[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28276-28281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11629]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0425; FRL-9341-8]


Penflufen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
penflufen in or on multiple commodities which are identified and 
discussed later in this document. Bayer CropScience requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 14, 2012. Objections and 
requests for hearings must be received on or before July 13, 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-2010-0425. 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: Marianne Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8043; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 
OCSPP test guidelines referenced in this document electronically, 
please go 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-2010-0425 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 
July 13, 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-2010-0425, 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

[[Page 28277]]

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 September 8, 2010 (75 FR 54631) (FRL-
8843-3), 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 
0F7711) by Bayer CropScience, 2 T.W. Alexander Drive P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
part 180 be amended by establishing tolerances for residues of the 
penflufen, N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-1H-
pyrazole-4-carboxamide, in or on alfalfa, forage; alfalfa, hay; 
vegetable, tuberous and corm, subgroup 1C; vegetable, legume, group 6; 
vegetable, foliage of legume, group 7; grain, cereal, group 15, grain, 
cereal, forage, fodder and straw, group 16; oilseed, group 19; cotton, 
gin by-products at 0.01 parts per million (ppm). That notice referenced 
a summary of the petition prepared by Bayer CropScience, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has made 
some minor modifications to some commodity definitions for consistency 
with EPA naming-conventions for those commodities. The reason for these 
changes is explained in Unit IV.D.

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 penflufen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with penflufen 
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. Penflufen is an alkylamide fungicide belonging to the 
chemical class of carboxamides. The reported pesticidal mode of action 
is as an inhibitor of mitochondrial respiration by inhibiting succinate 
dehydrogenase, an enzyme in the electron transport system.
    The liver and thyroid are target organs for penflufen. Increased 
liver weight, alterations in clinical chemistry parameters relevant to 
effects on the liver, and an increase in the incidence of 
hepatocellular hypertrophy were consistent findings across species and 
duration of exposure (28-day, 90-day, and 1- to 2-year exposure 
periods). The hepatic total cytochrome P-450 content, and 
benzoxyresorufin (BROD) and pentoxyresorufin (PROD) enzyme activities, 
were shown to be increased in rats of both sexes following subchronic 
oral exposure. Additionally, increased incidence of thyroid follicular 
cell hypertrophy/hyperplasia was observed across studies and species 
(no data provided on thyroid hormone levels). The liver and thyroid 
findings were mostly reversible after a 3-month recovery period in the 
rat. In the rat and mouse, following 104 week/78 week exposure periods 
at dose levels up to and/or greater than the limit dose, there was no 
increase in the incidence of liver or thyroid tumors.
    Reproductive toxicity was observed in the 2-generation reproduction 
study in rats. Delayed sexual maturation was observed in females in 
both generations, and magnitude of the associated decline in body 
weight was not considered to be a factor in the delay in sexual 
maturation. Developmental toxicity was not observed in the rat or 
rabbit, although the dose levels in both studies were not considered 
adequate to assess developmental toxicity potential of penflufen. 
However, there is little concern that new studies would identify a 
developmental endpoint with a no-observed-adverse-effect-level (NOAEL) 
lower than the NOAEL selected for risk assessment.
    Decreased motor/locomotor activity was observed in both sexes of 
rats following acute and in female rats following subchronic oral 
exposure, although neuropathological lesions were not observed in 
either study.
    There are no mutagenicity concerns. Carcinogenicity studies with 
penflufen found a statistically significant increase in histiocytic 
sarcomas in male rats; a marginal increase in brain astrocytomas, a 
fatal tumor, in male rats at the high dose; and ovarian adenomas in 
female rats at the high dose. Although these three tumors were 
considered treatment-related, they provided weak evidence of 
carcinogenicity due to the marginal nature of the tumor responses. 
There was no evidence of carcinogenicity in male or female mice. Given 
the weak evidence indicating any potential for carcinogenicity, EPA has 
determined that quantification of risk using a non-linear approach 
reference dose (i.e., RfD) will adequately account for all chronic 
toxicity, including carcinogenicity, which could result from exposure 
to penflufen. The NOAEL (38 milligram/kilogram/day (mg/kg/day)) used 
for establishing the Chronic RfD is approximately 10-fold lower than 
the dose (approximately 300 mg/kg/day) that induced a marginal tumor 
response. The EPA has determined that the chronic population adjusted 
dose is protective of all long-term effects, including potential 
carcinogenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by penflufen as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in document ``Penflufen. 
Human Health Risk Assessment to Support New Uses on Potato (Crop 
Subgroup 1C), Legume Vegetables (Crop Group 6 and Crop Group 7), Cereal 
Grains (Crop Group 15 and Crop Group 16), Oilseeds (Crop Group 20), and 
Alfalfa'' in docket ID number EPA-HQ-OPP-2010-0425.

[[Page 28278]]

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 (LOC) 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 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 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 penflufen used for 
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Penflufen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (all populations,    NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Acute neurotoxicity study in rats.
 including children and women 13-  UFA = 10x...........   kg/day.             LOAEL = 100 mg/kg/day based on
 49 years of age).                 UFH = 10x...........  aPAD = 0.5 mg/kg/     decreased motor and locomotor
                                   FQPA SF = 1x........   day.                 activity (39-81% on day of
                                                                               treatment) in females.
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Chronic dietary (All populations)  NOAEL= 38 mg/kg/day.  Chronic RfD = 0.38   Chronic toxicity study in dogs.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 357/425 mg/kg/day, based
                                   UFH = 10x...........  cPAD = 0.38 mg/kg/    on decreased terminal body weight
                                   FQPA SF = 1x........   day.                 and body weight gain (females),
                                                                               increased prothrombin time
                                                                               (males), increased alkaline
                                                                               phosphate activity, decreased
                                                                               cholesterol, increased GGT
                                                                               levels, decreased albumin and
                                                                               albumin/globulin ratio, decreased
                                                                               calcium and phosphorus, increased
                                                                               liver weights, increased
                                                                               incidence of focal hepatocellular
                                                                               brown pigment and hepatocellular
                                                                               hypertrophy, and an increased
                                                                               incidence of thyroid follicular
                                                                               cell hypertrophy in both sexes,
                                                                               and in increased incidence of
                                                                               zona glomerulosa vacuolation of
                                                                               the adrenal gland in females.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Quantification of risk using a non-linear approach (i.e., RfD) will
                                    adequately account for all chronic toxicity, including carcinogenicity that
                                    could result from exposure to penflufen.
----------------------------------------------------------------------------------------------------------------
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. UFDB = to account for the absence of data or other data deficiency. 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. Mg/kg/day = milligrams/kilograms/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to penflufen, EPA considered exposure under the petitioned-for 
tolerances. EPA assessed dietary exposures from penflufen 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 penflufen. 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 used tolerance-level residues, default dietary 
exposure evaluation model (DEEM) processing factors for dried potatoes 
and assumed 100 percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EP used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level 
residues, default DEEM processing factors for dried potatoes and 
assumed 100 PCT for all commodities.
    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, default DEEM processing factors for dried potatoes and 
assumed 100 PCT for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or non-linear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used based on an earlier non-
cancer key event. If carcinogenic mode of action data are not 
available, or if the mode of action data determines a mutagenic mode of 
action, a default linear cancer slope factor approach is utilized. 
Based on the data summarized in Unit III.A., EPA has concluded that a 
non-linear RfD approach is appropriate for assessing cancer risk to 
penflufen. Cancer risk was assessed using the same

[[Page 28279]]

exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for penflufen. Tolerance level residues and/or 100 PCT were assumed for 
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for penflufen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of penflufen. 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) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of penflufen for acute 
exposures are estimated to be 11.4 parts per billion (ppb) for surface 
water and 16.6 ppb for ground water. The EDWC of penflufen for chronic 
exposures for non-cancer assessments are estimated to be 1.8 ppb for 
surface water and 16.6 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 16.6 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 16.6 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).
    Penflufen 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 penflufen to share a common mechanism of toxicity 
with any other substances, and penflufen does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that penflufen 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. In the rat multi-generation 
reproduction study there was slight decrease in litter size, delayed 
sexual maturation, decreased body weight/gain, decreased brain, spleen, 
and thymus weights were noted in the offspring. At the same dose level 
the adults exhibited decreased body weight/gain, alteration in food 
consumption, decreased thymus weight, and decrease spleen weights. In 
the rat developmental toxicity study, the maternal findings (decreased 
body weight gain) at the highest dose tested (HDT) are considered 
minimal. No adverse effects were observed on the foetuses. In the 
rabbit developmental toxicity study, the maternal findings (decreased 
body weight gain) at the HDT are considered minimal. No adverse effects 
were observed at the HDT.
    3. Conclusion. The Agency recommends that the 10X FQPA safety 
factor for the protection of infants and children, be reduced to 1X. 
The risk assessments conducted for penflufen were based on the most 
sensitive endpoints in the toxicity database, and the NOAELs selected 
for risk assessment are considered protective of potential 
developmental, neurotoxic, and immunotoxic effects for infants and 
children. Highly conservative exposure estimates were incorporated into 
the risk assessment for penflufen. There are no residual uncertainties 
with regard to pre- and/or postnatal toxicity or neurotoxicity, and 
exposure; therefore, reduction of the 10X FQPA safety factor for 
penflufen to 1X is appropriate based on the following findings:
    i. The toxicity database for penflufen is complete for 
consideration of estimated risks for all populations of concern.
    ii. Although decreased motor activity was observed following acute 
oral exposure, no neuropathological lesions were observed and there is 
little concern for neurotoxicity. There is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. Although there is some evidence of qualitative sensitivity of 
the young (delayed sexual maturation and decreased litter size), the 
effects are well characterized, and there is a clear NOAEL. The dose 
level where offspring effects were identified in the reproduction study 
is comparable to the high dose used in the rat developmental toxicity 
study where no effects were identified in either the maternal or fetal 
rat. Since minimal/no effects were observed in the developmental 
toxicity studies following exposure of the maternal animals to dose 
levels equal to and greater than those tested in the studies used for 
risk assessment, there is little concern that new studies would 
identify a developmental endpoint with a NOAEL lower than the NOAELs 
selected for risk assessment.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to penflufen in drinking water. These assessments 
will not underestimate the exposure and risks posed by penflufen.

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.

[[Page 28280]]

    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. A highly conservative acute dietary exposure assessment 
demonstrated that penflufen does not pose an unacceptable aggregate 
risk.
    2. Chronic risk. There are no residential uses for penflufen; 
therefore, the chronic aggregate risk assessment includes exposures 
from dietary consumption of food and water only. A highly conservative 
chronic aggregate dietary exposure assessment demonstrated that 
penflufen does not pose an unacceptable aggregate chronic risk.
    3. Short-term risk. There are no residential uses of penflufen; 
therefore a short-term aggregate risk assessment was not conducted for 
this chemical.
    4. Intermediate-term risk. There are no residential uses of 
penflufen; therefore an intermediate-term aggregate risk assessment was 
not conducted for this chemical.
    5. Aggregate cancer risk for U.S. population. In a rat 
carcinogenicity study with penflufen a statistically significant 
increase in histiocytic sarcomas with a positive trend in male rats 
only (but in the absence of a dose response and lack of pre-neoplastic 
lesions) were seen. A marginal increase in brain astrocytomas was also 
observed in males at the high dose; however, this effect was not dose-
related, did not reach statistical significance, and there was no 
overall trend. In addition, there were no pre-neoplastic lesions, such 
as glial proliferations, which are a good indicator of chemical tumor 
induction (i.e., there will be changes in the cells prior to 
transformation to a neoplasm). The ovarian adenomas observed at the 
high dose also showed no dose response, no pair-wise significance, no 
decrease in latency, and there were no pre-neoplastic lesions such as 
hyperplasia of the epithelial cells of the endometrium. Additionally, 
there was no evidence of carcinogenicity in male or female mice (at 
doses that were judged to be adequate to assess the carcinogenic 
potential), no concern for mutagenicity (in vivo or in vitro) for the 
parent molecule or the two metabolites, and there were no other lines 
of evidence (such as structure-activity relationship). Although these 
three tumors were considered treatment-related, they provided weak 
evidence of carcinogenicity due to the marginal nature of the tumor 
responses and the other factors mentioned in this unit. Given the weak 
evidence indicating any potential for carcinogenicity, EPA has 
determined that quantification of risk using a non-linear approach 
(i.e., RfD) will adequately account for all chronic toxicity, including 
carcinogenicity, which could result from exposure to penflufen. The 
NOAEL (38 mg/kg/day) used for establishing the chronic RfD is 
approximately 10-fold lower than the dose (approximately 300 mg/kg/day) 
that induced a marginal tumor response. The EPA has determined that the 
chronic population adjusted dose is protective of all long-term 
effects, including potential carcinogenicity.
    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 penflufen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method involves extraction of samples with 
acetonitrile/water, cleanup using solid phase extraction, and analysis 
of penflufen by liquid chromatography/mass spectrometry (LC/MS/MS) (EL-
002-P09-03).

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 penflufen.

C. Revisions to Petitioned-For Tolerances

    Some minor modifications to commodity definitions initially 
submitted were made to be consistent with the updated EPA naming-
conventions for commodities.

V. Conclusion

    Therefore, tolerances are established for residues of penflufen, in 
or on alfalfa, forage; alfalfa, hay; vegetable, tuberous and corm, 
subgroup 1C; vegetable, legume, group 6; vegetable, foliage of legume, 
group 7; grain, cereal, group 15, grain, cereal, forage, fodder and 
straw, group 16; oilseed, group 19; cotton, gin by-products at 0.01 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian

[[Page 28281]]

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: May 3, 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. Section 180.664 is added to subpart C to read as follows:


Sec.  180.664  Penflufen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide penflufen, including its metabolites and degradates, in or on 
the following commodities listed in the table. Compliance with the 
tolerance levels specified in the table is to be determined by 
measuring only penflufen N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-
dimethyl-1H-pyrazole-4-carboxamide, in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.01
Alfalfa, hay................................................        0.01
Cotton, gin by-products.....................................        0.01
Grain cereal, forage, fodder and straw, group 16............        0.01
Grain, cereal, group 15.....................................        0.01
Oilseed, group 20...........................................        0.01
Vegetable, foliage of legume, group 7.......................        0.01
Vegetable, legume, group 6..................................        0.01
Vegetable, tuberous and corm subgroup 1C....................        0.01
------------------------------------------------------------------------

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

[FR Doc. 2012-11629 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P