Chlorantraniliprole; Pesticide Tolerances, 30470-30475 [E9-14996]
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Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations
TABLE 2—BREAKPOINTS FOR THE AQI
These breakpoints
O3 (ppm)
8-hour
O3 (ppm)
1-hour 1
0.000–0.059 ................
0.060–0.075 ................
0.076–0.095 ................
....................
....................
0.125–0.164
0.096–0.115 ................
0.116–0.374 ................
(2) ................................
(2) ................................
0.165–0.204
0.205–0.404
0.405–0.504
0.505–0.604
Equal these AQI’s
PM10
(μg/m3)
PM2.5
(μg/m3)
CO (ppm)
SO2 (ppm)
NO2
(ppm)
AQI
0.0–15.4
15.5–40.4
40.5–65.4
0–54
55–154
155–254
0.0–4.4
4.5–9.4
9.5–12.4
0.000–0.034
0.035–0.144
0.145–0.224
(3)
(3)
(3)
0–50
51–100
101–150
4 65.5–150.4
255–354
355–424
425–504
505–604
12.5–15.4
15.5–30.4
30.5–40.4
40.5–50.4
0.225–0.304
0.305–0.604
0.605–0.804
0.805–1.004
(3)
0.65–1.24
1.25–1.64
1.65–2.04
151–200
201–300
301–400
401–500
4 150.5–250.4
4 250.5–350.4
4 350.5–500.4
Category
Good.
Moderate.
Unhealthy for Sensitive Groups.
Unhealthy.
Very Unhealthy.
Hazardous.
1 Areas
are generally required to report the AQI based on 8-hour ozone values. However, there are a small number of areas where an AQI
based on 1-hour ozone values would be more precautionary. In these cases, in addition to calculating the 8-hour ozone index value, the 1-hour
ozone index value may be calculated, and the maximum of the two values reported.
2 8-hour O values do not define higher AQI values (≥ 301). AQI values of 301 or greater are calculated with 1-hour O concentrations.
3
3
3 NO has no short-term NAAQS, and can generate an AQI only above the value of 200.
2
4 If a different SHL for PM
2.5 is promulgated, these numbers will change accordingly.
*
*
*
*
Unit I.C. of the SUPPLEMENTARY
*
[FR Doc. E9–15326 Filed 6–25–09; 8:45 am]
INFORMATION).
BILLING CODE 1505–01–D
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0770. 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.kable@epa.gov.
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0770; FRL–8413–6]
Chlorantraniliprole; Pesticide
Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of
chlorantraniliprole in or on almonds;
nut, tree, crop group 14, and pistachios.
E.I. Du Pont de Nemours and Company
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA). This regulation also
establishes time-limited rotational crop
tolerances for residues of
chlorantraniliprole in or on cowpeas,
forage and hay; field peas, vines and
hay; forage, fodder and straw of cereal
grains, crop group 16; grass forage,
fodder and hay, crop group 17; leaves of
root and tuber vegetables, crop group 2,
leeks, nongrass animal feeds (forage,
fodder, straw and hay), crop group 18;
okra; onions, green; onions, Welsh;
peanuts, hay; shallots; soybeans, forage
and hay; strawberries and sugarcane,
sugar. The time-limited tolerances
expire on April 25, 2010.
DATES: This regulation is effective June
26, 2009. Objections and requests for
hearings must be received on or before
August 25, 2009, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
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SUPPLEMENTARY INFORMATION:
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 Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also 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.
I. General Information
C. Can I File an Objection or Hearing
Request?
A. Does this Action Apply to Me?
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
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
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Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations
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–2008–0770 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 August 25, 2009.
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–2008–0770, 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 and Notice of
Proposed Rulemaking
In the Federal Register of December 3,
2008 (73 FR 73640) (FRL–8390–4), 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 8F7409) 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-(3-chloro-2pyridinyl)-1 H-pyrazole-5-carboxamide,
in or on almond hulls at 5.0 parts per
million (ppm), nut, tree, crop group 14
at 0.07 ppm and pistachios at 0.07 ppm.
That notice referenced a summary of the
petition prepared by E.I. du Pont de
Nemours and Company, DuPont Crop
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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.
Based upon review of the data
supporting the petition, EPA has
reduced the recommended tolerance of
0.07 ppm for nut, tree, group 14 and
pistachios to 0.04 ppm. The reason for
these changes are explained in Unit
IV.D.
In the Federal Register of October 1,
2008 (73 FR 57040–57046) (FRL–8382–
4), EPA issued a proposed rule pursuant
to sections 408(e) of the Federal Food,
Drug and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d)(3). The rule proposed
that 40 CFR 180.628 be amended by
establishing time-limited tolerances for
indirect or inadvertent residues of
chlorantraniliprole, 3-bromo-N-[4chloro-2-methyl-6-[(methylamino)
carbonyl]phenyl]-1-(3-chloro-2pyridinyl)-1 H-pyrazole-5-carboxamide,
in or on cowpeas, forage and hay at 0.20
parts per million (ppm); field peas,
vines and hay at 0.20 ppm; forage,
fodder and straw of cereal grains, crop
group 16 at 0.20 ppm, grass forage,
fodder and hay, crop group 17 at 0.20
ppm; leaves of root and tuber
vegetables, crop group 2 at 0.20 ppm;
leeks at 0.20 ppm; nongrass animal
feeds (forage, fodder, straw and hay),
crop group 18 at 0.20 ppm; okra at 0.70
ppm; onions, green at 0.20 ppm; onions,
Welsh at 0.20 ppm; peanuts, hay at 0.20
ppm; shallots at 0.20 ppm; soybeans,
forage and hay at 0.20 ppm; strawberries
at 1.2 ppm; and sugarcane, sugar at 0.20
ppm. The proposal established a 60–day
public comment period. There were no
comments received in response to the
proposed rule.
This final rule completes Agency
action on both the petition from E.I. Du
Pont de Nemours and Company, DuPont
Crop Protection, and EPA’s proposed
rulemaking of October 1, 2008.
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
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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 the petitioned-for
tolerances for residues of
chlorantraniliprole on almond, hulls at
5.0 ppm, nut, tree, group 14 at 0.04 ppm
and pistachio at 0.04 ppm. EPA’s
assessment of exposures and risks
associated with establishing tolerances
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 toxicity 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 document
Chlorantraniliprole (DPX-E2Y45).
Human Health Risk Assessment for
Proposed Uses on the Tree Nut Group
and Pistachios and for Increases in the
Established Tolerances for Pome Fruits,
Stone Fruits, Grapes and Raisins due to
the Removal of Adjuvant Restrictions
from the Label for Pome Fruits, Stone
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Fruits, and Grapes, page 21 in docket ID
number EPA–HQ–OPP–2008–0770.
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 NOAEL in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, 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-term, and chronic-term
risks are evaluated by 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
document Chlorantraniliprole (DPXE2Y45). Human Health Risk Assessment
for Proposed Uses on the Tree Nut
Group and Pistachios and for Increases
in the Established Tolerances for Pome
Fruits, Stone Fruits, Grapes and Raisins
due to the Removal of Adjuvant
Restrictions from the Label for Pome
Fruits, Stone Fruits, and Grapes, page
10 in docket ID number EPA–HQ–OPP–
2008–0770.
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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 United States Department of
Agriculture (USDA) 1994–1996 and
1998 Continuing Survey of Food Intake
by Individuals (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 and/or PCT
information in the dietary assessment
for chlorantraniliprole. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for chlorantraniliprole in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of chlorantraniliprole.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
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Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
chlorantraniliprole for acute exposures
are estimated to be 26.862 parts per
billion (ppb) for surface water and 1.06
ppb for ground water. The estimated
drinking water concentrations (EDWCs)
of chlorantraniliprole for chronic
exposures are 3.650 parts per billion
(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 3.650
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. EPA
assessed residential exposure using the
following assumptions. Although
residential exposure could occur, due to
the lack of toxicity identified for shortand 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–2007–0275, pages 36 through
37).
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.
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D. Safety Factor for Infants and
Children
E. Aggregate Risks and Determination of
Safety
1. In general. Section 408(b)(2)(c) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There were no effects on fetal growth or
post-natal 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 reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
chlorantraniliprole is complete.
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.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to chlorantraniliprole in drinking water.
EPA used similarly conservative
assumptions to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by chlorantraniliprole.
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and 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. Shortterm, intermediate-term, and chronicterm 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 <1% of the cPAD for
(children 1–2 years) 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
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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. Chlorantraniliprole has
been classified as a ‘‘not likely human
carcinogen.’’ It 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 chromotagraphy/mass
spectrometry/mass spectrometry (LC/
MS/MC) 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
There are no international residue
limits that affect the Agency’s
recommendations at this time. There are
no Canadian, CODEX or Mexican
maximum residue limits (MRLs) for
chlorantraniliprole that exists at this
time.
C. Response to Comments
There were no comments received in
response to the notice of filing or
proposed rule.
D. Revisions to Petitioned-For
Tolerances
EPA has determined that the
appropriate tolerance level for the tree
nut group and pistachios is 0.04 ppm.
Residue field trial data for
chloroantraniliprole on almonds and
pecans showed that the highest
observed residue level on nutmeats was
0.016 ppm. Almonds and pecans are
representative commodities for the tree
nut group and pistachios. Evaluation of
these field trial data with EPA’s
statistical modeling procedures for field
residue data indicates that a tolerance of
0.04 ppm will be sufficient for the
labeled uses on tree nuts and pistachios.
The petitioner has requested a
tolerance of 0.07 ppm for these
commodities. A higher value was
requested because the field trials were
conducted without use of an adjuvant
but the petitioner now seeks approval of
a pesticide label allowing the use of
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Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations
adjuvants. Adjuvants may increase
residue levels of the pesticide by
altering the pattern of deposition,
retention and penetration. In the case of
chlorantraniliprole, several supervised
side-by-side studies conducted on
grape, peach, plum, and cherry with
chlorantraniliprole alone and in the
presence of an adjuvant, methylated
seed oils or non-ionic surfactants
showed that the adjuvants increased the
level of chlorantraniliprole by an
average factor of 2.1. EPA does not
believe, however, that use of an
adjuvant would increase
chlorantraniliprole residues in nutmeats
from the tree nut crop group and
pistachios because these foods have
very limited exposure to an applied
non-systemic chemical such as
chlorantraniliprole due to the physical
barrier, known as the exocarp (i.e., husk
or hull), surrounding the edible
commodity. Thus, the Agency does not
expect any increase in residue with the
use of an adjuvant on the tree nut group
or pistachios and EPA has revised the
requested tolerance amount for these
commodities downward to 0.04 ppm.
V. Conclusion
Therefore, tolerances are established
for residues of chlorantraniliprole, 3bromo-N-[4-chloro-2-methyl-6[(methylamino) carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1 H-pyrazole-5carboxamide, in or on almond, hulls at
5.0 ppm, nut, trees, group 14 at 0.04
ppm and pistachios at 0.04 ppm. In
addition, time-limited rotational crop
tolerances are established for residues of
chlorantraniliprole in or on cowpeas,
forage and hay at 0.20 parts per million
(ppm); field peas, vines and hay at 0.20
ppm; forage, fodder and straw of cereal
grains, crop group 16 at 0.20 ppm, grass
forage, fodder and hay, crop group 17 at
0.20 ppm; leaves of root and tuber
vegetables, crop group 2 at 0.20 ppm;
leeks at 0.20 ppm; nongrass animal
feeds (forage, fodder, straw and hay),
crop group 18 at 0.20 ppm; okra at 0.70
ppm; onions, green at 0.20 ppm; onions,
Welsh at 0.20 ppm; peanuts, hay at 0.20
ppm; shallots at 0.20 ppm; soybeans,
forage and hay at 0.20 ppm; strawberries
at 1.2 ppm; and sugarcane, sugar at 0.20
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
VerDate Nov<24>2008
14:59 Jun 25, 2009
Jkt 217001
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).
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).
Pursuant to the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that this
proposed action will not have
significant negative economic impact on
a substantial number of small entities.
Establishing a pesticide tolerance or an
exemption from the requirement of a
pesticide tolerance is, in effect, the
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Fmt 4700
Sfmt 4700
removal of a regulatory restriction on
pesticide residues in food and thus such
an action will not have any negative
economic impact on any entities,
including small entities.
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: June 11, 2009.
Debra Edwards,
Director, 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 amended by
alphabetically adding the following
commodities to the table in paragraph
(a), and revising paragraph (d) to read as
follows:
■
§ 180.628 Chlorantraniliprole; tolerances
for residues.
(a) * * *
Commodity
Parts per million
Almond, hulls ..................
*
*
*
*
5.0
*
Nut, tree, group 14 .........
*
*
*
*
0.04
*
Pistachio .........................
*
*
*
*
0.04
*
*
*
*
*
*
(d) Indirect or inadvertent residues.
Time-limited tolerances are established
for indirect or inadvertent residues of
the insecticide chlorantraniliprole (3bromo- N -[4-chloro-2-methyl-6-
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[(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following
commodities. The tolerances will expire
and are revoked on the dates specified
in the following table.
Commodity
Parts per million
Animal feed, nongrass, group 18 ................................................................................................................
Cowpea, forage ...........................................................................................................................................
Cowpea, hay ................................................................................................................................................
Field pea, hay ..............................................................................................................................................
Field pea, vine .............................................................................................................................................
Grain, cereal, forage, fodder and straw, group 16 ......................................................................................
Grass, forage, fodder and hay, group 17 ....................................................................................................
Leek .............................................................................................................................................................
Okra .............................................................................................................................................................
Onion, green ................................................................................................................................................
Onion, Welsh ...............................................................................................................................................
Peanut, hay ..................................................................................................................................................
Shallot ..........................................................................................................................................................
Soybean, forage ..........................................................................................................................................
Soybean, hay ...............................................................................................................................................
Strawberry ....................................................................................................................................................
Sugarcane ....................................................................................................................................................
Vegetable, leaves of root and tuber, group 2 .............................................................................................
[FR Doc. E9–14996 Filed 6–25–09; 8:45 am]
BILLING CODE 6560–50–S
GENERAL SERVICES
ADMINISTRATION
41 CFR Part 102–118
[FMR Amendment 2009–04; FMR Case
2009–102–4; Docket 2009–0002; Sequence
3]
RIN 3090–AI91
Federal Management Regulation;
Transportation Payment and Audit
AGENCY: Office of Governmentwide
Policy, General Services Administration
(GSA).
ACTION: Final rule.
The General Services
Administration (GSA) is amending the
Federal Management Regulation (FMR)
covering Transportation Payment and
Audit. This final rule updates
information and corrects mailing and
web site addresses.
DATES: Effective Date: This final rule is
effective June 26, 2009.
FOR FURTHER INFORMATION CONTACT: The
Regulatory Secretariat, Room 4035, GS
Building, Washington, DC 20405, (202)
208–7312, for information pertaining to
status or publication schedules. For
clarification of content, contact Patrick
O’Grady at (202) 208–4493. Please cite
FMR case 2009–102–4, Amendment
2009–04.
SUPPLEMENTARY INFORMATION:
SUMMARY:
A. Background
Federal Management Regulation
(FMR) part 102–118 (41 CFR part 102–
VerDate Nov<24>2008
14:59 Jun 25, 2009
Jkt 217001
118, Transportation Payment and
Audit) was last reviewed and amended
on September 24, 2004 (69 FR 57617).
GSA collaborated with four agencies to
conduct a review and determine if it is
still current and accurate. This final rule
reflects the changes recommended by
GSA and the other four agencies.
Because the changes only apply to
administrative matters, GSA has
determined it is not necessary to
comment on this amendment.
B. Substantive Changes
This revision eliminates references to
the GSA’s Federal Supply Service,
which was reorganized after the
regulation was last published and is
now called the GSA’s Federal
Acquisition Service (FAS). It also
updates addresses and names of other
GSA business lines, and it provides a
new address for courier mail for the
Civilian Board of Contract Appeals.
C. Executive Order 12866
GSA has determined that this final
rule is not a significant regulatory action
for the purposes of Executive Order
12866.
D. Regulatory Flexibility Act
This final rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.
Because the final rule only applies to
internal agency management, it will not
have a significant effect on the public.
E. Paperwork Reduction Act
The Paperwork Reduction Act does
not apply because the changes to the
FMR do not impose information
PO 00000
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30475
0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.70
0.20
0.20
0.20
0.20
0.20
0.20
1.20
0.20
0.20
Expiration/
revocation date
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
04/10/10
collection requirements that require the
approval of the Office of Management
and Budget under 44 U.S.C. 3501, et
seq.
F. Small Business Regulatory
Enforcement Fairness Act
This final rule is exempt from
Congressional review under 5 U.S.C.
801 since it relates solely to agency
management and personnel.
List of Subjects in 41 CFR Part 102–118
Accounting, Claims, Government
property management, Reporting and
recordkeeping requirements, Surplus
Government property, Transportation.
Dated: May 29, 2009.
Paul F. Prouty,
Acting Administrator of General Services.
For the reasons set forth in the
preamble, GSA is amending 41 CFR part
102–118 as set forth below:
■
PART 102–118—TRANSPORTATION
PAYMENT AND AUDIT
1. The authority citation for 41 CFR
part 102–118 continues to read as
follows:
■
Authority: 31 U.S.C. 3726; 40 U.S.C.
121(c), and 49 U.S.C. 10721, 13712, and
15504.
2. Amend part 102–118 by removing
‘‘Federal Supply Service Audit Division
(FBA), 1800 F Street, NW., Washington,
DC 20405’’ wherever it appears, and
adding ‘‘Transportation Audit Division
(QMCA), Crystal Plaza 4, Room 300,
2200 Crystal Drive, Arlington, VA
22202’’ in its place.
■ 3. Amend § 102–118.35 by revising
the definition of ‘‘Government Bill of
Lading (GBL)’’ to read as follows:
■
E:\FR\FM\26JNR1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Rules and Regulations]
[Pages 30470-30475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14996]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0770; FRL-8413-6]
Chlorantraniliprole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
chlorantraniliprole in or on almonds; nut, tree, crop group 14, and
pistachios. E.I. Du Pont de Nemours and Company requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This
regulation also establishes time-limited rotational crop tolerances for
residues of chlorantraniliprole in or on cowpeas, forage and hay; field
peas, vines and hay; forage, fodder and straw of cereal grains, crop
group 16; grass forage, fodder and hay, crop group 17; leaves of root
and tuber vegetables, crop group 2, leeks, nongrass animal feeds
(forage, fodder, straw and hay), crop group 18; okra; onions, green;
onions, Welsh; peanuts, hay; shallots; soybeans, forage and hay;
strawberries and sugarcane, sugar. The time-limited tolerances expire
on April 25, 2010.
DATES: This regulation is effective June 26, 2009. Objections and
requests for hearings must be received on or before August 25, 2009,
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-2008-0770. 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.kable@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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also 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
[[Page 30471]]
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-2008-0770 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 August 25, 2009.
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-2008-0770, 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 and Notice of Proposed Rulemaking
In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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
8F7409) 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)-1 H-pyrazole-
5-carboxamide, in or on almond hulls at 5.0 parts per million (ppm),
nut, tree, crop group 14 at 0.07 ppm and pistachios at 0.07 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.
Based upon review of the data supporting the petition, EPA has
reduced the recommended tolerance of 0.07 ppm for nut, tree, group 14
and pistachios to 0.04 ppm. The reason for these changes are explained
in Unit IV.D.
In the Federal Register of October 1, 2008 (73 FR 57040-57046)
(FRL-8382-4), EPA issued a proposed rule pursuant to sections 408(e) of
the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3).
The rule proposed that 40 CFR 180.628 be amended by establishing time-
limited tolerances for indirect or inadvertent residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide,
in or on cowpeas, forage and hay at 0.20 parts per million (ppm); field
peas, vines and hay at 0.20 ppm; forage, fodder and straw of cereal
grains, crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop
group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop group 2
at 0.20 ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder,
straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions,
green at 0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm;
shallots at 0.20 ppm; soybeans, forage and hay at 0.20 ppm;
strawberries at 1.2 ppm; and sugarcane, sugar at 0.20 ppm. The proposal
established a 60-day public comment period. There were no comments
received in response to the proposed rule.
This final rule completes Agency action on both the petition from
E.I. Du Pont de Nemours and Company, DuPont Crop Protection, and EPA's
proposed rulemaking of October 1, 2008.
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 the petitioned-for
tolerances for residues of chlorantraniliprole on almond, hulls at 5.0
ppm, nut, tree, group 14 at 0.04 ppm and pistachio at 0.04 ppm. EPA's
assessment of exposures and risks associated with establishing
tolerances 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 toxicity 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 document Chlorantraniliprole (DPX-E2Y45). Human
Health Risk Assessment for Proposed Uses on the Tree Nut Group and
Pistachios and for Increases in the Established Tolerances for Pome
Fruits, Stone Fruits, Grapes and Raisins due to the Removal of Adjuvant
Restrictions from the Label for Pome Fruits, Stone
[[Page 30472]]
Fruits, and Grapes, page 21 in docket ID number EPA-HQ-OPP-2008-0770.
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 NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, 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-term, and chronic-term risks are evaluated by
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 document Chlorantraniliprole (DPX-E2Y45). Human
Health Risk Assessment for Proposed Uses on the Tree Nut Group and
Pistachios and for Increases in the Established Tolerances for Pome
Fruits, Stone Fruits, Grapes and Raisins due to the Removal of Adjuvant
Restrictions from the Label for Pome Fruits, Stone Fruits, and Grapes,
page 10 in docket ID number EPA-HQ-OPP-2008-0770.
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 United States
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey
of Food Intake by Individuals (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 and/or PCT information in the
dietary assessment for chlorantraniliprole. Tolerance level residues
and/or 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for chlorantraniliprole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of chlorantraniliprole. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at 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 acute exposures are estimated to be 26.862
parts per billion (ppb) for surface water and 1.06 ppb for ground
water. The estimated drinking water concentrations (EDWCs) of
chlorantraniliprole for chronic exposures are 3.650 parts per billion
(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 3.650 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. EPA assessed residential exposure using the following
assumptions. Although residential exposure could occur, 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-2007-0275, pages 36
through 37).
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.
[[Page 30473]]
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There were no effects on
fetal growth or post-natal 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 reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for chlorantraniliprole is complete.
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. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to
chlorantraniliprole in drinking water. EPA used similarly conservative
assumptions to assess post-application 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 aPAD and 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 <1% of the cPAD
for (children 1-2 years) 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. Chlorantraniliprole
has been classified as a ``not likely human carcinogen.'' It 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 chromotagraphy/mass
spectrometry/mass spectrometry (LC/MS/MC) 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
There are no international residue limits that affect the Agency's
recommendations at this time. There are no Canadian, CODEX or Mexican
maximum residue limits (MRLs) for chlorantraniliprole that exists at
this time.
C. Response to Comments
There were no comments received in response to the notice of filing
or proposed rule.
D. Revisions to Petitioned-For Tolerances
EPA has determined that the appropriate tolerance level for the
tree nut group and pistachios is 0.04 ppm. Residue field trial data for
chloroantraniliprole on almonds and pecans showed that the highest
observed residue level on nutmeats was 0.016 ppm. Almonds and pecans
are representative commodities for the tree nut group and pistachios.
Evaluation of these field trial data with EPA's statistical modeling
procedures for field residue data indicates that a tolerance of 0.04
ppm will be sufficient for the labeled uses on tree nuts and
pistachios.
The petitioner has requested a tolerance of 0.07 ppm for these
commodities. A higher value was requested because the field trials were
conducted without use of an adjuvant but the petitioner now seeks
approval of a pesticide label allowing the use of
[[Page 30474]]
adjuvants. Adjuvants may increase residue levels of the pesticide by
altering the pattern of deposition, retention and penetration. In the
case of chlorantraniliprole, several supervised side-by-side studies
conducted on grape, peach, plum, and cherry with chlorantraniliprole
alone and in the presence of an adjuvant, methylated seed oils or non-
ionic surfactants showed that the adjuvants increased the level of
chlorantraniliprole by an average factor of 2.1. EPA does not believe,
however, that use of an adjuvant would increase chlorantraniliprole
residues in nutmeats from the tree nut crop group and pistachios
because these foods have very limited exposure to an applied non-
systemic chemical such as chlorantraniliprole due to the physical
barrier, known as the exocarp (i.e., husk or hull), surrounding the
edible commodity. Thus, the Agency does not expect any increase in
residue with the use of an adjuvant on the tree nut group or pistachios
and EPA has revised the requested tolerance amount for these
commodities downward to 0.04 ppm.
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)-1 H-pyrazole-5-carboxamide,
in or on almond, hulls at 5.0 ppm, nut, trees, group 14 at 0.04 ppm and
pistachios at 0.04 ppm. In addition, time-limited rotational crop
tolerances are established for residues of chlorantraniliprole in or on
cowpeas, forage and hay at 0.20 parts per million (ppm); field peas,
vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains,
crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17
at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20
ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, straw
and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, green at
0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots
at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; strawberries at 1.2
ppm; and sugarcane, sugar at 0.20 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency hereby certifies that this proposed action will not
have significant negative economic impact on a substantial number of
small entities. Establishing a pesticide tolerance or an exemption from
the requirement of a pesticide tolerance is, in effect, the removal of
a regulatory restriction on pesticide residues in food and thus such an
action will not have any negative economic impact on any entities,
including small entities.
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: June 11, 2009.
Debra Edwards,
Director, 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 amended by alphabetically adding the following
commodities to the table in paragraph (a), and revising paragraph (d)
to read as follows:
Sec. 180.628 Chlorantraniliprole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls........................................ 5.0
* * * * *
Nut, tree, group 14.................................. 0.04
* * * * *
Pistachio............................................ 0.04
* * * * *
------------------------------------------------------------------------
* * * * *
(d) Indirect or inadvertent residues. Time-limited tolerances are
established for indirect or inadvertent residues of the insecticide
chlorantraniliprole (3-bromo- N -[4-chloro-2-methyl-6-
[[Page 30475]]
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following commodities. The tolerances will
expire and are revoked on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Animal feed, nongrass, group 18... 0.20 04/10/10
Cowpea, forage.................... 0.20 04/10/10
Cowpea, hay....................... 0.20 04/10/10
Field pea, hay.................... 0.20 04/10/10
Field pea, vine................... 0.20 04/10/10
Grain, cereal, forage, fodder and 0.20 04/10/10
straw, group 16..................
Grass, forage, fodder and hay, 0.20 04/10/10
group 17.........................
Leek.............................. 0.20 04/10/10
Okra.............................. 0.70 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
Strawberry........................ 1.20 04/10/10
Sugarcane......................... 0.20 04/10/10
Vegetable, leaves of root and 0.20 04/10/10
tuber, group 2...................
------------------------------------------------------------------------
[FR Doc. E9-14996 Filed 6-25-09; 8:45 am]
BILLING CODE 6560-50-S
