[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Rules and Regulations]
[Pages 31479-31485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13587]



40 CFR Part 180

[EPA-HQ-OPP-2010-0426; FRL-8873-5]

Pyraflufen-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
pyraflufen-ethyl in or on multiple commodities which are identified and 
discussed later in this document. Nichino America, Inc., requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 

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

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0426. 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) 

FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; e-mail address: 


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 

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an

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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-2010-0426 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 
August 1, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0426, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 23, 2010 (75 FR 35801) (FRL-8831-
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 
0F7718) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be 
amended by establishing tolerances for residues of the herbicide, 
pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate and its acid metabolite, 
E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-
4-fluorophenoxyacetic acid, expressed in terms of the parent, in or on 
almond hulls at 0.02 parts per million (ppm); nuts, tree, group 14 at 
0.01 ppm; pistachio at 0.01 ppm; fruit, pome, group 11 at 0.01 ppm; 
fruit, stone, group 12 at 0.01 ppm; pomegranates at 0.01 ppm; olives at 
0.01 ppm; grapes at 0.01 ppm, and hops at 0.05 ppm. The notice 
referenced a summary of the petition prepared by Nichino America, Inc., 
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 is not 
establishing, at this time, the requested hop tolerance due to the lack 
of field trial information for the hop study. EPA is updating the 
proposed crop commodities terminology. The reason for the 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 pyraflufen-ethyl 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
pyraflufen-ethyl 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 
    Pyraflufen-ethyl has low to moderate toxicity from acute exposure 
and it is not a dermal sensitizer. The liver, kidney, and possibly the 
hematopoietic system are the target organs for pyraflufen-ethyl in the 
rat and/or the mouse. There is no evidence of increased sensitivity to 
the young in developmental and reproductive studies with pyraflufen-
ethyl. Pyraflufen-ethyl was not shown to be mutagenic in a battery of 
tests. Pyraflufen-ethyl was classified as ``Likely to be Carcinogenic 
to Humans'' based on male mouse hepatocellular adenomas, carcinomas 
and/or hepatoblastomas (combined) observed in the mouse carcinogenicity 
study. The method of quantification was linear cancer slope factor 
    Specific information on the studies received and the nature of the 
adverse effects caused by pyraflufen-ethyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Pyraflufen-ethyl: Human Health 
Risk Assessment for a Section 3 Registration of New Food Uses on Tree 
Nuts (Crop Group 14), Pistachios, Pome Fruit (Crop Group 11-10), And 
Stone Fruits (Crop Group 12), Hops, Grapes, Olives And Pomegranates,'' 
at page 17 in docket ID number EPA-HQ-OPP-2010-0426.

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 
pesticides. 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

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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 Pyraflufen-ethyl used 
for human risk assessment is shown in the following Table.

      Table--Summary of Toxicological Doses and Endpoints for Pyraflufen-Ethyl for Use in Human Health Risk
                                      Point of departure
         Exposure/scenario            and  uncertainty/      RfD, PAD, LOC for        Study and toxicological
                                        safety factors        risk assessment                 effects
Acute dietary (General population   None.................  None.................  An endpoint attributable to a
 including infants and children).                                                  single dose was not
                                                                                   identified from the available
Chronic dietary (All populations).  NOAEL = 20 mg/kg/day.  Chronic RfD = 0.20 mg/ Mouse Carcinogenicity LOAEL =
                                    UFA = 10x............   kg/day.                98 mg/kg/day based on liver
                                    UFH = 10x............  cPAD = 0.2 mg/kg/day.   toxicity.
                                    FQPA SF = 1x.........
Incidental oral short-term (1 to    NOAEL = 20 mg/kg/day.  LOC for MOE = 100....  Developmental Toxicity-Rabbit
 30 days).                          UFA = 10x............                          LOAEL = 60 mg/kg/day based on
                                    UFH = 10x............                          decreases in body weight and
                                    FQPA SF = 1x.........                          food consumption, GI
                                                                                   observations, and abortions.
Incidental oral intermediate-term   NOAEL = 20 mg/kg/day.  LOC for MOE = 100....  Mouse Carcinogenicity LOAEL =
 (1 to 6 months).                   UFA= 10x.............                          98 mg/kg/day based on liver
                                    UFH= 10x.............                          toxicity at interim
                                    FQPA SF = 1x.........                          sacrifice.
Dermal (All Durations)............  None.................  None.................  In a 28-day dermal toxicity
                                                                                   study in rats, no dermal or
                                                                                   systemic toxicity was seen at
                                                                                   the Limit Dose (1,000 mg/kg/
Inhalation (All Durations)........  Maternal NOAEL= 20 mg/ LOC for MOE            Developmental Toxicity-Rabbit
                                     kg/day.                (residential) = 100.   LOAEL = 60 mg/kg/day based on
                                    UFA = 10x............                          decreases in body weight and
                                    UFH = 10x............                          food consumption, GI
                                    FQPA SF = 1x.........                          observations, and abortions.
Cancer (Oral, dermal, inhalation).  Classification: ``Likely to be Carcinogenic to Humans'' by the oral route.
                                     Q1* = 3.32 x 10-2 (mg/kg/day)-1
GI = gastrointestinal. 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. LOC = level of concern.
  Mg/Kg/Day = milligram/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyraflufen-ethyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing pyraflufen-ethyl 
tolerances in 40 CFR 180.585. EPA assessed dietary exposures from 
pyraflufen-ethyl 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.
    No such effects were identified in the toxicological studies for 
pyraflufen-ethyl; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the following assumptions: 100 percent crop treated 
(PCT) and tolerance-level residues for pyraflufen-ethyl on all treated 
crops except corn, cottonseed, potato, soybean, wheat, pome fruit, 
stone fruit, pomegranate, olive, grape, tree nuts and pistachio for 
which one half of the combined Levels of Quantification (LOQs) for the 
parent and the metabolite were used since all field trial residue 
levels were less than the LOQ.
    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. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or non-linear approach is used and a cancer RfD is calculated 
based on an earlier noncancer 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 pyraflufen-ethyl should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk.
    In conducting the cancer dietary exposure assessment EPA used the 
same food consumption data from the U.S. Department of Agriculture 
(USDA) and assumptions for residue levels in food as the chronic 
exposure in Unit III. C. 1. ii., above.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pyraflufen-ethyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of pyraflufen-ethyl. Further information

[[Page 31482]]

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), 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, 
the estimated drinking water concentrations (EDWCs) of pyraflufen-ethyl 
for acute exposures are estimated to be 1,247 parts per trillion (ppt) 
for surface water and 1.8 ppt for ground water and for chronic 
exposures for non-cancer and cancer assessments, the EDWCs are 
estimated to be 281 ppt for surface water and 1.8 ppt for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic and cancer dietary 
risk assessment, the water concentration of value 281 ppt 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).
    Pyraflufen-ethyl is currently registered on the following 
residential sites that could result in residential exposures: Airports, 
nurseries, ornamental turf, golf courses, roadsides, railroads, non-
crop land, and uncultivated agricultural areas. The risk assessment was 
conducted using the following residential exposure assumptions: Adults 
and children may be exposed to residues of pyraflufen-ethyl through 
short term post application contact with treated residential/
recreational areas and residential handlers mixing, loading and 
applying liquid pyraflufen-ethyl in these areas.
    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 pyraflufen-ethyl to share a common mechanism of 
toxicity with any other substances, and pyraflufen-ethyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
pyraflufen-ethyl 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 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the developmental studies with pyraflufen-ethyl. There is 
no evidence of increased susceptibility of young rats in the 
reproduction study with pyraflufen-ethyl. EPA concluded there are no 
residual uncertainties for prenatal and/or postnatal exposure.
    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 
    i. The toxicity database for pyraflufen-ethyl is complete except 
for a 28-day inhalation study, acute and subchronic neurotoxicity 
studies and immunotoxicity study which are now included under 40 CFR 
158.500 as part of the toxicology data requirements for registration of 
a pesticide (food and non-food uses).
    In the absence of a route specific inhalation toxicity study, a 
point of departure (POD) for inhalation exposure risk assessment has 
been extrapolated from an oral study. EPA does not believe the 
aggregate risk assessment is under-protective of adult handlers. 
Residential handler MOEs based on the extrapolated endpoint are quite 
high (greater than 35 million), and the contribution of residential 
exposure to aggregate risk is small. Therefore, even if an inhalation 
study were to provide a lower POD than the oral study, it's not 
expected to have a significant impact on aggregate risk.
    ii. Pyraflufen-ethyl primarily impacts the parameters of food 
consumption, decreased body weight, and histopathological changes in 
the liver. There is no evidence that pyraflufen-ethyl causes neurotoxic 
effects in any of the available toxicity studies. Evidence of 
immunotoxic potential is limited to an adverse effect on the spleen 
reported in one study at a dose level (1,489 mg/kg/day) which is above 
the limit dose, and also caused death. EPA does not believe that 
conducting immunotoxicity and acute/subchronic neurotoxicity testing 
will result in a NOAEL less than 20 mg/kg/day, which is presently used 
as the POD for chronic risk assessment.
    iii. There is no evidence that pyraflufen-ethyl results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% of the crop treated and a conservative estimate of residues in 
food. EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to pyraflufen-ethyl in 
drinking water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by pyraflufen-ethyl.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified

[[Page 31483]]

and no acute dietary endpoint was selected. Therefore, pyraflufen-ethyl 
is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
pyraflufen-ethyl from food and water will utilize less than 1% of the 
cPAD for all population groups. Based on the explanation in Unit 
III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of pyraflufen-ethyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Pyraflufen-
ethyl is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to pyraflufen-ethyl.
    A short-term aggregate risk assessment was performed for 
residential handler exposure, children's incidental post-application 
oral exposure (from residential treatment) and dietary exposure to food 
and water (considered to be a background exposure level). The 
anticipated exposure level for children ages 1-2 years old (the highest 
exposed population) is below EPA's level of concern, with a MOE greater 
than 60,000.
    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 
    Pyraflufen-ethyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. No residential 
handler exposure is expected and post application inhalation exposure 
is expected to be negligible. Post application exposure to infants and 
children over the intermediate term duration (1-6 months) is not likely 
based on the use pattern. Therefore, the intermediate-term aggregate 
risk is the sum of the risk from exposure to pyraflufen-ethyl through 
food and water, which has already been addressed, and will not be 
greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. The aggregate cancer 
risk assessment for the general population takes into account exposure 
estimates from dietary consumption of pyraflufen-ethyl from food and 
drinking water sources. Average food plus water source dietary exposure 
was used. Estimated cancer risk for the U.S. population includes 
infants and children. The aggregate cancer risk estimate for 
pyraflufen-ethyl is 2.8 x 10-6. This risk estimate is based, 
in part, on the conservative assumption that 100% of all crops for 
which pyraflufen-ethyl is registered or proposed for registration are 
treated. Additional refinement using PCT estimates would result in a 
lower estimate of cancer risk.
    EPA generally considers cancer risks in the range of one in one 
million (1 x 10-6) or less to be negligible. The precision 
which can be assumed for cancer risk estimates is best described by 
rounding to the nearest integral order of magnitude on the log scale; 
for example, risks falling between 3 x 10-7 and 3 x 
10-6 are expressed as risks in the range of 10-6. 
Considering the precision with which cancer hazard can be estimated, 
the conservativeness of low-dose linear extrapolation, and the rounding 
procedure described above, cancer risk should generally not be assumed 
to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. This is particularly the case where some conservatism 
is maintained in the exposure assessment. Although the pyraflufen-ethyl 
exposure risk assessment is somewhat refined, it retains significant 
conservatism due, among other things, to the assumption that 100 
percent of registered crops are treated. Accordingly, EPA has concluded 
the cancer risk for all existing pyraflufen-ethyl uses and the uses 
associated with the tolerances established in this action fall within 
the range of 1 x 10-6 and are thus negligible.
    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 pyraflufen-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography with Mass 
Spectrometry (GC/MS)) is available to enforce the tolerance expression. 
The method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 

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 pyraflufen-ethyl. Canada 
has not established MRLs for the proposed use sites for pyraflufen-

C. Revisions to Petitioned-for Tolerances

    In the Federal Register of December 8, 2010 (75 FR 76284) (FRL-
8853-8), EPA issued a final rule that revised the crop grouping 
regulations. As part of this action, EPA expanded and revised the 
existing pome fruit group 11. Changes to crop group 11 included adding 
azarole; medlar; Asian pear; Chinese quince; Japanese quince; and 
tejocote; creating subgroups; revising the representative commodities; 
and naming the new crop group, Pome Fruit Group 11-10. Therefore, 
consistent with this rule, EPA is establishing tolerances for 
pyraflufen-ethyl residues on Pome Fruit Group 11-10 instead of the 
requested Pome Fruit Group 11 and is correcting the crops proposed in 
the Notice of Filing to the crop commodities specified in 40 CFR 
180.41: grape; nut, tree, group 14; olive and pomegranate.

 V. Conclusion

    Therefore, previously established tolerances are amended and new 
tolerances are established for residues of pyraflufen-ethyl, including 
its metabolites and degradates, 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,

[[Page 31484]]

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, 44 U.S.C. 
3501 et seq., nor does it require any special considerations under 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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, 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 18, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. Section 180.585 is amended by revising the introductory text of 
paragraph (a) and by alphabetically adding commodities to the table in 
paragraph (a) to read as follows:

Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, pyraflufen-ethyl, including its metabolites and degradates, 
in the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring pyraflufen-
ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid metabolite, E-1, 2-
fluorophenoxy]acetic acid, in or on the commodity:

                                    Parts per     Expiration/ revocation
           Commodity                 million               date
Almond, hulls.................              0.02  None.
                              * * * * * * *
Fruit, pome, group 11-10......              0.01  None.
Fruit, stone, group 12........              0.01  None.
Grape.........................              0.01  None.
                              * * * * * * *
Nut, tree, group 14...........              0.01  None.
Olive.........................              0.01  None.
Pistachio.....................              0.01  None.
Pomegranate...................              0.01  None.
                              * * * * * * *

[[Page 31485]]

* * * * *
[FR Doc. 2011-13587 Filed 5-31-11; 8:45 am]