[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11496]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Cyflumetofen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
cyflumetofen in or on multiple commodities which are identified and
discussed later in this document. BASF Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 21, 2014. Objections and
requests for hearings must be received on or before July 21, 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-2012-0269, 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,
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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0269 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
July 21, 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-2012-0269, 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. Summary of Petitioned-For Tolerance
In the Federal Register of May 23, 2012 (77 FR 30481) (FRL-9347-8),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 2F7973)
by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709.
The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the insecticide
cyflumetofen (2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
in or on almond, hulls at 4.0 parts per million (ppm); citrus, oil at
16 ppm; fruit, citrus, group 10 at 0.3 ppm; fruit, pome, group 11 at
0.3 ppm; grape at 0.6 ppm; grape, raisin at 0.9 ppm; nut, tree, group
14 at 0.01 ppm; strawberry at 0.6 ppm; and tomato at 0.2 ppm. That
document referenced a summary of the petition prepared by BASF
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA modified
some of the tolerance levels and commodity names requested by the
applicant. The reasons for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The major target organ in rats, mice, and dogs following
short-term and long-term oral administration of cyflumetofen is the
adrenal glands characterized by increased organ weight and
histopathology (vacuolation and hypertrophy of the adrenal cortical
Cyflumetofen has low acute toxicity by oral, dermal, and inhalation
routes of exposure. It is minimally irritating to the eyes but not to
the skin. It is a skin sensitizer.
Decreased serum hormone concentrations (FSH, progesterone, and 17
[beta]-estradiol) were observed in the mid- and high-dose F1
females in a rat reproduction study while no hormonal effect was
observed in the F1 male rats at any dose level. However,
there were no corresponding changes in reproductive performance at any
dose level. In the developmental toxicity study in rats, an increased
incidence of wavy ribs was noted at the high-dose (1,000 milligrams/
kilogram/day (mg/kg/day)), while an increased incidence of incompletely
ossified sternal centra was observed at the mid- and high-dose levels.
These incidences occurred in the presence of maternal toxicity. In the
developmental toxicity study in rabbits, a downward flexion of the
forepaws and/or hind paws was observed in the high-dose (1,000 mg/kg/
day) group pups and delays in skeletal ossification were observed in
pups at the mid- and high-doses. Maternal toxicity (adrenal effects)
was also observed at the mid- and high- doses.
No evidence of neurotoxicity or immunotoxicity was observed in any
of the submitted studies for cyflumetofen.
Although there is some evidence of thyroid tumors in rats, the
Agency has determined that quantification of risk using a non-linear
approach (i.e., reference dose (RfD)) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to cyflumetofen. This conclusion is based on the following
reasons. The single tumor type (thyroid c-cell) occurred in only one
sex (male) and one species (rat). This tumor effect was seen only at
high doses (250 mg/kg/day), which far exceeds the chronic no-observed-
adverse-effect-level (NOAEL) the Agency is using for its risk
assessment (16.5 mg/kg/day). And there is no concern for mutagenicity.
Specific information on the studies received and the nature of the
adverse effects caused by cyflumetofen as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document ``Cyflumetofen:
New Active Ingredient Human Health Risk Assessment to Support Uses on
Citrus (Crop Group 10-10), Pome Fruits Crop Group 11-10), Tree Nuts
(Crop Group 14-12), Grape, Strawberry, and Tomato'' section IV, pg. 12
in docket ID number EPA-HQ-OPP-2012-0269.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
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 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 Cyflumetofen used for
human risk assessment is shown in the following Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Cyflumetofen for Use in FFDCA Human Health Risk
Uncertainty/ RfD, PAD, level
Exposure/scenario Point of FQPA safety of concern for Study and toxicological
departure factors risk assessment effects
Acute Dietary (All An acute reference dose has not been established for either the general
populations). population or for Females 13-49 years of age since there were no appropriate
studies that demonstrated evidence of toxicity attributable to a single dose for
Chronic Dietary (All NOAEL = 16.5 mg/ UFA = 10x...... Chronic RfD = Three co-critical studies:
Populations). kg/day. UFH = 10x...... 0.17 mg/kg/day. 90-day feeding study in rats:
FQPA SF = 1x... cPAD = 0.17 mg/ LOAEL = 54.5/62.8 mg/kg/day (M/
kg/day. F) based on hematology and
organ weight changes in the
liver, adrenal, kidney and
ovaries; and histopathology
effects in the adrenals and
the ovaries. NOAEL = 16.5/19
carcinogenicity study in
LOAEL = 49.5/61.9 mg/kg/day in
(M/F) based on increased
adrenal weights and
histopathology. NOAEL = 16.5/
20.3 mg/kg/day (M/F).
Two generation reproduction
study in rats:
Parental: LOAEL = 30.6/46.6 mg/
kg/day (M/F) based on
increased organ weight and
histopathology in adrenals.
NOAEL = 9.2/13.8 mg/kg/day (M/
Inhalation (Short-, NOAEL = 16.5 mg/ UFA = 10x...... LOC for MOE = Same as chronic dietary
Intermediate- and Long-Term). kg/day. UFH = 10x...... 100. endpoint.
FQPA SF = 1x...
Cancer (oral, dermal, The quantification of risk using a non-linear approach (i.e., cRfD) will
inhalation). adequately account for all chronic toxicity, including carcinogenicity.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyflumetofen, EPA considered exposure under the petitioned-
for tolerances in 40 CFR 180. EPA assessed dietary exposures from
cyflumetofen in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for cyflumetofen; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). The partially refined chronic analysis
conducted was based on tolerance-level residues, 100% percent crop
treated (PCT) assumptions, and both empirically derived and default
iii. Cancer. Based on the data summarized in Unit III.A., the
Agency has determined that quantification of risk using a nonlinear
approach (i.e., RfD) would adequately account for all chronic toxicity,
including carcinogenicity, that could result from exposure to
cyflumetofen. Therefore, a separate cancer dietary exposure analysis
was not performed.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for cyflumetofen. 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 cyflumetofen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyflumetofen. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentrations in Ground Water Model
as well as Pesticide Root Zone Model--Groundwater, the estimated
drinking water concentrations (EDWCs) of cyflumetofen for chronic
exposure assessments are estimated to be 0.33 parts per billion (ppb)
for surface water and 0.0024 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.33 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). EPA assessed
residential exposure using the following assumptions: The use of
cyflumetofen on ornamentals in residential landscapes may result in
residential handler exposure. Residential handler exposure is expected
to be short-term in duration as
intermediate- or long-term exposures are not likely because of the
intermittent nature of applications by homeowners. The quantitative
exposure/risk assessment developed for residential handlers is based on
the following scenarios:
Mixing/loading/applying liquid to ornamentals with hose-
Mixing/loading/applying liquid to ornamentals with
Mixing/loading/applying liquid to ornamentals with
Mixing/loading/applying liquid to ornamentals with a
Since no dermal hazard was identified for cyflumetofen in the
toxicological database, only inhalation exposure assessments were
conducted for residential handlers. EPA did not assess post-application
exposure from the use of cyflumetofen in residential settings because:
1. No dermal hazard was identified in the toxicity database for
cyflumetofen, so a quantitative residential post-application dermal
risk assessment is not required;
2. Post-application inhalation exposure while performing activities
in previously treated gardens was not assessed due to the low vapor
pressure and the expected dilution in outdoor air after an application
3. The potential for post-application non-dietary ingestion
exposure for children (1 < 2 years old) is greatly diminished since
young children are not expected to engage in the types of activities
associated with these areas (e.g., gardening) or utilize these areas
for prolonged periods of play.
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 cyflumetofen to share a common mechanism of
toxicity with any other substances, and cyflumetofen does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyflumetofen does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
2. Prenatal and postnatal sensitivity. There is no evidence of
increased qualitative or quantitative susceptibility in the rat 2-
generation reproduction study; however, the rat and rabbit
developmental studies indicate susceptibility in the pups. There is
evidence of increased quantitative susceptibility in the rabbit
developmental toxicity study, since developmental effects (changes in
ossicification, paw flexion, and decreased fetal body weights) at the
limit dose were observed where no maternal toxicity was present. There
is evidence of increased qualitative susceptibility in the rat
developmental toxicity study as developmental effects (increased
incidence of incompletely ossified sternal centra) were seen at the
same dose that caused an increase in adrenal weights and organ-to-body
weight ratio in the maternal animals. Notwithstanding, the degree of
concern for these effects in infants and children is low because the
rat and rabbit developmental effects have clearly defined NOAEL/LOAELs
and the dose selected for chronic risk assessment is protective of
these effects. Therefore, the PODs based on adrenal effects in rat are
health protective of all lifestages.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
i. The toxicity database for cyflumetofen is complete.
ii. There is no indication that cyflumetofen is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is some evidence that cyflumetofen results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. However, as described in Unit III.D.2., because
of the low degree of concern for these effects, it is not necessary to
retain the 10X FQPA factor to adequately protect infants and children.
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 cyflumetofen in drinking water. These assessments
will not underestimate the exposure and risks posed by cyflumetofen.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyflumetofen is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyflumetofen from food and water will utilize 2.3% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
cyflumetofen is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
(considered to be a background exposure level).
Cyflumetofen is currently proposed 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 cyflumetofen.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures are above the Level of Concern (LOC) of 100
and are not of concern (MOEs >= 100).
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
cyflumetofen is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., EPA has concluded that the cPAD is
protective of potential cancer effects. Given the results of the
chronic risk assessment, cyflumetofen is not expected to pose a cancer
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 cyflumetofen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for cyflumetofen.
C. Revisions to Petitioned-For Tolerances
EPA revised the commodity names for the requested tolerances
consistent with its policy to establish crop group tolerances using the
most recently established crop groups. This policy was explained in the
most recent rulemaking establishing crop groups in the Federal Register
on August 22, 2012 (77 FR 50617) (FRL-9354-3). Under this policy,
rather than establish new tolerances under the pre-existing crop
groups, EPA intends to conform petitions seeking tolerances for crop
groups to the newer established crop groups, as part of its effort to
eventually convert tolerances for any pre-existing crop group to
tolerances with coverage under the revised crop group. Therefore,
although the petitioner had requested tolerances on fruit, citrus,
group 10; fruit, pome, group 11; and nut, tree, group 14. EPA evaluated
and is establishing tolerances for fruit, citrus, group 10-10; fruit,
pome, group 11-10; and nut, tree, group 14-12, respectively.
The petitioner requested a tolerance of 0.2 ppm for tomato based on
residues found in tomatoes that had been frozen and stored in
accordance with OECD Guideline 506 (October 16, 2007) to account for
residue loss that may have occurred during storage. EPA is establishing
a tolerance for tomato at 0.40 ppm. In addition, EPA is not
establishing a separate tolerance for grape, raisin of 0.9 ppm, as
requested, since the tolerance for the raw agricultural commodity grape
at 0.60 ppm is adequate to account for any residue concentration shown
in the processed commodity.
Therefore, tolerances are established for residues of cyflumetofen,
in or on almond, hulls at 4.0 ppm; citrus, oil at 16 ppm; grape at 0.60
ppm; fruit, citrus, group 10-10 at 0.30 ppm; fruit, pome, group 11-10
at 0.30 ppm; nut, tree, group 14-12 at 0.01 ppm; strawberry at 0.60
ppm; and tomato at 0.40 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 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
as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: May 9, 2014.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.677 is added to subpart C to read as follows:
Sec. 180.677 Cyflumetofen; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide cyflumetofen, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels for cyflumetofen is to be determined by measuring only
cyflumetofen, 2-methoxyethyl [alpha]-cyano-[alpha]-[4-(1,1-
in or on the commodity.
Almond, hulls.............................................. 4.0
Citrus, oil................................................ 16
Fruit, citrus, group 10-10................................. 0.30
Fruit, pome, group 11-10................................... 0.30
Nut, tree, group 14-12..................................... 0.01
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2014-11496 Filed 5-20-14; 8:45 am]
BILLING CODE 6560-50-P