[Federal Register Volume 78, Number 69 (Wednesday, April 10, 2013)]
[Rules and Regulations]
[Pages 21267-21272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08400]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0092; FRL-9381-5]


Dinotefuran; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
dinotefuran in or on all food/feed items (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments. BASF Corporation requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 10, 2013. Objections and 
requests for hearings must be received on or before June 10, 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-2012-0092, is available at http://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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 308-8291; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather

[[Page 21268]]

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://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-2012-0092 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 
June 10, 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-2012-0092, 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 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 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 1F7967) 
by BASF Corporation, c/o Landis International Inc., P.O. Box 5126, 3185 
Madison Highway, Valdosta, GA 31603. The petition requested that 40 CFR 
180.603 be amended by establishing tolerances for residues of the 
insecticide dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-
furanyl)methyl)guanidine in or on food/feed commodities not covered by 
a higher tolerance at 0.01 parts per million (ppm). That document 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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 dinotefuran including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with dinotefuran 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.
    Dinotefuran has low acute toxicity by oral, dermal, and inhalation 
exposure routes. It is not a dermal sensitizer, but causes a low level 
of skin irritation. The main target of toxicity is the nervous system, 
but effects on the nervous system were only observed at high doses. 
Nervous system toxicity was manifested as clinical signs and decreased 
motor activity seen after acute dosing (in both rats and rabbits) and 
changes in motor activity which are consistent with effects on the 
nicotinic cholinergic nervous system seen after repeated dosing. 
Typically, low to moderate levels of neonicotinoids, such as 
dinotefuran, activate the nicotinic acetylcholine receptors causing 
stimulation of the peripheral nervous system (PNS). High levels of 
neonicotinoids can over stimulate the PNS, maintaining cation channels 
in the open state which blocks the action potential and leads to 
paralysis.
    Dinotefuran was well tolerated at high doses following dietary 
administration for ninety days to mice, rats, and dogs. The most 
sensitive effects were decreases in body weight and/or body weight 
gain, but even these effects occurred at or near the limit dose. 
Changes in spleen and thymus weights were seen in mice, rats and dogs 
following subchronic and chronic dietary exposures. However, these 
weight changes were not corroborated with alterations in hematology 
parameters, histopathological lesions in these organs, or toxicity to 
the hematopoietic system. Furthermore, the toxicology data base 
contains immunotoxicity studies in mice and rats and a developmental 
immunotoxicity study in rats. In the immunotoxicity studies there were 
no effects on T-cell dependent antibody response when tested up to the 
limit dose in male and female mice and in male and female rats. There 
were no changes in spleen

[[Page 21269]]

and thymus weight and there were no histopathological lesions in these 
organs. In the developmental immunotoxicity study, there was no 
evidence of an effect on the functionality of the immune system in rats 
that were exposed to dinotefuran at the limit dose during the prenatal, 
postnatal, and post-weaning periods. Consequently, the thymus weight 
changes seen in dogs and the spleen weight changes seen in mice and 
rats were not considered to be toxicologically relevant.
    No systemic or neurotoxicity was seen following repeated dermal 
applications at the limit dose to rats for 28 days. No systemic or 
portal of entry effects were seen following repeated inhalation 
exposure at the maximum obtainable concentrations to rats for 28 days.
    In the prenatal studies, no maternal or developmental toxicity was 
seen at the limit dose in rats. In rabbits, maternal toxicity 
manifested as clinical signs of neurotoxicity, but no developmental 
toxicity was seen. In the reproduction study, parental, offspring, and 
reproductive toxicity was seen at the limit dose. Parental toxicity 
included decreased body weight gain, transient decrease in food 
consumption, and decreased thyroid weights. Offspring toxicity was 
characterized as decreased forelimb grip strength or hindlimb grip 
strength in the F1 pups. There was no adverse effect on 
reproductive performance at any dose. In the developmental 
neurotoxicity study, no maternal or offspring toxicity was seen at any 
dose including the limit dose.
    There was no evidence of carcinogenicity in male and female mice 
and in male and female rats fed diets containing dinotefuran at the 
limit dose for 78 weeks to mice and 104 weeks to rats. Dinotefuran was 
non-mutagenic in both in vivo and in vitro assays. Specific information 
on the studies received and the nature of the adverse effects caused by 
dinotefuran 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 document 
``Dinotefuran: Human Health Risk Assessment for Proposed Section 3 Uses 
on Rice and Food/Feed Handling Establishments, and New Horse Spot-On 
and Total Release Fogger Products'' pages 40-45 in docket ID number 
EPA-HQ-OPP-2012-0092.

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 (U/SF) 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 dinotefuran used for 
human risk assessment is shown in the Table of this unit. The 
dinotefuran hazard profile was updated in the risk assessment completed 
on July 20, 2012, and nothing has changed since this update. For a more 
detailed discussion of the endpoint selection, refer to Appendix A.3 on 
pp 44-47 in the document titled ``Dinotefuran: Human Health Risk 
Assessment for Proposed Section 3 Uses on Tuberous and Corm Vegetables 
Subgroup 1C, Onion Subgroup 3-07A, Onion Subgroup 3-07B, Small Fruit 
Subgroup 13-07F, Berry Subgroup 13-07H, Peach, and Watercress, And a 
Tolerance on Imported Tea'' in docket ID number EPA-HQ-OPP-2011-0433.

   Table--Summary of Toxicological Doses and Endpoints for Dinotefuran for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of Departure
        Exposure/scenario            and Uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      Safety Factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Developmental Toxicity Study in
 including infants and children).   day.                  kg/day.              Rabbits. LOAEL = 300 mg/kg/day
                                   UFA = 10x...........  aPAD = 1.25 mg/kg/    based on clinical signs in does
                                   UFH = 10x...........   day.                 (prone position, panting, tremor
                                   FQPA SF = 1x........                        and erythema) seen following the
                                                                               first dose on Gestation Day 6.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 99.7 mg/kg/    Chronic RfD = 1.0    Chronic Toxicity/Carcinogenicity
                                    day.                  mg/kg/day.           Study in Rats. LOAEL = 991 mg/kg/
                                   UFA = 10x...........  cPAD = 1.0 mg/kg/     day based on decreased body
                                   UFH = 10x...........   day.                 weight gain and nephrotoxicity.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 99.7 mg/kg/    LOC for MOE = 100..  Chronic Toxicity/Carcinogenicity
 30 days).                          day.                                       Study in Rats. LOAEL = 991 mg/kg/
                                   UFA = 10x...........                        day based on decreased body
                                   UFH = 10x...........                        weight gain and nephrotoxicity.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. 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).


[[Page 21270]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dinotefuran, EPA considered exposure under the petitioned-
for tolerances as well as all existing dinotefuran tolerances in 40 CFR 
180.603. EPA assessed dietary exposures from dinotefuran in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for dinotefuran. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) under the National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed 100 percent crop treated (PCT) 
and tolerance-level residues for all current crops.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA under 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance-level residues for all current crops.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that dinotefuran does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for dinotefuran. 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 dinotefuran in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of dinotefuran. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of dinotefuran for acute exposures are estimated 
to be 269 parts per billion (ppb) for surface water and 4.9 ppb for 
ground water, and for chronic exposures for non-cancer assessments are 
estimated to be 253-257 ppb, depending upon retention time from 10-30 
days, for surface water and 4.9 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 269 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 257 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. Dinotefuran is 
currently registered for the following uses that could result in 
residential exposures: Turf, ornamentals, vegetable gardens, roach and 
ant bait, pet spot-ons, indoor aerosol sprays, crack and crevice 
sprays, etc. EPA assessed residential exposure using the following 
assumptions: Because no dermal or inhalation endpoints were chosen for 
dinotefuran, post-application residential dermal and inhalation 
exposure scenarios were not assessed. As a result, risk assessments 
were only completed for post-application scenarios in which incidental 
oral exposures are expected. The post-application exposure and risk 
estimates for all existing residential uses resulted in risk estimates 
that are not of concern (MOEs ranged from 1,100 to 5,900,000). 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 dinotefuran to share a common mechanism of 
toxicity with any other substances, and dinotefuran does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
dinotefuran 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 SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. In the prenatal studies, no 
maternal or developmental toxicity was seen at the limit dose in rats. 
In rabbits, maternal toxicity manifested as clinical signs of 
neurotoxicity but no developmental toxicity was seen. In the rat 
reproduction study, parental, offspring, and reproductive toxicity was 
seen at the limit dose. Parental toxicity included decreased body 
weight gain, transient decrease in food consumption, and decreased 
thyroid weights. Offspring toxicity was characterized as decreased 
forelimb grip strength or hindlimb grip strength in the F1 
pups. There was no adverse effect on reproductive performance at any 
dose. In the developmental neurotoxicity study, no maternal or 
offspring toxicity was seen at any dose including the limit dose.
    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 dinotefuran is complete.
    ii. The neurotoxic potential of dinotefuran has been adequately 
considered. Dinotefuran is a neonicotinoid and has a neurotoxic mode of 
pesticidal action. Consistent with the mode of action, changes in motor 
activity were seen in repeat-dose studies, including the subchronic

[[Page 21271]]

neurotoxicity study. Additionally, decreased grip strength and brain 
weight were observed in the offspring of a multi-generation 
reproduction study albeit at doses close to the limit dose. For these 
reasons, a developmental neurotoxicity (DNT) study was required. The 
DNT study did not show evidence of a unique sensitivity of the 
developing nervous system; no effects on neurobehavioral parameters 
were seen in the offspring at any dose, including the limit dose.
    iii. As discussed in Unit III.D.2., there is no evidence that 
dinotefuran results in increased susceptibility in in utero rats or 
rabbits in the prenatal developmental studies or in young rats in the 
2-generation reproduction study.
    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 dinotefuran in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children from incidental oral exposures. These assessments will not 
underestimate the exposure and risks posed by dinotefuran.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to dinotefuran will occupy 7.6% of the aPAD for all infants < 1 year 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
dinotefuran from food and water will utilize 3.9 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 
dinotefuran 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). Dinotefuran 
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 dinotefuran.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 790. Because 
EPA's level of concern for dinotefuran is a MOE of 100 or below, these 
MOEs are not of concern.
    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). Intermediate-term exposure is not expected for the adult 
residential exposure pathway. Therefore, the intermediate-term 
aggregate risk would be equivalent to the chronic dietary exposure 
estimate. For children, intermediate-term incidental oral exposures 
could potentially occur from indoor uses. However, while it is possible 
for children to be exposed for longer durations, the magnitude of 
residues is expected to be lower due to dissipation or other 
activities. Since incidental oral short- and intermediate-term toxicity 
endpoints and points of departure are the same, the short-term 
aggregate risk estimate, which includes the highest residential 
exposure estimate (from turf), is protective of any intermediate-term 
exposures.
    5. Aggregate cancer risk for population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, dinotefuran is not expected to pose a cancer risk to humans.
    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 dinotefuran residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high performance liquid 
chromatography/tandem mass spectrometry (HPLC/MS/MS method for the 
determination of residues of dinotefuran, and the metabolites DN, and 
UF; an HPLC/ultraviolet (UV) detection method for the determination of 
residues of dinotefuran; and HPLC/MS and HPLC/MS/MS methods for the 
determination of DN and UF) 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: 
[email protected].

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 dinotefuran.

V. Conclusion

    Therefore, a tolerance of 0.01 ppm is established for residues of 
dinotefuran, (RS)-1-methyl-2-nitro3-((tetrahydro-3-
furanyl)methyl)guanidine, including its metabolites and degradates, in 
or on all food and/or feed commodities (other than those already 
covered by a higher tolerance as a result of use on growing crops or 
inadvertent residues) in food and/or feed handling establishments where 
food and/or feed products are held, stored, processed, prepared, or 
served. Compliance with the tolerance level is to be determined by 
measuring only dinotefuran.

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

[[Page 21272]]

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 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 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: April 2, 2013.
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. Section 180.603 is amended by adding paragraph (a)(3) to read as 
follows:


Sec.  180.603  Dinotefuran; tolerances for residues.

    (a) * * *
    (3) A tolerance of 0.01 parts per million is established for 
residues of the insecticide dinotefuran, (RS)-1-methyl-2-nitro-3-
((tetrahydro-3-furanyl)methyl)guanidine, including its metabolites and 
degradates, in or on all food and/or feed commodities (other than those 
covered by a higher tolerance as a result of use on growing crops or 
inadvertent residues) when residues result from application of 
dinotefuran in food and/or feed handling establishments where food and/
or feed products are held, stored, processed, prepared, or served. 
Compliance with the tolerance level is to be determined by measuring 
only dinotefuran.
* * * * *
[FR Doc. 2013-08400 Filed 4-9-13; 8:45 am]
BILLING CODE 6560-50-P