[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Rules and Regulations]
[Page 12596-12601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr09-17]
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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: pemberton.libby@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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: residuemethods@epa.gov.
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