[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Rules and Regulations]
[Pages 21631-21641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8120]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0046; FRL-7705-1]


Spiromesifen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for: Primary crops for 
the combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-
1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents; rotational 
crops for the inadvertent or indirect combined residues of spiromesifen 
(2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate), its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), and its metabolites 
containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-
2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), calculated as the 
parent compound equivalents; and livestock commodities for the combined 
residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), and its metabolites 
containing the enol (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one) and 4-hydroxymethyl (4-hydroxy-3-[4-
(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one) 
moieties, calculated as the parent compound equivalents. 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 April 27, 2005. Objections and 
requests for hearings must be received on or before June 27, 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-2005-0046. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Thomas Harris, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9423; 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

[[Page 21632]]

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 on E-CFR Beta Site Two athttp://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 July 28, 2004 (69 FR 45047) (FRL-7366-
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 
3F6537) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR part 180 be amended 
by establishing a tolerance for the combined residues of the 
insecticide/miticide:
    1. Spiromesifen; butanoic acid, 3,3-dimethyl-, 2-oxo-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester [subsequently 
referred to as (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one)] in or on 
strawberry at 2.0 parts per million (ppm); vegetable, tuberous and 
corm, crop subgroup 1C, at 0.01 ppm (subsequently revised to 0.02 ppm); 
vegetable, leafy greens (except Brassica), crop subgroup 4A at 10 ppm 
(subsequently revised to vegetable, leafy greens, subgroup 4A at 12 
ppm); vegetable, Brassica, head and stem, crop subgroup 5A, at 2.0 ppm; 
vegetable, Brassica, leafy, crop subgroup 5B at 12 ppm; vegetable, 
fruiting, crop group 8, at 0.30 ppm; tomato, paste at 0.60 ppm; 
vegetable, cucurbit, crop group 9, at 0.10 ppm; corn, field, grain, at 
0.01 ppm (subsequently revised to 0.02 ppm); corn, field, forage, at 
3.0 ppm; corn, field, stover, at 5.0 ppm; cotton (subsequently defined 
as cotton, undelinted seed) at 0.50 ppm; and cotton, gin byproducts, at 
15 ppm.
    2. Spiromesifen; butanoic acid, 3,3-dimethyl-, 2-oxo-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester [subsequently 
referred to as (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-4-yl 3,3-dimethylbutanoate), its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), and its 
metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-
(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one)] in 
or on the rotational crop commodities alfalfa, forage, at 1.5 ppm; 
alfalfa, hay, at 3.0 ppm; wheat, grain, at 0.01 ppm (subsequently 
revised to 0.03 ppm); wheat, forage, at 0.20 ppm; wheat, hay, at 0.15 
ppm; wheat, straw, at 0.25 ppm; wheat, bran, at 0.05 ppm (subsequently 
combined with wheat, shorts and defined together as ``wheat milled 
byproducts'' with no tolerance required); wheat, shorts, at 0.03 ppm 
(subsequently combined with wheat, bran and defined together as ``wheat 
milled byproducts'' with no tolerance required); barley, grain, at 0.02 
ppm (subsequently revised to 0.03 ppm); barley, hay, at 0.25 ppm; 
barley, straw, at 0.25 ppm (subsequently revised to 0.15 ppm); beet, 
sugar, tops, at 0.20 ppm; beet, sugar, roots, at 0.02 ppm (subsequently 
revised to 0.03 ppm); and beet, sugar, molasses, at 0.05 ppm (tolerance 
subsequently not required).
    3. Spiromesifen; butanoic acid, 3,3-dimethyl-, 2-oxo-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl ester [subsequently 
referred to as 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate), and its metabolites containing the enol 
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one) and 
4-hydroxymethyl (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-
oxaspiro[4.4]non-3-en-2-one) moieties)] in or on the raw agricultural 
commodities cattle, fat, at 0.05 ppm; cattle, meat byproducts, at 0.05 
ppm; milk at 0.01 ppm (tolerance subsequently not required); and milk, 
fat, at 0.03 ppm (subsequently revised to 0.10 ppm).
    Following the review of all data, tolerances are also required for 
the following commodities: Goat, fat at 0.05 ppm; goat meat byproducts 
at 0.05 ppm; sheep, fat at 0.05 ppm; sheep, meat byproducts at 0.05 
ppm; horse, fat at 0.05 ppm; and horse, meat byproducts at 0.05 ppm.
    That notice included a summary of the petition prepared by Bayer 
CropScience, the registrant. A comment was received from a private 
citizen who challenged the value of using animal testing for evaluating 
pesticide toxicity and questioned the data gaps related to the 
tolerance proposal process. This commenter's objections have been 
addressed in prior rulemaking documents. See (69 FR 63083, 63096) 
(October 29, 2004).
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for the combined residues of 
spiromesifen on the crops and animal commodities listed above.
    EPA's assessment of exposures and risks associated with 
establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as

[[Page 21633]]

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 
spiromesifen 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
----------------------------------------------------------------------------------------------------------------
870.3050                                 28-Day oral toxicity        NOAEL was not established
                                          (mouse)                    LOAEL (M/F) = 202.6/269.6 mg/kg/day based
                                                                      on decreased body weight gain
----------------------------------------
870.3050                                 28-Day oral toxicity        NOAEL was not established
                                          (mouse)                    LOAEL (M/F) = 444.3 mg/kg/day based on
                                                                      decreased body weight gain and increase in
                                                                      alkaline phosphatase
                                                                     ...........................................
----------------------------------------
870.3100                                 28-Day oral toxicity (rat)  NOAEL = 53.4 mg/kg/day
                                                                     LOAEL = 536.3 mg/kg/day based on clinical
                                                                      signs (piloerection, reduced motility,
                                                                      spastic gait, discolored feces and
                                                                      increased reactivity when touched),
                                                                      decrease in body weight gain, and food
                                                                      consumption, hematology (thromboplastin
                                                                      time increase), clinical chemistry
                                                                      (increased aspartateaminotransferase and
                                                                      alanine aminotransferase), liver enzyme
                                                                      (increased aldrin expoxidase and epoxide
                                                                      hydrolase), increased spleen and lymph
                                                                      node cell proliferation, organ-weights
                                                                      (increase brain, heartand kidneys,
                                                                      decrease in weights in the ovaries, spleen
                                                                      and thymus), gross pathology (thin
                                                                      appearance, discolored adrenal glands and
                                                                      white mucous in the duodenum and jejunum),
                                                                      and microscopic findings (vacuolation of
                                                                      the superficial mucosal cells in the
                                                                      jejunum and duodenum, increased follicular
                                                                      cell hypertrophy in the thyroid,
                                                                      indistinct corticomedullary junction in
                                                                      the thymus and cytoplasmic changes in the
                                                                      adrenal glands)
----------------------------------------
870.3150                                 90-Day oral toxicity        NOAEL = 9.2 mg/kg/day
                                          (nonrodent)                LOAEL = 71 mg/kg/day (HDT) based on
                                                                      clinical chemistry(increased ALP) and
                                                                      liver histopathology
----------------------------------------
870.3150                                 90-Day oral toxicity        NOAEL was not established
                                          (nonrodent)                LOAEL = 98.4 mg/kg/day (HDT) based on
                                                                      increase in alkalinephosphatase and liver
                                                                      histopathology (cytoplasmic changes)
----------------------------------------
870.3150                                 90-Day oral toxicity (rat)  NOAEL (M/F) = 31.7/7.7 mg/kg/day.
                                                                     LOAEL (F) = 36.6 mg/kg/day based on thyroid
                                                                      effects (increased thyroid stimulating
                                                                      hormone, thyroxine binding capacity and
                                                                      thyroid follicular cell hypertrophy),
                                                                      kidney effects (mineralization), and liver
                                                                      effect (increased ALP)
                                                                     LOAEL (M) = 204.0 mg/kg/day based on
                                                                      thyroid effect (colloidal alteration,
                                                                      follicular cell hypertrophy, decreased T3
                                                                      and T4 and increased TBC and TSH), kidney
                                                                      effects (Hyalin droplets), and liver
                                                                      effects (increase in ALP and ALAT)
----------------------------------------
870.3200                                 21/28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day (HDT)
                                          (rat)                      LOAEL was not established
----------------------------------------
870.3465                                 5-Day inhalation toxicity   NOAEL = 20.7 mg/kg/day
                                          (rat)                      LOAEL = 134.2 mg/kg/day based onthe
                                                                      clinical signs (tremors, clonic-tonic
                                                                      convulsions, reduced activity,bradypnea,
                                                                      labored breathing,vocalization, avoidance
                                                                      reaction,giddiness, piloerection,
                                                                      limp,emaciation, cyanosis,
                                                                      squattedposture, apathy, and salivation),
                                                                      andgross pathology (dark red areas orfoci
                                                                      in the lungs, bloated stomachsand pale
                                                                      liver)
----------------------------------------
870.3465                                 30-Day inhalation toxicity  NOAEL >21.1 mg/kg/day
                                          (rat)                      LOAEL was not established
----------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 10 mg/kg/day
                                          (rat)                      Maternal LOAEL = 70 mg/kg/daybased on
                                                                      decreased body weight gainand reduced food
                                                                      consumption.
                                                                     Developmental NOAEL >= 500mg/kg/day (HDT)
                                                                     Developmental LOAEL > 500 mg/kg day
----------------------------------------
870.3700                                 Prenatal developmental      Maternal NOAEL = 5 mg/kg/day
                                          (nonrodent)                Maternal LOAEL = 35 mg/kg/day based on body
                                                                      weight loss and reduced food consumption
                                                                     Developmental NOAEL >= 250 mg/kg/day
                                                                     Developmental LOAEL > 250 mg/kg/day
----------------------------------------

[[Page 21634]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL (M/F) = 2.2/3.8 mg/
                                          effects (rat)               kg/day
                                                                     Parental/Systemic LOAEL (M/F) = 8.8/13.2 mg/
                                                                      kg/day based on significantly decreased
                                                                      spleen weight (absolute and relative in
                                                                      parental females and F1 males) and
                                                                      significantly decreased growing ovarian
                                                                      follicles in females
                                                                     Reproductive NOAEL (M/F) = 37/64 mg/kg/day
                                                                      (HDT)
                                                                     Reproductive LOAEL = Not established
                                                                     Offspring NOAEL = 2.2 mg/kg/day
                                                                     Offspring LOAEL = 8.8 mg/kg/day based on
                                                                      pup body weight decrements during
                                                                      lactation
----------------------------------------
870.4100                                 Chronic toxicity (rat)      NOAEL (M/F) = 15.9/19.3 mg/kg/day
                                                                     LOAEL (M/F) = 42.4/51.7 mg/kg/day based on
                                                                      increase in T3 hormone in males, gross
                                                                      pathology (enlarged liver in males,
                                                                      dilated uterus and discolored adrenal
                                                                      gland in females) and histopathology
                                                                      (adrenal cytoplasmic eosinophilia,
                                                                      metritise, thyroid colloidal alteration in
                                                                      female and thyroid follicular cell
                                                                      hypertrophy in both males and females)
----------------------------------------
870.4100                                 Chronic toxicity            NOAEL (M/F) = 11.5/10.8 mg/kg/day
                                          (nonrodent)                LOAEL (M/F) = 109/117 mg/kg/day based on
                                                                      increase in alkaline phosphatase and liver
                                                                      histopathology (cytoplasmic changes,
                                                                      inclusions and vacuoles)
----------------------------------------
870.4200                                 Carcinogenicity (rat)       NOAEL (M/F) = 14.8/19.5 mg/kg/day
                                                                     LOAEL (M/F) = 40.0/53.5 mg/kg/day based on
                                                                      clinical signs (palpable masses, vaginal
                                                                      bleeding and pallor), gross necropsy
                                                                      (discolored area in the lungs, nodules/
                                                                      dilation of uterus) and hispathology
                                                                      (osseus metaplasia and granulomatous
                                                                      inflammation of the lungs in the males,
                                                                      liver necrosis; endometritis/metritis,
                                                                      endometrial hyperplasia of the cervix
                                                                      uteria and colloidal alteration of the
                                                                      thyroid gland in females) and increased
                                                                      TSH in females.
                                                                     No evidence of carcinogenicity
----------------------------------------
870.4200                                 Carcinogenicity (mouse)     NOAEL (M/F) = 3.3/3.8 mg/kg/day
                                                                     LOAEL (M/F) = 22/30 mg/kg/day based on
                                                                      gross (enlarged adrenal gland in males)
                                                                      and microscopic changes (cytoplamic
                                                                      eosinophilia, ceroid deposits, and diffuse
                                                                      fatty changes of the adrenal cortex and
                                                                      pancreatic amyloidosis in both sexes)
                                                                     No evidence of carcinogenicity
----------------------------------------
870.5100                                 Gene mutation--In Vitro     Negative
                                          bacteria
----------------------------------------
870.5300                                 Cytogenetics In Vitro       Negative
                                          Mammalian Gene Mutation
----------------------------------------
870.5375                                 Cytogenetics--In Vitro      Negative
                                          Mammalian
----------------------------------------
870.5395                                 Cytogenetics In Vivo        Negative
                                          Mammalian Micronucleus
                                          (mouse)
----------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = 2,000 mg/kg/day
                                          screening battery          LOAEL = Not established
----------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL (M/F) = 31.8/38.3 mg/kg/day.
                                          screening battery          LOAEL (M/F) = 122.7/149.3 mg/kg/day based
                                                                      on decreased body weight gain and food
                                                                      consumption.
----------------------------------------
870.7485                                 Metabolism and              Spiromesifen exhibits moderate absorption
                                          pharmacokinetics (rat)      (approximately 43%), relatively rapid
                                                                      excretion primarily via the urine and
                                                                      feces. Approximately 39% of the
                                                                      administered dose was excreted in the
                                                                      urine and 55 to 57% in the feces with 88
                                                                      to 90% of the dose being eliminated within
                                                                      the first 24 hours. Maximum concentration
                                                                      in the blood achieved within 1 to 6 hours
                                                                      post- dose depending upon the dose.
                                                                      Concentrations of residual radioactivity
                                                                      in the tissues were quite low at 72 hours
                                                                      post-dose. The test material was initially
                                                                      metabolized to the keto-enol by loss of
                                                                      the dimethylbutyric acid moiety. Both the
                                                                      phenyl and cyclopentyl rings were
                                                                      hydoxylated and the methyl groups on the
                                                                      phenyl ring were ultimately oxidized to a
                                                                      carboxylic acid. These metabolites were
                                                                      largely recovered in the bile and urine.
                                                                      The predominate moiety recovered in the
                                                                      feces was the unmetabolized test material.
----------------------------------------

[[Page 21635]]

 
870.7600                                 Dermal penetration          Intravenous injection resulted in excretion
                                          (nonrodent)                 of the radiolabel mainly via urine: Urine
                                                                      (54.32%), feces (13.08%), and cage debris/
                                                                      rinse (26.57%). Excretion was rapid in
                                                                      that 70% of the dose was excreted within
                                                                      24 hours. Dermal application of
                                                                      spiromesifen resulted in limited
                                                                      absorption after 8-hour exposure (3.3%),
                                                                      which a large portion was recovered from
                                                                      urine and cage debris/rinse showing that
                                                                      it is poorly absorbed through the skin
                                                                      layers.
----------------------------------------
870.7800                                 4-Week immunotoxicity       NOAEL (M/F) = 52.8/45.7 mg/kg/day
                                          (rat)                      LOAEL (M/F) = 291.6/288.6 mg/kg/day based
                                                                      on mortality, clinical signs and decreased
                                                                      body weights, body weight gains and food
                                                                      consumption.
----------------------------------------------------------------------------------------------------------------

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 spiromesifen used for 
human risk assessment is shown in Table 2 of this unit:

    Table 2.-- Summary of Toxicological Dose and Endpoints for Spiromesifen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          1Exposure Scenario               Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment               Effect
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 years of  Not applicable           None                     An endpoint of concern
 age)                                                                                     attributable to a
                                                                                          single dose was not
                                                                                          identified. An aRfD
                                                                                          was not established.
--------------------------------------
Acute dietary (general population)
--------------------------------------

[[Page 21636]]

 
Chronic dietary (all populations)      NOAEL= 2.2 mg/kg/day     Special FQPA SF = 1X     2-generation
                                       UF = 100X..............  .......................   reproduction study in
                                       Chronic RfD = 0.022 mg/  .......................   rats.
                                        kg/day.                 .......................  The parental systemic
                                                                                         LOAEL:
                                                                                         13.2 mg/kg/day based on
                                                                                          significantly
                                                                                          decreased spleen
                                                                                          weight (absolute and
                                                                                          relative in parental
                                                                                          females and F1 males)
                                                                                          and significantly
                                                                                          decreased growing
                                                                                          ovarian follicles in
                                                                                          females.
--------------------------------------
Cancer (oral, dermal, inhalation)             Classification: ``Not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
previously been established for spiromesifen. Risk assessments were 
conducted by EPA to assess dietary exposures from spiromesifen 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. Acute dietary exposure limits for all populations, 
including infants and children, were not performed because an endpoint 
of concern attributable to a single exposure (dose) was not identified 
from the oral toxicity studies.
    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\) and the Lifeline\TM\ 
model version 2.0, which incorporates food consumption data as reported 
by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII), and accumulated exposure 
to the chemical for each commodity. Percent crop treated and 
anticipated residues were not used.
    An unrefined, Tier 1 chronic dietary exposure assessment was 
conducted using the following:
    a. Recommended tolerances for all plant and livestock except the 
leafy-green and leafy-Brassica vegetable subgroups;
    b. EPA calculated residues of concern (parent and metabolites) for 
the leafy-green and leafy-Brassica vegetable subgroups;
    c. 100% crop treated (CT) information for all proposed uses; and
    d. Default processing factors for all commodities.
The metabolism studies show that the hydroxymethyl metabolite is formed 
along with the enol metabolite in the leafy-green and leafy-Brassica 
vegetable subgroups. EPA determined that these two metabolites along 
with the spiromesifen should be included in the chronic dietary risk 
assessment for these crops. Residue data are unavailable for the 4-
hydroxymethyl metabolite; to account for this metabolite in the risk 
assessment, the recommended tolerance levels for these crops was 
multiplied by a correction factor of 1.3x, where:
    1.3 = Metabolites in Risk Assessment (ppm)/Metabolites in Tolerance 
Expression (ppm).
    The dietary-exposure assessment was conducted for the general U.S. 
population and various population subgroups. This assessment concludes 
that the chronic dietary exposure estimates are below EPA's level of 
concern (<100% cPAD) for the general U.S. population (27% cPAD and 29% 
cPAD, based on the Lifeline\TM\ and DEEM-FCID\TM\ analyses, 
respectively) and all population subgroups. Both Lifeline\TM\ and DEEM-
FCID\TM\ estimate that children 3 to 5 years old are the most highly-
exposed subpopulation with risks of 30% cPAD and 37% cPAD, 
respectively.
    iii. Cancer. A cancer exposure assessment was not performed because 
spiromesifen is classified as ``not likely to be carcinogenic to 
humans.''
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for spiromesifen 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 spiromesifen.
    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.
    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

[[Page 21637]]

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 spiromesifen they are further discussed in 
the aggregate risk sections in Unit E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
spiromesifen for acute exposures are estimated to be 7.1 parts per 
billion (ppb) for surface water and 0.005 ppb for ground water. The 
EECs for chronic exposures are estimated to be 0.70 ppb for surface 
water and 0.005 ppb for ground water.
    EECs of spiromesifen and its metabolites for acute exposures are 
estimated to be 26 ppb for surface water and 28 ppb for ground water. 
The EECs for chronic exposures are estimated to be 11 ppb for surface 
water and 28 ppb 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).
    Spiromesifen 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 the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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 spiromesifen and any other 
substances and spiromesifen 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 spiromesifen 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 website 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 was no evidence of 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to spiromesifen. In a rat developmental toxicity 
study, no developmental toxicity was observed at doses up to 500 mg/kg/
day (the highest dose tested) in the presence of maternal toxicity. The 
rat maternal LOAEL was determined to be 70 mg/kg/day based on decreased 
body-weight gain and reduced food consumption. In the rabbit 
developmental toxicity study, there was no developmental toxicity 
observed at doses up to 250 mg/kg/day (the highest dose tested), but 
the maternal LOAEL was determined to be 35 mg/kg/day based on body 
weight loss and reduced food consumption. There is no qualitative and/
or quantitative evidence of increased susceptibility to spiromesifen 
following pre/postnatal exposure in a 2-generation reproduction study 
in rats.
    There is no concern for developmental neurotoxicity resulting from 
exposure to spiromesifen. Neurotoxic effects such as reduced motility, 
spastic gait, increased reactivity, tremors, clonic-tonic convulsions, 
reduced activity, labored breathing, vocalization, avoidance reaction, 
piloerection, limp, cyanosis, squatted posture, and salivation were 
observed in two studies (5-day inhalation and subchronic oral rat). 
However, these effects were considered as secondary, not neurotoxic, 
effects due to the high dosage. There was no evidence of neurotoxicity 
in the acute or subchronic neurotoxicity or any other studies.
    3. Conclusion. For spiromesifen, EPA determined that the 10X safety 
factor to protect infants and children should be removed. A 1X safety 
factor is appropriate because:
     There is a complete toxicity data base for spiromesifen.
     There is no evidence of increased susceptibility of rats 
or rabbits to in utero and/or postnatal exposure to spiromesifen. In 
the prenatal developmental toxicity studies in rats and rabbits and in 
the 2-generation reproduction study in rats, developmental toxicity to 
the offspring occurred at equivalent or higher doses than maternal 
toxicity.
     There are no neurotoxicity concerns based on acute and 
subchronic neurotoxicity studies.
     The dietary food exposure assessment uses proposed 
tolerance levels or higher residues and assumed 100% crop-treated (CT) 
information for all commodities. By using these screening-level 
assessments, chronic exposures and risks will not be underestimated. 
The ``higher residues'' are those that were calculated using a 
modifying factor to account for the lack of spiromesifen-4-
hydroxymethyl residue data.
     The dietary drinking water assessment (Tier 2 estimates) 
uses values generated by model and associated modeling parameters which 
are designed to provide conservative, health protective, and high-end 
estimates of water concentrations.
     Residential exposure is not expected--spiromesifen will be 
registered for agricultural and greenhouse/ornamental uses only.

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

[[Page 21638]]

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, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Spiromesifen is not expected to pose an acute risk 
because an endpoint of concern attributable to a single exposure (dose) 
was not identified from the oral toxicity studies.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure and the EECs from DEEM-FCID\TM\ as these were 
slightly higher, and thus are more conservative, than the Lifeline\TM\ 
estimates, EPA has concluded that exposure to spiromesifen from food 
will utilize 29% of the cPAD for the U.S. population, 15% of the cPAD 
for all infants less than 1 year old, and 37% of the cPAD for children 
3-5 years old. There are no residential uses for spiromesifen that 
result in chronic residential exposure to spiromesifen. There is no 
concern regarding spiromesifen in ground water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface water 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 Spiromesifen + Metabolites
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day       (Food)\1\      (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        0.022           29           11           28          545
------------------------------------------------
All Infants (<1 year old)                              0.022           15           11           28          187
------------------------------------------------
Children (1-2 years old)                               0.022           35           11           28          142
------------------------------------------------
Children (3-5 years old)                               0.002           37           11           28          138
------------------------------------------------
Children (6-12 years old)                              0.022           30           11           28          155
------------------------------------------------
Youth (13-19 years old)                                0.022           25           11           28          492
------------------------------------------------
Adults (20-49 years old)                               0.022           29           11           28          544
------------------------------------------------
Adults (50 + years old)                                0.022           29           11           28          470
------------------------------------------------
Females (13-49 years old)                              0.022           30           11           28         539
----------------------------------------------------------------------------------------------------------------
1Based on exposure estimates from DEEM-FCID

    3. Spiromesifen 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. Spiromesifen 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. Spiromesifen is not 
expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical enforcement methodologies, liquid 
chromatography LC)/mass spectrometry (MS)/MS, exist and have been 
successfully validated by independent laboratories.

B. International Residue Limits

    There are no international residue limits for spiromesifen listed 
in CODEX.

V. Conclusion

    Therefore, the tolerance is established for:
    1. Primary crops for the combined residues of spiromesifen (2-oxo-
3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as the 
parent compound equivalents in or on strawberries at 2.0 parts per 
million (ppm); vegetable, tuberous and corm, subgroup 1C at 0.02 ppm; 
vegetable, leafy greens, subgroup 4A at 12 ppm; vegetable, Brassica, 
head and stem, subgroup 5A at 2.0 ppm; vegetable, Brassica, leafy 
greens, subgroup 5B at 12 ppm; vegetable, fruiting, group 8 at 0.30 
ppm; tomato, paste at 0.60 ppm; vegetable, cucurbit, group 9 at 0.10 
ppm; corn, field, grain at 0.02 ppm; corn, field, forage at 3.0 ppm; 
corn, field, stover at 5.0 ppm; cotton,

[[Page 21639]]

undelinted seed at 0.50 ppm; and cotton, gin byproducts at 15 ppm.
    2. Rotational crops for the inadvertent or indirect combined 
residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), its enol metabolite 
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), 
and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-
[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), 
calculated as the parent compound equivalents in or on alfalfa, forage 
at 1.5 ppm; alfalfa, hay at 3.0 ppm; wheat, grain at 0.03 ppm; wheat, 
forage at 0.20 ppm; wheat, hay at 0.15 ppm; wheat, straw at 0.25 ppm; 
barley, grain at 0.03 ppm; barley, hay at 0.25 ppm; barley, straw at 
0.15 ppm; beet, sugar, tops at 0.20 ppm; and beet, sugar, roots at 0.03 
ppm.
    3. Livestock commodities for the combined residues of spiromesifen 
(2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate), and its metabolites containing the enol (4-hydroxy-
3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one) and 4-
hydroxymethyl (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-
oxaspiro[4.4]non-3-en-2-one) moieties, calculated as the parent 
compound equivalents in or on cattle, fat at 0.05 ppm; cattle, meat 
byproducts at 0.05 ppm; milk, fat at 0.10 ppm; goat, fat at 0.05 ppm; 
goat, meat byproducts at 0.05 ppm; sheep, fat at 0.05 ppm; sheep, meat 
byproducts at 0.05 ppm; horse, fat at 0.05 ppm; and horse, meat 
byproducts at 0.05 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0046 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 June 27, 
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-2005-0046, 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 
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

[[Page 21640]]

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: April 14, 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 180.607 is added to read as follows:


Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents in or on the 
following primary crop commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................         0.02
Corn, field, grain.........................................          3.0
Corn, field, stover........................................          5.0
Cotton, gin byproducts.....................................           15
Cotton, undelinted seed....................................         0.50
Strawberry.................................................          2.0
Tomato, paste..............................................         0.60
Vegetable, brassica, head and stem, subgroup 5A............          2.0
Vegetable, brassica, leafy greens, subgroup 5B.............           12
Vegetable, cucurbit, group 9...............................         0.10
Vegetable, fruiting, group 8...............................         0.30
Vegetable, leafy greens, subgroup 4A.......................           12
Vegetable, tuberous and corm, subgroup 1C..................         0.02
------------------------------------------------------------------------

    (2) Tolerances are established for the inadvertent or indirect 
combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1- 
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), its enol metabolite 
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), 
and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-
[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), 
calculated as the parent compound equivalents in the following 
rotational crop commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................          1.5
Alfalfa, hay...............................................          3.0
Barley, grain..............................................         0.03
Barley, hay................................................         0.25
Barley, straw..............................................         0.15
Beet, sugar, roots.........................................         0.20
Beet, sugar, tops..........................................         0.03
Wheat, forage..............................................         0.03
Wheat, grain...............................................         0.20
Wheat, hay.................................................         0.15
Wheat, straw...............................................         0.25
------------------------------------------------------------------------

    (3) Tolerances are established for the combined residues of 
spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate), and its metabolites containing the enol 
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one) and 
4-hydroxymethyl (4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-
oxaspiro[4.4]non-3-en-2-one) moieties, calculated as the parent 
compound equivalents in the following livestock commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.05
Cattle, meat byproducts....................................         0.05
Goat, fat..................................................         0.05
Goat, meat byproducts......................................         0.05
Horse, fat.................................................         0.05
Horse, meat byproducts.....................................         0.05
Milk, fat..................................................         0.10
Sheep, fat.................................................         0.05

[[Page 21641]]

 
Sheep, meat byproducts.....................................         0.05
------------------------------------------------------------------------

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

[FR Doc. 05-8120 Filed 4-26-05; 8:45 am]
BILLING CODE 6560-50-S