Indoxacarb; Pesticide Tolerances, 78731-78738 [2013-30585]
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not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Pesticide chemical
7758–99–8
*
*
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Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 20, 2013.
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. In § 180.940, alphabetically add the
following inert ingredient to the table in
paragraph (a) to read as follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0420; FRL–9903–92]
Indoxacarb; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of indoxacarb in
or on multiple commodities and
removes previously established
commodities that will be superseded by
tolerances established in this action,
SUMMARY:
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When ready for use, the end-use concentration is not to exceed 80
ppm
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which are identified and discussed later
in this document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 27, 2013. Objections and
requests for hearings must be received
on or before February 25, 2014, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0420, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
PO 00000
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Limits
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[FR Doc. 2013–31101 Filed 12–26–13; 8:45 am]
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List of Subjects in 40 CFR Part 180
CAS reg. no.
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Copper sulfate pentahydrate ........................................
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
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NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2012–0420 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before February 25, 2014. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2012–0420, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of July 25,
2012 (77 FR 43562) (FRL–9353–6), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 2E8029) by IR–4, 500
College Rd. East, Suite 201 W.,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.564 be
amended by establishing tolerances for
residues of the insecticide indoxacarb,
(S)-methyl 7-chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on bean, dry, seed at 0.07 parts per
million (ppm); bean, forage at 37 ppm;
bean, succulent at 0.64 ppm; berry, low
growing, except strawberry, subgroup
13–07H at 0.9 ppm; small fruit, vine
climbing, except fuzzy kiwifruit,
subgroup 13–07F at 2.0 ppm. The
petition additionally requested to
remove established tolerances of
indoxacarb in or on grape at 2.0 ppm
and cranberry at 0.90 ppm, upon
approval of the updated crop groups or
subgroups. That document referenced a
summary of the petition prepared on
behalf of IR–4 by DuPont Crop
Protection, the registrant, which is
available 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 revised
several proposed tolerances, has
corrected the commodity terminology
for bean forage to cowpea forage, and
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has determined that a tolerance should
be established on cowpea hay. The
reasons for these changes are explained
in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue* * *.’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for indoxacarb
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with indoxacarb 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.
Indoxacarb products are frequently
formulated as a mixture of the
insecticidally active S-enantiomer
(DPX–KN128) and the insecticidally
inactive R-enantiomer (DPX–MP062).
DPX–MP062 is an formula mixture
containing the indoxacarb S-enantiomer
and its R-enantiomer at approximately a
75:25 ratio. DPX–JW062 is the racemic
mixture of the enantiomers at a 50:50
ratio. EPA has determined that it is
appropriate to use data from DPX–
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JW062 (50:50) to satisfy the
requirements for dietary subchronic,
chronic, oncogenicity and reproductive
studies and that toxicology data using
DPX–JW062 and DPX–MP062 may be
bridged to DPX–KN128 formulations.
The toxicity profile for KN128,
MP062, and JW062 in rats, mice, and
dogs with both subchronic and chronic
oral exposures were qualitatively
similar. Dermal subchronic exposure in
the rat also resulted in a similar profile.
Signs of toxicity occurred at similar
doses and with a similar magnitude of
response (females generally being more
sensitive than males), and included
decreases in body weight, weight gain,
food consumption, and food efficiency.
These compounds also affected the
hematopoietic system by decreasing the
red blood cell count, hemoglobin, and
hematocrit in rats, dogs, and mice.
Exposure to indoxacarb was frequently
accompanied by an increase in
reticulocytes in all three species and an
increase in Heinz bodies in dogs and
mice only. These signs of toxicity did
not appear to increase in severity over
time.
Neurotoxicity was observed in rats
and mice, and was characterized by one
or more of the following symptoms in
both male and female rats and mice:
Weakness, head tilting, and abnormal
gait or mobility with inability to stand
or ataxia. There was possible evidence
of lung damage in the acute inhalation
studies with both MP062 and JW062.
The immunotoxicity study in mice
did not indicate toxicity to the immune
system at the highest dose tested. In the
28-day inhalation study in rats,
increased spleen weights, pigmentation,
and hematopoiesis in the spleen, and
hematological changes were observed at
the highest dose tested. Increased spleen
weights were also observed in the 28day dermal rat study. The increase in
spleen weights are not considered
immunological in origin but can be
considered a result of the hemolytic
effects, which is the mode of action of
indoxacarb.
There was no evidence of
carcinogenicity in either the rat or
mouse in acceptable studies (JW062).
JW062 was not mutagenic in a complete
battery of mutagenicity studies. There
was also no evidence of mutagenicity
with either KN128 or MP062. Therefore,
all formulations (KN128, MP062, and
JW062) were classified as not likely to
be carcinogenic in humans by all
relevant routes of exposure.
Specific information on the studies
received and the nature of the adverse
effects caused by indoxacarb as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document:
‘‘Indoxacarb. Human Health Risk
Assessment for the Proposed New Use
on Dry Beans, Succulent Beans, Small
Fruit Vine Climbing Subgroup (except
kiwifruit) 13–07F and Low Growing
Berry Subgroup (except strawberry) 13–
07H’’ at pp. 50–55 in docket ID number
EPA–HQ–OPP–2012–0420.
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B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for indoxacarb used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDOXACARB FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and
toxicological
effects
Acute dietary (General population including infants and
children and females 13–49
years old).
NOAEL = 12 mg/kg/
day UFA = 10x.
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.12
mg/kg/day.
aPAD = 0.12 mg/kg/
day
Acute oral rat neurotoxicity study. LOAEL = 50 mg/kg based on
decreased body weight and body-weight gain in females
(MP062).*
Chronic dietary (All populations)
NOAEL= 2.0 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.02
mg/kg/day.
cPAD = 0.02 mg/kg/
day
Weight of evidence approach was used from four studies:
1. Subchronic toxicity study—rat (MP062).
2. Subchronic neurotoxicity study—rat (MP062).
3. Chronic/carcinogenicity study—rat (JW062).
4. 2-generation rat reproduction study (JW062).
LOAEL = 3.3 mg/kg/day based on decreased body weight,
body-weight gain, food consumption, and food efficiency; decreased hematocrit, hemoglobin, and red blood cells only at
6 months.
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Exposure/scenario
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR INDOXACARB FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and
toxicological
effects
Incidental oral short-term (1 to
30 days), intermediate-term
(1 to 6 months), and longterm (> 6 months).
NOAEL= 2.0 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Weight of evidence approach was used from four studies:
1. Subchronic toxicity study—rat (MP062).
2. Subchronic neurotoxicity study—rat (MP062).
3. Chronic/carcinogenicity study—rat (JW062).
4. Two generation rat reproduction study (JW062).
LOAEL = 3.3 mg/kg/day based on decreased body weight,
body-weight gain, food consumption, and food efficiency; decreased hematocrit, hemoglobin and red blood cells only at 6
months.
Inhalation short-term (1 to 30
days).
Inhalation study
NOAEL= 6 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
28-day rat inhalation toxicity study (MP062). The LOAEL of
75.69 mg/kg/day is based on increased spleen weights, pigmentation, and hematopoiesis in the spleen, hematological
changes and mortality (females).
Cancer (Oral, dermal, inhalation).
‘‘Not likely’’ to be carcinogenic to humans since no evidence of carcinogenicity in either the rat or mouse studies, and no evidence of mutagenicity.
Exposure/scenario
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFH = potential variation in sensitivity among members of the human population
(intraspecies).
* The LOAEL of 50 mg/kg was based on a 7% body weight decrease in females only on day 8. No significant differences were noted for days
1, 2, or 15. Currently, a 10% decrease in adult body weight is the threshold for an adverse effect, thus this study NOAEL is considered to be
conservative.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
indoxacarb tolerances in 40 CFR
180.564. EPA assessed dietary
exposures from indoxacarb 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. Such effects were identified
for indoxacarb. In estimating acute
dietary exposure, EPA utilized Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEM-FCID) Version 3.16,
which uses food consumption data from
the U.S. Department of Agriculture’s
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA) from 2003
to 2008. Anticipated residues (ARs) for
most registered and proposed food
commodities were based on field trial
data, and in some crops tolerance-level
residues were used. Residue estimates
for some current uses were further
refined using percent crop treated (PCT)
data, and 100 PCT estimates were
assumed for the remaining uses.
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Available processing data for
indoxacarb were used to refine ARs for
apples/pears (juice), cotton (oil), grapes
(raisin and juice), peanut (oil), potato
(dry, chips), prunes (dried), mint (oil),
soybean (oil), and tomato (paste and
puree), and other commodities where
translation was applicable. DEEMFCIDTM (ver. 7.81) default processing
factors were assumed for all other
processed commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the same
assumptions as described in Unit
III.C.1.i.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that indoxacarb does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
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levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
The Agency estimated the PCT for
existing uses as follows for the acute
dietary assessment: Apples, 10%;
broccoli, 70%; cabbage, 35%;
cauliflower, 60%; cherries, 2.5%;
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lettuce, 40%; peaches, 2.5%; peanuts,
10%; pears, 2.5%; potatoes, 2.5%;
soybeans, 2.5%; spinach, 5%; sweet
corn, 10%; and tomatoes, 40%.
The Agency estimated the PCT for
existing uses as follows for the chronic
dietary risk assessment: Apples, 5%;
broccoli, 50%; cabbage, 25%;
cauliflower, 40%; celery, 5%; cherries,
1%; grapes, 1%; lettuce, 10%; peaches,
2.5%; peanuts, 2.5%; pears, 1%;
potatoes, 1%; soybeans, 1%; spinach,
2.5%; sweet corn, 2.5%; and tomatoes,
20%.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. In cases where the
average PCT is less than 2.5, 2.5% is
used as the average PCT. Similarly, in
cases where the maximum PCT is less
than 2.5, 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for
acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
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residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which indoxacarb may be applied in a
particular area.
2. Dietary exposure from drinking
water. A Total Toxic Residue (TTR)
approach was used for the parent
indoxacarb and the degradation
products with toxicological concern
(IN–JT333, IN–KG4333, IN–KT413, IN–
ML437–0H) for the drinking water
assessment. Therefore, the Agency used
screening level water exposure models
in the dietary exposure analysis and risk
assessment for indoxacarb and its
metabolites in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of indoxacarb.
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 Provisional Cranberry
Model and Screening Concentration in
Ground Water (SCI–GROW) models, the
estimated drinking water concentrations
(EDWCs) of indoxacarb and its
metabolites for surface water are
expected to be 59.26 parts per billion
(ppb) for acute exposures and 18.48 for
chronic exposures. For ground water,
the EDWC is estimated to be 0.33 ppb
for acute and chronic exposures.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. The
water concentration values of 59.26 ppb
and 18.48 ppb were used to assess the
contribution to drinking water for the
acute and chronic dietary risk
assessments, respectively.
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).
Indoxacarb is currently registered for
several uses that could result in
residential exposures:
• Ready-to-use (RTU) bait stations.
• Spot-on applications of gels (crack
and crevices and indoor spot directed
treatments) for household insect control
(indoor treatments).
• Spot-on treatments for the control
of fleas and ticks on dogs and cats.
• Broadcast, perimeter and ant
mound treatment on ornamentals, trees,
and lawns/turf, utilizing granular and
liquid formulations (outdoor
treatments).
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• Indoor spray applications with
granular and liquid formulations for
insect control on households/domestic
dwellings (crack and crevice and spot
directed treatments).
Adult handlers were assessed for
potential short-term inhalation toxicity
from mixing/loading/applying the
following:
• Granular formulation for insect
control on lawns/turf.
• Liquid flowable formulation for
insect control on lawns/turf.
• Water-soluble packaging
formulation for indoor spray
applications with manually pressurized
hand wand (crack and crevice and spot
directed treatments) for insect control in
households/domestic dwellings.
• Liquid flowable formulation for
indoor spray applications with
manually pressurized hand wand (crack
and crevice and spot directed
treatments) for insect control on
households/domestic dwellings.
Residential handler exposure is
expected to be short-term in duration
only, as intermediate-term exposures are
not likely because of the intermittent
nature of applications by homeowners.
Potential postapplication exposures to
indoxacarb were considered for adults
and children (1–<2 years old), based on
the following scenarios:
• Treated pets (dogs and cats) to
children from short-, intermediate-, and
long-term incidental oral exposures.
• Physical activities on turf to
children from short-term incidental oral
exposures.
• Crack and crevice and indoor spotdirected spray applications, including
short-term inhalation exposures to
adults and both short-term inhalation
and short-term incidental oral exposures
to children.
Since there is no expectation of nondietary oral exposures to adults from
contact with treated pets, that aggregate
risk is not quantified.
Since inhalation and incidental oral
exposure routes share a common
toxicological endpoint (i.e.,
hematological changes), risk estimates
have been combined for those routes.
Therefore, the postapplication exposure
scenarios that were combined for
children 1 < 2 years old are the
inhalation and hand-to-mouth (the
highest incidental oral exposure
assessment) for the indoor surfaces
directed spray applications. This
combination is considered protective of
children’s exposure to indoxacarb from
residential uses.
Because of the preventative nature of
pet products and the potential for
extended use in more temperate parts of
the country, the residential
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postapplication exposures to treated
pets may be short-, intermediate-, or
long-term in duration. Postapplication
incidental oral exposures from treated
golf courses were not quantified since
youth old enough to play golf are not
expected to exhibit significant hand-tomouth behavior. Furthermore, the
residential lawn assessment provides
the highest estimate of potential
exposure from turf applications and is
protective of any exposures to children
from indoxacarb turf treatment
scenarios. Finally, the residential
handler and postapplication
assessments consider inhalation and/or
oral exposures only, since a dermal
toxicity endpoint has not been
identified for indoxacarb.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found indoxacarb, an
oxadiazine class insecticide, to share a
common mechanism of toxicity with
any other substances, and indoxacarb
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that indoxacarb does not have
a common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at 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
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
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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 was no quantitative or qualitative
evidence of increased prenatal or
postnatal sensitivity in the two
developmental toxicity studies in rats
with DPX–JW062, one developmental
toxicity study in rats with DPX–MP062
and DPX–KN128, one developmental
toxicity study in rabbits with DPX–
JW062, one 2-generation reproduction
studies in rats with DPX–JW062, and
the developmental neurotoxicity (DNT)
study in rats with DPX–KN128. In these
studies, developmental toxicity was
observed only in the presence of
maternal toxicity.
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 indoxacarb
is complete.
ii. EPA has determined that an
additional uncertainty factor is not
needed to account for neurotoxicity.
Neurotoxicity was seen in animal
studies in rats and mice, but at higher
doses than the hematologic effects on
which EPA’s risk assessments are based.
To evaluate the potential for increased
sensitivity of infants and children to
neurotoxic effects, EPA required a rat
developmental neurotoxicity (DNT)
study. There was no evidence of
increased sensitivity of offspring in the
submitted study. Clinical observations,
motor activity, acoustic startle
habituation, and learning and memory
testing were all comparable between the
control and treated groups. Mean brain
weight, gross and microscopic
examinations, and morphometric
measurements of the brain were also
comparable between the controls and
treated groups.
iii. There is no evidence that
indoxacarb 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 acute and chronic dietary food
exposure assessments utilized
anticipated residues that are based on
reliable field trial, as well as PCT data.
For the new uses, a conservative
estimate of 100 PCT is assumed. EPA
made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
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to indoxacarb in drinking water. EPA
used similarly conservative assumptions
to assess postapplication exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by indoxacarb.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to indoxacarb will
occupy 49% of the aPAD for all infants
less than 1 year old, the population
group receiving the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to indoxacarb
from food and water will utilize 12% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. Long-term (chronic) aggregate
risk for indoxacarb also includes the
contribution from dietary (food and
drinking water) exposure plus the longterm postapplication exposure to treated
pets. EPA has concluded the combined
long-term food, water, and residential
exposures result in an aggregate MOE of
420 for children 1-<2 years old. Because
EPA’s level of concern for indoxacarb is
a MOE of 100 or below, this MOE is not
of concern.
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). Indoxacarb is currently
registered for uses that could result in
short-term residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
indoxacarb.
Using the exposure assumptions
described in this unit for short-term
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exposures, EPA has concluded the
aggregate short-term exposure (food,
water, and residential exposures) result
in the lowest aggregate MOEs of 110 for
children 1-<2 years old (resulting from
the postapplication crack and crevice
and spot directed treatment indoor
spray) and 1,600 for adults (resulting
from the handler turf use). Because
EPA’s level of concern for indoxacarb is
a MOE of 100 or below, these MOEs are
not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Indoxacarb is currently registered for
uses that could result in intermediateterm residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to indoxacarb.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures (from
pet treatments) result in an aggregate
MOE of 420 for children 1-<2 years old
Because EPA’s level of concern for
indoxacarb is a MOE of 100 or below,
this MOE is not of concern.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
indoxacarb 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 indoxacarb
residues.
IV. Other Considerations
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A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high-performance liquid
chromatography (HPLC)/column
switching/ultraviolet (UV) method AMR
2712–93 with confirmation/specificity
provided by gas chromatography (GC)/
mass-selective detector method AMR
3493–95, Supplement No. 4) 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
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has established MRLs for
indoxacarb in or on cranberries at 1
ppm, dry chickpea at 0.2 ppm, dry
cowpea at 0.1 ppm, dry mung bean at
0.2 ppm, and grapes at 2 ppm, based on
measurement of indoxacarb and its Renantiomer. U.S. tolerances for
subgroup 13–07F (represented by grape)
at 2 ppm and subgroup 13–07H
(represented by cranberry) at 1 ppm are
harmonized with the corresponding
Codex MRLs. Additionally, the U.S.
tolerance level for dry bean is being
established at 0.2 ppm, in order to
harmonize with the Codex MRLs for dry
chickpea and dry mung bean. The
Codex has not established MRLs for the
other commodities associated with this
action.
C. Revisions to Petitioned-For
Tolerances
Based on the data submitted with the
petition, EPA revised the proposed
tolerances for several commodities, as
follows: Succulent bean from 0.64 ppm
to 0.9 ppm; and low growing berry,
except strawberry, subgroup 13–07H
from 0.9 ppm to 1 ppm. EPA also
determined that the proposed tolerance
in or on bean forage at 37 ppm should
be revised to 50 ppm, and the Agency
determined that the commodity should
be listed as cowpea forage because the
cowpea forage and hay are the only
significant feedstuffs associated with
dry beans. Because of that reason, EPA
also determined that a tolerance is
necessary for cowpea hay at 100 ppm.
Finally, EPA revised the tolerance on
bean, dry, seed from 0.07 ppm to 0.2
ppm in order to harmonize with Codex
MRLs. The Agency revised these
tolerance levels based on analysis of the
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78737
residue field trial data using the
Organization of Economic Cooperation
and Development (OECD) tolerance
calculation procedures.
V. Conclusion
Therefore, tolerances are established
for residues of indoxacarb, (S)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
and its R-enantiomer, (R)-methyl 7chloro-2,5-dihydro-2[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate,
in or on bean, dry seed at 0.2 ppm; bean,
succulent at 0.9 ppm; cowpea, forage at
50 ppm; cowpea, hay at 100 ppm; berry,
low growing, except strawberry,
subgroup 13–07H at 1 ppm; and fruit,
small vine climbing, except fuzzy
kiwifruit, subgroup 13–07F at 2 ppm.
This regulation additionally removes
the established tolerances in or on
cranberry at 0.90 ppm and grape at 2.0
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
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the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or Tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
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. In § 180.564:
a. Remove the commodities
‘‘Cranberry’’ and ‘‘Grape’’ in the table in
paragraph (a)(1).
■ b. Add alphabetically the following
commodities to the table in paragraph
(a)(1). The amendments read as follows:
■
■
§ 180.564 Indoxacarb; tolerances for
residues.
(a) * * *
(1) * * *
Parts per
million
Commodity
*
*
*
*
Bean, dry, seed ........................
Bean, succulent ........................
*
*
*
*
*
Berry, low growing, except
strawberry, subgroup 13–07H
*
0.2
0.9
Lois
Rossi, Registration Division (7505P),
1 Office of Pesticide Programs,
Environmental Protection Agency, 1200
*
50 Pennsylvania Ave. NW., Washington,
100 DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
*
*
*
*
*
Cowpea, forage ........................
Cowpea, hay .............................
*
*
*
*
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup
13–07F ..................................
*
*
*
*
*
*
*
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
2
*
*
*
[FR Doc. 2013–30585 Filed 12–26–13; 8:45 am]
BILLING CODE 6560–50–P
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
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Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 16, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
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18:49 Dec 26, 2013
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0071; FRL–9904–04]
Pendimethalin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends the
current tolerance for combined residues
of pendimethalin and its metabolite,
expressed as pendimethalin equivalents
in or on almond, hulls. BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709 requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 27, 2013. Objections and
requests for hearings must be received
on or before February 25, 2014, and
SUMMARY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0071, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
E:\FR\FM\27DER1.SGM
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Agencies
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78731-78738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30585]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0420; FRL-9903-92]
Indoxacarb; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
indoxacarb in or on multiple commodities and removes previously
established commodities that will be superseded by tolerances
established in this action, which are identified and discussed later in
this document. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective December 27, 2013. Objections and
requests for hearings must be received on or before February 25, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0420, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 78732]]
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0420 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 25, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0420, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8029) by IR-4, 500 College Rd. East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.564 be amended by
establishing tolerances for residues of the insecticide indoxacarb,
(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on bean, dry, seed at
0.07 parts per million (ppm); bean, forage at 37 ppm; bean, succulent
at 0.64 ppm; berry, low growing, except strawberry, subgroup 13-07H at
0.9 ppm; small fruit, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 2.0 ppm. The petition additionally requested to remove
established tolerances of indoxacarb in or on grape at 2.0 ppm and
cranberry at 0.90 ppm, upon approval of the updated crop groups or
subgroups. That document referenced a summary of the petition prepared
on behalf of IR-4 by DuPont Crop Protection, the registrant, which is
available 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
revised several proposed tolerances, has corrected the commodity
terminology for bean forage to cowpea forage, and has determined that a
tolerance should be established on cowpea hay. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue* *
*.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for indoxacarb including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with indoxacarb 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.
Indoxacarb products are frequently formulated as a mixture of the
insecticidally active S-enantiomer (DPX-KN128) and the insecticidally
inactive R-enantiomer (DPX-MP062). DPX-MP062 is an formula mixture
containing the indoxacarb S-enantiomer and its R-enantiomer at
approximately a 75:25 ratio. DPX-JW062 is the racemic mixture of the
enantiomers at a 50:50 ratio. EPA has determined that it is appropriate
to use data from DPX-
[[Page 78733]]
JW062 (50:50) to satisfy the requirements for dietary subchronic,
chronic, oncogenicity and reproductive studies and that toxicology data
using DPX-JW062 and DPX-MP062 may be bridged to DPX-KN128 formulations.
The toxicity profile for KN128, MP062, and JW062 in rats, mice, and
dogs with both subchronic and chronic oral exposures were qualitatively
similar. Dermal subchronic exposure in the rat also resulted in a
similar profile. Signs of toxicity occurred at similar doses and with a
similar magnitude of response (females generally being more sensitive
than males), and included decreases in body weight, weight gain, food
consumption, and food efficiency. These compounds also affected the
hematopoietic system by decreasing the red blood cell count,
hemoglobin, and hematocrit in rats, dogs, and mice. Exposure to
indoxacarb was frequently accompanied by an increase in reticulocytes
in all three species and an increase in Heinz bodies in dogs and mice
only. These signs of toxicity did not appear to increase in severity
over time.
Neurotoxicity was observed in rats and mice, and was characterized
by one or more of the following symptoms in both male and female rats
and mice: Weakness, head tilting, and abnormal gait or mobility with
inability to stand or ataxia. There was possible evidence of lung
damage in the acute inhalation studies with both MP062 and JW062.
The immunotoxicity study in mice did not indicate toxicity to the
immune system at the highest dose tested. In the 28-day inhalation
study in rats, increased spleen weights, pigmentation, and
hematopoiesis in the spleen, and hematological changes were observed at
the highest dose tested. Increased spleen weights were also observed in
the 28-day dermal rat study. The increase in spleen weights are not
considered immunological in origin but can be considered a result of
the hemolytic effects, which is the mode of action of indoxacarb.
There was no evidence of carcinogenicity in either the rat or mouse
in acceptable studies (JW062). JW062 was not mutagenic in a complete
battery of mutagenicity studies. There was also no evidence of
mutagenicity with either KN128 or MP062. Therefore, all formulations
(KN128, MP062, and JW062) were classified as not likely to be
carcinogenic in humans by all relevant routes of exposure.
Specific information on the studies received and the nature of the
adverse effects caused by indoxacarb 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: ``Indoxacarb. Human Health Risk
Assessment for the Proposed New Use on Dry Beans, Succulent Beans,
Small Fruit Vine Climbing Subgroup (except kiwifruit) 13-07F and Low
Growing Berry Subgroup (except strawberry) 13-07H'' at pp. 50-55 in
docket ID number EPA-HQ-OPP-2012-0420.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for indoxacarb used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Indoxacarb for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 12 mg/kg/day Acute RfD = 0.12 mg/ Acute oral rat neurotoxicity
including infants and children UFA = 10x. kg/day. study. LOAEL = 50 mg/kg based on
and females 13-49 years old). UFH = 10x........... aPAD = 0.12 mg/kg/ decreased body weight and body-
FQPA SF = 1x........ day. weight gain in females (MP062).*
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 2.0 mg/kg/day Chronic RfD = 0.02 Weight of evidence approach was
UFA = 10x........... mg/kg/day. used from four studies:
UFH = 10x........... cPAD = 0.02 mg/kg/ 1. Subchronic toxicity study--rat
FQPA SF = 1x........ day. (MP062).
2. Subchronic neurotoxicity study--
rat (MP062).
3. Chronic/carcinogenicity study--
rat (JW062).
4. 2-generation rat reproduction
study (JW062).
LOAEL = 3.3 mg/kg/day based on
decreased body weight, body-
weight gain, food consumption,
and food efficiency; decreased
hematocrit, hemoglobin, and red
blood cells only at 6 months.
----------------------------------------------------------------------------------------------------------------
[[Page 78734]]
Incidental oral short-term (1 to NOAEL= 2.0 mg/kg/day LOC for MOE = 100.. Weight of evidence approach was
30 days), intermediate-term (1 UFA = 10x........... used from four studies:
to 6 months), and long-term (> 6 UFH = 10x........... 1. Subchronic toxicity study--rat
months). FQPA SF = 1x........ (MP062).
2. Subchronic neurotoxicity study--
rat (MP062).
3. Chronic/carcinogenicity study--
rat (JW062).
4. Two generation rat reproduction
study (JW062).
LOAEL = 3.3 mg/kg/day based on
decreased body weight, body-
weight gain, food consumption,
and food efficiency; decreased
hematocrit, hemoglobin and red
blood cells only at 6 months.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 Inhalation study LOC for MOE = 100.. 28-day rat inhalation toxicity
days). NOAEL= 6 mg/kg/day. study (MP062). The LOAEL of 75.69
UFA = 10x........... mg/kg/day is based on increased
UFH = 10x........... spleen weights, pigmentation, and
FQPA SF = 1x........ hematopoiesis in the spleen,
hematological changes and
mortality (females).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) ``Not likely'' to be carcinogenic to humans since no evidence of
carcinogenicity in either the rat or mouse studies, and no evidence of
mutagenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFH = potential variation in sensitivity among members of the human population (intraspecies).
* The LOAEL of 50 mg/kg was based on a 7% body weight decrease in females only on day 8. No significant
differences were noted for days 1, 2, or 15. Currently, a 10% decrease in adult body weight is the threshold
for an adverse effect, thus this study NOAEL is considered to be conservative.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to indoxacarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing indoxacarb tolerances in 40 CFR
180.564. EPA assessed dietary exposures from indoxacarb 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. Such effects were identified
for indoxacarb. In estimating acute dietary exposure, EPA utilized
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID) Version 3.16, which uses food consumption
data from the U.S. Department of Agriculture's National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA)
from 2003 to 2008. Anticipated residues (ARs) for most registered and
proposed food commodities were based on field trial data, and in some
crops tolerance-level residues were used. Residue estimates for some
current uses were further refined using percent crop treated (PCT)
data, and 100 PCT estimates were assumed for the remaining uses.
Available processing data for indoxacarb were used to refine ARs
for apples/pears (juice), cotton (oil), grapes (raisin and juice),
peanut (oil), potato (dry, chips), prunes (dried), mint (oil), soybean
(oil), and tomato (paste and puree), and other commodities where
translation was applicable. DEEM-FCIDTM (ver. 7.81) default
processing factors were assumed for all other processed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the same assumptions as described in Unit
III.C.1.i.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that indoxacarb does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the PCT for existing uses as follows for the
acute dietary assessment: Apples, 10%; broccoli, 70%; cabbage, 35%;
cauliflower, 60%; cherries, 2.5%;
[[Page 78735]]
lettuce, 40%; peaches, 2.5%; peanuts, 10%; pears, 2.5%; potatoes, 2.5%;
soybeans, 2.5%; spinach, 5%; sweet corn, 10%; and tomatoes, 40%.
The Agency estimated the PCT for existing uses as follows for the
chronic dietary risk assessment: Apples, 5%; broccoli, 50%; cabbage,
25%; cauliflower, 40%; celery, 5%; cherries, 1%; grapes, 1%; lettuce,
10%; peaches, 2.5%; peanuts, 2.5%; pears, 1%; potatoes, 1%; soybeans,
1%; spinach, 2.5%; sweet corn, 2.5%; and tomatoes, 20%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. In cases where the average PCT is less than 2.5, 2.5% is used as
the average PCT. Similarly, in cases where the maximum PCT is less than
2.5, 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute
dietary risk analysis. The maximum PCT figure is the highest observed
maximum value reported within the recent 6 years of available public
and private market survey data for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which indoxacarb may be applied in a particular area.
2. Dietary exposure from drinking water. A Total Toxic Residue
(TTR) approach was used for the parent indoxacarb and the degradation
products with toxicological concern (IN-JT333, IN-KG4333, IN-KT413, IN-
ML437-0H) for the drinking water assessment. Therefore, the Agency used
screening level water exposure models in the dietary exposure analysis
and risk assessment for indoxacarb and its metabolites in drinking
water. These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of indoxacarb. 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 Provisional Cranberry Model and Screening
Concentration in Ground Water (SCI-GROW) models, the estimated drinking
water concentrations (EDWCs) of indoxacarb and its metabolites for
surface water are expected to be 59.26 parts per billion (ppb) for
acute exposures and 18.48 for chronic exposures. For ground water, the
EDWC is estimated to be 0.33 ppb for acute and chronic exposures.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The water concentration values
of 59.26 ppb and 18.48 ppb were used to assess the contribution to
drinking water for the acute and chronic dietary risk assessments,
respectively.
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). Indoxacarb is
currently registered for several uses that could result in residential
exposures:
Ready-to-use (RTU) bait stations.
Spot-on applications of gels (crack and crevices and
indoor spot directed treatments) for household insect control (indoor
treatments).
Spot-on treatments for the control of fleas and ticks on
dogs and cats.
Broadcast, perimeter and ant mound treatment on
ornamentals, trees, and lawns/turf, utilizing granular and liquid
formulations (outdoor treatments).
Indoor spray applications with granular and liquid
formulations for insect control on households/domestic dwellings (crack
and crevice and spot directed treatments).
Adult handlers were assessed for potential short-term inhalation
toxicity from mixing/loading/applying the following:
Granular formulation for insect control on lawns/turf.
Liquid flowable formulation for insect control on lawns/
turf.
Water-soluble packaging formulation for indoor spray
applications with manually pressurized hand wand (crack and crevice and
spot directed treatments) for insect control in households/domestic
dwellings.
Liquid flowable formulation for indoor spray applications
with manually pressurized hand wand (crack and crevice and spot
directed treatments) for insect control on households/domestic
dwellings. Residential handler exposure is expected to be short-term in
duration only, as intermediate-term exposures are not likely because of
the intermittent nature of applications by homeowners.
Potential postapplication exposures to indoxacarb were considered
for adults and children (1-<2 years old), based on the following
scenarios:
Treated pets (dogs and cats) to children from short-,
intermediate-, and long-term incidental oral exposures.
Physical activities on turf to children from short-term
incidental oral exposures.
Crack and crevice and indoor spot-directed spray
applications, including short-term inhalation exposures to adults and
both short-term inhalation and short-term incidental oral exposures to
children.
Since there is no expectation of non-dietary oral exposures to
adults from contact with treated pets, that aggregate risk is not
quantified.
Since inhalation and incidental oral exposure routes share a common
toxicological endpoint (i.e., hematological changes), risk estimates
have been combined for those routes. Therefore, the postapplication
exposure scenarios that were combined for children 1 < 2 years old are
the inhalation and hand-to-mouth (the highest incidental oral exposure
assessment) for the indoor surfaces directed spray applications. This
combination is considered protective of children's exposure to
indoxacarb from residential uses.
Because of the preventative nature of pet products and the
potential for extended use in more temperate parts of the country, the
residential
[[Page 78736]]
postapplication exposures to treated pets may be short-, intermediate-,
or long-term in duration. Postapplication incidental oral exposures
from treated golf courses were not quantified since youth old enough to
play golf are not expected to exhibit significant hand-to-mouth
behavior. Furthermore, the residential lawn assessment provides the
highest estimate of potential exposure from turf applications and is
protective of any exposures to children from indoxacarb turf treatment
scenarios. Finally, the residential handler and postapplication
assessments consider inhalation and/or oral exposures only, since a
dermal toxicity endpoint has not been identified for indoxacarb.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found indoxacarb, an oxadiazine class insecticide, to
share a common mechanism of toxicity with any other substances, and
indoxacarb does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that indoxacarb does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at 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 Food Quality
Protection Act Safety Factor (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 was no quantitative or
qualitative evidence of increased prenatal or postnatal sensitivity in
the two developmental toxicity studies in rats with DPX-JW062, one
developmental toxicity study in rats with DPX-MP062 and DPX-KN128, one
developmental toxicity study in rabbits with DPX-JW062, one 2-
generation reproduction studies in rats with DPX-JW062, and the
developmental neurotoxicity (DNT) study in rats with DPX-KN128. In
these studies, developmental toxicity was observed only in the presence
of maternal toxicity.
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 indoxacarb is complete.
ii. EPA has determined that an additional uncertainty factor is not
needed to account for neurotoxicity. Neurotoxicity was seen in animal
studies in rats and mice, but at higher doses than the hematologic
effects on which EPA's risk assessments are based. To evaluate the
potential for increased sensitivity of infants and children to
neurotoxic effects, EPA required a rat developmental neurotoxicity
(DNT) study. There was no evidence of increased sensitivity of
offspring in the submitted study. Clinical observations, motor
activity, acoustic startle habituation, and learning and memory testing
were all comparable between the control and treated groups. Mean brain
weight, gross and microscopic examinations, and morphometric
measurements of the brain were also comparable between the controls and
treated groups.
iii. There is no evidence that indoxacarb 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 acute and chronic dietary food exposure assessments
utilized anticipated residues that are based on reliable field trial,
as well as PCT data. For the new uses, a conservative estimate of 100
PCT is assumed. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to indoxacarb
in drinking water. EPA used similarly conservative assumptions to
assess postapplication exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by indoxacarb.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
indoxacarb will occupy 49% of the aPAD for all infants less than 1 year
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
indoxacarb from food and water will utilize 12% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Long-term (chronic) aggregate risk for indoxacarb also
includes the contribution from dietary (food and drinking water)
exposure plus the long-term postapplication exposure to treated pets.
EPA has concluded the combined long-term food, water, and residential
exposures result in an aggregate MOE of 420 for children 1-<2 years
old. Because EPA's level of concern for indoxacarb is a MOE of 100 or
below, this MOE is not of concern.
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). Indoxacarb is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to indoxacarb.
Using the exposure assumptions described in this unit for short-
term
[[Page 78737]]
exposures, EPA has concluded the aggregate short-term exposure (food,
water, and residential exposures) result in the lowest aggregate MOEs
of 110 for children 1-<2 years old (resulting from the postapplication
crack and crevice and spot directed treatment indoor spray) and 1,600
for adults (resulting from the handler turf use). Because EPA's level
of concern for indoxacarb is a MOE of 100 or below, these MOEs are not
of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Indoxacarb is currently registered for uses that could result
in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with intermediate-term residential exposures to
indoxacarb.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures (from pet
treatments) result in an aggregate MOE of 420 for children 1-<2 years
old Because EPA's level of concern for indoxacarb is a MOE of 100 or
below, this MOE is not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, indoxacarb 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 indoxacarb residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography (HPLC)/column switching/ultraviolet (UV) method AMR
2712-93 with confirmation/specificity provided by gas chromatography
(GC)/mass-selective detector method AMR 3493-95, Supplement No. 4) 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.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for indoxacarb in or on cranberries
at 1 ppm, dry chickpea at 0.2 ppm, dry cowpea at 0.1 ppm, dry mung bean
at 0.2 ppm, and grapes at 2 ppm, based on measurement of indoxacarb and
its R-enantiomer. U.S. tolerances for subgroup 13-07F (represented by
grape) at 2 ppm and subgroup 13-07H (represented by cranberry) at 1 ppm
are harmonized with the corresponding Codex MRLs. Additionally, the
U.S. tolerance level for dry bean is being established at 0.2 ppm, in
order to harmonize with the Codex MRLs for dry chickpea and dry mung
bean. The Codex has not established MRLs for the other commodities
associated with this action.
C. Revisions to Petitioned-For Tolerances
Based on the data submitted with the petition, EPA revised the
proposed tolerances for several commodities, as follows: Succulent bean
from 0.64 ppm to 0.9 ppm; and low growing berry, except strawberry,
subgroup 13-07H from 0.9 ppm to 1 ppm. EPA also determined that the
proposed tolerance in or on bean forage at 37 ppm should be revised to
50 ppm, and the Agency determined that the commodity should be listed
as cowpea forage because the cowpea forage and hay are the only
significant feedstuffs associated with dry beans. Because of that
reason, EPA also determined that a tolerance is necessary for cowpea
hay at 100 ppm. Finally, EPA revised the tolerance on bean, dry, seed
from 0.07 ppm to 0.2 ppm in order to harmonize with Codex MRLs. The
Agency revised these tolerance levels based on analysis of the residue
field trial data using the Organization of Economic Cooperation and
Development (OECD) tolerance calculation procedures.
V. Conclusion
Therefore, tolerances are established for residues of indoxacarb,
(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, and its R-enantiomer, (R)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate, in or on bean, dry seed at 0.2
ppm; bean, succulent at 0.9 ppm; cowpea, forage at 50 ppm; cowpea, hay
at 100 ppm; berry, low growing, except strawberry, subgroup 13-07H at 1
ppm; and fruit, small vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 2 ppm. This regulation additionally removes the established
tolerances in or on cranberry at 0.90 ppm and grape at 2.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule,
[[Page 78738]]
the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 16, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.564:
0
a. Remove the commodities ``Cranberry'' and ``Grape'' in the table in
paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(1). The amendments read as follows:
Sec. 180.564 Indoxacarb; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Bean, dry, seed............................................ 0.2
Bean, succulent............................................ 0.9
* * * * *
Berry, low growing, except strawberry, subgroup 13-07H..... 1
* * * * *
Cowpea, forage............................................. 50
Cowpea, hay................................................ 100
* * * * *
Fruit, small vine climbing, except fuzzy kiwifruit, 2
subgroup 13-07F...........................................
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-30585 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P