[Federal Register Volume 69, Number 136 (Friday, July 16, 2004)]
[Rules and Regulations]
[Pages 42560-42571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16216]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0120; FRL-7367-1]


Spiroxamine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of spiroxamine in or on grape, banana, and hop, dried cones. Bayer 
CropScience and the Interregional Research Project Number 4 (IR-4), 
respectively, 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 16, 2004. Objections and 
requests for hearings must be received on or before September 14, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0120. All documents in the docket are listed in the 
EDOCKET index athttp://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. 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: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number:

[[Page 42561]]

(703) 305-7610; 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. 
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. 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. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

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

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at  http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of March 7, 2003 (68 FR 11088) (FRL-7290-
5), and December 10, 2003 (68 FR 68904) (FRL-7337-6), EPA issued 
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 0F6122, 3E6538, and 
3E6783) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709, and (PP 3E6518) by IR-4, 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390, respectively. 
These notices included a summary of the petitions prepared by Bayer 
CropScience, the registrant. There were no comments received in 
response to the notice of filing.
    The petitions requested that 40 CFR part 180 be amended by 
establishing tolerances for combined residues of the fungicide 
spiroxamine, 8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-
dioxaspiro[4,5]decane-2-methanamine, and its metabolites containing the 
N-ethyl-N-propyl-1,2-dihydroxy-3-aminopropane moiety (formerly known as 
the aminodiol moiety), in or on grape at 1.0 parts per million (ppm), 
and grape, raisin at 1.3 ppm (PP 0F6122); banana at 3.0 ppm (3E6538); 
hop, dried cones (import) at 50 ppm (3E6783); and hop (United States) 
at 11 ppm (3E6518). Subsequently, PP 0F6122 has been amended to delete 
grape, raisin at 1.3 ppm, and PP 3E6518 has been amended to increase 
the tolerance level for ``hop at 11 ppm'' to ``hop, dried cones at 50 
ppm.''
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
these actions. 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 import tolerances for combined residues of 
spiroxamine on grape at 1.0 ppm, banana at 3.0 ppm, and hop, dried 
cones at 50 ppm (import and U.S. grown). EPA's assessment of exposures 
and risks associated with establishing these tolerances follow.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by spiroxamine is 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.
    Subchronic studies show the target organ of spiroxamine toxicity is 
the liver. Subchronic studies were characterized by slight to mild 
hepatotoxicity, with associated elevation in liver enzymes. Mucous 
membranes of the esophagus and forestomach were keratinized and 
hyperplastic due to the strong irritant properties of spiroxamine. 
Long-term administration of spiroxamine in the dog resulted in 
hepatocytomegaly, cataracts, and liver discoloration. In the rat, it 
resulted in an increased mortality in females, decreased body weights 
and body weight gains in both sexes, and increased esophageal 
hyperkeratosis in both sexes, while in the mouse, chronic 
administration resulted in uterine nodules, hyperplasia in the adrenal 
gland of males, hyperkeratosis in the esophagus, forestomach, and 
tongue of females, and acanthosis in the pinnae and tails of females. 
In rats, developmental effects entailed delayed ossification. 
Developmental effects were not seen in rabbits. There was no evidence 
of increased susceptibility of the young animals following exposure to 
spiroxamine in any developmental toxicity studies in the data base. 
There was evidence of mild spiroxamine-induced neurotoxicity 
characterized by

[[Page 42562]]

piloerection and slight to moderate gait incoordination, and functional 
observational battery (FOB) effects of decreased forelimb grip strength 
and foot splay in males in the acute neurotoxicity study. No 
neuropathology was seen in either the acute or subchronic toxicity 
studies in rats and no neurotoxicity was detected in the subchronic 
study. Spiroxamine has no carcinogenic potential, as indicated in both 
the rat and the mouse carcinogenicity studies. In addition, spiroxamine 
has no mutagenicity potential, based on several in vivo and in vitro 
studies.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = M: 9.3, F:
                                   toxicity--rodents   13.2 mg/kg/day
                                   (rats) active      LOAEL = M: 54.9,
                                   ingredient (a.i.)   F: 75.1 mg/kg/day
                                                       based on
                                                       decreased body
                                                       weights and body
                                                       weight gains in
                                                       both sexes,
                                                       hyperkeratosis
                                                       and hyperplasia/
                                                       hypertrophy in
                                                       the esophagus of
                                                       both sexes and
                                                       hyperkeratosis in
                                                       the forestomach
                                                       of males. Minimal
                                                       to marked
                                                       hyperkeratosis in
                                                       the tongue of
                                                       both sexes.
                                                       Slight multifocal
                                                       hyperplasia in
                                                       the urinary
                                                       bladder of both
                                                       sexes. Minimal to
                                                       slight hyaline
                                                       droplet
                                                       degeneration in
                                                       the liver in
                                                       males.
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = M: 8.8, F:
                                   toxicity rodents    9.7 mg/kg/day
                                   (rats)             LOAEL = M: 45.0,
                                  Metabolite KWG       F: 53.6 mg/kg/day
                                   4168 N-oxide.       based on
                                                       hyperkeratosis in
                                                       the esophagus and
                                                       forestomach
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = M: 16.19,
                                   toxicity--          F: 15.05 mg/kg/
                                   nonrodents (dogs)   day
                                                      LOAEL = M: 20.02,
                                                       F: 21.29 mg/kg/
                                                       day based on
                                                       decreased albumin
                                                       in females,
                                                       increased
                                                       absolute and
                                                       relative liver
                                                       weights in males,
                                                       and increased
                                                       diffuse
                                                       hepatocytomegaly
                                                       in males
------------------------------------------------------------------------
870.3200                          21/28-Day dermal    NOAEL = 0.2 mg/kg/
                                   toxicity (rabbit)   day
                                                      LOAEL = 0.5 mg/kg/
                                                       day based on
                                                       erythema at the
                                                       application site
------------------------------------------------------------------------
870.3465                          28-Day inhalation   NOAEL = 23.6 mg/kg/
                                   toxicity (rats)     day (0.087 mg/L)
                                                      LOAEL = 140.5 mg/
                                                       kg/day (0.518 mg/
                                                       L) based on
                                                       decreased body
                                                       weights and body
                                                       weight gains,
                                                       increased
                                                       incidences of
                                                       clinical signs of
                                                       toxicity and
                                                       dermal
                                                       irritation,
                                                       thymic atrophy,
                                                       and toxicity to
                                                       the skin,
                                                       respiratory
                                                       system, and liver
------------------------------------------------------------------------
870.3700                          Prenatal (oral)     Maternal
                                   developmental-     NOAEL = 30 mg/kg/
                                   rodents (rats)      day
                                                      LOAEL = 100 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weights, body
                                                       weight gains, and
                                                       food consumption
                                                      Developmental
                                                      NOAEL = 30 mg/kg/
                                                       day
                                                      LOAEL = 100 mg/kg/
                                                       day based on
                                                       increased
                                                       incidence of
                                                       delayed skeletal
                                                       development
                                                       (incomplete
                                                       ossification) of
                                                       the os
                                                       interparietal
                                                       (fetal and litter
                                                       incidences) and
                                                       os parietale
                                                       (fetal
                                                       incidences)
------------------------------------------------------------------------

[[Page 42563]]

 
870.3700                          Prenatal (dermal)   Maternal
                                   developmental--     (Systemic)
                                   rodents (rats)     NOAEL = 5 mg/kg/
                                                       day
                                                      LOAEL = 10 mg/kg/
                                                       day based on
                                                       decreased body
                                                       weight gains
                                                      Maternal (Dermal)
                                                      NOAEL = less than
                                                       5 mg/kg/day
                                                      LOAEL (Dermal) = 5
                                                       mg/kg/day based
                                                       on very slight
                                                       erythema and/or
                                                       slight scaling of
                                                       skin
                                                      Developmental
                                                      NOAEL = 20 mg/kg/
                                                       day
                                                      LOAEL = 80 mg/kg/
                                                       day based on the
                                                       increased fetal
                                                       and litter
                                                       incidence of
                                                       incomplete/non-
                                                       ossification of
                                                       the os occipital
                                                       and the increased
                                                       non-ossification
                                                       of the left
                                                       distal phalanx of
                                                       digit number 4 of
                                                       the forelimb
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal
                                   developmental in   NOAEL = 20 mg/kg/
                                   nonrodents          day
                                   (rabbits)          LOAEL = 80 mg/kg/
                                                       day based on
                                                       mortality,
                                                       clinical signs of
                                                       toxicity
                                                       (encrusted mouth,
                                                       anal prolapse,
                                                       and little/soft
                                                       feces), decreased
                                                       body weight
                                                       gains, and
                                                       decreased food
                                                       consumption
                                                      Developmental
                                                      NOAEL = 80 mg/kg/
                                                       day
                                                      LOAEL: Not
                                                       Achieved
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects  NOAEL = M: 2.5, F:
                                   (rats)              2.7 mg/kg/day
                                                      LOAEL = M: 10.8,
                                                       F: 11.9 mg/kg/day
                                                       based on
                                                       decreased food
                                                       consumption
                                                       during lactation
                                                       and on increased
                                                       incidences of
                                                       esophageal
                                                       hyperkeratosis in
                                                       females
                                                      Reproductive
                                                      NOAEL = M: 44.8,
                                                       F: 48.8 mg/kg/day
                                                      LOAEL = Not
                                                       achieved
                                                      Offspring
                                                      NOAEL = M: 10.8,
                                                       F: 11.9 mg/kg/day
                                                      LOAEL = M: 44.8,
                                                       F: 48.8 mg/kg/day
                                                       based on
                                                       decreased litter
                                                       size and pup
                                                       weight and
                                                       increased
                                                       clinical signs of
                                                       toxicity in the
                                                       F1 generation
------------------------------------------------------------------------
870.4100                          Chronic toxicity--  NOAEL = M: 2.47,
                                   dogs                F: 2.48 mg/kg/day
                                                      LOAEL = M: 28.03,
                                                       F: 25.84 mg/kg/
                                                       day based on
                                                       hepato/
                                                       cytomegaly,
                                                       cataracts, and
                                                       decreased albumin
                                                       in males and
                                                       females; liver
                                                       discoloration and
                                                       decreased
                                                       triglycerides in
                                                       females; and
                                                       increased alanine
                                                       aminotransferase
                                                       in males
------------------------------------------------------------------------
870.4200                          Carcinogenicity--   NOAEL = M: 4.22,
                                   rats                F: 5.67 mg/kg/day
                                                      LOAEL = M: 32.81,
                                                       F: 43.04 mg/kg/
                                                       day based on
                                                       increased
                                                       mortality in
                                                       females,
                                                       decreased body
                                                       weights and body
                                                       weight gains in
                                                       both sexes, and
                                                       increased
                                                       esophageal
                                                       lesions in both
                                                       sexes
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.4300                          Carcinogenicity--   NOAEL = M: 41.0,
                                   mice                F: 64.6 mg/kg/day
                                                      LOAEL = M: 149.8,
                                                       F: 248.1 mg/kg/
                                                       day based on
                                                       uterine nodules,
                                                       hyperplasia in
                                                       the adrenal gland
                                                       of males,
                                                       hyperkeratosis in
                                                       the esophagus,
                                                       forestomach, and
                                                       tongue of
                                                       females, and
                                                       acanthosis in the
                                                       pinnae and tails
                                                       of females
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.5100                          Gene mutation       Negative, S9 up to
                                                       cytotoxic 1,000
                                                       [mu]g/plate
------------------------------------------------------------------------

[[Page 42564]]

 
870.5395                          Cytogenetics        Negative, at
                                                       clinically toxic
                                                       i.p. dose
------------------------------------------------------------------------
870.5300                          Mammalian cells in  Negative, S9 up to
                                                       cytotoxic/
                                                       precipitation 200
                                                       [mu]g/mL
------------------------------------------------------------------------
870.5375                          Chromosome          Negative, S9 up to
                                                       cytotoxic doses
------------------------------------------------------------------------
870.5550                          Unscheduled DNA     Negative, S9 up to
                                                       severe
                                                       cytotoxicity
------------------------------------------------------------------------
870.6200                          Acute               NOAEL = 10 mg/kg
                                   neurotoxicity      LOAEL = 30 mg/kg
                                   screening battery   based on clinical
                                                       signs
                                                       (piloerection and
                                                       slight to
                                                       moderate gait
                                                       incoordination)
                                                       and FOB effects
                                                       (decreased
                                                       forelimb grip
                                                       strength and foot
                                                       splay) in males
------------------------------------------------------------------------
870.6200                          Subchronic          NOAEL = M: 2.4, F:
                                   neurotoxicity       2.5 mg/kg/day
                                   screening battery  LOAEL = M: 10.6,
                                                       F: 11.1 mg/kg/day
                                                       based on
                                                       decreased
                                                       bodyweight gain,
                                                       food consumption
                                                       (males), and
                                                       hyperkeratosis in
                                                       the stomach,
                                                       esophagus, and
                                                       tongue
------------------------------------------------------------------------
870.7485                          Metabolism and      Absorption was at
                                   pharmacokinetics    least 60-70% and
                                   (rats)              began immediately
                                                       after
                                                       administration
                                                       with peak plasma
                                                       concentrations at
                                                       1.5-2 hours post-
                                                       dose at 1 mg/kg,
                                                       and delayed to 8
                                                       hours at 100 mg/
                                                       kg. More than 97%
                                                       of the recovered
                                                       radioactivity was
                                                       excreted via
                                                       urine and feces
                                                       within 48 hours
                                                       in all dose
                                                       groups and more
                                                       than 80% within
                                                       24 hours. Renal
                                                       excretion
                                                       accounted for the
                                                       majority of the
                                                       radioactivity
                                                       (1.8:1
                                                       urine:feces on
                                                       average).
------------------------------------------------------------------------
870.7600                          Dermal penetration  Dermal absorption
                                   (rats)              factor: 52.5% at
                                                       8 hours
------------------------------------------------------------------------

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 data base 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

[[Page 42565]]

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.

     Table 2.--Summary of Toxicological Dose and Endpoints for Spiroxamine for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 10 mg/kg/day     Special FQPA SF = 1X     Acute neurotoxicity in
 including infants and children)       UF = 100...............  aPAD = acute RfD/         rats
                                       Acute RfD = 0.1 mg/kg/    Special FQPA SF = 0.1   LOAEL = 30 mg/kg/day
                                        day.                     mg/kg/day.               based on clinical
                                                                                          signs (piloerection
                                                                                          and slight to moderate
                                                                                          gait incoordination)
                                                                                          and FOB effects
                                                                                          (decreased forelimb
                                                                                          grip strength and foot
                                                                                          splay) in males on day
                                                                                          0-1
-----------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 2.5 mg/kg/day    Special FQPA SF = 1X     Chronic oral toxicity
                                       UF = 300...............  cPAD = chronic RfD/       study in dogs
                                       Chronic RfD = 0.0083 mg/  Special FQPA SF =       LOAEL = 28.03/25.84 mg/
                                        kg/day.                  0.0083 mg/kg/day.        kg/day M/F based on
                                                                                          hepatocytomegaly,
                                                                                          cataracts, and
                                                                                          decreased albumin in
                                                                                          males and females;
                                                                                          liver discoloration
                                                                                          and decreased
                                                                                          triglycerides in
                                                                                          females; and increased
                                                                                          alanine
                                                                                          aminotransferase in
                                                                                          males
-----------------------------------------------------------------------------------------
Dermal exposure: Short- and            Dermal (or oral) study   Residential LOC for MOE  Prenatal toxicity study
 intermediate-term (Residential)        NOAEL= 5 mg/kg/day       = N/A                    in rats (Dermal) the
                                                                                          maternal LOAEL
                                                                                          (systemic) = 20 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight gains
-----------------------------------------------------------------------------------------
Dermal exposure: Long-term             Oral study NOAEL = 2.5   Residential LOC for MOE  Chronic oral toxicity
 (Residential)                          mg/kg/day (dermal        = N/A                    in dogs
                                        absorption rate = 53%)                           LOAEL = 28.03/25.84 mg/
                                                                                          kg/day (M/F) based on
                                                                                          hepatocytomegaly,
                                                                                          cataracts, and
                                                                                          decreased albumin in
                                                                                          males and females;
                                                                                          liver discoloration
                                                                                          and decreased
                                                                                          triglycerides in
                                                                                          females; and increased
                                                                                          alanine
                                                                                          aminotransferase in
                                                                                          males
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days)   Inhalation study NOAEL   Residential LOC for MOE  28-Day inhalation
 (Residential)                          = 0.087 mg/L = 23.6 mg/  = N/A                    toxicity study in rats
                                        kg/day                                           LOAEL = 0.518 mg/L =
                                                                                          140.5 mg/kg/day based
                                                                                          on decreased body
                                                                                          weights and body
                                                                                          weight gains,
                                                                                          increased incidences
                                                                                          of clinical signs of
                                                                                          toxicity and dermal
                                                                                          irritation, thymic
                                                                                          atrophy, and toxicity
                                                                                          to the skin,
                                                                                          respiratory system,
                                                                                          and liver
-----------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6      Inhalation NOAEL =       Residential LOC for MOE  Subchronic inhalation
 months) (Residential)                  0.087 mg/L = 23.6 mg/    = N/A                    toxicity study in rats
                                        kg/day                                           LOAEL = 0.518 mg/L =
                                                                                          140.5 mg/kg/day based
                                                                                          on decreased body
                                                                                          weights and body
                                                                                          weight gains,
                                                                                          increased incidences
                                                                                          of clinical signs of
                                                                                          toxicity and dermal
                                                                                          irritation, thymic
                                                                                          atrophy, and toxicity
                                                                                          to the skin,
                                                                                          respiratory system,
                                                                                          and liver
-----------------------------------------------------------------------------------------

[[Page 42566]]

 
Long-term inhalation (greater than 6   Oral study NOAEL = 2.5   Residential LOC for MOE  Chronic oral toxicity
 months) (Residential)                  mg/kg/day (inhalation    = N/A                    study in dogs
                                        absorption rate =                                LOAEL = 28.03/25.84 mg/
                                        100%)                                             kg/day M/F based on
                                                                                          hepatocytomegaly,
                                                                                          cataracts, and
                                                                                          decreased albumin in
                                                                                          males and females;
                                                                                          liver discoloration
                                                                                          and decreased
                                                                                          triglycerides in
                                                                                          females; and increased
                                                                                          alanine
                                                                                          aminotransferase in
                                                                                          males
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Spiroxamine is a new 
chemical and therefore, these are the first tolerances to be 
established for the residues of spiroxamine. Tolerance level residues, 
average residues from field trial data, the concentration/reduction 
factors from processing studies, and 100% crop treated information were 
used. Partially refined acute and chronic dietary risk assessments for 
spiroxamine were conducted using the Dietary Exposure Evaluation Model 
(DEEM-FCID, Version 1.33), which uses food consumption data from the 
U.S. Department of Agriculture (USDA) Continuing Surveys of Food 
Intakes by Individuals (CSFII) from 1994-1996 and 1998. Risk 
assessments were conducted by EPA to assess dietary exposures from 
spiroxamine in food as follows:
    i. Acute exposure. The acute assessment was a partially refined 
deterministic assessment. Tolerances were used for the nonblended and 
partially blended raw agricultural commodities (3.0 ppm for bananas and 
1.0 ppm for grapes). For the processed commodities of grapes, the 
highest average field trial (HAFT) value of 0.613 ppm was used as the 
residue value, which was computer-multiplied by the processing factors 
(adjustment factors 1) of 0.67x for grape juice and 1.3x for 
raisins. For the blended commodity hops, the average residue value from 
the field trials for imported hops (16 ppm) was used. Data on projected 
market share or percent crop treated were not used.
    ii. Chronic exposure. The chronic assessment was a partially 
refined deterministic assessment. Average residue values from the field 
trials were used for bananas, grapes, and hops (1.13 ppm for unbagged 
bananas, 0.17 ppm for grapes, and 16 ppm for imported hops.) The 
tolerance level for grapes (1.0 ppm) was used for grape leaves and 
wine. For the processed commodities of grapes other than wine, the 
average value of 0.17 ppm was used as the residue value, which was 
computer-multiplied by the processing factors (adjustment factors 
1) of 0.67x for grape juice and 1.3x for raisins. Data on 
projected market share or percent crop treated were not used.
    iii. Cancer. Spiroxamine has been classified as not likely to be 
carcinogenic to humans. Therefore, a quantitative risk assessment was 
not conducted to assess cancer risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for spiroxamine 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 spiroxamine.
    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 Concentration 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 (DWLOC) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to spiroxamine they are 
further discussed in the aggregate risk section.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
spiroxamine for acute and chronic exposures are estimated to be 17.8 
parts per billion (ppb), and 14 ppb, respectively for surface water. 
The EEC of spiroxamine for acute and chronic exposures is 0.27 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,

[[Page 42567]]

indoor pest control, termiticides, and flea and tick control on pets).
    Spiroxamine 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 spiroxamine and any other 
substances and spiroxamine 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 spiroxamine has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs (OPP) concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the 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 for 
quantitative or qualitative susceptibility following oral or dermal 
exposures to rats in utero or oral exposure to rabbits in utero.
    There is no concern for neurotoxicity resulting from exposure to 
spiroxamine.
    3. Conclusion. The toxicology and exposure data bases for 
spiroxamine are complete with the exception of certain confirmatory or 
clarifying studies. The toxicity data base contains acceptable/
guideline acute and subchronic neurotoxicity studies; two acceptable/
guideline developmental toxicity studies in rats (oral and dermal), and 
rabbits (oral); and an acceptable/nonguideline 2-generation rat 
reproduction study. The 2-generation rat reproduction study is 
classified as acceptable/nonguideline because of questions concerning 
the increased lactation indices and clinical signs of toxicity in the 
second generation. There are enough data to satisfy the requirements 
for a 1-generation reproduction study and the study is acceptable and 
potentially upgradable to an Acceptable/Guideline study (2-generation 
reproduction) upon submission of clarifying data regarding the 
lactation indices and clinical signs of toxicity in the second 
generation.
    In the acute neurotoxicity study in the rat, there was evidence of 
mild spiroxamine-induced neurotoxicity characterized by piloerection 
and slight to moderate gait in coordination, and FOB effects of 
decreased forelimb grip strength and foot splay in males at a dose 
level of 30 mg/kg/day. In subchronic neurotoxicity studies in the rat, 
clinical signs, FOB, motor activity, brain weight, ophthalmology, gross 
necropsy, and neuropathology were unaffected by treatment. Treatment-
related effects at 155 ppm (10.6 mg/kg/day) were limited to 
hyperkeratosis of the esophagus in one male and one female. No 
treatment-related effects were observed at 35 ppm (2.4 mg/kg/day).
    In rat prenatal toxicity studies - oral, developmental toxicity 
showed no effects of treatment on maternal survival or clinical signs. 
There were no abortions, premature deliveries, or complete litter 
resorptions. Similarly, there were no effects of treatment on the 
number of resorptions (early or late), number of fetuses (live or 
dead), post-implantation loss, or fetal sex ratio. There were no 
treatment-related external, visceral, or skeletal variations.
    Rat prenatal toxicity studies - dermal, showed there were no 
effects of treatment on maternal survival, clinical signs, food 
consumption, or gross pathologly.
    In rabbit prenatal toxicity study, there were no effects of 
treatment on maternal gross pathology or the number of resorptions 
(early, late, or complete litter), number of fetuses (live or dead), 
number of litters, post-implantation loss, fetal weights, or sex ratio. 
There were no treatment-related external or skeletal variations.
    4. Degree of concern analysis and residual uncertainties. There are 
no concerns for residual uncertainty for prenatal toxicity in the 
available developmental studies. However, until clarifying data are 
provided on the 2-generation rat reproduction study, there is some 
uncertainty with regard to postnatal toxicity.
    A 3X (as opposed to 10X) FQPA data base uncertainty factor was 
determined to be sufficient to address questions regarding the 2-
generation rat reproduction study because the available data from the 
1-generation show offspring effects occurring at doses higher than the 
dose that caused parental effects and the dose (2.5 mg/kg/day) used for 
driving the chronic RfD is approximately 3-fold lower than the 
offspring NOAEL (10.8 mg/kg/day). The 3X data base UF should be applied 
only to the chronic dietary risk assessment because the required study 
(2-generation reproduction toxicity study) could provide an endpoint 
applicable to chronic exposure scenario, but not for an acute exposure 
scenario. There are no residential uses at the present time.
    Based on the above data, no special FQPA safety factor (i.e., 1X) 
is required since there are no residual uncertainties for prenatal 
toxicity and the lack of a fully acceptable 2-generation toxicity study 
is addressed by the data base uncertainty factor of 3X.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This

[[Page 42568]]

allowable exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
spiroxamine will occupy 7.4% of the aPAD for the U.S. population, 6.2% 
of the aPAD for females 13 years and older, 27% of the aPAD for infants 
less than 1 year old, and 31% of the aPAD for children 1-2 years old. 
In addition, there is potential for acute dietary exposure to 
spiroxamine in drinking 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 aPAD, as shown in 
Table 3 of this unit:

                      Table 3.--Aggregate Risk Assessment for Acute Exposure to Spiroxamine
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      %aPAD/     Water EEC/   Water EEC/  Acute DWLOC/
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          0.1          7.4           18         0.27        3,200
---------------------------------------------------------------------------
Females (13-50 years old)                                0.1          6.2           18         0.27        2,800
---------------------------------------------------------------------------
Infants (less than 1 year old)                           0.1           27           18         0.27          730
---------------------------------------------------------------------------
Children (1-2 years old)                                 0.1           31           18         0.27          690
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
spiroxamine from food will utilize 8.3% of the cPAD for the U.S. 
population, 6.0% of the aPAD for females 13 years and older, 18% of the 
cPAD for infants less than 1 year old, and 29% of the cPAD for children 
1-2 years old. There are no residential uses for spiroxamine that 
result in chronic residential exposure to spiroxamine. In addition, 
there is potential for chronic dietary exposure to spiroxamine in 
drinking 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 4 of this unit:

              Table 4.- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Spiroxamine
----------------------------------------------------------------------------------------------------------------
                                                                             Surface      Ground/
              Population/Subgroup                cPAD/mg/kg/    %/cPAD/     Water EEC/   Water EEC/    Chronic/
                                                     day         (Food)       (ppb)        (ppb)      DWLOC(ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                       0.0083          8.3           14         0.27          270
---------------------------------------------------------------------------
Females (13-50 years old)                             0.0083          6.0           14         0.27          230
---------------------------------------------------------------------------
Infants (less than 1 year old)                        0.0083           18           14         0.27           70
---------------------------------------------------------------------------
Children (1-2 years old)                              0.0083           29           14         0.27           60
----------------------------------------------------------------------------------------------------------------

    3. Aggregate cancer risk for U.S. population. Spiroxamine has been 
classified as not likely to be carcinogenic to humans. Therefore, 
spiroxamine is not expected to pose a cancer risk.
    4. 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 spiroxamine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A proposed enforcement method (Bayer AG Method No. 00407) for 
analysis of spiroxamine and its metabolites containing the aminodiol 
moiety in plants has been submitted. The method was written for grapes 
and processed commodities. An independent laboratory validation (ILV) 
was conducted on grapes. Minor modifications were made for analysis of 
bananas and hops. The method will be adequate for establishment of 
tolerances and conditional registrations when the confirmatory method 
is modified to use more than single-ion monitoring or an interference 
study is conducted, and when the analytical reference standard for N-
ethyl-N-propyl-1,2-dihydroxy-3-

[[Page 42569]]

aminopropane is sent to the National Pesticide Standards Repository. As 
a condition of registration (for continued registration) and for 
continuation of importation of bananas and hops, a method validation 
for Bayer AG Method No. 00407 must be conducted by EPA's laboratory, 
however, EPA has conducted a paper review of this method and found the 
method acceptable.
    Using the common moiety method (Bayer AG Method No. 00407), 
spiroxamine residues are converted to a single analyte, N-ethyl-N-
propyl-1,2-dihydroxy-3-aminopropane (also known as aminodiol), which is 
derivatized to and measured as the di-trimethylsilyl derivative. All 
spiroxamine residues containing the aminodiol moiety are quantitated by 
gas chromatography/mass selective detector (GC/MSD) operated in a 
single-ion mode. The data collection method used for the quantitation 
of residues in grape commodities from the field trial, processing, and 
storage stability studies is identical to the proposed enforcement 
method. Minor modifications were made for analysis of bananas and hops.
    Adequate enforcement methodology (gas chromotography/mass selective 
detection), Bayer AG Method No. 00407, is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address:[email protected].

B. International Residue Limits

    There are currently no Codex, Canadian, or Mexican maximum residue 
levels or tolerances for spiroxamine. A proposal for registration of 
spiroxamine on hops in the European Community (Germany) with a maximum 
residue level of 50.0 ppm is consistent with the proposal for U.S. 
registration of spiroxamine on hops with a tolerance of 50.0 ppm. The 
U.S. tolerance of 50.0 ppm was proposed to harmonize with the European 
Community's proposed maximum residue level. International harmonization 
is not an issue at this time.

C. Conditions

    Additional data are needed in the following areas:
     Banana--Storage stability data are needed on bananas 
stored frozen for 6 months. Information regarding soil types and 
temperature recordings for the banana field trials should be submitted 
if available.
     Hops, dried cones--Additional storage stability 
information is needed to support the hop field trials which were 
conducted in Germany.
     Clarifying data on the 2-generation reproduction study for 
rat pertaining to the increased lactation indices and clinical toxicity 
in the second generation.

V. Conclusion

    Therefore, import tolerances are established for combined residues 
of spiroxamine, 8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-
dioxaspiro[4,5]decane-2-methanamine and its metabolites containing the 
N-ethyl-N-propyl-1,2-dihydroxy-3-aminopropane moiety, in or on grape at 
1.0 ppm, banana at 3.0 ppm, and hop, dried cones at 50 ppm (import and 
U.S. grown).

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0120 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 
14, 2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1801 
S. Bell St., Arlington, VA. The Office of the Hearing Clerk is open 
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The telephone number for the Office of the Hearing Clerk is (703) 603-
0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its

[[Page 42570]]

inclusion in the official record that is described in Unit I.B.1. Mail 
your copies, identified by docket ID number OPP-2004-0120, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to:[email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

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

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: July 1, 2004.
James Jones,
Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. Section 180.602 is added to subpart C to read as follows:


Sec.  180.602  Spiroxamine; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of

[[Page 42571]]

the fungicide spiroxamine (8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-
dioxaspiro[4,5]decane-2-methanamine) and its metabolites containing the 
N-ethyl-N-propyl-1,2-dihydroxy-3-aminopropane moiety, calculated as 
parent equivalent, in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                    Commodity                        Parts per million
------------------------------------------------------------------------
Banana (import)                                                      3.0
Grape (import)                                                       1.0
Hop, dried cones                                                      50
------------------------------------------------------------------------

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

[FR Doc. 04-16216 Filed 7-15-04; 8:45 am]
 BILLING CODE 6560-50-S