[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Rules and Regulations]
[Pages 11563-11572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4335]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0022; FRL-7699-8]


Clofentezine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
clofentezine in or on grapes and persimmons. Makhteshim-Agan of North 
America, Inc. and the Interregional Research Project Number 4 (IR-4) 
requested these tolerances 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 March 9, 2005. Objections and 
requests for hearings must be received on or before May 9, 2005.

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-2005-0022. 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), Room 119, Crystal Mall 2, 1801 S. 
Bell Street, Arlington, VA 22202-4501. 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: Carmen Rodia, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0327; fax number: (703) 305-6596; 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), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers;

[[Page 11564]]

greenhouse, nursery, and floriculture workers; ranchers; pesticide 
applicators.
     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.

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 athttp://www.epa.gov/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of July 12, 2000 (65 FR 43004) (FRL-6591-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F6119) by Aventis CropScience, 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.446 be 
amended by establishing a tolerance for residues of the miticide 
clofentezine [(3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine), in or on 
grapes at 0.35 parts per million (ppm). Subsequently, Aventis 
CropScience sold all proprietary rights for clofentezine to Makhteshim-
Agan of North America, Inc., 551 Fifth Avenue, Suite 1100, New York, NY 
10176. Further, in the Federal Register of August 27, 2004 (69 FR 
52688) (FRL-7676-3), EPA issued a similar notice announcing the filing 
of a pesticide petition (PP 4E6824) by the Interregional Research 
Project Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 
08902, requesting that 40 CFR 180.446 be amended by establishing a 
tolerance for residues of clofentezine, in or on persimmons at 0.05 
ppm. These notices included a summary of the petitions prepared by the 
registrants. In order to harmonize with existing Codex maximum residue 
limits (MRLs) for grapes, the proposed tolerance level for grapes was 
subsequently revised to 1.0 ppm. There were no substantive comments 
received in response to these notices.
    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 clofentezine per se 
on grapes at 1.0 ppm and on persimmons at 0.05 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 clofentezine are 
discussed below in Table 1 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 and Chronic Toxicity Profile of Clofentezine
                               Technical.
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day subchronic   Incorporated into
                                   feeding toxicity,   the 2-year mouse
                                   mouse               oncogenicity
                                                       study.
------------------------------------------------------
870.3100                          90-Day subchronic   NOAEL (systemic):
                                   feeding toxicity,   2.0 mg/kg/day
                                   rat                LOAEL (systemic):
                                                       20.0 mg/kg/day
                                                       based on
                                                       increased
                                                       cholesterol
                                                       levels, liver-to-
                                                       body weight
                                                       ratios, liver
                                                       weights, and
                                                       centrilobular
                                                       hepatocellular
                                                       enlargement.
------------------------------------------------------
870.3150                          90-Day subchronic   NOAEL was not
                                   feeding,            established.
                                   nonrodent (dog)    LOAEL (systemic):
                                                       <80.0 mg/kg/day
                                                       based on
                                                       increased liver
                                                       weights in both
                                                       sexes and
                                                       electrocardiograp
                                                       hic changes in
                                                       females.
------------------------------------------------------

[[Page 11565]]

 
870.3700                          Prenatal            Maternal NOAEL:
                                   Developmental       1,280 mg/kg/day
                                   Toxicity, Rat       (above the Limit
                                                       Dose of 1,000 mg/
                                                       kg/day)
                                                      Maternal LOAEL:
                                                       3,200 mg/kg/day
                                                       based on
                                                       differential
                                                       staining and
                                                       slight
                                                       enlargement of
                                                       the centrilobular
                                                       hepatocytes.
                                                      Developmental
                                                       NOAEL: >3,200 mg/
                                                       kg/day (above the
                                                       Limit Dose)
                                                      Developmental
                                                       LOAEL: >3,200 mg/
                                                       kg/day (above the
                                                       Limit Dose)
------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL:
                                   Developmental       1,000 mg/kg/day
                                   Toxicity, Rabbit    (Limit Dose)
                                                      Maternal LOAEL:
                                                       3,000 mg/kg/day
                                                       based on
                                                       decreased body
                                                       weight and food
                                                       consumption.
                                                      Developmental
                                                       NOAEL: 1,000 mg/
                                                       kg/day (Limit
                                                       Dose)
                                                      Developmental
                                                       LOAEL: 3,000 mg/
                                                       kg/day based on
                                                       decreased mean
                                                       fetal weight.
------------------------------------------------------
870.3800                          2-Generation        Parental/Systemic
                                   Reproductive and    NOAEL: >=20.0 mg/
                                   Fertility           kg/day
                                   Effects, Rat       Parental/Systemic
                                                       LOAEL: >20.0 mg/
                                                       kg/day
                                                      Reproductive
                                                       NOAEL: >=20.0 mg/
                                                       kg/day
                                                      Reproductive
                                                       LOAEL: >20.0 mg/
                                                       kg/day
                                                      Offspring NOAEL:
                                                       >=20.0 mg/kg/day
                                                      Offspring LOAEL:
                                                       >20.0 mg/kg/day
------------------------------------------------------
870.4100                          Chronic Feeding     NOAEL (systemic):
                                   Toxicity,           1.25 mg/kg/day
                                   Nonrodent (Dog)    LOAEL (systemic):
                                                       25.0 mg/kg/day
                                                       based on
                                                       increased liver
                                                       weights,
                                                       hepatocellular
                                                       enlargement, and
                                                       increased serum
                                                       cholesterol,
                                                       triglycerides,
                                                       and alkaline
                                                       phosphatase
                                                       levels.
------------------------------------------------------
870.4200                          Chronic             NOAEL (systemic):
                                   Carcinogenicity     50.70 mg/kg/day
                                   (Feeding), Mouse   LOAEL (systemic):
                                                       543.0 mg/kg/day
                                                       based on
                                                       decreased body
                                                       weights and body
                                                       weight gains,
                                                       increased
                                                       incidence of
                                                       eosinophilic
                                                       areas in
                                                       hepatocytes of
                                                       males. In
                                                       females,
                                                       increased
                                                       incidence of
                                                       basophilic and/or
                                                       eosinophilic foci
                                                       or areas of
                                                       hepatocyte
                                                       alterations,
                                                       mortality with
                                                       amyloidosis as a
                                                       contributing
                                                       factor for
                                                       increased
                                                       mortality. No
                                                       evidence of
                                                       carcinogenicity.
------------------------------------------------------
870.4300                          Combined Chronic    NOAEL (systemic):
                                   Feeding Toxicity/   1.72 mg/kg/day
                                   Carcinogenicity    LOAEL (systemic):
                                   Study, Rat          17.3 mg/kg/day
                                                       based on
                                                       increased liver
                                                       weights and liver-
                                                       to-body weight
                                                       ratios and
                                                       increased
                                                       thyroxin levels;
                                                       and centrilobular
                                                       hepatocellular
                                                       hypertrophy and
                                                       vacuolation,
                                                       focal cystic
                                                       degeneration of
                                                       hepatocytes, and
                                                       diffuse
                                                       distribution of
                                                       fat deposits in
                                                       liver (M).
                                                       Evidence of
                                                       carcinogenicity
                                                       in male rats
                                                       [thyroid tumors].
------------------------------------------------------
870.5200                          Mouse Lymphoma      Non-mutagenic
                                                       ()
                                                       activation.
------------------------------------------------------
870.5250                          Gene Mutation,      Non-mutagenic
                                   Salmonella          ()
                                                       activation.
------------------------------------------------------
870.5395                          In vitro Mammalian  Non-mutagenic.
                                   Cytogenetics Test
                                   (Erythocyte
                                   Micronucleus
                                   Assay), Mice
------------------------------------------------------
870.5450                          Rodent Dominant     Non-mutagenic.
                                   Lethal Assay, Rat
------------------------------------------------------
870.5575                          Mitotic Gene        Non-mutagenic and
                                   Conversion in       negative for
                                   Saccharomyces       mitotic
                                   cerevisiae          recombination.
------------------------------------------------------
870.7485                          General             Male and female
                                   Metabolism, Rat     rats given
                                                       clofentezine
                                                       technical at
                                                       1,000 mg/kg
                                                       manifested peak
                                                       plasma levels of
                                                       between 14 and 16
                                                       ppm at 6-8 hours
                                                       post-dosing which
                                                       then declined to
                                                       3 ppm at 24 hours
                                                       post-dosing.
                                                       Plasma half-life
                                                       was approximately
                                                       3.5 hours. Whole
                                                       body
                                                       autoradiography
                                                       of rats given a
                                                       10 mg/kg dose
                                                       indicated poor
                                                       gastrointestinal
                                                       absorption with
                                                       60-70% of the
                                                       given dose
                                                       excreted in the
                                                       feces during the
                                                       first 24 hours
                                                       and about 20%
                                                       excreted in the
                                                       urine. Major
                                                       metabolites were
                                                       3-(2'-methyl-thio-
                                                       3' hydroxy
                                                       phenyl)-6-(2'-
                                                       chloro-phenyl)-
                                                       1,2,4,5-tetrazine
                                                       and 3-,4-, and 5-
                                                       hydroxyclofentezi
                                                       ne. Both liver
                                                       and kidney had
                                                       the highest
                                                       tissue
                                                       concentration
                                                       after 72 hours.
------------------------------------------------------------------------


[[Page 11566]]

B. Toxicological Endpoints

    The dose at which 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 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: The 
``traditional uncertainty factor;'' the ``special FQPA safety factor;'' 
and the ``default FQPA safety factor.'' By the term ``traditional 
uncertainty factor,'' 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-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    In general, clofentezine has low acute toxicity by the oral, dermal 
and inhalation routes of exposure (Categories III and IV) although mild 
eye irritation has been observed in rabbits. No appropriate 
toxicological endpoint (effect) attributable to a single exposure 
(dose) was identified in any study including the available oral studies 
in the rat and developmental studies in the rat and rabbit; therefore, 
an acute RfD was not established and no risk is expected from acute 
exposure. Long-term dermal exposure and risk is not expected, based on 
the current use pattern. In addition, based on the overall low toxicity 
of clofentezine, there is minimal concern for short-, intermediate-, 
and long-term inhalation exposure and risk. A summary of the 
toxicological endpoints used for the clofentezine human health risk 
assessment is shown below in Table 2.

    Table 2.--Summary of Toxicological Dose and Endpoints for Clofentezine for Use in Human Risk Assessment.
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Chronic Dietary                        NOAEL= 1.25 mg/kg/day    Special FQPA SF = 1x     Chronic Feeding
(General U.S. Population including     UF = 100...............  cPAD = chronic RfD.....   Toxicity, Nonrodent
 infants and children).                Chronic RfD =..........  Special FQPA SF = 0.013   (Dog)
                                       0.013 mg/kg/day........   mg/kg/day.              LOAEL = 25.0 mg/kg/day
                                       .......................                            based on
                                                                                          histopathology in the
                                                                                          liver and elevated
                                                                                          serum cholesterol,
                                                                                          triglycerides, and
                                                                                          alkaline phosphatase
                                                                                          observed at the LOAEL.
----------------------------------------------------------------
Short-Term Dermal                      Oral study NOAEL = 2 mg/ LOC for MOE =            90-Day subchronic
(1 to 30 days).......................   kg/day                  100 (Residential)......   feeding toxicity, Rat
(Residential)........................  (dermal absorption rate                           LOAEL = 20 mg/kg/day
                                        = 1%).                                            based on increased
                                                                                          cholesterol, increased
                                                                                          liver weights, thyroid
                                                                                          colloid depletion and
                                                                                          thyroid follicular
                                                                                          cell hypertrophy.
----------------------------------------------------------------
Intermediate-Term Dermal               Oral study NOAEL = 2 mg/ LOC for MOE =            90-Day Subchronic
(1 to 6 months)......................   kg/day                  100 (Residential)......   Feeding Toxicity, Rat
(Residential)........................  (dermal absorption rate                           LOAEL = 20 mg/kg/day
                                        = 1%).                                            based on increased
                                                                                          cholesterol, increased
                                                                                          liver weights, thyroid
                                                                                          colloid depletion and
                                                                                          thyroid follicular
                                                                                          cell hypertrophy.
----------------------------------------------------------------------------------------------------------------


[[Page 11567]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.446) for the residues of clofentezine per se, 
in or on a variety of raw agricultural commodities (RACs). 
Specifically, tolerances for clofentezine are established for almonds, 
apples, apricots, cherries, nectarines, peaches, pears, and walnuts. 
Risk assessments were conducted by EPA to assess dietary exposures from 
clofentezine in food as follows:
    i. Acute exposure. As discussed in Unit III.B, an acute dietary 
exposure assessment was not performed because an endpoint of concern 
attributable to a single oral dose was not selected for any population 
subgroup (including infants and children).
    ii. Chronic exposure. In conducting the chronic and cancer dietary 
(food only) exposure assessments for clofentezine, EPA used the Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID\TM\), Version 2.03, and the Lifeline\TM\Model, 
Version 2.0, which incorporates food consumption data 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 and cancer dietary exposure assessments: The Agency has 
determined that clofentezine per se and the 3-(2-chloro-4-
hydroxyphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine metabolite are the 
residues of concern for the chronic dietary analysis. The chronic 
dietary analysis for clofentezine was based on anticipated residue 
levels (ARs) in the form of average field trial residue values, and the 
analysis included estimates for percent crop treated (PCT).
    iii. Cancer. As explained in Unit III.C.1.ii above, the Agency 
assessed cancer dietary exposure for clofentezine using the same 
assumptions used for chronic dietary exposure. Cancer risk is 
determined for the general U.S. population only. The estimated exposure 
of the general U.S. population to clofentezine is 0.000023 mg/kg/day.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the FFDCA authorizes EPA to use available data and information on 
the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must, pursuant to section 
408(f)(1), require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. For the present action, EPA will issue such 
data call-ins for information relating to anticipated residues as are 
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA 
section 408(f)(1). Such data call-ins will be required to be submitted 
no later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
(food only) risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT. The Agency used PCT information as follows:
    For existing uses, the Agency used estimates of PCT for the chronic 
dietary (food only) risk assessment, which was determined using USDA's 
National Agricultural Statistics Service (NASS) usage data and EPA 2003 
proprietary usage data (DOANE 2003). Table 3 below displays the chronic 
PCT estimates used for the existing uses of clofentezine. When the PCT 
for a commodity is estimated as <1%, the PCT used for risk assessment 
purposes is 1%.

  Table 3.--Clofentezine Estimates of Percent Crop Treated for Existing
                                  Uses.
------------------------------------------------------------------------
                 Commodity                      Percent Crop Treated
------------------------------------------------------------------------
Almonds                                     <1
------------------------------------------------------------------------
Apples                                      5
------------------------------------------------------------------------
Apricots                                    5
------------------------------------------------------------------------
Cherries                                    <1
------------------------------------------------------------------------
Nectarines                                  10
------------------------------------------------------------------------
Peaches                                     5
------------------------------------------------------------------------
Pears                                       5
------------------------------------------------------------------------
Prunes & Plums                              <1
------------------------------------------------------------------------
Walnuts                                     <1
------------------------------------------------------------------------

    For the new uses, the Agency used PCT estimates for the chronic 
dietary (food only) risk assessment based on ``screening level'' usage 
data for agricultural crops. This information was retrieved from 1998-
2003 USDA National Agricultural Statistics Service (NASS) usage data 
and EPA 2003 proprietary usage data (DOANE 2003) for the historically, 
most widely used miticide for control of pests for each crop. The 2003 
NASS data were compared to the DOANE 2003 data, both yielded similar 
results and did not make a difference. As a result of this comparison, 
the highest, most conservative PCT estimate for each crop was used for 
the chronic dietary (food only) risk assessment. These highly 
conservative estimates should not underestimate actual usage of 
clofentezine on the new crops/sites. Some of these numbers may be based 
on information that does not cover all 50 states; therefore, it is 
possible that if the remaining (usually minor states for the crop) had 
been included, the quantity (pounds) of active ingredient would be 
slightly higher.
    To further support the reliability of these PCT estimates, as a 
condition of registration, the registrant will be required to agree to 
report annually on the market share attained for the new uses for which 
clofentezine is registered. As a condition of registration, they will 
also be required to agree to mitigate dietary risk as deemed 
appropriate by the Agency should the market share data raise a concern 
for increased dietary risk. The Agency will then compare that market 
share information with the PCT estimates used to evaluate potential 
dietary risk. In those instances where percent market share is 
approaching or exceeding the predicted PCT estimate used in the 
Agency's risk assessment, EPA will conduct a new dietary risk 
assessment to evaluate the new dietary risk. If the market share data 
raise a concern for increased pesticide risk, the Agency will act to 
mitigate that dietary risk and

[[Page 11568]]

could employ several approaches, including but not limited to 
production caps, geographical limitations, removal of uses, or other 
means deemed appropriate by the Agency. Table 4 below displays the 
chronic PCT estimates used for the new uses of clofentezine. When the 
PCT for a commodity is estimated as <1%, the PCT used for risk 
assessment purposes is 1%.

 Table 4.--Clofentezine Estimates of Percent Crop Treated for New Uses.
------------------------------------------------------------------------
                 Commodity                      Percent Crop Treated
------------------------------------------------------------------------
Grapes                                      13
------------------------------------------------------------------------
Persimmons                                  <1
------------------------------------------------------------------------

    The Agency believes that the three conditions listed in this Unit 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. As to Conditions 2 and 3, regional consumption information 
and consumption information for significant subpopulations is taken 
into account through EPA's computer-based model for evaluating the 
exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group, and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available information on the regional consumption of food to 
which clofentezine may be applied in a particular area.
    2.  Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for clofentezine 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 clofentezine.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) to 
produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow ground water. For a screening-level assessment for surface 
water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a 
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that 
uses a specific high-end runoff scenario for pesticides. Both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, and both models 
include a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead, drinking water levels of comparison (DWLOCs) are calculated 
and used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to clofentezine, they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of clofentezine 
for acute exposures are estimated to be 4.2 parts per billion (ppb) for 
surface water and 0.1 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.2 ppb for surface water and 0.1 ppb for 
ground water.
    3. From nondietary exposure. The term ``residential exposure'' is 
used in this document to refer to nonoccupational, nondietary exposure 
(e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Clofentezine is not 
registered for use on any sites that would result in residential 
exposure. Therefore, a residential exposure assessment was not 
conducted.
    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 clofentezine and any other 
substances and clofentezine 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 clofentezine has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the 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 
an MOE analysis or through using uncertainty (safety) factors in 
calculating a dose

[[Page 11569]]

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 no indication of an 
increased susceptibility of rat or rabbit fetuses/pups to in utero and/
or postnatal exposure in the developmental and reproductive toxicity 
studies.
    3. Conclusion. EPA has determined that there are reliable data 
supporting removal of the additional 10x factor for the protection of 
infants and children. This decision was based on the following 
conclusions:
    i. The toxicology database is complete;
    ii. There is no indication of increased susceptibility of rats or 
rabbit fetuses/pups [quantitatively or qualitatively] to in utero and/
or postnatal exposure to clofentezine in the developmental and 
reproductive toxicity studies;
    iii. A developmental neurotoxicity study (DNT) is not required;
     iv. Exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures; and
    v. There are currently no registered residential uses of 
clofentezine.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. A DWLOC is a theoretical 
upper limit on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food, drinking water, and 
through 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 toxicological endpoint, drinking 
water consumption, and body weights. Default body weights and 
consumption values as used by the EPA's Office of Water are used to 
calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult 
female), and 1L/10 kg (child). Default body weights and drinking water 
consumption values vary on an individual basis. This variation will be 
taken into account in more refined screening-level and quantitative 
drinking water exposure assessments. Different populations will have 
different DWLOCs. Generally, a DWLOC is calculated for each type of 
risk assessment used: Acute, short-term, intermediate-term, chronic, 
and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    Human health aggregate risk assessments have been conducted for the 
chronic and cancer (food + drinking water) exposure scenarios. An acute 
aggregate risk assessment was not performed because an endpoint of 
concern attributable to a single oral dose was not identified for any 
population subgroup (including infants and children). Short-, 
intermediate- and long-term aggregate risk assessments were not 
performed because there are no registered or proposed residential uses 
for clofentezine. All potential exposure pathways were assessed in the 
aggregate risk assessment. All aggregate exposure and risk estimates do 
not exceed EPA's LOC for the chronic and cancer (food + drinking water) 
exposure scenarios.
    1.  Acute risk. As discussed in Unit III.E., clofentezine is not 
expected to pose an acute risk because an endpoint of concern 
attributable to a single oral dose was not identified for any 
population subgroup (including infants and children).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
clofentezine from food will utilize 0.1% of the cPAD for the general 
U.S. population, 0.3% of the cPAD for all infants (<1 year old), and 
0.4% of the cPAD for children (1-2 years old). There are no residential 
uses for clofentezine that result in chronic residential exposure to 
clofentezine. In addition, there is potential for chronic dietary 
exposure to clofentezine 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 
below in Table 5.

                                 Table 5. --Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clofentezine.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC/     Ground/Water EEC/
        Population/Subgroup              cPAD/mg/kg/day           %/cPAD/(Food)              (ppb)                  (ppb)           Chronic/DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population              0.013.................  0.1...................  0.2..................  0.1..................  450
-------------------------------------------------------------
All infants (<1 year old)            0.013.................  0.3...................  0.2..................  0.1..................  130
-------------------------------------------------------------
Children (1-2 years old)             0.013.................  0.4...................  0.2..................  0.1..................  130
-------------------------------------------------------------
Females (13-49 years old)            0.013.................  0.1...................  0.2..................  0.1..................  390
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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). Clofentezine 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 LOC.
    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). Clofentezine 
is not

[[Page 11570]]

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 LOC.
    5. Aggregate cancer risk for U.S. population. In conducting the 
aggregate cancer risk assessment, only food and drinking water pathways 
of exposure were considered. At this time, there are no uses for 
clofentezine that would result in any non-occupational, non-dietary 
exposure (i.e., there are no dermal or inhalation routes of exposure 
that should be included in an aggregate assessment). The cancer risk 
from exposure to clofentezine residues in food was calculated as 4.31 x 
10-\7\. This is below EPA's level of concern for cancer risk 
(risks in the range of one in a million). A DWLOC was derived for the 
general U.S. population based on EPA's LOC for cancer or a risk in the 
range of one in one million (using the value of 1 x 10-\6\ 
as a first Tier value in calculating a conservative estimate of DWLOC 
that is consistent with the range of one in one million). The DWLOC is 
compared to the EECs of clofentezine in surface and ground water and is 
used to determine whether or not aggregate cancer exposures are likely 
to result in risk estimates that exceed EPA's LOC. Table 6 below 
summarizes the cancer aggregate exposure estimates to clofentezine 
residues.

                                        Table 6.--Aggregate Risk Assessment for Cancer Exposure to Clofentezine.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                 Surface
                                   Maximum Exposure (mg/ Food Exposure (mg/kg/     Maximum Water                             Ground/Water EEC/    Water
       Population/Subgroup                kg/day)                day)          Exposure (mg/kg/day)   Cancer DWLOC (ppb)           (ppb)           EEC/
                                                                                                                                                  (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. Population            2.66 x 10-\5\         1.1 x 10-\5\          1.56 x 10-\5\         0.6                   0.1                    0.2
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The EECs calculated for ground and surface water are less than 
EPA's calculated cancer DWLOC. Therefore, the cancer aggregate risk 
associated with the proposed use of clofentezine does not exceed EPA's 
level of concern for the general U.S. population and all population 
subgroups.
    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 U.S. population, and to infants and children, from 
aggregate exposure to clofentezine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A high-performance liquid chromatography (HPLC) analytical method 
exists for the determination of clofentezine residues. A petition 
method validation (PMV) was successfully completed by the analytical 
chemistry laboratory (ACL), and the method was found acceptable. The 
limit of quantitation (LOQ) and limit of detection (LOD) reported were 
0.01 ppm and 0.003 ppm, respectively. The Agency concluded that the 
method was suitable for enforcement purposes. The method was forwarded 
to FDA for inclusion in Pesticide Analytical Manual (PAM)-Volume II. 
PAM-Volume I multiresidue methods are not acceptable for tolerance 
enforcement.
    Adequate enforcement methodology (example --gas chromatography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    Codex MRLs exist for clofentezine on grapes. The Codex MRLs for 
grapes and the U.S. tolerances established for clofentezine on grapes 
by this rule are harmonized at 1.0 ppm. No Codex MRLs exist for 
clofentezine on persimmons.

V. Conclusion

    Therefore, tolerances are established for residues of clofentezine 
per se, (3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine), in or on grapes at 
1.0 ppm and persimmons at 0.05 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-2005-0022 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 May 9, 
2005.
    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 Street, NW., 
Washington, DC 20005-3419. The

[[Page 11571]]

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-2005-0022, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Avenue, 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 
FFDCA in response to petitions submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: February 25, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

[[Page 11572]]

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 180.446 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.446   Clofentezine; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grapes                                      1.0
                                * * * * *
Persimmons                                  0.05
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-4335 Filed 3-8-05; 8:45 am]
BILLING CODE 6560-50-S