
[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Rules and Regulations]               
[Page 74634-74640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de10-10]                         

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

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.

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

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: (703) 305-9096; e-mail address: gibson.tamue@epa.gov.

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

[[Page 74635]]

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 (703) 305-5805.

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

[[Page 74636]]

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.

[[Page 74637]]


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

[[Page 74638]]

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).

[[Page 74639]]

    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: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

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.


[[Page 74640]]


    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

