[Federal Register: August 11, 2004 (Volume 69, Number 154)]
[Rules and Regulations]
[Page 48799-48805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au04-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0145; FRL-7362-1]
Forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea; Time-
LimitedPesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea in
or on almond, apple, blueberry, cranberry, fig, grapes, kiwifruit,
olive, pear, and plums (fresh). Siemer and Associates Incorporated,
agent for KIM-C1, LLC requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA). The tolerance will expire on May 31,
2006.
DATES: This regulation is effective August 11, 2004. Objections and
requests for hearings must be received on or before October 12, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0145. 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: Cynthia Giles-Parker, Registration
Division, (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7740; e-mail address:
giles-parker.cynthia@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)
Animal production (NAICS 112)
Food Manufacturing (NAICS 311)
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. 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
RelatedInformation?
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 April 7, 2004 (69 FR 18375)(FRL-7349-9),
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7G4906) by KIM-C1, LLC, c/o Siemer and Associates, Inc., 4672 West
Jennifer Street, Suite 103, Fresno, CA 93722. This notice included a
summary of the petition prepared by KIM-C1, the registrant.
The petition requested that 40 CFR 180.569 be amended by
establishing an extension of a time-limited tolerance for residues of
the fungicide forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea,
in or on the raw agricultural commodities almonds, apples, blueberries,
figs, grapes, kiwi fruit, pears, and plums at 0.01 parts per million
(ppm). The tolerance will expire on May 31, 2006.
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
[[Page 48800]]
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 (62 FR 62961, November 26, 1997) (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 residues of
forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea on the raw
agricultural commodities almonds, apples, blueberries, figs, grapes,
kiwi fruit, pears, and plums at 0.01 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 forchlorfenuron; N-
(2-chloro-4-pyridinyl)-N'-phenylurea 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 NOAEL = M*400; F*
toxicity rats = 84milligrams/
kilogram/day (mg/
kg/day);
LOAEL = M* = not
determined, F =
428mg/kg/day
based on decrease
body weight, body
weight gainand
food efficiency.
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL = M = 16.8;
toxicity in dogs F = 19.1 mg/kg/
day
LOAEL = M = 162.4;
F = 188.7 mg/kg/
daybased on
decreases (10%)
in body weight
gain, FC andfood
efficiency.
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 200 mg/kg/day
rodents Maternal LOAEL =
400 mg/kg/day
based on
increased
incidence of
alopecia;
decrease body
weight and body
weight gains
Developmental
NOAEL = 200 mg/kg/
day
Development LOAEL
= 400 mg/kg/day
based on
decreased mean
fetal body weight
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870.3700 Prenatal Maternal NOAEL =
developmental in 100 mg/kg/day
nonrodents Maternal LOAEL =
not determined
Developmental
NOAEL = 100 mg/kg/
day
Development LOAEL
= not determined
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870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL = M 11/13;
F13/15 effects mg/
kg/day
Parental/Systemic
LOAEL = 144-202mg/
kg/day based on
decreased FC F0
and F1;clinical
signs of toxicity
and lower body
weight in F1Mand
F and growth
retardation in F1
and F2 pups
Reproductive NOAEL
= M144/168; F =
169/202 mg/kg/day
Reproductive LOAEL
= 544-926 mg/kg/
day based on
increased pup
mortality (F1a,
F1b and F2a),
emaciation in
F1b, and decrease
in F1 pups litter
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870.4300 Chronic NOAEL = M = 7; F =
carcinogenicity 9 mg/kg/day
rat LOAEL = M = 93; F
= 122 mg/kg/day
basedon reduced
body weight and
body weight gain
and FC; kidney
toxicity(M =
suppurative
inflammation, F =
non-suppurative
interstitialnephr
itis. No evidence
of
carcinogenicity
------------------------------------------------------------------------
*M = Male; F = Female; FC = Food Consumption
[[Page 48801]]
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. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor 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 Safety Factor
(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 forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea
used for human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-
phenylurea for Use in Human Risk Assessment
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FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
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Acute dietary ................. None .......................
-----------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 7 mg/kg/day FQPA SF = 10X 2-Year rat feeding
UF = 100............... cPAD = 0.007mg/kg/day. study
Chronic RfD =0.07 mg/kg/ Applyto all LOAEL = M = 93; F =
day. populationsubgroups. 122mg/kg/day based on
decreasesin body
weight, body
weightgain and food
consumption aswell as
effects on the kidney
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Short-term dermal (1 to 7 days) NOAEL= 200 mg/kg/day LOC is MOE = 1,000 Developmental rat study
(dermal absorption (residentialexposures). (oral);decreases in
rate= 100%). maternal bodyweights
and body weight
gainsas well as
decrease in mean
fetalbody weights
-----------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to NOAEL = 17 mg/kg/day LOC is MOE = 1,000 90-Day feeding study in
several months) (dermalabsorption rate (residentialexposures). dogs(oral); based on
= 100%). decreases inbody
weight gain and food
consumption
-----------------------------------------------------------------------------------------
Long-term dermal (several months None None .....................
tolifetime)
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) NOAEL= 200mg/kg/day LOC = same asshort term Developmental rat study
(inhalationabsorption dermal (oral);decreases in
rate = 100%). maternal bodyweights
and body weight
gainsas well as
decrease in mean
fetalbody weights
-----------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week NOAEL = 17 mg/kg/day LOC for MOE = same 90-Day feeding study in
to several months) (inhalation absorption asintermediate-term dogs (oral):Based on
rate= 100%). dermal decreases in body
weight gain and
foodconsumption
-----------------------------------------------------------------------------------------
Long-term inhalation (several months None None .....................
to lifetime)
-----------------------------------------------------------------------------------------
Cancer ............... Not yet classified .....................
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional safety factor retained due to concerns unique to the
FQPA.
[[Page 48802]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Temporary tolerances
were previously established (40 CFR 180.569) for the residues of
forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from forchlorfenuron; N-
(2-chloro-4-pyridinyl)-N'-phenylurea 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. An acute exposure assessment is unnecessary because no
toxicological endpoint was selected.
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 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: This
chronic dietary DEEM analysis was a Tier 1 (assumptions: Time-limited
tolerance level residues of the subject commodities and 100% crop
treated). The DEEM default concentration factors were used for the
processed commodities of all the subject crops. The resulting dietary
food exposures occupy 1.5% of the cPAD for the most highly exposed
population subgroup, non-nursing infants. These results should be
viewed as conservative (health protective) risk estimates. Refinements
such as the use of percent crop-treated information (this is a limited
acreage EUP use) and/or anticipated residue values would yield lower
estimates of chronic dietary exposure.
iii. Cancer. No concerns for cancer risks were identified. Data
from available studies do not indicate a treatment-related tumor
problem, and cancer risk endpoints have not been identified.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for forchlorfenuron; N-(2-chloro-
4-pyridinyl)-N'-phenylurea 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 forchlorfenuron; N-(2-
chloro-4-pyridinyl)-N'-phenylurea.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
Screening Concentrations in Groundwater (SCI-GROW), which predicts
pesticide concentrations in ground water. In general, EPA will use
GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) for a
screening-level assessment for surface water. The GENEEC model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporates an index reservoir environment in place
of the previous pond scenario. 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 %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 forchlorfenuron; N-(2-
chloro-4-pyridinyl)-N'-phenylurea, they are further discussed in the
aggregate risk sections below.
Based on the GENEEC and SCI-GROW models, the estimated EECs of
forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea for acute
exposures are estimated to be 4.7 parts per billion (ppb) (peak and 56
day average) for surface water and 26 ppb (acute and chronic) 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).
Forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to 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 forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea has a
common mechanism of toxicity with other substances or how to include
this pesticide in a cumulative risk assessment. Unlike other pesticides
for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-
phenylurea 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 forclorfenuron: N-(2-chloro-4-pyridinyl)-N'-
phenylurea 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 final rule for Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
D. Safety Factor for Infants and Children
1. In general. Section 408 of the 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 bases 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
[[Page 48803]]
either directly through use of a MOE analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans.
2. Conclusion. There is an adequate toxicity database for
forchlorfenuron; N-(2-chloro-pyridinyl)-N'-phenylurea, 71049-EUP-2, to
support the extension of this EUP and time-limited tolerances. The
available data suggest there is no increased qualitative or
quantitative susceptibility based on the results of developmental and
reproduction studies, no evidence of neurotoxicity and therefore no
need to require a developmental neurotoxicity study. In addition, data
used to evaluate exposure are adequate, and conservative assumptions
were used to evaluate aggregate exposure through food and drinking
water; therefore, exposure has not been underestimated. However, for
the purposes of the experimental use permit only (and associated time-
limited tolerances), the FQPA safety factor has been retained (10X) as
a default for all population groups, pending final review of data
submitted to support permanent tolerances for several crops.
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 (i.e., 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 USEPA 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. Not applicable; no acute dietary endpoint was
identified.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea from food will
utilize 0.3% of the cPAD for the U.S. population, 1.5% of the cPAD for
non-nursing infants and 1.0% of the cPAD for children (1-6 years).
There are no residential uses for forchlorfenuron; N-(2-chloro-4-
pyridinyl)-N'-phenylurea that result in chronic residential exposure to
forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea. In addition,
there is potential for chronic dietary exposure to forchlorfenuron; N-
(2-chloro-4-pyridinyl)-N'-phenylurea 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 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Forchlorfenuron; N-(2-Chloro-4-pyridinyl)-N'-phenylurea
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC Chronic DWLOC
Population Subgroup cPAD mg/kg/day % cPAD (Food) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.007 0.3 4.7 26 240
-------------------------------------------------------------------------------------------------
Females (13 to 50 years) 0.007 0.1 4.7 26 210
-------------------------------------------------------------------------------------------------
Non-nursing infants 0.007 1.5 4.7 26 70
-------------------------------------------------------------------------------------------------
Non-hispanic 0.007 0.3 4.7 26 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
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). Forchlorfenuron; N-(2-
chloro-4-pyridinyl)-N'-phenylurea is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risks are the sum of the risks from food and water, which do
not exceed the Agency's level of concern.
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).
Forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risks are the sum of the risks from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. No concern for cancer
risks were identified. Data from available studies do not indicate a
treatment-related tumor problem and cancer risk endpoint has not been
identified.
6. Determination of safety. Based on these risk assessments, EPA
concludes
[[Page 48804]]
that there is a reasonable certainty that no harm will result to the
general population, and to infants and children from aggregate exposure
to forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
1. Plants. The proposed enforcement method is a high performance
liquid chromatography procedure using ultraviolet detection (HPLC/UV)
which measures parent forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-
phenylurea. For the purpose of the Experimental Use Permit, the method
has been adequately validated. The limit of quantitation (LOQ) is 0.01
ppm and the limit of detection is 0.003 ppm.
2. Animals. Depending on the results of a ruminant metabolism
study, an enforcement method for the regulated residue in animal
commodities may be required to support a section 3 registration with
permanent tolerances.
Adequate enforcement methodology--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 no Codex, Canadian, or Mexican maximum residue levels for
forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea.
C. Conditions
There are no conditions for the registration.
V. Conclusion
Therefore, the time-limited tolerance is established for residues
of forchlorfenuron; N-(2-chloro-4-pyridinyl)-N'-phenylurea in or on
almond, apple, blueberry, cranberry, fig, grapes, kiwifruit, olive,
pear, and plums (fresh) at 0.01 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. 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
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),
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-2004-0145 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before October
12, 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 in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0145, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of 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
[[Page 48805]]
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. 801et 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: July 29, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.569 is amended by revising the table in paragraph (a) to
read as follows:
Sec. 180.569 Forchlorfenuron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per Expiration/
Commodity million revocation date
------------------------------------------------------------------------
Almond.................................. 0.01 05/31/06
Apple................................... 0.01 05/31/06
Blueberry............................... 0.01 05/31/06
Cranberry............................... 0.01 05/31/06
Fig..................................... 0.01 05/31/06
Grape................................... 0.01 05/31/06
Kiwifruit............................... 0.01 05/31/06
Olive................................... 0.01 05/31/06
Pear.................................... 0.01 05/31/06
Plum (fresh)............................ 0.01 05/31/06
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-18383 Filed 8-10-04; 8:45 am]
BILLING CODE 6560-50-S