[Federal Register Volume 70, Number 133 (Wednesday, July 13, 2005)]
[Rules and Regulations]
[Pages 40202-40212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13774]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0075; FRL-7714-3]


Spirodiclofen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-
yl 2,2-dimethylbutanoate) in or on grape; grape, raisin; grape, juice; 
fruit, citrus, crop group 10; citrus, oil; citrus, juice; fruit, pome, 
crop group 11; apple, wet pomace; fruit, stone, crop group 12; nut, 
tree, crop group 14; almond, hulls; and pistachio; and for residues of 
spirodiclofen and its free enol metabolite (3-(2,4-dichlorophenyl)-4-
hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on cattle, fat; cattle, 
meat byproducts; cattle, meat; goat, fat; goat, meat byproducts; goat, 
meat; sheep, fat; sheep, meat byproducts; sheep, meat; horse, fat; 
horse, meat byproducts; horse, meat; milk; and milk, fat. Bayer 
CropScience 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 July 13, 2005. Objections and 
requests for hearings must be received on or before September 12, 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-2005-0075. 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 Mall2, 1801 S. Bell 
St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8291; 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; 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 at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of February 18, 2004 (69 FR 7632) (FRL-
7343-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F6469) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
part 180 be amended by establishing a tolerance for residues of the 
insecticide spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-
oxaspiro[4,5]dec-3]-en-4-yl 2,2-dimethylbutanoate), in or on citrus 
fruit group at 0.3 parts per million (ppm), citrus pulp, dried, at 0.4 
ppm, citrus oil at 20 ppm, pome fruit group at 0.8 ppm, pome fruit 
pomace, wet, at 6.0 ppm, stone fruit group at 1.0 ppm, tree nut group 
at 0.05 ppm, almond hulls at 20 ppm, pistachios at 0.05 ppm, grape at 
2.0 ppm and grape, raisin at 4.0 ppm; and for combined residues of 
spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3]-en-4-
yl 2,2-dimethylbutanoate), and/or its enol metabolite, 3-(2,4-
dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one, in or on 
cattle, fat, at 0.01 ppm and cattle, meat by-products, at 0.05 parts 
per million (ppm). That notice included a summary of the petition 
prepared by Bayer CropScience, the registrant. There were no comments 
received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA

[[Page 40203]]

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 spirodiclofen on 
grape at 2.0 ppm; grape, raisin at 4.0 ppm; grape, juice at 2.4 ppm; 
citrus, fruit, crop group 10 at 0.50 ppm; citrus, oil at 20 ppm; 
citrus, juice at 0.60 ppm; fruit, pome, crop group 11 at 0.80 ppm; 
apple, wet pomace at 2.0 ppm; fruit, stone, crop group 12 at 1.0 ppm; 
nut, tree, crop group 14 at 0.10 ppm; almond, hulls at 20 ppm; 
pistachio at 0.10 ppm; and for combined residues of spirodiclofen and 
its free enol metabolite BAJ 2510 in or on cattle, meat and cattle, fat 
at 0.02 ppm; cattle, meat byproducts at 0.10 ppm; goat, meat and goat, 
fat at 0.02 ppm; goat, meat byproducts at 0.10 ppm; sheep, meat and 
sheep, fat at 0.02 ppm; sheep, meat byproducts at 0.10 ppm; horse, meat 
and horse, fat at 0.02 ppm; horse, meat byproducts at 0.10 ppm; milk at 
0.01 ppm, and milk, fat at 0.03 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.
    Spirodiclofen has low acute toxicity via oral, dermal, or 
inhalation route. It is not an eye or dermal irritant. However, it is a 
potential skin sensitizer. The nature of the toxic effects caused by 
spirodiclofen 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 Profile for
                              Spirodiclofen
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          Subchronic oral -   For males, NOAEL =
                                   rat                 32.1 milligram/
                                                       kilogram/day (mg/
                                                       kg/day), LOAEL =
                                                       166.9 mg/kg/day
                                                       based on
                                                       increased
                                                       incidence and
                                                       severity of small
                                                       cytoplasmic
                                                       vacuolation in
                                                       the cortex of
                                                       adrenal glands,
                                                       decreased
                                                       cholesterol (week
                                                       5 and 13), and
                                                       decreased
                                                       triglycerides
                                                       (week 5),
                                                      For females, NOAEL
                                                       = 8.1 mg/kg/day,
                                                       LOAEL = 47.1 mg/
                                                       kg/day based on
                                                       increased
                                                       incidence of
                                                       small cytoplasmic
                                                       vacuolation in
                                                       the cortex of
                                                       adrenal glands
---------------------------------
870.3100                          Subchronic oral -   For males, NOAEL =
                                   mouse               15 mg/kg/day,
                                                       LOAEL= 164 mg/kg/
                                                       day based on an
                                                       increased
                                                       incidence of
                                                       hypertrophic
                                                       Leydig cells in
                                                       the testes
                                                      For females, NOAEL
                                                       = 30 mg/kg/day,
                                                       LOAEL = 234 mg/kg/
                                                       day based on an
                                                       increased
                                                       incidence of
                                                       cytoplasmic
                                                       vacuolation of
                                                       the adrenal
                                                       cortex
---------------------------------
870.3150                          Subchronic oral -   For males, NOAEL =
                                   dog                 7.7 mg/kg/day,
                                                       LOAEL = 26.6 mg/
                                                       kg/day based on
                                                       decreased body
                                                       weight gains,
                                                       increased liver
                                                       and adrenal
                                                       weights,
                                                       decreased
                                                       prostate weights,
                                                       and
                                                       histopathology
                                                       findings in the
                                                       adrenal glands,
                                                       testes,
                                                       epididymis,
                                                       thymus, and
                                                       prostates
                                                      For females, NOAEL
                                                       <=8.4 mg/kg/day.
                                                       LOAEL = 8.4 mg/kg/
                                                       day based on
                                                       increased adrenal
                                                       gland weight (two
                                                       out of four
                                                       animals) which
                                                       coincided with
                                                       histopathology
                                                       findings
                                                       (cytoplasmic
                                                       vacuoles in the
                                                       Zona fasciculata
                                                       of the adrenal
                                                       glands)
---------------------------------

[[Page 40204]]

 
870.3200                          21-Day dermal       NOAEL is 1,000 mg/
                                   toxicity - rat      kg/day (highest
                                                       dose tested
                                                       (HDT)); however,
                                                       the
                                                       histopathology
                                                       was not
                                                       appropriately
                                                       conducted as
                                                       required by the
                                                       guideline. The
                                                       study did not
                                                       examine all of
                                                       the tissues,
                                                       especially the
                                                       possible target
                                                       organs (i.e.,
                                                       uterus, prostate,
                                                       etc)
---------------------------------
870.3700                          Prenatal            Maternal: NOAEL =
                                   developmental -     1,000 mg/kg/day
                                   rat                 (HDT)
                                                      Developmental:
                                                       NOAEL = 300 mg/kg/
                                                       day, LOAEL =
                                                       1,000 mg/kg/day
                                                       based on an
                                                       increased
                                                       incidence of
                                                       slight dilatation
                                                       of the renal
                                                       pelvis
---------------------------------
870.3700                          Prenatal            Maternal: NOAEL =
                                   developmental -     100 mg/kg/day,
                                   rabbit              LOAEL = 300 mg/kg/
                                                       day based on body
                                                       weight loss and
                                                       decreased food
                                                       consumption
                                                      Developmental:
                                                       NOAEL = 1,000 mg/
                                                       kg/day (HDT)
---------------------------------
870.3800                          Reproduction and    Parental/system:
                                   fertility effects  For males: NOAEL =
                                   - rat               5.2-6.4 mg/kg/
                                                       day, LOAEL = 26.2-
                                                        30.2 mg/kg/day
                                                       based on
                                                       decreased body
                                                       weight in F
                                                       males; decreased
                                                       absolute and
                                                       relative liver
                                                       weight in F0
                                                       males; decreased
                                                       cholesterol and
                                                       triglycerides in
                                                       F1 males; and
                                                       increased
                                                       severity of
                                                       adrenal cortical
                                                       vacuolation in F1
                                                       males. For
                                                       females, NOAEL =
                                                       5.5-7.0 mg/kg/
                                                       day, LOAEL = 27.6-
                                                       34.4 mg/kg/day
                                                       based on
                                                       decreased
                                                       unesterified
                                                       fatty acids in F1
                                                       females, and
                                                       increased
                                                       severity of
                                                       adrenal cortical
                                                       vacuolation in F0
                                                       and F1 females
                                                      Reproductive:
                                                      For males: NOAEL =
                                                       26.2-30.2 mg/kg/
                                                       day, LOAEL =
                                                       134.8- 177.6 mg/
                                                       kg/day based on
                                                       delayed sexual
                                                       maturation;
                                                       decreased
                                                       testicular
                                                       spermatid and
                                                       epididymal sperm
                                                       counts
                                                       (oligospermia);
                                                       and atrophy of
                                                       the testes,
                                                       epididymides,
                                                       prostate and
                                                       seminal vesicles.
                                                       For females:
                                                       NOAEL = 27.6-34.4
                                                       mg/kg/day, LOAEL
                                                       = 139.2-192.7 mg/
                                                       kg/day based on
                                                       increased
                                                       severity of
                                                       ovarian luteal
                                                       cell vacuolation/
                                                       degeneration
                                                      Offspring:
                                                      NOAEL = 5.2-6.4
                                                       (M)/5.5-7.0 (F)
                                                       mg/kg/day, LOAEL
                                                       = 26.2-30.2 (M)/
                                                       27.6-34.4(F) mg/
                                                       kg/day based on
                                                       decreased body
                                                       weight and weight
                                                       gain in F1 male
                                                       and female pups
---------------------------------
870.4100                          Chronic toxicity -  NOAEL = 1.38 (M)/
                                   dog                 1.52(F) mg/kg/
                                                       day, LOAEL =
                                                       4.33(M)/4.74 (F)
                                                       mg/kg/day based
                                                       on increased
                                                       relative adrenal
                                                       weights in both
                                                       sexes, increased
                                                       relative testis
                                                       weight in males
                                                       and
                                                       histopathology
                                                       findings in the
                                                       adrenal gland of
                                                       both sexes
---------------------------------

[[Page 40205]]

 
870.4200                          Carcinogenicity -   NOAEL = 4.1(M)/
                                   mouse               5.1(F) mg/kg/day,
                                                       LOAEL = 610 (M)
                                                       mg/kg/day based
                                                       on increased
                                                       absolute and
                                                       relative liver
                                                       and adrenal
                                                       weights,
                                                       decreased
                                                       absolute and
                                                       relative kidney
                                                       weight, enlarged
                                                       adrenal gland,
                                                       discolored
                                                       testis, adrenal
                                                       gland
                                                       vacuolization,
                                                       interstitial cell
                                                       degeneration of
                                                       the testes. For
                                                       females, LOAEL =
                                                       722 mg/kg/day
                                                       based on
                                                       increased
                                                       absolute and
                                                       relative adrenal
                                                       weight, decreased
                                                       absolute and
                                                       relative kidney
                                                       weight, increased
                                                       incidences of
                                                       adrenal gland
                                                       pigmentation, and
                                                       adrenal
                                                       vacuolization.
                                                      Hepatocellular
                                                       adenoma and
                                                       carcinoma
---------------------------------
870.4300                          Chronic toxicity -  For males: NOAEL =
                                   rat                 14.7 mg/kg/day,
                                                       LOAEL = 110.1 mg/
                                                       kg/day based on
                                                       decreased body
                                                       weights,
                                                       decreased body
                                                       weight gain,
                                                       increased APh
                                                       levels, decreased
                                                       cholesterol and
                                                       triglyceride
                                                       levels, increased
                                                       vacuolated
                                                       jejunum
                                                       enterocytes, and
                                                       increased
                                                       incidences of
                                                       Leydig cell
                                                       hyperplasia
                                                      For females: NOAEL
                                                       = 19.9 mg/kg/day,
                                                       LOAEL = 152.9 mg/
                                                       kg/day based on
                                                       decreased body
                                                       weights,
                                                       decreased body
                                                       weight gain,
                                                       increased APh
                                                       levels, increased
                                                       TSH, uterus
                                                       nodules, and
                                                       increased
                                                       vacuolated
                                                       jejunum
                                                       enterocytes
                                                      testes Leydig cell
                                                       adenoma in males,
                                                       uterine adenoma
                                                       and/or
                                                       adenocarcinoma in
                                                       females
---------------------------------
870.5100                          Gene mutation -     There was no
                                   Salmonella          evidence of
                                   typhimurium         increased
                                                       revertant
                                                       colonies above
                                                       control in 5
                                                       Salmonella
                                                       strains (TA1535,
                                                       TA1537, TA1538,
                                                       TA100, TA98)
                                                        S9
                                                       at concentrations
                                                       up to 5,000 [mu]g/
                                                       plate
---------------------------------
870.5300                          In vitro mammalian  Negative, tested
                                   gell gene           in Chinese
                                   mutation            Hamster lung
                                                       fibroblast V79
                                                       cells at
                                                       concentrations up
                                                       to 300 [mu]g/mL -
                                                       S9 and +S9.
                                                       Cytotoxicity was
                                                       observed at >=15
                                                       [mu]g/mL -S9 and
                                                       80 [mu]g/mL +S9
---------------------------------
870.5375                          In vitro mammalian  Negative, tested
                                   chromosome          in Chinese
                                   aberration          hamster lung
                                                       (V79) cells at
                                                       concentrations 5-
                                                       80 [mu]g/mL or
                                                       0.75-12 [mu]g/mL
                                                       S9 or 10-160
                                                       [mu]g/mL +S9
---------------------------------
870.5395                          In vivo mouse bone  Negative, tested
                                   morrow              at a dose 800 mg/
                                   micronucleus        kg (MTD).
                                                       Clinical signs
                                                       and cytotoxicity
                                                       were seen at 800
                                                       mg/kg
---------------------------------
870.6200                          Acute               NOAEL = 2,000 mg/
                                   neurotoxicity -     kg/day, no
                                   rat                 neurotoxicity
                                                       observed
---------------------------------
870.6200                          Subchronic          NOAEL = 70.3(M)/
                                   neurotoxicity -     87.3(F) mg/kg/
                                   rat                 day. LOAEL =
                                                       1088.8(M)/
                                                       1306.5(F) mg/kg/
                                                       day based on
                                                       decreased body
                                                       weights, food
                                                       consumption, and
                                                       increased urine
                                                       staining in both
                                                       sexes and
                                                       decreased motor
                                                       and locomotor
                                                       activity (week 4)
                                                       in females only
---------------------------------

[[Page 40206]]

 
870.6300                          Developmental       Maternal NOAEL =
                                   neurotoxicity       135.9/273.8 mg/kg/
                                                       day
                                                      LOAEL = Not
                                                       established
                                                      Offspring NOAEL =
                                                       Not established
                                                      LOAEL = 6.5/14.0
                                                       mg/kg/day based
                                                       on effects in
                                                       memory phase of
                                                       the water maze
                                                       test in PND 60
                                                       females
                                                      The study
                                                       classification is
                                                       reserved for the
                                                       guideline
                                                       requirement
                                                       pending receipt
                                                       of additional
                                                       morphometric
                                                       measurements for
                                                       the low and mid
                                                       dose groups
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: `` 
Traditional uncertainty factors;'' the ``special FQPA safety factor;'' 
and the ``default FQPA safety factor.'' By the term ``traditional 
uncertainty factor,'' 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.
    A summary of the toxicological endpoints for spirodiclofen used for 
human risk assessment is shown in Table 2 of this unit:

    Table 2.--Summary of Toxicological Dose and Endpoints for Spirodiclofen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          Acute RfD = Not            An effect of concern attributable to a single
                                        established                          dose was not identified
--------------------------------------
Chronic dietary (all populations)      LOAEL = 6.5 mg/kg/day    FQPA SF = 1X             Developmental
                                       UF = 1,000.............  cPAD = Chronic RfD/FQPA   Neurotoxicity Study -
                                       Chronic RfD = 0.0065 mg/  SF = 0.0065 mg/kg/day.   Rat
                                        kg/day.                                          LOAEL of 6.5 mg/kg/day
                                                                                          based on decreased
                                                                                          retention (memory) in
                                                                                          females on day 60 in
                                                                                          the water maze at all
                                                                                          doses
--------------------------------------
Cancer (Oral, dermal, inhalation)       Classification: ``Likely to be Carcinogenic to Humans'' with Q1* (mg/kg/
                                                                  day)-1 = 1.49 x 10-2
----------------------------------------------------------------------------------------------------------------


[[Page 40207]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have not 
been established for (40 CFR 180.000) for the residues of 
spirodiclofen, in or on a variety of raw agricultural commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
spirodiclofen in food as follows:
    i. Acute exposure. Acute quantitative 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. No appropriate single-dose endpoint was 
available for the acute oral exposure of the general population, 
including infants and children. Therefore, an acute quantitative 
dietary assessment was not performed.
    ii. Chronic exposure. In conducting the chronic and cancer dietary 
risk assessment EPA used the Lifeline (version 2.0) and Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID\TM\), both of 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 and cancer analyses were refined through the use of average 
field trial residues, experimentally determined processing factors, and 
projected average percent crop treated estimates. These averages were 
based on the typical average of all insecticides used to control all 
pests on the specific crop.
    The projected average percent crop treated estimates were provided 
for apple, peach, grape, orange, and grapefruit. These averages were 
based on the typical average of all insecticides used to control all 
pests on the specific crop. The Agency determined that it is 
appropriate to translate the projected percent crop treated estimates 
for peach, apple, and grapefruit to the remaining crops in the stone 
fruit, pome fruit, and citrus crop groups, respectively.
    Since the analysis made use of average residues derived from crop 
field trial studies (maximum application rate and minimum preharvest 
interval (PHI)), incorporated maximum theoretical processing factors 
for juice, and surface drinking water estimates which assumed 87% of 
the basin cropped and 100% of the cropped area treated at the maximum 
rate (citrus, pecan, apple, peach, and grape), the Agency concluded 
that the exposure estimates are unlikely to underestimate actual 
exposure.
    iii. Cancer. The Agency has classified spirodiclofen as ``likely to 
be carcinogenic to humans.'' Quantification of cancer risk used a 
Q1*(mg/kg/day)-1 of 1.49 x 10-2 in 
human equivalents based on male rat testes Leydig cell adenoma.
    As indicated above, the chronic and cancer analyses incorporated 
average field trial residues; processing factors from the apple, grape, 
plum, and orange processing studies (DEEM-FCID\TM\ (ver. 7.76) default 
processing factors assumed for juice commodities); projected average 
percent crop treated estimates; and the SCI-GROW and/or PRZM-EXAMS 
drinking water estimates.
    DEEM-FCID\TM\ resulted in similar chronic and cancer risk estimates 
(all included drinking water), but due to differing drinking water 
assumptions, the result was a higher risk estimate using DEEM-FCID\TM\. 
Based on a critical commodity analysis conducted in DEEM-FCID\TM\, the 
major contributors to the cancer risk were water (34% of the total 
exposure), orange (20% of the total exposure) and apple (16% of the 
total exposure).
    iv. Anticipated residue and percent crop treated (PCT) information. 
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 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:
    A routine chronic dietary exposure analysis for spirodiclofen was 
based on projected PCT for the following crops: Grapefruit - 20%; 
oranges except temple - 10%; grapes - 4%; peaches - 12%; apples - 13%. 
These are typical averages of all insecticides used to control all 
pests on the specific crop, taken from the Agricultural Chemical Usage 
2003 Fruit Summary report published by United States Department of 
Agriculture National Agriculture Statistics Service (USDA/NASS). The 
projected percent crop treated estimates for peach, apple, and 
grapefruit were applied to the remaining crops in the stone fruit, pome 
fruit, and citrus crop groups, respectively.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described in Unit. C for spirodiclofen is reliable and has 
a valid basis. These are average usage figures of all insecticides used 
on the crops in question. EPA has not taken into account whether the 
insecticide use was directed against the pest that spirodiclofen 
controls but instead has averaged each insecticide's total usage. Thus, 
these averages are likely to overstate spirodiclofen use because many 
insecticides are effective against several pests and total usage of 
these pesticides will be significantly higher than an insecticide, such 
as spirodiclofen, which is used primarily against a single pest. For 
acute risk assessment, the highest percentages of the insecticide used 
on the specific crop without naming a specific pest, taken from USDA/
NASS Agricultiral Chemical Usage 2003 Fruit Summary was used. This 
indicates the maximum use of an insecticide. Spirodiclofen use could be 
much lower than this because its use is targeted at a single pest and 
there exist other equally efficacious pesticides, that treat mites 
only, that are priced competitively with spirodiclofen. 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 spirodiclofen 
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

[[Page 40208]]

analysis and risk assessment for spirodiclofen 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 spirodiclofen.
    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 Screening Concentrations in Groundwater (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.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
spirodiclofen (total residue including its three metabolites: 
Spirodiclofen-enol, spirodiclofen-ketohydroxy, and spirodiclofen-
dihydroxy) for acute exposures are estimated to be 22.86 parts per 
billion (ppb) for surface water and 0.44 ppb for ground water. The EECs 
for chronic (non-cancer) exposures are estimated to be 4.99 ppb for 
surface water and 0.44 ppb for ground water. The EECs for chronic 
(cancer) exposures are estimated to be 1.67 ppb for surface water and 
0.44 for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Spirodiclofen 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 spirodiclofen and any 
other substances and spirodiclofen 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 spirodiclofen 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 the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data 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 is no evidence of 
increased susceptibility following in utero and/or prenatal/postnatal 
exposure in the developmental toxicity studies in rabbits and 2-
generation reproduction studies in rats.
    In the DNT study, toxicity in the offspring (effects in the memory 
phase of the water maze test at post natal day 60 in females) was 
observed in the absence of maternal toxicity, indicating increased 
susceptibility.
    3. Conclusion. The 10X FQPA Safety Factor was retained for the use 
of LOAEL in a critical study in calculating the reference dose for 
chronic risk.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. There is no risk from acute dietary exposure, as an 
appropriate single-dose endpoint was not identified for the acute oral 
exposure of the general population, including infants and children.
    2. Chronic risk. To assess aggregate chronic risk, drinking water 
estimates were incorporated directly into the dietary analysis, rather 
than using back-calculated drinking water levels of comparison 
(DWLOCs). To better evaluate aggregate risk associated with exposure 
through food and drinking water, EPA is no longer comparing Estimated 
Drinking Water Concentration (EDWCs) generated by water quality models 
with Drinking Water Levels of Comparison (DWLOC). Instead, EPA is now 
directly incorporating the actual water quality model output 
concentrations into the risk assessment. This method of incorporating 
water concentrations into our aggregate assessments relies on actual 
CSFII-reported drinking water consumptions and more appropriately 
reflects the full distribution of drinking water concentrations. Using 
the exposure assumptions described in this unit for chronic exposure, 
the Lifeline\TM\ chronic risk estimates (including drinking water) were 
less than the Agency's level of concern at <=6.1% chronic population-
adjusted dose (cPAD); children 1-2 years old were the most highly 
exposed population. The DEEM-FCID\TM\ chronic risk estimates (including 
drinking water) were also less than the Agency's level of concern at 
<=8.0% cPAD; all infants (<1 year old) were the most highly exposed 
population. EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 3 of this unit:

[[Page 40209]]



    Table 3.-- Aggregate Risk Assessment (including water) for Chronic (Non-Cancer) Exposure to Spirodiclofen
----------------------------------------------------------------------------------------------------------------
                                                                Chronic Exposure (mg/kg/           %cPAD
                                                                          day)           -----------------------
                 Population Subgroup                  cPAD (mg/--------------------------
                                                       kg/day)     DEEM-                    DEEM-   Lifeline\TM\
                                                                 FCID\TM\   Lifeline\TM\  FCID\TM\
----------------------------------------------------------------------------------------------------------------
General U.S. population                                           0.000177     0.000092        3.7         1.4
-----------------------------------------------------          ------------                           < 1 year
-----------------------------------------------------          ------------
-----------------------------------------------------          ------------
-----------------------------------------------------          ------------
-----------------------------------------------------          ---------------------------
-----------------------------------------------------          ---------------------------
-----------------------------------------------------          ---------------------------
-----------------------------------------------------          ---------------------------
----------------------------------------------------------------------------------------------------------------

    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).
    Spirodiclofen is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Spirodiclofen is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Under the reasonable 
certainty of no harm standard, in FFDCA section 408(b)(2)(A)(ii), 
cancer risks must be no greater than negligible. EPA has consistently 
interpreted negligible cancer risks to be risks within the range of an 
increased cancer risk of 1 in 1 million. Risks as high as 3 in 1 
million have been considered to be within this risk range. To assess 
aggregate cancer risk, drinking water estimates were incorporated 
directly into the dietary analysis, as explained above in section 2 for 
chronic risk. Lifeline and DEEM are capable of combining exposure from 
food and drinking water sources for an estimate of aggregate risk from 
all dietary sources. Cancer aggregate risk was calculated for the U.S. 
population only. The Lifeline\TM\ cancer risk estimates with drinking 
water estimates included was 1.36 in 1 million. Using DEEM-FCID\TM\, 
the cancer risk estimate with drinking water was 1.59 in 1 million. 
DEEM-FCID\TM\ resulted in in a higher cancer risk estimate due to 
differing drinking water assumptions. Lifeline permits incorporation of 
the entire PRZM-EXAMS distribution when conducting a cancer analysis 
while DEEM-FCID\TM\ permits only a point estimate. The estimated cancer 
risk of 1.59 in 1 million is within the negligible risk range. The 
Agency also notes that the cancer risk estimates were generated using 
average residues derived from crop field trial studies (maximum 
application rate and minimum preharvest interval), incorporated maximum 
theoretical processing factors for juice, and incorporated surface 
drinking water estimates which assumed 87% of the basin was cropped and 
100% of the cropped area was treated at the maximum rate. EPA concludes 
that the estimated cancer risk within the range of a risk of 1 in 1 
million and therefore is negligible. A summary of aggregate cancer risk 
is given in Table 4 of this unit:

                  Table 4.--Cancer Aggregate Risk (including drinking water) for Spirodiclofen
----------------------------------------------------------------------------------------------------------------
                                                         Cancer Exposure (mg/kg/            Cancer Risk
                                                                  day)           -------------------------------
             Population Subgroup                 Q1*   --------------------------
                                                           DEEM-                   DEEM-FCID\TM\   Lifeline\TM\
                                                         FCID\TM\   Lifeline\TM\
----------------------------------------------------------------------------------------------------------------
General U.S. population\1\                      0.0149    0.000177     0.000092      1.59 x 10-6     1.36 x 10-6
----------------------------------------------------------------------------------------------------------------
\1\ differences between DEEM-FCID\TM\ and Lifeline\TM\ cancer risk estimates due to differences in the water
  estimates permitted in each program; DEEM-FCID\TM\ permits only a single point drinking water estimate when
  conducting a cancer analysis; Lifeline\TM\ permits incorporation of the entire PRZM-EXAMS distribution and
  incorporation of the SCI-GROW point estimate


[[Page 40210]]

    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to spirodiclofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    There are no Codex or Mexican maximum residue limits (MRLs) in/on 
the requested crops.

C. Conditions

    The following confirmatory data are needed:
    Toxicology. In the developmental neurotoxicity study, additional 
morphometric analyses of the caudate putamen, parietal cortex, 
hippocampal gyrus, and dentate gyrus at the mid and low doses are 
requested for both sexes.
    Residue chemistry. Apple (juice) and grape (juice) processing 
studies which monitor for residue of spirodiclofen, BAJ2510, 3-OH-enol, 
and 4-OH-enol. Default factors were used for the risk assessment, and 
these studies are needed to refine the risk.

V. Conclusion

    Therefore, the tolerance is established for residues of 
spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-
yl 2,2-dimethylbutanoate) on grape at 2.0 ppm; grape, raisin at 4.0 
ppm; grape, juice at 2.4 ppm; citrus, fruit, crop group 10 at 0.50 ppm; 
citrus, oil at 20 ppm; citrus, juice at 0.60 ppm; fruit, pome, crop 
group 11 at 0.80 ppm; apple, wet pomace at 2.0 ppm; fruit, stone, crop 
group 12 at 1.0 ppm; nut, tree, crop group 14 at 0.10 ppm; almond, 
hulls at 20 ppm; pistachio at 0.10 ppm; and for combined residues of 
spirodiclofen and its free enol metabolite BAJ 2510 in or on cattle, 
meat and cattle, fat at 0.02 ppm; cattle, meat byproducts at 0.10 ppm; 
goat, meat and goat, fat at 0.02 ppm; goat, meat byproducts at 0.10 
ppm; sheep, meat and sheep, fat at 0.02 ppm; sheep, meat byproducts at 
0.10 ppm; horse, meat and horse, fat at 0.02 ppm; horse, meat 
byproducts at 0.10 ppm; milk at 0.01 ppm, and milk, fat at 0.03 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-2005-0075 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 September 
12, 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 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0075, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to:[email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

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

[[Page 40211]]

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: June 30, 2005.
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 180.608 is added to read as follows:


Sec.  180.608  Spirodiclofen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
spirodiclofen per se (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-
3-en-4-yl 2,2-dimethylbutanoate) in or on the following plant 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        20.0
Apple, wet pomace...........................................         2.0
Citrus, juice...............................................        0.60
Citrus, oil.................................................        20.0
Fruit, citrus, crop group 10................................        0.50
Fruit, pome, crop group 11..................................        0.80
Fruit, stone, crop group 12.................................         1.0
Grape.......................................................         2.0
Grape, juice................................................         2.4
Grape, raisin...............................................         4.0
Nut, tree, crop group 14....................................        0.10
Pistachio...................................................        0.10
------------------------------------------------------------------------


    (2) Tolerances are established for residues of spirodiclofen (3-
(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate) and its free enol metabolite BAJ 2510 (3-(2,4-
dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on the 
following livestock commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, meat byproducts.....................................        0.10
Cattle, meat................................................        0.02
Goat, fat...................................................        0.02
Goat, meat byproducts.......................................         0.1
Goat, meat..................................................        0.02
Horse, fat..................................................        0.02
Horse, meat byproducts......................................         0.1
Horse, meat.................................................        0.02
Milk........................................................        0.01
Milk, fat...................................................        0.03
Sheep, fat..................................................        0.02
Sheep. meat byproducts......................................         0.1
Sheep. meat.................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 40212]]

    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 05-13774 Filed 7-12-05; 8:45 am]
BILLING CODE 6560-50-S