
[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Rules and Regulations]
[Pages 14291-14297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5650]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0349; FRL-9335-7]


Penthiopyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
penthiopyrad in or on multiple commodities which are identified and 
discussed later in this document. Mitsui Chemical Agro, Inc. c/o Landis 
International Inc. requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 9, 2012. Objections and 
requests for hearings must be received on or before May 8, 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-2010-0349. 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: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; email address: maignan.tawanda@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 http://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 to http://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-2010-0349 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

[[Page 14292]]

received by the Hearing Clerk on or before May 8, 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-2010-0349, 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 Tolerances

    In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-
8848-3), 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 
9F7661) by Mitsui Chemical Agro, Inc. c/o Landis International Inc., 
P.O. Box 5126 Valdosta, GA 31603-5126. The petition requested that 40 
CFR part 180 be amended by establishing tolerances for residues of the 
fungicide penthiopyrad, (RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-
methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide, in or on fruit, 
pome, group 11 at 0.4 parts per million (ppm); apple, wet pomace at 1.0 
ppm; fruit, stone, group 12 at 4.0 ppm; low growing berry, subgroup 13-
07G at 3.0 ppm; vegetable, bulb, group 3 at 4.0 ppm; vegetable, 
brassica head and stem, subgroup 5A at 8.0 ppm; vegetable, brassica 
leafy, subgroup 5B at 45 ppm; vegetable, fruiting, group 8 at 2.5 ppm; 
tomato, paste at 5.0 ppm; vegetable, cucurbit, group 9 at 1.0 ppm; 
vegetable, leafy, except brassica, group 4 at 20 ppm; vegetable, root, 
subgroup 1A at 2.5 ppm; vegetable, tuberous and corm, subgroup 1C at 
0.06 ppm; vegetables, leaves of root and tuber, group 2 at 55 ppm; 
vegetable, edible-podded legume, subgroup 6A at 2.5 ppm; vegetable, 
succulent, shelled peas and beans, subgroup 6B at 0.4 ppm; vegetable, 
pea and bean, dried shelled, except soybean, subgroup 6C at 0.3 ppm; 
soybean, seed at 0.3 ppm; soybean, hulls at 1.0 ppm; peanut, nutmeat at 
0.04 ppm; grain, cereal (except corn, millet, sorghum) at 0.2 ppm; 
corn, field, sweet, pop at 0.01 ppm; corn, refined oil at 0.03 ppm; 
cereal grain, millet at 0.9 ppm; cereal grain, sorghum at 0.9 ppm; nut, 
tree, group 14 (including pistachios) at 0.05 ppm; almond, hulls at 6.0 
ppm; canola at 1.0 ppm; sunflower at 0.8 ppm; cotton, seed at 0.35 ppm; 
cotton, gin byproducts at 10 ppm; alfalfa, forage at 10 ppm; alfalfa, 
hay at 25 ppm; foliage of legume vegetables, group 7, hay at 80 ppm; 
foliage of legume vegetables, group 7, vines/forage at 30 ppm; peanut, 
hay at 50 ppm; grain, cereal, group 16, hay at 90 ppm; grain, cereal, 
group 16, forage at 25 ppm; grain, cereal, group 16, straw at 2 ppm; 
grain, cereal, stover at 11 ppm and establishing tolerances for 
residues of penthiopyrad, (RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-
methyl-3-(trifluoromethyl)-pyrazole-4-carboxamide and its major 
metabolite PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) 
in animal commodities hog, meat at 0.01 ppm; hog, fat at 0.01 ppm; hog, 
liver at 0.01 ppm; hog, kidney at 0.01 ppm; hog, meat byproducts at 
0.01 ppm; cattle, meat at 0.05 ppm; cattle, fat at 0.05 ppm; cattle, 
liver at 0.2 ppm; cattle, kidney at 0.1 ppm; cattle, meat byproducts at 
0.2 ppm; sheep, meat at 0.01 ppm; sheep, fat at 0.02 ppm; sheep, liver 
at 0.05 ppm; sheep, kidney at 0.02 ppm; sheep, meat byproducts at 0.05 
ppm; milk at 0.05 ppm; milk, fat at 0.01 ppm; poultry, meat at 0.01 
ppm; poultry, fat at 0.01 ppm; poultry, liver at 0.01 ppm; poultry, 
meat byproducts at 0.01 ppm; poultry, eggs at 0.01 ppm. That notice 
referenced a summary of the petition prepared by Mitsui Chemical Agro, 
Inc. c/o Landis International, the registrant, which is available in 
the docket, http://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 
revised several of the proposed tolerance levels. The reasons for these 
changes are 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 penthiopyrad including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with penthiopyrad 
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.
    For penthiopyrad, the liver and thyroid are the target organs. In 
toxicity studies, short-term oral exposure resulted in liver 
alterations in rats and mice at similar doses, and in dogs at higher 
doses. Short-term exposure also resulted in thyroid changes in mice and 
rats. Other effects observed were body weight changes and hematological 
alterations in rats and dogs, along with gallbladder effects in dogs. 
Short-term dermal exposure did not result in dermal irritation or 
systemic effects up to the limit dose tested.
    Long-term exposure in rats resulted in liver effects; adrenal, 
ovarian, and

[[Page 14293]]

thyroid hypertrophy; and thyroid tumors. In mice, chronic exposure led 
to liver and thyroid effects and liver tumors. In dogs, effects noted 
(liver, gallbladder, and adrenal glands) were similar to those seen in 
subchronic dog studies, with the addition of more progressive 
gallbladder effects.
    No evidence of increased quantitative or qualitative susceptibility 
was observed in developmental toxicity studies in rats or rabbits or in 
a reproduction toxicity study in rats. However, increased quantitative 
susceptibility was seen in a developmental neurotoxicity (DNT) study in 
rats. In the DNT, decreased body weight, increased motor activity, and 
tremors were seen in offspring animals in the absence of maternal 
toxicity.
    Clinical signs (hunched posture, unsteady gait, reduced body 
temperature, and increased landing foots play) were observed in the 
acute neurotoxicity study in rats. However, no clinical signs were 
observed in the subchronic neurotoxicity study in rats. In the 
immunotoxicity study in mice, decreased plaque forming ability was 
observed at the limit dose. However, in the immunotoxicity study in 
rats, no evidence of immunotoxicity was observed up to the highest dose 
tested. Penthiopyrad has been classified as having ``suggestive 
evidence of carcinogenicity.'' Although liver tumors were seen in a 
cancer study in the mouse, the tumors were only observed at high doses 
and only noted in one sex and one species. The no-observed-adverse-
effect-level (NOAEL) (27 milligrams/kilogram/day (mg/kg)) used for 
establishing the chronic reference dose is approximately 10-fold lower 
than the lowest dose (200 mg/kg/day) that induced liver tumors in mice. 
Based on these factors, including the fact that the only tumors seen 
were liver tumors in mice, the Agency has determined that the 
quantification of risk using a non-linear approach will adequately 
account for all chronic toxicity, including carcinogenicity that could 
result from exposure to penthiopyrad. The EPA received a number of 
studies for penthiopyrad metabolites, including subchronic oral, 
mutagenicity studies, etc.; however, none of these studies indicated 
that metabolites were more toxic than the parent.
    Specific information on the studies received and the nature of the 
adverse effects caused by penthiopyrad as well as the NOAEL and can be 
found at http://www.regulations.gov in the document ``Penthiopyrad. 
Human Health Risk Assessment for the Section 3 Registration Action on 
Numerous Agricultural Crops, Turfgrass, and Ornamentals,'' starting on 
page 23 in docket ID number EPA-HQ-OPP-2010-0349.

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 penthiopyrad used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Penthiopyrad for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/Scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)....  NOAEL = 125 mg/kg/day.  Acute RfD = 1.25 mg/kg/ Acute Neurotoxicity in Rats
                                     UFA = 10x.............   day.                    LOAEL = 500 mg/kg/day
                                     UFH = 10x.............  aPAD = 1.25 mg/kg/day.   based on transient
                                     FQPA SF = 1x..........                           functional alterations
                                                                                      (e.g., hunched posture,
                                                                                      unsteady gait, reduced
                                                                                      body temperature, and
                                                                                      increased landing foot
                                                                                      splay) and decreased motor
                                                                                      activity at the estimated
                                                                                      time[dash]to-peak-effect
                                                                                      (4 hours) on the day of
                                                                                      administration.
Chronic dietary (All populations)..  NOAEL = 27 mg/kg/day..  Chronic RfD = 0.27 mg/  Co-critical studies.
                                                              kg/day.
                                     UFA = 10x               cPAD = 0.27 mg/kg/day   Chronic Toxicity/
                                     UFH = 10x.............                           Carcinogenicity in Rats
                                     FQPA SF = 1x..........                          LOAEL = 83 mg/kg/day, based
                                                                                      on decreased body weight
                                                                                      gain and adrenal effects
                                                                                      in females and hepatic
                                                                                      periportal fatty
                                                                                      degeneration in males.
                                                                                     Chronic Toxicity in Rats
                                                                                     LOAEL = 100 mg/kg/day,
                                                                                      based on altered plasma
                                                                                      chemistry profile,
                                                                                      increased liver weight and
                                                                                      alterations in the adrenal
                                                                                      and thyroid glands.
Incidental Oral short-term (1 to 30  NOAEL = 27 mg/kg/day..  Residential LOC for     28-Day Oral Toxicity in
 days) and intermediate-term (1 to   UFA = 10x.............   MOE = 100.              Dogs LOAEL = 80 mg/kg/day,
 6 months).                          UFH = 10x.............                           based on mucosal edema in
                                     FQPA SF = 1x..........                           the gall bladder.

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Children's Dermal short-term (1 to   NOAEL = 100 mg/kg/day   Residential LOC for     Postnatal Developmental
 30 days) and intermediate-term (1    (dermal absorption      MOE = 100.              Neurotoxicity in Rats
 to 6 months).                        factor = 40%.                                  LOAEL = 250 mg/kg/day,
                                     UFA = 10x.............                           based on decreased body
                                     UFH = 10x.............                           weight (8%) in offspring
                                     FQPA SF = 1x..........                           animals seen in the
                                                                                      absence of maternal
                                                                                      toxicity.
Adult Dermal short-term (1 to 30     NOAEL = 75 mg/kg/day    Residential LOC for     Developmental in Rabbits
 days) and intermediate-term (1 to    (dermal absorption      MOE = 100.             LOAEL = 225 mg/kg/day,
 6 months).                           factor = 40%.                                   based on abortion.
                                     UFA = 10x.............
                                     UFH = 10x.............
Inhalation short-term (1 to 30       Inhalation (or oral)    LOC for MOE = 100.....  28-Day Oral Toxicity in
 days) and intermediate-term (1 to    study.                                          Dogs LOAEL = 80 mg/kg/day,
 6 months).                          NOAEL = 27 mg/kg/day                             based on mucosal edema in
                                      (inhalation                                     the gall bladder.
                                      absorption factor =
                                      100%).
                                     UFA = 10x.............
                                     UFH = 10x.............
                                     FQPA SF = 1x..........
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Cancer (Oral, dermal, inhalation)..   Classification: ``Suggestive Evidence of Carcinogenicity'' based on liver
                                      tumors in male mice. The dose and non-cancer endpoint selected for chronic
                                          dietary exposure (cRfD) are protective of potential cancer effects.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern. milligrams/kilograms/day = mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penthiopyrad, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from penthiopyrad 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 penthiopyrad. In estimating acute 
dietary exposure, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intakes by Individuals (CSFII). As to 
residue levels in food, EPA used tolerance-level residues, 100% crop 
treated assumptions for all commodities, and both default and empirical 
processing factors.
    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 used tolerance-level 
residues, 100% crop treated assumptions for all commodities, and both 
default and empirical processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
determined that quantification using a linear low dose approach was not 
required, and the chronic dose and endpoint are considered to be 
protective of cancer effects. Thus, no separate exposure assessment was 
performed in assessing cancer risk.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for penthiopyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of penthiopyrad. 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 First Index Reservoir Screening Tool (FIRST), 
provisional Tier 1 Cranberry and Screening Concentration in Ground 
Water (SCI-GROW) models, the estimated drinking water concentrations 
(EDWCs) of penthiopyrad for acute exposures are estimated to be 289 
parts per billion (ppb) for surface water and <=98 ppb for groundwater. 
For chronic exposures are estimated to be 222 ppb for surface water and 
<=98 ppb for groundwater. The surface water estimates were used for 
both the acute and chronic (non-cancer/cancer) assessments because they 
were higher than the groundwater estimates. Modeled estimates of 
drinking water concentrations were directly entered into the dietary 
exposure model.
    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).
    Penthiopyrad is currently registered for the following use that 
could result in residential exposures: Turfgrass. EPA assessed 
residential exposure using the following assumptions:
    No chemical-specific unit exposure data were provided in support of 
this submission; therefore, the Occupational Pesticide Handler Unit 
Exposure Surrogate Reference Table (June 2011) and the Outdoor 
Residential Exposure Task Force (OREFT) study unit exposures were used 
to estimate handler exposures. These unit exposures were based on 
residential handlers wearing short pants, short-sleeved shirt, and no 
gloves.
    Postapplication scenarios include children (1 to 3 years old) 
playing on treated turf, adults performing yard work on treated turf, 
and adults playing golf on treated turf. The postapplication scenarios 
resulting from commercial and residential applications were assessed 
using default assumptions and transfer coefficients from the EPA Draft 
SOPs for Residential Exposure Assessments, 2000. As the short- and 
intermediate-term dermal endpoints are the same for each route of 
exposure, only short-term dermal exposures were assessed for adults and 
children. EPA estimates short-term dermal postapplication exposure 
based on day-0 residues, that is, the residue

[[Page 14295]]

present on the day of application. Using day-0 residues to assess 
intermediate-term exposure does not take into account dissipation of 
residues over time and, thus, results in a conservative estimate. 
Therefore, the short-term dermal postapplication exposure assessment 
represents the worst case scenario and is protective of intermediate-
term dermal exposure. Additionally, oral non-dietary ingestion 
exposures were assessed for children (i.e., soil ingestion, and hand-/
object-to-mouth). Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 penthiopyrad to share a common mechanism of 
toxicity with any other substances, and penthiopyrad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
penthiopyrad 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 evidence of 
increased quantitative or qualitative susceptibility in developmental 
toxicity studies on rats/rabbits or in a reproduction toxicity study on 
rats. However, there is evidence of increased susceptibility following 
prenatal/or postnatal exposure in preliminary and definitive DNT 
studies on rats. Effects include decreased body weight, increased motor 
activity, and tremors (definitive), as well as mortality (preliminary).
    Although increased susceptibility was seen in the DNT studies, the 
EPA concluded that there is a low concern and no residual uncertainties 
for prenatal and/or postnatal toxicity effects of penthiopyrad because:
     The pup body weight changes noted in the definitive and 
preliminary DNT studies were observed in other developmental/
reproduction studies at similar doses. Additionally, the body weight 
changes in these studies occurred in the presence of significant 
maternal toxicity and there was no evidence of increased 
susceptibility. Although clinical signs (tremors and increased motor 
activity) were noted in offspring animals in the DNT study, the 
neurotoxic potential of penthiopyrad has been adequately characterized 
in the available neurotoxicity studies. In the preliminary DNT study, 
mortality was observed in the offspring animals at the limit dose. 
However, this finding is attributed to the poor condition (body weight 
loss, under activity, pallor) of the offspring animals in this dose 
group.
     Clear NOAELs have been identified for all offspring 
effects and the risk assessments are based on the most sensitive 
endpoints. Therefore, the NOAELs selected for risk assessment are 
protective of potential developmental and offspring effects.
    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. The toxicity database for penthiopyrad is complete.
    ii. There is no concern for neurotoxicity after exposure to 
penthiopyrad. A complete neurotoxicity battery is available for 
penthiopyrad. This includes acute neurotoxicity, subchronic 
neurotoxicity, and DNT studies in rats. As a result, the neurotoxic 
potential of penthiopyrad is well characterized and no additional data 
are needed
    iii. There is no residual concern regarding increased quantitative 
or qualitative prenatal and/or postnatal susceptibility for the reasons 
explained in Unit III.D.2.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated and tolerance-level residues. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to penthiopyrad in drinking water. EPA 
used similarly conservative assumptions to assess residential 
exposures, including those of adults applying penthiopyrad and 
postapplication exposures of adults and children as well as incidental 
oral exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by penthiopyrad.

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 PAD (aPAD) and chronic PAD (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 penthiopyrad will occupy 7% of the aPAD for the general U.S. 
population and 11% of the aPAD for children 1 to 2 years old (the 
population group receiving the greatest exposure). Since acute 
aggregate risk results from exposure to residues in food and water 
alone, the acute aggregate risks are not of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
penthiopyrad from food and water will utilize 11% of the cPAD for the 
general U.S. population and 19% of the cPAD for children 1 to 2 years 
old (the population group receiving the greatest exposure). Since there 
are no residential scenarios that result in long-term exposure to 
penthiopyrad, the chronic aggregate risks are equivalent to the chronic 
dietary risks and are not of concern.
    3. Short-/intermediate-term risk. Short-/intermediate-term 
aggregate exposure takes into account short-/intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). The short-/

[[Page 14296]]

intermediate-term toxicological endpoints for penthiopyrad are the same 
for each route of exposure. Therefore, for residential exposure 
scenarios, only short-term exposures were assessed, and are protective 
of intermediate-term exposure and risk. Penthiopyrad is proposed for 
registration for uses that could result in short-/intermediate-term 
residential exposures, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short -term residential exposures to penthiopyrad.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food, 
water, and residential exposures result in adult aggregate estimated 
MOEs of 580 for males and females. Furthermore, although there is the 
potential for exposure to children resulting from two different routes 
(i.e. dermal and oral exposure), the toxicological effects from the 
dermal and oral routes of exposure are different. As a result, a 
combined residential exposure assessment was not conducted for 
children. The short-term aggregate risk assessment for children 
resulted in estimated MOEs of 500 for dermal and 410 for oral exposure. 
Because EPA's level of concern for penthiopyrad is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the relevant 
cancer studies EPA has concluded that the pesticide poses no greater 
than a negligible cancer risk and the chronic dietary risk assessment 
is protective of cancer effects and, therefore, cancer risk resulting 
from exposure to penthiopyrad is not of concern.
    5. 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 penthiopyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography methods with tandem mass 
spectrometry (LC/MS/MS) are available to enforce the tolerance 
expressions for penthiopyrad in plant (Method CEMR 3727 also known as 
Method CEM 3399-001) and livestock (Methods LDA0082 and LDA0083) 
matrices.
    The methods 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 MRLs for the new active ingredient 
penthiopyrad.

C. Revisions to Petitioned-For Tolerances

    The EPA has revised several of the proposed tolerance levels. The 
major reason for the modifications is that the petitioner determined 
the proposed tolerances using the tolerance calculation procedure 
utilized by countries in the North American Free Trade Agreement but 
EPA conducted a joint review of this chemical with the United Kingdom 
and utilized a similar, but slightly different tolerance calculation 
procedure followed by the Organization for Economic Co-operation and 
Development.

V. Conclusion

    Therefore, tolerances are established for residues of penthiopyrad, 
N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide, in or on plant and livestock commodities as 
indicated below.

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 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

[[Page 14297]]

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: February 24, 2012.
Steven Bradbury,
Director, 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. Add Sec.  180.658 to subpart C to read as follows:


Sec.  180.658  Penthiopyrad; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
penthiopyrad, 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 penthiopyrad (N-
[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................         7.0
Alfalfa, hay................................................          20
Almond, hulls...............................................         6.0
Apple, wet pomace...........................................         1.5
Barley, grain...............................................        0.15
Barley, hay.................................................          80
Barley, milled byproducts...................................        0.90
Barley, straw...............................................         1.0
Beet, sugar, dried pulp.....................................         1.5
Beet, sugar, roots..........................................         0.5
Berry, low growing, subgroup 13-07G.........................         3.0
Brassica, head and stem, subgroup 5A........................         5.0
Brassica, leafy greens, subgroup 5B.........................          50
Buckwheat, grain............................................        0.15
Canola......................................................         1.5
Corn, field, forage.........................................          40
Corn, field, grain..........................................        0.01
Corn, field, refined oil....................................        0.05
Corn, field, stover.........................................          15
Corn, pop, grain............................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Cotton, seed................................................         1.5
Cotton, gin byproducts......................................          15
Fruit, pome, group 11-10....................................        0.50
Fruit, stone, group 12......................................         4.0
Grain, aspirated fractions..................................          30
Millet, spp.................................................        0.80
Nut, tree, group 14.........................................        0.06
Oat, forage.................................................          40
Oat, grain..................................................        0.15
Oat, hay....................................................          80
Oat, straw..................................................         1.0
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.40
Peanut......................................................        0.04
Peanut, hay.................................................          30
Peanut, refined oil.........................................        0.06
Pistachio...................................................        0.06
Potato, processed potato waste..............................        0.20
Rye, forage.................................................          40
Rye, grain..................................................        0.15
Rye, straw..................................................         1.0
Sorghum, forage.............................................          40
Sorghum, grain, grain.......................................        0.80
Sorghum, stover.............................................          15
Soybean, seed...............................................        0.40
Sunflower, seed.............................................         1.5
Teosinte, grain.............................................        0.15
Tomato, paste...............................................         3.5
Triticale, forage...........................................          40
Triticale, grain............................................        0.15
Triticale, hay..............................................          80
Triticale, straw............................................         1.0
Vegetable, bulb, group 3-07.................................         3.0
Vegetable, cucurbit, group 9................................        0.60
Vegetable, foliage of legume, group 7, hay..................         200
Vegetable, foliage of legume, group 7, vines/forage.........          50
Vegetable, fruiting, group 8-10.............................         3.0
Vegetable, leafy, except brassica, group 4..................          30
Vegetable, leaves of root and tuber, group 2................          50
Vegetable, legume, edible podded, subgroup 6A...............         4.0
Vegetable, legume, succulent shelled, subgroup 6B...........        0.40
Vegetable, root, subgroup 1B, except sugar beet.............         3.0
Vegetable, tuber and corm, subgroup 1C......................        0.06
Wheat, forage...............................................          40
Wheat, grain................................................        0.15
Wheat, hay..................................................          80
Wheat, milled byproducts....................................        0.30
Wheat, straw................................................         1.0
------------------------------------------------------------------------

     (2) Tolerances are established for residues of penthiopyrad, 
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 sum of penthiopyrad (N-[2-
(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide) and its metabolite (1-methyl-3-trifluoromethyl-
1H-pyrazole-4-carboxamide), calculated as the stoichiometric equivalent 
of penthiopyrad, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.03
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................        0.09
Goat, fat...................................................        0.03
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................        0.09
Horse, fat..................................................        0.03
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.09
Milk........................................................        0.02
Sheep, fat..................................................        0.03
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................        0.09
------------------------------------------------------------------------

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

[FR Doc. 2012-5650 Filed 3-8-12; 8:45 am]
BILLING CODE 6560-50-P


