[Federal Register: September 17, 2004 (Volume 69, Number 180)]
[Rules and Regulations]
[Page 55963-55975]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se04-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0155; FRL-7368-1]
Dinotefuran; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of dinotefuran N-methyl-N'-nitro-N'-[(tetrahydro-3-
furanyl)methyl)]guanidine and its metabolites DN [1-methy-3-
(tetrahydro-3-furylmethyl)]guanidine and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea], expressed as dinotefuran in or on vegetable, leafy,
except Brassica, group 4. Mitsui Chemicals, Inc. requested this
tolerance 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 17, 2004. Objections and
requests for hearings must be received on or before November 16, 2004.
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
ID number OPP-2004-0155. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket. Although listed in the
index, some information is not publicly available, i.e., 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: Rita Kumar, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 308-8291; e-mail address: kumar.rita@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;
[[Page 55964]]
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 (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of July 2, 2003 (FR 39547) (FRL-7312-8),
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 (PP 2F6427)
by Mitsui Chemicals, Inc., Chiyoda-ku, Tokyo, Japan. That notice
included a summary of the petition prepared by Mitsui Chemicals, Inc.,
the registrant. One comment was received from a private citizen, in
support of this notice.
The petition requested that 40 CFR 180.603 be amended by
establishing a tolerance for combined residues of the insecticide
dinotefuran, N-methyl-N'-nitro-N'-[(tetrahydro-3-
furanyl)methyl)]guanidine and its metabolites DN [1-methyl-3-
(tetrahydro-3-furylmethyl)]guanidine and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea], expressed as dinotefuran, in or on vegetable, leafy,
except Brassica, group 4 at 5.0 parts per million (ppm).
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 of
dinotefuran, N-methyl-N'-nitro-N'-[(tetrahydro-3-
furanyl)methyl)]guanidine and its metabolites DN [1-methyl-3-
(tetrahydro-3-furylmethyl)]guanidine and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea] expressed as dinotefuran on vegetable, leafy, except
Brassica, group 4 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 nature of the toxic effects caused by dinotefuran 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.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3100 90-Day oral toxicity in rats NOAEL: 38/384 male and female (M/F)
milligrams/kilogram/day (mg/kg/day)
LOAEL: 384 M mg/kg/day based on
adrenal histopathology; 1,871 F mg/
kg/day based on decreased body
weight/body weight gain, changes in
hematology/clinical chemistry,
changes in organ weights, and
adrenal histopathology
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870.3100 90-Day oral toxicity in mice NOAEL: 4,442/5,414 M/F mg/kg/day
LOAEL: 10,635/11,560 M/F mg/kg/day,
based on decreased body weight,
body weight gain
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870.3150 90-Day oral toxicity in dogs NOAEL: 307/not determined M/F mg/kg/
day
LOAEL: 862 M mg/kg/day, based on
body weight gain, hemorrhagic lymph
nodes; < 59 F, based on decreased
body weight, body weight gain
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[[Page 55965]]
870.3200 28-Day dermal toxicity (rats) Systemic
NOAEL: 1,000 mg/kg/day
LOAEL: not determined (no effects
seen)
Dermal
NOAEL: 1,000 M, < =200 F mg/kg/day
LOAEL: not determined/ < =1,000 M/F
mg/kg/day based on lack of effects
in males, increase in acanthosis/
hyperkeratosis in high dose females
(lower doses not evaluated
histopathologically)
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870.3465 28-Day inhalation toxicity (rat) NOAEL: < 0.22 M mg/L, 0.22 F mg/
LOAEL: decreased body weight gain,
food consumption M; increased
clinical signs (protruding eyes) F
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870.3700 Prenatal developmental toxicity Maternal
study (rats) NOAEL: 300 mg/kg/day
LOAEL: 1,000 mg/kg/day based on body
weight gain and food consumption
Developmental
NOAEL: 1,000 mg/kg/day
LOAEL: not determined (no effects
seen)
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870.3700 Prenatal developmental toxicity Maternal
study (rabbits) NOAEL: 52 mg/kg/day
LOAEL: 125 mg/kg/day based on body
weight gains, food consumption, and
necropsy findings
Developmental
NOAEL: 300 mg/kg/day
LOAEL: > 300 mg/kg/day (no effects
seen)
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870.3800 Reproduction and fertility Parental/systemic
effects (rats) NOAEL: 241/268 M/F mg/kg/day
LOAEL: 822/907 M/F mg/kg/day, based
on decreased food consumption,
weight gain in males, soft feces in
females, and decreased spleen
weights in both sexes
Reproductive (tentative)
NOAEL: 241/268 M/F mg/kg/day
LOAEL: 822/907 M/F mg/kg/day, based
on decreased uterine weights and
microscopic alterations in the
uterus and vagina of F0 females,
decreased numbers of primordial
follicles in F1 females, altered
estrous cyclicity in F0 and F1
females, increase in abnormal sperm
morphology in F0 and F1 males,
decreased testicular sperm count in
F0 males, and decreased in sperm
motility in F1 males
Developmental
NOAEL: 241/268 M/F mg/kg/day
LOAEL: 822-935/907-1,005 M/F mg/kg/
day based on decreased body
weights, body weight gains, and
spleen weights in F and F2 males
and females, decreased thymus
weights in F2 males and females,
and decreased forelimb grip
strength (F1 males) or hindlimb
grip strength (F1 females)
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870.4100 Chronic toxicity (rats) See 870.4300 Combined chronic
toxicity/carcinogenicity (rats)
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870.4100 Chronic toxicity (dogs) NOAEL: < 20/22 M/F mg/kg/day
LOAEL: 20/108 M/F mg/kg/day based on
decreased thymus weight, decreased
food efficiency, body weight, and
body weight gain in females,
decreased thymus weight in males
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870.4200 Carcinogenicity (rats) See 870.4300 Combined chronic
toxicity/carcinogenicity (rats)
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[[Page 55966]]
870.4200 Carcinogenicity (mice) NOAEL: < 3 M, < 4 F mg/kg/day
LOAEL: 3/4 M/F mg/kg/day based on
decreased spleen weights at week 79
terminal sacrifice in males and
increased ovarian weights at week
53 in females
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870.4300 Combined chronic toxicity/ NOAEL: 99.7/127.3 M/F mg/kg/day
carcinogenicity (rats) LOAEL: 991/1,332 M/F mg/kg/day based
on decreased body weight gain, food
efficiency in females, increased
incidences of kidney pelvic
mineralization and ulceration in
males
----------------------------------------------------------------------------------------------------------------
870.5100 Bacterial reverse mutation test Negative, S9 up to
16,000 [mu]g/plate
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870.5100 Bacterial reverse mutation test Negative, S9 up to
limit dose of 5,000 [mu]g/plate
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870.5300 In vitro mammalian cell gene Negative, S9 up to
mutation test 2,002 [mu]g/mL
(Mouse lymphoma L5178Y cells)
----------------------------------------------------------------------------------------------------------------
870.5375 In vitro mammalian chromosome Negative for clastogenic/aneugenic
aberration test activity up to 2,000 [mu]g/mL
(CHL/IU cells)
----------------------------------------------------------------------------------------------------------------
870.5395 In vivo mammalian cytogenics- Negative at oral doses up to 1,080
micronucleus assay mg/kg/day for 2 days
----------------------------------------------------------------------------------------------------------------
870.6200 Acute neurotoxicity screening NOAEL: 750 M, 325 F mg/kg/day
battery LOAEL: 1,500 M, 750 F mg/kg/day
based on decreased motor activity
on day 1
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870.6200 Subchronic neurotoxicity NOAEL: 33/40 M/F mg/kg/day
screening battery LOAEL: 327/400 M/F mg/kg/day based
on increased motor activity during
week 2
----------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and pharmacokinetics Absorption was > 90% regardless of
(rats) dose. The radiolabel was widely
distributed through the body and
was completely excreted within 168
hours of treatment. Urine was the
primary elimination route,
accounting for 88-99.8%. Excretion
into the urine was rapid, being 84-
99% complete within 24 hours of
treatment. Absorption of the
radioactivity was linear within the
dose range of 50 and 1,000 mg/kg.
Elimination of radioactivity was
fast for all groups with a T1/2
ranging from 3.64 to 15.2 hours for
the low and high doses,
respectively. Radioactivity was
rapidly transferred from maternal
blood to milk and widely
distributed in the fetal tissues.
The Cmax for milk and fetal tissues
was detected 0.5 hours after
maternal treatment. The
concentrations of radioactivity in
fetal tissue and maternal milk
declined quickly and were below
detection limits 24 hours post-
treatment. After IV or oral
treatment, 75-93% of the
administered radiolabeled test
material, or nearly 93-97% of total
urinary radiolabel, was excreted
unchanged in the urine. The parent
compound was also the primary
component in the plasma, milk,
bile, feces, and most tissues
collected 4-8 hours after treatment
and at both dose levels. Less than
10% of the parent compound was
metabolized into numerous minor
metabolites that were not well
resolved by High Performance Liquid
Chromotography (HPLC) or 2D-TLC.
For all parameters measured in this
study, no sex-related or dose-
related differences or label
position effects were found.
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[[Page 55967]]
Special study: Neonatal rat metabolism study After a single oral 50 mg/kg dose of
(12-day old rat pups) G-14C MTI-446 to 12-day old rats,
absorption was high (absorption
could not be adequately determined
but may have approached 80%) and
the radiolabel was widely
distributed within the body.
Approximately 32-36% of the
administered dose was excreted
within 4 hours of treatment. Urine
was the primary elimination route
as indirectly evidenced by finding
high radioactive areas in the
kidneys and bladder by whole body
autoradiography. No areas of tissue
sequestration were found and no
gender-related differences were
identified. The test material was
essentially not metabolized, the
parent compound accounting for >97%
of the radiolabel in the excreta,
plasma, kidneys, and stomach, and
nearly 61-83% in intestines (and
contents), and liver.
----------------------------------------------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which 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 LOAELs of concern
are identified 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.
Three other types of safety or UFs may be used. ``Traditional
UFs,'' the ``special FQPA safety factor,'' and the `` default FQPA
safety factor.'' By the term ``traditional UF,'' EPA is referring to
those additional UFs used prior to FQPA passage to account for data
base deficiencies. These traditional UFs 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 uncertainty
factor 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 dinotefuran used for
human risk assessment is shown in following Table 2.
Table 2.--Summary of Toxicological Dose and Endpoints for dinotefuran for Use in Human Risk Assessment
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Special FQPA SF and
Exposure/Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 125 mg/kg/day FQPA SF = 1 Developmental toxicity
(General population including infants UF = 100............... aPAD = acute RfD /..... study in rabbits
and children). Acute RfD = 1.25 mg/kg/ FQPA SF = 1.25 mg/kg/ LOAEL = 300 mg/kg/day
day. day. based on clinical
signs in does (prone
position, panting,
tremor, erythema) seen
following a single
dose.
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[[Page 55968]]
Chronic dietary LOAEL= 20 mg/kg/day FQPA SF = 1 Chronic toxicity study
(All populations).................... UF = 1,000............. cPAD = chronic RfD /... in dogs
Chronic RfD = 0.02 mg/ FQPA SF = 0.02 mg/kg/ LOAEL = 20 mg/kg/day
kg/day. day. based on decreased
thymus weight in males
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Short-term NOAEL= 33 mg/kg/day Residential LOC for MOE Subchronic
Incidental oral (1 to 30 days)....... = 100 neurotoxicity study in
Occupational = NA...... rats
LOAEL = 327 mg/kg/day
based on increased
motor activity during
week 2
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Intermediate-term NOAEL= 22 mg/kg/day Residential LOC for MOE Chronic toxicity study
Incidental oral (1 to 6 months)...... =100 in dogs
Occupational = NA...... LOAEL = 108 mg/kg/day
based on decreased
body weight and body
weight gain in females
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 30 days) No quantitation Residential LOC for MOE No quantitation
required = NA required. No systemic
Occupational LOC for toxicity was seen at
MOE = NA. the limit dose in a 28-
day dermal toxicity
study in which
neurotoxicity was
evaluated. No
developmental toxicity
concerns.
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Intermediate-term dermal (1 to 6 Oral study NOAEL = 22 Residential LOC for MOE Chronic toxicity study
months) mg/kg/day (dermal =100 in dogs
absorption rate = 30%) Occupational LOC for LOAEL = 108 mg/kg/day
MOE =100. based on decreased
body weight and body
weight gain in females
----------------------------------------------------------------------------------------------------------------
Long-term dermal (>6 months) Oral study LOAEL= 20 mg/ Residential LOC for MOE Chronic toxicity study
kg/day (dermal = 1,000 in dogs
absorption rate = 30%) Occupational LOC for LOAEL = 20 mg/kg/day
MOE = 1,000. based on decreased
thymus weight in males
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) Inhalation study LOAEL Residential LOC for MOE 28-day inhalation
= 60 mg/kg/day = 1,000 toxicity study in rats
Occupational LOC for LOAEL = 60 mg/kg/day
MOE = 1,000. based on decreased
body weight gain in
males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 to 6 Inhalation study LOAEL Residential LOC for MOE 28-day Inhalation
months) = 60 mg/kg/day = 1,000 toxicity study in rats
Occupational LOC for LOAEL = 60 mg/kg/day
MOE = 1,000. based on decreased
body weight gain in
males
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (< 6 months) Oral study LOAEL= 20 mg/ Residential LOC for MOE Chronic toxicity study
kg/day = 1,000 in dogs
(inhalation absorption Occupational LOC for LOAEL = 20 mg/kg/day
rate = 100%). MOE = 1,000. based on decreased
thymus weight in males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Not required; no
evidence of
carcinogenicity
----------------------------------------------------------------------------------------------------------------
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. Currently there are no
tolerances established for dinotefuran on any commodity. Risk
assessments were conducted by EPA to assess dietary exposures from
dinotefuran 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
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), which incorporates food
consumption data as reported by respondents in the United States
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. The following
assumptions were made for the acute exposure assessments: The dietary
risk analyses incorporated tolerance level residues and assumed 100% of
the leafy vegetables had been treated with dinotefuran. The acute risk
estimates are below the Agency's level of concern (< 100% aPAD) for the
general U.S. population and all population subgroups.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM software with the FCID, which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 CSFII, and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: The dietary risk analyses incorporated tolerance level
residues and assumed 100% of the leafy vegetables had been treated with
[[Page 55969]]
dinotefuran. The chronic risk estimates are below the Agency's level of
concern (< 100% cPAD) for the general U.S. population and all population
subgroups.
iii. Cancer. Dinotefuran is classified as ``not likely to be a
carcinogen,'' therefore, an exposure assessment for quantifying cancer
risk was not conducted.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for dinotefuran 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 dinotefuran.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/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. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include 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 screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would 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), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %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 dinotefuran they are
further discussed in the aggregate risk sections below.
Based on the Index Reservoir Screening Tool (FIRST) and SCI-GROW
models, the EECs of dinotefuran for acute exposures are estimated to be
75.78 parts per billion (ppb) for surface water and 5.06 ppb for ground
water. The EECs for chronic exposures are estimated to be 20.97 ppb for
surface water and 5.06 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).
Dinotefuran is proposed to be registered for use on the following
residential non-dietary sites: Professional turf management,
professional ornamental production, residential indoor, lawn and
garden. The risk assessment was conducted using the following
residential exposure assumptions: Outdoor uses for turf farms, golf
courses and residential lawns, ornamentals and vegetable gardens.
There is a potential for exposure to homeowners in residential
settings during the application of products containing dinotefuran.
There is also a potential for exposure from entering areas previously
treated with dinotefuran such as lawns where children might play, or
golf courses, home gardens that could lead to exposures for adults. As
a result, risk assessments have been completed for both residential
handler and post-application scenarios.
Residential handlers may be exposed dermally and by inhalation
during mixing, loading and application of dinotefuran for short-term
durations. However, a short-term dermal endpoint was not identified.
For this reason, and because the short-term and intermediate-term
inhalation endpoints are the same, intermediate-term risks are assessed
for residential handlers as a screen for their potential short-term
exposures. Because common toxicity endpoints were identified for both
dermal and inhalation routes, a combined risk from both routes of
exposure is assessed. Combined risk was estimated by calculating an
aggregate risk index (ARI). All residential handler estimated exposures
meet or exceed the Agency's target ARI of 1, and are therefore, not of
concern.
Residential post-application exposures are assumed to be mostly of
short-term duration (1 to 30 days); although intermediate-term (1 to 6
months) exposures are possible. Because there are numerous dinotefuran
use products and scenarios, those scenarios assessed were chosen to
cover the major residential use sites (i.e. turf, home garden etc.) and
highest use rates and exposures. The margins of exposure (MOEs) for
post-application exposure to dinotefuran are above the target MOE of
100, and therefore, do not exceed Agency's level of concern for the
following scenarios: (1) Exposure to adults and children from turf
products; and (2) exposure to adults in vegetable gardens.
The Agency combines risks resulting from exposures to individual
chemicals when it is likely they can occur simultaneously based on the
use pattern and the behavior associated with the exposed population.
For this assessment, the Agency has added together risk values for
adults applying dinotefuran to residential lawns and then being exposed
to the treated lawn. For children, dermal and incidental oral exposures
from activities on treated lawn were combined. These are considered to
represent worst case scenarios for co-occurring residential exposures.
The risks from the combined exposures of adults applying
dinotefuran to residential lawns and then being dermally exposed from
post-application activities on the treated lawn do not exceed the
Agency's level of concern. Children's combined risks from activities on
treated lawns do not exceed the Agency's level of concern.
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.''
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 dinotefuran and any other
substances and dinotefuran does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has
[[Page 55970]]
not assumed that dinotefuran 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 OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site at http://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 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. Prenatal developmental
toxicity studies in rats and rabbits provided no indication of
increased susceptibility (qualitative or quantitative) of rat or rabbit
fetuses to in utero exposure to dinotefuran. There was no indication of
increased (quantitative) susceptibility in the fetuses as compared to
parental animals in the two generation reproduction study. Qualitative
susceptibility was observed in the reproduction study; however, the
degree of concern is low because the observed effects are well
characterized (decreased body weight, decreased thymus weight, and
decreased grip strength) and there are clear NOAELs/LOAELs.
3. Conclusion. Although there is generally low concern and no
residual uncertainties for pre- and/or postnatal toxicity resulting
from exposure to dinotefuran, some uncertainty is raised by a
deficiency in the data (lack of a NOAEL in the chronic dog study) and
the need for a developmental immunotoxicity study (DIT).
The absence of a NOAEL for the chronic dog study and the need for a
DIT study generate some uncertainty regarding the protectiveness of
chronic regulatory endpoint and long-term level of concern.
Accordingly, EPA does not have reliable data supporting adoption of a
safety factor other than the default additional 10X factor as specified
in FFDCA section 408(b)(2)(C). The chronic endpoint and long-term level
of concern have therefore been generated using a overall safety/
uncertainty factor of 1,000 (representing 100X for inter-and intra-
species variation and an additional 10X pursuant to FFDCA section
408(b)(2)(C).
The Agency does not have similar concerns regarding acute, short-
term, and intermediate term risk assessments. First, the absence of a
NOAEL only occurred in a chronic study. Second, reliable data show that
the DIT is unlikely to result in a NOAEL for acute, short-term, or
intermediate term effects that is lower than the NOAELs currently being
used to assess the risk from such effects. EPA has required a
Developmental Immunotoxicity Study (DIT) with dinotefuran based on the
changes in the thymus weight in offspring in the reproduction study and
in adult rats and dogs. There is, however, little evidence to support a
direct effect of dinotefuran on immune function. This is because
lymphoid organ weight changes can be secondary to generalized toxicity
(e.g., reductions in body weight, body weight gain, and/or food
efficiency). In the reproduction study, decreased thymus weights were
seen in offspring in the presence of decreased body weight only at the
Limit Dose (10,000 ppm). In the 1-year dog study, decrease in thymus
weight was seen in the absence of other toxicity, however, no decrease
in thymus weight was seen in the subchronic study in dogs which was
conducted at higher doses (i.e., the results of the 1-year study was
not supported by the results of the 90-day study).
Further, the only evidence on dinotefuran's potential immunological
effect is found in studies with prolonged exposure. In the reproduction
study, the effect of concern [i.e, decrease in thymus weight in only
one generation (F2)] was seen only following approximately 13 weeks of
exposure to the parental animals at close to the Limit Dose (1,000 mg/
kg). Similarly, thymus effects in the chronic dog study were only
observable after long-term exposures, but were not seen in the 90-day
dog study.
Finally, it is clear that DIT study, which is performed in the rat,
will have to be conducted at high doses (close to the Limit Dose) to
elicit a potential single dose effect and this will result in a
potential NOAEL higher than that currently used for various risk
assessments. As noted, in the rat reproduction study, effects only
occurred at doses close to the Limit Dose (1,000 mg/kg/day). The Limit
Dose is the maximum dose recommended for testing in the Series 870
Health Effects Harmonized Test Guidelines; toxic effects occurring only
at or near the Limit Dose are of less concern for human health since
they may be specifically related to the high dose exposure and may not
occur at the much lower doses to which humans are exposed.
Additionally, in the acute neurotoxicity study in the rat, the LOAEL
was 750 mg/kg/day in females and 1,500 mg/kg/day in males based on
reductions in motor activity indicating that high doses are required to
elicit Dinotefuran-induced toxicity in rats.
The NOAELs in the critical studies selected for acute dietary (125
mg/kg/day), short term incidental oral (33 mg/kg/day), and intermediate
term incidental oral and dermal (22 mg/kg/day) exposure scenarios are
lower than the offspring NOAEL (241 mg/kg/day) in the reproduction
study. Therefore, EPA is confident that the doses selected for these
risk assessments will address the concerns for the thymus weight
changes seen in the offspring in the reproduction study and will not
underestimate the potential risk from exposure to dinotefuran.
The Agency believes there are reliable data showing that the
regulatory endpoints are protective of children despite the need for a
developmental neuorotoxicity study. Developmental neurotoxicity data
received and reviewed for other compounds in this chemical class
(neonicotinoids) including thiacloprid, clothianidin, and imidacloprid,
indicate that the results of the required DNT study will not likely
impact the regulatory doses selected for dinotefuran.
In addition, the acute and chronic dietary food exposure assessment
utilized proposed tolerance level residues and 100% crop treated
information for all commodities. By using these screening-level
assessments, acute and chronic exposure/risks will not be
underestimated. Furthermore, the dietary drinking water assessment
(Tier 1 estimates) uses values generated by models and associated
modeling parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. Finally, the
residential assessment for children's postapplication exposures is
based upon
[[Page 55971]]
maximum application rates in conjunction with chemical-specific study
data and are not expected to underestimate risk.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
dinotefuran will occupy 0.68% of the aPAD for the U.S. population,
0.76% of the aPAD for females 13 years and older, 0.21% of the aPAD for
infants < 1 year old, and 0.76% of the aPAD for children 3 to 5 years
old. In addition, there is potential for acute dietary exposure to
dinotefuran 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 dinotefuran
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population/Subgroup aPAD (mg/kg/ % aPAD Water EEC Water EEC Acute DWLOC
day) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 1.25 0.68 75.78 5.06 43,000
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 1.25 0.21 75.78 5.06 12,000
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 1.25 0.76 75.78 5.06 12,000
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 1.25 0.76 75.78 5.06 37,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dinotefuran from food will utilize 8.6% of the cPAD for the U.S.
population, 4.4% of the cPAD for infants < 1 year old, 8.6% of the cPAD
for children 3-5 years old and 9.4% of the cPAD for females 13-49 years
old. In addition, there is potential for chronic dietary exposure to
dinotefuran 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.
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to dinotefuran
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population/Subgroup cPAD (mg/kg/ %cPAD Water EEC Water EEC Chronic
day) (FOOD) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.02 8.6 20.97 5.06 640
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 0.02 4.4 20.97 5.06 190
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 0.02 8.6 20.97 5.06 180
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.02 9.4 20.97 5.06 550
----------------------------------------------------------------------------------------------------------------
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).
Dinotefuran is proposed 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 dinotefuran, short-term and intermediate-term aggregate
risk assessments based on exposure from oral, inhalation, and dermal
routes were considered.
[[Page 55972]]
However, for short-term aggregate exposure assessment, oral and
inhalation risk estimates cannot be combined due to the different bases
of their endpoints; i.e., neurotoxicity for oral and decrease in body
weight for inhalation. Also, because no systemic toxicity was seen at
the limit dose in a 28-day dermal toxicity study, no quantification of
short-term dermal risk is required. Therefore, a short-term aggregate
risk assessment cannot be performed for dinotefuran. However, an
intermediate-term aggregate risk assessment was performed as a
screening level assessment, which will apply to short-term aggregate
risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Dinotefuran is proposed for uses 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 dinotefuran. An intermediate-term aggregate risk
assessment was performed as a screening level assessment for adults and
children.
The child subgroup with the highest estimated chronic dietary
exposure (children 3-5 years old) was used to calculate the
intermediate-term aggregate risk, including chronic dietary (food and
drinking water) and residential dermal and oral exposures. All
acceptable MOEs must be identical for all MOEs to be included in the
intermediate-term risk assessment. Based on the toxicity endpoint
information, all acceptable MOEs are 100, and an oral endpoint for
hand-to-mouth residential exposure was identified. In this case, the
chronic dietary endpoint (NOAEL) was used to incorporate dietary (food
and water), and residential exposures in the aggregate risk assessment.
An intermediate-term residential exposure scenario was identified and
includes dermal and oral exposure routes. To complete the aggregate
intermediate-term exposure and risk assessment, chronic dietary (food
and drinking water) and residential dermal and oral exposures must be
included.
For children's combined exposure on turf, the total residential MOE
was estimated to be 590. The average (chronic) dietary exposure for the
highest exposed child subgroup (children 3-5 years old) was estimated
to be 0.0017 mg/kg/day. The aggregate risk assessment for intermediate-
term exposure to children is summarized in the following Table 5.
Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure of Children to Dinotefuran.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Average Surface
NOAEL/mg/ Target Max Food Residential Aggregate MOE Max Water Ground Water Intermediate-
Population kg/day MOE1 Exposure2/ Exposure mg/ Exposure3 (food and Exposure5 Water EEC6 EEC6 Term DWLOC7
mg/kg/day kg/day mg/kg/day residential)4 mg/kg/day [mu]g/L [mu]g/L [mu]g/L
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 yrs old 22 100 0.22 0.0017 0.037227 565 0.181 20.97 5.06 1,810
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 The target MOE of 100 is based on the standard inter-species and intra-species safety factors, 10x for intra-species variability and 10x for inter-species extrapolation.
2 Maximum exposure (mg/kg/day) = NOAEL/Target MOE.
3 Residential exposure to children playing on treated lawns (combined dermal + oral hand-to-mouth + oral object-to-mouth + oral soil ingestion).
4 Aggregate MOE = NOAEL/(Avg. Food Exposure + Residential Exposure).
5 Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure).
6 The use site producing the highest level was used; i.e. turf.
7 DWLOC ([mu]g/L) = Maximum water exposure (mg/kg/day) x body weight (10 kg) Water exposure (1L) x 103 mg/[mu]g.
Compared with the EECs, the aggregate intermediate-term DWLOC does
not exceed Agency's level of concern for the subgroup population of
children 3-5 years old.
For adults, the worst case intermediate-term aggregate risk
assessment includes the following scenarios: (1) Dermal and inhalation
exposures to residential handlers (i.e. M/L/A of liquids to lawns by
hose-end sprayers); (2) dermal post-application exposures on treated
lawns; and (3) oral dietary exposures (i.e. food + drinking water).
Based on the toxicity endpoint information, the acceptable MOEs are not
all identical. The intermediate-term inhalation endpoint has a UF/MOE
of 1,000, because a NOAEL was not reached and a LOAEL was used instead,
while the assessments for incorporating food, water and dermal
exposures have UFs/MOEs of 100. In this case, the aggregate risk index
(ARI) method was used to calculate DWLOC values for the adult aggregate
intermediate-term risk assessment.
The highest estimated average (chronic) dietary exposure occurred
with females 13-49 years old (i.e. 0.0019 mg/kg/day). The adult
residential combined risks from dermal (ARI = 17) and inhalation (ARI =
970) exposures to residential handlers; and dermal postapplication
exposures (ARI = 12) on treated lawns were assessed and combined. The
aggregate risk assessment for intermediate-term exposure to adults is
summarized in following Table 6.
[[Page 55973]]
Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure of Adults to Dinotefuran.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Residential ARIs3
---------------------------------------
Applicators Post- Max Water Ground Surface Intermediate-
Polulation Target ARI1 ARI Food2 -------------------------- application Exposure Water EEC5 Water EEC5 Term DWLOC6
Dermal Inhalation Dermal ARI4 [mu]g/L [mu]g/L [mu]g/L
Exposure Exposure Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 14-49 years old 1 116 17 970 12 1.18 20.97 5.06 5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 ARI (Aggregate Risk Index) = MOEcalculated/MOEacceptable
2 ARIFood = 22 / 0.0019 / 100 = 116
3. ARIdermal = MOEcalculated/100 and, ARIinhal = MOEinhal/1,000
4. ARI Water = 1/1/1- (1/ARIResidential aplicator dermal) + (1/ARIResidential applicator inhalation) + (1/ARI Post-application dermal)
5. The use site producing the highest level was used; i.e. turf.
6. DWLOC ([mu]g/L) = [Maximum water exposure (mg/kg/day) x body weight (60 kg)] / [Water exposure (2 L) x 10-3 mg/[mu]g]; where Maximum water exposure =
NOAEL (22) / ARI Water (1.18) x 100 = 0.1866 mg/kg/day.
Compared with the EEC, the aggregate intermediate-term DWLOC does
not exceed Agency's level of concern for the subgroup population of
females 13-49 years old.
5. Aggregate cancer risk for U.S. population. Dinotefuran is not
expected to pose a cancer risk.
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 dinotefuran residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (High Performance Liquid
Chromatography/Ultraviolet for the determination of residues of
dinotefuran per se in lettuce, and High Performance Liquid
Chromatography/Mass Spectrometry and High Performance Liquid
Chromatography/Mass Spectrometry/Mass Spectrometry method for the
determination of dinotefuran metabolites DN [1-methyl-3-(tetrahydro-3-
furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea] in lettuce) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are currently no established Codex, Canadian, or Mexican
maximum residue limits for residues of dinotefuran in/on plant or
livestock commodities.
V. Conclusion
Therefore, the tolerance is established for combined residues of
dinotefuran, N-methyl-N'-nitro-N-[tetrahydro-3-furanyl)methyl]guanidine
and its metabolites DN [1-methyl-3-[tetrahydro-3-furylmethyl]guanidine
and UF [1-methyl-3-(tetrahydro-3-furylmethyl)urea], expressed as
dinotefuran, in or on vegetable, leafy, except Brassica, group 4 at 5.0
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-2004-0155 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
16, 2004.
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, Environmental Protection Agency, 1099 14th
Street NW., Suite 350, Washington DC 20005, (telephone number (202)
564-6255). 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. 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-2004-0155, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide
[[Page 55974]]
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 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: September 9, 2004.
James Jones,
Director, 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.
0
2. Section 180.603 is added to subpart C to read as follows:
Sec. 180.603 Dinotefuran; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of Dinotefuran, N-methyl-N'-nitro-N-(tetrahydro-3-
furanyl)methyl)guanidine and its metabolites DN 1-mehyl-3-(tetrahydro-
3-furylmethyl)guanidine and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea], expressed as dinotefuran.
[[Page 55975]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Vegetable, leafy, except Brassica, group 4 5.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 04-20981 Filed 9-16-04; 8:45 am]
BILLING CODE 6560-50-S