Cyflumetofen; Pesticide Tolerances, 29103-29108 [2014-11496]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Rules and Regulations]
[Pages 29103-29108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11496]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0269; FRL-9905-80]


Cyflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective May 21, 2014. Objections and 
requests for hearings must be received on or before July 21, 2014, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0269, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2012-0269 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 21, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0269, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 23, 2012 (77 FR 30481) (FRL-9347-8), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 2F7973) 
by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. 
The petition requested that 40 CFR part 180 be

[[Page 29104]]

amended by establishing tolerances for residues of the insecticide 
cyflumetofen (2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate), 
in or on almond, hulls at 4.0 parts per million (ppm); citrus, oil at 
16 ppm; fruit, citrus, group 10 at 0.3 ppm; fruit, pome, group 11 at 
0.3 ppm; grape at 0.6 ppm; grape, raisin at 0.9 ppm; nut, tree, group 
14 at 0.01 ppm; strawberry at 0.6 ppm; and tomato at 0.2 ppm. That 
document referenced a summary of the petition prepared by BASF 
Corporation, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA modified 
some of the tolerance levels and commodity names requested by the 
applicant. The reasons for these changes are 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 including exposure resulting 
from the tolerances established by this action. EPA's assessment of 
exposures and risks associated with 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. The major target organ in rats, mice, and dogs following 
short-term and long-term oral administration of cyflumetofen is the 
adrenal glands characterized by increased organ weight and 
histopathology (vacuolation and hypertrophy of the adrenal cortical 
cells).
    Cyflumetofen has low acute toxicity by oral, dermal, and inhalation 
routes of exposure. It is minimally irritating to the eyes but not to 
the skin. It is a skin sensitizer.
    Decreased serum hormone concentrations (FSH, progesterone, and 17 
[beta]-estradiol) were observed in the mid- and high-dose F1 
females in a rat reproduction study while no hormonal effect was 
observed in the F1 male rats at any dose level. However, 
there were no corresponding changes in reproductive performance at any 
dose level. In the developmental toxicity study in rats, an increased 
incidence of wavy ribs was noted at the high-dose (1,000 milligrams/
kilogram/day (mg/kg/day)), while an increased incidence of incompletely 
ossified sternal centra was observed at the mid- and high-dose levels. 
These incidences occurred in the presence of maternal toxicity. In the 
developmental toxicity study in rabbits, a downward flexion of the 
forepaws and/or hind paws was observed in the high-dose (1,000 mg/kg/
day) group pups and delays in skeletal ossification were observed in 
pups at the mid- and high-doses. Maternal toxicity (adrenal effects) 
was also observed at the mid- and high- doses.
    No evidence of neurotoxicity or immunotoxicity was observed in any 
of the submitted studies for cyflumetofen.
    Although there is some evidence of thyroid tumors in rats, the 
Agency has determined that quantification of risk using a non-linear 
approach (i.e., reference dose (RfD)) will adequately account for all 
chronic toxicity, including carcinogenicity, that could result from 
exposure to cyflumetofen. This conclusion is based on the following 
reasons. The single tumor type (thyroid c-cell) occurred in only one 
sex (male) and one species (rat). This tumor effect was seen only at 
high doses (250 mg/kg/day), which far exceeds the chronic no-observed-
adverse-effect-level (NOAEL) the Agency is using for its risk 
assessment (16.5 mg/kg/day). And there is no concern for mutagenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyflumetofen as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at https://www.regulations.gov in document ``Cyflumetofen: 
New Active Ingredient Human Health Risk Assessment to Support Uses on 
Citrus (Crop Group 10-10), Pome Fruits Crop Group 11-10), Tree Nuts 
(Crop Group 14-12), Grape, Strawberry, and Tomato'' section IV, pg. 12 
in docket ID number EPA-HQ-OPP-2012-0269.

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 the NOAEL and the LOAEL are identified. 
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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for Cyflumetofen used for 
human risk assessment is shown in the following Table 1 of this unit.

[[Page 29105]]



    Table 1--Summary of Toxicological Doses and Endpoints for Cyflumetofen for Use in FFDCA Human Health Risk
                                                   Assessment
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                                                  Uncertainty/   RfD, PAD, level
      Exposure/scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
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Acute Dietary (All                  An acute reference dose has not been established for either the general
 populations).                    population or for Females 13-49 years of age since there were no appropriate
                                studies that demonstrated evidence of toxicity attributable to a single dose for
                                                               these populations.
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Chronic Dietary (All           NOAEL = 16.5 mg/ UFA = 10x......  Chronic RfD =    Three co-critical studies:
 Populations).                  kg/day.         UFH = 10x......   0.17 mg/kg/day. 90-day feeding study in rats:
                                                FQPA SF = 1x...  cPAD = 0.17 mg/  LOAEL = 54.5/62.8 mg/kg/day (M/
                                                                  kg/day.          F) based on hematology and
                                                                                   organ weight changes in the
                                                                                   liver, adrenal, kidney and
                                                                                   ovaries; and histopathology
                                                                                   effects in the adrenals and
                                                                                   the ovaries. NOAEL = 16.5/19
                                                                                   mg/kg/day (M/F).
                                                                                  Chronic toxicity/
                                                                                   carcinogenicity study in
                                                                                   rats:
                                                                                  LOAEL = 49.5/61.9 mg/kg/day in
                                                                                   (M/F) based on increased
                                                                                   adrenal weights and
                                                                                   histopathology. NOAEL = 16.5/
                                                                                   20.3 mg/kg/day (M/F).
                                                                                  Two generation reproduction
                                                                                   study in rats:
                                                                                  Parental: LOAEL = 30.6/46.6 mg/
                                                                                   kg/day (M/F) based on
                                                                                   increased organ weight and
                                                                                   histopathology in adrenals.
                                                                                   NOAEL = 9.2/13.8 mg/kg/day (M/
                                                                                   F).
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Inhalation (Short-,            NOAEL = 16.5 mg/ UFA = 10x......  LOC for MOE =    Same as chronic dietary
 Intermediate- and Long-Term).  kg/day.         UFH = 10x......   100.             endpoint.
                                                FQPA SF = 1x...
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,          The quantification of risk using a non-linear approach (i.e., cRfD) will
 inhalation).                   adequately account for all chronic toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyflumetofen, EPA considered exposure under the petitioned-
for tolerances in 40 CFR 180. EPA assessed dietary exposures from 
cyflumetofen 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 cyflumetofen; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 2003-2008 
food consumption data from the U.S. Department of Agriculture's 
(USDA's) National Health and Nutrition Examination Survey, What We Eat 
in America, (NHANES/WWEIA). The partially refined chronic analysis 
conducted was based on tolerance-level residues, 100% percent crop 
treated (PCT) assumptions, and both empirically derived and default 
processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., the 
Agency has determined that quantification of risk using a nonlinear 
approach (i.e., RfD) would adequately account for all chronic toxicity, 
including carcinogenicity, that could result from exposure to 
cyflumetofen. Therefore, a separate cancer dietary exposure analysis 
was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for cyflumetofen. 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 cyflumetofen in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyflumetofen. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentrations in Ground Water Model 
as well as Pesticide Root Zone Model--Groundwater, the estimated 
drinking water concentrations (EDWCs) of cyflumetofen for chronic 
exposure assessments are estimated to be 0.33 parts per billion (ppb) 
for surface water and 0.0024 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.33 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). EPA assessed 
residential exposure using the following assumptions: The use of 
cyflumetofen on ornamentals in residential landscapes may result in 
residential handler exposure. Residential handler exposure is expected 
to be short-term in duration as

[[Page 29106]]

intermediate- or long-term exposures are not likely because of the 
intermittent nature of applications by homeowners. The quantitative 
exposure/risk assessment developed for residential handlers is based on 
the following scenarios:
     Mixing/loading/applying liquid to ornamentals with hose-
end sprayer.
     Mixing/loading/applying liquid to ornamentals with 
manually-pressurized handwand.
     Mixing/loading/applying liquid to ornamentals with 
backpack.
     Mixing/loading/applying liquid to ornamentals with a 
sprinkler can.
    Since no dermal hazard was identified for cyflumetofen in the 
toxicological database, only inhalation exposure assessments were 
conducted for residential handlers. EPA did not assess post-application 
exposure from the use of cyflumetofen in residential settings because:
    1. No dermal hazard was identified in the toxicity database for 
cyflumetofen, so a quantitative residential post-application dermal 
risk assessment is not required;
    2. Post-application inhalation exposure while performing activities 
in previously treated gardens was not assessed due to the low vapor 
pressure and the expected dilution in outdoor air after an application 
has occurred;
    3. The potential for post-application non-dietary ingestion 
exposure for children (1 < 2 years old) is greatly diminished since 
young children are not expected to engage in the types of activities 
associated with these areas (e.g., gardening) or utilize these areas 
for prolonged periods of play.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://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 cyflumetofen to share a common mechanism of 
toxicity with any other substances, and cyflumetofen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyflumetofen does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of 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 qualitative or quantitative susceptibility in the rat 2-
generation reproduction study; however, the rat and rabbit 
developmental studies indicate susceptibility in the pups. There is 
evidence of increased quantitative susceptibility in the rabbit 
developmental toxicity study, since developmental effects (changes in 
ossicification, paw flexion, and decreased fetal body weights) at the 
limit dose were observed where no maternal toxicity was present. There 
is evidence of increased qualitative susceptibility in the rat 
developmental toxicity study as developmental effects (increased 
incidence of incompletely ossified sternal centra) were seen at the 
same dose that caused an increase in adrenal weights and organ-to-body 
weight ratio in the maternal animals. Notwithstanding, the degree of 
concern for these effects in infants and children is low because the 
rat and rabbit developmental effects have clearly defined NOAEL/LOAELs 
and the dose selected for chronic risk assessment is protective of 
these effects. Therefore, the PODs based on adrenal effects in rat are 
health protective of all lifestages.
    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 cyflumetofen is complete.
    ii. There is no indication that cyflumetofen is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is some evidence that cyflumetofen results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies. However, as described in Unit III.D.2., because 
of the low degree of concern for these effects, it is not necessary to 
retain the 10X FQPA factor to adequately protect infants and children.
    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 cyflumetofen in drinking water. These assessments 
will not underestimate the exposure and risks posed by cyflumetofen.

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 and no acute dietary endpoint was selected. Therefore, 
cyflumetofen 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 
cyflumetofen from food and water will utilize 2.3% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
cyflumetofen 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

[[Page 29107]]

(considered to be a background exposure level).
    Cyflumetofen is currently proposed 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 cyflumetofen.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures are above the Level of Concern (LOC) of 100 
and are not of concern (MOEs >= 100).
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
cyflumetofen is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the data 
summarized in Unit III.A., EPA has concluded that the cPAD is 
protective of potential cancer effects. Given the results of the 
chronic risk assessment, cyflumetofen is not expected to pose a cancer 
risk.
    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 cyflumetofen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
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 cyflumetofen.

C. Revisions to Petitioned-For Tolerances

    EPA revised the commodity names for the requested tolerances 
consistent with its policy to establish crop group tolerances using the 
most recently established crop groups. This policy was explained in the 
most recent rulemaking establishing crop groups in the Federal Register 
on August 22, 2012 (77 FR 50617) (FRL-9354-3). Under this policy, 
rather than establish new tolerances under the pre-existing crop 
groups, EPA intends to conform petitions seeking tolerances for crop 
groups to the newer established crop groups, as part of its effort to 
eventually convert tolerances for any pre-existing crop group to 
tolerances with coverage under the revised crop group. Therefore, 
although the petitioner had requested tolerances on fruit, citrus, 
group 10; fruit, pome, group 11; and nut, tree, group 14. EPA evaluated 
and is establishing tolerances for fruit, citrus, group 10-10; fruit, 
pome, group 11-10; and nut, tree, group 14-12, respectively.
    The petitioner requested a tolerance of 0.2 ppm for tomato based on 
residues found in tomatoes that had been frozen and stored in 
accordance with OECD Guideline 506 (October 16, 2007) to account for 
residue loss that may have occurred during storage. EPA is establishing 
a tolerance for tomato at 0.40 ppm. In addition, EPA is not 
establishing a separate tolerance for grape, raisin of 0.9 ppm, as 
requested, since the tolerance for the raw agricultural commodity grape 
at 0.60 ppm is adequate to account for any residue concentration shown 
in the processed commodity.

V. Conclusion

    Therefore, tolerances are established for residues of cyflumetofen, 
in or on almond, hulls at 4.0 ppm; citrus, oil at 16 ppm; grape at 0.60 
ppm; fruit, citrus, group 10-10 at 0.30 ppm; fruit, pome, group 11-10 
at 0.30 ppm; nut, tree, group 14-12 at 0.01 ppm; strawberry at 0.60 
ppm; and tomato at 0.40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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

[[Page 29108]]

as described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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 9, 2014.
Jack Housenger,
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 180.677 is added to subpart C to read as follows:


Sec.  180.677  Cyflumetofen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide cyflumetofen, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels for cyflumetofen is to be determined by measuring only 
cyflumetofen, 2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
dimethylethyl)phenyl]-[beta]-oxo-2-(trifluoromethyl)benzenepropanoate, 
in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................          4.0
Citrus, oil................................................           16
Fruit, citrus, group 10-10.................................         0.30
Fruit, pome, group 11-10...................................         0.30
Grape......................................................         0.60
Nut, tree, group 14-12.....................................         0.01
Strawberry.................................................         0.60
Tomato.....................................................         0.40
------------------------------------------------------------------------

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

[FR Doc. 2014-11496 Filed 5-20-14; 8:45 am]
BILLING CODE 6560-50-P