Document ID: EPA-HQ-OPP-2011-0985-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flonicamid
Posted Date: 2012-11-14T05:00Z

[Federal Register Volume 77, Number 220 (Wednesday, November 14, 2012)]
[Rules and Regulations]
[Pages 67771-67777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27702]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0985; FRL-9368-7]

Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flonicamid in or on Berry, low growing, subgroup 13-07G; Rapeseed 
subgroup 20A, and cucumber. Interregional Research Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 14, 2012. Objections and 
requests for hearings must be received on or before January 14, 2013, 
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-2011-0985, is available at http://www.regulations.gov or at the Office of Pesticide Programs

[[Page 67772]]

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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; email address: jackson.sidney@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 http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0985 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 
January 14, 2013. 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-2011-0985, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (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 http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, March 14, 2012 (77 FR 15012) 
(FRL-9335-9), 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 1E7842) by IR-4, IR-4 Project Headquarters, 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested 
that 40 CFR 180.613 be amended by establishing tolerances for combined 
residues of the insecticide, flonicamid, N-(cyanomethyl)-4-
(trifluoromethyl)-3-pyridinecarboxamide and its metabolites TFNA, 4-
trifluoromethylnicotinic acid, TFNA-AM, 4-trifluoromethylnicotinamide, 
TFNG, N-(4-trifluoromethylnicotinoyl)glycine, in or on cucumber at 1.3 
parts per million (ppm), Berry, low growing subgroup 13-07G at 1.4 and 
Rapeseed subgroup 20A at 1.5 ppm. That document referenced a summary of 
the petition prepared by ISK Biosciences, 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 and/or 
current Agency policies, EPA has revised/modified the petitioned-for 
flonicamid residue tolerance level in certain commodities and revised 
the tolerance expression for flonicamid residues. EPA is also revising 
the existing crop group tolerance on ``Vegetable, cucurbit, group 9'' 
to exclude cucumbers. The reasons for these changes are explained in 
Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Consistent with 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 flonicamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flonicamid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also

[[Page 67773]]

considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    Flonicamid has low acute toxicity via the oral, inhalation and 
dermal routes of exposure. Flonicamid is nonirritating to the eye and 
skin and is not a dermal sensitizer. Its metabolites, TFNA, TFNA-AM, 
TFNG, TFNG-AM, and TFNA-OH, also demonstrated low toxicity in acute 
oral toxicity studies. In the 28-day dermal study with flonicamid 
technical no dermal or systemic toxicity was seen at the limit dose. In 
oral studies using rats and dogs, the kidney and liver are the target 
organs for flonicamid toxicity. Increased kidney weight and hyaline 
droplet deposition were observed as well as liver centrilobular 
hypertrophy in the rat 28-day oral range-finding, 90-day oral, 
developmental, and reproductive studies. The 90-day dog study showed 
kidney tubular vacuolation as well as increased adrenal weights, 
increased reticulocytes and decreased thymus weights. Increased 
reticulocyte count was noted in both the subchronic and chronic dog 
studies.
    In rats, developmental effects including increased incidence of 
cervical ribs were observed at maternally toxic (liver and kidney gross 
and histopathological effects) dose levels. In rabbits, developmental 
effects were not observed at any dose level including maternally toxic 
doses. Offspring effects (decreased body weight and delayed sexual 
maturation) in the multi-generation study were seen only in the 
presence of parental toxicity (kidney effects in males, blood effects 
in females). Thus, there is no evidence that flonicamid results in 
increased susceptibility (qualitative or quantitative) in in utero rats 
or rabbits in the prenatal developmental studies or in young rats in 
the 2-generation reproduction study.
    There are no concerns for flonicamid neurotoxicity. Although 
clinical signs suggesting potential neurotoxic effects (e.g., decreased 
motor activity, tremors) were seen in the acute and subchronic 
neurotoxicity studies; other effects in these studies (e.g., increased 
mortality, and significant decreases in food consumption and body 
weight) indicated that the clinical signs were a result of the animals 
being in an extreme condition or otherwise compromised and in a state 
of general malaise. Also, these types of effects were not observed in 
the other subchronic or chronic studies in mice, rats or dogs. Thus, 
there is not clear evidence of neurotoxicity. Lastly, clear no-
observed-adverse-effect-levels (NOAELs) and lowest-observed-adverse-
effect-levels (LOAELs) were defined for the clinical signs, which are 
above the levels currently used for risk assessment purposes. 
Preliminary results of a 28-day oral (dietary) immunotoxicity study of 
technical flonicamid in female CD-1 mice suggest that flonicamid is not 
an immuno-suppressant, either structurally or functionally up to and 
including dose levels exceeding the Limit Dose.
    Although there is some limited evidence suggesting that flonicamid 
has a potential for carcinogenic effects, EPA determined that 
quantification of risk using a non-linear approach (i.e., using a 
chronic reference dose (cRfD)) adequately accounts for all chronic 
toxicity, including carcinogenicity that could result from exposure to 
flonicamid. The following considerations support that determination. 
First, mutagenicity studies were negative for the parent chemical, 
flonicamid, and its metabolites, TFNA, TFNA-AM, TFNG, TFNG-AM, and 
TFNA-OH. Second, although flonicamid is carcinogenic in CD-1 mice, 
based on increased incidences of lung tumors associated with Clara cell 
activation, this tumor type is associated with species and strain 
sensitivity and is not directly correlated with cancer risks in humans. 
Third, nasal cavity tumors seen in male Wistar rats were linked to 
incisor inflammation and not considered to be treatment related. These 
tumor findings were confounded by the lack of a dose-response and the 
biological significance is questionable.
    Specific information on the studies received and the nature of the 
adverse effects caused by flonicamid as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at http://www.regulations.gov in 
document, ``Flonicamid: Human Health Risk Assessment for the Proposed 
Use on Low Growing Berry, Rapeseed, and Greenhouse Grown Cucumbers'' at 
page 29 in docket ID number EPA-HQ-OPP-2011-0985.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flonicamid used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Flonicamid for Use in Human Health Risk Assessment
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                                   POD and uncertainty/   RfD, PAD, LOC for
        Exposure/scenario             safety factors       risk assessment      Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  None/NA.............  None/NA............  No toxicological effects seen in a
 including infants and children).                                              single dose study.
Chronic dietary (All populations)  NOAEL= 3.7 mg/kg/day  cRfD = 0.04 mg/kg/   2-Generation reproduction rat
                                   UFA = 10x...........   day.                 study.
                                   UFH = 10x...........  cPAD = 0.04 mg/kg/   Parental LOAEL = 22 mg/kg/day
                                   FQPA SF = 1x........   day.                 based on increased kidney
                                                                               weights, kidney hyaline
                                                                               deposition, increased blood serum
                                                                               LH (F1 females).

[[Page 67774]]

 
Cancer...........................  A nonlinear RfD approach was used to assess cancer risk.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. POD = Point of Departure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR 
180.613. EPA assessed dietary exposures from flonicamid 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 flonicamid; 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 U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Continuing Service of Food 
Intake by Individuals (CSFII). As to residue levels in food, EPA used 
an unrefined chronic dietary assessment conducted assuming 100 percent 
crop treated (PCT) estimates, tolerance-level residues for all 
commodities, and empirical or Dietary Exposure Evaluation Model-Food 
Commodity Intake Database (DEEM-FCIDTM) default processing 
factors.
    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 nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear 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 
determine 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 nonlinear RfD approach is appropriate 
for assessing cancer risk to flonicamid. Cancer risk was assessed using 
the same exposure estimates as discussed in Unit III.C.1.ii., chronic 
exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for flonicamid. Tolerance-level residues and 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 flonicamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flonicamid. 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.
    The drinking water assessment was conducted using a parent only and 
total toxic residues of flonicamid (flonicamid TTR) approach. Total 
toxic residues include TFNA, TFNA-AM, TFNA-OH, TFNG, and TFNG-AM.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) Screening Concentration in Ground Water (SCI-GROW) 
models, the estimated drinking water concentrations (EDWCs) of total 
toxic residues of flonicamid for chronic exposures for non-cancer 
assessments are estimated to be 1.9 parts per billion (ppb) for surface 
water and 0.00132 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 1.9 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). Flonicamid is 
currently registered for the following uses that could result in non-
occupational exposures: Commercial ornamentals, interiorscapes, and 
nurseries. However, these product labels do not allow use in home 
gardens and greenhouses or in any residential settings. Therefore, 
residential handler scenarios are not expected and need not be 
assessed. Additionally, because no dermal toxicity endpoint was 
identified for flonicamid, a post-application residential exposure/risk 
assessment is not necessary. Post-application inhalation exposures are 
expected to be negligible. Therefore, no residential exposure is 
expected.
    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 flonicamid to share a common mechanism of 
toxicity with any other substances, and flonicamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
flonicamid 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

[[Page 67775]]

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. The prenatal and postnatal 
toxicity database for flonicamid includes prenatal developmental 
toxicity studies in rats and rabbits and a multi-generation 
reproduction toxicity study in rats. There is no evidence that 
flonicamid results in increased susceptibility (qualitative or 
quantitative) in in utero rats or rabbits in the prenatal developmental 
studies or in young rats in the multi-generation reproduction study. No 
developmental effects were seen in rabbits. In the multi-generation 
reproduction study, developmental delays in the offspring (decreased 
body weights, delayed sexual maturation) were seen only in the presence 
of parental toxicity (kidney and blood effects). Also, there are clear 
NOAELs and LOAELs for all effects. The degree of concern for prenatal 
and/or post-natal susceptibility is, therefore, low due to the lack of 
evidence of qualitative and quantitative susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for chronic dietary and other exposures, 
except as noted below. That decision is based on the following 
findings:
    i. The toxicity database for flonicamid is complete except for an 
immunotoxicity study and a subchronic inhalation study. Existing data 
are sufficient for endpoint selection for exposure/risk assessment 
scenarios, and for evaluation of the requirements under the FQPA. 
Except for decreased thymus weights in the subchronic dog study, there 
are no other indications in the available studies that organs 
associated with immune function are affected by flonicamid, and 
preliminary results of the above-mentioned immunotoxicity study 
suggested that flonicamid is not an immunosuppressant. EPA does not 
believe that the final results of the immunotoxicity study will result 
in a dose less than the point of departure already used in this risk 
assessment and an additional database uncertainty factor for potential 
immunotoxicity does not need to be applied.
    A subchronic 28-day inhalation study is required and is outstanding 
at this time. In the absence of a route specific inhalation study, EPA 
has retained a 10X FQPA SF to assess risks for inhalation exposure 
scenarios. However, residential inhalation exposures are not expected.
    ii. The available data base includes acute and subchronic 
neurotoxicity studies. As discussed in Unit III.A., EPA has concluded 
that the clinical signs observed in those studies were not the result 
of a neurotoxic mechanism and that therefore a developmental 
neurotoxicity study is not required.
    iii. There was no evidence for quantitative or qualitative 
susceptibility following oral exposures to rats in utero or oral 
exposure to rabbits in utero.
    iv. There are no residual uncertainties identified in the exposure 
databases. An unrefined conservative chronic dietary exposure 
assessment for food and drinking water was conducted, assuming 
tolerance level residues for all existing and proposed commodities and 
100 PCT of registered and proposed crops treated. The drinking water 
assessment utilized water concentration values generated by models and 
associated modeling parameters which are designed to produce 
conservative, health protective, high-end estimates of water 
concentrations which are not likely to be exceeded. The dietary (food 
and drinking water) exposure assessment does not underestimate the 
potential exposure for infants, children, or women of child bearing 
age.

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. An endpoint attributable to a single oral dose was not 
identified in the toxicity database; therefore, flonicamid 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 
flonicamid from food and water will utilize 11% of the cPAD for the 
general U.S. population and 28% of the cPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure. There are no 
expected long-term residential exposures. Because drinking water 
estimates have been combined with dietary exposures, the dietary 
assessment discussed in Unit III.C.3., serves as the aggregate exposure 
and risk assessment for flonicamid.
    3. Short-term and Intermediate-term risk. Short- and intermediate-
term aggregate exposures take into account short- and intermediate-term 
residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term aggregate risk assessments were not conducted because 
residential exposure is not expected from the use pattern proposed in 
this registration request, or from any registered uses.
    4. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA has concluded that the cPAD is 
protective of possible cancer effects.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available to enforce the 
tolerances for flonicamid and the major metabolites in plants and 
livestock. The proposed method for plants uses Liquid Chromatography 
with Tandem Mass Spectrometry (LC/MS/MS) (FMC No. P-3561M) to determine 
the residues of flonicamid and its major metabolites, TFNA-AM, TFNA, 
and TFNG.
    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

[[Page 67776]]

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.
    There are no Codex MRLs established on the proposed crops.

C. Revisions to Petitioned-For Tolerances

    Based on results from the Organization for Economic Cooperation and 
Development (OECD) spreadsheet tolerance calculation procedures, EPA 
modified certain IR-4 proposed tolerances for flonicamid residues. EPA 
increased the proposed tolerance from 1.4 to 1.5 ppm for Berry, low 
growing, subgroup 13-07G and from 1.3 to 1.5 ppm for cucumber. Because 
there is an existing crop group tolerance for ``Vegetable, cucurbit, 
group 9'' that applies to cucumbers, EPA, for the sake of clarity, is 
revising that existing crop group tolerance to exclude cucumbers.
    Finally, EPA has revised the tolerance expression to clarify (1) 
that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of flonicamid not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for the residues of 
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, 
and its metabolites TFNA (4- trifluoromethylnicotinic acid, TFNA-AM (4-
trifluoromethylnicotinamide) and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, in or on cucumber at 1.5 ppm; Berry, 
low growing, subgroup 13-07G at 1.5 ppm; and Rapeseed subgroup 20A at 
1.5 ppm. Additionally, the tolerance entry for Vegetable, cucurbit 
group 9, is revised to exclude cucumber.

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 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: November 1, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Amend Sec.  180.613 as follows:
0
i. Revise the introductory text of paragraph (a)(1).
0
ii. Remove the entry ``Vegetable, cucurbit, group 9'' from the table in 
paragraph (a)(1), and add alphabetically four new entries.
0
iii. Revise the introductory text of paragraph (a)(2).
    The added and revised text read as follows:

Sec.  180.613  Flonicamid; tolerances for residues.

    (a) * * * (1) Tolerances are established for the residues of the 
insecticide flonicamid, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, 
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM 
(4-trifluoromethylnicotinamide),

[[Page 67777]]

and TFNG, N-(4-trifluoromethylnicotinoyl)glycine, calculated as the 
stoichiometric equivalent of flonicamid, in or on the following 
commodities.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G.....................             1.5
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Cucumber................................................             1.5
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Rapeseed subgroup 20A...................................             1.5
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Vegetable, cucurbit, group 9, except cucumber...........             0.4
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for the residues of the insecticide 
flonicamid, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, 
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), and TFNA-
AM (4-trifluoromethylnicotinamide), calculated as the Stoichiometric 
equivalent of flonicamid, in or on the following commodities.
* * * * *

[FR Doc. 2012-27702 Filed 11-13-12; 8:45 am]
BILLING CODE 6560-50-P