[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Rules and Regulations]
[Pages 44815-44821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18708]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0888; FRL-8875-5]
Chlorantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
chlorantraniliprole in or on multiple commodities which are identified
and discussed later in this document. This regulation additionally
amends previously established tolerances in or on multiple commodities
and deletes tolerances in or on several commodities that will be
superceded by inclusion in crop group tolerances. E. I. du Pont de
Nemours and Company, DuPont Crop Protection, requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 27, 2011. Objections and
requests for hearings must be received on or before September 26, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0888. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available,
[[Page 44816]]
e.g., Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8291; e-mail address: kumar.rita@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to 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
INFORMATION CONTACT.
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-2010-0888 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 26, 2011. 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-2010-0888, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of February 25, 2011 (76 FR 10584) (FRL-
8863-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7763) by, E. I. du Pont de Nemours and Company, DuPont Crop
Protection, 1700 Market St., Wilmington, DE 19898. The petition
requested that 40 CFR 180.628 be amended by establishing tolerances for
residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-
methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, in or on bushberry, subgroup 13-07B at 2.5
parts per million (ppm); large shrub/tree berry, subgroup 13-07C at 2.5
ppm; low growing berry, subgroup 13-07G at 2.5 ppm; ti palm, roots at
0.35 ppm; ti palm, leaves at 13 ppm; root and tuber vegetables, group 1
at 0.35 ppm; leaves of root and tuber vegetables, group 2 at 40 ppm;
sugar beet molasses at 11 ppm; onion, bulb, subgroup 3-07A at 0.35 ppm;
peanut, nutmeat at 0.35 ppm; peanut, hay at 90 ppm; tea, dried leaves
at 50 ppm; and to increase tolerances in or on fruiting vegetables
(except cucurbits), group 8 from 0.7 ppm to 0.90 ppm; cucurbit
vegetables, group 9 from 0.25 ppm to 0.30 ppm; and okra from 0.70 ppm
to 0.90 ppm. That notice referenced a summary of the petition prepared
by E. I. du Pont de Nemours and Company, DuPont Crop Protection, 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 has
revised the tolerances for some of the petitioned commodities.
Additionally, the Agency is revising tolerances for several proposed
individual and group commodities and is revoking multiple established
tolerances. The reason 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
[[Page 44817]]
result to infants and children from aggregate exposure to the pesticide
chemical residue. * * *''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 chlorantraniliprole
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
chlorantraniliprole 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.
Sufficient toxicology information exists for chlorantraniliprole
for selecting doses and endpoints needed for assessing its risk to
humans when used as an insecticide. Chlorantraniliprole is not
genotoxic, neurotoxic, immunotoxic, carcinogenic, or developmentally
toxic. Chlorantraniliprole is not acutely toxic via oral, dermal or
inhalation routes of exposure. Neither is chlorantraniliprole an eye or
skin irritant nor a dermal sensitizer. There was only one animal
toxicity study (18-month carcinogenicity study in mice) in the
toxicology database which evidenced any adverse effect of
chlorantraniliprole exposure. This study was used to establish a point
of departure (POD), based on hepatocellular effects, for the chronic
dietary exposure scenario.
Specific information on the studies received and the nature of the
adverse effects caused by chlorantraniliprole 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 ``Human Health Risk Assessment for
Proposed Label Amendments to Remove Adjuvant Restrictions with
Concomitant Increase in Tolerance for Fruiting and Leafy Vegetables and
to Add Oilseed Rotational Crops,'' at page 22 in docket ID number EPA-
HQ-OPP-2010-0888.
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 (LOC) 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 chlorantraniliprole
used for human risk assessment is shown in the following Table.
Table--Summary of Toxicological Doses and Endpoints for Chlorantraniliprole for Use in Human Health Risk
Assessment
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Point of departure and
Exposure/Scenario uncertainty/Safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (All populations)...... Not Applicable (N/A)... N/A.................... No acute hazard
attributable to a
single dose was
identified; therefore,
an acute dietary
endpoint was not
selected for
quantitative risk
assessment.
Chronic dietary (All populations).... NOAEL = 158 milligrams/ Chronic RfD = 1.58 mg/ 18-Month Oral (feeding)/
kilogram/day (mg/kg/ kg/day mouse LOAEL = 935 mg/
day). cPAD = 1.58 mg/kg/day.. kg/day based on
UFA = 10x.............. eosinophilic foci
UFH = 10 x............. accompanied by
FQPA SF = 1x........... hepatocellular
hypertrophy and
increased liver weight
(males only).
Incidental oral short/intermediate- N/A.................... N/A.................... There was no hazard
term (1 to 30 days). identified via the
oral route over the
short- and
intermediate-term and
therefore, no endpoint
was selected for
quantitative risk
assessment.
Dermal short/intermediate-term....... N/A.................... N/A.................... There was no hazard
identified via the
dermal route (and no
concerns for
developmental,
reproductive or
neurotoxic effects)
and therefore, no
dermal endpoint was
selected for
quantitative risk
assessment.
[[Page 44818]]
Inhalation short/intermediate-term... N/A.................... N/A.................... Based on the lack of
hazard identified in
the acute inhalation
study, lack of acute
irritation, and
extremely low oral
toxicity--no
inhalation endpoint
was selected for
quantitative risk
assessment.
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Cancer (Oral, dermal, inhalation).... Classification: ``Not likely to be Carcinogenic to Humans'' based on
weight of evidence of data: no treatment-related tumors reported in the
submitted chronic and oncogenicity studies in rats and mice, subchronic
studies in mice, dogs and rats and that no mutagenic concern was
reported in the genotoxicity studies.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = Food Quality Protection Act Safety Factor. PAD = population-adjusted dose (a= acute, c = chronic). RfD =
reference dose. MOE = margin of exposure. LOC = level of corcern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorantraniliprole, EPA considered exposure under the
petitioned-for tolerances as well as all existing chlorantraniliprole
tolerances in 40 CFR 180.628. EPA assessed dietary exposures from
chlorantraniliprole 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
chlorantraniliprole; 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 Continuing Survey of Food Intake by Individual (CSFII). As to
residue levels in food, EPA assumed recommended and/or established
tolerance level residues and 100 percent crop treated (PCT). DEEM
default processing factors were used.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that chlorantraniliprole 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 chlorantraniliprole. 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 chlorantraniliprole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of chlorantraniliprole. 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 Screening Concentration in Ground Water (SCI-GROW) models,
the acute and chronic estimated drinking water concentrations (EDWCs)
of chlorantraniliprole were 55.30 parts per billion (ppb) and 39.87
ppb, respectively.
The surface water concentration of 39.87 ppb was used for chronic
exposure for the chronic, non-cancer dietary risk assessment.
No acute dietary risk assessment was performed because no acute
hazard was identified.
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).
Chlorantraniliprole is currently registered for the following uses
that could result in residential exposures: Turfgrass and ornamental
plants. Residential exposure could occur for short-term and
intermediate-term exposures however, due to the lack of toxicity
identified for short- and intermediate-term durations via relevant
routes of exposure, no risk is expected from these exposures.
Additional information on residential exposure assumptions can be found
at http//www.regulations.gov (Docket ID EPA-HQ-OPP-2010--0888, ``Human
Health Risk Assessment for Proposed Label Amendments to Remove Adjuvant
Restrictions with Concomitant Increase in Tolerance for Fruiting and
Leafy Vegetables and to Add Oilseed Rotational crops '', page 37).
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 chlorantraniliprole to share a common mechanism
of toxicity with any other substances, and chlorantraniliprole does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
chlorantraniliprole 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
[[Page 44819]]
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 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. There were no effects on
fetal growth or postnatal development up to the limit dose of 1,000 mg/
kg/day in rats or rabbits in the developmental or 2-generation
reproduction studies. Additionally, there were no treatment related
effects on the numbers of litters, fetuses (live or dead), resorptions,
sex ratio, or post-implantation loss and no effects on fetal body
weights, skeletal ossification, and external, visceral, or skeletal
malformations or variations.
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
findings:
i. The toxicity database for chlorantraniliprole is complete, and
considered adequate for this risk assessment (including 40 CFR 158.500
requirements for dermal toxicity, immunotoxicity, and acute/subchronic
neurotoxicity effective December 26, 2007).
ii. There is no indication that chlorantraniliprole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that chlorantraniliprole results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
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 water and surface water modeling
used to assess exposure to chlorantraniliprole in drinking water. Due
to the lack of toxicity via the dermal route, as well as the lack of
toxicity over the acute-, short- and intermediate-term via the oral
route--no risk is expected from postapplication exposure of children as
well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by chlorantraniliprole.
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
aPAD and 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,
chlorantraniliprole 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
chlorantraniliprole from food and water will utilize 6% 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
chlorantraniliprole 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).
Although short-term residential exposure could occur with the use
of chlorantraniliprole, no toxicological effects resulting from short-
term dosing were observed. Therefore, the aggregate risk is the sum of
the risk from food and water and will not be greater than the chronic
aggregate risk.
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).
Although intermediate-term residential exposure could result from
the use of chlorantraniliprole, no toxicological effects resulting from
intermediate-term dosing were observed. Therefore, the aggregate risk
is the sum of the risk from food and water and will not be greater than
the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two rodent carcinogenicity studies,
chlorantraniliprole 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 chlorantraniliprole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography mass
spectrometry (LC/MS/MS)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
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 U.N. 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 and Canada have established maximum residue levels (MRLs)
for chlorantraniliprole in or on a number of crops and animal
commodities. These MRLs are different than the tolerances established
for chlorantraniliprole in the United States. There are no Mexican MRLs
for chlorantraniliprole as Mexico adopts
[[Page 44820]]
Codex or US standards for its export purposes. Refer to the
International Residue Limit Status appended at the end of the document
``Human Health Risk Assessment for Proposed Label Amendments to Remove
Adjuvant Restrictions with Concomitant Increase in Tolerance for
Fruiting and Leafy Vegetables and to Add Oilseed Rotational Crops,''
pages 52-53, and an addendum to this risk assessment, at http://www.regulations.gov (Docket ID EPA-HQ-OPP-2010-0888).
Although the tolerance expression achieved harmonization,
harmonized MRLs were only achieved for a few commodities. This is the
result of differences in crop grouping and removing the adjuvant
restriction in the United States. To allow for the use of adjuvant in
the United States it was necessary to adjust the tolerances by a factor
of two for some crop groups after reviewing bridging residue data. This
causes disharmony with Codex MRLs for berries, curcubits, fruiting
vegetable, root and tuber vegetables, and leaves of root and tuber
vegetables; and with Canada MRLs for curcubit vegetables and fruiting
vegetables.
C. Response to Comments
There were no comments received in response to the notice of
filing.
D. Revisions to Petitioned-For Tolerances
Based on residue data submitted with this petition, several
petitioned-for tolerances were revised. The revisions include:
increases for fruiting vegetables except cucurbits from 0.9 to 1.4 ppm,
and cucurbits from 0.3 to 0.5 ppm; decreases in low growing berries
from 2.5 to 1.0 ppm, onions, bulb from 0.35 to 0.30 ppm, beet, sugar,
molasses from 11 to 9 ppm, Ti, root from 0.35 to 0.30 ppm, and root and
tuber vegetables from 0.35 to 0.30 ppm.
Tolerances for okra, strawberry, and vegetables, tuberous and corm,
subgroup 1C were deleted as these commodities are now covered by
fruiting vegetables crop group 8-10, berry, low-growing subgroup 13-
07G, and vegetable, root and tuber, group 1, respectively.
The proposed tolerances for peanut hay and peanut nutmeat are not
being established at this time. More residue data are needed.
In Sec. 180.628(d), the tolerance for vegetables, leaves of root
and tuber, group 2 was replaced by the tolerance for this crop group in
Sec. 180.628(a). The tolerance for shallot, fresh leaves was added to
Sec. 180.628(d).
V. Conclusion
Therefore, tolerances are established for residues of
chlorantraniliprole, including its metabolites and degradates, in or on
the commodities listed in Sec. 180.368. Compliance with the tolerance
levels specified below is to be determined by measuring only
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide. 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide. Tolerances are established in or on the following
commodities: Bushberry, subgroup 13-07B at 2.5 ppm; Vegetable,
cucurbit, group 9 at 0.5 ppm; vegetable fruiting, group 8-10 at 1.4
ppm; Berry, large shrub/tree, subgroup 13-07C at 2.5 ppm; Vegetable,
leaves of root and tuber, group 2 at 40 ppm; Berry, low growing
subgroup 13-07G at 1.0 ppm; Onion, bulb, subgroup 3-07A at 0.30 ppm;
Vegetable, root and tuber, group 1 at 0.30 ppm; Beet, sugar, molasses
at 9 ppm; Tea, dried at 50 ppm; Ti, leaves, at 13 ppm; and Ti, root, at
0.30 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, 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
note).
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
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 44821]]
Dated: July 12, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180. 628 is amended as follows:
0
i. Add alphabetically tolerances for beet, sugar, molasses; berry large
shrub/tree, subgroup 13-07C; berry, low growing, subgroup at 13-07G;
onion, bulb, subgroup 3-07A; tea, dried; Ti, leaves; Ti, root;
vegetable, leaves of root and tuber, group 2; vegetable, root and
tuber, group 1; to the table in paragraph (a);
0
ii. Revise the tolerances for vegetable, cucurbit, group 9; and
vegetable, fruiting, group 8-10 in the table to paragraph (a);
0
iii. Remove the entries for okra, strawberry, and vegetable, tuberous
and corm, subgroup 1C from the table in paragraph (a);
0
iv. Remove the entries for shallot and vegetables, leaves of root and
tuber, group 2 from paragraph (d); and
0
v. Add alphabetically an entry for shallot, green leaves to the table
in paragraph (d).
The added and revised text read as follows:
Sec. 180.628 Chlorantraniliprole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Beet, sugar, molasses........................................ 9.0
Berry, large shrub/tree, subgroup 13-07C..................... 2.5
Berry, low growing, subgroup 13-07G.......................... 1.0
* * * * *
Onion, bulb, subgroup 3-07A.................................. 0.30
* * * * *
Tea, dried................................................... 50.0
* * * * *
Ti, leaves................................................... 13.0
Ti, root..................................................... 0.3
* * * * *
Vegetable, cucurbit, group 9................................. 0.5
* * * * *
Vegetable, fruiting, group 8-10.............................. 1.4
* * * * *
Vegetable, leaves of root and tuber, group 2................. 40.0
* * * * *
Vegetable, root and tuber, group 1........................... 0.30
* * * * *
------------------------------------------------------------------------
* * * * *
(d) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
* * * * *
Shallots, fresh leaves...................... 0.20 04/10/14
* * * * *
------------------------------------------------------------------------
[FR Doc. 2011-18708 Filed 7-26-11; 8:45 am]
BILLING CODE 6560-50-P