[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Rules and Regulations]
[Page 74634-74640]
[DOCID:fr01de10-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0136; FRL-8850-9]

Spiroxamine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
spiroxamine, [(8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1, 4-
dioxaspiro[4,5]decane-2-methanamine)], including its metabolites and
degradates in or on artichoke, globe, import at 0.7 parts per million
(ppm) asparagus, import at 0.05 ppm; and vegetables, fruiting, crop
group 8, import at 1.2 ppm. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 1, 2010. Objections and
requests for hearings must be received on or before January 31, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0136. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide

for readers regarding entities likely to be affected by this action.
Other types of entities not listed in this unit could also be affected.
The North American Industrial Classification System (NAICS) codes have
been provided to assist you and others in determining whether this
action might apply to certain entities. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0136 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 31, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0136, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 24, 2010 (75 FR 14154) (FRL-8815-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E7564) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, North Carolina 27709. The petition requested
that 40 CFR part 180 be amended by establishing tolerances for 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, calculated as
parent equivalent, in or on artichoke, globe at 0.7 parts per million
(ppm); asparagus at 0.05 ppm and vegetable, fruiting, group 8 at 1.2
ppm. That notice referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    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. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for spiroxamine including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with spiroxamine
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by spiroxamine as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Spiroxamine: Human Health Risk
Assessment for Spiroxamine on Imported Artichoke, Asparagus and
Fruiting Vegetables (Corp Group 8),'' pp. 33-36 in docket ID number
EPA-HQ-OPP-2010-0136.
    Spiroxamine has low acute oral and inhalation toxicity and is not
irritating to the eye. However, spiroxamine is a skin sensitizer when
tested in guinea pigs and is a severe dermal irritant. Spiroxamine
subchronic studies show the target organ of toxicity is the liver.
These 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 as a result
of the strong irritant properties of spiroxamine. Administration of
spiroxamine in long-term studies 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.
Developmental effects in rats entailed delayed ossification which may
be considered secondary to decreased body weight. Treatment-related
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
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.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spiroxamine used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Spiroxamine for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                        RfD, PAD, level
       Exposure scenario              Point of       Uncertainty/FQPA    of concern for          Study and
                                     departure        safety factors    risk assessment    toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General           NOAEL = 10 mg/kg/  UFA = 10X........  aRfD = 0.1 mg/kg/  Acute Neurotoxicity in
 population, including infants    day.              UFH = 10X........   day.               Rats. LOAEL = 30 mg/
 and children.                                      FQPA = 1X........  aPAD = 0.1 mg/kg/   kg based on clinical
                                                                        day.               signs (piloerection
                                                                                and slight to
                                                                                moderate gait in
                                                                                coordination) and FOB
                                                                                effects (decreased
                                                                                forelimb grip
                                                                                strength and foot
                                                                                splay) in males on
                                                                                Day 0-1.
                                --------------------------------------------------------------------------------
Acute Dietary (females 13-49                                  No hazard identified.
 years old).
                                --------------------------------------------------------------------------------
Chronic Dietary--general         NOAEL = 2.5 mg/kg/ UFA = 10X........  cRfD = 0.025 mg/   Chronic Oral Toxicity
 population, including infants    day.              UFH = 10X........   kg/day.            Study in Dogs. LOAEL
 and children.                                      FQPA = 1X........  cPAD = 0.025 mg/    = 28.03/25.84 mg/kg/
                                                                        kg/day.            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 (1-30 days)                                  No residential uses are proposed.
 Incidental Oral.
                                --------------------------------------------------------------------------------
Intermediate Term (1-6 months)                          No residential uses are proposed.
 Incidental Oral.
                                --------------------------------------------------------------------------------
Short-term (1-30 days) Dermal..  NOAEL 5 mg/kg/day  UFA = 10X........  LOC =............  Prenatal Toxicity
                                                    UFH = 10X........  MOE <= 100.......   study in Rats
                                                    FQPA = 1X........                      (Dermal).
                                                                                The maternal LOAEL
                                                                                (systemic) is 20 mg/
                                                                                kg/day based on
                                                                                decreased body weight
                                                                                gains.
Intermediate term (1-6 months)   NOAEL 5 mg/kg/day  UFA = 10X........  LOC =............  Prenatal Toxicity
 Dermal.                                            UFH = 10X........  MOE <= 100.......   study in Rats
                                                    FQPA = 1X........                      (Dermal).
                                                                                The maternal LOAEL
                                                                                (systemic) is 20 mg/
                                                                                kg/day based on
                                                                                decreased body weight
                                                                                gains.

Short term (1-30 days)           NOAEL = 23.6 mg/   UFA = 10X........  LOC =............  28-day Inhalation
 Inhalation.                      kg/day.           UFH = 10X........  MOE <= 100.......   Toxicity Study in
                                                    FQPA = 1X........                      Rats.
                                                                                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 (1-6 months)   NOAEL = 23.6 mg/   UFA = 10X........  LOC =............  28-day Inhalation
 Inhalation.                      kg/day.           UFH = 10X........  MOE <= 100.......   Toxicity Study in
                                                    FQPA = 1X........                      Rats.
                                                                                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.
                                --------------------------------------------------------------------------------
Cancer (oral, dermal,            Classification: Not likely to be carcinogenic to humans based on negative
 inhalation).                     genotoxicity and carcinogenicity in long term cancer studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA = FQPA Safety Factor. PAD
  = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiroxamine, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiroxamine tolerances in 40 CFR
180.602. EPA assessed dietary exposures from spiroxamine in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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. Such effects were identified
for spiroxamine. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
assumed tolerance levels residues and 100 percent crop-treated (PCT)
for the requested uses for spiroxamine.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance
level residues and 100 PCT for the requested and currently registered
uses of spiroxamine.
    iii. Cancer. The Agency classified spiroxamine as ``Not Likely to
be Carcinogenic to Humans'' based on the results of the carcinogenicity
studies in rats and mice. Spiroxamine was determined to be non-
mutagenic in bacteria, negative in an in vivo mammalian cytogenetics
assay, and did not cause unscheduled DNA synthesis in mammalian cells
in vitro. Accordingly, an exposure assessment to evaluate cancer risk
is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for spiroxamine. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for spiroxamine in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of spiroxamine. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and SCI-GROW model, the estimated drinking water
concentrations (EDWCs) of spiroxamine for acute exposures are estimated
to be 19 parts per billion (ppb) for surface water and 0.035 ppb for
ground water. For chronic exposures for non-cancer assessments are
estimated to be 15 ppb for surface water and 0.035 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). Spiroxamine is not
registered for any specific use patterns 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.''
    EPA has not found spiroxamine to share a common mechanism of
toxicity with 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 assumed that
spiroxamine does not have 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 EPA's Web site at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no concern for pre-
or postnatal toxicity due to spiroxamine exposure. Delays in
ossification, balanopreputial separation and vaginal patency were
observed in the rat and may be secondary to decreased body weight. The
latter two delays were resolved within the appropriate age range of
puberty and no effects on reproductive function were observed in the
multigeneration study in rats. Delayed balanopreputial separation was
seen only in the presence of maternal toxicity and is not more severe
than the maternal effects of decreased body weight and esophageal
hyperkeratosis (due to irritation) seen at the common LOAEL of the
multigeneration study. Delayed balanopreputial separation or vaginal
patency does not cause concern for increased sensitivity to the young.
There were no other treatment-related effects on fertility, viability
or lactation indices or other reproductive parameters in either
generation of the 2-generation reproductive toxicity study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. Except for an immunotoxicity study, the toxicity database for
spiroxamine is complete. In accordance with the revised part 158 an
immunotoxicity study is required. Although a test-article related
structural effect on the immune system was observed in the 90-day rat
inhalation study in the form of thymic atrophy accompanied by decreased
platelets and consequent increased clotting time, decreased lymphocytes
and increased neutrophils, these lesions were seen only when inhalation
was the route of administration and at the highest dose tested of 3,000
mg/m\3\ (equivalent to 141 mg/kg/day) which exceeds the limit dose of 1
mg/L (1,000 mg/m\3\). These route-specific lesions are likely secondary
to local (respiratory system) irritation, inflammation and injury and
not attributable to frank immunotoxicity. The Agency does not believe
that conducting the immunotoxicity study will result in a dose less
than the POD used in this risk assessment: NOAEL = 2.5 mg/kg/day based
on liver toxicity at approximately 25 mg/kg/day. Hepatotoxicity was
accompanied by decreased body weight and food consumption which were
also considered secondary to local (digestive system) irritation
resulting in test-article related hyperkeratosis of the tongue,
esophagus and stomach.
    ii. There is no concern for neurotoxicity with spiroxamine. Signs
of neurotoxicity were reported in the acute neurotoxicity study only.
Minimal clinical signs of neurotoxicity was observed only in males at
the lower dose level. However, no evidence of neurotoxicity were
observed at the highest dose level in the subchronic neurotoxicity
study. Therefore, there is no need for a developmental neurotoxicity
study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spiroxamine results in increased
susceptibility in utero rats or rabbits in the prenatal developmental
studies or in young rats in the 2-generation reproduction study.
    iv. Although storage and stability sampling and analysis dates have
been requested for hops, there are no residual uncertainties identified
in the exposure database because there is no indication of residue
degradation during frozen storage. The acute and chronic dietary
exposure assessments were performed based on 100 PCT and tolerance-
level residues. Conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to spiroxamine in
drinking water. Residential exposures are not expected. These
assessments will not underestimate exposures and risks posed by
spiroxamine.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-term, intermediate-term, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to spiroxamine will occupy 36% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spiroxamine from food and water will utilize 40% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no proposed or existing residential uses for
spiroxamine. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
spiroxamine is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Spiroxamine is not registered for any use patterns that would
result in residential exposure. Therefore, there is no potential for
short-term risk to spiroxamine.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).

    Spiroxamine is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, there is
no potential for intermediate-term risk to spiroxamine.
    5. Aggregate cancer risk for U.S. population. For spiroxamine,
there were no observed evidence of carcinogenicity in two adequate
rodent carcinogenicity studies, spiroxamine was determined to be non-
mutagenic in bacteria, negative in an in vivo mammalian cytogenetics
assay and did not cause unscheduled DNA synthesis in mammalian cells in
vitro. Therefore, spiroxamine is not expected to pose a cancer risk to
humans.
    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, or to infants and children from aggregate
exposure to spiroxamine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass
spectrometry (GC/MS) 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:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no currently established Codex, Canadian, or Mexican
maximum residue limits for spiroxamine on artichoke, asparagus and
fruiting vegetables (crop group 8).

C. Revisions to Petitioned-for Tolerances

    EPA is revising the tolerance expression to spiroxamine to clarify
the chemical moieties that are covered by the tolerances and specify
how compliance with the tolerances is to be measured. The revised
tolerance expression makes clear that the tolerances cover residues of
the spiroxamine, including its metabolites and degradates, but that
compliance with the specified tolerance levels is to be determined by
measuring only the sum of spiroxamine and its metabolites containing
the N-ethyl-N-propyl-1,2-dihyroxy-3-amino propane moiety, calculated as
the stoichiometric equivalent of spiroxamine, in or on the commodity.
In addition, although it was not noted in the company petition, a
request for import tolerances (only) was petitioned of the Agency for
the uses in this final rule.

V. Conclusion

    Therefore, tolerances are established for residues of spiroxamine,
including its metabolites and degradates in or on artichoke, globe,
import at 0.7 ppm; asparagus, import at 0.05 ppm and vegetables,
fruiting (crop group 8), import at 1.2 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: November 17, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, 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 amended by revising paragraph (a) introductory
text and alphabetically adding the following commodities to the table
in paragraph (a) to read as follows:

Sec.  180.602  Spiroxamine; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide spiroxamine, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only spiroxamine, [(8-(1,1-dimethylethyl)-N-ethyl-N-propyl-
1,4-dioxaspiro[4,5]decane-2-methanamine) in or on the commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Artichoke, globe, import \1\..............................          0.7
Asparagus \1\.............................................          0.05

                                * * * * *
Vegetable, fruiting , crop group 8 \1\....................          1.2
------------------------------------------------------------------------
\1\ No U.S. registration as of December 1, 2010.

* * * * *
[FR Doc. 2010-30114 Filed 11-30-10; 8:45 am]
BILLING CODE 6560-50-P