[Federal Register Volume 69, Number 106 (Wednesday, June 2, 2004)]
[Rules and Regulations]
[Pages 31013-31022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12316]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0125; FRL-7359-2]


Novaluron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
novaluron in or on fruit, pome (group 11), apple, wet pomace; cotton, 
undelinted seed; cotton, gin byproducts; vegetables, tuberous and corm, 
subgroup 1C; meat, fat, and meat byproducts of sheep, horse, cattle, 
goat, hog, and poultry; milk; milk, fat; and eggs. Makhteshim-Agan of 
North America, Inc. requested this tolerance under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective June 2, 2004. Objections and 
requests for hearings must be received on or before August 2, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0125. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis 
Hwy., 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: Daniel C. Kenny, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-7546; 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.

[[Page 31014]]

     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; 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/.

II. Background and Statutory Findings

    In the Federal Register of February 25, 2004 (69 FR 8649) (FRL-
7344-6), 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 
2F6430) by Makhteshim-Agan of North America, Inc., 551 Fifth Avenue, 
Suite 1100, New York, NY 10176. That notice included a summary of the 
petition prepared by Makhteshim-Agan of North America, Inc., the 
registrant. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR 180 be amended by establishing 
tolerances for residues of the insecticide novaluron, 1-[3-chloro-4-
(1,1,2-trifluoro-2-trifluoro-methoxyethoxy)phenyl]-3-(2,6-
difluorobenzoyl)urea, in or on fruit, pome (group 11) at 2.0 parts per 
million (ppm), apple, wet pomace at 8.0 ppm; cotton, undelinted seed at 
0.60 ppm; cotton, gin byproducts at 30 ppm; vegetables, tuberous and 
corm, subgroup 1C at 0.05 ppm; sheep, horse, cattle, and goat, meat at 
0.60 ppm; sheep, horse, cattle, and goat, meat byproducts (except liver 
and kidney) at 0.60 ppm; sheep, horse, cattle, and goat, fat at 11 ppm; 
sheep, horse, cattle, and goat, liver at 1.0 ppm; sheep, horse, cattle, 
and goat, kidney at 1.0 ppm; milk at 1.0 ppm; milk, fat at 20 ppm; hog, 
meat at 0.01 ppm; hog, meat byproducts at 0.01 ppm; hog, fat at 0.05 
ppm; poultry, meat at 0.03 ppm; poultry, meat byproducts at 0.04 ppm; 
poultry, fat at 0.40 ppm; and eggs at 0.05 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (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 tolerances for residues of novaluron on fruit, 
pome (group 11) at 2.0 ppm, apple, wet pomace at 8.0 ppm; cotton, 
undelinted seed at 0.60 ppm; cotton, gin byproducts at 30 ppm; 
vegetables, tuberous and corm, subgroup 1C at 0.05 ppm; sheep, horse, 
cattle, and goat, meat at 0.60 ppm; sheep, horse, cattle, and goat, 
meat byproducts (except liver and kidney) at 0.60 ppm; sheep, horse, 
cattle, and goat, fat at 11 ppm; sheep, horse, cattle, and goat, liver 
at 1.0 ppm; sheep, horse, cattle, and goat, kidney at 1.0 ppm; milk at 
1.0 ppm; milk, fat at 20 ppm; hog, meat at 0.01 ppm; hog, meat 
byproducts at 0.01 ppm; hog, fat at 0.05 ppm; poultry, meat at 0.03 
ppm; poultry, meat byproducts at 0.04 ppm; poultry, fat at 0.40 ppm; 
and eggs 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 novaluron are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No               Study Type            Results
------------------------------------------------------------------------
870.3200                         28-day Dermal      Systemic NOAEL=
                                  toxicity - rat     1,000 mg/kg/day;
                                                     LOAEL= not
                                                     established
                                                    Dermal NOAEL= 1,000
                                                     mg/kg/day; LOAEL=
                                                     not established
------------------------------------------------------------------------
870.3700                         Prenatal           Maternal NOAEL:
                                  Developmental in   >=1,000; LOAEL: not
                                  rodents-rat.       established
                                                    Developmental NOAEL:
                                                     >= 1,000; LOAEL:
                                                     not established
------------------------------------------------------------------------

[[Page 31015]]

 
870.3700                         Prenatal           Maternal NOAEL:
                                  developmental in   >=1,000; LOAEL: not
                                  nonrodents-        established
                                  rabbit.           Developmental NOAEL:
                                                     >= 1,000; LOAEL:
                                                     not established
------------------------------------------------------------------------
870.3800                         Reproduction and   Parental NOAEL= Not
                                  fertility- rat     established; LOAEL
                                                     (M/F)= 74.2/84.0 mg/
                                                     kg/day based on
                                                     increased absolute
                                                     and relative spleen
                                                     weights.
                                                    Offspring NOAEL= Not
                                                     established; LOAEL
                                                     (M/F)= 74.2/84.0 mg/
                                                     kg/day based on
                                                     increased absolute
                                                     and relative spleen
                                                     weights.
                                                    Reproductive NOAEL
                                                     (M/F)= 74.2
                                                     >=1009.8 mg/kg/day;
                                                     LOAEL= 297.5 mg/kg/
                                                     day based on
                                                     decreased
                                                     epididymal sperm
                                                     counts and
                                                     increased age of
                                                     preputial
                                                     separation in the
                                                     F1 generation,
                                                     reproductive LOAEL
                                                     for females was not
                                                     established
------------------------------------------------------------------------
870.4100                         Chronic toxicity - NOAEL= 10 mg/kg/day
                                   dog              LOAEL=100 mg/kg/day
                                                     based on
                                                     hematologic changes
                                                     associated with
                                                     histopathological
                                                     changes in liver
                                                     and spleen
------------------------------------------------------------------------
870.4300                         Chronic/           NOAEL (M/F) =1.1/1.4
                                  carcinogenicity-   mg/kg/day
                                  rat               LOAEL (M/F)=30.6/
                                                     39.5 mg/kg/day
                                                     based on
                                                     Erythrocyte damage
                                                     and turnover
                                                     resulting in a
                                                     regenerative mild
                                                     anemia
------------------------------------------------------------------------
870.4300                         Chronic/           NOAEL (M/F)=3.6/4.3
                                  carcinogenicity-   mg/kg/day
                                  mouse             LOAEL (M/F)=53.4/
                                                     63.3 mg/kg/day
                                                     based on increased
                                                     erythrocyte
                                                     turnover due to
                                                     hemoglobin
                                                     oxidation and
                                                     resulting in a mild
                                                     anemia
------------------------------------------------------------------------
870.5100                         Salmonella         Novaluron, tested up
                                  typhimurium and    to the limit of
                                  Escherichia coli   solubility (2,500
                                  Reverse Mutation   [mu]g/plate) and
                                  Assay.             the limit dose
                                                     (5,000 [mu]g/
                                                     plate), was not
                                                     cytotoxic with or
                                                     without S9
                                                     activation in four
                                                     S. typhimurium
                                                     strains and one
                                                     strain of E. coli,
                                                     and did not induce
                                                     a genotoxic
                                                     response in any
                                                     strain
------------------------------------------------------------------------
870.5100                         Salmonella         Novaluron, tested up
                                  typhimurium -      to the limit of
                                  bacterial          solubility (3333
                                  reverse gene       [mu]g/plate), was
                                  mutation assay.    not cytotoxic with
                                                     or without S9
                                                     activation in five
                                                     S. typhimurium
                                                     strains, and did
                                                     not induce a
                                                     genotoxic response
                                                     in any strain
------------------------------------------------------------------------
870.5300                         Gene mutation      There was no
                                                     evidence of
                                                     biologically
                                                     significant
                                                     induction of mutant
                                                     colonies over
                                                     background
------------------------------------------------------------------------
870.5375                         In vitro           Novaluron produced
                                  mammalian          no evidence of
                                  chromosome         clastogenic
                                  aberration test.   activity in primary
                                                     human lymphocytes,
                                                     in the presence or
                                                     absence of S9
                                                     activation
------------------------------------------------------------------------
870.5395                         Mammalian          There was no
                                  erythrocyte        statistically
                                  micronucleus       significant
                                  test in mice.      increase in the
                                                     frequency of
                                                     micronucleated
                                                     polychromatic
                                                     erythrocytes in
                                                     mouse bone marrow
                                                     at any dose or
                                                     harvest time
------------------------------------------------------------------------
870.5550                         Unscheduled DNA    Novaluron was
                                  Synthesis in       considered not to
                                  HeLa S3 Human      show any evidence
                                  Epitheliod cells.  of causing DNA
                                                     damage to HeLa S3
                                                     epithelioid cells
                                                     in this unscheduled
                                                     DNA synthesis test
                                                     for mutagenic
                                                     potential
------------------------------------------------------------------------
870.5500                         Mutagenicity-rec   Novaluron was
                                  assay with         equivocal for
                                  Bacillus           bacterial DNA
                                  subtilis.          damage in the
                                                     absence of S9
                                                     activation, and
                                                     negative for
                                                     bacterial DNA
                                                     damage in the
                                                     presence of S9
                                                     activation
870.6200                         Acute              NOAEL= 650 mg/kg/
                                  neurotoxicity      day; LOAEL=2,000 mg/
                                  screening          kg/day based on
                                  battery- rat.      clinical signs
                                                     (piloerection,
                                                     irregular
                                                     breathing), FOB
                                                     parameters
                                                     (increased head
                                                     swaying, abnormal
                                                     gait) and
                                                     neuropathology
                                                     (sciatic and tibial
                                                     nerve
                                                     degeneration).
------------------------------------------------------------------------
870.6200                         Subchronic         NOAEL (M/F)=>=1,752/
                                  neurotoxicity      >=2,000 mg/kg/day;
                                  screening          LOAEL= not
                                  battery- rat.      established
------------------------------------------------------------------------
870.7485                         Metabolism-rat     Novaluron exhibited
                                                     marginal absorption
                                                     (16-18%),
                                                     relatively rapid
                                                     and complete
                                                     excretion within 48
                                                     hours primarily via
                                                     the feces and to a
                                                     lesser extent via
                                                     urine in rat
------------------------------------------------------------------------
870.7600                         Rat Dermal         Recovery of
                                  penetration        administered
                                                     radioactivity was
                                                     an acceptable 90.19-
                                                     105.26%. The
                                                     maximum total
                                                     absorbed dose
                                                     (expressed as per
                                                     cent of
                                                     administered dose
                                                     and determined as
                                                     the sum of
                                                     radioactivity in
                                                     excreta, cage wash,
                                                     untreated skin,
                                                     fat, blood, and
                                                     residual carcass)
                                                     ranged from about
                                                     0.5% to 10% of that
                                                     administered.
------------------------------------------------------------------------
M - Male; F - Female


[[Page 31016]]

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: 
``Traditional uncertainty factors;'' 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 106), or one in ten 
million (1 x 107). Under certain specific circumstances, MOE 
calculations will be used for the carcinogenic risk assessment. In this 
non-linear approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for novaluron used for 
human risk assessment is shown in Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for novaluron for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,
          Exposure Scenario                Interspecies and       Special FQPA SF* and   Study and Toxicological
                                         Intraspecies and any   LOC for Risk Assessment          Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          Not applicable           None                     An endpoint of concern
                                                                                          attributable to a
                                                                                          single dose was not
                                                                                          identified. An acute
                                                                                          RfD was not
                                                                                          established
----------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 1.1 mg/kg/day     FQPA SF = 1X cPAD =      Combined chronic
                                       UF = 100...............   chronic RfD/FQPA SF      toxicity/
                                       Chronic RfD = 0.011 mg/  = 0.011 mg/kg/day......   carcinogenicity
                                        kg/day.                                           feeding in rat
                                                                                         LOAEL = 30.6 mg/kg/day
                                                                                          based on erythrocyte
                                                                                          damage and turnover
                                                                                          resulting in a
                                                                                          regenerative anemia
----------------------------------------------------------------
Short-term incidental oral (1-30       NOAEL= 4.38 mg/kg/day    Residential LOC for MOE  90-day feeding study in
 days)                                                           = 100                    rat
                                                                Occupational LOC for     LOAEL = 8.64 mg/kg/day
                                                                 MOE = 100.               based on clinical
                                                                                          chemistry (decreased
                                                                                          hemoglobin, hematocrit
                                                                                          and RBC counts) and
                                                                                          histopathology
                                                                                          (increased
                                                                                          hematopoiesis and
                                                                                          hemosiderosis in
                                                                                          spleen and liver).
----------------------------------------------------------------
Intermediate-term incidental oral (1-  NOAEL= 4.38 mg/kg/day    Residential LOC for MOE  90-day feeding study in
 6 months)                                                       = 100                    rat
                                                                Occupational LOC for     LOAEL = 8.64 mg/kg/day
                                                                 MOE = 100.               based on clinical
                                                                                          chemistry (decreased
                                                                                          hemoglobin, hematocrit
                                                                                          and RBC counts) and
                                                                                          histopathology
                                                                                          (increased
                                                                                          hematopoiesis and
                                                                                          hemosiderosis in
                                                                                          spleen and liver)
----------------------------------------------------------------
Short-term dermal (1 to 30 days)       Not applicable           None                     No toxicity observed at
                                                                                          the limit dose in
                                                                                          dermal study and there
                                                                                          were no developmental
                                                                                          toxicity concerns at
                                                                                          the limit-dose;
                                                                                          therefore,
                                                                                          quantification of
                                                                                          short-term dermal risk
                                                                                          is not necessary
----------------------------------------------------------------

[[Page 31017]]

 
Intermediate-term dermal (1 to 6       Oral NOAEL = 4.38 mg/kg/ Residential LOC for MOE  90-day feeding study in
 months)                                day(dermal-absorption    = 100                    rat
                                        rate = 10%)             Occupational LOC for     LOAEL = 8.64 mg/kg/day
                                                                 MOE = 100.               based on clinical
                                                                                          chemistry (decreased
                                                                                          hemoglobin, hematocrit
                                                                                          and RBC counts) and
                                                                                          histopathology
                                                                                          (increased
                                                                                          hematopoiesis and
                                                                                          hemosiderosis in
                                                                                          spleen and liver)
----------------------------------------------------------------
Long-term dermal (>6months)            Oral NOAEL= 1.1 mg/kg/   Residential LOC for MOE  Combined chronic
                                        day (dermal-absorption   = 100                    toxicity/
                                        rate = 10 %)            Occupational LOC for      carcinogenicity
                                                                 MOE = 100.               feeding in rat
                                                                                         LOAEL = 30.6 mg/kg/day
                                                                                          based on erythrocyte
                                                                                          damage and turnover
                                                                                          resulting in a
                                                                                          regenerative anemia
----------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Oral NOAEL = 4.38 mg/kg/ Residential LOC for MOE  90-day feeding study in
                                        day (inhalation          = 100                    rat
                                        absorption rate =       Occupational LOC for     LOAEL = 8.64 mg/kg/day
                                        100%)                    MOE = 100.               based on clinical
                                                                                          chemistry (decreased
                                                                                          hemoglobin, hematocrit
                                                                                          and RBC counts) and
                                                                                          histopathology
                                                                                          (increased
                                                                                          hematopoiesis and
                                                                                          hemosiderosis in
                                                                                          spleen and liver)
----------------------------------------------------------------
Intermediate-term inhalation (1 to 6   Oral NOAEL = 4.38 mg/kg/ Residential LOC for MOE  90-day feeding study in
 months)                                day (inhalation          = 100                    rat
                                        absorption rate =       Occupational LOC for     LOAEL = 8.64 mg/kg/day
                                        100%)                    MOE = 100.               based on clinical
                                                                                          chemistry (decreased
                                                                                          hemoglobin, hematocrit
                                                                                          and RBC counts) and
                                                                                          histopathology
                                                                                          (increased
                                                                                          hematopoiesis and
                                                                                          hemosiderosis in
                                                                                          spleen and liver).
----------------------------------------------------------------
Long-term inhalation (>6 months)       Oral NOAEL= 1.1 mg/kg/   Residential LOC for MOE  Combined chronic
                                        day (inhalation          = 100                    toxicity/
                                        absorption rate =       Occupational LOC for      carcinogenicity
                                        100%)                    MOE = 100.               feeding in rat
                                                                                         LOAEL = 30.6 mg/kg/day
                                                                                          based on erythrocyte
                                                                                          damage and turnover
                                                                                          resulting in a
                                                                                          regenerative anemia
----------------------------------------------------------------
Cancer                                                  Not likely to be carcinogenic to humans
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Currently, no 
tolerances have been established for the residues of novaluron, in or 
on any raw agricultural commodities. Risk assessments were conducted by 
EPA to assess dietary exposures from novaluron in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. An endpoint of concern attributable to a single dose 
of novaluron was not identified. Therefore, an acute dietary risk 
assessment was not conducted.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), 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 exposure 
assessments: The chronic analysis assumed 100% crop treated for all 
commodities; incorporated average field trial residues; empirical 
processing factors for apple juice (translated to pear juice); and 
DEEM\TM\ (ver 7.76) default processing factors for the remaining 
processed commodities. Anticipated residues were calculated for meat 
and milk commodities and recommended tolerances were used for poultry 
commodities.
    iii. Cancer. Novaluron is classified as ``not likely to be 
carcinogenic to humans'' based on the lack of evidence for 
carcinogenicity in mice and rats. Therefore, a quantitative cancer risk 
assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of 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 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. As required by section 408(b)(2)(E) of FFDCA, EPA 
will issue a data call-in for information relating to anticipated 
residues to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for novaluron 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

[[Page 31018]]

the physical characteristics of novaluron. Novaluron may reach surface 
water or ground water via the parent compound or via its chlorophenyl 
urea and chloroaniline degradates. Therefore, concentrations of 
novaluron and its chlorophenyl urea and chloroaniline degradates in 
surface water and ground water were estimated by using modeling.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and screening concentration in ground water (SCI-GROW), which 
predicts pesticide concentrations in ground water. In general, EPA will 
use GENEEC (a Tier I model) before using PRZM/EXAMS (a Tier II model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin. Tier II Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) modeling 
was performed to estimate drinking water concentrations for novaluron 
(parent) in surface water.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The 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 I model) before 
using PRZM/EXAMS (a Tier II 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. The FIRST model was used to obtain surface 
water estimates for the degradate chlorophenyl urea and chloroaniline. 
The estimated drinking water concentration values are meant to 
represent upper-bound estimates of the concentrations that might be 
found in surface water and ground water based upon existing and 
proposed uses. Of the three estimated drinking water concentration 
values, chronic estimates for the terminal metabolite, chloroaniline 
are the highest (100% conversion from parent to aniline was assumed). 
This is consistent with the expected degradation pattern for novaluron. 
Therefore, the estimated drinking water concentration value for 
chloroaniline was used to assess chronic aggregate risk.
    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 
LOC.
    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 novaluron they are 
further discussed in the aggregate risk sections in this Unit.
    Based on the PRZM/EXAMS, FIRST and SCI-GROW models, the EECs of 
novaluron for chronic exposures are estimated to be 2.61 parts per 
billion (ppb) for surface water and 0.009 ppb for ground water. Since 
an acute dietary risk assessment was not needed, EECs of novaluron for 
acute exposures to surface water and ground water were not used.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Novaluron 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 novaluron and any other 
substances and novaluron 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 novaluron 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 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using 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 are no residual 
uncertainties for pre-/post-natal toxicity. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure to novaluron in developmental toxicity

[[Page 31019]]

studies. There is no quantitative or qualitative evidence of increased 
susceptibility to novaluron following pre-/post-natal exposure in a 2-
generation reproduction study.
    3. Conclusion. There is a complete toxicity data base for novaluron 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. The FQPA SF was reduced to 
1X, based upon the following: As mentioned above, there is no 
quantitative or qualitative evidence of increased susceptibility of rat 
and rabbit fetuses to in utero exposure to novaluron in developmental 
toxicity studies. There is no quantitative or qualitative evidence of 
increased susceptibility to novaluron following pre-/post-natal 
exposure in a 2-generation reproduction study. In addition, there is no 
concern for developmental neurotoxicity resulting from exposure to 
novaluron, and a developmental neurotoxicity study (DNT) study is not 
required. Furthermore, the chronic dietary food exposure assessment 
assumes 100% crops treated for all commodities. The dietary drinking 
water assessment utilizes water concentration values generated by model 
and associated modeling parameters which are designed to provide 
conservative, health protective, high-end estimates of water 
concentrations which will not likely be exceeded. Finally, there are no 
proposed or existing uses for novaluron which result in residential 
exposure.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An endpoint of concern attributable to a single dose 
was not identified. Therefore, no acute risk is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to novaluron 
from food will utilize 18% of the cPAD for the U.S. population, 68% of 
the cPAD for children 1 to 2 years old. There are no residential uses 
for novaluron that result in chronic residential exposure to novaluron. 
In addition, there is potential for chronic dietary exposure to 
novaluron in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of 
this unit:

               Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Novaluron
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.011           18         2.61        0.009          320
----------------------------------------------------------------------------------------------------------------
Females, (13-49 years old)                             0.011           12         2.61        0.009          290
----------------------------------------------------------------------------------------------------------------
All infants                                            0.011           31         2.61        0.009           76
----------------------------------------------------------------------------------------------------------------
Children, (1-2 years old)                              0.011           68         2.61        0.009           35
----------------------------------------------------------------------------------------------------------------
Youth, (13-19 years)                                   0.011           16         2.61        0.009          280
----------------------------------------------------------------------------------------------------------------

    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). Novaluron 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). Novaluron 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.
    5. Aggregate cancer risk for U.S. population. Novaluron has not 
been shown to be carcinogenic. Therefore, novaluron 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

[[Page 31020]]

population, and to infants and children from aggregate exposure to 
novaluron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology -- is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits for novaluron.

V. Conclusion

    Therefore, the tolerances are established for residues of 
novaluron, 1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-
methoxyethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea, in or on fruit, pome 
(group 11) at 2.0 ppm, apple, wet pomace at 8.0 ppm; cotton, undelinted 
seed at 0.60 ppm; cotton, gin byproducts at 30 ppm; vegetables, 
tuberous and corm, subgroup 1C at 0.05 ppm; sheep, horse, cattle, and 
goat, meat at 0.60 ppm; sheep, horse, cattle, and goat, meat byproducts 
(except liver and kidney) at 0.60 ppm; sheep, horse, cattle, and goat, 
fat at 11 ppm; sheep, horse, cattle, and goat, liver at 1.0 ppm; sheep, 
horse, cattle, and goat, kidney at 1.0 ppm; milk at 1.0 ppm; milk, fat 
at 20 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01 ppm; 
hog, fat at 0.05 ppm; poultry, meat at 0.03 ppm; poultry, meat 
byproducts at 0.04 ppm; poultry, fat at 0.40 ppm; and eggs 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-2004-0125 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 August 2, 
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 (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. 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 Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2004-0125, 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 Unit I.B.1. 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).

[[Page 31021]]

VII. Statutory and Executive Order Reviews

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

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 20, 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 180.598 is added to read as follows:


Sec.  180.598  Novaluron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide novaluron, 1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoro-
methoxyethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea, in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple, wet pomace....................................                8.0
Cattle, fat..........................................                 11
Cattle, kidney.......................................                1.0
Cattle, liver........................................                1.0
Cattle, meat.........................................               0.60
Cattle, meat byproducts, except liver and kidney.....               0.60
Cotton, gin byproducts...............................                 30
Cotton, undelinted seed..............................               0.60
Eggs.................................................               0.05
Fruit, pome, group 11................................                2.0
Goat, fat............................................                 11
Goat, kidney.........................................                1.0
Goat, liver..........................................                1.0
Goat, meat...........................................               0.60
Goat, meat byproducts except liver and kidney........               0.60
Hog, fat.............................................               0.05
Hog, meat............................................               0.01
Hog, meat byproducts.................................               0.01
Horse, fat...........................................                 11
Horse, kidney........................................                1.0
Horse, liver.........................................                1.0
Horse, meat..........................................               0.60
Horse, meat byproducts, except liver and kidney......               0.60
Milk.................................................                1.0
Milk, fat............................................                 20
Poultry, fat.........................................               0.40
Poultry, meat........................................               0.03
Poultry, meat byproducts.............................               0.04
Sheep, fat...........................................                 11
Sheep, kidney........................................                1.0
Sheep, liver.........................................                1.0
Sheep, meat..........................................               0.60
Sheep, meat byproducts, except liver and kidney......               0.60
Vegetables, tuberous and corn, subgroup 1C...........               0.05
------------------------------------------------------------------------


[[Page 31022]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[FR Doc. 04-12316 Filed 6-1-04; 8:45 am]
BILLING CODE 6560-50-S