[Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Rules and Regulations]
[Page 55858-55870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se03-22]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0315; FRL-7328-6]
Sethoxydim; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of sethoxydim (2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one) and its metabolites containing the 2-
cyclohexen-1-one moiety (calculated as the herbicide) in or on corn,
sweet, forage; corn, sweet, stover; juneberry; lingonberry; pistachio;
salal; and safflower and increases the tolerance on cattle, meat by
products; corn, sweet, kernels plus cob with husk removed; goat, meat
byproducts; hog, meat byproducts; horse, meat byproducts; milk; and
sheep, meat byproducts. BASF Corporation requested the tolerances for
corn, sweet, forage; corn, sweet, stover and the increase in tolerance
for corn, sweet, kernels plus cob with husk removed; milk; and meat
products under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
Interregional Project 4 (IR-4) requested the tolerances on
juneberry, lingonberry, pistachio, salal, and safflower under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 29, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0315,
must be received on or before November 28, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5697; e-mail address: tompkins.jim@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:
[sbull] Crop Production (NAICS 111)
[sbull] Animal Production (NAICS 112)
[sbull] Food Manufacturing (NAICS 311)
[sbull] Pesticide Manufacturing (NAICS 32532)
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. To determine
whether you or your business may be affected by
[[Page 55859]]
this action, you should carefully examine the applicability provisions
in Unit II. 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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0315. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/http://.
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html/, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of January 18, 2000 (65 FR 2612) (FRL-6486-
4), August 7, 2002 (67 FR 51267) (FRL-7191-3), and September 11, 2002
(67 FR 57593) (FRL-7198-11), EPA issued a notice pursuant to section
408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170),
announcing the filing of pesticide petitions (9E6012, 9E6021, and
0E6150) by the Interregional Research Project Number 4, Technology
Centre and Rutgers State University of New Jersey, 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390 and pesticide petition
(2F4075) by BASF Corporation, P.O. Box 13528, Research Triangle Park,
NC 27709-3528. These notices included summaries of the petitions
prepared by BASF Corporation, the registrant. There were no comments
received in response to these notices of filing.
These petitions requested that 40 CFR part 180 be amended to
establish tolerances for cyclohexen-1-one moiety (calculated as the
herbicide), in or on corn, sweet, forage at 3.0 parts per million
(ppm); corn, sweet, stover at 3.5 ppm; lingonberry at 5.0 ppm;
juneberry at 5.0 ppm; pistachios at 0.2 ppm; safflower at 15.0 ppm and
salal at 5.0 ppm, and increase the tolerance in cattle, meat byproducts
from 0.2 ppm to 1.0 ppm; corn, sweet, kernels plus cob with husk
removed from 0.2 ppm to 0.4 ppm; goat, meat byproducts from 0.2 ppm to
1.0 ppm; horse, meat byproducts from 0.2 ppm to 1.0 ppm; milk from 0.05
ppm to 0.5 ppm, and sheep, meat byproducts from 0.2 ppm to 1.0 ppm. The
tolerance increases were a result of a 15-day reduction in the pre-
harvest interval for sweet corn requested by the registrant.
Section 408(b)(2)(A)(i) of the 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 the 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 the 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 the 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 the 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 the FFDCA, for a tolerance for combined residues of the
herbicide sethoxydim, (2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one) and its metabolites
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide),
in or on corn, sweet, kernels plus cob with husk removed at 0.4 ppm;
corn, sweet, forage at 3.0 ppm; corn, sweet, stover at 3.5 ppm;
lingonberry at 5.0 ppm; juneberry at 5.0 ppm; milk at 0.5 ppm; cattle,
meat byproducts at 1.0 ppm; goat, meat byproducts at 1.0 ppm; hog, meat
byproducts at 1.0 ppm; horse, meat byproducts at 1.0 ppm and sheep meat
byproducts at 1.0 ppm; pistachio at 0.2 ppm; safflower at 15.0 ppm and
salal at 5.0 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
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 natures of the toxic effects caused by sethoxydim are
discussed in Table 1 of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed-adverse effect level
(LOAEL) from the toxicity studies reviewed.
[[Page 55860]]
Table 1.--Toxicology Profile for Sethoxydim Technical
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Guideline No. Study Type Results
------------------------------------------------------------------------
870.1100 Acute oral--rats LD50 = male (M):
3,125 milligram/
kilogram (mg/kg);
female (F) 2,676 mg/
kg (category III)
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870.1200 Acute dermal-- LD50 = > 5,000 mg/kg
rats (category III)
------------------------------------------------------------------------
870.1300 Acute inhalation-- LC50 = M: 6.03 meter/
rats Liter (m/L); F 6.28
m/L (category III)
------------------------------------------------------------------------
870.2400 Primary eye No irritation
irritation--rabb (category IV)
its
------------------------------------------------------------------------
870.2500 Primary skin No irritation
irritation--rabb (category IV)
its
------------------------------------------------------------------------
870.2600 Dermal Waived based on lack
sensitization--g of sensitization in
uinea pigs guinea pigs with a
formulated product
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870.3100 90-Day oral Males
toxicity rodents NOAEL = 60.4
(rats) LOAEL = 196.3 mg/kg/
day
Females
NOAEL = 66.2
LOAEL = 200.5 mg/kg/
day Based on
decreases in body
weight, body weight
gain, and food
efficiency
------------------------------------------------------------------------
870.3100 90-Day oral Males
toxicity rodents NOAEL = 45.6
(mice) LOAEL = 137.1 mg/kg/
day
Females
NOAEL = 52.7
LOAEL = 164.4 mg/kg/
day based on
increased liver
weight and
histopathological
evidence of
hepatocellular
hypertrophy
------------------------------------------------------------------------
870.3150 90-Day oral Males and females
toxicity NOAEL not identified
(nonrodents- LOAEL = 3.4 mg/kg/
dogs) day (tentative)
based on possible
treatment-related
clinical findings
of cystitis of
urinary bladders
------------------------------------------------------------------------
870.3200 21-Day dermal Males and females
toxicity NOAEL = 1,000 mg/kg/
(rabbits) day higest dose
tested (HDT)
LOAEL not
established. No
localized or
systemic effects
------------------------------------------------------------------------
870.3465 4-Week inhalation Males and females
toxicity (rats) NOAEL = 0.3 mg/L (81
mg/kg/day)
LOAEL of 2.4 mg/L
(651 mg/kg/day),
based on increased
liver weight,
clinical chemistry
(increased total
serum bilirobin),
and liver
histopathology
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental NOAEL = 180 mg/kg/
toxicity (rats) day
LOAEL = 650 mg/kg/
day (irregular
gaits, decreased
activity, excessive
salivation, and
anogenital
staining)
Developmental
NOAEL = 180 mg/kg/
day
LOAEL = 650 mg/kg/
day (21-22%
decrease in fetal
weights,
filamentous tail
and lack of tail
due to the absence
of sacral, and/or
caudal vertebrae,
and delayed
ossification in the
hyoids, vertebral
centrum, and/or
transverse
processes,
sternebrae and/or
metatarsals, and
pubes)
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental NOAEL = 320 mg/kg/
toxicity day
(rabbits) LOAEL = 400 mg/kg/
day, (based on 37%
reduction in body
weight gain without
significant
differences in
group mean body
weights, and
decreased food
consumption during
dosing)
Developmental
NOAEL 320 mg/kg/day
LOAEL = 400 mg/kg/
day HDT based on an
increase in the
incidence of
incompletely
ossified 6th
sternebrae
------------------------------------------------------------------------
[[Page 55861]]
870.3800 Reproduction and Systemic
fertility NOAEL >=150 mg/kg/
effects (rats) day
LOAEL >150 mg/kg/day
Reproductive
NOAEL >=150 mg/kg/
day
LOAEL >150 mg/kg/day
Offspring
NOAEL = 30 mg/kg/day
LOAEL = 150 mg/kg/
day, based on
decreased body
weight in F2b pups
during lactation
and tail
abnormalities seen
in F1a and F1b
offspring
------------------------------------------------------------------------
870.4100 Chronic toxicity Males
(dogs) NOAEL = 17.5 mg/kg/
day
LOAEL = 110 mg/kg/
day
Females
NOAEL = 19.9 mg/kg/
day
LOAEL = 129 mg/kg/
day, based on
increase
hemosiderosis in
the spleen and
depressed myeloid
erythropoiesis in
the sternal bone
marrow, increased
absolute and
relative liver
weights, increased
alkaline
phosphatase and ALT
levels
------------------------------------------------------------------------
870.4200 Carcinogenicity Males
(mice) NOAEL = 13.8 mg/kg/
day
LOAEL = 41.2 mg/kg/
day, based on early
onset of liver
effects including
hepatocellular
hypertrophy and
fatty degeneration
in male mice. No
evidence of
carcinogenicity
------------------------------------------------------------------------
870.4300 Combined chronic/ Male
carcinogenicity NOAEL = 12 mg/kg/day
(rats) LOAEL = 48 mg/kg/
day, based on liver
toxicity
(centrilobular
hepatocellular
hypertrophy)
Females
NOAEL = 66 mg/kg/day
LOAEL = 204 mg/kg/
day, based on
decreased body
weight, body weight
gain, liver
toxicity
(centrilobular
hepatocellular
hypertrophy), and
lung lesions (heart
failure cells and
interstitial
fibrosis)
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.5100 Bacterial reverse Negative
mutation Concentrations 313-
5,000 [mu]g/plate
------------------------------------------------------------------------
870.5300 In vitro Negative
mammalian cell Concentrations 500-
gene mutation 5,000 [mu]g/mL
------------------------------------------------------------------------
870.5300 In vitro Negative
mammalian cell 10,000 mg/kg
gene mutation
------------------------------------------------------------------------
870.5300 In vitro Negative
mammalian cell
gene mutation
------------------------------------------------------------------------
870.5550 Unscheduled DNA Negative
synthesis (rat Concentrations 10 to
hepatocyte 507 [mu]g/mL
cells)
------------------------------------------------------------------------
870.5915 In vivo sister Negative
chromatid Dose 0, 0.5, 1.67, 5
exchange gram (g)/kg
(chinese hamster
bone marrow)
------------------------------------------------------------------------
870.7485 Metabolism and Excretion is
pharmacokinetics extremely rapid and
(rats) tissue accumulation
is negligible,
assuming DMSO
vehicle does not
affect excretion or
storage of NP-55,
78% excreted into
urine and 20.1% in
feces
------------------------------------------------------------------------
870.7485 Metabolism and Administration of
pharmacokinetics radioactively
(rats) labeled NP-55
yielded 0.8%
radioactivity in
urine identified as
hydroxymetabolites
represented by 6-OH
M2SO2 and 2 other
metabolites found
by mass
spectrometry were
MSO and M1SO
------------------------------------------------------------------------
[[Page 55862]]
B. Toxicological Endpoints
The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are
identified (the LOAEL) 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. A UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Acceptable developmental toxicity studies were performed in rats and
rabbits, with evidence of neurotoxicity in the rat study, and an
acceptable 2-generation reproduction study in rats. The developmental
toxicity rabbit study did not exhibit either quantitative of
qualitative susceptibility. Neurotoxicity studies are not available.
Although, the Agency has concluded that there is a concern for prenatal
and/or postnatal toxicity resulting from exposure to sethoxydim, the
concern is reduced because the fetal effects in the developmental rat
study were seen only at the high dose. Concern is also low because the
LOAEL for offspring toxicity for the 2-generation reproduction rat
study is based on conservative determinations of offspring toxicity.
However, due to lack of subchronic and developmental neurotoxicity
studies with evidence of developmental (tail) abnormalities in the rat
developmental and reproductive studies the additional 10X FQPA safety
factor (SF) in the form of a data base UF was retained.
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 reference dose (RfD) is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional SF is retained due
to concerns unique to the FQPA, 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 FQPA SF.
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 is expressed as 1 x 10-\6\ or one in a million).
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 sethoxydim used for human risk assessment is shown in the
following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for Sethoxydim for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessmentk Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of NOAEL = 180 mg/kg/day) Special FQPA SF = 1X Rat developmental
age and including infants and UF = 1,000............. aPAD = acute RfD /..... toxicity
children) Acute RfD = 0.18 mg/kg/ Special FQPA SF = 0.18 Developmental
day. mg/kg/day. LOAEL = 650 mg/kg/day
based on decreased
fetal body weight,
tail abnormalities,
delayed ossification
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 180 mg/kg/day Special FQPA SF = 1X Rat developmental
(General population)................. UF = 1,000............. aPAD = acute RfD /..... toxicity
Acute RfD = 0.18 mg/kg/ Special FQPA SF = 0.18 Maternal
day. mg/kg/day. LOAEL = 650 mg/kg/day
based on irregular
gait that was observed
in 12/34 dams on the
first day of dosing
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 14 mg/kg/day Special FQPA SF = 1X Mouse carcinogenicity
(All populations).................... UF = 1,000............. cPAD = chronic RfD /... study
Chronic RfD = 0.014 mg/ Special FQPA SF = 0.014 LOAEL = 41 mg/kg/day
kg/day. mg/kg/day. based on liver
hypertrophy and fatty
degeneration
----------------------------------------------------------------------------------------------------------------
Short-term NOAEL= 180 mg/kg/day Residential Rat developmental
Incidental oral (1-30 days).......... LOC for MOE = 1,000.... toxicity
Maternal
LOAEL = 650 mg/kg/day
based on irregular
gait that was observed
in 12/34 dams on the
first day of dosing
----------------------------------------------------------------------------------------------------------------
Intermediate-term NOAEL = 45.6 mg/kg/day Residential 90-Day mouse oral
Incidental oral (1-6 months)......... LOC for MOE = 1,000.... toxicity
LOAEL = 137 mg/kg/day
based on increased
liver weight and
hepatocellular
hypertrophy
----------------------------------------------------------------------------------------------------------------
[[Page 55863]]
Short-term dermal (1 to 30 days) Dermal (or oral) study Residential Quantification of
NOAEL= NA.............. LOC for MOE = NA....... dermal exposure risk
assessment is not
required because of
lack of dermal and pre-
natal toxicity in
rabbits, and the low
dermal absorption
physical and chemical
properties of
sethoxydim
----------------------------------------------------------------------------------------------------------------
Intermedia-term dermal (1 to 6 Dermal (or oral) study Residential Quantification of
months) NOAEL = NA............. LOC for MOE = NA....... dermal exposure risk
assessment is not
required because of
lack of dermal and
prenatal toxicity in
rabbits, and the low
dermal absorption
physical and chemical
properties of
sethoxydim
----------------------------------------------------------------------------------------------------------------
Long-term dermal > 6 months) Dermal (or oral) study Residential Quantification of
NOAEL= NA.............. LOC for MOE = NA....... dermal exposure risk
assessment is not
required because of
lack of dermal and
prenatal toxicity in
rabbits, and the low
dermal absorption
physical and chemical
properties of
sethoxydim
----------------------------------------------------------------------------------------------------------------
Short-term Inhalation study Residential 28-Day rat inhalation
Inhalation (1 to 30 days)............ NOAEL= 81 mg/kg/day.... LOC for MOE = 1,000.... LOAEL = 651 mg/kg/day
based on increased
liver weight, clinical
chemistry (increased
total serum
bilirobin), and liver
histopathology
----------------------------------------------------------------------------------------------------------------
Intermediate-term Inhalation study Residential 28-Day rat inhalation
Inhalation (1 to 6 months)........... NOAEL = 81 mg/kg/day... LOC for MOE = 1,000.... LOAEL = 651 mg/kg/day
based on increased
liver weight, clinical
chemistry (increased
total serum
bilirobin), and liver
histopathology
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Not likely human carcinogen'' based on the lack of evidence of
carcinogenicity in rats and mice
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, PAD = population-adjusted dose (a = acute, c = chronic) RfD = reference
dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.412) for the combined residues of sethoxydim
and its metabolites, in or on a variety of raw agricultural
commodities. Tolerances are also currently established for secondary
residues in meat, fat, and meat byproducts of cattle, goats, hogs,
horses, poultry, and sheep at 0.2 ppm (except 2.0 ppm in poultry meat
byproducts); eggs at 2.0 ppm, and milk at 0.05 ppm. Time limited
tolerances (to expire by 12/31/03) are established for residues in milk
at 0.5 ppm and the meat byproducts of cattle, goats, hogs, horses, and
sheep at 1.0 ppm. Risk assessments were conducted by EPA to assess
dietary exposures from sethoxydim 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. This acute assessment used tolerance level residues
for most of the crops but limited refinement was obtained though the
incorporation of field trial data and experimental processing factors
for some of the crops expected to be more highly associated with
dietary exposure to sethoxydim. Specifically, field trial data were
incorporated for apples, pears, and other pome fruits, grapes, oranges,
potatoes, strawberries, peaches, succulent green peas, succulent green
beans, and succulent lima beans. Empirical processing data for apples,
grapes, tomatoes, potatoes and oranges were also used. The processing
data for orange juice was also translated to other citrus juices.
Percent crop treated (PCT) information was available for most crops and
was used wherever possible to refine the assessment. Tolerance level
residues were used for meat, poultry, milk and eggs. With the
refinements incorporated in this assessment, the acute dietary analyses
for sethoxydim show that the estimated risks from acute dietary
exposure to sethoxydim are below <100% aPAD for the U.S. population.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the U.S. Department of Agriculture (USDA) 1989-1992
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: The chronic
analyses (limited refined dietary risk assessment) used tolerance level
residues for all crops and the PCT for many crops. For the chronic
analyses, refinement was obtained by calculation of anticipated
residues for meat and
[[Page 55864]]
milk, and without using field trial data. The results of this analysis
indicate that the chronic dietary risk (food only) associated with
existing uses of sethoxydim is below <100% cPAD for the U.S.
population.
iii. Cancer. Sethoxydim is classified as ``not likely to be a human
carcinogen''. Therefore, a quantitative assessment of aggregate cancer
risk was not performed.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must require that data be
provided 5 years after the tolerance is established, modified, or left
in effect, demonstrating that the levels in food are not above the
levels anticipated. Following the initial data submission, EPA is
authorized to require similar data on a time frame it deems
appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will
issue a Data Call-In for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
The Agency used PCT information as follows.
Alfalfa 0.1%; apples 0.1%; apricot 0.02%; asparagus 5%; beans, lima
9%; beans/peas, dried 14%; beets, sugar 8%; broccoli 1%; cabbage 1%;
canola 4%; cantaloupe 8%; carrots 2%; cauliflower 2%; cherries 0.4%;
collards 2%; corn, field 0.1%; corn, sweet 0.5%; cotton 0.5%;
cranberries 8%; cucumbers 6%; eggplant/peppers 5%; flax 38%; grapefruit
1%; grapes 1%; lemons 5%; lettuce 1%; nectarines 0.1%; oranges 3%;
peaches 0.4%; peanuts 5%; peppers, bell 3%; peppers, chili 11%; pears
0.03%; peas, green 2%; potatoes 4%; potatoes, sweet 18%; pumpkins 8%;
root/tuber vegetables (other than carrots, potatoes, and sugar beets)
5%; soybeans 2%; spinach 0.3%; squash 8%; strawberries 5%; sunflowers
14%; tomatoes 4%; vegetables, other 6%; watermelons 12%.
The Agency believes that the three conditions listed in Unit IV
have been met. With respect to condition 1, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant sub population group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which sethoxydim may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for sethoxydim in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of sethoxydim.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Groundwater (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a Tier
1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a percent reference dose (%RfD or
percent population adjusted dose (%PAD)). Instead, drinking water
levels of comparison (DWLOCs) are calculated and used as a point of
comparison against the model estimates of a pesticide's concentration
in 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 from residential uses. Since DWLOCs address
total aggregate exposure to sethoxydim they are further discussed in
the aggregate risk section Unit III. E.
Based on the FIRST and SCI-GROW models the EECs of sethoxydim for
[[Page 55865]]
acute exposures are estimated to be 100 parts per billion (ppb) for
surface water and 1 ppb for ground water. The EECs for chronic
exposures are estimated to be 20 ppb for surface water and 1 ppb for
ground water.
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). Sethoxydim is
currently registered for use on the following residential non-dietary
sites: Ornamentals and flowering plants, recreational areas, and
buildings/structures (non-agricultural-outdoor). The risk assessment
was conducted using the following exposure assumptions:
i. Residential handler. There is potential sethoxydim exposure to
residential handlers who mix, load and apply sethoxydim for use on
residential turf and ornamentals. Because dermal toxicity endpoints
were not identified, only the following exposure scenarios were
assessed:
[sbull] Adult inhalation exposure from mixing/loading/applying
sethoxydim for spot treatment with a low-pressure handwand.
[sbull] Adult inhalation exposure from mixing/loading/applying
sethoxydim for spot treatment with a hose-end sprayer.
ii. Residential post-application. The labeled use pattern for
sethoxydim only suggests spot treatments for non-agricultural sites
(e.g., fence lines, at base of ornamental plantings, etc.). The Agency
considered the potential residential post-application exposure from
spot treatment to be negligible. However, an exposure/risk assessment
for broadcast turf treatment, using the applicable endpoints, was
included in this assessment because there is no labeled recommendation
against broadcast treatment of lawns. Sethoxydim treatment may take up
to 3 weeks before visible burnback of turf is seen, and the previous
risk assessment for other agricultural use sites included residential
post-application exposure from turf use.
Broadcast turf treatment would result in the potential for dermal
(adults and children) and incidental oral exposure (children only)
during post-application activities. However, because the appropriate
dermal toxicity endpoints for sethoxydim were not identified, and
because inhalation is considered negligible for post-application
exposure, only the following post-application exposure scenarios were
assessed:
1. Incidental non-dietary ingestion of pesticide residues on lawns
from hand-to-mouth transfer.
2. Incidental non-dietary ingestion of residues from object-to-
mouth activities (pesticide-treated turfgrass).
3. Incidental non-dietary ingestion of soil (base of pesticide-
treated ornamentals).
Post-application exposures from various activities following lawn
treatment are considered to be the most common and significant in
residential settings.
The exposure via incidental non-dietary ingestion involving other
plant material (i.e., resulting from children's handling of treated
ornamentals) may occur but is considered negligible.
The exposure and risk estimates for the three residential exposure
scenarios are assessed for the day of application (day ``0'') because
it is assumed that toddlers could contact the lawn immediately after
application. On the day of application, it was assumed that 5% of the
application rate is available from the turf grass as transferrable
residue (20% for object-to-mouth activities). Intermediate-term
exposure is also expected (up to 6 months) because reapplications are
not limited, and may be necessary to continue suppression of grass. The
application rates used for turf and ornamental gardens are 0.33 and
0.49 lb active ingredient acres (ai/A) respectively.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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 does not have, at this time, available data to determine
whether sethoxydim has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to sethoxydim
and any other substances and sethoxydim does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that sethoxydim has a
common mechanism of toxicity with other substances. 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 Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA will
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 toxicity and exposure
unless EPA determines 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 margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. EPA determined that there
are no residual uncertainties for prenatal and/or postnatal toxicity
based on the following:
i. There was evidence of qualitative susceptibility in the
developmental rat study with the occurrence of more severe effects in
the fetuses (tail abnormalities and delayed ossification) than the
maternal animals (clinical signs of neurotoxicity). Tail abnormalities
were also seen in the F1a and F1b offspring of the 2-generation
reproduction rat study. However, the degree of concern is low for the
fetal effects in the developmental rat study since the fetal anomalies
were seen only at the high dose 650 mg/kg/day which is close to the
Limit Dose (LTD) (1,000 mg/kg/day). They were seen in the presence of
maternal toxicity (clinical signs of neurotoxicity) and clear NOAELs/
LOAELs were established for maternal and developmental toxicities.
ii. Evidence of quantitative susceptibility was indicated in the 2-
generation reproduction rat study, by a slightly higher decrease (11-
13%) in the body weights of offspring during lactation as compared to
an 8-10% decrease in the body weights of the parental animals. Again,
the degree of concern is also low for the 2-generation reproduction rat
study since the LOAEL for offspring toxicity is based on a conservative
determination of a minimal response in pup body weight decrements at
the same dose that also caused decreases in body weights in the
parental animals.
[[Page 55866]]
iii. The developmental toxicity study in the rabbits did not
exhibit either quantitative or qualitative susceptibility.
3. Conclusion. Exposure data for sethoxydim are complete or are
estimated based on data that reasonably accounts for potential
exposures. The toxicity data base, however, is not complete. Due to
evidence of developmental (Tail) abnormalities in the rat developmental
and reproductive studies, EPA has required submission of subchronic and
developmental neurotoxicity studies. After reviewing the data base, EPA
concluded that there was not a reliable basis for establishing an
additional safety factor for the protection of children at a value
different than the statutory default of 10X. Accordingly, EPA has
retained the additional 10X FQPA safety factor in the form of a Data
base Uncertainty Factor.
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 the model estimates of
a pesticide's concentration in water (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 U.S. EPA Office of Water are used to calculate
DWLOCs: 2 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, OPP 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
sethoxydim will occupy 52% of the aPAD for the U.S. population, 92% of
the aPAD for children aged 1-2 and 92% of the aPAD for children aged 3-
5. In addition, there is potential for acute dietary exposure to
sethoxydim in drinking water. After calculating DWLOCs and comparing
them to the EECs for surface 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 Sethoxydim
----------------------------------------------------------------------------------------------------------------
Acute Food Surface Ground
Population Subgroup aPAD (mg/ Exp mg/kg/ Water EEC Water EEC Acute DWLOC
kg) day (ppb)1 (ppb)1 (ppb)2
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.18 0.096 100 1.0 2,940
----------------------------------------------------------------------------------------------------------------
Children 1-2 years 0.18 0.165 100 1.0 150
----------------------------------------------------------------------------------------------------------------
Children 3-5 years 0.18 0.165 100 1.0 152
----------------------------------------------------------------------------------------------------------------
1 The crop producing the highest risk level was used.
2 Chronic DWLOC( [mu]g/L) = maximum chronic water exposure (mg/kg/day) x body weight (kg) water consumption (L)
x 103 mg/[mu]g.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
sethoxydim from food will utilize 24% of the cPAD for the U.S.
population, and 75% of the cPAD for infants <1 year old. Based on the
use pattern, chronic residential exposure to residues of sethoxydim is
not expected. In addition, there is potential for chronic dietary
exposure to sethoxydim in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
the following Table 4:
Table 4.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Sethoxydim.
----------------------------------------------------------------------------------------------------------------
Chronic Surface Ground Chronic
Population Subgroup cPAD (mg/ Food Exp mg/ Water EEC Water EEC DWLOC
kg) kg/day (ppb)1 (ppb)1 (ppb)2
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.014 0.0038 20 1.0 358
----------------------------------------------------------------------------------------------------------------
Infants (<1 year) 0.014 0.0105 20 1.0 35.3
----------------------------------------------------------------------------------------------------------------
1 The crop producing the highest level was used.
2 Chronic DWLOC ([mu]g/L) = [maximum chronic water exposure (mg/kg/day) x body weight (kg)] / [water consumption
(L) x 10-3 mg/[mu]g.]
[[Page 55867]]
3. Short-term risk (1-30 days). Short-term aggregate exposure takes
into account residential exposure plus chronic exposure to food and
water (considered to be a background exposure level).
Sethoxydim is currently registered for uses 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
exposures for sethoxydim.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of greater than 1,000 for all
exposure scenarios in children aged 1-2 years, which includes oral
hand-to-mouth, oral object-to-mouth and soil ingestion. These aggregate
MOEs do not exceed the Agency's level of concern for aggregate exposure
to food and residential uses. Short-term aggregate risk assessments
were not calculated for adult handlers because oral and inhalation
endpoints lack a common toxicity endpoint. The children 1-2 years-of-
age scenario was chosen because it was the highest estimated food
exposure and thus, also protective of children 3-5 years of age. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of sethoxydim in ground 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 Sethoxydim
----------------------------------------------------------------------------------------------------------------
Target
Maximum Surface Ground Short-Term
Population Subgroup Target MOE Exposure1 Water EEC2 Water EEC2 DWLOC (ppb)
(mg/kg/day) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 1,000 0.18 2 0 1 1,650
----------------------------------------------------------------------------------------------------------------
1 Target Maximum Exposure = NOAEL/Target MOE.
2 Estimate for the highest use rate was chosen.
4. Intermediate-term risk (1-6 months). Intermediate-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water (considered to be a background exposure level).
Sethoxydim is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for sethoxydim.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of greater
than 1,000 for all exposure scenarios in children aged 1-2 years old,
which includes oral hand-to-mouth, oral object-to-mouth and soil
ingestion. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses.
Intermediate term aggregate risk assessments were not calculated for
adult handlers because oral and inhalation endpoints lack a common
toxicity endpoint. The children 1-2 years- of -age scenario were chosen
because it was the highest estimated food exposure and thus, also
protective of children 3-5 years of age. After calculating DWLOCs and
comparing them to the EECs for surface water and ground water, EPA does
not expect intermediate-term aggregate exposure to exceed the Agency's
level of concern, as shown in the following Table 6:
Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Sethoxydim
----------------------------------------------------------------------------------------------------------------
Target
Maximum Surface Ground Intermediate-
Population Subgroup Target MOE Exposure1 Water EEC2 Water EEC Term DWLOC
(mg/kg/day) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 1,000 0.046 20 1 330
----------------------------------------------------------------------------------------------------------------
1Target Maximum Exposure = NOAEL/Target MOE.
2Estimate for the highest use rate was chosen.
5. Aggregate cancer risk for U.S. population. Sethoxydim is not
expected to pose a cancer risk because no evidence of carcinogenicity
was found in adequate animal tests in two different species.
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 sethoxydim residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas-liquid chromatography with
flame photometric detection (GLC/FPD) in the sulfur mode) is available
[BASF Wyandotte Corporation's (BWC's) Method No. 30, 3/15/82; MRID
44864501; Method I, PAM II] to enforce the tolerance expression in
plant and livestock commodities.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits or
tolerances for sethoxydim on lingonberry, juneberry, salal, or
safflower. Therefore, international harmonization is not an issue for
the proposed uses of sethoxydim on lingonberry, juneberry, salal,
pistachio, or safflower.
There are no Codex or Mexican maximum residue limits or tolerances
for sethoxydim on sweet corn. There is a Canadian tolerance on corn of
0.5 ppm for sethoxydim and metabolites
[[Page 55868]]
containing the cyclohex-2-enone moiety expressed as sethoxydim. The
tolerance for the proposed use of sethoxydim on sweet corn is not being
harmonized with the Canadian tolerance until the Agency can revise its
risk assessment to evaluate the risks of the harmonization with the
Canadian tolerance.
C. Conditions
As a condition of registration, the registrant must submit:
1. Residue chemistry. i. To support the proposed use on safflower,
storage stability data for sethoxydim, MSO, and 5-OH-MSO2 in safflower
oil (or another oil) stored frozen for 1 year are needed since storage
stability data for sethoxydim residues in oil have not previously been
submitted.
ii. As recommended in OPPTS 860.1500, five field trials are
required for safflower, with suggested distribution in Region 7 (two
Trials) and Region 10 (three Trials). Four studies, which were
conducted in 1988, were submitted from Region 10 (one study), Region 5
(two studies), and Region 7 (one study). EPA has determined that two
additional studies from Region 10 must be submitted.
2. Toxicology. i. Subchronic neurotoxicity study--rat.
ii. Developmental neurotoxicity study (DNT)--rat.
V. Conclusion
Therefore, tolerances are established for the combined residues of
sethoxydim, (2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one) and its metabolites containing the 2-
cyclohexen-1-one moiety (calculated as the herbicide), in or on corn,
sweet, kernels plus cob with husk removed at 0.4 parts per million
(ppm); corn, sweet, forage at 3.0 ppm; corn, sweet, stover at 3.5 ppm;
lingonberry at 5.0 ppm; juneberry at 5.0 ppm; milk at 0.5 ppm; cattle,
meat byproducts at 1.0 ppm; goat, meat byproducts at 1.0 ppm; hog, meat
byproducts at 1.0 ppm; horse, meat byproducts at 1.0 ppm; sheep, meat
byproducts at 1.0 ppm; pistachio at 0.2 ppm; safflower at 15.0 ppm and
salal at 5.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. EPA's 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
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the 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-2003-0315 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 November
28, 2003.
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 (1900C),
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 Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. 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 Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0315, 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 Unit I.B.1. 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
[[Page 55869]]
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 the
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 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 the 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 the 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 record
keeping requirements.
Dated: September 23, 2003.
Debra Edwards,
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), 346(a) and 371.
0
2. Section 180.412 is amended as follows:
0
i. In the table to paragraph (a) by revising the entries for cattle,
meat byproducts; corn, sweet, kernel plus cob with husks removed; goat
meat byproducts; hog, meat byproduct; horse, meat byproduct; milk; and
sheep, meat byproduct, and by alphabetically adding the commodities
corn, sweet, forage; corn sweet, stover, juneberry; lingonberry;
pistachio; salal; and safflower.
0
ii. By removing the text from paragraph (b) and reserving the paragraph
designation and heading.
0
The amended, added, and revised portions of Sec. 180.412 read as
follows:
Sec. 180.412 Sethoxydim; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
* * * * *
Cattle, meat byproducts....................... 1.0 None
* * * * *
Corn, sweet, forage........................... 3.0 None
Corn, sweet, kerenel plus cob with husks 0.4 None
removed......................................
[[Page 55870]]
Corn, sweet stover............................ 3.5 None
* * * * *
Goat, meat byproducts......................... 1.0 None
* * * * *
Hog, meat byproducts.......................... 1.0 None
* * * * *
Horse, meat byproducts........................ 1.0 None
* * * * *
Juneberry..................................... 5.0 None
* * * * *
Lingonberry................................... 5.0 None
* * * * *
Milk.......................................... 0.5 None
* * * * *
Pistachio..................................... 0.2 None
* * * * *
Salal......................................... 5.0 None
Safflower..................................... 15.0 None
* * * * *
Sheep, meat byproducts........................ 1.0 None
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 03-24562 Filed 9-26-03; 8:45 am]
BILLING CODE 6560-50-S