Tepraloxydim; Pesticide Tolerances, 82146-82152 [2011-33477]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Rules and Regulations]
[Pages 82146-82152]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33477]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0865; FRL-9330-2]


Tepraloxydim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tepraloxydim in or on the imported commodities ``Pea and bean, dried 
shelled, except soybean, subgroup 6C'' and ``Sunflower subgroup 20B''. 
BASF Corporation requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). This regulation also removes 
established tolerances for residues of tepraloxydim on ``Lentil, seed'' 
and ``Pea, dry, seed,'' as residues on these commodities will be 
covered by the new tolerance on the pea and bean subgroup (6C).

DATES: This regulation is effective December 30, 2011. Objections and 
requests for hearings must be received on or before February 28, 2012, 
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-2010-0865. All documents in the 
docket are listed in the docket index available at https://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 https://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.

[[Page 82147]]


FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; email address: stanton.susan@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 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 https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
harmonized test guidelines referenced in this document electronically, 
please go https://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

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-2010-0865 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 
February 28, 2012. 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-2010-0865, by one of the following methods:
     Federal eRulemaking Portal: https://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 December 15, 2010 (75 FR 78240) (FRL-
8853-1), 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 
0E7788) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.573 be amended by 
establishing tolerances for residues of the herbicide tepraloxydim, 2-
[1-[[[(2E)-3-chloro-2-propen-1-yl]oxy]imino]propyl]-3-hydroxy-5-
(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one and its metabolites 
convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and 
OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), 
calculated as tepraloxydim, in or on Pea and bean, dried shelled, 
except soybean, subgroup 6C and Sunflower subgroup 20B at 0.10 parts 
per million (ppm) and 0.25 ppm, respectively. That notice referenced a 
summary of the petition prepared by BASF Corporation, the registrant, 
which is available in the docket, https://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
reduced the proposed tolerance for Sunflower subgroup 20B from 0.25 ppm 
to 0.20 ppm. The reason for this change is explained in Unit IV.C.

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 tepraloxydim including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with tepraloxydim 
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.
    Tepraloxydim has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. It produces minimal

[[Page 82148]]

eye irritation, is a slight dermal irritant, and is not a dermal 
sensitizer.
    In subchronic and chronic toxicity studies, the main target organs 
for tepraloxydim toxicity were the liver, the spleen/hematopoietic 
system and reproductive system. Liver findings were reported in all 
subchronic and chronic toxicity/carcinogenicity feeding studies and 
included increased incidences of hepatocellular foci, abnormal liver 
function parameters, increased relative liver weight, hepatocyte 
hypertrophy, and increased hepatocellular neoplasms in the mouse and 
rat carcinogenicity studies. Tepraloxydim also affected the 
hematopoietic system. In dogs, hemolytic anemia was demonstrated by 
depressed hematocrit, hemoglobin, and red blood cells (RBCs). These 
changes were accompanied by compensatory responses, including splenic 
hematopoiesis, femoral and sternal bone marrow hyperplasia, increased 
erythroid precursors and hemosiderin-laden macrophages, and splenic 
hemosiderosis. The reproductive system was affected by tepraloxydim at 
relatively high doses (in excess of LOAELs (lowest observed adverse 
effect levels) established in repeat-dose mouse, rat and dog studies). 
Reproductive effects included morphological microscopic changes 
indicative of reduced secretory activity in the seminal vesicles and 
preputial glands in male mice; increased uterine sclerosis, decreased 
corpora lutea, and decreased follicles in female mice; increased 
incidences of focal calcification of the testes in the high dose group 
in the rat carcinogenicity feeding study; and effects on male sex 
organs at high doses in dogs.
    In the rat developmental toxicity study, fetal effects (reduced 
fetal body weights, delayed ossification and the occurrence of 
hydroureter) were seen at a dose threefold lower than the dose 
resulting in maternal toxicity (reduced body weight and body weight 
gain). Additional developmental anomalies or malformations (dilatation 
of both heart ventricles and filiform tails that were observed 
externally and corresponded to absent caudal and sacral vertebrae) were 
observed at the maternal LOAEL in the study. The results indicate 
potential increased quantitative and qualitative susceptibility of 
fetuses to tepraloxydim exposure. In contrast, no developmental effects 
were seen in the rabbit developmental toxicity study up to the highest 
tested dose, the LOAEL for maternal toxicity (reduced body weight and 
food consumption). In the multi-generation rat reproduction study, 
there were no effects on any of the measured reproductive parameters up 
to and including the highest tested dose and no evidence of 
quantitative or qualitative susceptibility of the offspring.
    In both the acute and subchronic rat neurotoxicity studies, there 
were mild changes in motor activity and grip strength indices. On day 0 
of the acute oral neurotoxicity study in rats, motor activity was 
decreased in all treated female groups, while forelimb grip strength 
was slightly increased in all treated females. In the rat subchronic 
neurotoxicity study, motor activity was increased in the high dose 
females at day 50 and in both sexes on day 85 at the highest dose 
tested. None of the studies, including both neurotoxicity studies, 
reported treatment-related effects on brain weight or gross/microscopic 
lesions in the tissues of the nervous system.
    In cancer studies conducted in rats and mice, there was weak and/or 
conflicting evidence of carcinogenicity. In rats, there was some 
evidence of carcinogenicity in the females based on an increased 
incidence of liver tumors at the high dose only in the carcinogenicity 
phase of the study, but this finding was not supported by the results 
of the chronic phase in the same strain and sex of rats. In mice, liver 
tumors were seen in females at an excessively toxic dose. EPA's concern 
for carcinogenicity is low, and the Agency has determined that the 
chronic population-adjusted dose (cPAD) of 0.05 milligrams/kilogram/day 
(mg/kg/day) will adequately account for all chronic effects, including 
carcinogenicity, likely to result from exposure to tepraloxydim. This 
determination is based on the following considerations:
     The liver tumors in female rats were seen only at the high 
dose (i.e., lack of dose response);
     The incidences of these tumors were within the ranges for 
the historical controls;
     The rat liver tumors observed in one study were not seen 
in a parallel study conducted at the same dose and duration (i.e., 
tumorogenic potential not replicated);
     In mice, liver tumors were seen only at excessive doses 
(i.e., greater than the Limit Dose of 1,000 mg/kg/day) which may have 
resulted in indirect effects that may not occur at lower doses;
     The liver tumors did not result in reduced latency in 
either species;
     There is no concern for mutagenicity/genotoxicity; and
     The NOAEL (no observed adverse effect level) of 5 mg/kg/
day used for deriving the chronic reference dose (cRfD) is 
approximately 55-fold lower than the lowest dose (272 mg/kg/day) that 
induced liver tumors in rats.
    Specific information on the studies received and the nature of the 
adverse effects caused by tepraloxydim as well as the NOAEL and the 
lowest-observed-adverse-effect-level LOAEL from the toxicity studies 
can be found at https://www.regulations.gov in the document ``Amended: 
Tepraloxydim: Human Health Risk Assessment for New Tolerances on 
Imported Dry Bean and Dry Pea Subgroup 6C and Sunflower Subgroup 20B'' 
at page 31 in docket ID number EPA-HQ-OPP-2010-0865.

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 point of departure (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 PAD or a 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for 
tepraloxydim used for human risk assessment is shown in the following 
Table .

[[Page 82149]]



  Table--Summary of Toxicological Doses and Endpoints for Tepraloxydim for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors               asssessment                 effects
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Acute dietary (General population    LOAEL = 500 (mg/kg/     Acute RfD = 0.5 mg/kg/  Acute neurotoxicity
 including infants and children).     day).                   day.                    screening battery LOAEL =
                                     UFA = 10x.............  aPAD = 0.5 mg/kg/day..   500 mg/kg/day based on
                                     UFH = 10x.............                           decreased motor activity
                                     FQPA SF retained as                              in females. (The NOAEL is
                                      UFL = 10x.                                      not identified.)
Acute dietary......................  NOAEL = 40 mg/kg/day    Chronic RfD = 0.4 mg/   Rat developmental toxicity
(Females 13-49 years of age).......  UFA = 10x.............   kg/day.                 LOAEL = 120 mg/kg/day
                                     UFH = 10x.............  cPAD = 0.4 mg/kg/day..   based on findings of
                                     FQPA SF = 1x..........                           reduced ossification
                                                                                      indicative of delayed
                                                                                      maturation, and the
                                                                                      occurrence of hydroureter.
Chronic dietary (All populations)..  NOAEL = 5 mg/kg/day     Chronic RfD = 0.05 mg/  Rat carcinogenicity study
                                     UFA = 10x.............   kg/day.                 LOAEL = 30 mg/kg/day based
                                     UFH = 10x.............  cPAD = 0.05 mg/kg/day.   on male liver microscopic
                                     FQPA SF = 1x..........                           lesions (eosinophilic
                                                                                      foci).
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Cancer.............................   Weak and/or conflicting evidence of carcinogenicity in the rat and mouse;
(Oral, dermal, inhalation).........     the chronic population-adjusted dose of 0.05 mg/kg/day will adequately
                                              account for all chronic effects, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tepraloxydim, EPA considered exposure under the petitioned-
for tolerances as well as all existing tepraloxydim tolerances in 40 
CFR 180.573. EPA assessed dietary exposures from tepraloxydim 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 tepraloxydim. As shown in the Table above, EPA identified different 
points of departure for assessing acute dietary exposure for the 
general population (including infants and children) and women of 
childbearing age (13 to 49).
    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 that 
residues are present in all commodities at the tolerance level and that 
100% of commodities are treated with tepraloxydim.
    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 that residues 
are present in all commodities at the tolerance level and that 100% of 
commodities are treated with tepraloxydim.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that tepraloxydim does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tepraloxydim in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tepraloxydim. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of tepraloxydim for 
acute exposures are estimated to be 1.4 parts per billion (ppb) for 
surface water and 0.002 ppb for ground water. EDWCs for chronic 
exposures for non-cancer assessments are estimated to be 0.7 ppb for 
surface water and 0.002 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 1.4 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.7 ppb was used to assess 
the contribution to drinking 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). Tepraloxydim 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 
tepraloxydim to share a common mechanism of toxicity with any other 
substances, and tepraloxydim does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that tepraloxydim 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 https://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

[[Page 82150]]

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. As discussed in Unit III.A, 
there was evidence of increased qualitative and quantitative 
susceptibility of fetuses in the rat developmental toxicity study. 
There was no evidence of increased susceptibility seen in the rabbit 
developmental toxicity study or multi-generation rat reproduction 
study. The degree of concern is low for the increased susceptibility 
seen in the developmental study in rats (prenatal exposure), since a 
clear NOAEL/LOAEL was established for developmental toxicity and the 
endpoints of concern are used to assess exposure for the most sensitive 
population of concern (i.e., Females 13to 49). There is no residual 
uncertainty for prenatal and/or postnatal toxicity.
    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 for all exposure scenarios, except acute 
dietary exposure of the general population.
    A 10x FQPA Safety Factor in the form of a UFL is 
retained for assessing acute dietary risk for the general population, 
including infants and children, to account for the uncertainty 
resulting from using a LOAEL, rather than a NOAEL, as the POD (i.e., a 
NOAEL was not identified in the critical study). The critical effect 
(decreased motor activity in females) observed at the LOAEL of 500 mg/
kg/day in the acute neurotoxicity study was neither severe nor 
irreversible; and the dose-responsive decrease in motor activity was 
observed in females on Day 0 in the absence of any other treatment-
related clinical signs (including functional observation battery) or 
neurohistopathological effects. The dose-response relationship of 
tepraloxydim indicates that an uncertainty factor of 10x is 
sufficiently protective against the critical effect and any other 
adverse effects at the aRfD.
    The decision to reduce the FQPA SF to 1x for all other exposure 
scenarios is based on the following findings:
    i. The toxicity database is complete except for immunotoxicity 
testing (OPPTS Guideline 870.7800). Recent changes to 40 CFR part 158 
make this testing required for pesticide registration. In the absence 
of specific immunotoxicity studies, EPA has evaluated the available 
tepraloxydim toxicity database to determine whether an additional 
database uncertainty factor is needed to account for potential 
immunotoxicity. No evidence of immunotoxicity was found. Treatment-
related effects seen in the spleen (splenic hematopoiesis) and bone 
marrow (hyperplasia) are compensatory responses to tepraloxydim-induced 
hemolytic anemia.
    Considering the lack of evidence of immunotoxicity in the database 
for tepraloxydim, EPA does not believe that conducting an 
immunotoxicity study will result in a NOAEL less than that (5 mg/kg/
day) used to derive the current cRfD. Consequently, the EPA believes 
the existing data are sufficient for endpoint selection for exposure/
risk assessment purposes and for evaluation of the requirements under 
the FQPA, and an additional database uncertainty factor is unnecessary.
    ii. In both the acute and subchronic rat neurotoxicity studies, 
there were mild changes in motor activity and grip strength indices. 
However, EPA has concluded that there is no need for a developmental 
neurotoxicity (DNT) study or additional UFs to account for 
neurotoxicity, based on the following considerations:
     Neurotoxic effects were seen at high doses of 500 mg/kg 
(\1/4\ of the limit dose), 1,000 mg/kg, and 2,000 mg/kg following bolus 
(gavage) dosing in the acute neurotoxicity study and at 428 mg/kg/day 
in males and 513 mg/kg/day in females following dietary administration 
in the subchronic neurotoxicity study.
     In the two-generation reproduction study, no clinical 
signs indicative of neurotoxicity were seen in the parental animals or 
offspring; nor was there evidence for increased susceptibility of 
offspring.
     Because a DNT study would necessarily be conducted at high 
doses in order to elicit neurotoxicity, it would not yield a POD lower 
than those currently used for acute (40 mg/kg [aPAD = 0.40 mg/kg] and 
500 mg/kg [cPAD = 0.5 mg/kg]) and chronic (5 mg/kg/day) risk 
assessments.
    iii. Although there was evidence of increased qualitative and 
quantitative susceptibility of fetuses in the rat developmental 
toxicity study, the concern for the increased susceptibility is low, 
and EPA did not identify any residual uncertainties after establishing 
toxicity endpoints and traditional UFs to be used in the risk 
assessment of tepraloxydim.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and tolerance-level residues. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to tepraloxydim in drinking water. 
These assessments will not underestimate the exposure and risks posed 
by tepraloxydim.

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 
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, 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 tepraloxydim will occupy 2.2% of the aPAD for children, 1 to 2 years 
old, the population group receiving the greatest exposure. The acute 
dietary exposure from food and water to tepraloxydim will occupy 1.0% 
or less of the aPAD for all other population subgroups, including 
females 13 to 49 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tepraloxydim from food and water will utilize 9.6% of the cPAD for 
children, 1 to 2 years old, the population group receiving the greatest 
exposure. There are no residential uses for tepraloxydim.
    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). A short-term 
adverse effect was identified; however, tepraloxydim is not registered 
for any use patterns that would result in short-term residential 
exposure. Short-term risk is assessed based on short-term residential 
exposure plus chronic dietary exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately

[[Page 82151]]

protective cPAD (which is at least as protective as the POD used to 
assess short-term risk), no further assessment of short-term risk is 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short-term risk for tepraloxydim.
    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). An intermediate-term adverse effect was identified; however, 
tepraloxydim is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
tepraloxydim.
    5. Aggregate cancer risk for U.S. population. Based on the results 
of two adequate rodent carcinogenicity studies and the explanation 
given in Unit III.A, tepraloxydim 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 tepraloxydim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass 
spectrometry (GC/MS) BASF Analytical Method D9701/1) 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; 
email 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.
    The Codex has not established a MRL for tepraloxydim.

C. Revisions to Petitioned-For Tolerances

    EPA has reduced the proposed tolerance for Sunflower subgroup 20B 
from 0.25 ppm to 0.20 ppm to harmonize with the established MRL in 
Canada. Since the highest average field trial residue and maximum field 
trial residue for sunflower seed were 0.14 ppm and 0.18 ppm, 
respectively, EPA has determined that the Canadian level is adequate to 
cover expected residues on commodities in subgroup 20B.
    EPA is also revising the introductory text of Sec.  180.573(a)(1), 
(a)(2) and (c), which contain the tolerance expression for the existing 
and new tolerances, to clarify the chemical moieties that are covered 
by the tolerances and specify how compliance with the tolerances is to 
be determined. Tolerances for plant commodities are currently expressed 
in terms of the combined residues tepraloxydim, 2-[1-[[[(2E)-3-chloro-
2-propen-1-yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-
2-cyclohexen-1-one, and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as 
tepraloxydim. Livestock tolerances are currently expressed in terms of 
the combined residues of tepraloxydim and its metabolites convertible 
to GP, OH-GP, and GL (3-(2-oyotetrahydropyran-4-yl)-1,5-dioic acid), 
calculated as tepraloxydim. The tolerance expression for plants is 
being revised to make clear that the tolerances cover residues of 
tepraloxydim, including its metabolites and degradates, but that 
compliance with the tolerances is to be determined by measuring only 
the combined residues of tepraloxydim and its metabolites convertible 
to GP and OH-GP, calculated as tepraloxydim. Similarly, the tolerance 
expression for livestock commodities is being revised to clarify that 
the tolerances cover residues of tepraloxydim, including its 
metabolites and degradates, but that compliance with the tolerance 
levels will be determined by measuring only the combined residues of 
tepraloxydim and its metabolites convertible to GP, OH-GP, and GL, 
calculated as tepraloxydim. EPA has determined that it is reasonable to 
make these changes final without prior proposal and opportunity for 
comment, because public comment is not necessary, in that the changes 
have no substantive effect on the tolerances, but rather are merely 
intended to clarify the existing tolerance expressions.
    Finally, EPA is removing established tolerances for residues of 
tepraloxydim on ``Lentil, seed'' and ``Pea, dry, seed'' because 
residues on these commodities are covered by the new tolerances for 
residues of tepraloxydim on the pea and bean subgroup 6C.

V. Conclusion

    Therefore, the established tolerances for residues of tepraloxydim 
on ``Lentil, seed'' and ``Pea, dry, seed'' are removed, and new 
tolerances are established for residues of tepraloxydim, including its 
metabolites and degradates, in or on ``Pea and bean, dried shelled, 
except soybean, subgroup 6C'' and ``Sunflower subgroup 20B'' as set 
forth in the regulatory text.

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

[[Page 82152]]

under section 408(d) of FFDCA, such as the tolerances 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: December 14, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. Amend Sec.  180.573 as follows:
0
a. Revise the introductory text in paragraphs (a)(1), (a)(2), and (c);
0
b. Remove the commodities ``Lentil, seed'' and ``Pea, dry, seed'' from 
the table in paragraph (a)(1);
0
c. Add alphabetically the commodities ``Pea and bean, dried shelled, 
except soybean, subgroup 6C'' and ``Sunflower subgroup 20B'' and add 
footnote 1 to the table in paragraph (a)(1).
    The revised and added text read as follows:


Sec.  180.573  Tepraloxydim; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
tepraloxydim, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the combined 
residues of tepraloxydim, (2-[1-[[[(2E)-3-chloro-2-propen-1-
yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-
cyclohexen-1-one) and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as 
tepraloxydim, in or on the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                 * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C \1\.       0.10
 
                                 * * * *
Sunflower subgroup 20B \1\...................................       0.20
 
                                * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for commodities in this subgroup.

    (2) Tolerances are established for residues of tepraloxydim, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only the combined residues of 
tepraloxydim (2-[1-[[[(2E)-3-chloro-2-propen-1-yl]oxy]imino]propyl]-3-
hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one) and its 
metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-
dioic acid), OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic 
acid), and GL (3-(2-oxotetrahydropyran-4-yl)-1,5-dioic acid), 
calculated as tepraloxydim, in or on the commodities.
* * * * *
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec.  180.1(l), is established for 
residues of tepraloxydim, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the 
combined residues of tepraloxydim (2-[1-[[[(2E)-3-chloro-2-propen-1-
yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-
cyclohexen-1-one) and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as 
tepraloxydim, in or on the commodities.
* * * * *
[FR Doc. 2011-33477 Filed 12-29-11; 8:45 am]
BILLING CODE 6560-50-P