[Federal Register Volume 88, Number 93 (Monday, May 15, 2023)]
[Notices]
[Pages 30985-30986]
[FR Doc No: 2023-10317]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-1069; FDA-2019-E-1075; and FDA-2019-E-1073]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Onpattro

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Onpattro and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by July 14, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by November 13, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 14, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-1069; FDA-2019-E-1075; and FDA-2019-E-1073 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ONPATTRO.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670)

generally provide that a patent may be extended for a period of up to 5
years so long as the patented item (human drug or biologic product,
animal drug product, medical device, food additive, or color additive)
was subject to regulatory review by FDA before the item was marketed.
Under these acts, a product's regulatory review period forms the basis
for determining the amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Onpattro
(patisiran), indicated for the treatment of the polyneuropathy of
hereditary transthyretin-mediated amyloidosis in adults. Subsequent to
this approval, the USPTO received patent term restoration applications
for Onpattro (U.S. Patent Nos. 8,168,775; 8,741,866; 9,234,196) from
Alnylam Pharmaceuticals, Inc., and the USPTO requested FDA's assistance
in determining the patents' eligibility for patent term restoration. In
a letter dated July 14, 2020, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of Onpattro represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Onpattro is 1,901 days. Of this time, 1,658 days occurred during the
testing phase of the regulatory review period, while 243 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
May 29, 2013. Alnylam Pharmaceuticals, Inc. claims that June 7, 2013,
is the date the investigational new drug application (IND) became
effective. However, FDA's records indicate that the effective date of
the IND was May 29, 2013, which was the first date after receipt of the
IND that the investigational studies could proceed.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: December 11,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for Onpattro (NDA 210922) was initially submitted on
December 11, 2017.
    3. The date the application was approved: August 10, 2018. FDA has
verified the applicant's claim that NDA 210922 was approved on August
10, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 593 days, 887 days or 1,025 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: May 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10317 Filed 5-12-23; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

                                                                     OFFICE OF CHEMICAL SAFETY AND

                                                                                POLLUTION PREVENTION

June 30, 2010

SUBJECT:	S-metolachlor - Acute and Chronic Dietary and Drinking Water Exposure and Risk Assessment for Proposed New Use of  S-metolachlor on Bushberry Subgroup 13-07B; Caneberry Subgroup 13-07A; Carrot; Cucumber; Leafy Brassica Greens Subgroup 5B; Melon Subgroup 9A; Okra; Bulb Onion Subgroup 3-07A; Green Onion Subgroup 3-07B; Sesame Seed; Sorghum; and Turnip Greens.

PC Code:  108800	DP Barcode: 370429

Decision No.:  418569	Registration No.: 100-816, 100-818

Petition No.:  9E7607	Regulatory Action:  Section 3

Risk Assessment Type:  Dietary	Case No.:  NA

TXR No.:  NA	CAS No.:  87392-12-9

MRID No.:  NA	40 CFR:  §180.368(a)(2)

FROM:	Becky Daiss, Biologist

		Risk Assessment Branch IV

		Health Effects Division (7509P)

THROUGH:	Thurston Morton, Chemist

		Susan Hummel, Branch Senior Scientist

		Risk Assessment Branch IV

		Health Effects Division (7509P)

TO:		Sydney Jackson, Risk Manager Reviewer

		RIMUER Branch

		Registration Division (7505P)

This document provides acute and chronic dietary and drinking water risk analyses of exposures resulting from use of S-metolochalor as an herbicide on food crops.  Executive Summary

Acute and chronic dietary risk assessments were conducted for S-metolachlor 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.  The analyses were performed to support a Section 3 request for proposed new uses of S-metolachlor on Bushberry Subgroup 13-07B; Caneberry Subgroup 13-07A; Carrot; Cucumber; Leafy Brassica Greens Subgroup 5B; Melon Subgroup 9A; Okra; Bulb Onion Subgroup 3-07A; Green Onion Subgroup 3-07B; Sesame Seed; Sorghum; and Turnip Greens.

Acute Dietary Exposure Results and Characterization

A conservative acute dietary exposure analysis was performed for the general U.S. population and various population subgroups.  Tolerance level residues and 100 crop treated assumptions were used.  DEEM default processing factors were used to modify the tolerance values. The acute analysis incorporated the 1 in 10 year peak surface drinking water estimate from application of S-metolachlor on turf.  This assessment concludes that, for all supported commodities, the acute dietary exposure estimates are below HED’s level of concern.    SEQ CHAPTER \h \r 1 The 95th percentile acute dietary exposure estimate for the highest exposed population subgroup, infants < 1 year old, is 0.05 mg/kg/day or 2% of the aPAD.

Chronic Dietary Exposure Results and Characterization

A conservative chronic dietary exposure analysis was performed for the general U.S. population and various population subgroups.  Tolerance level residues and 100 crop treated assumptions were used.  DEEM default processing factors were used to modify the tolerance values.  The chronic analysis incorporated the 10 year average surface drinking water estimate from application of S-metolachlor to turf.  The chronic dietary exposure estimate for the highest exposed population subgroup, infants < 1 year old, is 0.012 mg/kg/day or 12% of the cPAD.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the Reference Dose (RfD) divided by the FQPA Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:    HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA_PEST/2000/July/Day_12/6061.pdf  ; or see SOP 99.6 (8/20/99).

II.	Residue Information

	S-metolachlor is an isomer enriched formula comprised of 88% S-isomer and 12% R-isomer.  S-metolachlor is registered by Syngenta.  Permanent tolerances are established at 40 CFR §180.368(a)(2) for S-metolachlor in/on a variety of crop commodities, at levels ranging from 0.02 in/on meat and dairy products to 20 ppm in/on peanut hay.  The Metabolism Assessment Review Committee (MARC) determined that the residues of concern for plant and animal commodities are metolachlor and its metabolites, determined as the derivatives CGA-37913 and CGA-49751.  Metabolites of metolachlor are assumed to be toxicologically equivalent to parent metolachlor.  The residues of concern for S-metolachlor are the same as those for metolachlor.  (D226780, L. Kutney, 11/12/96)   In cases where separate tolerance listings occur for both metolachlor and S-metolachlor on the same commodity, the higher value of the two is used in the analyses.  Residues used in the acute and chronic dietary analyses are provided in Tables 1 and 2.

Table 1. Metolachlor Tolerances

Commodity	Tolerance (ppm)

Almond, hulls	0.3

Animal feed, nongrass, group 18	1

Cattle, fat; Cattle, meat	0.02

Cattle, kidney	0.2

Cattle, liver	0.05

Cattle, meat byproducts, except kidney and liver	0.04

Corn, field, forage; Corn, field, stover; Corn, sweet, forage; Corn, sweet, stover	6

Corn, field, grain	0.1

Corn, sweet, kernel plus cob with husks removed	0.1

Cotton, gin byproducts	4

Cotton, undelinted seed	0.1

Dillweed	0.5

Egg	0.02

Goat, fat; Goat, meat	0.02

Goat, kidney	0.2

Goat, liver	0.05

Goat, meat byproducts, except kidney and liver	0.04

Grass, forage	10

Grass, hay	0.2

Horse, fat; Horse, meat	0.02

Horse, kidney	0.2

Horse, liver	0.05

Horse, meat byproducts, except kidney and liver	0.04

Milk	0.02

Nut, tree, group 14	0.1

Okra	0.5

Peanut	0.2

Peanut, hay	20

Peanut, meal	0.4

Potato	0.2

Poultry, fat; Poultry, meat	0.02

Poultry, meat byproducts	0.05

Safflower, seed	0.1

Sheep, fat; Sheep, meat	0.02

Sheep, kidney	0.2

Sheep, liver	0.05

Sheep, meat byproducts, except kidney and liver	0.04

Sorghum, grain, forage	1

Sorghum, grain, grain	0.3

Sorghum, grain, stover	4

Soybean, forage	5

Soybean, hay	8

Soybean, seed	0.2

Tomato	0.1

Vegetable, foliage of legume, subgroup 7A, except soybean	15

Vegetable, legume, group 6	0.3

Table 2. S-Metolachlor Tolerances

Commodity	Tolerance (ppm)

Asparagus	0.1

Beet, sugar, molasses	2

Beet, sugar, roots	0.5

Beet, sugar, tops	15

Brassica, head and stem, subgroup 5A	0.6

Bushberry subgroup 13-07B	0.15

Caneberry, Subgroup 13-07A	0.1

Carrot	0.40

Cattle, fat; Cattle, meat	0.02

Cattle, kidney	0.2

Cattle, liver	0.05

Cattle, meat byproducts, except kidney and liver	0.04

Corn, field, grain	0.1

Corn, field, forage; Corn, field, stover; Corn, pop, stover; Corn, sweet, forage; Corn, sweet, stover	6

Corn, pop, grain	0.1

Corn, sweet, kernel plus cob with husks removed	0.1

Cotton, gin byproducts	4

Cotton, undelinted seed	0.1

Cucumber	0.1

Egg	0.02

Garlic, bulb	0.1

Grain, aspirated fractions	0.7

Goat, fat; Goat, meat	0.02

Goat, kidney	0.2

Goat, liver	0.05

Goat, meat byproducts, except kidney and liver	0.04

Grass, forage	10

Grass, hay	0.2

Horse, fat; Horse, meat	0.02

Horse, kidney	0.2

Horse, liver	0.05

Horse, meat byproducts, except kidney and liver	0.04

Leafy Brassica Greens, Subgroup 5-B	1.8

Leaf petioles, subgroup 4B	0.1

Milk	0.02

Melon subgroup 9A	0.1

Okra	0.10

Onion, Bulb, Subgroup 3-07A	0.1

Onion, Green, Subgroup 3-07B	2

Peanut	0.2

Peanut, hay	20

Peanut, meal	0.4

Pepper, non-bell	0.50

Pepper, tobasco	0.50

Poultry, fat; Poultry, meat	0.02

Poultry, meat byproducts	0.05

Pumpkin	0.1

Safflower, seed	0.1

Sesame, seed	0.13

Sesame, seed-babyfood	0.13

Sesame, oil	0.13

Sesame, oil-babyfood	0.13

Shallot, bulb	0.1

Sheep, fat; Sheep, meat	0.02

Sheep, kidney	0.2

Sheep, liver	0.05

Sheep, meat byproducts, except kidney and liver	0.04

Sorghum, grain, forage	1

Sorghum, grain, grain	0.3

Sorghum, grain, stover	4

Soybean, forage	5

Soybean, hay	8

Soybean, seed	0.2

Spinach	0.5

Squash, winter	0.1

Sunflower, seed	0.5

Sunflower, meal	1

Tomato, paste	0.3

Turnip Greens	1.8

Vegetable, foliage of legume, except soybean, subgroup 7A	15

Vegetable, fruiting, group 8, except tabasco pepper	0.1

Vegetable, legume, group 6	0.3

Vegetable, root, except sugar beet, subgroup 1B	0.3

Vegetable, tuberous and corm, subgroup 1C	0.2

Table 3. Metolachlor Inadvertant Tolerances

Commodities	Tolerance (ppm)

Animal feed, nongrass, group 18	1.0

Barley, grain	0.10

Barley, hay	0.80

Barley, straw	0.80

Buckwheat, grain	0.10

Millet, forage	0.50

Millet, grain	0.10

Millet, hay	0.80

Millet, straw	0.80

Oat, forage	0.50

Oat, grain	0.10

Oat, hay	0.80

Oat, straw	0.80

Rice, grain	0.10

Rye, forage	0.50

Rye, grain	0.10

Rye, straw	0.80

Wheat, forage	0.50

Wheat, grain	0.10

Wheat, hay	0.80

Wheat, straw	0.80

Table 4. S-Metolachlor Inadvertant Tolerances

Commodity	Tolerance (ppm)

Animal feed, nongrass, group 18	1.0

Barley, grain	0.10

Barley, hay	0.50

Barley, straw	0.50

Buckwheat, grain	0.10

Millet, forage	0.50

Millet, grain	0.10

Millet, hay	0.50

Millet, straw	0.50

Oat, forage	0.50

Oat, grain	0.10

Oat, hay	0.50

Oat, straw	0.50

Rice, grain	0.10

Rye, forage	0.50

Rye, grain	0.10

Rye, straw	0.50

Wheat, forage	0.50

Wheat, grain	0.10

Wheat, hay	0.50

Wheat, straw	0.50

III.	Water Data

The Environmental Fate and Effects Division (EFED) calculated conservative, Tier I Estimated Drinking Water Concentrations (EDWCs) of metolachlor and S-metolachlor in ground water and surface water for use in the human health risk assessment (D368735, C. Koper, 4/22/10).  EDWCs for metolachlor and S-metolachlor were calculated for both the parent compound and the ethanesulfonic acid (ESA) and oxanilic acid (OA) degradates.  Although it was determined by the MARC that the ESA and OA metabolites appear to be less toxic than parent metolachlor, they are included in the risk assessment since they were found in greater abundance than the parent in water monitoring studies.

This drinking water assessment was conducted on the parent S-metolachlor and its major degradates ethanesulfonic acid (ESA) and oxanilic acid (OA).  The environmental fate data has been bridged from the racemic mixture (50:50) of metolachlor to the newer isomer (88:12) s-metolachlor, based on similarities in environmental fate behavior.  Tier I and Tier II screening models were employed for this assessment.  For surface water, PRZM/EXAMS (PE5) and FIRST (FQPA Index Reservoir Screening Tool) Version1.1.1 models were used to estimate drinking water concentrations for the parent s-metolachlor and the ESA and OA degradates, respectively.  The SCI-GROW model (Screening Concentration in Ground Water Program Version 2.3) was used to predict the maximum acute and chronic concentrations present in shallow groundwater.  In addition, since the previous EDWCs for surface water for the parent s-metolachlor were based on NAWQA monitoring data, a search of the available monitoring data was performed on March 30, 2010 to ensure that the most current monitoring data were considered in this assessment.  The data set captured the timeframe of October 1991 to October 2009 and included the parent s-metolachlor and its degradates ESA and OA.  Based on a review of the current monitoring data, concentrations of parent s-metolachlor and its degradates were less than values reported from the previous monitoring data (US EPA, 2002).  Therefore, EDWCs based on previous monitoring are still valid.  The recommended total EEC’s for peak and average surface water respectively are 219 ppb (78 ppb parent + 48 ppb ESA+ 94 ppb OA) and 119 ppb (18 ppb parent + 34 ppb ESA+ 34 ppb OA).  Recommended groundwater EECs (peak and average) are 126 ppb (33 ppb parent + 64 ppb ESA+ 30 OA).  A summary of recommended surface and groundwater EDWCs for the human dietary risk assessment for the parent s-metolachlor and its degradates ESA and OA are presented in Table 5.

Table 5. Recommended Drinking Water Concentrations (EDWCs) and Source for Surface Water and Groundwater for Human Dietary Health Risk Assessment

Chemical Identity 	Acute  (µg/L)	Average (µg/L)	Cancer Chronic (µg/L)

Surface Water

S-Metolachlor (parent)

	77.60 (monitoring data)	18.15CA (cole crop)	9.15 (KS sorghum)

Ethanesulfonic Acid (ESA)

	47.61(caneberry)	34.04 (caneberry)	34.04 (caneberry)

Oxanilic Acid (OA)

	93.57 (caneberry)	66.62 (caneberry)	66.62 (caneberry)

Total 	218.78	118.81	109.81

Groundwater

S-Metolachlor (parent)

	32.8 (monitoring data)	32.8 (monitoring data)	32.8 (monitoring data)

Ethanesulfonic Acid (ESA)

	63.7 (monitoring data)	63.7 (monitoring data)	63.7 (monitoring data)

Oxanilic Acid (OA)

	29.7 (caneberry)	29.7 (caneberry)	29.7 (caneberry)

Total 	126.2	126.2	126.2

IV.	DEEM-FCID™ Program and Consumption Information

S-metolachlor 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.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption 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., 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 significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

V.	Toxicological Information

HED evaluated the toxicology data base for S-metolachlor and selected the following doses and endpoints for acute and chronic dietary and drinking water risk assessments.

Table 6. Summary of Toxicological Endpoints for S-metolachlor for Use in Dietary Human Health Risk Assessments

Exposure

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, LOC for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(general population)	NOAEL = 300 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Acute RfD = 3.0 mg/kg/day

aPAD = 3.0 mg/kg/day	Developmental Toxicity Study - Rat

LOAEL = 1000 mg/kg/day based increased incidence of death, clinical signs (clonic and/or tonic convulsions, excessive salivation, urine-stained abdominal fur and/or excessive lacrimation) and decreased body weight gain.

Chronic Dietary

(all populations)	NOAEL = 9.7

mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Chronic RfD = 0.097

mg/kg/day

cPAD = 0.97mg/kg/day	Chronic Toxicity - Dog;

LOAEL = 33 mg/kg/day based decreased body weight gain in females

Cancer

(all routes)	Metolachlor has been classified as a Group C carcinogen with risk quantitated using a non-linear (Margin of Exposure) approach.

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.

NOAEL = no observed adverse effect level.

LOAEL = lowest observed adverse effect level.

UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).

FQPA SF = FQPA Safety Factor.

PAD = population adjusted dose (a = acute, c = chronic).

RfD = reference dose.

VI.	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 Tables 7 and 8 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary Exposure Analysis

Table 7:  Summary of Acute Dietary Exposure and Risk for S-metolachlor and Metolachlor

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

Exposure (mg/kg/day)	%aPAD

General U.S. Population	3.0	0.0146	<1

All Infants (< 1 year old)

0.0460	2

Children 1-2 years old

0.0248	<1

Children 3-5 years old

0.0222	<1

Children 6-12 years old

0.0154	<1

Youth 13-19 years old

0.0115	<1

Adults 20-49 years old

0.0127	<1

Adults 50+ years old

0.0114	<1

Females 13-49 years old

0.0126	<1

Results of Chronic Dietary Exposure Analysis

Table 8:  Summary of Chronic Dietary Exposure and Risk for S-metolachlor and Metolachlor

Population Subgroup	cPAD (mg/kg/day)	Chronic

Exposure (mg/kg/day)	%cPAD

General U.S. Population	0.1	0.0045	5

All Infants (< 1 year old)

0.0114	11

Children 1-2 years old

0.0085	9

Children 3-5 years old

0.0077	8

Children 6-12 years old

0.0053	5

Youth 13-19 years old

0.0036	4

Adults 20-49 years old

0.0039	4

Adults 50+ years old

0.0040	4

Females 13-49 years old

0.0039	4

VI.	Characterization of Inputs/Outputs

The acute and chronic dietary analyses are very conservative.  Tolerance level residues used in the analysis are expected to exceed the residues actually consumed.  In addition, the 100% crop treated estimate used for all crops in the assessment will considerably overestimate the actual percent crop treated.

VII.	Conclusions

Based on analyses of estimated dietary risks for the general U.S. population and various population subgroups, the acute and chronic dietary exposure estimates for S-metolachlor are significantly below HED’s level of concern for all supported commodities (Tables 7 and 8).  The 95th percentile acute dietary exposure estimate for the highest exposed population subgroup, infants < 1 year old is 0.05 mg/kg/day or 2% of the aPAD.  The chronic dietary exposure estimate for the highest exposed population subgroup, infants < 1 year old is 0.012 mg/kg/day or 12% of the cPAD.

VIII.	List of Attachments

1.  Acute DEEM-FCID Residue Input File.

2.  Results of Acute DEEM-FCID Dietary Exposure Analysis.

3.  Chronic DEEM-FCID Residue Input File.

4.  Results of Chronic DEEM-FCID Dietary Exposure Analysis.

Attachment 1 Acute DEEM-FCID Residue Input File

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for METOLACHLOR AND S-METOLACHLOR

Residue file name: F:\S-metolachlor\108801a4-28-10.R98

Analysis Date 04-29-2010             Residue file dated: 06-22-2010/14:44:23/8

Reference dose: aRfD = 3 mg/kg bw/day  NOEL = 300 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

14000030 14   Almond                             0.100000   1.000      1.000

14000031 14   Almond-babyfood                    0.100000   1.000      1.000

14000040 14   Almond, oil                        0.100000   1.000      1.000

14000041 14   Almond, oil-babyfood               0.100000   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

95000190 O    Asparagus                          0.100000   1.000      1.000

15000250 15   Barley, pearled barley             0.100000   1.000      1.000

15000251 15   Barley, pearled barley-babyfood    0.100000   1.000      1.000

15000260 15   Barley, flour                      0.100000   1.000      1.000

15000261 15   Barley, flour-babyfood             0.100000   1.000      1.000

15000270 15   Barley, bran                       0.100000   1.000      1.000

06030300 6C   Bean, black, seed                  0.300000   1.000      1.000

06020310 6B   Bean, broad, succulent             0.300000   1.000      1.000   Additional data required.

06030320 6C   Bean, broad, seed                  0.300000   1.000      1.000

06020330 6B   Bean, cowpea, succulent            0.300000   1.000      1.000   Additional data required.

06030340 6C   Bean, cowpea, seed                 0.300000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.300000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.300000   1.000      1.000

06020370 6B   Bean, lima, succulent              0.300000   1.000      1.000   Additional data required.

06030380 6C   Bean, lima, seed                   0.300000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.300000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.300000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.300000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.300000   1.000      1.000

06010430 6A   Bean, snap, succulent              0.300000   1.000      1.000   Additional data required.

06010431 6A   Bean, snap, succulent-babyfood     0.300000   1.000      1.000   Additional data required.

21000440 M    Beef, meat                         0.020000   1.000      1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000      1.000

21000450 M    Beef, meat, dried                  0.020000   1.920      1.000

21000460 M    Beef, meat byproducts              0.040000   1.000      1.000

21000461 M    Beef, meat byproducts-babyfood     0.040000   1.000      1.000

21000470 M    Beef, fat                          0.020000   1.000      1.000

21000471 M    Beef,fat-babyfood                  0.020000   1.000      1.000

21000480 M    Beef, kidney                       0.200000   1.000      1.000

21000490 M    Beef, liver                        0.050000   1.000      1.000

21000491 M    Beef, liver-babyfood               0.050000   1.000      1.000

01010500 1AB  Beet, garden, roots                0.300000   1.000      1.000

01010501 1AB  Beet, garden, roots-babyfood       0.300000   1.000      1.000

01010520 1A   Beet, sugar                        0.500000   1.000      1.000

01010521 1A   Beet, sugar-babyfood               0.500000   1.000      1.000

01010530 1A   Beet, sugar, molasses              2.000000   1.000      1.000

01010531 1A   Beet, sugar, molasses-babyfood     2.000000   1.000      1.000

13010550 13A  Blackberry                         0.100000   1.000      1.000   PP#6E7607

13010560 13A  Blackberry, juice                  0.100000   1.000      1.000   PP#6E7607

13010561 13A  Blackberry, juice-babyfood         0.100000   1.000      1.000   PP#6E7607

13020570 13B  Blueberry                          0.150000   1.000      1.000   PP#6E7607

13020571 13B  Blueberry-babyfood                 0.150000   1.000      1.000   PP#6E7607

13010580 13A  Boysenberry                        0.100000   1.000      1.000   PP#6E7607

14000590 14   Brazil nut                         0.100000   1.000      1.000

05010610 5A   Broccoli                           0.600000   1.000      1.000

05010611 5A   Broccoli-babyfood                  0.600000   1.000      1.000

05010620 5A   Broccoli, Chinese                  0.600000   1.000      1.000

05020630 5B   Broccoli raab                      1.800000   1.000      1.000   PP#6E7607

05010640 5A   Brussels sprouts                   0.600000   1.000      1.000

15000650 15   Buckwheat                          0.100000   1.000      1.000   Additional data required.

15000660 15   Buckwheat, flour                   0.100000   1.000      1.000   Additional data required.

01010670 1AB  Burdock                            0.300000   1.000      1.000

14000680 14   Butternut                          0.100000   1.000      1.000

05010690 5A   Cabbage                            0.600000   1.000      1.000

05020700 5B   Cabbage, Chinese, bok choy         1.800000   1.000      1.000   PP#6E7607

05010710 5A   Cabbage, Chinese, napa             0.600000   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          0.600000   1.000      1.000

09010750 9A   Cantaloupe                         0.100000   1.000      1.000   PP#6E7607

04020760 4B   Cardoon                            0.100000   1.000      1.000

01010780 1AB  Carrot                             0.400000   1.000      1.000   PP#6E7607

01010781 1AB  Carrot-babyfood                    0.400000   1.000      1.000   PP#6E7607

01010790 1AB  Carrot, juice                      0.400000   1.000      1.000   PP#6E7607

09010800 9A   Casaba                             0.100000   1.000      1.000   PP#6E7607

14000810 14   Cashew                             0.100000   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                        0.600000   1.000      1.000

01010840 1AB  Celeriac                           0.300000   1.000      1.000

04020850 4B   Celery                             0.100000   1.000      1.000

04020851 4B   Celery-babyfood                    0.100000   1.000      1.000

04020860 4B   Celery, juice                      0.100000   1.000      1.000

04020870 4B   Celtuce                            0.100000   1.000      1.000

14000920 14   Chestnut                           0.100000   1.000      1.000

40000930 P    Chicken, meat                      0.020000   1.000      1.000

40000931 P    Chicken, meat-babyfood             0.020000   1.000      1.000

40000940 P    Chicken, liver                     0.050000   1.000      1.000

40000950 P    Chicken, meat byproducts           0.050000   1.000      1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.020000   1.000      1.000

40000960 P    Chicken, fat                       0.040000   1.000      1.000

40000961 P    Chicken, fat-babyfood              0.040000   1.000      1.000

40000970 P    Chicken, skin                      0.050000   1.000      1.000

40000971 P    Chicken, skin-babyfood             0.050000   1.000      1.000

06030980 6C   Chickpea, seed                     0.300000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.300000   1.000      1.000

06030990 6C   Chickpea, flour                    0.300000   1.000      1.000

01011000 1AB  Chicory, roots                     0.300000   1.000      1.000

05021170 5B   Collards                           1.800000   1.000      1.000   PP#6E7607

15001200 15   Corn, field, flour                 0.100000   1.000      1.000

15001201 15   Corn, field, flour-babyfood        0.100000   1.000      1.000

15001210 15   Corn, field, meal                  0.100000   1.000      1.000

15001211 15   Corn, field, meal-babyfood         0.100000   1.000      1.000

15001220 15   Corn, field, bran                  0.100000   1.000      1.000

15001230 15   Corn, field, starch                0.100000   1.000      1.000

15001231 15   Corn, field, starch-babyfood       0.100000   1.000      1.000

15001240 15   Corn, field, syrup                 0.100000   1.500      1.000

15001241 15   Corn, field, syrup-babyfood        0.100000   1.500      1.000

15001250 15   Corn, field, oil                   0.100000   1.000      1.000

15001251 15   Corn, field, oil-babyfood          0.100000   1.000      1.000

15001260 15   Corn, pop                          0.100000   1.000      1.000

15001270 15   Corn, sweet                        0.100000   1.000      1.000

15001271 15   Corn, sweet-babyfood               0.100000   1.000      1.000

95001280 O    Cottonseed, oil                    0.100000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.100000   1.000      1.000

09021350 9B   Cucumber                           0.100000   1.000      1.000   PP#6E7607

13021360 13B  Currant                            0.150000   1.000      1.000   PP#6E7607

13021370 13B  Currant, dried                     0.150000   1.000      1.000   PP#6E7

  Full comment: PP#6E7607

01031390 1CD  Dasheen, corm                      0.200000   1.000      1.000

13011420 13A  Dewberry                           0.100000   1.000      1.000   PP#6E7607

70001450 P    Egg, whole                         0.020000   1.000      1.000

70001451 P    Egg, whole-babyfood                0.020000   1.000      1.000

70001460 P    Egg, white                         0.020000   1.000      1.000

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000      1.000

70001470 P    Egg, yolk                          0.020000   1.000      1.000

70001471 P    Egg, yolk-babyfood                 0.020000   1.000      1.000

08001480 8    Eggplant                           0.100000   1.000      1.000

13021490 13B  Elderberry                         0.150000   1.000      1.000   PP#6E7607

04021520 4B   Fennel, Florence                   0.100000   1.000      1.000

14001550 14   Filbert                            0.100000   1.000      1.000

14001560 14   Filbert, oil                       0.100000   1.000      1.000

03001640 3    Garlic                             0.100000   1.000      1.000

03001650 3    Garlic, dried                      0.100000   9.000      1.000

03001651 3    Garlic, dried-babyfood             0.100000   9.000      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                     0.300000   1.000      1.000

23001690 M    Goat, meat                         0.020000   1.000      1.000

23001700 M    Goat, meat byproducts              0.040000   1.000      1.000

23001710 M    Goat, fat                          0.020000   1.000      1.000

23001720 M    Goat, kidney                       0.200000   1.000      1.000

23001730 M    Goat, liver                        0.050000   1.000      1.000

13021740 13B  Gooseberry                         0.150000   1.000      1.000   PP#6E7607

06031820 6C   Guar, seed                         0.300000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.300000   1.000      1.000

14001850 14   Hickory nut                        0.100000   1.000      1.000

09011870 9A   Honeydew melon                     0.100000   1.000      1.000   PP#6E7607

24001890 M    Horse, meat                        0.020000   1.000      1.000

01011900 1AB  Horseradish                        0.300000   1.000      1.000

13021910 13B  Huckleberry                        0.150000   1.000      1.000   PP#6E7607

05021940 5B   Kale                               1.800000   1.000      1.000   PP#6E7607

05011960 5A   Kohlrabi                           0.600000   1.000      1.000

03001980 3    Leek                               2.000000   1.000      1.000

06032030 6C   Lentil, seed                       0.300000   1.000      1.000

13012080 13A  Loganberry                         0.100000   1.000      1.000   PP#6E7607

14002130 14   Macadamia nut                      0.100000   1.000      1.000

27002220 D    Milk, fat                          0.020000   1.000      1.000

27002221 D    Milk, fat - baby food/infant for   0.020000   1.000      1.000

27012230 D    Milk, nonfat solids                0.020000   1.000      1.000

27012231 D    Milk, nonfat solids-baby food/in   0.020000   1.000      1.000

27022240 D    Milk, water                        0.020000   1.000      1.000

27022241 D    Milk, water-babyfood/infant form   0.020000   1.000      1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.020000   1.000      1.000

15002260 15   Millet, grain                      0.100000   1.000      1.000

05022290 5B   Mustard greens                     1.800000   1.000      1.000   PP#6E7607

15002310 15   Oat, bran                          0.100000   1.000      1.000

15002320 15   Oat, flour                         0.100000   1.000      1.000

15002321 15   Oat, flour-babyfood                0.100000   1.000      1.000

15002330 15   Oat, groats/rolled oats            0.100000   1.000      1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.100000   1.000      1.000

08002340 8    Okra                               0.500000   1.000      1.000   PP#6E7607

03002370 3    Onion, dry bulb                    0.100000   1.000      1.000   PP#6E7607

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000      1.000   PP#6E7607

03002380 3    Onion, dry bulb, dried             0.100000   9.000      1.000   PP#6E7607

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000      1.000   PP#6E7607

03002390 3    Onion, green                       2.000000   1.000      1.000   PP#6E7607

01012500 1AB  Parsley, turnip rooted             0.300000   1.000      1.000

01012510 1AB  Parsnip                            0.300000   1.000      1.000

01012511 1AB  Parsnip-babyfood                   0.300000   1.000      1.000

06022550 6B   Pea, succulent                     0.300000   1.000      1.000   Additional data required.

06022551 6B   Pea, succulent-babyfood            0.300000   1.000      1.000

06032560 6C   Pea, dry                           0.300000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.300000   1.000      1.000

06012570 6A   Pea, edible podded, succulent      0.300000   1.000      1.000   Additional data required.

06032580 6C   Pea, pigeon, seed                  0.300000   1.000      1.000

06022590 6B   Pea, pigeon, succulent             0.300000   1.000      1.000   Additional data required.

95002630 O    Peanut                             0.200000   1.000      1.000

95002640 O    Peanut, butter                     0.200000   1.890      1.000

95002650 O    Peanut, oil                        0.200000   1.000      1.000

14002690 14   Pecan                              0.100000   1.000      1.000

08002700 8    Pepper, bell                       0.100000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.100000   1.000      1.000

08002710 8    Pepper, bell, dried                0.100000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.100000   1.000      1.000

08002720 8    Pepper, nonbell                    0.500000   1.000      1.000   Tabasco peppers @ 0.5 ppm

08002721 8    Pepper, nonbell-babyfood           0.500000   1.000      1.000   Tabasco peppers @ 0.5 ppm

08002730 8    Pepper, nonbell, dried             0.500000   1.000      1.000   Tabasco peppers @ 0.5 ppm

14002820 14   Pistachio                          0.100000   1.000      1.000

01032960 1C   Potato, chips                      0.200000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.200000   6.500      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.200000   6.500      1.000

01032980 1C   Potato, flour                      0.200000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.200000   1.000      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               0.020000   1.000      1.000

60003020 P    Poultry, other, liver              0.050000   1.000      1.000

60003030 P    Poultry, other, meat byproducts    0.050000   1.000      1.000

60003040 P    Poultry, other, fat                0.020000   1.000      1.000

60003050 P    Poultry, other, skin               0.050000   1.000      1.000

09023080 9B   Pumpkin                            0.100000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000      1.000

01013140 1AB  Radish, roots                      0.300000   1.000      1.000

01013160 1AB  Radish, Oriental, roots            0.300000   1.000      1.000

05023180 5B   Rape greens                        1.800000   1.000      1.000   PP#9E7607

13013200 13A  Raspberry                          0.100000   1.000      1.000   PP#6E7607

13013201 13A  Raspberry-babyfood                 0.100000   1.000      1.000   PP#6E7607

13013210 13A  Raspberry, juice                   0.100000   1.000      1.000   PP#6E7607

13013211 13A  Raspberry, juice-babyfood          0.100000   1.000      1.000   PP#6E7607

04023220 4B   Rhubarb                            0.100000   1.000      1.000

15003230 15   Rice, white                        0.100000   1.000      1.000

15003231 15   Rice, white-babyfood               0.100000   1.000      1.000

15003240 15   Rice, brown                        0.100000   1.000      1.000

15003241 15   Rice, brown-babyfood               0.100000   1.000      1.000

15003250 15   Rice, flour                        0.100000   1.000      1.000

15003251 15   Rice, flour-babyfood               0.100000   1.000      1.000

15003260 15   Rice, bran                         0.100000   1.000      1.000

15003261 15   Rice, bran-babyfood                0.100000   1.000      1.000

01013270 1AB  Rutabaga                           0.300000   1.000      1.000

15003280 15   Rye, grain                         0.100000   1.000      1.000

15003290 15   Rye, flour                         0.100000   1.000      1.000

20003300 20   Safflower, oil                     0.100000   1.000      1.000

20003301 20   Safflower, oil-babyfood            0.100000   1.000      1.000

01013310 1AB  Salsify, roots                     0.300000   1.000      1.000

95003360 O    Sesame, seed                       0.130000   1.000      1.000   PP#6E7607

95003361 O    Sesame, seed-babyfood              0.130000   1.000      1.000   PP#6E7607

95003370 O    Sesame, oil                        0.130000   1.000      1.000   PP#6E7607

95003371 O    Sesame, oil-babyfood               0.130000   1.000      1.000   PP#6E7607

03003380 3    Shallot                            0.100000   1.000      1.000

26003390 M    Sheep, meat                        0.020000   1.000      1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.040000   1.000      1.000

26003410 M    Sheep, fat                         0.020000   1.000      1.000

26003411 M    Sheep, fat-babyfood                0.020000   1.000      1.000

26003420 M    Sheep, kidney                      0.200000   1.000      1.000

26003430 M    Sheep, liver                       0.050000   1.000      1.000

15003440 15   Sorghum, grain                     0.300000   1.000      1.000

15003450 15   Sorghum, syrup                     4.000000   1.000      1.000   PP#9E7607

06003470 6    Soybean, seed                      0.200000   1.000      1.000

06003480 6    Soybean, flour                     0.200000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.200000   1.000      1.000

06003490 6    Soybean, soy milk                  0.200000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.200000   1.000      1.000

06003500 6    Soybean, oil                       0.200000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.200000   1.000      1.000

04013550 4A   Spinach                            0.500000   1.000      1.000

04013551 4A   Spinach-babyfood                   0.500000   1.000      1.000

09023570 9B   Squash, winter                     0.100000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000      1.000

20003640 20   Sunflower, seed                    0.500000   1.000      1.000

20003650 20   Sunflower, oil                     0.500000   1.000      1.000

20003651 20   Sunflower, oil-babyfood            0.500000   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                        0.100000   1.000      1.000

01033710 1CD  Tanier, corm                       0.200000   1.000      1.000

08003740 8    Tomatillo                          0.100000   1.000      1.000

08003750 8    Tomato                             0.100000   1.000      1.000

08003751 8    Tomato-babyfood                    0.100000   1.000      1.000

08003760 8    Tomato, paste                      0.300000   5.400      1.000

08003761 8    Tomato, paste-babyfood             0.300000   5.400      1.000

08003770 8    Tomato, puree                      0.100000   3.300      1.000

08003771 8    Tomato, puree-babyfood             0.100000   3.300      1.000

08003780 8    Tomato, dried                      0.100000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.100000  14.300      1.000

08003790 8    Tomato, juice                      0.100000   1.500      1.000

95003800 O    Tomato, Tree                       0.100000   1.000      1.000

15003810 15   Triticale, flour                   0.100000   1.000      1.000

15003811 15   Triticale, flour-babyfood          0.100000   1.000      1.000

50003820 P    Turkey, meat                       0.020000   1.000      1.000

50003821 P    Turkey, meat-babyfood              0.020000   1.000      1.000

50003830 P    Turkey, liver                      0.050000   1.000      1.000

50003831 P    Turkey, liver-babyfood             0.050000   1.000      1.000

50003840 P    Turkey, meat byproducts            0.020000   1.000      1.000

50003841 P    Turkey, meat byproducts-babyfood   0.020000   1.000      1.000

50003850 P    Turkey, fat                        0.020000   1.000      1.000

50003851 P    Turkey, fat-babyfood               0.020000   1.000      1.000

50003860 P    Turkey, skin                       0.020000   1.000      1.000

50003861 P    Turkey, skin-babyfood              0.020000   1.000      1.000

01033870 1CD  Turmeric                           0.200000   1.000      1.000

01013880 1AB  Turnip, roots                      0.300000   1.000      1.000

05023890 5B   Turnip, greens                     1.800000   1.000      1.000   PP#9E7607

14003910 14   Walnut                             0.100000   1.000      1.000

86010000 O    Water, direct, all sources         0.219000   1.000      1.000

86020000 O    Water, indirect, all sources       0.219000   1.000      1.000

09013990 9A   Watermelon                         0.100000   1.000      1.000   PP#6E7607

09014000 9A   Watermelon, juice                  0.100000   1.000      1.000   PP#6E7607

15004010 15   Wheat, grain                       0.100000   1.000      1.000

15004011 15   Wheat, grain-babyfood              0.100000   1.000      1.000

15004020 15   Wheat, flour                       0.100000   1.000      1.000

15004021 15   Wheat, flour-babyfood              0.100000   1.000      1.000

15004030 15   Wheat, germ                        0.100000   1.000      1.000

15004040 15   Wheat, bran                        0.100000   1.000      1.000

15004050 15   Wild rice                          0.100000   1.000      1.000

01034060 1CD  Yam, true                          0.200000   1.000      1.000

01034070 1CD  Yam bean                           0.200000   1.000      1.000

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for METOLACHLOR AND S-METOLACHLOR       (1994-98 data)

Residue file: 108801a6-22-10.R98                      Adjustment factor #2 used.

Analysis Date: 06-22-2010/11:58:43    Residue file dated: 06-22-2010/11:44:40/8

NOEL (Acute) = 300.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: ""

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

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

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

U.S. Population:

  0.014583    0.49   20571    0.025112    0.84   11946    0.045324    1.51    6619

All infants:

  0.045989    1.53    6523    0.064649    2.15    4640    0.112342    3.74    2670

Children 1-2 yrs:

  0.024848    0.83   12073    0.037380    1.25    8025    0.051245    1.71    5854

Children 3-5 yrs:

  0.022147    0.74   13546    0.031638    1.05    9482    0.055819    1.86    5374

Children 6-12 yrs:

  0.015424    0.51   19450    0.023470    0.78   12782    0.031138    1.04    9634

Youth 13-19 yrs:

  0.011508    0.38   26068    0.019041    0.63   15755    0.033797    1.13    8876

Adults 20-49 yrs:

  0.012652    0.42   23712    0.019710    0.66   15220    0.034741    1.16    8635

Adults 50+ yrs:

  0.011412    0.38   26288    0.016008    0.53   18740    0.026010    0.87   11533

Females 13-49 yrs:

  0.012546    0.42   23912    0.019347    0.64   15506    0.034301    1.14    8746

Attachment 3.  Chronic DEEM-FCID Residue Input File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for METOLACHLOR AND S-METOLACHLOR      1994-98 data

Residue file: F:\S-metolachlor\108801c4-28-10.R98          Adjust. #2 NOT used

Analysis Date 04-29-2010             Residue file dated: 06-22-2010/14:47:25/8

Reference dose (RfD) = 0.1 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

14000030 14   Almond                             0.100000   1.000      1.000

14000031 14   Almond-babyfood                    0.100000   1.000      1.000

14000040 14   Almond, oil                        0.100000   1.000      1.000

14000041 14   Almond, oil-babyfood               0.100000   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

95000190 O    Asparagus                          0.100000   1.000      1.000

15000250 15   Barley, pearled barley             0.100000   1.000      1.000

15000251 15   Barley, pearled barley-babyfood    0.100000   1.000      1.000

15000260 15   Barley, flour                      0.100000   1.000      1.000

15000261 15   Barley, flour-babyfood             0.100000   1.000      1.000

15000270 15   Barley, bran                       0.100000   1.000      1.000

06030300 6C   Bean, black, seed                  0.300000   1.000      1.000

06020310 6B   Bean, broad, succulent             0.300000   1.000      1.000   Additional data required.

06030320 6C   Bean, broad, seed                  0.300000   1.000      1.000

06020330 6B   Bean, cowpea, succulent            0.300000   1.000      1.000   Additional data required.

06030340 6C   Bean, cowpea, seed                 0.300000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.300000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.300000   1.000      1.000

06020370 6B   Bean, lima, succulent              0.300000   1.000      1.000   Additional data required.

06030380 6C   Bean, lima, seed                   0.300000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.300000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.300000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.300000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.300000   1.000      1.000

06010430 6A   Bean, snap, succulent              0.300000   1.000      1.000   Additional data required.

06010431 6A   Bean, snap, succulent-babyfood     0.300000   1.000      1.000   Additional data required.

21000440 M    Beef, meat                         0.020000   1.000      1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000      1.000

21000450 M    Beef, meat, dried                  0.020000   1.920      1.000

21000460 M    Beef, meat byproducts              0.040000   1.000      1.000

21000461 M    Beef, meat byproducts-babyfood     0.040000   1.000      1.000

21000470 M    Beef, fat                          0.020000   1.000      1.000

21000471 M    Beef,fat-babyfood                  0.020000   1.000      1.000

21000480 M    Beef, kidney                       0.200000   1.000      1.000

21000490 M    Beef, liver                        0.050000   1.000      1.000

21000491 M    Beef, liver-babyfood               0.050000   1.000      1.000

01010500 1AB  Beet, garden, roots                0.300000   1.000      1.000

01010501 1AB  Beet, garden, roots-babyfood       0.300000   1.000      1.000

01010520 1A   Beet, sugar                        0.500000   1.000      1.000

01010521 1A   Beet, sugar-babyfood               0.500000   1.000      1.000

01010530 1A   Beet, sugar, molasses              2.000000   1.000      1.000

01010531 1A   Beet, sugar, molasses-babyfood     2.000000   1.000      1.000

13010550 13A  Blackberry                         0.100000   1.000      1.000   PP#6E7607

13010560 13A  Blackberry, juice                  0.100000   1.000      1.000   PP#6E7607

13010561 13A  Blackberry, juice-babyfood         0.100000   1.000      1.000   PP#6E7607

13020570 13B  Blueberry                          0.150000   1.000      1.000   PP#6E7607

13020571 13B  Blueberry-babyfood                 0.150000   1.000      1.000   PP#6E7607

13010580 13A  Boysenberry                        0.100000   1.000      1.000   PP#6E7607

14000590 14   Brazil nut                         0.100000   1.000      1.000

05010610 5A   Broccoli                           0.600000   1.000      1.000

05010611 5A   Broccoli-babyfood                  0.600000   1.000      1.000

05010620 5A   Broccoli, Chinese                  0.600000   1.000      1.000

05020630 5B   Broccoli raab                      1.800000   1.000      1.000   PP#6E7607

05010640 5A   Brussels sprouts                   0.600000   1.000      1.000

15000650 15   Buckwheat                          0.100000   1.000      1.000   Additional data required.

15000660 15   Buckwheat, flour                   0.100000   1.000      1.000   Additional data required.

01010670 1AB  Burdock                            0.300000   1.000      1.000

14000680 14   Butternut                          0.100000   1.000      1.000

05010690 5A   Cabbage                            0.600000   1.000      1.000

05020700 5B   Cabbage, Chinese, bok choy         1.800000   1.000      1.000   PP#6E7607

05010710 5A   Cabbage, Chinese, napa             0.600000   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          0.600000   1.000      1.000

09010750 9A   Cantaloupe                         0.100000   1.000      1.000   PP#6E7607

04020760 4B   Cardoon                            0.100000   1.000      1.000

01010780 1AB  Carrot                             0.400000   1.000      1.000   PP#6E7607

01010781 1AB  Carrot-babyfood                    0.400000   1.000      1.000   PP#6E7607

01010790 1AB  Carrot, juice                      0.400000   1.000      1.000   PP#6E7607

09010800 9A   Casaba                             0.100000   1.000      1.000   PP#6E7607

14000810 14   Cashew                             0.100000   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                        0.600000   1.000      1.000

01010840 1AB  Celeriac                           0.300000   1.000      1.000

04020850 4B   Celery                             0.100000   1.000      1.000

04020851 4B   Celery-babyfood                    0.100000   1.000      1.000

04020860 4B   Celery, juice                      0.100000   1.000      1.000

04020870 4B   Celtuce                            0.100000   1.000      1.000

14000920 14   Chestnut                           0.100000   1.000      1.000

40000930 P    Chicken, meat                      0.020000   1.000      1.000

40000931 P    Chicken, meat-babyfood             0.020000   1.000      1.000

40000940 P    Chicken, liver                     0.050000   1.000      1.000

40000950 P    Chicken, meat byproducts           0.050000   1.000      1.000

40000951 P    Chicken, meat byproducts-babyfoo   0.020000   1.000      1.000

40000960 P    Chicken, fat                       0.040000   1.000      1.000

40000961 P    Chicken, fat-babyfood              0.040000   1.000      1.000

40000970 P    Chicken, skin                      0.050000   1.000      1.000

40000971 P    Chicken, skin-babyfood             0.050000   1.000      1.000

06030980 6C   Chickpea, seed                     0.300000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.300000   1.000      1.000

06030990 6C   Chickpea, flour                    0.300000   1.000      1.000

01011000 1AB  Chicory, roots                     0.300000   1.000      1.000

05021170 5B   Collards                           1.800000   1.000      1.000   PP#6E7607

15001200 15   Corn, field, flour                 0.100000   1.000      1.000

15001201 15   Corn, field, flour-babyfood        0.100000   1.000      1.000

15001210 15   Corn, field, meal                  0.100000   1.000      1.000

15001211 15   Corn, field, meal-babyfood         0.100000   1.000      1.000

15001220 15   Corn, field, bran                  0.100000   1.000      1.000

15001230 15   Corn, field, starch                0.100000   1.000      1.000

15001231 15   Corn, field, starch-babyfood       0.100000   1.000      1.000

15001240 15   Corn, field, syrup                 0.100000   1.500      1.000

15001241 15   Corn, field, syrup-babyfood        0.100000   1.500      1.000

15001250 15   Corn, field, oil                   0.100000   1.000      1.000

15001251 15   Corn, field, oil-babyfood          0.100000   1.000      1.000

15001260 15   Corn, pop                          0.100000   1.000      1.000

15001270 15   Corn, sweet                        0.100000   1.000      1.000

15001271 15   Corn, sweet-babyfood               0.100000   1.000      1.000

95001280 O    Cottonseed, oil                    0.100000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.100000   1.000      1.000

09021350 9B   Cucumber                           0.100000   1.000      1.000   PP#6E7607

13021360 13B  Currant                            0.150000   1.000      1.000   PP#6E7607

13021370 13B  Currant, dried                     0.150000   1.000      1.000   PP#6E7

  Full comment: PP#6E7607

01031390 1CD  Dasheen, corm                      0.200000   1.000      1.000

13011420 13A  Dewberry                           0.100000   1.000      1.000   PP#6E7607

70001450 P    Egg, whole                         0.020000   1.000      1.000

70001451 P    Egg, whole-babyfood                0.020000   1.000      1.000

70001460 P    Egg, white                         0.020000   1.000      1.000

70001461 P    Egg, white (solids)-babyfood       0.020000   1.000      1.000

70001470 P    Egg, yolk                          0.020000   1.000      1.000

70001471 P    Egg, yolk-babyfood                 0.020000   1.000      1.000

08001480 8    Eggplant                           0.100000   1.000      1.000

13021490 13B  Elderberry                         0.150000   1.000      1.000   PP#6E7607

04021520 4B   Fennel, Florence                   0.100000   1.000      1.000

14001550 14   Filbert                            0.100000   1.000      1.000

14001560 14   Filbert, oil                       0.100000   1.000      1.000

03001640 3    Garlic                             0.100000   1.000      1.000

03001650 3    Garlic, dried                      0.100000   9.000      1.000

03001651 3    Garlic, dried-babyfood             0.100000   9.000      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                     0.300000   1.000      1.000

23001690 M    Goat, meat                         0.020000   1.000      1.000

23001700 M    Goat, meat byproducts              0.040000   1.000      1.000

23001710 M    Goat, fat                          0.020000   1.000      1.000

23001720 M    Goat, kidney                       0.200000   1.000      1.000

23001730 M    Goat, liver                        0.050000   1.000      1.000

13021740 13B  Gooseberry                         0.150000   1.000      1.000   PP#6E7607

06031820 6C   Guar, seed                         0.300000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.300000   1.000      1.000

14001850 14   Hickory nut                        0.100000   1.000      1.000

09011870 9A   Honeydew melon                     0.100000   1.000      1.000   PP#6E7607

24001890 M    Horse, meat                        0.020000   1.000      1.000

01011900 1AB  Horseradish                        0.300000   1.000      1.000

13021910 13B  Huckleberry                        0.150000   1.000      1.000   PP#6E7607

05021940 5B   Kale                               1.800000   1.000      1.000   PP#6E7607

05011960 5A   Kohlrabi                           0.600000   1.000      1.000

03001980 3    Leek                               2.000000   1.000      1.000

06032030 6C   Lentil, seed                       0.300000   1.000      1.000

13012080 13A  Loganberry                         0.100000   1.000      1.000   PP#6E7607

14002130 14   Macadamia nut                      0.100000   1.000      1.000

27002220 D    Milk, fat                          0.020000   1.000      1.000

27002221 D    Milk, fat - baby food/infant for   0.020000   1.000      1.000

27012230 D    Milk, nonfat solids                0.020000   1.000      1.000

27012231 D    Milk, nonfat solids-baby food/in   0.020000   1.000      1.000

27022240 D    Milk, water                        0.020000   1.000      1.000

27022241 D    Milk, water-babyfood/infant form   0.020000   1.000      1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.020000   1.000      1.000

15002260 15   Millet, grain                      0.100000   1.000      1.000

05022290 5B   Mustard greens                     1.800000   1.000      1.000   PP#6E7607

15002310 15   Oat, bran                          0.100000   1.000      1.000

15002320 15   Oat, flour                         0.100000   1.000      1.000

15002321 15   Oat, flour-babyfood                0.100000   1.000      1.000

15002330 15   Oat, groats/rolled oats            0.100000   1.000      1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.100000   1.000      1.000

08002340 8    Okra                               0.500000   1.000      1.000   PP#6E7607

03002370 3    Onion, dry bulb                    0.100000   1.000      1.000   PP#6E7607

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000      1.000   PP#6E7607

03002380 3    Onion, dry bulb, dried             0.100000   9.000      1.000   PP#6E7607

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000      1.000   PP#6E7607

03002390 3    Onion, green                       2.000000   1.000      1.000   PP#6E7607

01012500 1AB  Parsley, turnip rooted             0.300000   1.000      1.000

01012510 1AB  Parsnip                            0.300000   1.000      1.000

01012511 1AB  Parsnip-babyfood                   0.300000   1.000      1.000

06022550 6B   Pea, succulent                     0.300000   1.000      1.000   Additional data required.

06022551 6B   Pea, succulent-babyfood            0.300000   1.000      1.000

06032560 6C   Pea, dry                           0.300000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.300000   1.000      1.000

06012570 6A   Pea, edible podded, succulent      0.300000   1.000      1.000   Additional data required.

06032580 6C   Pea, pigeon, seed                  0.300000   1.000      1.000

06022590 6B   Pea, pigeon, succulent             0.300000   1.000      1.000   Additional data required.

95002630 O    Peanut                             0.200000   1.000      1.000

95002640 O    Peanut, butter                     0.200000   1.890      1.000

95002650 O    Peanut, oil                        0.200000   1.000      1.000

14002690 14   Pecan                              0.100000   1.000      1.000

08002700 8    Pepper, bell                       0.100000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.100000   1.000      1.000

08002710 8    Pepper, bell, dried                0.100000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.100000   1.000      1.000

08002720 8    Pepper, nonbell                    0.500000   1.000      1.000   Tabasco peppers @ 0.5 ppm

08002721 8    Pepper, nonbell-babyfood           0.500000   1.000      1.000   Tabasco peppers @ 0.5 ppm

08002730 8    Pepper, nonbell, dried             0.500000   1.000      1.000   Tabasco peppers @ 0.5 ppm

14002820 14   Pistachio                          0.100000   1.000      1.000

01032960 1C   Potato, chips                      0.200000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.200000   6.500      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.200000   6.500      1.000

01032980 1C   Potato, flour                      0.200000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.200000   1.000      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               0.020000   1.000      1.000

60003020 P    Poultry, other, liver              0.050000   1.000      1.000

60003030 P    Poultry, other, meat byproducts    0.050000   1.000      1.000

60003040 P    Poultry, other, fat                0.020000   1.000      1.000

60003050 P    Poultry, other, skin               0.050000   1.000      1.000

09023080 9B   Pumpkin                            0.100000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.100000   1.000      1.000

01013140 1AB  Radish, roots                      0.300000   1.000      1.000

01013160 1AB  Radish, Oriental, roots            0.300000   1.000      1.000

05023180 5B   Rape greens                        1.800000   1.000      1.000   PP#9E7607

13013200 13A  Raspberry                          0.100000   1.000      1.000   PP#6E7607

13013201 13A  Raspberry-babyfood                 0.100000   1.000      1.000   PP#6E7607

13013210 13A  Raspberry, juice                   0.100000   1.000      1.000   PP#6E7607

13013211 13A  Raspberry, juice-babyfood          0.100000   1.000      1.000   PP#6E7607

04023220 4B   Rhubarb                            0.100000   1.000      1.000

15003230 15   Rice, white                        0.100000   1.000      1.000

15003231 15   Rice, white-babyfood               0.100000   1.000      1.000

15003240 15   Rice, brown                        0.100000   1.000      1.000

15003241 15   Rice, brown-babyfood               0.100000   1.000      1.000

15003250 15   Rice, flour                        0.100000   1.000      1.000

15003251 15   Rice, flour-babyfood               0.100000   1.000      1.000

15003260 15   Rice, bran                         0.100000   1.000      1.000

15003261 15   Rice, bran-babyfood                0.100000   1.000      1.000

01013270 1AB  Rutabaga                           0.300000   1.000      1.000

15003280 15   Rye, grain                         0.100000   1.000      1.000

15003290 15   Rye, flour                         0.100000   1.000      1.000

20003300 20   Safflower, oil                     0.100000   1.000      1.000

20003301 20   Safflower, oil-babyfood            0.100000   1.000      1.000

01013310 1AB  Salsify, roots                     0.300000   1.000      1.000

95003360 O    Sesame, seed                       0.130000   1.000      1.000   PP#6E7607

95003361 O    Sesame, seed-babyfood              0.130000   1.000      1.000   PP#6E7607

95003370 O    Sesame, oil                        0.130000   1.000      1.000   PP#6E7607

95003371 O    Sesame, oil-babyfood               0.130000   1.000      1.000   PP#6E7607

03003380 3    Shallot                            0.100000   1.000      1.000

26003390 M    Sheep, meat                        0.020000   1.000      1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.040000   1.000      1.000

26003410 M    Sheep, fat                         0.020000   1.000      1.000

26003411 M    Sheep, fat-babyfood                0.020000   1.000      1.000

26003420 M    Sheep, kidney                      0.200000   1.000      1.000

26003430 M    Sheep, liver                       0.050000   1.000      1.000

15003440 15   Sorghum, grain                     0.300000   1.000      1.000

15003450 15   Sorghum, syrup                     4.000000   1.000      1.000   PP#9E7607

06003470 6    Soybean, seed                      0.200000   1.000      1.000

06003480 6    Soybean, flour                     0.200000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.200000   1.000      1.000

06003490 6    Soybean, soy milk                  0.200000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.200000   1.000      1.000

06003500 6    Soybean, oil                       0.200000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.200000   1.000      1.000

04013550 4A   Spinach                            0.500000   1.000      1.000

04013551 4A   Spinach-babyfood                   0.500000   1.000      1.000

09023570 9B   Squash, winter                     0.100000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.100000   1.000      1.000

20003640 20   Sunflower, seed                    0.500000   1.000      1.000

20003650 20   Sunflower, oil                     0.500000   1.000      1.000

20003651 20   Sunflower, oil-babyfood            0.500000   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                        0.100000   1.000      1.000

01033710 1CD  Tanier, corm                       0.200000   1.000      1.000

08003740 8    Tomatillo                          0.100000   1.000      1.000

08003750 8    Tomato                             0.100000   1.000      1.000

08003751 8    Tomato-babyfood                    0.100000   1.000      1.000

08003760 8    Tomato, paste                      0.300000   5.400      1.000

08003761 8    Tomato, paste-babyfood             0.300000   5.400      1.000

08003770 8    Tomato, puree                      0.100000   3.300      1.000

08003771 8    Tomato, puree-babyfood             0.100000   3.300      1.000

08003780 8    Tomato, dried                      0.100000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.100000  14.300      1.000

08003790 8    Tomato, juice                      0.100000   1.500      1.000

95003800 O    Tomato, Tree                       0.100000   1.000      1.000

15003810 15   Triticale, flour                   0.100000   1.000      1.000

15003811 15   Triticale, flour-babyfood          0.100000   1.000      1.000

50003820 P    Turkey, meat                       0.020000   1.000      1.000

50003821 P    Turkey, meat-babyfood              0.020000   1.000      1.000

50003830 P    Turkey, liver                      0.050000   1.000      1.000

50003831 P    Turkey, liver-babyfood             0.050000   1.000      1.000

50003840 P    Turkey, meat byproducts            0.020000   1.000      1.000

50003841 P    Turkey, meat byproducts-babyfood   0.020000   1.000      1.000

50003850 P    Turkey, fat                        0.020000   1.000      1.000

50003851 P    Turkey, fat-babyfood               0.020000   1.000      1.000

50003860 P    Turkey, skin                       0.020000   1.000      1.000

50003861 P    Turkey, skin-babyfood              0.020000   1.000      1.000

01033870 1CD  Turmeric                           0.200000   1.000      1.000

01013880 1AB  Turnip, roots                      0.300000   1.000      1.000

05023890 5B   Turnip, greens                     1.800000   1.000      1.000   PP#9E7607

14003910 14   Walnut                             0.100000   1.000      1.000

86010000 O    Water, direct, all sources         0.126000   1.000      1.000

86020000 O    Water, indirect, all sources       0.126000   1.000      1.000

09013990 9A   Watermelon                         0.100000   1.000      1.000   PP#6E7607

09014000 9A   Watermelon, juice                  0.100000   1.000      1.000   PP#6E7607

15004010 15   Wheat, grain                       0.100000   1.000      1.000

15004011 15   Wheat, grain-babyfood              0.100000   1.000      1.000

15004020 15   Wheat, flour                       0.100000   1.000      1.000

15004021 15   Wheat, flour-babyfood              0.100000   1.000      1.000

15004030 15   Wheat, germ                        0.100000   1.000      1.000

15004040 15   Wheat, bran                        0.100000   1.000      1.000

15004050 15   Wild rice                          0.100000   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 4  Results of Chronic DEEM-FCID Dietary Exposure Analysis

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for METOLACHLOR AND S-METOLACHLOR    (1994-98 data)

Residue file name: F:\S-metolachlor\108801c6-22-10.R98

                                                     Adjustment factor #2 used.

Analysis Date 06-22-2010/14:35:11     Residue file dated: 06-22-2010/11:45:20/8

Reference dose (RfD, Chronic) = .1 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)                     0.004487                 4.5%

U.S. Population (spring season)             0.004459                 4.5%

U.S. Population (summer season)             0.004693                 4.7%

U.S. Population (autumn season)             0.004407                 4.4%

U.S. Population (winter season)             0.004386                 4.4%

Northeast region                            0.004222                 4.2%

Midwest region                              0.004552                 4.6%

Southern region                             0.004326                 4.3%

Western region                              0.004914                 4.9%

Hispanics                                   0.004919                 4.9%

Non-hispanic whites                         0.004343                 4.3%

Non-hispanic blacks                         0.004578                 4.6%

Non-hisp/non-white/non-black                0.005583                 5.6%

All infants (< 1 year)                      0.011439                11.4%

Nursing infants                             0.004491                 4.5%

Non-nursing infants                         0.014076                14.1%

Children 1-6  yrs                           0.007846                 7.8%

Children 7-12 yrs                           0.005013                 5.0%

Females 13-19 (not preg or nursing)         0.003407                 3.4%

Females 20+ (not preg or nursing)           0.004005                 4.0%

Females 13-50 yrs                           0.004067                 4.1%

Females 13+ (preg/not nursing)              0.004066                 4.1%

Females 13+ (nursing)                       0.005399                 5.4%

Males 13-19 yrs                             0.003842                 3.8%

Males 20+ yrs                               0.003876                 3.9%

Seniors 55+                                 0.003967                 4.0%

Children 1-2 yrs                            0.008540                 8.5%

Children 3-5 yrs                            0.007728                 7.7%

Children 6-12 yrs                           0.005286                 5.3%

Youth 13-19 yrs                             0.003636      †††††㌠㘮ഥ摁汵獴㈠ⴰ㤴礠獲†††††††† ††††††⸰〰㤳〴††††††††㌠㤮ഥ摁汵獴 㔠⬰礠獲†††††††††††††††⸰〰㤳㌷† †††††††㐠〮ഥ敆慭敬⁳㌱㐭‹特⁳††††† ††††††††⸰〰㠳㔷††††††††㌠㤮ഥ

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S-Metolachlor			Dietary Exposure and Risk Assessment                   DP # D370429:

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