Chlorantraniliprole; Pesticide Tolerances, 5526-5535 [2010-2254]
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established for residues of spiromesifen
and its metabolites on the requested
crops.
C. Response to Comments
One comment was received from an
anonymous citizen who objected to the
proposed use of spiromesifen because of
the amounts of pesticides already
approved and being approved. The
Agency understands the commenter’s
concerns and recognizes that some
individuals believe that pesticides
should be banned completely. However,
under the existing legal framework
provided by section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA)
EPA is authorized to establish pesticide
tolerances or exemptions where persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute.
D. Revisions to Petitioned-For
Tolerances
Vegetable, bulb, group 3-07. Due to
the detection of residues on onion after
performing an extensive rotational crop
study, Bayer then proposed changing
the tolerance from 0.07 ppm to 0.09
ppm. The Agency concurred with this
proposed tolerance. Using the North
American Free Trade Agreement
(NAFTA) Maximum Residue Limits/
Tolerance Harmonization Workgroup
methodology for evaluating field trial
data, the Agency determined that the
requested establishment of permanent
tolerances in/on vegetable, bulb, group
3-07 proposed at 0.09 ppm should be
made.
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V. Conclusion
Therefore, tolerances are established
for inadvertent or indirect combined
residues of the insecticide spiromesifen,
(2-oxo-3-(2,4,6-trimethylphenyl)-1oxaspiro[4.4]non-3-en-4-yl 3,3dimethylbutanoate), its enol metabolite
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1oxaspiro[4.4]non-3-en-2-one), and its
metabolites containing the 4hydroxymethyl moiety (4-hydroxy-3-[4(hydroxymethyl)-2,6-dimethylphenyl]1-oxaspiro[4.4]non-3-en-2-one),
calculated as the parent compound
equivalents, in or on vegetable, bulb,
group 3-07 at 0.09 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
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14:52 Feb 02, 2010
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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) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
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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.
Dated: January 25, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.607 is amended by
alphabetically adding the following
commodity to the table in paragraph (d)
to read as follows:
■
§ 180.607 Spiromesifen; tolerances for
residues.
*
*
*
(d) * * *
*
*
Parts per
million
Commodity
*
*
*
*
Vegetable, bulb, group 3-07 .........
*
*
*
*
*
*
*
*
*
0.09
*
*
[FR Doc. 2010–2144 Filed 2–2–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0261; FRL–8809–3]
Chlorantraniliprole; Pesticide
Tolerances
AGENCY: Environmental Protection
Agency (EPA).
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ACTION:
Final rule.
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 replaced by this action. 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
February 3, 2010. Objections and
requests for hearings must be received
on or before April 5, 2010, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0261. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://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:
Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0415; e-mail address:
davis.kabl@epa.gov.
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ADDRESSES:
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
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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
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0261 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before April 5, 2010.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2009–0261, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
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• 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. Petition for Tolerance
In the Federal Register of May 6, 2009
(Volume 74 FR 20949) (FRL–8412–7),
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 9F7513) by E.I. du
Pont de Nemours and Company, DuPont
Crop Protection,1090 Elkton Road,
Newark, DE 19711. The petition
requested that 40 CFR 180.628 be
amended by establishing tolerances for
residues of the insecticide
chlorantraniliprole, 3-bromo-N-[4chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide, in or on acerola at 2.0
parts per million (ppm); almond, hull at
5.0 ppm; apple, wet pomace at 2.5 ppm;
artichoke at 4.0 ppm; asparagus at 13.0
ppm; atemoya at 4.0 ppm; avocado at
4.0 ppm; banana at 4.0 ppm; biriba at
4.0 ppm; black sapote at 4.0 ppm; cacao
bean, bean at 0.15 ppm; cacao, roasted
beans at 1.4 ppm; canistel at 4.0 ppm;
cattle, fat at 0.3 ppm; cattle, liver at 0.3
ppm; cattle, meat at 0.05 ppm; cattle,
meat byproducts except liver at 0.2
ppm; cherimoya at 4.0 ppm; chocolate
at 3.0 ppm; citrus, dried pulp at 14.0
ppm; cocoa powder at 3.0 ppm; coffee,
bean, green at 0.5 ppm; coffee, instant
at 2.5 ppm; corn, sweet at 0.02 ppm;
corn, field, grain at 0.04 ppm; corn, pop
at 0.04 ppm; corn, aspirated grain
fractions at 2.0 ppm; corn, processed
commodities at 0.1 ppm; crambe at 0.3
ppm; crayfish at 8.0 ppm; custard apple
at 4.0 ppm; egg at 0.1 ppm; feijoa at 4.0
ppm; figs at 4.0 ppm; forage, fodder, and
straw of cereal grains, group 16, forage
and fodder at 25.0 ppm; forage, fodder,
and straw of cereal grains, group 16, hay
and straw at 90.0 ppm; fruit, caneberry,
subgroup 13–07A at 1.8 ppm; fruit,
citrus, group 10 at 1.4 ppm; fruit, pome,
group 11 at 1.2 ppm; fruit, small vine
climbing, subgroup 13–07D at 2.5 ppm;
fruit, stone, group 12 at 4.0 ppm; goat,
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fat at 0.3 ppm; goat, liver at 0.3 ppm;
goat, meat at 0.05 ppm; goat, meat
byproducts, except liver at 0.2 ppm;
grass, forage, fodder and hay, group 17,
forage and fodder at 25.0 ppm; grass,
forage, fodder and hay, group 17, hay
and straw at 90.0 ppm; guava at 4.0
ppm; hare’s ear mustard at 0.3 ppm;
herbs and spices, subgroup 19A, dried
at 90.0 ppm; herbs and spices, subgroup
19A, fresh at 25.0 ppm; herbs and
spices, subgroup 19B, spices at 7.0 ppm;
hops at 90.0 ppm; horse, fat at 0.3 ppm;
horse, liver at 0.3 ppm; horse, meat at
0.05 ppm; horse, meat byproducts,
except liver at 0.2 ppm; ilama at 4.0
ppm; jaboticaba at 2.0 ppm; jojoba at 0.3
ppm; lesquerella at 0.3 ppm; longan at
4.0 ppm; lunaria at 0.3 ppm; lychee at
2.0 ppm; mango at 4.0 ppm; milk at 0.05
ppm; milkweed at 0.3 ppm; mint at 9.0
ppm; mustard at 0.3 ppm; non-grass
animal feeds, group 18, forage and
fodder at 13.0 ppm; non-grass animal
feeds, group 18, hay and straw at 45.0
ppm; non-grass animal feeds, group 18,
seeds at 3.5 ppm; nut, tree, group 14 at
0.04 ppm; oil radish at 0.3 ppm; okra at
0.7 ppm; olive at 4.0 ppm; olive, oil at
40.0 ppm; papaya at 2.0 ppm; passion
fruit at 2.0 ppm; peanut at 0.1 ppm;
peanut hay at 90.0 ppm; persimmon at
4.0 ppm; pineapple at 1.5 ppm;
pineapple process residue at 3.0 ppm;
pistachio at 0.04 ppm; pomegranate at
4.0 ppm; poppy seed at 0.3 ppm;
poultry, fat at 0.02 ppm; poultry, meat
at 0.02 ppm; poultry, meat byproducts
at 0.02 ppm; prickly pear cactus at 13.0
ppm; pulasan at 4.0 ppm; raisins at 5.0
ppm; rambutan at 4.0 ppm; rapeseed at
0.3 ppm; rice, grain at 0.15 ppm; rice,
hulls at 0.3 ppm; rice, straw at 0.3 ppm;
rose hip at 0.3 ppm; sapodilla at 4.0
ppm; sapote, mamey at 4.0 ppm; sesame
at 0.3 ppm; sheep, fat at 0.3 ppm; sheep,
liver at 0.3 ppm; sheep, meat at 0.05
ppm; sheep, meat byproducts except
liver at 0.2 ppm; soursop at 4.0 ppm;
spanish lime at 4.0 ppm; star apple at
4.0 ppm; starfruit at 4.0 ppm;
strawberries at 1.0 ppm; sugar apple at
4.0 ppm; sugarcane, cane at 14.0 ppm;
sugarcane molasses at 420.0 ppm;
tallowwood at 0.3 ppm; tea oil plant at
0.3 ppm; ti palm, leaves at 13.0 ppm; ti
palm, roots at 0.1 ppm; vegetables,
brassica leafy, group 5 at 11.0 ppm;
vegetables, foliage of legume, group 7,
forage/vines at 30.0 ppm; vegetables,
foliage of legume, group 7, hay at 90.0
ppm; vegetables, legume, group 6,
except soybeans at 2.0 ppm; vegetables,
tuberous and corm, subgroup 1C at 0.01
ppm; wax jambu at 4.0 ppm; white
sapote (casimiroa) and other cultivars
and/or hybrids at 4.0 ppm. that notice
referenced a summary of the petition
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prepared by E.I. du Pont de Nemours
and Company, Dupont Crop Protection,
the registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
EPA has determined that tolerances
are not required for several petitioned
commodities. Additionally, the Agency
is revising tolerances for several
proposed individual and group
commodities and is amending multiple
established tolerances. Finally, EPA is
deleting several existing tolerances. The
details on the specific changes being
made and 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 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
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sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Chlorantraniliprole is not genotoxic,
neurotoxic, immunotoxic, carcinogenic,
or teratogenic. Chlorantraniliprole has
been found to have low acute toxicity by
the oral, dermal, and inhalation routes
of exposure and has little to no irritation
effect on the eyes or skin. Additionally,
chlorantraniliprole is not a dermal
sensitizer. There was only one toxicity
study in the toxicology database that
indicated that Chlorantraniliprole
yielded an adverse effect (18-month
oral/mouse). This study was used to
establish a point of departure based on
hepatocellular effects for chronic risk.
Specific information on the studies
received and the nature of the adverse
effects caused by chlorantraniliprole as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document;
‘‘Chlorantraniliprole (DPX-E2Y45).
Human Health Risk Assessment for
Section 3 Registration Request to
Expand Uses of Coragen, Altacor, and
Dermacor X-100 Labels on Various
Field, Vegetable, and Fruit Crops,’’ page
31 in docket ID number EPA–HQ–OPP–
2009–0261.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a benchmark dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-, and
chronic-term risks are evaluated by
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comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the level of concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for chlorantraniliprole used
for human risk assessment can be found
at https://www.regulations.gov in the
document; ‘‘Chlorantraniliprole (DPXE2Y45). Human Health Risk Assessment
for Section 3 Registration Request to
Expand Uses of Coragen, Altacor, and
Dermacor X-100 Labels on Various
Field, Vegetable, and Fruit Crops,’’ in
docket ID number EPA–HQ–OPP–2009–
0261.
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 all foods for
which there are tolerances were treated
and contain tolerance-level residues.
iii. Cancer. Chlorantraniliprole was
classified as ‘‘Not likely to be
Carcinogenic to Humans’’ based on
evidence showing no treatment-related
tumors in the submitted chronic and
oncogenicity studies in rats and mice,
and subchronic studies in mice, dogs,
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and rats, and no mutagenic concerns in
the genotoxicity studies. Therefore, an
exposure assessment to evaluate cancer
risk is unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or PCT
information in the dietary assessment
for chlorantraniliprole. 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 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
https://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 (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
chlorantraniliprole for chronic
exposures for non-cancer assessments
are estimated to be 3.65 ppb for surface
water and 1.06 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 3.65 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 nonoccupational, 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
www.regulations.gov (Docket ID EPA–
HQ–OPP–2009–0261, pages 24 through
25).
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
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5529
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
chemicals, see EPA’s website at https://
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 milligrams/kilogram/day
(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 postimplantation 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 to reduced 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,
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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 chronic dietary food exposure
assessment utilized tolerance-level
residues and 100 PCT data. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
chlorantraniliprole in drinking water.
Due to the lack of toxicity identified for
short-term and intermediate-term
durations via relevant routes of
exposure, 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 pesticide exposures are safe by
comparing aggregate exposure estimates
to the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD
represent the highest safe exposures,
taking into account all appropriate SFs.
EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs.
For linear cancer risks, EPA calculates
the probability of additional cancer
cases given the estimated aggregate
exposure. Short-term, intermediateterm, and chronic-term risks are
evaluated by comparing the estimated
aggregate food, water, and residential
exposure to the POD to ensure that the
MOE called for by the product of all
applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute 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
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chlorantraniliprole from food and water
will utilize 5% of the cPAD for children
1 to 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 evidence showing
no treatment-related tumors in the
submitted chronic and oncogenicity
studies in rats and mice, and subchronic
studies in mice, dogs, and rats, and no
mutagenic concerns in the genotoxicity
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; email address: residuemethods@epa.gov.
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B. International Residue Limits
Regarding international Maximum
Residue Levels (MRLs) for
chlorantraniliprole, all tolerances are
harmonized (tolerances and MRLs have
equivalent residue levels and tolerance
expressions) or U.S. tolerances are
higher than Codex based on submitted
data and differences in U.S. use
patterns. U.S. tolerances exceed Codex
MRLs for the following commodities:
Grapes, edible offal (mammalian), milks,
meat (from mammals), pome fruits,
stone fruits and eggs. All other MRLs are
harmonized with Codex.
C. Response to Comments
There were no comments received in
response to the notice of filing.
D. Revisions to Petitioned-For
Tolerances
EPA has revised the proposed
tolerance levels of chlorantraniliprole
on the following commodities: cacao
bean from 0.15 ppm to 0.08 ppm; cacao
bean, roasted bean from 1.4 ppm to 0.8
ppm; cacao bean, chocolate from 3.0
ppm to 1.5 ppm; cacao bean, cocoa
powder from 3.0 ppm to 1.5 ppm;
coffee, green bean from 0.5 ppm to 0.4
ppm; coffee, instant from 2.5 ppm to 2.0
ppm; egg from 0.1 ppm to 0.2 ppm;
herbs and spices, subgroup 19B, spices
from 7.0 ppm to 14 ppm; animal feed,
nongrass, group 18, forage from 13.0
ppm to 25 ppm; animal feed, nongrass,
group 18, hay from 45 ppm to 90 ppm;
alfalfa, seed from 3.5 ppm to 7.0 ppm;
poultry, fat from 0.02 ppm to 0.01 ppm;
rice, hulls from 0.3 ppm to 0.4 ppm.
EPA revised the tolerance levels based
on analysis of the residue field trial data
using the Agency’s tolerance
spreadsheet in accordance with the
Agency’s Guidance for Setting Pesticide
Tolerances Based on Field Trial Data.
The commodity, fruit, pome, group 11
is being revised to read fruit, pome,
group 11, except mayhaw. A separate
tolerance of 0.6 ppm is being
established for mayhaw. The
commodity, fruit, stone, group 12 is
being revised to read fruit, stone, group
12, except cherry, chickasaw plum, and
damson plum. Separate tolerances of 2.0
ppm are being established for cherry,
sweet; cherry, tart; plum, chickasaw;
plum, damson. for these two groups the
EPA has determined that for those
commodities in these groups considered
small fruit it is not approriatate to
establish the higher tolerance because
they have differing use directions with
a longer phi that will result in lower
residue levels.
The petitioner requested tolerances on
forage, fodder, and straw of cereal
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grains, group 16, forage and fodder at
25.0 ppm; and forage, fodder, and straw
of cereal grains, group 16, hay and straw
at 90.0 ppm. However, no tolerances
were proposed for cereal grains, crop
group 15. Without a tolerance for cereal
grains, crop group 15, tolerances for
cereal grains, crop group 16, forage,
fodder and straw are not appropriate.
However, based on submitted data and
translation, the tolerance of 14 ppm can
be established for the following
individual crop group 16 commodities:
corn, field, forage; corn, field, stover;
corn, pop, forage; corn, pop, stover;
corn, sweet, forage, and corn, sweet,
stover.
Based upon the re-examination of the
available ruminant feeding study, EPA
is establishing tolerance levels of
chlorantraniliprole on the following
commodities: Hog, fat at 0.02 ppm and
hog, meat byproducts at 0.02 ppm.
The current established tolerance of
0.01 ppm for residues of
chlorantraniliprole on potatoes is
revoked upon the establishment of
tolerances on vegetables, tuberous and
corm, subgroup 1C at 0.01 ppm. The
petitioner requested tolerances be
established for fruit, small vine
climbing, subgroup 13–07D at 2.5 ppm.
The representative commodities for
this subgroup are grape and fuzzy
kiwifruit. Data are only available for
grape. Therefore, the EPA is establishing
a tolerance for fruit, small vine
climbing, subgroup 13–07F at 2.5 ppm
which is a subset of subgroup 13–07D.
The current established tolerance of 1.2
ppm for residues of chlorantraniliprole
on grapes is revoked upon the
establishment of tolerances on fruit,
small vine climbing, subgroup 13–07F
at 2.5 ppm.
Finally, EPA has revised the tolerance
expression to clarify (1) that, as
provided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of chlorantraniliprole not
specifically mentioned; and (2) that
compliance with the specified tolerance
levels is to be determined by measuring
only the specific compounds mentioned
in the tolerance expression.
V. Conclusion
Therefore, tolerances are established
for residues of chlorantraniliprole, 3bromo-N-[4-chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide, in or on acerola at 2.0
ppm; animal feed, nongrass, group 18,
forage at 25 ppm; animal feed, nongrass,
group 18, hay at 90 ppm; alfalfa, seed
at 7.0 ppm; artichoke, globe at 4.0 ppm;
asparagus at 13 ppm; atemoya at 4.0
ppm; avocado at 4.0 ppm; banana at 4.0
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ppm; biriba at 4.0 ppm; cacao bean at
0.08 ppm; cacao bean, chocolate at 1.5
ppm; cacao bean, cocoa powder at 1.5
ppm; cacao bean, roasted bean at 0.8
ppm; cactus at 13 ppm; canistel at 4.0
ppm; cattle, liver at 0.3 ppm; cherimoya
at 4.0 ppm; citrus, dried pulp at 14 ppm;
coffee, green bean at 0.4 ppm; coffee,
instant at 2.0 ppm; corn, sweet, kernel
plus cobs with hush removed at 0.02
ppm; corn, field, grain at 0.04 ppm;
corn, field, milled byproducts at 0.1
ppm; corn, pop, grain at 0.04 ppm;
crambe, seed at 0.3 ppm; crayfish at 8.0
ppm; custard apple at 4.0 ppm ; egg at
0.2 ppm; feijoa at 4.0 ppm; fig at 4.0
ppm; fruit, caneberry, subgroup 13-07A
at 1.8 ppm; fruit, citrus, group 10 at 1.4
ppm; fruit, small vine climbing,
subgroup 13-07F at 2.5 ppm; goat, liver
at 0.3 ppm; grass forage, fodder and hay,
group 17 at 90 ppm; grain, aspirated
fractions at 2.0 ppm; guava at 4.0 ppm;
hare’s ear mustard, seed at 0.3 ppm;
herb subgroup 19A, dried leaves at 90
ppm; herb subgroup 19A, fresh leaves at
25 ppm; hop, dried cones at 90 ppm;
horse, liver at 0.3 ppm; ilama at 4.0
ppm; jaboticaba at 2.0 ppm; jojoba, seed
at 0.3 ppm; lesquerella, seed at 0.3 ppm;
longan at 4.0 ppm; lunaria, seed at 0.3
ppm; lychee at 2.0 ppm; mango at 4.0
ppm; milkweed, seed at 0.3 ppm;
mustard seed at 0.3 ppm; oil, radish,
seed at 0.3 ppm; okra at 0.7 ppm; olive
at 4.0 ppm; olive, oil at 40.0 ppm;
papaya at 2.0 ppm; passionfruit at 2.0
ppm; peppermint, tops at 9.0 ppm;
persimmon at 4.0 ppm; pineapple at 1.5
ppm; pineapple, process residue at 3.0
ppm; pomegranate at 4.0 ppm; poppy,
seed at 0.3 ppm; poultry, fat at 0.01
ppm; poultry, meat byproducts at 0.02
ppm; pulasan at 4.0 ppm; rambutan at
4.0 ppm; rapeseed, seed at 0.3 ppm;
rice, grain at 0.15 ppm; rice, hulls at 0.4
ppm; rose hip, seed at 0.3 ppm;
sapodilla at 4.0 ppm; sapote, black at 4.0
ppm; sapote, mamey at 4.0 ppm; sapote,
white at 4.0 ppm; sesame, seed at 0.3
ppm; sheep, liver at 0.3 ppm; soursop at
4.0 ppm; spanish lime at 4.0 ppm;
spearmint, tops at 9.0 ppm; spice,
subgroup 19B at 14 ppm; star apple at
4.0 ppm; starfruit at 4.0 ppm;
strawberries at 1.0 ppm; sugar apple at
4.0 ppm; sugarcane, cane at 14 ppm;
sugarcane, molasses at 420 ppm;
tallowwood, seed at 0.3 ppm; tea oil
plant, seed at 0.3 ppm; vegetables,
foliage of legume, except soybean,
subgroup 7A, forage at 30 ppm;
vegetables, foliage of legume, except
soybean, subgroup 7A, hay at 90 ppm;
vegetables, legume, group 6, except
soybeans at 2.0 ppm; vegetables,
tuberous and corm, subgroup 1C at 0.01
ppm; wax jambu at 4.0 ppm.
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Additionally, tolerances are amended
for residues of chlorantraniliprole in or
on apple, wet pomace from 0.60 ppm to
2.5 ppm; cattle, fat from 0.01 ppm to 0.3
ppm; cattle, meat from 0.01 ppm to 0.05
ppm; cattle, meat byproducts from 0.01
ppm to 0.2 ppm; fruit, pome, group 11,
except mayhaw from 0.30 ppm to 1.2
ppm; fruit, stone, group 12, except
cherry, chickasaw plum, and damson
plum from 0.30 ppm to 4.0 ppm; goat,
fat from 0.01 ppm to 0.3 ppm; goat, meat
from 0.01 ppm to 0.05 ppm; goat, meat
byproduct from 0.01 ppm to 0.2 ppm;
grape, raisin from 2.5 ppm to 5.0 ppm;
horse, fat from 0.01 ppm to 0.3 ppm;
horse, meat from 0.01 ppm to 0.05 ppm;
horse, meat byproduct from 0.01 ppm to
0.2 ppm; milk from 0.01 ppm to 0.05
ppm; sheep, fat from 0.01 ppm to 0.3
ppm; sheep, meat from 0.01 ppm to 0.05
ppm; sheep, meat byproduct from 0.01
ppm to 0.2 ppm.
Although requests were made to
amend residues of chlorantraniliprole in
or on Crop Groups 11 and 12, the
following individual commodities
required separate tolerances. Tolerances
are established for residues of
chlorantraniliprole in or on cherry,
sweet at 2.0 ppm; cherry, tart at 2.0
ppm; mayhaw at 0.6 ppm; plum,
chickasaw at 2.0 ppm and plum,
damson at 2.0 ppm.
In addition, requests were made to
establish tolerances of
chlorantraniliprole in or on Crop Group
15, however adequate data were only
submitted to support the establishment
of tolerances for specific commodities.
tolerances are established for residues of
chlorantraniliprole in or on corn, field,
forage at 14.0 ppm; corn, field, stover at
14.0 ppm; corn, pop, forage at 14.0 ppm;
corn, pop, stover at 14.0 ppm; corn,
sweet, forage at 14.0 ppm and corn,
sweet, stover at 14.0 ppm.
This regulation deletes a tolerance in
or on grape at 1.2 ppm and potato at
0.01 ppm. Additionally, the following
time-limited section 18 emergency
exemption tolerances are deleted: corn,
sweet, cannery waste at 6.0 ppm; corn,
sweet, forage at 6.0 ppm; corn, sweet,
kernel plus cob with husks removed at
0.01 ppm; corn, sweet, stover at 6.0
ppm; milk at 0.03 ppm; rice, grain at
0.10 ppm and rice, straw at 0.25 ppm.
Finally, this regulation deletes timelimited tolerances for indirect/
inadvertent residues of
chlorantraniliprole in or on animal feed,
nongrass, group 18 at 0.20 ppm;
cowpea, forage at 0.20 ppm; cowpea,
hay at 0.20 ppm; field pea, hay at 0.20
ppm; field pea, vine at 0.20 ppm; grass,
forage, fodder and hay, group 17 at 0.20
ppm; okra at 0.70 ppm; strawberry at
1.20 ppm and sugarcane at 0.20 ppm.
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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) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
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.
Dated: January 26, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.628 is revised to read
as follows:
■
§ 180.628 Chlorantraniliprole; tolerances
for residues.
(a) General. Tolerances are
established for residues of the
insecticide chlorantraniliprole,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
chlorantraniliprole, 3-bromo-N-[4chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide.
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Commodity
Parts per million
Acerola .............................................................................................................................................................
Alfalfa, seed .....................................................................................................................................................
Almond, hulls ...................................................................................................................................................
Animal feed, nongrass, group 18, forage ........................................................................................................
Animal feed, nongrass, group 18, hay
Apple, wet pomace ..........................................................................................................................................
Artichoke, globe ...............................................................................................................................................
Asparagus ........................................................................................................................................................
Atemoya ...........................................................................................................................................................
Avocado ...........................................................................................................................................................
Banana .............................................................................................................................................................
Biriba ................................................................................................................................................................
Brassica, head and stem, subgroup 5A ..........................................................................................................
Brassica, leafy greens, subgroup 5B ..............................................................................................................
Cacao bean .....................................................................................................................................................
Cacao bean, chocolate ....................................................................................................................................
Cacao bean, cocoa powder .............................................................................................................................
Cacao bean, roasted bean ..............................................................................................................................
Cactus ..............................................................................................................................................................
Canistel ............................................................................................................................................................
Cattle, fat .........................................................................................................................................................
Cattle, liver .......................................................................................................................................................
Cattle, meat .....................................................................................................................................................
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2.0
7.0
5.0
25
90
2.5
4.0
13
4.0
4.0
4.0
4.0
4.0
11
0.08
1.5
1.5
0.8
13
4.0
0.3
0.3
0.05
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Commodity
Parts per million
Cattle, meat byproducts, except liver ..............................................................................................................
Cherimoya ........................................................................................................................................................
Cherry, sweet ...................................................................................................................................................
Cherry, tart .......................................................................................................................................................
Citrus, dried pulp .............................................................................................................................................
Coffee, green bean ..........................................................................................................................................
Coffee, instant ..................................................................................................................................................
Corn, field, forage ............................................................................................................................................
Corn, field, grain ..............................................................................................................................................
Corn, field, milled byproducts ..........................................................................................................................
Corn, field, stover ............................................................................................................................................
Corn, pop, forage .............................................................................................................................................
Corn, pop, grain ...............................................................................................................................................
Corn, pop, stover .............................................................................................................................................
Corn, sweet, forage .........................................................................................................................................
Corn, sweet, kernel plus cobs with husk removed .........................................................................................
Corn, sweet, stover ..........................................................................................................................................
Cotton, gin byproduct ......................................................................................................................................
Cotton, hulls .....................................................................................................................................................
Cotton, undelinted seed ...................................................................................................................................
Crambe, seed ..................................................................................................................................................
Crayfish ............................................................................................................................................................
Custard apple ..................................................................................................................................................
Egg ...................................................................................................................................................................
Feijoa ...............................................................................................................................................................
Fig ....................................................................................................................................................................
Fruit, caneberry, subgroup 13–07A .................................................................................................................
Fruit, citrus, group 10 ......................................................................................................................................
Fruit, pome, group 11, except mayhaw ...........................................................................................................
Fruit, small vine climbing, subgroup 13–07F ..................................................................................................
Fruit, stone, group 12, except cherry, chickasaw plum, and damson plum ...................................................
Goat, fat ...........................................................................................................................................................
Goat, liver ........................................................................................................................................................
Goat, meat .......................................................................................................................................................
Goat, meat byproducts, except liver ................................................................................................................
Grain, aspirated fractions ................................................................................................................................
Grape, raisin ....................................................................................................................................................
Grass forage, fodder and hay, group 17 .........................................................................................................
Guava ..............................................................................................................................................................
Hare’s ear mustard, seed ................................................................................................................................
Herb subgroup 19A, dried leaves ....................................................................................................................
Herb subgroup 19A, fresh leaves ....................................................................................................................
Hog, fat ............................................................................................................................................................
Hog, meat byproducts .....................................................................................................................................
Hop, dried cones .............................................................................................................................................
Horse, fat .........................................................................................................................................................
Horse, liver .......................................................................................................................................................
Horse, meat .....................................................................................................................................................
Horse, meat byproducts, except liver ..............................................................................................................
Ilama ................................................................................................................................................................
Jaboticaba ........................................................................................................................................................
Jojoba, seed ....................................................................................................................................................
Lesquerella, seed ............................................................................................................................................
Longan .............................................................................................................................................................
Lunaria, seed ...................................................................................................................................................
Lychee .............................................................................................................................................................
Mango ..............................................................................................................................................................
Mayhaw ............................................................................................................................................................
Milk ...................................................................................................................................................................
Milkweed, seed ................................................................................................................................................
Mustard, seed ..................................................................................................................................................
Nut, tree, group 14 ..........................................................................................................................................
Oil, radish, seed ...............................................................................................................................................
Okra .................................................................................................................................................................
Olive .................................................................................................................................................................
Olive, oil ...........................................................................................................................................................
Papaya .............................................................................................................................................................
Passionfruit ......................................................................................................................................................
Peppermint, tops ..............................................................................................................................................
Persimmon .......................................................................................................................................................
Pineapple .........................................................................................................................................................
Pineapple, process residue .............................................................................................................................
Pistachio ..........................................................................................................................................................
Plum, chickasaw ..............................................................................................................................................
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03FER1
5534
Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations
Commodity
Parts per million
Plum, damson ..................................................................................................................................................
Pomegranate ...................................................................................................................................................
Poppy, seed .....................................................................................................................................................
Poultry, fat ........................................................................................................................................................
Poultry, meat byproducts .................................................................................................................................
Pulasan ............................................................................................................................................................
Rambutan ........................................................................................................................................................
Rapeseed, seed ...............................................................................................................................................
Rice, grain ........................................................................................................................................................
Rice, hulls ........................................................................................................................................................
Rose hip, seed .................................................................................................................................................
Sapodilla ..........................................................................................................................................................
Sapote, black ...................................................................................................................................................
Sapote, mamey ................................................................................................................................................
Sapote, white ...................................................................................................................................................
Sesame, seed ..................................................................................................................................................
Sheep, fat ........................................................................................................................................................
Sheep, liver ......................................................................................................................................................
Sheep, meat ....................................................................................................................................................
Sheep, meat byproducts, except liver .............................................................................................................
Soursop ............................................................................................................................................................
Spanish lime ....................................................................................................................................................
Spearmint, tops ................................................................................................................................................
Spice, subgroup 19B .......................................................................................................................................
Star apple ........................................................................................................................................................
Starfruit ............................................................................................................................................................
Strawberry ........................................................................................................................................................
Sugar apple .....................................................................................................................................................
Sugarcane, cane ..............................................................................................................................................
Sugarcane, molasses ......................................................................................................................................
Tallowwood, seed ............................................................................................................................................
Tea oil plant, seed ...........................................................................................................................................
Vegetable, cucurbit, group 9 ...........................................................................................................................
Vegetable, foliage of legume, except soybean, subgroup 7A, forage ............................................................
Vegetable, foliage of legume, except soybean, subgroup 7A, hay ................................................................
Vegetable, fruiting, group 8 .............................................................................................................................
Vegetable, leafy, except brassica, group 4 .....................................................................................................
Vegetable, legume, group 6, except soybeans ...............................................................................................
Vegetable, tuberous and corm, subgroup 1C .................................................................................................
Wax jambu .......................................................................................................................................................
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
Time-limited tolerances are established
for the indirect or inadvertent residues
of the insecticide chlorantraniliprole,
including its metabolites and
degradates, in or on the commodities in
the table below when present therein as
a result of the application of
chlorantraniliprole to the growing crops
listed in paragraph (a) of this section.
Commodity
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14:52 Feb 02, 2010
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Compliance with the tolerance levels
specified below is to be determined by
measuring only chlorantraniliprole, 3bromo-N-[4-chloro-2-methyl-6[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5carboxamide.
Parts per million
Grain, cereal, forage, fodder and straw, group 16 ..........................
Leek .................................................................................................
Onion, green ....................................................................................
Onion, welsh ....................................................................................
Peanut, hay ......................................................................................
Shallot ..............................................................................................
Soybean, forage ..............................................................................
Soybean, hay ...................................................................................
Vegetable, leaves of root and tuber, group 2 .................................
VerDate Nov<24>2008
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4.0
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0.01
0.02
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4.0
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4.0
4.0
4.0
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0.3
0.3
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0.2
4.0
4.0
9.0
14
4.0
4.0
1.0
4.0
14
420
0.3
0.3
0.25
30
90
0.70
13
2.0
0.01
4.0
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03FER1
Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations
[FR Doc. 2010–2254 Filed 2–2–10; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 26
[Docket No. OST–2010–0021]
RIN 2105–AD76
Participation by Disadvantaged
Business Enterprises in Department of
Transportation Financial Assistance
Programs
AGENCY:
Office of the Secretary (OST),
DOT.
ACTION:
Final rule.
SUMMARY: This final rule changes the
Department of Transportation
(Department) regulation concerning how
often recipients of DOT financial
assistance are required to submit to the
appropriate DOT operating
administration for approval the
methodology and process used to
establish their overall disadvantaged
business enterprise (DBE) goal for
federally funded contracting
opportunities. Under the rule, recipients
will submit overall goals for review
every three years, rather than annually.
DATES: Effective Date: This rule is
effective March 5, 2010.
FOR FURTHER INFORMATION CONTACT:
Robert C. Ashby, Deputy Assistant
General Counsel for Regulation and
Enforcement, U.S. Department of
Transportation, 1200 New Jersey
Avenue, SE., Room W94–302,
Washington, DC 20590, 202 366–9310,
Bob.Ashby@dot.gov.
On April
8, 2009, the Department published in
the Federal Register at 74 FR 15910, a
notice of proposed rulemaking (NPRM)
inviting public comment on a proposal
to establish a staggered three-year
schedule for the submission by DOT
recipients subject to the regulations at
49 CFR part 26 of their overall goal for
DBE participation on DOT-assisted
contracts. Recipients are currently
required to make a DBE goal submission
each year on August 1st. This proposed
rule change was modeled largely on the
comparable provision in the airport
concessions DBE rule in Part 23 of this
Title, with which the Department has
had successful experience.
The Department received
approximately 27 comments from state
departments of transportation, airports,
transit authorities, DBEs, contractor
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SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
14:52 Feb 02, 2010
Jkt 220001
associations, and transportation
consultants. This final rule responds to
the substantive concerns raised in the
comments from those who supported or
opposed the adoption of the proposed
rule.
The majority of commenters
supported the proposed rule change as
long as recipients are either required to
conduct annual reviews to account for
changes that may warrant a
modification of the overall goal or are
simply allowed to make adjustments to
the overall goal during the three-year
period based on changed circumstances
without necessarily requiring annual
reviews. Some of the circumstances or
conditions that may indicate the need
for an adjustment include, but are not
limited to, the collection of new data, a
significant change in the recipient’s
DOT assisted contracting program (e.g.,
new contracting opportunities presented
by the availability of new or different
grant opportunities), a marked increase
or decrease in the availability of DBEs
in the recipient’s contracting market, or
a significant change in the legal
standards governing the DBE program.
Some supporters also thought it
advisable to give recipients the
flexibility to request a waiver to set their
own schedule or to submit an overall
goal that covers a one-, two-, or threeyear period as appropriate due to the
nature of the recipient’s contracting
program. The ability to maintain the
status quo—i.e., set annual overall
goals—was an approach strongly
endorsed by some airports, some
representatives of the aviation industry,
and some representatives of general
contractors.
The commenters opposed to the
proposed rule change raised several
concerns about moving to a three-year
cycle: (1) The difficulty in estimating a
DBE goal beyond one year given the
changes in the political landscape or
changes in the kind of projects that are
funded; (2) locking in goals for three
years undermines the ability to assess
market conditions and DBE availability;
(3) requiring annual reviews during the
three-year period defeats the purpose of
reducing the administrative burden
associated with the annual goal setting
process since an annual review will
likely result in the need for an
adjustment and thereby trigger the
annual goal setting process; and (4) it
fails to achieve a level playing field or
ensure narrow tailoring.
Having considered the comments, the
Department believes going to a system
of staggered three-year overall DBE goal
submissions would not compromise the
ability of recipients to implement a
narrowly tailored program and would
PO 00000
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5535
enable recipients to improve the data
collection, analysis, and consultation
required to establish an overall goal that
truly aims to reflect the level of DBE
participation one would expect absent
the effects of discrimination. Since the
DBE program rules were substantially
revised in 1999, generally we have not
seen huge variances in the annual DBE
goal submissions made by recipients
over the last ten years. Thus, we do not
assume that requiring an annual review
would necessarily lead to annual
adjustments resulting from a process
that mimics the current yearly process.
That said, we do not think it necessary
to mandate annual reviews. Instead, we
believe recipients or operating
administrations should be allowed,
based on changed circumstances, to
initiate mid-course reviews as needed to
determine if adjustments to the overall
goal are warranted. Also, we do not
think it prudent to allow each recipient
to establish a different schedule for
submission. Such a series of exceptions
would likely swallow the rule. It also
would make it much more difficult for
operating administrations to manage
reviews and oversee compliance.
However, in those cases where a
recipient believes its situation differs
from other similarly situated recipients,
the existing program waiver process
offers the recipient the opportunity to
seek an exception. These program
waivers, unlike the general program
waiver provisions of 49 CFR 26.15,
could be granted by an operating
administration and would not have to
be approved by the Secretary.
Under the final rule, each operating
administration is required to establish a
schedule for submissions to be posted
on its Web site. The schedules are
intended to be posted no later than 30
days after the effective date of this rule.
During the transition to this new
system, specific notice of the deadline
for overall goal submissions and the
consequences of failing to meet the
deadline should be provided to
recipients. The schedules established by
the operating administrations should
include each year a proportionate or
representative number of recipients
from all regions of the country (e.g.,
north, south, east, and west). During the
transition to the new scheduling system,
recipients should continuing using or
operating under the goals last approved
by the operating administration.
Regulatory Analyses and Notices
Executive Order 12866 and Regulatory
Flexibility Act
The Department has determined that
this action is not a significant regulatory
E:\FR\FM\03FER1.SGM
03FER1
Agencies
[Federal Register Volume 75, Number 22 (Wednesday, February 3, 2010)]
[Rules and Regulations]
[Pages 5526-5535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2254]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0261; FRL-8809-3]
Chlorantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
[[Page 5527]]
ACTION: Final rule.
-----------------------------------------------------------------------
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
replaced by this action. 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 February 3, 2010. Objections and
requests for hearings must be received on or before April 5, 2010, 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-2009-0261. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://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: Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0415; e-mail address: davis.kabl@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 cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0261 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before April 5, 2010.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0261, by one of the following methods:
Federal eRulemaking Portal: https://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. Petition for Tolerance
In the Federal Register of May 6, 2009 (Volume 74 FR 20949) (FRL-
8412-7), 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
9F7513) by E.I. du Pont de Nemours and Company, DuPont Crop
Protection,1090 Elkton Road, Newark, DE 19711. 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 acerola at 2.0 parts per million (ppm); almond,
hull at 5.0 ppm; apple, wet pomace at 2.5 ppm; artichoke at 4.0 ppm;
asparagus at 13.0 ppm; atemoya at 4.0 ppm; avocado at 4.0 ppm; banana
at 4.0 ppm; biriba at 4.0 ppm; black sapote at 4.0 ppm; cacao bean,
bean at 0.15 ppm; cacao, roasted beans at 1.4 ppm; canistel at 4.0 ppm;
cattle, fat at 0.3 ppm; cattle, liver at 0.3 ppm; cattle, meat at 0.05
ppm; cattle, meat byproducts except liver at 0.2 ppm; cherimoya at 4.0
ppm; chocolate at 3.0 ppm; citrus, dried pulp at 14.0 ppm; cocoa powder
at 3.0 ppm; coffee, bean, green at 0.5 ppm; coffee, instant at 2.5 ppm;
corn, sweet at 0.02 ppm; corn, field, grain at 0.04 ppm; corn, pop at
0.04 ppm; corn, aspirated grain fractions at 2.0 ppm; corn, processed
commodities at 0.1 ppm; crambe at 0.3 ppm; crayfish at 8.0 ppm; custard
apple at 4.0 ppm; egg at 0.1 ppm; feijoa at 4.0 ppm; figs at 4.0 ppm;
forage, fodder, and straw of cereal grains, group 16, forage and fodder
at 25.0 ppm; forage, fodder, and straw of cereal grains, group 16, hay
and straw at 90.0 ppm; fruit, caneberry, subgroup 13-07A at 1.8 ppm;
fruit, citrus, group 10 at 1.4 ppm; fruit, pome, group 11 at 1.2 ppm;
fruit, small vine climbing, subgroup 13-07D at 2.5 ppm; fruit, stone,
group 12 at 4.0 ppm; goat,
[[Page 5528]]
fat at 0.3 ppm; goat, liver at 0.3 ppm; goat, meat at 0.05 ppm; goat,
meat byproducts, except liver at 0.2 ppm; grass, forage, fodder and
hay, group 17, forage and fodder at 25.0 ppm; grass, forage, fodder and
hay, group 17, hay and straw at 90.0 ppm; guava at 4.0 ppm; hare's ear
mustard at 0.3 ppm; herbs and spices, subgroup 19A, dried at 90.0 ppm;
herbs and spices, subgroup 19A, fresh at 25.0 ppm; herbs and spices,
subgroup 19B, spices at 7.0 ppm; hops at 90.0 ppm; horse, fat at 0.3
ppm; horse, liver at 0.3 ppm; horse, meat at 0.05 ppm; horse, meat
byproducts, except liver at 0.2 ppm; ilama at 4.0 ppm; jaboticaba at
2.0 ppm; jojoba at 0.3 ppm; lesquerella at 0.3 ppm; longan at 4.0 ppm;
lunaria at 0.3 ppm; lychee at 2.0 ppm; mango at 4.0 ppm; milk at 0.05
ppm; milkweed at 0.3 ppm; mint at 9.0 ppm; mustard at 0.3 ppm; non-
grass animal feeds, group 18, forage and fodder at 13.0 ppm; non-grass
animal feeds, group 18, hay and straw at 45.0 ppm; non-grass animal
feeds, group 18, seeds at 3.5 ppm; nut, tree, group 14 at 0.04 ppm; oil
radish at 0.3 ppm; okra at 0.7 ppm; olive at 4.0 ppm; olive, oil at
40.0 ppm; papaya at 2.0 ppm; passion fruit at 2.0 ppm; peanut at 0.1
ppm; peanut hay at 90.0 ppm; persimmon at 4.0 ppm; pineapple at 1.5
ppm; pineapple process residue at 3.0 ppm; pistachio at 0.04 ppm;
pomegranate at 4.0 ppm; poppy seed at 0.3 ppm; poultry, fat at 0.02
ppm; poultry, meat at 0.02 ppm; poultry, meat byproducts at 0.02 ppm;
prickly pear cactus at 13.0 ppm; pulasan at 4.0 ppm; raisins at 5.0
ppm; rambutan at 4.0 ppm; rapeseed at 0.3 ppm; rice, grain at 0.15 ppm;
rice, hulls at 0.3 ppm; rice, straw at 0.3 ppm; rose hip at 0.3 ppm;
sapodilla at 4.0 ppm; sapote, mamey at 4.0 ppm; sesame at 0.3 ppm;
sheep, fat at 0.3 ppm; sheep, liver at 0.3 ppm; sheep, meat at 0.05
ppm; sheep, meat byproducts except liver at 0.2 ppm; soursop at 4.0
ppm; spanish lime at 4.0 ppm; star apple at 4.0 ppm; starfruit at 4.0
ppm; strawberries at 1.0 ppm; sugar apple at 4.0 ppm; sugarcane, cane
at 14.0 ppm; sugarcane molasses at 420.0 ppm; tallowwood at 0.3 ppm;
tea oil plant at 0.3 ppm; ti palm, leaves at 13.0 ppm; ti palm, roots
at 0.1 ppm; vegetables, brassica leafy, group 5 at 11.0 ppm;
vegetables, foliage of legume, group 7, forage/vines at 30.0 ppm;
vegetables, foliage of legume, group 7, hay at 90.0 ppm; vegetables,
legume, group 6, except soybeans at 2.0 ppm; vegetables, tuberous and
corm, subgroup 1C at 0.01 ppm; wax jambu at 4.0 ppm; white sapote
(casimiroa) and other cultivars and/or hybrids at 4.0 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 to the public in the docket, https://www.regulations.gov.
There were no comments received in response to the notice of filing.
EPA has determined that tolerances are not required for several
petitioned commodities. Additionally, the Agency is revising tolerances
for several proposed individual and group commodities and is amending
multiple established tolerances. Finally, EPA is deleting several
existing tolerances. The details on the specific changes being made and
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 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.
Chlorantraniliprole is not genotoxic, neurotoxic, immunotoxic,
carcinogenic, or teratogenic. Chlorantraniliprole has been found to
have low acute toxicity by the oral, dermal, and inhalation routes of
exposure and has little to no irritation effect on the eyes or skin.
Additionally, chlorantraniliprole is not a dermal sensitizer. There was
only one toxicity study in the toxicology database that indicated that
Chlorantraniliprole yielded an adverse effect (18-month oral/mouse).
This study was used to establish a point of departure based on
hepatocellular effects for chronic risk.
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 https://www.regulations.gov in the document; ``Chlorantraniliprole (DPX-E2Y45).
Human Health Risk Assessment for Section 3 Registration Request to
Expand Uses of Coragen, Altacor, and Dermacor X-100 Labels on Various
Field, Vegetable, and Fruit Crops,'' page 31 in docket ID number EPA-
HQ-OPP-2009-0261.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-, and chronic-term risks are evaluated by
[[Page 5529]]
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
level of concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for chlorantraniliprole
used for human risk assessment can be found at https://www.regulations.gov in the document; ``Chlorantraniliprole (DPX-E2Y45).
Human Health Risk Assessment for Section 3 Registration Request to
Expand Uses of Coragen, Altacor, and Dermacor X-100 Labels on Various
Field, Vegetable, and Fruit Crops,'' in docket ID number EPA-HQ-OPP-
2009-0261.
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 all foods for which there are
tolerances were treated and contain tolerance-level residues.
iii. Cancer. Chlorantraniliprole was classified as ``Not likely to
be Carcinogenic to Humans'' based on evidence showing no treatment-
related tumors in the submitted chronic and oncogenicity studies in
rats and mice, and subchronic studies in mice, dogs, and rats, and no
mutagenic concerns in the genotoxicity studies. Therefore, an exposure
assessment to evaluate cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for chlorantraniliprole. 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 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 https://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
chlorantraniliprole for chronic exposures for non-cancer assessments
are estimated to be 3.65 ppb for surface water and 1.06 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 3.65 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).
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 www.regulations.gov (Docket ID EPA-HQ-OPP-2009-0261, pages 24
through 25).
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 chemicals, see EPA's website at https://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
milligrams/kilogram/day (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 to reduced 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,
[[Page 5530]]
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 chronic dietary food exposure assessment utilized
tolerance-level residues and 100 PCT data. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to chlorantraniliprole in drinking water. Due to the
lack of toxicity identified for short-term and intermediate-term
durations via relevant routes of exposure, 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 pesticide exposures are
safe by comparing aggregate exposure estimates to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD represent the highest safe exposures, taking into account
all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the
POD by all applicable UFs. For linear cancer risks, EPA calculates the
probability of additional cancer cases given the estimated aggregate
exposure. Short-term, intermediate-term, and chronic-term risks are
evaluated by comparing the estimated aggregate food, water, and
residential exposure to the POD to ensure that the MOE called for by
the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute 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 5% of the cPAD for
children 1 to 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 evidence
showing no treatment-related tumors in the submitted chronic and
oncogenicity studies in rats and mice, and subchronic studies in mice,
dogs, and rats, and no mutagenic concerns in the genotoxicity 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
Regarding international Maximum Residue Levels (MRLs) for
chlorantraniliprole, all tolerances are harmonized (tolerances and MRLs
have equivalent residue levels and tolerance expressions) or U.S.
tolerances are higher than Codex based on submitted data and
differences in U.S. use patterns. U.S. tolerances exceed Codex MRLs for
the following commodities: Grapes, edible offal (mammalian), milks,
meat (from mammals), pome fruits, stone fruits and eggs. All other MRLs
are harmonized with Codex.
C. Response to Comments
There were no comments received in response to the notice of
filing.
D. Revisions to Petitioned-For Tolerances
EPA has revised the proposed tolerance levels of
chlorantraniliprole on the following commodities: cacao bean from 0.15
ppm to 0.08 ppm; cacao bean, roasted bean from 1.4 ppm to 0.8 ppm;
cacao bean, chocolate from 3.0 ppm to 1.5 ppm; cacao bean, cocoa powder
from 3.0 ppm to 1.5 ppm; coffee, green bean from 0.5 ppm to 0.4 ppm;
coffee, instant from 2.5 ppm to 2.0 ppm; egg from 0.1 ppm to 0.2 ppm;
herbs and spices, subgroup 19B, spices from 7.0 ppm to 14 ppm; animal
feed, nongrass, group 18, forage from 13.0 ppm to 25 ppm; animal feed,
nongrass, group 18, hay from 45 ppm to 90 ppm; alfalfa, seed from 3.5
ppm to 7.0 ppm; poultry, fat from 0.02 ppm to 0.01 ppm; rice, hulls
from 0.3 ppm to 0.4 ppm. EPA revised the tolerance levels based on
analysis of the residue field trial data using the Agency's tolerance
spreadsheet in accordance with the Agency's Guidance for Setting
Pesticide Tolerances Based on Field Trial Data.
The commodity, fruit, pome, group 11 is being revised to read
fruit, pome, group 11, except mayhaw. A separate tolerance of 0.6 ppm
is being established for mayhaw. The commodity, fruit, stone, group 12
is being revised to read fruit, stone, group 12, except cherry,
chickasaw plum, and damson plum. Separate tolerances of 2.0 ppm are
being established for cherry, sweet; cherry, tart; plum, chickasaw;
plum, damson. for these two groups the EPA has determined that for
those commodities in these groups considered small fruit it is not
approriatate to establish the higher tolerance because they have
differing use directions with a longer phi that will result in lower
residue levels.
The petitioner requested tolerances on forage, fodder, and straw of
cereal
[[Page 5531]]
grains, group 16, forage and fodder at 25.0 ppm; and forage, fodder,
and straw of cereal grains, group 16, hay and straw at 90.0 ppm.
However, no tolerances were proposed for cereal grains, crop group 15.
Without a tolerance for cereal grains, crop group 15, tolerances for
cereal grains, crop group 16, forage, fodder and straw are not
appropriate. However, based on submitted data and translation, the
tolerance of 14 ppm can be established for the following individual
crop group 16 commodities: corn, field, forage; corn, field, stover;
corn, pop, forage; corn, pop, stover; corn, sweet, forage, and corn,
sweet, stover.
Based upon the re-examination of the available ruminant feeding
study, EPA is establishing tolerance levels of chlorantraniliprole on
the following commodities: Hog, fat at 0.02 ppm and hog, meat
byproducts at 0.02 ppm.
The current established tolerance of 0.01 ppm for residues of
chlorantraniliprole on potatoes is revoked upon the establishment of
tolerances on vegetables, tuberous and corm, subgroup 1C at 0.01 ppm.
The petitioner requested tolerances be established for fruit, small
vine climbing, subgroup 13-07D at 2.5 ppm.
The representative commodities for this subgroup are grape and
fuzzy kiwifruit. Data are only available for grape. Therefore, the EPA
is establishing a tolerance for fruit, small vine climbing, subgroup
13-07F at 2.5 ppm which is a subset of subgroup 13-07D. The current
established tolerance of 1.2 ppm for residues of chlorantraniliprole on
grapes is revoked upon the establishment of tolerances on fruit, small
vine climbing, subgroup 13-07F at 2.5 ppm.
Finally, EPA has revised the tolerance expression to clarify (1)
that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of chlorantraniliprole not specifically
mentioned; and (2) that compliance with the specified tolerance levels
is to be determined by measuring only the specific compounds mentioned
in the tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on acerola at 2.0 ppm; animal feed, nongrass, group
18, forage at 25 ppm; animal feed, nongrass, group 18, hay at 90 ppm;
alfalfa, seed at 7.0 ppm; artichoke, globe at 4.0 ppm; asparagus at 13
ppm; atemoya at 4.0 ppm; avocado at 4.0 ppm; banana at 4.0 ppm; biriba
at 4.0 ppm; cacao bean at 0.08 ppm; cacao bean, chocolate at 1.5 ppm;
cacao bean, cocoa powder at 1.5 ppm; cacao bean, roasted bean at 0.8
ppm; cactus at 13 ppm; canistel at 4.0 ppm; cattle, liver at 0.3 ppm;
cherimoya at 4.0 ppm; citrus, dried pulp at 14 ppm; coffee, green bean
at 0.4 ppm; coffee, instant at 2.0 ppm; corn, sweet, kernel plus cobs
with hush removed at 0.02 ppm; corn, field, grain at 0.04 ppm; corn,
field, milled byproducts at 0.1 ppm; corn, pop, grain at 0.04 ppm;
crambe, seed at 0.3 ppm; crayfish at 8.0 ppm; custard apple at 4.0 ppm
; egg at 0.2 ppm; feijoa at 4.0 ppm; fig at 4.0 ppm; fruit, caneberry,
subgroup 13-07A at 1.8 ppm; fruit, citrus, group 10 at 1.4 ppm; fruit,
small vine climbing, subgroup 13-07F at 2.5 ppm; goat, liver at 0.3
ppm; grass forage, fodder and hay, group 17 at 90 ppm; grain, aspirated
fractions at 2.0 ppm; guava at 4.0 ppm; hare's ear mustard, seed at 0.3
ppm; herb subgroup 19A, dried leaves at 90 ppm; herb subgroup 19A,
fresh leaves at 25 ppm; hop, dried cones at 90 ppm; horse, liver at 0.3
ppm; ilama at 4.0 ppm; jaboticaba at 2.0 ppm; jojoba, seed at 0.3 ppm;
lesquerella, seed at 0.3 ppm; longan at 4.0 ppm; lunaria, seed at 0.3
ppm; lychee at 2.0 ppm; mango at 4.0 ppm; milkweed, seed at 0.3 ppm;
mustard seed at 0.3 ppm; oil, radish, seed at 0.3 ppm; okra at 0.7 ppm;
olive at 4.0 ppm; olive, oil at 40.0 ppm; papaya at 2.0 ppm;
passionfruit at 2.0 ppm; peppermint, tops at 9.0 ppm; persimmon at 4.0
ppm; pineapple at 1.5 ppm; pineapple, process residue at 3.0 ppm;
pomegranate at 4.0 ppm; poppy, seed at 0.3 ppm; poultry, fat at 0.01
ppm; poultry, meat byproducts at 0.02 ppm; pulasan at 4.0 ppm; rambutan
at 4.0 ppm; rapeseed, seed at 0.3 ppm; rice, grain at 0.15 ppm; rice,
hulls at 0.4 ppm; rose hip, seed at 0.3 ppm; sapodilla at 4.0 ppm;
sapote, black at 4.0 ppm; sapote, mamey at 4.0 ppm; sapote, white at
4.0 ppm; sesame, seed at 0.3 ppm; sheep, liver at 0.3 ppm; soursop at
4.0 ppm; spanish lime at 4.0 ppm; spearmint, tops at 9.0 ppm; spice,
subgroup 19B at 14 ppm; star apple at 4.0 ppm; starfruit at 4.0 ppm;
strawberries at 1.0 ppm; sugar apple at 4.0 ppm; sugarcane, cane at 14
ppm; sugarcane, molasses at 420 ppm; tallowwood, seed at 0.3 ppm; tea
oil plant, seed at 0.3 ppm; vegetables, foliage of legume, except
soybean, subgroup 7A, forage at 30 ppm; vegetables, foliage of legume,
except soybean, subgroup 7A, hay at 90 ppm; vegetables, legume, group
6, except soybeans at 2.0 ppm; vegetables, tuberous and corm, subgroup
1C at 0.01 ppm; wax jambu at 4.0 ppm.
Additionally, tolerances are amended for residues of
chlorantraniliprole in or on apple, wet pomace from 0.60 ppm to 2.5
ppm; cattle, fat from 0.01 ppm to 0.3 ppm; cattle, meat from 0.01 ppm
to 0.05 ppm; cattle, meat byproducts from 0.01 ppm to 0.2 ppm; fruit,
pome, group 11, except mayhaw from 0.30 ppm to 1.2 ppm; fruit, stone,
group 12, except cherry, chickasaw plum, and damson plum from 0.30 ppm
to 4.0 ppm; goat, fat from 0.01 ppm to 0.3 ppm; goat, meat from 0.01
ppm to 0.05 ppm; goat, meat byproduct from 0.01 ppm to 0.2 ppm; grape,
raisin from 2.5 ppm to 5.0 ppm; horse, fat from 0.01 ppm to 0.3 ppm;
horse, meat from 0.01 ppm to 0.05 ppm; horse, meat byproduct from 0.01
ppm to 0.2 ppm; milk from 0.01 ppm to 0.05 ppm; sheep, fat from 0.01
ppm to 0.3 ppm; sheep, meat from 0.01 ppm to 0.05 ppm; sheep, meat
byproduct from 0.01 ppm to 0.2 ppm.
Although requests were made to amend residues of
chlorantraniliprole in or on Crop Groups 11 and 12, the following
individual commodities required separate tolerances. Tolerances are
established for residues of chlorantraniliprole in or on cherry, sweet
at 2.0 ppm; cherry, tart at 2.0 ppm; mayhaw at 0.6 ppm; plum, chickasaw
at 2.0 ppm and plum, damson at 2.0 ppm.
In addition, requests were made to establish tolerances of
chlorantraniliprole in or on Crop Group 15, however adequate data were
only submitted to support the establishment of tolerances for specific
commodities. tolerances are established for residues of
chlorantraniliprole in or on corn, field, forage at 14.0 ppm; corn,
field, stover at 14.0 ppm; corn, pop, forage at 14.0 ppm; corn, pop,
stover at 14.0 ppm; corn, sweet, forage at 14.0 ppm and corn, sweet,
stover at 14.0 ppm.
This regulation deletes a tolerance in or on grape at 1.2 ppm and
potato at 0.01 ppm. Additionally, the following time-limited section 18
emergency exemption tolerances are deleted: corn, sweet, cannery waste
at 6.0 ppm; corn, sweet, forage at 6.0 ppm; corn, sweet, kernel plus
cob with husks removed at 0.01 ppm; corn, sweet, stover at 6.0 ppm;
milk at 0.03 ppm; rice, grain at 0.10 ppm and rice, straw at 0.25 ppm.
Finally, this regulation deletes time-limited tolerances for indirect/
inadvertent residues of chlorantraniliprole in or on animal feed,
nongrass, group 18 at 0.20 ppm; cowpea, forage at 0.20 ppm; cowpea, hay
at 0.20 ppm; field pea, hay at 0.20 ppm; field pea, vine at 0.20 ppm;
grass, forage, fodder and hay, group 17 at 0.20 ppm; okra at 0.70 ppm;
strawberry at 1.20 ppm and sugarcane at 0.20 ppm.
[[Page 5532]]
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) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
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.
Dated: January 26, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.628 is revised to read as follows:
Sec. 180.628 Chlorantraniliprole; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide chlorantraniliprole, including its metabolites and
degradates, in or on the commodities in the table below. 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.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Acerola............................. 2.0
Alfalfa, seed....................... 7.0
Almond, hulls....................... 5.0
Animal feed, nongrass, group 18, 25
forage.............................
Animal feed, nongrass, group 18, hay 90
Apple, wet pomace................... 2.5
Artichoke, globe.................... 4.0
Asparagus........................... 13
Atemoya............................. 4.0
Avocado............................. 4.0
Banana.............................. 4.0
Biriba.............................. 4.0
Brassica, head and stem, subgroup 5A 4.0
Brassica, leafy greens, subgroup 5B. 11
Cacao bean.......................... 0.08
Cacao bean, chocolate............... 1.5
Cacao bean, cocoa powder............ 1.5
Cacao bean, roasted bean............ 0.8
Cactus.............................. 13
Canistel............................ 4.0
Cattle, fat......................... 0.3
Cattle, liver....................... 0.3
Cattle, meat........................ 0.05
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Cattle, meat byproducts, except 0.2
liver..............................
Cherimoya........................... 4.0
Cherry, sweet....................... 2.0
Cherry, tart........................ 2.0
Citrus, dried pulp.................. 14
Coffee, green bean.................. 0.4
Coffee, instant..................... 2.0
Corn, field, forage................. 14
Corn, field, grain.................. 0.04
Corn, field, milled byproducts...... 0.1
Corn, field, stover................. 14
Corn, pop, forage................... 14
Corn, pop, grain.................... 0.04
Corn, pop, stover................... 14
Corn, sweet, forage................. 14
Corn, sweet, kernel plus cobs with 0.02
husk removed.......................
Corn, sweet, stover................. 14
Cotton, gin byproduct............... 30
Cotton, hulls....................... 0.40
Cotton, undelinted seed............. 0.30
Crambe, seed........................ 0.3
Crayfish............................ 8.0
Custard apple....................... 4.0
Egg................................. 0.2
Feijoa.............................. 4.0
Fig................................. 4.0
Fruit, caneberry, subgroup 13-07A... 1.8
Fruit, citrus, group 10............. 1.4
Fruit, pome, group 11, except mayhaw 1.2
Fruit, small vine climbing, subgroup 2.5
13-07F.............................
Fruit, stone, group 12, except 4.0
cherry, chickasaw plum, and damson
plum...............................
Goat, fat........................... 0.3
Goat, liver......................... 0.3
Goat, meat.......................... 0.05
Goat, meat byproducts, except liver. 0.2
Grain, aspirated fractions.......... 2.0
Grape, raisin....................... 5.0
Grass forage, fodder and hay, group 90
17.................................
Guava............................... 4.0
Hare's ear mustard, seed............ 0.3
Herb subgroup 19A, dried leaves..... 90
Herb subgroup 19A, fresh leaves..... 25
Hog, fat............................ 0.02
Hog, meat byproducts................ 0.02
Hop, dried cones.................... 90
Horse, fat.......................... 0.3
Horse, liver........................ 0.3
Horse, meat......................... 0.05
Horse, meat byproducts, except liver 0.2
Ilama............................... 4.0
Jaboticaba.......................... 2.0
Jojoba, seed........................ 0.3
Lesquerella, seed................... 0.3
Longan.............................. 4.0
Lunaria, seed....................... 0.3
Lychee.............................. 2.0
Mango............................... 4.0
Mayhaw.............................. 0.6
Milk................................ 0.05
Milkweed, seed...................... 0.3
Mustard, seed....................... 0.3
Nut, tree, group 14................. 0.04
Oil, radish, seed................... 0.3
Okra................................ 0.7
Olive............................... 4.0
Olive, oil.......................... 40
Papaya.............................. 2.0
Passionfruit........................ 2.0
Peppermint, tops.................... 9.0
Persimmon........................... 4.0
Pineapple........................... 1.5
Pineapple, process residue.......... 3.0
Pistachio........................... 0.04
Plum, chickasaw..................... 2.0
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Plum, damson........................ 2.0
Pomegranate......................... 4.0
Poppy, seed......................... 0.3
Poultry, fat........................ 0.01
Poultry, meat byproducts............ 0.02
Pulasan............................. 4.0
Rambutan............................ 4.0
Rapeseed, seed...................... 0.3
Rice, grain......................... 0.15
Rice, hulls......................... 0.4
Rose hip, seed...................... 0.3
Sapodilla........................... 4.0
Sapote, black....................... 4.0
Sapote, mamey....................... 4.0
Sapote, white....................... 4.0
Sesame, seed........................ 0.3
Sheep, fat.......................... 0.3
Sheep, liver........................ 0.3
Sheep, meat......................... 0.05
Sheep, meat byproducts, except liver 0.2
Soursop............................. 4.0
Spanish lime........................ 4.0
Spearmint, tops..................... 9.0
Spice, subgroup 19B................. 14
Star apple.......................... 4.0
Starfruit........................... 4.0
Strawberry.......................... 1.0
Sugar apple......................... 4.0
Sugarcane, cane..................... 14
Sugarcane, molasses................. 420
Tallowwood, seed.................... 0.3
Tea oil plant, seed................. 0.3
Vegetable, cucurbit, group 9........ 0.25
Vegetable, foliage of legume, except 30
soybean, subgroup 7A, forage.......
Vegetable, foliage of legume, except 90
soybean, subgroup 7A, hay..........
Vegetable, fruiting, group 8........ 0.70
Vegetable, leafy, except brassica, 13
group 4............................
Vegetable, legume, group 6, except 2.0
soybeans...........................
Vegetable, tuberous and corm, 0.01
subgroup 1C........................
Wax jambu........................... 4.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. Time-limited tolerances are
established for the indirect or inadvertent residues of the insecticide
chlorantraniliprole, including its metabolites and degradates, in or on
the commodities in the table below when present therein as a result of
the application of chlorantraniliprole to the growing crops listed in
paragraph (a) of this section. 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.
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Grain, cereal, forage, fodder and straw, 0.20 04/10/10
group 16...............................
Leek.................................... 0.20 04/10/10
Onion, green............................ 0.20 04/10/10
Onion, welsh............................ 0.20 04/10/10
Peanut, hay............................. 0.20 04/10/10
Shallot................................. 0.20 04/10/10
Soybean, forage......................... 0.20 04/10/10
Soybean, hay............................ 0.20 04/10/10
Vegetable, leaves of root and tuber, 0.20 04/10/10
group 2................................
----------------------------------------------------------------------------------------------------------------
[[Page 5535]]
[FR Doc. 2010-2254 Filed 2-2-10; 8:45 am]
BILLING CODE 6560-50-S