[Federal Register Volume 79, Number 14 (Wednesday, January 22, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01079]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Dinotefuran; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation modifies existing time-limited tolerances
established at 40 CFR 180.603 under section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), for residues of dinotefuran in or on
pome fruit and stone fruit by raising them from 1.0 ppm to 2.0 ppm. A
document published in the Federal Register of November 9, 2012, which
first established the tolerances 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 pome fruit and stone fruit. The previous tolerances were supported
by surrogate residue data in pears. Additional residue data has been
produced on peach indicating that residues may be higher than suggested
by the residue data in pears. Review of the new data has concluded that
the tolerance levels for pome and stone fruits should be increased to
2.0 ppm. Therefore, this regulation modifies the maximum permissible
level for residues of dinotefuran in or on these commodities by raising
them from 1.0 ppm to 2.0 ppm. The time-limited tolerances expire on
December 31, 2015.
DATES: This regulation is effective January 22, 2014. Objections and
requests for hearings must be received on or before March 24, 2014, 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-2012-0755, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703)305-7090; email address: RDFRNotices@epa.gov.
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 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under 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.
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-
2012-0755 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 March 24, 2014. 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-2012-0755, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
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. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is modifying
the time-limited tolerances for residues of dinotefuran, (RS)-1-methyl-
2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine including its
degradates DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF,
methyl-3-(tetrahydro-3-furylmethyl)urea in or on Fruit, stone, Group
11, and Fruit, pome, Group 12 by revising to 2.0 parts per million
(ppm). The current time-limited tolerances were first established for
these crop groups at 1.0 ppm in a rule published in the Federal
Register document on November 9, 2012. These modified time-limited
tolerances expire on December 31, 2015.
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 FIFRA
section 18. Such tolerances can be established or modified without
providing notice or period for public comment. EPA does not intend for
its actions on FIFRA section 18 related time-limited tolerances to set
binding precedents for the application of FFDCA section 408 and the
safety standard to other tolerances and exemptions. Section 408(e) of
FFDCA allows EPA to establish or modify 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 Pome and Stone Fruit and
Eight state lead agricultural agencies have requested and received
emergency exemptions for the use of dinotefuran on pome and stone
fruits to control the brown marmorated stink bug (BMSB) for the past
two years. The states are: Delaware, Maryland, Michigan, New Jersey,
North Carolina, Pennsylvania, Virginia, and West Virginia. The States
claimed that the abrupt increase and spread of damaging populations of
BMSB, a recently introduced invasive species, resulted in an urgent and
non-routine situation with significant economic losses of over 20%
expected without the use of dinotefuran as an additional pest
After having reviewed the submissions, EPA determined that
emergency conditions exist for these States, and that the criteria for
approval of emergency exemptions are met. EPA has authorized specific
exemptions under FIFRA section 18 for the use of dinotefuran on pome
fruit and stone fruit for control of the BMSB in the eight states
listed previously. Time-limited tolerances were established at 1.0 ppm
in or on stone and pome fruits, previously, in connection with these
actions. The tolerances were supported by surrogate residue data in
pears. Since then, additional residue data has been produced in peach
indicating that residues may be higher than suggested by the pear data.
EPA has reviewed the new data and concluded that a tolerance level of
2.0 ppm is appropriate.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by raising the tolerances
for residues of dinotefuran in or on pome fruit and stone fruit. In
doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerance under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18.
Consistent with the need to move quickly on the emergency
exemptions in order to address an urgent non-routine situation and to
ensure that the resulting food is safe and lawful, EPA is issuing this
modification of the initial tolerances without notice and opportunity
for public comment as provided in FFDCA section 408(l)(6). Although
these time-limited tolerances expire on December 31, 2015, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on pome fruit and
stone fruit after that date will not be unlawful, provided the
pesticide was applied in a 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 were approved under emergency
conditions, EPA has not made any decisions about whether dinotefuran
meets FIFRA's registration requirements for use on pome fruit and stone
fruit or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that these
time-limited tolerance decisions serve as a basis for registration of
dinotefuran by a State for special local needs under FIFRA section
24(c). Nor do these tolerances by themselves serve as the authority for
persons in any State other than those named previously in this notice
to use this pesticide on the applicable 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
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 use and the
time-limited tolerances for residues of dinotefuran on pome fruit and
stone fruit at 2.0 ppm. EPA's assessment of exposures and risks
associated with these time-limited tolerances follows.
A. 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 discussed in Unit III of the final rule published in
the Federal Register of September 12, 2012 (77 FR 56133) (FRL-9359-6).
These endpoints remain unchanged since that date.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dinotefuran, EPA considered exposure under the time-limited
tolerances as modified 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 and Chronic exposures. Acute and chronic effects were
identified for dinotefuran. In estimating acute and chronic dietary
exposures, 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 percent crop treated (PCT) and
tolerance level residues for all commodities.
ii. Cancer. Based on the data referenced in Unit IV.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.
iii. 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
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),
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and the 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 for surface water and 4.9 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure models. For acute dietary risk
assessment, the water concentration value of 269 ppb was used to assess
the dietary exposure contribution from drinking water. For chronic
dietary risk assessment, the water concentration value of 257 ppb was
used to assess the dietary exposure contribution from 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, pets,
indoor aerosol sprays, and crack and crevice sprays. EPA assessed
residential exposure using the following assumptions: Residential
handler exposures were not assessed because no dermal or inhalation
hazards were identified. For this same reason, postapplication
residential dermal and inhalation exposure scenarios were not assessed.
The Agency only considered post-application scenarios in which
incidental oral exposures to children are expected. The oral exposures
assessed included incidental oral exposures from turf, ant bait, ready
to use garden trigger sprayers, dog and cat spot-on treatment, indoor
broadcast, and indoor crack and crevice uses. Of all these scenarios,
treated turf was determined to result in the highest levels of
exposure. In assessing risks from residential exposures, EPA combines
different residential sources of exposure that could reasonably be
expected to occur on the same day. While it is possible for children to
be exposed to indoor broadcast sprays on hard surfaces/carpets and to
spot-on treatment to cats or dogs on the same day, these exposures have
not been combined in this assessment because incidental oral hand-to-
mouth exposure from treated turf is higher and still results in an MOE
that does not exceed the Agency's Level of Concern (LOC). 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.
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. 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
reproduction study, parental and offspring 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 that 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 study was required. Upon review of the
developmental neurotoxicity study, it was concluded that there is no
evidence of a unique sensitivity to the developing nervous system since
no effects on neurobehavioral parameters were seen in the offspring at
doses that approached or exceeded 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 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to dinotefuran from potential residues in drinking
water. EPA used similarly conservative assumptions to assess
postapplication exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by dinotefuran.
D. 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 12% of the aPAD for Children 1-2 years 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 5.7% of the cPAD for
Children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in the unit 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 MOE of 690 for Children
1-2 years old from hand to mouth exposure from treated turf, the
scenario with the highest exposure. Because EPA's level of concern for
dinotefuran is when MOEs are less than 100, this MOE is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
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 pathways. 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 risks from
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. A more detailed discussion of the
aggregate risk assessments and determination of safety may be found at
http://www.regulations.gov in Docket ID number EPA-HQ-OPP-2012-0755, in
the aggregate human risk assessment document for this action, entitled
``Dinotefuran ID: 13MI04 Section 18 Emergency Exemption for
Use on Pome Fruits and Stone Fruits in Michigan to Control Brown
Marmorated Stink Bugs.''
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies (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) are available to enforce the tolerance
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
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 MRLs for dinotefuran in or on pome fruit and stone fruit.
Therefore, the established time-limited tolerances for residues of
furanyl)methyl)guanidine including its metabolites and degradates, in
or on pome fruit and stone fruit are modified by raising them to 2.0
ppm. These tolerances expire on December 31, 2015.
VII. Statutory and Executive Order Reviews
This final rule modifies tolerances under FFDCA sections 408(e) and
408(l)(6). 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 FFDCA sections 408(e) and 408(l)(6), 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, but 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).
VIII. 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: January 10, 2014.
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. In Sec. 180.603, revise the table in paragraph (b) to read as
Sec. 180.603 Dinotefuran; tolerances for residues.
* * * * *
(b) * * *
Commodity Parts per revocation
Fruit, pome, Group 11........................... 2.0 12/31/2015
Fruit, stone, Group 12.......................... 2.0 12/31/2015
* * * * *
[FR Doc. 2014-01079 Filed 1-21-14; 8:45 am]
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