S-metolachlor; Pesticide Tolerance, 51628-51638 [05-17367]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Rules and Regulations]
[Pages 51628-51638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17367]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0326; FRL-7716-1]


S-metolachlor; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
(free and bound) of S-metolachlor in or on certain commodities as set 
forth in Unit II. of the SUPPLEMENTARY INFORMATION. The Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, 
North Brunswick, NJ 08902-3390, requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA), on behalf of the registrant, 
Syngenta Crop Protection, Swing Road, Greensboro, NC 276419.

DATES: This regulation is effective August 31, 2005. Objections and

[[Page 51629]]

requests for hearings must be received on or before October 31, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2004-0326. All documents in the docket 
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at https://www.epa.gpo/ opptsfrs/home/ 
guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of August 13, 2004 (69 FR 50196) (FRL-7371-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition 
(3E6787) by IR-4 on behalf of Syngenta Crop Protection, Swing Road, 
Greensboro, NC 27419. The petition requested that 40 CFR 180.368 be 
amended by establishing tolerances for combined residues (free and 
bound) of the herbicide S-metolachlor [S-2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its R-enantiomer, 
and its metabolites, determined as the derivatives, 2-(2-ethyl-6-
methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-
5-methyl-3-morpholinone, each expressed as the parent compound, S-
metolachlor. It should be noted that the above chemical nomenclature 
for S-metolachlor differs slightly from that previously listed under 40 
CFR 180.368(a)(2). The Agency is establishing these tolerances for 
residues of S-metolachlor under a new paragraph, 180.368 (a)(3), using 
this nomenclature because it is more technically accurate in terms of 
the nature of the residues and the components determined by the 
analytical method. The Agency has determined that the tolerance 
expression as listed in paragraph (a)(2) should be changed and will be 
proposing that change in an upcoming rule. Further chemical definition 
of S-metolachlor can be found in Unit III. A. of this document. In 
petition, PP 3E6787, IR-4 requested tolerances for S-metolachlor in or 
on the following raw agricultural commodities (RACs):
    1. Brassica, head and stem, subgroup 5A at 0.5 parts per million 
(ppm).
    2. Cattle, fat at 0.04 ppm; cattle, kidney at 0.20 ppm; cattle, 
meat at 0.04 ppm; cattle, meat byproducts, except kidney at 0.04 ppm.
    3. Corn, field, grain at 0.10 ppm; corn, field, stover at 6.0 ppm; 
corn, field, forage at 6.0 ppm; corn, sweet, forage at 6.0 ppm; corn, 
sweet, stover at 6.0 ppm; corn, pop, stover at 6.0 ppm; corn, pop, 
grain at 6.0 ppm; corn, sweet, kernel plus cob with husk removed at 0.1 
ppm.
    4. Cotton, gin byproducts at 4.0 ppm; cotton, undelinted seed at 
0.1 ppm.
    5. Egg at 0.04 ppm.
    6. Garlic, bulb at 0.1 ppm.
    7. Goat, fat 0.04 ppm; goat, kidney at 0.20 ppm; goat, meat at 0.04 
ppm; goat, meat byproducts, except kidney at 0.04 ppm.
    8. Horse, fat 0.04 ppm; horse, kidney at 0.20 ppm; horse, meat at 
0.04 ppm; horse, meat byproducts, except kidney at 0.04 ppm.
    9. Leafy petioles subgroup 4B at 0.10 ppm.
    10. Milk at 0.02 ppm.
    11. Onion, dry bulb at 0.1 ppm; onion, green at 2.0 ppm.
    12. Pea and bean, dried shelled, except soybean, subgroup 6C at 0.1 
ppm.
    13. Peanut 0.2 ppm; peanut, hay at 20 ppm; peanut, meal at 0.40 
ppm.
    14. Poultry, fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, 
meat byproducts, except liver at 0.04 ppm.
    15. Safflower, seed at 0.1 ppm.
    16. Shallot at 0.1 ppm.
    17. Sheep, fat at 0.04 ppm; sheep, kidney at 0.20 ppm; sheep, meat 
at 0.04 ppm; sheep, meat byproducts, except kidney at 0.04 ppm.
    18. Sorghum grain, stover at 4.0 ppm; sorghum grain, forage at 1.0 
ppm; sorghum grain, grain at 0.3 ppm.
    19. Soybean, seed at 0.2 ppm; soybean, forage at 5.0 ppm; soybean, 
hay at 8.0 ppm.
    20. Vegetable, foliage of legume, except soybean, subgroup 7A at 15 
ppm.
    21. Vegetable, fruiting, group 8 at 0.5 ppm.
    22. Vegetable, legume, edible podded, subgroup 6A at 0.5 ppm.
    23. Vegetable, root, except sugar beet, subgroup 1B at 0.3 ppm.
    24. Vegetable, tuberous and corm, subgroup 1C at 0.2 ppm.
    Several of the proposed tolerances were subsequently amended as 
follows:

[[Page 51630]]

Tolerances for vegetable, fruiting, group 8 (except tabasco pepper) at 
0.1 ppm; tomato, paste at 0.3 ppm; a separate regional tolerance for 
pepper, tabasco at 0.5 ppm; brassica, head and stem increased from 0.5 
to 0.6 ppm; corn, pop, grain decreased from 6.0 to 0.1 and barley straw 
from 0.1 to 0.5 ppm. Furthermore, the proposed tolerance of cattle, 
goat, horse and sheep meat byproducts, except kidney at 0.04 ppm was 
subsequently amended to establish tolerances for meat byproducts, 
except kidney and liver of cattle, goat, horse and sheep at 0.04 ppm 
and separate tolerances for liver of cattle, goat, horse and sheep at 
0.1 ppm. The tolerance for poultry, meat byproducts, except liver at 
0.04 ppm was also amended to poultry, meat byproducts at 0.04 ppm.
    Additionally, IR-4 proposed to amend 40 CFR 180.368(a)(2) by 
removing tolerances established for the combined residues (free and 
bound) of the herbicide S-metolachlor [S-2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], and its 
metabolites, determined as the derivatives, 2-(2-ethyl-6-
methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-
5-methyl-3-morpholinone, each expressed as the parent compound, in or 
on the following RAC's: Carrot, roots at 0.20 ppm; Horseradish at 0.20 
ppm; onion, green at 0.20; rhubarb at 0.10 ppm; swiss chard at 0.10 
ppm; and tomato at 0.1 ppm. The Agency concurs with this proposal based 
on the fact that these uses are covered by crop group and/or crop 
subgroup tolerances promulgated under section (a)(3) of this ruling.
    Additionally, IR-4 proposed to amend 40 CFR 180.368(d) by 
establishing tolerances for indirect or inadvertent combined residues 
(free and bound) of the herbicide S-metolachlor [S-2-chloro-N-(2-ethyl-
6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide] its R-
enantiomer,, and its metabolites, determined as the derivatives, 2-(2-
ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound, 
S-metolachlor in or on the following RAC's:
    1. Animal feed, nongrass, group 18 at 1.0 ppm
    2. Barley, grain at 0.1 ppm; barley straw at 0.1 ppm
    3. Buckwheat, grain at 0.1 ppm
    4. Oat, forage at 0.5 ppm; oat, grain at 0.1 ppm; oat straw at 0.5 
ppm
    5. Peanut, meal at 0.4 ppm
    6. Rice, grain at 0.1 ppm; rice, straw at 0.5 ppm
    7. Rye, forage at 0.5 ppm; rye, grain at 0.1 ppm; rye straw at 0.5 
ppm
    8. Wheat, forage at 0.5 ppm; wheat grain at 0.1 ppm; wheat straw at 
0.5 ppm
    These tolerances for the various grains (barley, buckwheat, oats, 
rice, rye, wheat) and nongrass animal feeds are being established to 
cover residues of S-metolachlor in these crops when planted as 
rotational crops following treatment of a primary crop. The Agency 
concludes that these tolerances should be assigned to Sec.  180.368(d) 
for indirect and inadvertent residues, and that adequate data are 
available to set the rotational crop tolerance for the nongrass animal 
feeds at 1.0 ppm. In addition, the Agency has concluded that tolerances 
should be established on the hays of barley, oats, and wheat at 1.0 ppm 
in paragraph (d). The peanut meal tolerance will be established under 
paragraph (a)(3) and is not necessary as proposed in (d).
    The notice proposing these tolerances included a summary of the 
petition prepared by Syngenta Crop Protection, Incorporated, the 
registrant. There were no comments received in response to the notice 
of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues (free and 
bound) of S-metolachlor on commodities and at tolerance levels 
presented in Unit II. of this document. EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    Metolachlor is a chloroacetanilide herbicide that was first 
registered as a pesticide in 1976. Metolachlor (known as racemic 
metolachlor) is a mixture consisting of 50% each of the R-enantiomer 
(CGA 77101) and the S-enantiomer (CGA 77102). The S-enantiomer is the 
herbicidally active isomer.S-metolachlor is also a racemic mixture 
comprised of 88% S-enantiomer and 12% R-enantiomer. The Agency has 
determined that S-metolachlor has either comparable or decreased 
toxicity as compared to racemic metolachlor.
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by S-metolachlor as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed are discussed in Unit III.A. of the Federal Register of April 
2, 2003 (68 FR 15945) (FRL-7299-8).

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL of concern is 
sometimes used for risk assessment if no NOAEL was achieved in the 
toxicology study selected. An uncertainty factor (UF) is applied to 
reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.

[[Page 51631]]

    Three other types of safety or UFs may be used: ``Traditional UF;'' 
the ``special FQPA safety factor;'' and the ``default FQPA safety 
factor.'' By the term ``traditional UF,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional UF or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by an UF of 100 to account for 
interspecies and intraspecies differences and any traditional 
uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a 
special FQPA safety factor or the default FQPA safety factor is used, 
this additional factor is applied to the RfD by dividing the RfD by 
such additional factor. The acute or chronic Population Adjusted Dose 
(aPAD or cPAD) is a modification of the RfD to accommodate this type of 
safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5), one in a million (1 X 10-6), or one in ten 
million (1 X 10-7). Under certain specific circumstances, 
MOE calculations will be used for the carcinogenic risk assessment. In 
this non-linear approach, a ``point of departure'' is identified below 
which carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer= point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for S-metolachlor used for human 
risk assessment is discussed in Unit III.B. of the final rule published 
in the Federal Register of April 2, 2003 (68 FR 15945) (FRL-7299-8). 
Should you desire additional information in this regard, please refer 
to that document.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.368(a)(2)) for the combined residues of S-
metolachlor, in or on a variety of RAC's. S-metolachlor is a selective, 
chloroacetanilide herbicide that is applied as a preplant, preplant-
incorporated (PPI), pre-emergence, or post-emergence application, 
primarily for the control of grass weeds. S-metolachlor is registered 
to Syngenta Crop Protection, Inc., for use on a wide variety of crops 
including: Corn, cotton, grasses grown for seed, legume vegetables, 
peanuts, potatoes, safflower, sorghum, sunflower, and tomatoes and 
complement the metolachlor (racemic mixture) product line with S-
metolachlor products that contain a higher percentage of active 
pesticidal ingredient.
    Permanent tolerances for the combined S-metolachlor residues have 
been established in/on plant commodities ranging from 0.1 ppm in/on a 
variety of plant commodities to 15 ppm in/on sugar beet tops 40 CFR 
180.368(a))(2). Permanent tolerances are also established for combined 
residues of racemic metolachlor in 180.368(a)(1) and (c) at levels of 
0.02 to 30 ppm.
    The Agency has recently reviewed plant metabolism data on S-
metolachlor from field tests on soybeans and corn, in vitro tests on 
corn seedlings, and greenhouse tests on seedlings of corn, sorghum, 
soybeans and peanuts. These data support the petitioners assertion that 
the metabolism of S-metolachlor in plants is similar to the racemic 
mixture, metolachlor. The Agency has also recently reviewed animal 
metabolism data on S-metolachlor. Data from a goat metabolism study 
indicated that the residues of concern for S-metolachlor in animals are 
the same as for metolachlor. For both metolachlor and S-metolachlor the 
residues of concern in plants and animals include the parent compound 
and its metabolites, determined as the derivatives CGA-37913 and CGA-
49751. In the case of S-metolachlor tolerances, the residues of the R-
enantiomer should be included in the expression.
    Risk assessments were conducted by EPA to assess dietary exposures 
from S-metolachlor in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. In conducting the acute dietary risk assessment EPA 
used the Lifeline\TM\ Model, Version 2.0, which incorporates food 
consumption data as reported by respondents in the United State 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII), and 
accumulated exposure to the chemical for each commodity. A conservative 
Tier 1 acute dietary exposure assessment was conducted for all labeled 
metolachlor and all labeled and proposed S-metolachlor food uses using 
100% crop treated (CT) and tolerance level residues.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Lifeline\TM\ Model, Version 2.0, which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII), and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: A conservative Tier 1 chronic dietary exposure assessment 
was conducted for all labeled metolachlor and all labeled and proposed 
S-metolachlor food uses using 100% CT and tolerance level residues.
    Both the acute and chronic analyses assume tolerance-level residues 
on all crops with established, pending, or proposed tolerances for 
metolachlor and/or S-metolachlor (collectively referred to as 
metolachlor in this document). 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. The 
analyses also assume that 100% of the crops included in the assessment 
were treated with metolachlor. These assumptions result in 
overestimates of exposure and are, therefore, highly conservative with 
respect to dietary risk assessment.
    iii. Cancer. Metolachlor has been classified as a Group C, possible 
human carcinogen based on liver tumors in rats at the highest dose 
tested (HDT). The

[[Page 51632]]

chronic NOAEL, 15 milligram/kilogram/day (mg/kg/day), that was 
established based on tumors in the rat seen at the HDT of 150 mg/kg/
day) is comparable to the NOAEL of 9.7 mg/kg/day selected for 
establishing the chronic reference dose for metolachlor. The Agency 
concludes that the chronic dietary PAD is protective for cancer dietary 
risk. Therefore, a separate cancer dietary risk assessment was not 
conducted.
    2. Dietary exposure from drinking water. The environmental fate 
database is complete for S-metolachlor. Parent metolachlor/S-
metolachlor appear to be moderately persistent to persistent, and range 
from mobile to highly mobile in different soils. Metolachlor and S-
metolachlor are expected to have similar degradation pathways and rates 
in soil and water environments.
    Drinking water assessment was conducted based on monitoring data 
from several sources, as well as on Tier 1 First Index Reservoir 
Screening Tool (FIRST) and Screening Concentration In Groundwater (SCI-
GROW) and Tier II modeling (PRZM/EXAMS) for selected vulnerable sites. 
This assessment is a worst-case scenario and demonstrates high end 
numbers. It is important to note that the analytical methods used to 
obtain the monitoring data are not able to distinguish between 
metolachlor and S-metolachlor; therefore, the estimated environmental 
concentrations (EECs) presented in this risk assessment are 
representative of both racemic metolachlor and S-metolachlor.
    EECs for metolachlor and S-metolachlor were calculated for both the 
parent compound and the ethanesulfonic acid (ESA) and oxanilic acid 
(OA) degradates. The PRZM/EXAMS model was used to estimate the EECs for 
the surface water concentrations of the parent compound and the FIRST 
model was used to estimate the EECs for the surface water 
concentrations of the ESA and OA degradates. Groundwater concentrations 
were modeled using the SCI-GROW. Although it was determined by the 
Agency 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.
    The EECs were estimated for the crops with the highest maximum 
seasonal application rates, turf (S-metolachlor only) and corn (racemic 
metolachlor and S-metolachlor) with a maximum seasonal application rate 
of 4.0 lbs ai per acre (lbs ai/acre).
    i. Surface water modeling of parent metolachlor/S-metolachlor. 
Based on PRZM/EXAMS modeling the maximum peak and annual average 
concentrations of metolachlor/S-metolachlor in surface water were 199 
[mu]g/l and 9.2 [mu]g/l, respectively. Based on an evaluation of U.S. 
Geological Survey (USGS) National Water Quality Assessment (NAWQA) 
surface water monitoring data, the estimate of the maximum drinking 
water concentration from surface water sources of parent metolachlor/S-
metolachlor is 77.6 [mu]g/l, and the EEC is 4.3 [mu]g/l for the maximum 
annual time-weighted mean concentration for parent metolachlor/S-
metolachlor. These data suggest that the PRZM/EXAMS estimates for 
metolachlor/S-metolachlor are slightly overestimating the potential 
impact of metolachlor/S-metolachlor use on surface water.
    ii. Surface water modeling of degradates. Based on FIRST modeling 
results, the estimate of the drinking water concentration from surface 
water sources of metolachlor ESA (ground application with no spray 
drift) is not likely to exceed 31.9 [mu]g/L for the annual peak 
concentration and 22.8 [mu]g/L for the annual average exposure for use 
on turf/corn at a maximum annual application rate of 4.0 lbs ai per 
acre. Based on FIRST modeling results, the estimate of the drinking 
water concentration from surface water sources of metolachlor OA 
(ground application with no spray drift) is not likely to exceed 91.4 
[mu]g/L for the annual peak concentration and 65.1 [mu]g/L for the 
annual average exposure for use on turf/corn at a maximum annual 
application rate of 4.0 lbs ai per acre.
    iii. Groundwater modeling of parent metolachlor/S-metolachlor. 
Metolachlor/S-metolachlor appears to be mobile in different soil types. 
Metolachlor/S-metolachlor and its degradates have been detected in 
ground water demonstrating that it is likely to impact ground water 
resources. In order to augment existing monitoring data, the (SCI GROW) 
screening model was used to estimate ground water concentrations. The 
model estimates the upper bound ground water concentrations of 
pesticides likely to occur when the pesticide is used at the maximum 
allowable rate in areas with ground water vulnerable to contamination. 
The estimated concentration of metolachlor/S-metolachlor in drinking 
water from shallow ground water sources is 5.5 [mu]g/l for application 
on corn at a seasonal maximum rate of 4.0 lbs ai. per acre. This 
concentration is appropriate for both the peak and annual average 
exposures.
    From the available ground water monitoring data , the highest 
annual maximum concentration from the (NAWQA) ground water monitoring 
data for acute exposure to metolachlor/S-metolachlor is 32.8 [mu]g/l. 
Data collected in Iowa as part of the NAWQA program indicate that 
metolachlor/S-metolachlor has been detected in ground water at 
concentrations as high as 15.4 [mu]g/l. However, these data are not 
used quantitatively in the risk assessment because the next highest 
concentration detected is 1.7 [mu]g/l suggesting that the maximum 
concentration may be an outlier. Additionally, recent data collected by 
the Suffolk County, New York Department of Health Services, Bureau of 
Groundwater Resources indicate that both metolachlor/S-metolachlor 
(analytical methods did not determine the enantiomeric ratio) and its 
degradates have been detected in ground water. In data collected 
between 1997 and 2001, metolachlor/S-metolachlor was detected in 60 
well samples with a maximum concentration of 83 [mu]g/l. No information 
was available on frequency of detection and since only summary 
statistics were provided, these data are not used quantitatively in 
this assessment. Nonetheless, even use of the 83 [mu]g/l value as the 
exposure level in drinking water would not raise the aggregate risk 
estimate, as discussed in Unit III.E. of this document the level of 
concern.
    iv. Groundwater modeling of degradates. The EEC for metolachlor ESA 
from use on turf/corn is not expected to exceed 65.8 [mu]g/l for peak 
and annual average exposures. The EEC for metolachlor OA from use on 
turf/corn is not expected to exceed 31.7 [mu]g/l for peak and annual 
average exposures. These values exceed the maximum values detected in 
the Iowa NAWQA study (63.7 [mu]g/l for metolachlor ESA and 4.4 [mu]g/l 
for metolachlor OA and also exceed those detected in the two PGW 
studies (metolachlor ESA was detected at a maximum concentration of 24 
[mu]g/l, while metolachlor OA was detected at a maximum concentration 
of 15.6 [mu]g/l).
    Recent data collected by the Suffolk County, New York Department of 
Health Services, Bureau of Groundwater Resources indicate that both 
metolachlor/S-metolachlor (analytical methods did not determine the 
enantiomeric ratio) and its degradates have been detected in ground 
water. In data collected between 1997 and 2001, metolachlor ESA was 
detected in 296 wells with a maximum concentration of 39.7 [mu]g/l, 
while metolachlor OA was detected in 228 wells with a maximum 
concentration of 49.6 [mu]g/l. No information was available on 
frequency of detection and only summary statistics were provided on 
these data. Therefore,

[[Page 51633]]

these data are not used quantitatively in this assessment. However, 
these data suggest that the screening level SCI-GROW estimates for 
metolachlor ESA and OA are slightly overestimating the potential impact 
of metolachlor/S-metolachlor use on ground water.
    A summary of metolachlor EEC's in surface water and ground water is 
presented in Table 1.

                                           Table 1.--Metolachlor EEC's
----------------------------------------------------------------------------------------------------------------
                                         Surface Water (peak)   Surface Water (average)        Ground Water
----------------------------------------------------------------------------------------------------------------
Parent                                                     199                      9.2                      5.5
----------------------------------------------------------------------------------------------------------------
Metolachlor ESA                                           31.9                     22.8                     65.8
----------------------------------------------------------------------------------------------------------------
Metolachlor OA                                            91.4                     65.1                     31.7
----------------------------------------------------------------------------------------------------------------
Total EECs (ppb)                                         322.3                     97.1                    103.0
----------------------------------------------------------------------------------------------------------------

    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    S-metolachlor is registered (as an emulsifiable concentrate 
formulation) for use on lawn, turf (including sod farms), golf courses, 
sports fields, and ornamental gardens and marketed to commercial 
applicators. Current product labels include the statement, ``Not 
intended for homeowner purchase or use.'' Therefore, a residential 
handler assessment was not conducted.
    Based on the use pattern of residential products, duration of post 
application exposure is expected to be short term. A short-term dermal 
endpoint was not selected, since no systemic toxicity was seen at the 
limit dose of 1,000 mg/kg/day; therefore, a dermal risk assessment was 
not conducted.
    Post-application inhalation exposure is also expected to be minimal 
since S-metolachlor is only applied in an outdoor setting and the label 
specifies that residents should not re-enter treated areas until after 
sprays have dried. Based on these assumptions, a postapplication 
inhalation exposure was not calculated.
    However, the following post-application incidental oral scenarios 
following application to lawns and turf have been identified:
    i. Short-term oral exposure to toddlers and children following 
hand-to-mouth exposure
    ii. Short-term oral exposure to toddlers and children following 
object-to-mouth exposure
    iii. Short-term oral exposure to toddlers and children following 
soil ingestion. The term ``incidental'' is used to distinguish the 
inadvertent oral exposure of small children from exposure that may be 
expected from treated foods or residues in drinking water.
    The exposure estimates for the three post-application scenarios 
(object-to-mouth, hand-to-mouth, and incidental soil ingestion) were 
combined to represent the possible (if not likely) high-end oral 
exposure resulting from lawn (or similar) use. Table 2 summarizes the 
results of the residential post-application assessment.

                      Table 2.--Summary of Short-term Residential Post-application Exposure
----------------------------------------------------------------------------------------------------------------
             Exposure Scenarioa                       S-metolachlorb                 Oral Dose (mg/kg/day)
----------------------------------------------------------------------------------------------------------------
Object-to-mouth                               S-metolachlor                                               0.0092
----------------------------------------------------------------------------------------------------------------
Hand-to-mouth                                 S-metolachlor                                                0.037
----------------------------------------------------------------------------------------------------------------
Soil ingestion                                S-metolachlor                                              0.00012
----------------------------------------------------------------------------------------------------------------
Combined exposure                             S-metolachlor                                                0.046
----------------------------------------------------------------------------------------------------------------
aExposure scenario represents oral exposure of children, with an assumed body weight of 15 kg.
bS-metolachlor application rate is 2.47 lb ai/acre.
 

    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has examined the common 
mechanism potential for S-metolachlor and has concluded that S-
metolachlor should not be included with the chloroacetanilide 
pesticides designated as a ``Common Mechanism Group.'' The Agency's 
position is that only some chloroacetanailides, namely acetochlor, 
alachlor and butachlor should be considered as a ``Common Mechanism 
Group'' due to their ability to cause nasal turbinate tumors.
    For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's web site at https://www.epa.gov/pesticides/
cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on

[[Page 51634]]

toxicity and exposure unless EPA determines based on reliable data that 
a different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a MOE analysis or through using UF (safety) in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional UFs and/or special FQPA 
safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of 
quantitative or qualitative increased susceptibility of rats or rabbits 
to in utero and/or postnatal exposure in the available toxicity data.
    3. Conclusion. There is a sufficient toxicity data base and 
exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. The FQPA Safety Factor for 
the protection of infants and children has been reduced to 1X because:
    i. The toxicology data base is complete for the FQPA assessment.
    ii. There is no indication of quantitative or qualitative increased 
susceptibility of rats or rabbits to in utero and/or postnatal exposure 
to metolachlor in the available toxicity data.
    iii. A developmental neurotoxicity study is not required for S-
metolachlor.
    iv. The dietary (food and drinking water) and non-dietary exposure 
(residential) assessments will not underestimate the potential 
exposures for infants and children from the use of S-metolachlor.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. The acute aggregate risk assessment addresses 
potential exposure from combined residues of metolachlor/S-metolachlor 
on food and total residues of metolachlor/S-metolachlor plus ESA and OA 
degradates in drinking water (surface water and ground water). Using 
the exposure assumptions discussed in this unit for acute exposure, the 
acute dietary exposure from food to metolachlor/S-metolachlor will 
occupy <1% of the aPAD for the U.S. population and all population 
subgroups. In addition, there is potential for acute dietary exposure 
to metolachlor/S-metolachlor and the ESA and OA degradates in drinking 
water. After calculating DWLOCs and comparing them to the EECs for 
surface water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in the following Table 3:

                                   Table 3.--Aggregate Risk Assessment for Acute Exposure to Metolachlor/S-metolachlor
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC
                   Population Subgroup                        aPAD (mg/kg)       %aPAD (Food)          (ppb)              (ppb)        Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                          3.0                 <1                322                103            105,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants (<1year)                                                         3.0                 <1                322                103             30,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                                     3.0                 <1                322                103             30,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years)                                                    3.0                 <1                322                103             90,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    2. Chronic risk. The chronic aggregate risk assessment addresses 
potential exposure from combined residues of metolachlor/S-metolachlor 
on food and total residues of metolachlor/S-metolachlor plus ESA and OA 
degradates in drinking water (surface water and ground water). There 
are no residential uses that result in chronic residential exposure to 
S-metolachlor. EPA has concluded that chronic exposure to metolachlor/
S-metolachlor from food will utilize 1% of the cPAD for the U.S. 
population, 4% of the cPAD for children 1 to 2 years, the 
subpopulations at greatest exposure and 1% of the cPAD for females 13 
to 49 years. In addition, there is potential for chronic dietary 
exposure to metolachlor/S-metolachlor and ESA and OA degradates in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 4:

[[Page 51635]]



        Table 4.-Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Metolachlor/S-metolachlor
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          0.1            1           97          103        3,500
----------------------------------------------------------------------------------------------------------------
Infants (<1 year)                                        0.1            2           97          103        1,000
----------------------------------------------------------------------------------------------------------------
Children (1 to 2 years)                                  0.1            4           97          103        1,000
----------------------------------------------------------------------------------------------------------------
Females (13 to 49 years)                                 0.1            1           97          103        3,000
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    S-metolachlor is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
residential exposures for metolachlor/S-metolachlor.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in an aggregate MOE of 1,000 for children 1 to 2 
years. This aggregate MOE does not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of metolachlor/S-metolachlor and ESA and OA degradates in 
ground water and surface water. After calculating DWLOCs and comparing 
them to the EECs for surface water and ground water, EPA does not 
expect short-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 5:

            Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Metolachlor/S-metolachlor
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                                   1,000          100           97          103        4,500
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. An intermediate-term aggregate risk 
assessment considers potential exposure from food, drinking water, and 
non-occupational (residential) pathways of exposure. However, for 
metolachlor/S-metolachlor, no intermediate-term non-occupational 
exposure scenarios (greater than 30 days exposure) are expected to 
occur. Therefore, intermediate-term DWLOC values were not calculated 
and an intermediate-term aggregate risk assessment was not performed.
    5. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk assessment considers potential carcinogenic exposure from food, 
drinking water, and non-occupational (residential) pathways of 
exposure. However, the NOAEL (15 mg/kg/day), that was established based 
on tumors in the rat (seen at the HDT of 150 mg/kg/day) is comparable 
to the NOAEL of 9.7 mg/kg/day selected for establishing the cRfD dose 
for metolachlor. Therefore, the chronic risk assessment is protective 
for cancer as well as other chronic risks.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to metolachlor/S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual (PAM) Vol. II, lists a GC/NPD 
method (Method I) for determining residues in/on plants and a GC/MSD 
method (Method II) for determining residues in livestock commodities. 
These methods determine residues of metolachlor and its metabolites as 
either CGA-37913 or CGA-49751 following acid hydrolysis. Residue data 
from the most recent field trials and processing studies were obtained 
using an adequate GC/NPD method (AG-612), which is a modification of 
Method I. Adequate data are available on the recovery of metolachlor 
through Multi-residue Method Testing Protocols. The FDA PESTDATA 
database indicates that metolachlor is completely recovered through 
Method 302, PAM Vol. I (3rd ed., revised 10/97).

B. International Residue Limits

    No maximum residue limits for either metolachlor or S-metolachlor 
have been established or proposed by Codex, Canada, or Mexico for any 
agricultural commodity; therefore, no compatibility issues exist with 
respect to U.S. tolerances.

V. Conclusion

    Therefore, the tolerances are established at 180.368 for combined 
residues (free and bound) of the herbicide S-metolachlor [S-2-chloro-N-
(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its R-
enantiomer, and its metabolites, determined as the derivatives, 2-[2-
ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-
2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent 
compound S-metolachlor, in or on vegetable brassica, head and stem, 
subgroup 5A at 0.6 ppm; cattle, fat at 0.04 ppm; cattle, kidney at 0.20 
ppm; cattle liver at 0.1 ppm; cattle, meat at 0.04 ppm; cattle, meat 
byproducts, except kidney and liver at 0.04 ppm; corn, field, grain at 
0.10 ppm; corn, field, stover at 6.0 ppm; corn, field, forage at 6.0 
ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, stover at 6.0 ppm; 
corn, pop, stover at 6.0 ppm; corn, pop, grain at 0.1 ppm; corn, sweet, 
kernel plus cob with husk removed at 0.1 ppm; cotton, gin byproducts at 
4.0 ppm; cotton, undelinted seed at 0.1 ppm; egg at 0.04 ppm; garlic, 
bulb at 0.1 ppm;

[[Page 51636]]

goat, fat 0.04 ppm; goat, kidney at 0.20 ppm; goat, liver at 0.1 ppm; 
goat, meat at 0.04 ppm; goat, meat byproducts, except kidney and liver 
at 0.04 ppm; horse, fat 0.04 ppm; horse, kidney at 0.20 ppm; horse 
liver at 0.1 ppm; horse, meat at 0.04 ppm; horse, meat by-products, 
except kidney and liver at 0.04 ppm; vegetable leaf petioles subgroup 
4B at 0.10 ppm; milk at 0.02 ppm; onion, dry bulb at 0.1 ppm; onion, 
green at 2.0 ppm; vegetable legumes, pea and bean, dried shelled, 
except soybean, subgroup 6C at 0.1 ppm; peanut at 0.2 ppm; peanut, hay 
at 20 ppm; peanut, meal at 0.40 ppm; poultry, fat at 0.04 ppm; poultry, 
meat a 0.04 ppm; poultry, meat by-products, at 0.04 ppm; safflower, 
seed at 0.1 ppm; shallot, bulb at 0.1 ppm; sheep, fat at 0.04 ppm; 
sheep, kidney at 0.20 ppm; sheep, liver at 0.1 ppm; sheep, meat at 0.04 
ppm; sheep, meat by-products, except kidney and liver at 0.04 ppm; 
sorghum grain, stover at 4.0 ppm; sorghum grain, forage at 1.0 ppm; 
sorghum grain, grain at 0.3 ppm; soybean, seed at 0.2 ppm; soybean, 
forage at 5.0 ppm; soybean, hay at 8.0 ppm; tomato, paste at 0.3 ppm; 
vegetable, foliage of legume, except soybean, subgroup 7A at 15 ppm; 
vegetable, fruiting, group 8, except tabasco pepper, at 0.1 ppm; 
vegetable, legume, edible podded, subgroup 6A at 0.5 ppm; vegetable, 
root, except sugar beet, subgroup 1B at 0.3 ppm; and vegetable, 
tuberous and corm, subgroup 1C at 0.2 ppm; pepper tabasco at 0.5 ppm; 
nongrass, animal feed (forage, fodder, straw, hay), group 18 at 1.0 
ppm; barley, grain at 0.1 ppm; barley straw at 0.5 ppm; barley hay at 
1.0 ppm; buckwheat, grain at 0.1 ppm; oat, forage at 0.5 ppm; oat, 
grain at 0.1 ppm; oat, straw at 0.5 ppm; rice, grain at 0.1 ppm; rice, 
straw at 0.5 ppm; rye, forage at 0.5 ppm; rye, grain at 0.1 ppm; rye, 
straw at 0.5 ppm; wheat, forage at 0.5 ppm; wheat, grain at 0.1 ppm; 
wheat, straw at 0.5 ppm and wheat, hay at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0326 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
31, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0326, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income

[[Page 51637]]

Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under section 408(d) of FFDCA, 
such as the tolerance in this final rule, do not require the issuance 
of a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 23, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

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2. Section 180.368 is amended:
    i. In paragraph (a)(2), in the table, by removing the commodities 
carrot, root