[Federal Register Volume 69, Number 154 (Wednesday, August 11, 2004)]
[Rules and Regulations]
[Pages 48799-48805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18383]


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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: [email protected].

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
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
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: [email protected].

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: [email protected]. 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