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[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Rules and Regulations]
[Pages 12596-12601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6253]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0845; FRL-8401-5]

Dinotefuran; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of dinotefuran, [ N -methyl- N '-nitro- N'' -
((tetrahydro-3-furanyl)methyl)guanidine] and its metabolites DN [1-
methyl-3-(tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-
(tetrahydro-3-furylmethyl)urea], expressed as dinotefuran in or on 
rice, grain. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on rice. This regulation establishes a maximum permissible level for 
residues of dinotefuran in this food commodity. The time-limited 
tolerance expires and is revoked on December 31, 2009.

DATES: This regulation is effective March 25, 2009. Objections and 
requests for hearings must be received on or before May 26, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0845. All documents in the 
docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; e-mail 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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

[[Page 12597]]

     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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. 
The EPA procedural regulations which govern the submission of 
objections and requests for hearings appear in 40 CFR part 178. 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-
2008-0845 in the subject line on the first page of your submission. All 
requests must be in writing, and must be mailed or delivered to the 
Hearing Clerk on or before May 26, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0845, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for combined residues of dinotefuran. This 
time-limited tolerance expires and is revoked on December 31, 2009. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerances for the combined residues of the insecticide, dinotefuran, 
[N -methyl- N '-nitro- N'' -((tetrahydro-3-furanyl)methyl)guanidine] 
and its metabolites DN [1-methyl-3-(tetrahydro-3-furylmethyl)guanidine] 
and UF [1-methyl-3-(tetrahydro-3-furylmethyl)urea], expressed as 
dinotefuran from the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Dinotefuran on Rice and FFDCA Tolerances

    Texas declared a crisis exemption under FIFRA section 18 for the 
use of dinotefuran on rice for control of rice stink bug (Oebalus 
pugnax (F.).
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by the combined residues of 
dinotefuran, [ N -methyl- N '-nitro- N'' -((tetrahydro-3-
furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3-
(tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea], expressed as dinotefuran in or on rice, grain. In 
doing so, EPA considered the safety standard in section 408(b)(2) of 
FFDCA, and EPA decided that the necessary tolerance under section 
408(l)(6) of FFDCA would be consistent with the safety standard and 
with FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6) of FFDCA. Although these time-
limited tolerances expire and are revoked on December 31, 2009, under 
section 408(l)(5) of FFDCA, residues of the pesticide not in excess of 
the amounts specified in the tolerance remaining in or on rice, grain 
after that date will not be unlawful, provided the pesticide was 
applied in a

[[Page 12598]]

manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
dinotefuran meets FIFRA's registration requirements for use on rice or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of dinotefuran by 
a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance serve as the basis for persons in any State other than 
Texas to use this pesticide on these crops under FIFRA section 18 
absent the issuance of an emergency exemption applicable within that 
State. For additional information regarding the emergency exemption for 
dinotefuran, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for combined residues of the insecticide, 
dinotefuran, [ N -methyl- N '-nitro- N'' -((tetrahydro-3-
furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3-
(tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea], expressed as dinotefuran. EPA's assessment of 
exposures and risks associated with establishing time-limited 
tolerances follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in 
document Section 18 Emergency Exemptions for the Use of Dinotefuran on 
Rice in Texas to Control Stink Bugs, on page number 6 in docket ID 
number EPA-HQ-OPP-2008-0845.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dinotefuran, EPA considered exposure under the time-limited 
tolerance established by this action 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. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed 100% crop treated (PCT) and tolerance level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA insert 
1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed 100 
PCT and tolerance level residues.
    iii. Cancer. Dinotefuran is classified as not likely to be a 
carcinogen, so no dietary assessment was performed for cancer.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue 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 First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of dinotefuran for 
surface water, the acute and chronic total EDWCs (parent + metabolites) 
are 281 parts per billion

[[Page 12599]]

(ppb) for acute and 139 ppb for chronic, respectively. The acute and 
chronic ground water total EDWC (parent + metabolites) is 4.9 ppb.
    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 uses that could result in 
residential exposures during the application of products containing 
dinotefuran and from entering areas previously treated with 
dinotefuran, such as lawns where children might play, or golf courses 
and home gardens that could lead to exposures for adults. The Agency 
combines risks resulting from exposures to individual chemicals when it 
is likely they can occur simultaneously based on the use pattern and 
the behavior associated with the exposed population. For this 
assessment, the Agency has added together risk values for adults 
applying dinotefuran to residential lawns and then being exposed to the 
treated lawn. For children, dermal and incidental oral exposures from 
activities on treated lawn were combined. These are considered to 
represent worst case scenarios for co-occurring residential exposures. 
The proposed section 18 uses of dinotefuran do not add any additional 
residential exposures or risks.
    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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. EPA evaluated the potential 
for increased susceptibility of infants and children from exposure to 
dinotefuran. EPA concluded that the toxicology database for dinotefuran 
is adequate for FQPA assessment. Available studies include 
developmental toxicity studies in rats and rabbits, a reproductive 
toxicity study in rats, and acute and subchronic neurotoxicity studies 
in rats. EPA concluded that there is low concern for prenatal and/or 
postnatal toxicity resulting from exposure to dinotefuran. However, 
there is a concern for neurotoxicity and developmental neurotoxicity 
resulting from exposure to dinotefuran, and also a concern for 
immunotoxicity following exposure to dinotefuran during the period of 
organogenesis.
    3. Conclusion. Considering the overall toxicity profile and the 
doses and endpoints selected for risk assessment for dinotefuran, the 
EPA characterized the degree of concern for the effects observed in the 
rat reproduction study as low, noting these effects occurred in the 
presence of parental toxicity and only at the highest dose tested. For 
all toxicity endpoints established for dinotefuran, a NOAEL lower than 
this offspring NOAEL is used. No residual uncertainties were 
identified.
    The absence of a NOAEL for the chronic dog study and the need for a 
developmental immunotoxicity (DIT) study generate some uncertainty 
regarding the protectiveness of the chronic regulatory endpoint and 
long-term LOC. Accordingly, EPA does not have reliable data supporting 
adoption of a safety factor other than the default additional 10x 
factor as specified in FFDCA section 408(b)(2)(C). The chronic endpoint 
and long-term LOC have therefore been generated using an overall 
safety/uncertainty factor of 1,000 (representing 100x for inter-species 
extrapolation and intra-species variation, and an additional 10x 
pursuant to FFDCA section 408(b)(2)(C), i.e., use of a LOAEL). However, 
the Agency does not have similar concerns regarding acute, short-term, 
and intermediate-term risk assessments, since the absence of a NOAEL 
only occurred in a chronic study.
    EPA concluded that there is concern for developmental neurotoxicity 
following exposure to dinotefuran, and recommended that a developmental 
neurotoxicity (DNT) study in rats be conducted. However, EPA determined 
that a database uncertainty factor (UFDB) is not needed to account for 
the lack of the DNT study. The Agency believes there are reliable data 
showing that the regulatory endpoints are protective of children 
despite the need for a developmental neurotoxicity study. Developmental 
neurotoxicity data received and reviewed for other compounds in this 
chemical class (i.e., neonicotinoids) including thiacloprid, 
clothianidin, and imidacloprid, indicate that the results of the 
required DNT study will not likely impact the regulatory doses selected 
for dinotefuran.
    EPA also concluded that there is a concern for immunotoxicity 
following exposure to dinotefuran during the period of organogenesis. 
This concern was based on the decreases in absolute and adjusted thymus 
and spleen weights observed in several species in various studies. In 
addition, the available data indicate that the juvenile rats appeared 
to be more sensitive/susceptible to these effects than adults in the 2-
generation reproduction study. Therefore, EPA recommended that testing 
be conducted to assess immune system function in adults and young 
animals following exposure during the period of organogenesis. A 
protocol for this testing was developed by the registrant and these 
studies are now ongoing.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-

[[Page 12600]]

term risks are evaluated by comparing the estimated aggregate food, 
water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. The aggregate acute risk estimates include exposure 
to residues of dinotefuran in food and drinking water. Since the acute 
dietary exposure assessment already includes the highest acute exposure 
from the drinking water modeling data, no further calculations are 
necessary. The acute risk estimate for all populations, resulting from 
aggregate exposure to dinotefuran in food and drinking water is below 
EPA's LOC. The food and drinking water exposure estimates for the most 
highly exposed subgroup, children 1-2 yrs old, is 4.4% of the aPAD.
    2. Chronic risk. The aggregate chronic risk estimates include 
exposure to residues of dinotefuran in food and drinking water. Since 
the chronic dietary exposure assessment already includes the highest 
chronic exposure from the drinking water modeling data, no further 
calculations are necessary. The EPA concluded that dinotefuran exposure 
from food consumption will utilize 42% of the cPAD for the general U. 
S. population and 86% for children 1-2 years old, the most sensitive 
subgroup. Dinotefuran is not expected to pose a chronic dietary risk 
for the general population (including children and infants). The 
chronic risk estimate for all populations, resulting from aggregate 
exposure to dinotefuran in food and drinking water is below EPA's LOC.
    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). Because there 
are existing residential uses of dinotefuran, short-term aggregate risk 
assessments based on exposure from oral, inhalation, and dermal routes 
were considered. However, the toxicological effects for oral and 
inhalation routes of exposure are different (i.e., neurotoxicity for 
oral and decrease in body weight for inhalation); and therefore, these 
exposure scenarios have not been combined. Also, because no systemic 
toxicity was seen at the limit dose in a 28-day dermal toxicity study, 
no quantification of short-term dermal risk is required. Therefore, a 
short-term aggregate risk assessment was not performed. An 
intermediate-term aggregate risk assessment was performed as a 
screening level assessment, which will apply to short-term aggregate 
risk.
    4. Intermediate-term risk. An intermediate-term aggregate risk 
assessment was performed as a screening level assessment. Intermediate-
term aggregate risk assessments were performed for adults and children. 
For children, the subgroup with the highest estimated chronic dietary 
exposure (children 1-2 years old) was aggregated with residential 
exposures to children playing on treated lawns (dermal and oral hand-
to-mouth exposures) in order to calculate the worst case intermediate-
term aggregate risk to children. The reciprocal MOE method was used to 
conduct the intermediate-term aggregate risk assessment for children, 
since the LOCs are identical for all MOEs in the calculation. For 
adults, the aggregate risk index (ARI) method was used, since LOC are 
not identical for all types of exposure in the calculation. For 
children, the aggregate MOE is 400 which is greater than 100, and 
therefore does not exceed EPA's LOC. For adults, the total aggregate 
ARI is 5.5 which is greater than 1, and therefore does not exceed EPA's 
LOC.
    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 dinotefuran residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (for plant commodities (High 
Performance Liquid Chromatography (HPLC)/Mass Spectrometry (MS); HPLC/
Ultraviolet (UV); and HPLC/MS/MS)) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits for residues of dinotefuran in/on plant or 
livestock commodities.

VI. Conclusion

    Therefore, time-limited tolerances are established for combined 
residues of the insecticide, dinotefuran, [ N -methyl- N '-nitro- N'' -
((tetrahydro-3-furanyl)methyl)guanidine] and its metabolites DN [1-
methyl-3-(tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-
(tetrahydro-3-furylmethyl)urea], expressed as dinotefuran, in or on 
rice, grain at 2.8 parts per million (ppm). These tolerances expire and 
are revoked on December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) of FFDCA in response to a petition submitted to the Agency. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175,

[[Page 12601]]

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) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 24, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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 revising paragraph (b) to read as 
follows:

Sec.  180.603  Dinotefuran; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for combined residues 
of Dinotefuran, [ N -methyl- N '-nitro- N'' -((tetrahydro-3-
furanyl)methyl)guanidine] and its metabolites DN [1-methyl-3-
(tetrahydro-3-furylmethyl)guanidine] and UF [1-methyl-3-(tetrahydro-3-
furylmethyl)urea], expressed as dinotefuran in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FFIFRA section 18 emergency exemptions. The tolerances expire and 
are revoked on the date specified in the table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Rice, grain.......................                2.8           12/31/09
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-6253 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S
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