[Federal Register Volume 77, Number 133 (Wednesday, July 11, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16824]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Methoxyfenozide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
methoxyfenozide in or on multiple commodities which are identified and
discussed later and for indirect or inadvertent combined residues of
the methoxyfenozide on various other commodities. In addition, this
regulation removes established tolerances for certain commodities/
groups superseded by this action and revises the tolerance expression.
The Interregional Research Project 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 11, 2012. Objections and
requests for hearings must be received on or before September 10, 2012,
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-2011-0343, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, 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: Debra Rate, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 306-0309; email address: firstname.lastname@example.org.
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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0343 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
September 10, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0343, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on line information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
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 July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7842)
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.544 be amended by establishing
tolerances for residues of the insecticide methoxyfenozide (benzoic
acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl
hydrazide), in or on the raw agricultural commodities fruit, citrus,
group 10-10 at 1.9 parts per million (ppm); lemon, oil at 45 ppm;
citrus, oil (except lemon) at 100 ppm; vegetable, root, except sugar
beet, subgroup 1B at 0.8 ppm; and beet, sugar at 0.5 ppm. In addition,
the petition proposed that 40 CFR 180.544 be amended by removing the
tolerance for vegetable, root, subgroup 1A from paragraph (a) and the
tolerances for fruit, citrus and citrus, oil from paragraph (c).
Lastly, the petition proposed to revise the tolerance expressions in 40
CFR 180.544. That notice referenced a summary of the petition prepared
by Dow AgroSciences LLC, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-
8848-3), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7776) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN
46268. The petition proposed to reestablish tolerances which were
inadvertently allowed to expire in 2010. The proposed tolerances in 40
CFR 180.544 are for indirect or inadvertent combined residues of the
insecticide methoxyfenozide, (benzoic acid, 3-methoxy-2-methyl-, 2-
(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) and its
metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-
dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-methylbenzoyl)
hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-
dimethylbenzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide) and RH-152,072 the malonylglycosyl conjugate
of RH-117,236, in or on the raw agricultural commodities: Vegetable,
root and tuber, group 1 at 0.1 ppm; vegetable, leaves of root and
tuber, group 2 at 0.2 ppm; vegetable, bulb, group 3 at 0.2 ppm;
vegetable, legume, group 6 at 0.1 ppm; vegetable, foliage of legume,
group 7 at 10 ppm; grain, cereal, forage, fodder, and straw, group 16
at 10 ppm; grass, forage, fodder and hay, group 17 at 10 ppm; animal
feed, non-grass, group 18 at 10 ppm; and herb and spice, group 19 at 10
ppm. That notice referenced a summary of the petition prepared by Dow
AgroSciences LLC, 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 petitions, EPA has
modified the levels at which tolerances are being established for some
of the commodities. The reasons for these changes are explained in Unit
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 methoxyfenozide including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with methoxyfenozide
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
Methoxyfenozide is not acutely toxic and not a dermal sensitizer.
Minimal or no toxic effects were observed in studies in which
methoxyfenozide was administered by the dermal or inhalation routes of
The main target organs in the rat and dog were the liver, thyroid
and red blood cells (RBC). The most consistent findings across species
and studies were decreased red blood cell parameters and increased
liver, thyroid, adrenal and spleen weights. In the rat metabolism
study, liver contained 2-9% of the administered radioactivity at
maximum concentration (Cmax), but levels decreased and
bioaccumulation was not observed. Levels in the blood were negligible.
The effects of methoxyfenozide on the blood (methemoglobinemia,
decreased red blood cell parameters, Heinz body formation) are
consistent with those of other hydrazine compounds.
Acute and subchronic oral neurotoxicity studies in the rat did not
show evidence of potential neurotoxicity. In the acute study, decreased
hindlimb grip strength on Day 0 was reported in males. This finding was
only observed at the limit dose in males and was not observed in the
subchronic neurotoxicity study and was therefore not considered
evidence of neurotoxicity. No clinical signs of toxicity or
neurohistopathology were observed in other guideline studies.
No maternal or developmental effects were observed in either the
rat or rabbit oral developmental toxicity studies. In the rat 2-
generation reproductive toxicity study, parental effects were limited
to increased liver weight and microscopic periportal hypertrophy. No
offspring or reproductive toxicity was observed. In a 28-day dietary
immunotoxicity study in the rat, no immunotoxicity was observed. The
only observed effect was increased liver weight.
Dermal effects were not observed in the rat following a 28-day
exposure period (5 exposure days per week for a total of 20 exposures).
This finding is consistent with the relatively low dermal absorption of
2% of the applied dose, observed in an in vivo dermal absorption study
in rats treated with an 80% wettable powder (WP) formulation product.
There was no evidence of carcinogenicity in the rat dietary 24-
month chronic toxicity/carcinogenicity study or the mouse dietary 18-
month carcinogenicity study. No mutagenic or clastogenic potential was
observed in the battery of genotoxicity studies on methoxyfenozide.
Based on these findings, methoxyfenozide is classified as ``not likely
to be carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by methoxyfenozide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document titled ``Methoxyfenozide Human Health
Risk Assessment'' starting at page 14 in docket ID number EPA-HQ-OPP-
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for methoxyfenozide used
for human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Methoxyfenozide for Use in Human Health Risk Assessment
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
Acute dietary (General population No hazard was identified for a single oral exposure.
including infants and children
and Females 13-49 years of age).
Chronic dietary.................. NOAEL = 10.2 mg/kg/ Chronic RfD = 0.10 Co-critical studies: Combined oral
(All populations)................ day. mg/kg/day. chronic toxicity/carcinogenicity-
UFA = 10x........... cPAD = 0.10 mg/kg/ rat LOAEL = 411/491 mg/kg/day M/F
UFH = 10x........... day. based on hematological changes
FQPA SF = 1x........ (decreased RBC parameters),
periportal liver hypertrophy,
thyroid hypertrophy and altered
colloid; possibly increased
Chronic oral toxicity-dog NOAEL =
9.8/12.6 mg/kg/day M/F LOAEL =
106.1/110.6 mg/kg/day based on
hematological changes (decreased
RBC parameters, slight
methemoglobinemia) and increased
Inhalation Short-Term (1-30 days) NOAEL = 16.8 mg/kg/ LOC for MOE = 100.. Two-week oral range finding study-
and Intermediate-Term (1-6 day. dog LOAEL = 90.8 mg/kg/day based
months). UFA = 10x........... on hematological changes
UFH = 10x........... (decreased RBC parameters,
FQPA SF = 1x........ increased Heinz body count,
reticulocyte counts, erythrocyte
morphology and methemoglobinemia)
and increased spleen weights.
Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to methoxyfenozide, EPA considered exposure under the
petitioned-for tolerances as well as all existing methoxyfenozide
tolerances in 40 CFR 180.544. EPA assessed dietary exposures from
methoxyfenozide 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 methoxyfenozide; 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 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues, Dietary Exposure Evaluation Model (DEEM) (Ver. 7.81) default
processing factors (as necessary), an empirical processing factor for
orange juice, and 100 percent crop treated (PCT) for all commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that methoxyfenozide does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for methoxyfenozide. 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 methoxyfenozide in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of methoxyfenozide. 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 Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of
methoxyfenozide for chronic exposures for non-cancer assessments are
estimated to be 43.4 parts per billion (ppb) for surface water and 4.13
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 43.4 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).
Methoxyfenozide is currently registered for the following uses that
could result in residential exposures: Ornamentals. EPA assessed
residential exposure using the following assumptions: Adults may be
exposed to methoxyfenozide from its currently registered use on
ornamentals. Residential pesticide handlers may be exposed for short-
term durations of exposure (1-30 days) only. The inhalation (short-
term) residential exposure was assessed for a ``homeowner'' mixer/
loader/applicator using a manually pressurized handwand, backpack
sprayer, or hose-end sprayer.
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
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 methoxyfenozide to share a common mechanism of
toxicity with any other substances, and methoxyfenozide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
methoxyfenozide 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 Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. Based on the results in the
developmental toxicity studies in rats and rabbits and in the 2-
generation reproduction study in rats, no increased sensitivity of
fetuses or pups (as compared to adults) was demonstrated for
methoxyfenozide. There are no concerns or residual uncertainties for
prenatal/postnatal toxicity following exposure to methoxyfenozide.
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 methoxyfenozide is complete. Although
a 28-day inhalation toxicity study has not been submitted, EPA has
determined that this study is not needed based on a weight of evidence
approach that considered all of the available hazard and exposure
information, including the use of a conservative oral POD that results
in MOEs ranging from 28,000 to 4,100,000 for risk via the inhalation
route due to residential and occupational exposures. Therefore, there
is no need for additional UFs to account for missing studies.
ii. There is no indication that methoxyfenozide is a neurotoxic
chemical and there is no need for additional UFs to account for
iii. There is no evidence that methoxyfenozide 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 assessment utilized 100 PCT and
tolerance-level residues (established or recommended). EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to methoxyfenozide in drinking water.
These assessments will not underestimate the exposure and risks posed
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. 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,
methoxyfenozide 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
methoxyfenozide from food and water will utilize 58% 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
methoxyfenozide 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).
Methoxyfenozide is currently registered for uses that could result in
short-term residential exposure for adults, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term residential exposures to
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 670. Because
EPA's level of concern for methoxyfenozide is a MOE of 100 or below,
these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because no intermediate-term adverse effect was identified,
methoxyfenozide is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, methoxyfenozide is not expected to pose a cancer risk to
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 methoxyfenozide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography (HPLC), with either tandem mass spectrometric detection
(LC/MS/MS) or ultraviolet detection (HPLC/UV)) 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 established MRLs for methoxyfenozide in or on citrus
fruits at 0.7 ppm, carrots at 0.5 ppm, and radishes at 0.4 ppm. These
MRLs are different than the tolerances established for methoxyfenozide
in the United States. Harmonization of tolerances in the currently
requested commodities is not possible, as the U.S. and Codex use
patterns differ potentially resulting in residues in citrus and
vegetable, root, except sugar beet, subgroup 1B, which includes carrots
and radishes, under U.S. use patterns that are greater than the
corresponding Codex MRLs.
C. Revisions to Petitioned-For Tolerances
EPA is establishing a slightly higher tolerance of 0.90 ppm for
vegetable, root, except sugar beet, subgroup 1B, than was proposed. The
0.90 ppm tolerance was calculated using the Organization for Economic
Co-operation and Development (OECD) tolerance calculation procedure.
Similarly, EPA is establishing tolerances for citrus commodities that
are higher than that proposed by IR-4. IR-4 proposed separate
tolerances for residues in lemon oil and residues in all other citrus
oils. However, because residues from the citrus field trials are
similar enough to warrant a crop group tolerance, and a single
processing factor was used to derive the oil tolerance, EPA is
establishing a conservative tolerance in citrus oil at 100 ppm, and no
separate tolerance for residues in lemon oil will be established.
Tolerances proposed for inadvertent residues will not be established
for vegetable, root and tuber group 1 at 1 ppm since a tolerances exist
in Sec. 180.544(a) for subgroups 1A and 1D. Therefore, only a
tolerance for potato will be established at the Agency determined level
of 0.02 ppm. Tolerances will not be established for vegetable, bulb,
group 3 at 0.20 ppm since a tolerance exists in Sec. 180.544(a) for
subgroup 3-07B. Only a tolerance for onion, bulb, subgroup 3-07A will
be established at the Agency determined level of 0.10 ppm. Tolerances
also are not needed for vegetable, legume group 6, grass forage,
fodder, and hay group 17, since tolerances for these groups exist under
Sec. 180.544(a). Also, since a tolerance exists in Sec. 180.544(a)
for coriander, leaves, a tolerance for Herb and spice, group 19, except
coriander, leaves will be established at a lower, Agency determined
level of 4.5 ppm.
Therefore, tolerances are established for residues of
methoxyfenozide (benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimehtylbenzoyl)-2-(1,1-dimethylethyl hydrazide), in or on fruit,
citrus, group 10-10 at 3.0 ppm; citrus, oil at 100 ppm; vegetable,
root, except sugar beet, subgroup 1B at 0.90 ppm; and beet, sugar 0.50
ppm. Also, due to the tolerances established above by this document,
the following existing tolerance is removed as unnecessary; vegetable,
root, subgroup 1A. All of the commodities covered by this crop subgroup
are covered by the tolerances for vegetable, root, except sugar beet,
subgroup 1B, and beet, sugar. In addition, concurrent with the
establishment of tolerances for fruit, citrus, group 10-10 at 3.0 ppm
and citrus, oil at 100 ppm in Sec. 180.544(a), the tolerances for
fruit, citrus, group 10 (10 ppm) and citrus oil (100 ppm) will be
removed from Sec. 180.544(c). Tolerances will be established under
Sec. 180.544(d)(1) for onion, bulb subgroup 3-07A at 0.10 ppm and for
potato at 0.02 ppm. Tolerances will be established under Sec.
180.544(d)(2) for grain, cereal, forage, fodder and straw, group 16
except corn at 6.0 ppm; animal feed, nongrass, group 18, straw at 8.0
ppm; and herb and spice, group 19, except coriander, leaves at 4.5 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 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
VII. 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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 29, 2012.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.544:
i. Revise the introductory text in paragraph (a)(1);
ii. Remove the entry for ``Vegetable, root, subgroup 1A'' from the
table in paragraph (a)(1), and add alphabetically the following
commodities to the table;
iii. Revise introductory text in paragraph (a)(2); and
iv. Revise paragraphs (b), (c) and (d).
The amendments read as follows:
Sec. 180.544 Methoxyfenozide; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
insecticide methoxyfenozide, including its metabolites and degradates,
in or on the commodities listed in the following table. Compliance with
the tolerance levels specified in the following table is to be
determined by measuring only methoxyfenozide (3-methoxy-2-methylbenzoic
acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on
* * * * *
Beet, sugar, roots...................................... 0.50
* * * * *
Citrus, oil............................................. 100
* * * * *
Fruit, citrus, group 10-10.............................. 3.0
* * * * *
Vegetable, root, except sugar beet, Subgroup 1B......... 0.90
* * * * *
(2) Tolerances are established for residues of the insecticide
methoxyfenozide, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only the sum of methoxyfenozide [3-methoxy-2-methylbenzoic
acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and its
glucuronide metabolite ([beta]-D-Glucopyranuronic acid, 3-[[2-(1,1-
methylphenyl-), calculated as the stoichiometric equivalent of
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
insecticide methoxyfenozide, including its metabolites and degradates,
in or on the specified agricultural commodities, resulting from use of
the pesticide pursuant to FFIFRA section 18 emergency exemptions.
Compliance with the tolerance levels specified in the following table
is to be determined by measuring only methoxyfenozide [benzoic acid, 3-
dimethylethyl)hydrazide]. The expired tolerances will be revoked on the
date specified in the table.
* * * * *
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent tolerances. (1) Tolerances are
established for the indirect or inadvertent residues of the insecticide
methoxyfenozide, including its metabolites and degradates, in or on the
raw agricultural commodities in the following table, when present
therein as a result of the application of methoxyfenozide to growing
crops as listed in paragraph (a) of this section. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only methoxyfenozide [3-methoxy-2-methylbenzoic acid 2-
Onion, bulb, subgroup 3-07A............................. 0.10
(2) Tolerances are established for the indirect or inadvertent
residues of the insecticide methoxyfenozide, including its metabolites
and degradates, in or on the raw agricultural commodities in the
following table, when present therein as a result of the application of
methoxyfenozide to growing crops as listed in paragraph (a) of this
section. Compliance with the tolerance levels specified in the
following table is to be determined by measuring only the sum of
methoxyfenozide [3-methoxy-2-methylbenzoic acid, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide] and the following
metabolites (all calculated as the stoichiometric equivalent of
methoxyfenozide): free phenol of methoxyfenozide [3,5-dimethylbenzoic
acid N-tert-butyl-N'-(3-hydroxy-2-methylbenzoyl) hydrazide], the
glucose conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-
and the malonylglycosyl conjugate of the phenol [3,5-dimethyl benzoic
acid N-tert-butyl-N'-[3 ([beta]-D-6-malonyl-glucopyranosyl-1-oxy)-2-
Animal feed, nongrass, group 18, straw.................. 8.0
Grain, cereal, forage, fodder and straw group 16, except 6.0
Herb and spice, group 19, except coriander, leaves...... 4.5
[FR Doc. 2012-16824 Filed 7-10-12; 8:45 am]
BILLING CODE 6560-50-P