[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Rules and Regulations]
[Pages 58314-58322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21932]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0272; FRL-7681-5]


Forchlorfenuron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
forchlorfenuron, N -(2-chloro-4-pyridinyl)-N'-phenylurea in or on 
grapes and kiwifruit. Siemer & Associates, Inc. on behalf of 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).

DATES: This regulation is effective September 30, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0272. 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 <greek-i>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: Dennis McNeilly, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: 703-308-6742; e-mail address:<a href="/cdn-cgi/l/email-protection#4e232d202b27222237602a2b2020273d0e2b3e2f60292138"><span class="__cf_email__" data-cfemail="cfa2aca1aaa6a3a3b6e1abaaa1a1a6bc8faabfaee1a8a0b9">[email protected]</span></a>.

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

[[Page 58315]]

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

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

II. Background and Statutory Findings

    In the Federal Register of May 16, 2003 (68 FR 26607-26611) (FRL-
7303-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F6550) by Siemer & Associates, 4672 W. Jennifer, Suite 103, Fresno, 
California 93722. The petition requested that 40 CFR 180.569 be amended 
by establishing a tolerance for residues of the plant growth regulator 
forchlorfenuron, N-(2-chloro-4-pyridinyl)-N'-phenylurea, in or on 
grapes, raisins and kiwifruit at 0.03 parts per million (ppm). That 
notice included a summary of the petition prepared by Siemer & 
Associates, Inc., the registrant. The proposed uses are the first 
section 3 tolerances for this new active ingredient. Time-limited 
tolerances are currently in effect (69 FR 48799-48805, Aug 11, 2004) 
for residues of forchlorfenuron in or on grapes, kiwifruit, apples, 
blueberries, cranberries, figs, pears, plums (fresh), olives and 
almonds. These time-limited tolerances were established in conjunction 
with the granting of an Experimental Use Permit (EUP) originally issued 
on May 21, 2001. The time-limited tolerances were first established in 
the Federal Register on May 7, 2001 (66 FR 22930-22936 (FRL 6781-4)). 
Agency review of the submitted residue studies indicate that higher 
tolerances are required for raisins at 0.06 ppm and kiwifruit at 0.04 
ppm. There were no comments received in response to the notice of 
filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (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 FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of forchlorfenuron, N-
(2-chloro-4-pyridinyl)-N'-phenylurea on grapes at 0.03 ppm; raisins at 
0.06 ppm; and kiwifruit at 0.04 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, 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 is 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 toxicity- rat  NOAEL = M >= 400, F = 84 milligrams/
                                                                      kilogram/day (mg/kg/day)
                                                                     LOAEL = M = not determined, F = 428:
                                                                      decrease BW gain and food efficiency mg/kg/
                                                                      day
----------------------------------------
870.3150                                 90 day oral toxicity -dogs  NOAEL = M = 16.8, F = 19.1 mg/kg/day
                                                                     LOAEL = M = 162.4, F = 188.7; decreases (>=
                                                                      10%) in BW gain, FC and food efficiency mg/
                                                                      kg/day
----------------------------------------
870.3700                                 Developmental tox-rat.....  Maternal NOAEL = 200 mg/kg/day
                                                                     Maternal LOAEL = 400 mg/kg/day based on
                                                                      increased incidence of alopecia: decrease
                                                                      in BW and BW gains
                                                                     Developmental NOAEL = 200 mg/kg/day
                                                                     Developmental LOAEL = 400 mg/kg/day based
                                                                      on decreased mean fetal BW
----------------------------------------
870.3700                                 Developmental tox -         Maternal NOAEL = >=100 mg/kg/day
                                          nonrodent.                 Maternal LOAEL = not determined
                                                                     Developmental NOAEL = >=100 mg/kg/day
                                                                     Developmental LOAEL = not determined
----------------------------------------

[[Page 58316]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = M = 11/13, F= 13/
                                          effects.                    15 mg/kg/day
                                                                     Parental/Systemic LOAEL = 144-202 mg/kg/day
                                                                      based on decreased FC in F0 and F1 M;
                                                                      clinical signs of toxicity and lower BW in
                                                                      F1 M and F and growth retardation in F1
                                                                      and F2 pups
                                                                     Reproductive NOAEL = M = 144/168, 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 F2 pups/litter
----------------------------------------
870.4300                                 Chronic carcinogenicity     NOAEL = M = 7, F = 9 mg/kg/day
                                          rat.                       LOAEL = M = 93, F = 122 mg/kg/day based on
                                                                      Reduced BW and BW gain and FC; kidney
                                                                      toxicity (M = suppurative inflammation, F
                                                                      = non-suppurative interstitial nephritis)
                                                                     No evidence of carcinogenicity
----------------------------------------
870.4100                                 1-year feeding study-dogs.  NOAEL (in mg/kg/day): M = 87, F = 91
                                                                     ...........................................
                                                                     LOAEL (in mg/kg/day): M = 195, F = 246,
                                                                      decreases in BW, BW gains and FC
----------------------------------------
870.4200                                 18-month carcinogenicity    NOAEL (in mg/kg/day): M = 10.0, F = 9.9
                                          study-mice.                LOAEL (in mg/kg/day): M = 991.4, F =
                                                                      1001.8, decreases in BW and BW gains in M
                                                                      and F
                                                                     Not carcinogenic
----------------------------------------
870.7485                                 Metabolism study-rat......  Recovery of 97% (M and F) by 168 hours.
                                                                      Absorbed dose 72-84%. Urine 62-74%. Feces
                                                                      16-28%. Biliary excretion, 20-23% in bile.
                                                                      Urine and feces, elimination half-life
                                                                      13.1-16.2 hours. Analyses identified
                                                                      parent and six metabolites in excreta.
                                                                      Parent not in urine and 1-2% in feces.
                                                                      Major metabolite forchlorfenuron-sulfate
                                                                      in urine of males (84%) and females (57%).
                                                                      Hydroxy forchlorfenuron (2 isomers) <4% in
                                                                      urine; predominant metabolite in feces
                                                                      (11% males and 18% females).
                                                                     Other metabolites: hydroxy forchlorfenuron-
                                                                      sulfate, methoxy forchlorfenuron-sulfate,
                                                                      forchlorfenuron glucuronide and dihydroxy
                                                                      forchlorfenuron (each <5%). Metabolism of
                                                                      forchlorfenuron in rats: conjugation with
                                                                      sulfate at phenyl ring before (major
                                                                      pathway), conjugation with glucuronide at
                                                                      phenyl ring, methylation of hydroxy group
                                                                      of hydroxy forchlorfenuron-sulfate and
                                                                      hydroxylation of both chloropyridinyl and
                                                                      phenyl rings.
----------------------------------------
870.5375                                 In vitro mammalian          No increase in chromosomal aberrations over
                                          cytogenetics assay in       background <plus-minus> S9
                                          Chinese Hamster CHO-KI
                                          cells 10, 20, 40, and 80
                                          [mu]g/mL <plus-minus> S9
                                          activation.
----------------------------------------
870.5550                                 Unscheduled DNA synthesis   No increase in unscheduled DNA synthesis
                                          in primary rat
                                          hepatocytes/mammalian
                                          cell cultures 0.1 to 30
                                          7[mu]g/mL.
----------------------------------------
870.5265                                 Salmonella/mammalian        Evidence of a positive response in tester
                                          activation gene mutation    strain TA1535 in absence of S9 at 50, 100,
                                          assay.                      and 200 [mu]g/plate
                                         10-1000 [mu]g/plate +S9...
                                         2-200 [mu]g/plate -S9.....
----------------------------------------
870.5265                                 Salmonella/mammalian        Evidence of induced mutany colonies over
                                          activation gene mutation    background in tester strain TA1535 in
                                          assay.                      absence of S9
                                         10-1,000 [mu]g/plate +S9..
                                         2-200 [mu]g/plate -S9.....
----------------------------------------------------------------------------------------------------------------

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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,''

[[Page 58317]]

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

   Table 2.--Summary of Toxicological Dose and Endpoints for Forchlorfenuron for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
          Exposure Scenario                Dose(mg/kg/day)              Endpoint                  Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          NOAEL - assumed to be    aPAD = 1.0 mg/kg/day     Rabbit developmental
                                        100                                               study
                                       UF = 100...............
--------------------------------------
Chronic Dietary                        NOAEL = 7.0              Decreases in body        2-year rat feeding
                                                                 weight, body weight      study
                                                                 gain and food
                                                                 consumption as well as
                                                                 effects on the kidney
                                                                 at the LOEAL of 93 and
                                                                 122 mg/ kg/day for
                                                                 males and females,
                                                                 respectively.
--------------------------------------
                                       UF = 100                 Chronic RfD = 0.07 mg/   NA
                                       FQPA = 1x..............   kg/day
                                                                Chronic Population-
                                                                 Adjusted Dose (cPAD) =
                                                                 0.07 mg/kg/day; apply
                                                                 to all population
                                                                 subgroups.
--------------------------------------
Short-Term (Dermal)                    NOAEL = 200              Decreases in maternal    developmental rat study
                                                                 body weights and body
                                                                 weight gains as well
                                                                 as a decrease in mean
                                                                 fetal body weights.
--------------------------------------
Intermediate-Term (Dermal)             NOAEL = 87               Based on decreases in    1-Year feeding study in
                                                                 body weight, bw gain,    dogs
                                                                 and food consumption.
--------------------------------------
Long-Term (Dermal)                     NA                       Based on the limited     NA
                                                                 use, long-term
                                                                 exposure is not
                                                                 expected anda risk
                                                                 assessment not
                                                                 conducted
--------------------------------------
Short-Term (Inhalation)                NOAEL = 200              Same as short-term       developmental rat study
                                                                 dermal
--------------------------------------
Intermediate-Term (Inhalation)         NOAEL = 87               Same as intermediate-    1-Year feeding study in
                                                                 term dermal              dogs
--------------------------------------

[[Page 58318]]

 
Long-Term (Inhalation)                 NA                       Based on the limited     NA
                                                                 use, long-term
                                                                 exposure is not
                                                                 expected anda risk
                                                                 assessment not
                                                                 conducted
--------------------------------------
Cancer                                 NA                       Not likely to be a       NA
                                                                 human carcinogen
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses-- i. Acute exposure. In 
conducting this acute dietary risk assessment the Lifeline Model 
Version 2.0 and the Dietary Exposure Evaluation Model 
(DEEM<SUP>TM</SUP>, Version 2.03) analysis evaluated the individual 
food consumption as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the acute exposure assessments: 
Tolerance-level residues and 100% crop treated assumptions were used. 
DEEM (Version 7.81) default processing factors were used to modify the 
tolerance values for processed commodities for which separate 
tolerances are not being established.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Lifeline Model Version 2.0 and the DEEM<SUP>TM</SUP> 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: A conservative chronic dietary 
exposure analysis was performed for the general U.S. population and 
various population subgroups. Tolerance-level residues and 100% crop 
treated assumptions were used. The 1-in-10-year average surface water 
concentration from the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM-EXAMS) Model was used as a point estimate for 
drinking water in the dietary analyses.
    iii. Cancer. A quantitative cancer dietary exposure assessment is 
not needed for forchlorfenuron since it is not a carcinogen.
    2. Dietary exposure from drinking water. The Agency usesthe FQPA 
Index Reservoir Screening Tool (FIRST) or the PRZM/EXAMS, to produce 
estimates of pesticide concentrations in an index reservoir. The 
screening concentration in ground water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will use FIRST (a tier 
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index 
reservoir environment, and both models include a percent crop area 
factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency has generally not used estimated 
environmental drinking water concentrations (EDWCs), which are the 
model estimates of a pesticide's concentration in water. EDWCs derived 
from these models are used to quantify drinking water exposure and risk 
as a %RfD or %PAD. Instead, drinking water levels of comparison 
(DWLOCs) are calculated and used as a point of comparison against the 
model estimates of a pesticide's concentration in water. DWLOCs are 
theoretical upper limits on a pesticide's concentration in drinking 
water in light of total aggregate exposure to a pesticide in food, and 
from residential uses. Since DWLOCs address total aggregate exposure to 
forchlorfenuron they are further discussed in the aggregate risk Unit 
III. E. below.
    As EPA has gathered more information regarding pesticide residues 
in drinking water and drinking water consumption amounts, it has been 
working toward refining the screening-level DWLOC approach to 
conducting aggregate risk assessments that combine exposures across all 
pathways. As a first step in this process, EPA has begun using the 
chronic and cancer EDWCs directly in chronic and cancer dietary 
exposure assessments to calculate aggregate dietaryfood + water risk. 
This is done by using the relevant PRZM-EXAMS value as a residue for 
water (all sources) in the dietary exposure assessment. The principal 
advantage of this approach is that the actual individual body weight 
and water consumption data from the Continuing Survey of Food Intake by 
Individuals (CSFII) are used, rather than assumed weights and water 
consumption for broad age groups.
    Accordingly, the 1-in-10-year average surface water concentration 
from the PRZM-EXAMS Model was used as a point estimate for drinking 
water in the chronic dietary analysis. Estimated concentrations in 
drinking water were not included in the acute analysis. Instead, the 
maximum allowable exposure from drinking water was calculated by 
subtracting the exposure in food from the total allowable exposure. The 
maximum allowable exposure from drinking water is converted to the 
maximum allowable drinking water concentration, or DWLOCs. These values 
are then compared to the estimated drinking water concentrations.
    Based on the PRZM/EXAMS and SCI-GROW models, the EDWCs of 
forchlorfenuron for chronic exposures are estimated to be 0.32 parts 
per billion (ppb) for surface water and 0.003 ppb for ground water. 
Based on the PRZM/EXAMS and SCI-GROW models, the EDWCs of 
forchlorfenuron for acute exposures are estimated to be 0.54 ppb for 
surface water and 0.003 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in

[[Page 58319]]

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 is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to forchlorfenuron and any 
other substances and forchlorfenuron 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 forchlorfenuron 
has a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs (OPP) concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is a lack of increased 
qualitative or quantitative susceptibility in developmental or 
reproductive studies. There are no concerns and no residual 
uncertainties with regard to pre-and/or postnatal toxicity.
    3. Conclusion. As indicated, available data do not show any 
increased susceptibility to the young from exposure to forchlorfenuron 
and there are no residual uncertainties regarding pre- or post-natal 
toxicity. There is an adequate toxicity database for forchlorfenuron. 
As there was no evidence of neurotoxicity, it is not necessary to 
require a developmental neurotoxicity study. In addition, data used to 
evaluate exposure are adequate, and conservative assumptions are being 
used to evaluate aggregate exposure through food and drinking water. As 
a result, exposures are probably considerably overestimated. 
Accordingly, EPA concludes it has reliable data supporting removal of 
the additional FQPA 10-fold safety factor for the protection of infants 
and children.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency either calculates 
DWLOCs which are used as a point of comparison against EDWCs or uses 
the EDWCs directly in the aggregate exposure assessment. DWLOC values 
are not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer. As explained 
above, however, EPA is beginning to use EDWCs directly in estimating 
aggregate exposure in chronic and cancer assessment.
    When EDWCs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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. From the Lifeline Model, the U.S. population and all 
population subgroups had risk estimates that were below 1% of the acute 
population adjusted dose (aPAD) from exposure to forchlorfenuron in 
food. The most highly exposed population subgroup was children 1-2 
years old, which had a risk estimate of 0.08% of the aPAD. The general 
U.S. population utilized 0.02% of the aPAD. In addition, there is 
potential for acute dietary exposure to forchlorfenuron in drinking 
water. After calculating DWLOCs and comparing them to the EDWCs for 
surface and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the aPAD, as shown in the following Table 3:

[[Page 58320]]



                    Table 3.--Aggregate Risk Assessment for Acute Exposure to Forchlorfenuron
----------------------------------------------------------------------------------------------------------------
                                                                   Surface Water   Ground Water     Acute DWLOC
               Population Subgroup                 % aPAD (Food)    EDWCs (ppb)     EDWCs (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.000157            0.54           0.003          35,000
-------------------------------------------------
All Infants                                             0.000526            0.54           0.003          10,000
-------------------------------------------------
Children 1-2 years                                      0.000846            0.54           0.003          10,000
-------------------------------------------------
Children 3-5 years                                      0.000557            0.54           0.003          10,000
-------------------------------------------------
Children 6-12 years                                     0.000217            0.54           0.003          10,000
-------------------------------------------------
Youth 13-19 years                                       0.000089            0.54           0.003          30,000
-------------------------------------------------
Adults 20-49 years                                      0.000101            0.54           0.003          35,000
-------------------------------------------------
Adults 50+ years                                        0.000105            0.54           0.003          35,000
-------------------------------------------------
Females 13-49                                           0.000112            0.54           0.003          30,000
----------------------------------------------------------------------------------------------------------------
\1\ Maximum Allowable Water Exposure = PAD - sum of all quantifiable exposures.
\2\ Drinking Water Level of Comparison = Maximum Allowable Water Exposure x Body Weight (10 kg infants and
  children, 60 kg females, 70 kg all others) x 1,000 [mu]g/mg / Consumption (1 L/day infants and children, 2 L/
  day all others).

    2. Chronic risk. The U.S. population and all population subgroups 
had risk estimates that were below 1% of the chronic population 
adjusted dose (cPAD) from exposure to forchlorfenuron in food. The most 
highly exposed population subgroup was children 1-2 years old, which 
had a risk estimate of 0.3% of the cPAD. There are no residential uses 
for forchlorfenuron that result in chronic residential exposure to 
forchlorfenuron. Based on the use pattern, chronic residential exposure 
to residues of forchlorfenuron is not expected. However, there is 
potential for chronic dietary exposure to forchlorfenuron in drinking 
water. The Agency does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 4 of this unit:
    Chronic (non-cancer) aggregate risk is the sum of exposures 
resulting from chronic dietary food + chronic drinking water + chronic 
residential uses. Forchlorfenuron has no registered or proposed 
residential uses. Therefore, this risk assessment is the aggregate of 
chronic food and chronic drinking water exposures only. As stated 
above, the drinking water EDWCs were included in the dietary exposure 
analysis. As a result, the aggregate risk assessment is equivalent to 
the dietary analysis, the results of which are reported in Table 4 
below. The results of the DEEM-FCID analysis were comparable to those 
of the Lifeline analysis. In the DEEM-FCID analysis, the general U.S. 
population and all population subgroups used <1% of the cPAD.

             Table 4--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Forchlorfenuron
----------------------------------------------------------------------------------------------------------------
                                              Exposure (mg/kg/day)                          %cPAD
         Population Subgroup         ---------------------------------------------------------------------------
                                           Lifeline          DEEM-FCID           Lifeline          DEEM-FCID
----------------------------------------------------------------------------------------------------------------
General U.S. Population                        0.000032           0.000040               <1.0               <1.0
-------------------------------------
All Infants (<1 year old)                      0.000122           0.000142               <1.0               <1.0
-------------------------------------
Children 1-2 years old                         0.000217           0.000230               <1.0               <1.0
-------------------------------------
Children 3-5 years old                         0.000140           0.000140               <1.0               <1.0
-------------------------------------
Children 6-12 years old                        0.000047           0.000053               <1.0               <1.0
-------------------------------------
Youth 13-19 years old                          0.000017           0.000021               <1.0               <1.0
-------------------------------------
Adults 20-49 years old                         0.000019           0.000023               <1.0               <1.0
-------------------------------------
Adults 50+ years old                           0.000020           0.000026               <1.0               <1.0
-------------------------------------
Females 13-49 years old                        0.000021           0.000025               <1.0               <1.0
----------------------------------------------------------------------------------------------------------------

    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 is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk 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).

[[Page 58321]]

    Forchlorfenuron is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Forchlorfenuron was 
classified as not likely to be a human carcinogen, and therefore 
forchlorfenuron is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to forchlorfenuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The proposed enforcement method is a high performance liquid 
chromatography with ultra violet detection HPLC/UV procedure that 
measures parent forchlorfenuron. The method, including the confirmatory 
Mass spectrometry with mass spectrometry (MS/MS) analysis, has been 
adequately validated. The Analytical Chemistry Branch of BEAD performed 
a tolerance method validation (TMV) trial on the enforcement method 
using grapes. For grapes, the laboratory reported a limit of 
quantitation of 0.010 ppm and a limit of detection of 0.002 ppm.
    An enforcement method for the regulable residue in animal 
commodities is not required for section 3 registrations on grapes and 
kiwifruit.
    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: <a href="/cdn-cgi/l/email-protection#c9bbacbaa0adbcaca4acbda1a6adba89acb9a8e7aea6bf"><span class="__cf_email__" data-cfemail="20524553494455454d4554484f4453604550410e474f56">[email protected]</span></a>.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican MRLs for forchlorfenuron.

C. Conditions

    Conditions of registration are discussed in the Notice of 
Registration.

V. Conclusion

    Therefore, tolerances are established for residues of 
forchlorfenuron, N-(2-chloro-4-pyridinyl)-N'-phenylurea, in or on 
grapes at 0.03 ppm; raisins at 0.06 ppm; and kiwifruit at 0.04 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0272 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
29, 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 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0272, 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: <a href="/cdn-cgi/l/email-protection#4f203f3f622b202c242a3b0f2a3f2e61282039"><span class="__cf_email__" data-cfemail="cda2bdbde0a9a2aea6a8b98da8bdace3aaa2bb">[email protected]</span></a>. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of

[[Page 58322]]

significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 21, 2004.
James Jones,
Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.569 is amended by redesignating paragraph (a) as 
paragraph (a)(2), by removing the entries for grape and kiwifruit from 
the table in newly designated paragraph (a)(2), and by adding new 
paragraph (a)(1) to read as follows:


Sec.  180.569  Forchlorfenuron; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
plant growth regulator forchlorfenuron; N-(2-chloro-4-pyridinyl)-
N'phenyl urea in or on the following commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grape...................................................            0.03
Grape, raisin...........................................            0.06
Kiwifruit...............................................            0.04
------------------------------------------------------------------------

* * * * *

[FR Doc. 04-21932 Filed 9-29-04; 8:45 am]
BILLING CODE 6560-50-S


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