[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28472]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Dinotefuran; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
dinotefuran in or on rice grain, egg, and poultry meat byproducts.
Mitsui Chemicals Agro Inc., c/o Landis International, Inc., requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
DATES: This regulation is effective November 28, 2012. Objections and
requests for hearings must be received on or before January 28, 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-2012-0060, 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
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
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-8291; email address: email@example.com.
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-2012-0060 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 28, 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-2012-0060, 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
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
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
1F7953) by Mitsui Chemicals Agro, Inc., c/o Landis International Ltd.,
P. O. Box 5126, 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-
furyl)methyl)guanidine and its major metabolites DN, 1-methyl-3-
(tetrahydro-3-furylmethyl)guanidine and UF, 1- methyl-3-(tetrahydro-3-
furylmethyl)-urea, in or on rice, grain at 10 parts per million (ppm).
That document referenced a summary of the petition prepared by Mitsui
Chemicals Agro, Inc., the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the level for which the tolerance is being established for
rice, grain. EPA has also established tolerances for residues of
dinotefuran in eggs and poultry, meat byproducts. The reason for these
changes is 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 denotefuran including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with denotefuran 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
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
Dinotefuran was well tolerated at high doses following dietary
administration for 90 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 effect 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 and thymus weight and there were no
histopathological lesions in these organs in those studies. 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,'' at pages 40-45 in docket ID number
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 dinotefuran used for
human risk assessment is shown in Table 1 of this unit. The dinotefuran
hazard profile was updated in the most recent risk assessment completed
on July 20, 2012, and nothing has changed since that update. For a more
detailed discussion of the endpoint selection, refer to Appendix A.3 on
pages 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 1--Summary of Toxicological Doses and Endpoints for Dinotefuran for Use in Human Health Risk Assessment
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
Acute dietary (General population NOAEL = 125 mg/kg/day. aRfD = 1.25 mg/kg/day. Developmental Toxicity
including infants and children). UFA = 10X............. aPAD = 1.25 mg/kg/day. Study in Rabbits
UFH = 10X............. LOAEL = 300 mg/kg/day based
FQPA SF = 1X.......... on clinical signs in does
(prone position, panting,
tremor and erythema) seen
following the first dose
on Gestation Day 6.
Chronic dietary (All populations).. NOAEL= 99.7 mg/kg/day. cRfD = 1.0 mg/kg/day.. Chronic Toxicity/
UFA = 10X............. cPAD = 1.0 mg/kg/day.. Carcinogenicity Study in
UFH = 10X............. Rats
FQPA SF = 1X.......... LOAEL = 991 mg/kg/day based
on decreased body weight
gain and nephrotoxicity.
Incidental Oral Short-Term (1-30 NOAEL= 99.7 mg/kg/day. LOC for MOE = 100..... Chronic Toxicity/
days). UFA = 10X............. Carcinogenicity Study in
UFH = 10X............. Rats
FQPA SF = 1X.......... LOAEL = 991 mg/kg/day based
on decreased body weight
gain and nephrotoxicity.
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. UFA = extrapolation from
animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
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
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 U.S.
Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. As to residue levels in
food, EPA assumed 100 percent crop treated (PCT) and tolerance-level
residues for all current and proposed crops.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Survey of Food Intake (CSFII). As to residue levels
in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level
residues for all current and proposed 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% CT 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 to
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 and 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, pet spot-ons, indoor aerosol sprays, crack and crevice sprays.
EPA assessed residential exposure using the following assumptions: Each
of these existing residential use patterns were reassessed in the
latest human health risk assessment using the updated 2012 Residential
Standard Operating Procedures and body weights. Refer to 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.
There are no non-dietary exposure scenarios associated with use on
rice. 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 Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. In the pre-natal 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
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
neurotoxicity study. Additionally, decreased grip strength and brain
weight was 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. 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
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 percent crop treated (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
postapplication exposure of children for incidental oral exposures.
These assessments will not underestimate the exposure and risks posed
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 percent 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 percent of the cPAD
for children 1 to 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 for children
for co-occurring post-application exposure resulting in the greatest
exposure (i.e., from the potentially co-occurring use of the total
release fogger product and the existing cat and dog spot-on uses.
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
5. Aggregate cancer risk for U.S. 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 methods 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:
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 for any of the
commodities in this rule.
C. Revisions to Petitioned-For Tolerances
Use of the Organization of Economic Cooperation and Development
tolerance calculation procedures indicates that the tolerances for
residues in or on rice grain should be established at 9.0 ppm, instead
of 10.0 ppm proposed by the registrant. The appropriate residue
definition is rice, grain.
EPA has also concluded that poultry tolerances in egg and poultry
meat byproducts at 0.01 ppm are now needed as a result of the increased
dietary burden resulting from addition of rice grain and bran to the
Therefore, tolerances are established for residues of dinotefuran,
including its metabolites and degradates, in or on rice, grain at 9.0
ppm, and in or on egg and poultry, meat byproducts at 0.01 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 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
Dated: October 26, 2012.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.603 is amended as follows:
i. Add an entry for ``rice, grain'' in alphabetical order to the table
in paragraph (a)(1).
ii. Add entries for ``egg'' and ``poultry, meat byproducts'' in
alphabetical order to the table in paragraph (a)(2).
iii. Revise paragraph (b) to read as set forth below.
The added and revised text read as follows:
Sec. 180.603 Dinotefuran, tolerances for residues.
(a) * * * (1) * * *
* * * * *
Rice, grain................................................ 9.0
* * * * *
(2) * * *
* * * * *
* * * * *
Poultry, meat byproducts................................... 0.01
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2012-28472 Filed 11-27-12; 8:45 am]
BILLING CODE 6560-50-P