metzger, Chief
>
> Reregistration Branch 1
>
> Health Effects Division (7509P)

**TO:** Andrea Conrath/Tony Britten/ Dan Rosenblatt

MUIERB

Registration Division (7505P)

**I.** **CONCLUSIONS**

Acute and chronic dietary (food and water) aggregate risks are not of
concern for the existing and newly proposed uses of linuron.

**II. ACTION REQUESTED**

Conduct a dietary (food and water) aggregate risk assessment to support
a new Section 18 use of linuron on lentils.

**III. BACKGROUND**

The States of Washington and Idaho have requested Section 18 emergency
exemptions to allow the use of linuron to control dog fennel and prickly
lettuce in lentils.

**IV. RESULTS/DISCUSSION**

At the 99.9^th^ percentile, the exposure to females 13 -- 49 years old
from the existing and proposed uses of linuron results in an estimated
risk equivalent to 6.0% of the acute population adjusted dose.

For the U.S. Population the existing and new uses for linuron resulted
in an exposure which is equivalent to an estimated risk of 7% of the
chronic population adjusted dose. The most highly exposed subpopulation
was all infants with an exposure equivalent to an estimated risk of 22%
of the chronic population adjusted dose.

**EXECUTIVE SUMMARY**

Acute probabilistic and 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 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 Section 18 Emergency Exemption
Requests for the use of linuron on lentils in Washington and Idaho.

[Acute Dietary (Food and Drinking Water) Exposure Results and
Characterization]{.underline}

A probabilistic acute dietary assessment for females 13- 49 years old
was conducted to support the proposed Section 18 use; no toxic effect
attributable to a single dose was identified for other populations. For
blended commodities, an average of the field trial data corrected for
the maximum %CT supplied by BEAD was used in the assessment. For
non-blended or partially-blended commodities, all values from the field
trials were included in the residue distribution file (RDF) along with
the use of maximum %CT in the form of zero values in the RDF. For the
new use on lentils, field trial values were included in the lentil RDF
and 100% CT was assumed. For all commodities, residues reported at or
below the method limit of quantitation (LOQ) were incorporated into the
assessment at the LOQ level. A single high end modeled peak surface
water EDWC (estimated drinking water concentration) provided by EFED was
used as a point estimate for drinking water. Concentration/reduction
factors were incorporated for some commodities based on empirical data;
for all other processed commodities, DEEM (version 7.81) default
processing factors were used.

At the 99.9^th^ percentile, the exposure to females 13 -- 49 years old
from the existing and proposed uses of linuron results in an estimated
risk equivalent to 6.0% of the acute population adjusted dose.

[Chronic Dietary (Food and Drinking Water) Exposure Results and
Characterization]{.underline}

A chronic dietary assessment was conducted using average field trial
values and average %CT information supplied by BEAD. 100% CT was assumed
for the new Section 18 use on lentils. The surface water annual mean
modeled EDWC from the use likely to result in the highest concentration
of linuron in water was incorporated into the dietary assessment.
Processing/reduction factors based on empirical data were used where
available. For all other processed commodities, DEEM (version 7.81)
default processing factors were used.

For the U.S. Population the existing and new uses for linuron resulted
in an exposure which is equivalent to an estimated risk of 7% of the
chronic population adjusted dose. The most highly exposed subpopulation
was all infants with an exposure equivalent to an estimated risk of 22%
of the chronic population adjusted dose.

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

Linuron has been classified as a Group C carcinogen and quantification
of human cancer risk is not required.

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

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD. 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 linuron was conducted by J.
Punzi (1/15/02, D279340).

**RESIDUE INFORMATION**

Tolerances are established for the combined residues of the herbicide
linuron (3-(3,4-dichlorophenyl)-1-methoxy-1- methylurea) and its
metabolites convertible to 3,4-

dichloraniline, calculated as linuron under 40 CFR 180.184 in various
plant commodities ranging from 0.25 ppm in small grains to 7 ppm in
asparagus. Tolerances are also established at 1.0 ppm for ruminant and
swine commodities.

The qualitative nature of the residue in plants and animals is
adequately understood. The residue of concern for plants and animals for
both the tolerance expression and risk assessment purposes is the
combined residues of linuron and its metabolites convertible to
3,4-dichloraniline, calculated as linuron. It should be noted that
3,4-dichloraniline *per se* is not of regulatory concern in connection
with the use of linuron due to the very low levels at which the chemical
is detected in plants and animals.

[Residue Data used for the Acute Probabilistic and Chronic Dietary
Assessments]{.underline}

For both the acute and chronic dietary assessments, anticipated residues
in plant commodities were derived based on field trial data. For
residues reported below the method LOQ, the residues were assigned a
value at the LOQ prior to calculating the anticipated residue.
Anticipated residue information for all existing uses was taken from the
most recent dietary risk assessment. Calculated anticipated residues for
plant commodities from that memorandum were corrected for the updated
%CT information, but not modified in any other way for this new
assessment. Details on the derivation of the anticipated residues for
the existing uses can be found in the memorandum entitled *Linuron.
Anticipated Residues and Dietary Exposure Assessment* (D279340,
1/15/2002, J. Punzi).

Two new tolerances were proposed in the TRED (5/31/02 letter from L.
Rossi to R. Landis) on celeriac and rhubarb and these tolerances have
been established. These crops were incorporated into the acute and
chronic runs at the tolerance level recommended in the TRED and with the
assumption that 100% of the crop was treated.

Anticipated residues for both the acute and chronic assessment were also
derived for livestock commodities. Since this new Section 18 use on
lentils is not expected to impact the ruminant and swine dietary burden,
HED used the ARs for ruminant and swine commodities as well as for milk
that were derived for and are detailed in the memorandum cited above.
HED notes that the theoretical maximum dietary burdens calculated in
2002 reflect a diet consisting primarily of carrot culls, sweet corn
forage, cotton gin byproducts and cotton seed meal. If recalculated by
current policy to reflect a more realistic, nutritious diet, it is
likely that the dietary burden would decrease significantly, resulting
in much lower anticipated residues in livestock commodities.

In conjunction with the most recent dietary risk assessment for linuron,
cited above, BEAD provided % crop treated data. For this new Section 18
use, BEAD has provided an updated Screening Level Usage Analysis (SLUA,
D350048, 3/11/2008, A. Grube). In conducting the dietary risk
assessments to support this Section 18 request, HED has used the most
recent %CT information from the 2008 SLUA. For any crop that did not
appear in the 2008 SLUA, but did appear in the 2002 dietary assessment,
HED assumed %CT. Maximum %CT values were used for the acute assessment
and average %CT values were used for the chronic assessment.

Where available, concentration/reduction factors were incorporated into
the analysis based on empirical data and are shown in Table 1 below. See
the 2002 J. Punzi dietary memorandum cited above for the details on the
processing/reduction factors incorporated into this assessment. In the
absence of processing data, DEEM (version 7.81) default processing
factors were incorporated into both the acute and chronic assessments.

[Acute Probabilistic Assessment Anticipated Residues]{.underline}

For blended commodities, in the acute dietary assessment, an average of
the field trial data corrected for the maximum %CT was used in the
assessment. For non-blended or partially-blended commodities, all values
from the field trials were included in the residue distribution file
(RDF) along with the use of maximum %CT in the form of zero values in
the RDF. For the new use on lentils, since lentils are a blended
commodity, the average of the submitted field trial values was
incorporated into the acute assessment and 100% CT was assumed.

[Chronic Assessment Anticipated Residues]{.underline}

For the chronic assessment, an average of the field trial data was
corrected for average %CT to derive an anticipated residue value. For
the new use on lentils, the average of the field trial data was used and
100% CT was assumed.

The existing and new use residue values used in these dietary risk
assessments are shown in Table 1, below.

+----------+----------+----------+----------+---------+--------------+
| **       |          |          |          |         |              |
| Table 1. |          |          |          |         |              |
| Residue  |          |          |          |         |              |
| Data     |          |          |          |         |              |
| Used in  |          |          |          |         |              |
| Exposure |          |          |          |         |              |
| Calcul   |          |          |          |         |              |
| ations** |          |          |          |         |              |
+==========+==========+==========+==========+=========+==============+
| Crop     | Percent  |          | Ant      |         | Processi     |
|          | Crop     |          | icipated |         | ng/Reduction |
|          | Treated  |          | Residue  |         | Factor       |
+----------+----------+----------+----------+---------+--------------+
|          | Average  | Maximum  | Chronic  | Acute   |              |
+----------+----------+----------+----------+---------+--------------+
| **       |          |          |          |         |              |
| Existing |          |          |          |         |              |
| Uses**   |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| A        | 20       | 35       | 0.541750 | RDF1    | Washing --   |
| sparagus |          |          |          | nb, pb  | 0.4\*\*      |
| ^♣^      |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Carrot   | 80       | 95       | 0.294667 | RDF2    |              |
| ^♣^      |          |          |          | nb, pb  |              |
+----------+----------+----------+----------+---------+--------------+
| Celeriac | 100      | 100      | 1.0      | 1.0     |              |
+----------+----------+----------+----------+---------+--------------+
| Celery   | 15       | 25       | 0.018844 | RDF3    |              |
| ^♣^      |          |          |          | nb, pb  |              |
+----------+----------+----------+----------+---------+--------------+
| Corn,    | 1        | 2.5      | 0.000633 | 0       | Oil 1x       |
| grain    |          |          |          | .001575 |              |
| (i       |          |          |          | b       | Bran 1x      |
| ncluding |          |          |          |         |              |
| pop) ^♣^ |          |          |          |         | Flour 1x     |
|          |          |          |          |         |              |
|          |          |          |          |         | Default HFCS |
|          |          |          |          |         | 1.5          |
+----------+----------+----------+----------+---------+--------------+
| Corn,    | 1        | 2.5      | 0.000138 | RDF 4   |              |
| sweet    |          |          |          | nb, pb  |              |
| ^♣^      |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Cotton   | 1        | 2.5      | 0        | 0       | Meal 1x      |
| ^♣^      |          |          | .0005000 | .000625 |              |
|          |          |          |          | b       | Oil 1x       |
+----------+----------+----------+----------+---------+--------------+
| Parsley  | 100      | 100      | 0.113333 | RDF5    |              |
| ♦        |          |          |          | nb, pb  |              |
+----------+----------+----------+----------+---------+--------------+
| Parsnip  | 100      | 100      | 0.05     | RDF6    |              |
| ♦        |          |          |          | nb, pb  |              |
+----------+----------+----------+----------+---------+--------------+
| Potato   | 5        | 10       | 0.002643 | 0       | Baked 1.5x   |
| ^♣^      |          |          |          | .005285 |              |
|          |          |          |          | b       | Default      |
|          |          |          |          |         | Dried 6.5x   |
|          |          |          |          | RDF7    |              |
|          |          |          |          | nb, pb  |              |
+----------+----------+----------+----------+---------+--------------+
| Rhubarb  | 100      | 100      | 0.5      | 0.5     |              |
+----------+----------+----------+----------+---------+--------------+
| Sorghum  | 1        | 2.5      | 0.002500 | 0       |              |
| ^♣^      |          |          |          | .006250 |              |
|          |          |          |          | b       |              |
+----------+----------+----------+----------+---------+--------------+
| Soybean  | 1        | 2.5      | 0.002796 | 0       | Oil 0.2x     |
| ^♣^      |          |          |          | .006990 |              |
|          |          |          |          | b       | Meal 1.2x    |
+----------+----------+----------+----------+---------+--------------+
| Wheat ♦  | 100      | 100      | 0.045    | 0.045 b | Bran 1x      |
|          |          |          |          |         |              |
|          |          |          |          |         | Flour 1x     |
|          |          |          |          |         |              |
|          |          |          |          |         | Germ 1x      |
+----------+----------+----------+----------+---------+--------------+
| Beef,    | N/A      | N/A      | 0.012567 | 0       | Default      |
| Goat,    |          |          |          | .067391 | Dried 1.92   |
| Horse &  |          |          |          |         |              |
| Sheep,   |          |          |          |         |              |
| meat \*  |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Beef &   | N/A      | N/A      | 0.085405 | 0       | N/A          |
| Sheep,   |          |          |          | .114493 |              |
| fat \*   |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Beef &   | N/A      | N/A      | 0.337838 | 1       | N/A          |
| Sheep,   |          |          |          | .775362 |              |
| liver    |          |          |          |         |              |
|          |          |          |          |         |              |
| (kidney  |          |          |          |         |              |
| & meat   |          |          |          |         |              |
| byp      |          |          |          |         |              |
| roducts) |          |          |          |         |              |
| \*       |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Pork,    | N/A      | N/A      | 0.002435 | 0       | N/A          |
| meat \*  |          |          |          | .003039 |              |
+----------+----------+----------+----------+---------+--------------+
| Pork,    | N/A      | N/A      | 0.004136 | 0       | N/A          |
| fat \*   |          |          |          | .005130 |              |
+----------+----------+----------+----------+---------+--------------+
| Pork,    | N/A      | N/A      | 0.065445 | 0       | N/A          |
| liver    |          |          |          | .081169 |              |
|          |          |          |          |         |              |
| (kidney  |          |          |          |         |              |
| & meat   |          |          |          |         |              |
| byp      |          |          |          |         |              |
| roducts) |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Milk     | N/A      | N/A      | 0.010000 | 0       | N/A          |
|          |          |          |          | .053623 |              |
+----------+----------+----------+----------+---------+--------------+
| *        |          |          |          |         |              |
| *Section |          |          |          |         |              |
| 18 Use** |          |          |          |         |              |
+----------+----------+----------+----------+---------+--------------+
| Lentils  | 100      | 100      | 0.017667 | 0       |              |
|          |          |          |          | .017667 |              |
+----------+----------+----------+----------+---------+--------------+

NB = non-blended; PB = partially-blended; B = blended; N/A = not
applicable

♣ Percent crop treated from 2008 SLUA -- chronic averages recalculated
from Punzi memo and RDFs modified to reflect new % CT.

♦ No use reported in 2008 SLUA, even though use likely to be negligible,
used 100% CT.

\* Residues in animal commodities calculated in 1/15/2002 J. Punzi Memo
(D279340).

\*\* Processing factors from 1/15/02 J. Punzi memo (D279340).

**DRINKING WATER DATA**

EFED has provided a drinking water assessment for this Section 18
dietary assessment in their memorandum entitled *Linuron: Transmittal of
S18 for Linuron to Control Dog Fennel and Prickly Lettuce in Lentils in
Washington and Idaho.* (D348520, D348521, 2/15/2008, M. Davy). However,
HED notes that the estimated drinking water concentrations provided by
EFED for carrots (Drinking Water Assessment for Linuron on Carrots in
California, 10/14/2001, I. Abdel-Saheb) generated for the HED Chapter of
the TRED (D271950, 1/30/02, C. Christensen) are higher than the EDWCs
for lentil, so this Section 18 dietary assessment used the higher values
from the carrot use. The drinking water residues from the carrot use
were incorporated directly into this dietary assessment. Water residues
were incorporated in the DEEM-FCID into the food categories "water,
direct, all sources" and "water, indirect, all sources."

The Agency currently lacks sufficient water-related exposure data from
monitoring to complete a quantitative water exposure assessment for
linuron and its metabolites. Therefore, EDWCs in surface water were
generated using the PRZM-EXAMS model. Ground water EDWCs were generated
using SCI-GROW model. The modeled peak surface water value of 38 ppb was
used in the acute dietary assessment. The modeled annual mean surface
water value of 18 ppb was used in the chronic dietary assessment. The
EDWCs for linuron and its metabolites for the use on carrots are
summarized in Table 2, below.

  ---------------------- ------------- ------------- -------------- ---------------- -----------
  **Table 2. Estimated                                                               
  Drinking Water                                                                     
  Concentrations in                                                                  
  Surface and                                                                        
  Groundwater for                                                                    
  Linuron use on                                                                     
  Carrots.**                                                                         

                         **EDWCs                                                     
                         (µg/L)**                                                    

                         **Linuron**   **Desmethyl   **Desmethoxy   **Norlinuron**   **Total**
                                       Linuron**     Linuron**                       

  Surface water/ peak    31.3          1.69          3.26           1.26             38
  (90th percentile                                                                   
  annual daily max.)                                                                 

  Surface water/ 90th    12.5          1.60          3.10           1.20             18
  percentile (annual                                                                 
  mean)                                                                              

  Surface water/ 36-year 7.31          1.17          2.28           0.88             12
  overall mean                                                                       

  Groundwater/peak and   0.54          0.047         0.094          0.035            0.7
  long term average                                                                  
  ---------------------- ------------- ------------- -------------- ---------------- -----------

**DEEM-FCID™ PROGRAM AND CONSUMTION INFORMATION**

Linuron 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 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.

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

The Linuron S18 Risk Assessment Team reviewed the most recent endpoints,
doses and uncertainty factors selected for risk assessment and concluded
that the toxicity endpoints and safety factors are consistent with
current policy with the exception of the Food Quality Protection Act
Safety Factor (FQPA SF). The team concluded that the FQPA SF could be
reduced to 1X for the following reasons:

-   The linuron toxicology database is considered sufficient to support
    this Section 18 request.

```{=html}
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-   Since there are no neurotoxic effects seen in the toxicology
    database, the previously required DNT study is no longer required.

-   While there is evidence of increased susceptibility seen in the
    multi-generation reproduction study in rats, the anti-androgenic
    effects of linuron are well established and there is a clear NOAEL
    for the effects. Further, the toxicity endpoint selected for risk
    assessment is protective of both the hematological effects seen and
    the anti-androgenic effects of linuron.

-   Exposure estimates are not likely to underestimate risk.

The endpoints and safety factors used for this risk assessment are
summarized in Table 3 below.

+---------+-------+-------------+-------------+---------------------+
| **Table |       |             |             |                     |
| 3       |       |             |             |                     |
| Summary |       |             |             |                     |
| of      |       |             |             |                     |
| Toxico  |       |             |             |                     |
| logical |       |             |             |                     |
| Doses   |       |             |             |                     |
| and     |       |             |             |                     |
| En      |       |             |             |                     |
| dpoints |       |             |             |                     |
| for     |       |             |             |                     |
| Linuron |       |             |             |                     |
| for Use |       |             |             |                     |
| in      |       |             |             |                     |
| Dietary |       |             |             |                     |
| E       |       |             |             |                     |
| xposure |       |             |             |                     |
| Risk    |       |             |             |                     |
| Assess  |       |             |             |                     |
| ments** |       |             |             |                     |
+---------+-------+-------------+-------------+---------------------+
| **Expo  | **    | **Uncer     | **RfD, PAD, | **Study and         |
| sure/** | Point | tainty/FQPA | Level of    | Toxicological       |
|         | of    | Safety      | Concern**   | Effects**           |
| **Sce   | D     | Factors**   |             |                     |
| nario** | epart |             |             |                     |
|         | ure** |             |             |                     |
+---------+-------+-------------+-------------+---------------------+
| Acute   | No    |             |             |                     |
| Dietary | toxic |             |             |                     |
| (       | af    |             |             |                     |
| General | fects |             |             |                     |
| Popu    | attri |             |             |                     |
| lation, | buted |             |             |                     |
| in      | to a  |             |             |                     |
| cluding | s     |             |             |                     |
| Infants | ingle |             |             |                     |
| and     | dose  |             |             |                     |
| Ch      | were  |             |             |                     |
| ildren) | i     |             |             |                     |
|         | denti |             |             |                     |
|         | fied. |             |             |                     |
+---------+-------+-------------+-------------+---------------------+
| Acute   | NOAEL | UF~A~= 10x  | aRfD = 0.12 | Developmental Rat   |
| Dietary | = 12  |             | mg/kg/day   | Study               |
|         | mg/k  | UF~H~=10x   |             |                     |
| (       | g/day |             | aPAD = 0.12 | At the LOAEL of 50  |
| Females |       | FQPA SF= 1x | mg/kg/day   | mg/kg/day increased |
| 13-49   |       |             |             | post-implantation   |
| years   |       |             |             | loss and            |
| of age) |       |             |             | fetal/litter        |
|         |       |             |             | resorptions were    |
|         |       |             |             | seen.               |
+---------+-------+-------------+-------------+---------------------+
| Chronic | N     | UF~A~= 10Xx | cRfD =      | Chronic Feeding     |
| Dietary | OAEL= |             | 0.0077      | Study in the Dog    |
| (All    | 0.77  | UF~H~=10x   |             |                     |
| Popul   | mg/k  |             | mg/kg/day   | At the LOAEL of     |
| ations) | g/day | FQPA SF= 1x |             | 4.17 (males) and    |
|         |       |             | cPAD =      | 3.5 (females)       |
|         |       |             | 0.0077      | increased met- and  |
|         |       |             | mg/kg/day   | sulfhemoglobin      |
|         |       |             |             | levels were seen.   |
+---------+-------+-------------+-------------+---------------------+
| Cancer  |       | Clas        |             |                     |
| (oral,  |       | sification: |             |                     |
| dermal, |       | Group C     |             |                     |
| inha    |       | carcinogen; |             |                     |
| lation) |       | qua         |             |                     |
|         |       | ntification |             |                     |
|         |       | not         |             |                     |
|         |       | required.   |             |                     |
+---------+-------+-------------+-------------+---------------------+

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

**RESULTS/DISCUSSION**

As stated above, for acute and 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 4 are for females
13--49 years of age, since this is the only subpopulation for which an
acute endpoint was established. Table 5 summarizes the results of both
the acute and chronic assessments and shows the chronic risks 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 for chronic risk. A cancer risk assessment was not
conducted since quantification of human carcinogenic risk is not
required for linuron.

[Results of Acute Dietary (Food and Drinking Water) Exposure
Analysis]{.underline}

The results of the acute dietary exposure analysis at the 95^th^,
99^th^, and 99.9^th^ percentiles of exposure for females 13-49 years old
are reported in Table 4.

  ---------------------------------------------------------------------------------------------------------
  **Table 4.                                                                                       
  Results of                                                                                       
  Acute Dietary                                                                                    
  (Food and                                                                                        
  Drinking                                                                                         
  Water)                                                                                           
  Exposure                                                                                         
  Analysis Using                                                                                   
  DEEM FCID**                                                                                      
  -------------- --------------- --------------- -------- --------------- -------- --------------- --------
  **Population   **aPAD          **95th                   **99th                   **99.9th        
  Subgroup**     (mg/kg/day)**   Percentile**             Percentile**             Percentile**    

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

  Females 13-49  0.12            0.002512        2.1      0.003846        3.2      0.007184        6.0
  years old                                                                                        
  ---------------------------------------------------------------------------------------------------------

[Results of Chronic Dietary (Food and Drinking Water) Exposure
Analysis]{.underline}

For the U.S. Population the existing and new uses for linuron resulted
in a chronic dietary exposure which is equivalent to an estimated risk
of 7% of the cPAD. The most highly exposed subpopulation was all infants
with an exposure equivalent to an estimated risk of 22% of the cPAD. The
results of the chronic dietary exposure analysis for all subpopulations
of concern are reported in the summary table below.

[Results of Cancer Dietary (Food and Drinking Water) Exposure
Analysis]{.underline}

Linuron has been classified as Group C carcinogen and quantification of
human cancer risk is not required; therefore a cancer dietary risk
assessment was not conducted

+-----------------+--------+-------+--------+-------+--------+-------+
| **Table 5.      |        |       |        |       |        |       |
| Summary of      |        |       |        |       |        |       |
| Dietary (Food   |        |       |        |       |        |       |
| and Drinking    |        |       |        |       |        |       |
| Water) Exposure |        |       |        |       |        |       |
| and Risk for    |        |       |        |       |        |       |
| Linuron**       |        |       |        |       |        |       |
+=================+========+=======+========+=======+========+=======+
| **Population    | *      |       | **C    |       | **Ca   |       |
| Subgroup**      | *Acute |       | hronic |       | ncer** |       |
|                 | Die    |       | Die    |       |        |       |
|                 | tary** |       | tary** |       |        |       |
|                 |        |       |        |       |        |       |
|                 | **(99  |       |        |       |        |       |
|                 | .9^th^ |       |        |       |        |       |
|                 | P      |       |        |       |        |       |
|                 | ercent |       |        |       |        |       |
|                 | ile)** |       |        |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
|                 | **D    | **%   | **D    | **%   | **D    | **R   |
|                 | ietary | aPA   | ietary | c     | ietary | isk** |
|                 | Ex     | D\*** | Expo   | PAD** | Expo   |       |
|                 | posure |       | sure** |       | sure** |       |
|                 | (      |       |        |       |        |       |
|                 | mg/kg/ |       | **(    |       | **(    |       |
|                 | day)** |       | mg/kg/ |       | mg/kg/ |       |
|                 |        |       | day)** |       | day)** |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| General U.S.    | NR; An |       | 0.     | 7     | NR;    |       |
| Population      | acute  |       | 000556 |       | Qu     |       |
|                 | en     |       |        |       | antifi |       |
|                 | dpoint |       |        |       | cation |       |
|                 | was    |       |        |       | of     |       |
|                 | not    |       |        |       | cancer |       |
|                 | se     |       |        |       | risk   |       |
|                 | lected |       |        |       | not    |       |
|                 | for    |       |        |       | re     |       |
|                 | these  |       |        |       | quired |       |
|                 | sub    |       |        |       | for    |       |
|                 | popula |       |        |       | li     |       |
|                 | tions. |       |        |       | nuron. |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| All Infants (\< |        |       | **0.00 | *     |        |       |
| 1 year old)     |        |       | 1718** | *22** |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Children 1-2    |        |       | 0.     | 16    |        |       |
| years old       |        |       | 001220 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Children 3-5    |        |       | 0.     | 13    |        |       |
| years old       |        |       | 000974 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Children 6-12   |        |       | 0.     | 8     |        |       |
| years old       |        |       | 000641 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Youth 13-19     |        |       | 0.     | 5     |        |       |
| years old       |        |       | 000411 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Adults 20-49    |        |       | 0.     | 6     |        |       |
| years old       |        |       | 000474 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Adults 50+      |        |       | 0.     | 6     |        |       |
| years old       |        |       | 000498 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+
| Females 13-49   | **0.00 | **    | 0.     | 6     |        |       |
| years old       | 7184** | 6.0** | 000472 |       |        |       |
+-----------------+--------+-------+--------+-------+--------+-------+

NR = Not required

The most highly exposed subpopulation is bolded.

**CHARACTERIZATION OF INPUTS/OUTPUTS**

The acute dietary assessment is considered to be a slightly refined
probabilistic assessment given the use of a distribution of residue
values from field trials, the incorporation of percent crop treated
information and the use of empirical processing factors in the
assessment. However, additional refinement to the assessment is possible
by the use of ½ the LOQ for those field trial values reported at \<LOQ
and/or with the use of monitoring data. Additionally, several crops
which were included in the 2002 assessment were included in this
assessment at 100% crop treated even though they do not appear on the
most recent SLUA and for which there may only be minimal or no use of
linuron. Lastly, the Section 18 use on lentils was included in the
assessment assuming 100% CT, which is likely an overestimate. Given the
additional refinements that are still possible for this assessment, HED
concludes that the acute dietary assessment is unlikely to underestimate
the risks from the existing and newly proposed uses of linuron.

The chronic dietary assessment was slightly refined by the use of
average field trial data. However, averages were calculated assuming
that all residues reported at or below the LOQ were assigned a value at
the LOQ. Additionally, as with the acute assessment, commodities
included in the 2002 assessment which did not appear in the 2008 SLUA
were included in this assessment assuming 100% CT. The assessment could
be further refined using ½ LOQ for field trial values reported at or
below the LOQ. Additionally, the assessment could also be refined by
incorporating monitoring data. Lastly, the 100%CT assumption for lentils
is likely an overestimate. Based on the conservative assumptions that
went into the chronic dietary assessment, HED concludes that the
assessment is unlikely to underestimate chronic dietary risks from the
existing and newly proposed uses of linuron.

**CONCLUSIONS**

A probabilistic acute dietary risk assessment was conducted for the
existing and newly proposed uses of linuron combined with estimated peak
residues of linuron and its metabolites in water. At the 99.9^th^
percentile, the exposure to females 13 -- 49 years old from the existing
and proposed uses of linuron results in an estimated risk equivalent to
6.0% of the aPAD. Since the estimated risk is not greater than 100% of
the aPAD, acute risk does not exceed HED's level of concern.

HED conducted a slightly refined chronic dietary risk assessment using
average field trial values, %CT and processing factors for the existing
and newly proposed uses of linuron combined with estimated average
residues of linuron and its metabolites in water. For the U.S.
Population the existing and new uses for linuron resulted in an exposure
which is equivalent to an estimated risk of 7% of the cPAD. The most
highly exposed subpopulation was all infants with an exposure equivalent
to an estimated risk of 22% of the cPAD. Since the estimated risks are
not greater than 100% of the cPAD for any population subgroup, chronic
dietary risks do not exceed HED's level of concern.

**LIST OF ATTACHMENTS**

1.  Acute Food plus Water Residue Input file

2.  Residue Distribution Files

3.  Acute Results file

4.  Chronic Food plus Water Residue Input file

5.  Chronic Results file

6.  SLUA from BEAD

cc: D. Davis

Attachment 1. Acute Food Plus Water Residue Input File

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID Acute analysis for LINURON

Residue file name: C:\\Documents and Settings\\ddavis05\\DEEM
files\\linuron acute f_w.R98

Analysis Date 04-14-2008 Residue file dated: 04-14-2008/10:36:27/8

Reference dose: aRfD = 0.12 mg/kg bw/day NOEL = 12 mg/kg bw/day

Comment: Acute Dietary Endpoint is for Females 13 - 49 years old only

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

RDL indices and parameters for Monte Carlo Analysis:

Index Dist Parameter #1 Param #2 Param #3 Comment

\# Code

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

1 6 asparagus.rdf

2 6 carrot.rdf

3 6 celery.rdf

4 6 sweetcorn.rdf

5 6 parsley.rdf

6 6 parsnip.rdf

7 6 potato.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment

Code Grp (ppm) #1 #2 Pntr

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

95000190 O Asparagus 1.000000 0.400 1.000 1 RDF ba

Full comment: RDF based on FTs; 35% CT;washing factor

21000440 M Beef, meat 0.067391 1.000 1.000

21000441 M Beef, meat-babyfood 0.067391 1.000 1.000

21000450 M Beef, meat, dried 0.067391 1.920 1.000 Defaul

Full comment: Default Drying CF

21000460 M Beef, meat byproducts 1.775362 1.000 1.000 transl

Full comment: translated from liver AR

21000461 M Beef, meat byproducts-babyfood 1.775362 1.000 1.000 transl

Full comment: translated from liver AR

21000470 M Beef, fat 0.114493 1.000 1.000

21000471 M Beef,fat-babyfood 0.114493 1.000 1.000

21000480 M Beef, kidney 1.775362 1.000 1.000 transl

Full comment: translated from liver AR

21000490 M Beef, liver 1.775362 1.000 1.000 transl

Full comment: translated from liver AR

21000491 M Beef, liver-babyfood 1.775362 1.000 1.000 transl

Full comment: translated from liver AR

01010780 1AB Carrot 1.000000 1.000 1.000 2 RDF ba

Full comment: RDF based on FT; 95% CT

01010781 1AB Carrot-babyfood 1.000000 1.000 1.000 2 RDF ba

Full comment: RDF based on FT; 95% CT

01010790 1AB Carrot, juice 1.000000 1.000 1.000 2 RDF ba

Full comment: RDF based on FT; 95% CT

01010840 1AB Celeriac 1.000000 1.000 1.000 Tolera

Full comment: Tolerance from the TRED

04020850 4B Celery 1.000000 1.000 1.000 3 RDF ba

Full comment: RDF based on FT; 25% CT

04020851 4B Celery-babyfood 1.000000 1.000 1.000 3 RDF ba

Full comment: RDF based on FT; 25% CT

04020860 4B Celery, juice 1.000000 1.000 1.000 3 RDF ba

Full comment: RDF based on FT; 25% CT

15001200 15 Corn, field, flour 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001201 15 Corn, field, flour-babyfood 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001210 15 Corn, field, meal 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001211 15 Corn, field, meal-babyfood 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001220 15 Corn, field, bran 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001230 15 Corn, field, starch 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001231 15 Corn, field, starch-babyfood 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001240 15 Corn, field, syrup 0.001575 1.500 1.000 Avg FT

Full comment: Avg FT; 2.5% CT; default CF for HFCS

15001241 15 Corn, field, syrup-babyfood 0.001575 1.500 1.000 Avg FT

Full comment: Avg FT; 2.5% CT; default CF for HFCS

15001250 15 Corn, field, oil 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001251 15 Corn, field, oil-babyfood 0.001575 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5% CT

15001260 15 Corn, pop 0.001575 1.000 1.000 Transl

Full comment: Translated from field corn

15001270 15 Corn, sweet 1.000000 1.000 1.000 4 RDF ba

Full comment: RDF based on FT; 2.5%CT

15001271 15 Corn, sweet-babyfood 1.000000 1.000 1.000 4 RDF ba

Full comment: RDF based on FT; 2.5%CT

95001280 O Cottonseed, oil 0.000625 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

95001281 O Cottonseed, oil-babyfood 0.000625 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

23001690 M Goat, meat 0.067391 1.000 1.000

23001700 M Goat, meat byproducts 1.775362 1.000 1.000

23001710 M Goat, fat 0.114493 1.000 1.000

23001720 M Goat, kidney 1.775362 1.000 1.000

24001890 M Horse, meat 0.067391 1.000 1.000

06032030 6C Lentil, seed 0.017667 1.000 1.000 Sectio

Full comment: Section 18 use; AR is avg FT; 100% CT

27002220 D Milk, fat 0.053623 1.000 1.000

27002221 D Milk, fat - baby food/infant for 0.053623 1.000 1.000

27012230 D Milk, nonfat solids 0.053623 1.000 1.000

27012231 D Milk, nonfat solids-baby food/in 0.053623 1.000 1.000

27022240 D Milk, water 0.053623 1.000 1.000

27022241 D Milk, water-babyfood/infant form 0.053623 1.000 1.000

27032251 D Milk, sugar (lactose)-baby food/ 0.053623 1.000 1.000

19012490 19A Parsley, dried leaves 1.000000 1.000 1.000 5 RDF ba

Full comment: RDF based on FT; 100% CT

19012491 19A Parsley, dried leaves-babyfood 1.000000 1.000 1.000 5 RDF
ba

Full comment: RDF based on FT; 100% CT

01012500 1AB Parsley, turnip rooted 1.000000 1.000 1.000 5 RDF ba

Full comment: RDF based on FT; 100% CT

01012510 1AB Parsnip 1.000000 1.000 1.000 6 RDF ba

Full comment: RDF based on FT; 100% CT

01012511 1AB Parsnip-babyfood 1.000000 1.000 1.000 6 RDF ba

Full comment: RDF based on FT; 100% CT

25002900 M Pork, meat 0.003039 1.000 1.000

25002901 M Pork, meat-babyfood 0.003039 1.000 1.000

25002910 M Pork, skin 0.005130 1.000 1.000

25002920 M Pork, meat byproducts 0.081169 1.000 1.000

25002921 M Pork, meat byproducts-babyfood 0.081169 1.000 1.000

25002930 M Pork, fat 0.005130 1.000 1.000

25002931 M Pork, fat-babyfood 0.005130 1.000 1.000

25002940 M Pork, kidney 0.081169 1.000 1.000

25002950 M Pork, liver 0.081169 1.000 1.000

01032960 1C Potato, chips 0.005285 1.500 1.000 Avg FT

Full comment: Avg FT; 10%CT; baking factor

01032970 1C Potato, dry (granules/ flakes) 0.005285 6.500 1.000 Avg FT

Full comment: Avg FT; 10%CT; Default CF for drying

01032971 1C Potato, dry (granules/ flakes)-b 0.005285 6.500 1.000 Avg FT

Full comment: Avg FT; 10%CT; Default CF for drying

01032980 1C Potato, flour 0.005285 1.500 1.000 Avg FT

Full comment: Avg FT; 10%CT; baking factor

01032981 1C Potato, flour-babyfood 0.005285 1.500 1.000 Avg FT

Full comment: Avg FT; 10%CT; baking factor

01032990 1C Potato, tuber, w/peel 1.000000 1.500 1.000 7 RDF ba

Full comment: RDF based on FT; 10%CT

01032991 1C Potato, tuber, w/peel-babyfood 1.000000 1.500 1.000 7 RDF ba

Full comment: RDF based on FT; 10%CT

01033000 1C Potato, tuber, w/o peel 1.000000 1.500 1.000 7 RDF ba

Full comment: RDF based on FT; 10%CT

01033001 1C Potato, tuber, w/o peel-babyfood 0.005285 1.500 1.000 7 RDF
ba

Full comment: RDF based on FT; 10%CT

04023220 4B Rhubarb 0.500000 1.000 1.000 Tolera

Full comment: Tolerance from the TRED

26003390 M Sheep, meat 0.067391 1.000 1.000 transl

Full comment: translated from beef

26003391 M Sheep, meat-babyfood 0.067391 1.000 1.000 transl

Full comment: translated from beef

26003400 M Sheep, meat byproducts 1.775362 1.000 1.000 transl

Full comment: translated from beef

26003410 M Sheep, fat 0.114493 1.000 1.000 transl

Full comment: translated from beef

26003411 M Sheep, fat-babyfood 0.114493 1.000 1.000 transl

Full comment: translated from beef

26003420 M Sheep, kidney 1.775362 1.000 1.000 transl

Full comment: translated from beef

26003430 M Sheep, liver 1.775362 1.000 1.000 transl

Full comment: translated from beef

15003440 15 Sorghum, grain 0.006250 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

15003450 15 Sorghum, syrup 0.006250 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

06003470 6 Soybean, seed 0.006990 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

06003480 6 Soybean, flour 0.006990 1.200 1.000 Avg FT

Full comment: Avg FT; 2.5%CT; meal conc factor

06003481 6 Soybean, flour-babyfood 0.006990 1.200 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

06003490 6 Soybean, soy milk 0.006990 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

06003491 6 Soybean, soy milk-babyfood or in 0.006990 1.000 1.000 Avg FT

Full comment: Avg FT; 2.5%CT

06003500 6 Soybean, oil 0.006990 0.200 1.000 Avg FT

Full comment: Avg FT; 2.5%CT; oil reduction factor

06003501 6 Soybean, oil-babyfood 0.006990 0.200 1.000 Avg FT

Full comment: Avg FT; 2.5%CT; oil reduction factor

86010000 O Water, direct, all sources 0.038000 1.000 1.000 Highes

Full comment: Highest Peak Surface Water EEC from TRED

86020000 O Water, indirect, all sources 0.038000 1.000 1.000 Highes

Full comment: Highest Peak Surface Water EEC from TRED

15004010 15 Wheat, grain 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT; 100% CT

15004011 15 Wheat, grain-babyfood 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT; 100% CT

15004020 15 Wheat, flour 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT; 100% CT

15004021 15 Wheat, flour-babyfood 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT; 100% CT

15004030 15 Wheat, germ 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT; 100% CT

15004040 15 Wheat, bran 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT; 100% CT

Attachment 2. Residue Distribution Files (RDFs)

**Asparagus** FT data, 35% CT maximum

TOTALNZ=8

TOTALZ=15

6.75

5.95

1.74

1.74

1.13

0.86

2.0

1.5

**Carrot** FT data, 95% CT maximum

TOTALNZ=6

TOTALZ=0

0.30

0.28

0.40

0.50

0.39

0.34

**Celery** FT data, 25% CT maximum

TOTALNZ=16

TOTALZ=48

0.08

0.07

0.10

0.12

0.05

0.06

0.04

0.04

0.12

0.14

0.42

0.18

0.32

0.17

0.05

0.05

**Sweet corn** FT data, 2.5% CT maximum

TOTALNZ=18

TOTALZ=702

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.01

0.048

0.04

**Parsley** FT data, 6% CT maximum

TOTALNZ=6

TOTALZ=94

0.08

0.18

0.08

0.12

0.11

0.11

**Parsnip** FT data, 3% CT maximum

TOTALNZ=6

TOTALZ=194

0.05

0.05

0.05

0.05

0.05

0.05

**Potato** FT data, 10% CT maximum

TOTALNZ=7

TOTALZ=63

0.05

0.05

0.05

0.05

0.05

0.05

0.07

Attachment 3. Acute Results File

U.S. Environmental Protection Agency Ver. 2.02

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

Residue file: linuron acute f_w.R98 Adjustment factor #2 NOT used.

Analysis Date: 04-14-2008/10:38:26 Residue file dated:
04-14-2008/10:36:27/8

NOEL (Acute) = 12.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

MC iterations = 1000 MC list in residue file MC seed = 10

Run Comment: \"Acute Dietary Endpoint is for Females 13 - 49 years old
only\"

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

Summary calculations (per capita):

95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

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

Females 13-49 yrs:

0.002512 2.09 4776 0.003846 3.21 3120 0.007184 5.99 1670

Attachment 4. Chronic Food Plus Water Input File

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for LINURON 1994-98 data

Residue file: C:\\Documents and Settings\\ddavis05\\DEEM files\\linuron
chronic f_w.R98

Adjust. #2 NOT used

Analysis Date 03-25-2008 Residue file dated: 03-25-2008/10:09:13/8

Reference dose (RfD) = 0.0077 mg/kg bw/day

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

Food Crop Residue Adj.Factors Comment

EPA Code Grp Food Name (ppm)

#1 #2

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

95000190 O Asparagus 0.541750 0.400 1.000 Residu

Full comment: Residue is avg FT corrected for 20% CT

21000440 M Beef, meat 0.012567 1.000 1.000

21000441 M Beef, meat-babyfood 0.012567 1.000 1.000

21000450 M Beef, meat, dried 0.012567 1.920 1.000 Defaul

Full comment: Default processing factor for dried beef

21000460 M Beef, meat byproducts 0.337838 1.000 1.000

21000461 M Beef, meat byproducts-babyfood 0.337838 1.000 1.000

21000470 M Beef, fat 0.085405 1.000 1.000

21000471 M Beef,fat-babyfood 0.085405 1.000 1.000

21000480 M Beef, kidney 0.337838 1.000 1.000

21000490 M Beef, liver 0.337838 1.000 1.000

21000491 M Beef, liver-babyfood 0.337838 1.000 1.000

01010780 1AB Carrot 0.294667 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 80% CT

01010781 1AB Carrot-babyfood 0.294667 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 80% CT

01010790 1AB Carrot, juice 0.294667 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 80% CT

01010840 1AB Celeriac 1.000000 1.000 1.000 Tolera

Full comment: Tolerance from the TRED

04020850 4B Celery 0.018844 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 15% CT

04020851 4B Celery-babyfood 0.018844 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 15% CT

04020860 4B Celery, juice 0.018844 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 15% CT

15001200 15 Corn, field, flour 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001201 15 Corn, field, flour-babyfood 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001210 15 Corn, field, meal 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001211 15 Corn, field, meal-babyfood 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001220 15 Corn, field, bran 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001230 15 Corn, field, starch 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001231 15 Corn, field, starch-babyfood 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001240 15 Corn, field, syrup 0.000633 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT; Default HFCS CF

15001241 15 Corn, field, syrup-babyfood 0.000633 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT; Default HFCS CF

15001250 15 Corn, field, oil 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001251 15 Corn, field, oil-babyfood 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001260 15 Corn, pop 0.000633 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001270 15 Corn, sweet 0.000138 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

15001271 15 Corn, sweet-babyfood 0.000138 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

95001280 O Cottonseed, oil 0.000500 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1%CT

95001281 O Cottonseed, oil-babyfood 0.000500 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1%CT

23001690 M Goat, meat 0.012567 1.000 1.000

23001700 M Goat, meat byproducts 0.337838 1.000 1.000

23001710 M Goat, fat 0.085405 1.000 1.000

23001720 M Goat, kidney 0.337838 1.000 1.000

23001730 M Goat, liver 0.337838 1.000 1.000

24001890 M Horse, meat 0.012567 1.000 1.000

06032030 6C Lentil, seed 0.017667 1.000 1.000 Sectio

Full comment: Section 18 Use; Avg FT; 100%CT

27002220 D Milk, fat 0.010000 1.000 1.000

27002221 D Milk, fat - baby food/infant for 0.010000 1.000 1.000

27012230 D Milk, nonfat solids 0.010000 1.000 1.000

27012231 D Milk, nonfat solids-baby food/in 0.010000 1.000 1.000

27022240 D Milk, water 0.010000 1.000 1.000

27022241 D Milk, water-babyfood/infant form 0.010000 1.000 1.000

27032251 D Milk, sugar (lactose)-baby food/ 0.010000 1.000 1.000

04012480 4A Parsley, leaves 0.113333 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

19012490 19A Parsley, dried leaves 0.113333 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

19012491 19A Parsley, dried leaves-babyfood 0.113333 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

01012500 1AB Parsley, turnip rooted 0.113333 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

01012510 1AB Parsnip 0.050000 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

01012511 1AB Parsnip-babyfood 0.050000 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

25002900 M Pork, meat 0.002435 1.000 1.000

25002901 M Pork, meat-babyfood 0.002435 1.000 1.000

25002910 M Pork, skin 0.004136 1.000 1.000

25002920 M Pork, meat byproducts 0.065445 1.000 1.000

25002921 M Pork, meat byproducts-babyfood 0.065445 1.000 1.000

25002930 M Pork, fat 0.004136 1.000 1.000

25002931 M Pork, fat-babyfood 0.004136 1.000 1.000

25002940 M Pork, kidney 0.065445 1.000 1.000

25002950 M Pork, liver 0.065445 1.000 1.000

01032960 1C Potato, chips 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT;baking factor

01032970 1C Potato, dry (granules/ flakes) 0.002643 6.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT;default drying factor

01032971 1C Potato, dry (granules/ flakes)-b 0.002643 6.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT;default drying factor

01032980 1C Potato, flour 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT; baking factor

01032981 1C Potato, flour-babyfood 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT; baking factor

01032990 1C Potato, tuber, w/peel 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT; baking factor

01032991 1C Potato, tuber, w/peel-babyfood 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT; baking factor

01033000 1C Potato, tuber, w/o peel 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT; baking factor

01033001 1C Potato, tuber, w/o peel-babyfood 0.002643 1.500 1.000 Avg FT

Full comment: Avg FT corrected for 5% CT; baking factor

04023220 4B Rhubarb 0.500000 1.000 1.000 Tolera

Full comment: Tolerance from the TRED

26003390 M Sheep, meat 0.012567 1.000 1.000

26003391 M Sheep, meat-babyfood 0.012567 1.000 1.000

26003400 M Sheep, meat byproducts 0.337838 1.000 1.000

26003410 M Sheep, fat 0.085405 1.000 1.000

26003411 M Sheep, fat-babyfood 0.085405 1.000 1.000

26003420 M Sheep, kidney 0.337838 1.000 1.000

26003430 M Sheep, liver 0.337838 1.000 1.000

15003440 15 Sorghum, grain 0.002500 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1%CT

15003450 15 Sorghum, syrup 0.002500 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1%CT

06003470 6 Soybean, seed 0.002796 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

06003480 6 Soybean, flour 0.002796 1.200 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT; meal CF applied

06003481 6 Soybean, flour-babyfood 0.002796 1.200 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT; meal CF applied

06003490 6 Soybean, soy milk 0.002796 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

06003491 6 Soybean, soy milk-babyfood or in 0.002796 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT

06003500 6 Soybean, oil 0.002796 0.200 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT; oil reduction factor

06003501 6 Soybean, oil-babyfood 0.002796 0.200 1.000 Avg FT

Full comment: Avg FT corrected for 1% CT; oil reduction factor

86010000 O Water, direct, all sources 0.018000 1.000 1.000 EEC fr

Full comment: EEC from TRED

86020000 O Water, indirect, all sources 0.018000 1.000 1.000 EEC fr

Full comment: EEC from TRED

15004010 15 Wheat, grain 0.045000 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

15004011 15 Wheat, grain-babyfood 0.000450 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

15004020 15 Wheat, flour 0.000450 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

15004021 15 Wheat, flour-babyfood 0.000450 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

15004030 15 Wheat, germ 0.000450 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

15004040 15 Wheat, bran 0.000450 1.000 1.000 Avg FT

Full comment: Avg FT corrected for 100% CT

Attachment 5. Chronic Results File

U.S. Environmental Protection Agency Ver. 2.00

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

Residue file name: C:\\Documents and Settings\\ddavis05\\DEEM
files\\linuron chronic f_w.R98

Adjustment factor #2 NOT used.

Analysis Date 03-25-2008/10:11:32 Residue file dated:
03-25-2008/10:09:13/8

Reference dose (RfD, Chronic) = .0077 mg/kg bw/day

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

Total exposure by population subgroup

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

Total Exposure

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

Population mg/kg Percent of

Subgroup body wt/day Rfd

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

U.S. Population (total) 0.000556 7.2%

U.S. Population (spring season) 0.000553 7.2%

U.S. Population (summer season) 0.000571 7.4%

U.S. Population (autumn season) 0.000550 7.1%

U.S. Population (winter season) 0.000550 7.1%

Northeast region 0.000524 6.8%

Midwest region 0.000568 7.4%

Southern region 0.000519 6.7%

Western region 0.000631 8.2%

Hispanics 0.000632 8.2%

Non-hispanic whites 0.000545 7.1%

Non-hispanic blacks 0.000517 6.7%

Non-hisp/non-white/non-black 0.000675 8.8%

All infants (\< 1 year) 0.001718 22.3%

Nursing infants 0.000710 9.2%

Non-nursing infants 0.002101 27.3%

Children 1-6 yrs 0.001036 13.5%

Children 7-12 yrs 0.000602 7.8%

Females 13-19 (not preg or nursing) 0.000388 5.0%

Females 20+ (not preg or nursing) 0.000498 6.5%

Females 13-50 yrs 0.000501 6.5%

Females 13+ (preg/not nursing) 0.000528 6.9%

Females 13+ (nursing) 0.000707 9.2%

Males 13-19 yrs 0.000431 5.6%

Males 20+ yrs 0.000464 6.0%

Seniors 55+ 0.000500 6.5%

Children 1-2 yrs 0.001220 15.8%

Children 3-5 yrs 0.000974 12.7%

Children 6-12 yrs 0.000641 8.3%

Youth 13-19 yrs 0.000411 5.3%

Adults 20-49 yrs 0.000474 6.2%

Adults 50+ yrs 0.000498 6.5%

Females 13-49 yrs 0.000472 6.1%

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

Attachment 6. SLUA

![](media/image2.wmf){width="5.990277777777778in"
height="6.501388888888889in"}