[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Pages 43329-43335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17676]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0232; FRL-9929-57]


Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
novaluron in or on multiple commodities and removes several existing 
tolerances which are identified and discussed later in this document. 
This regulation additionally revises existing tolerances in or on 
vegetable, cucurbit, group 9; and plum, prune, dried. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 22, 2015. Objections and 
requests for hearings must be received on or before September 21, 2015, 
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-2014-0232, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton 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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 http://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-2014-0232 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 21, 2015. 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-2014-0232, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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 
4E8241) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W., Princeton, NJ 08540. The petition requested 
that 40 CFR part 180 be amended by establishing tolerances for residues 
of the insecticide novaluron, (N-[[[3-chloro-4-[1,1,2-trifluoro-2- 
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide), 
in or on avocado at 0.60 parts per million (ppm); carrot at 0.05 ppm; 
bean at 0.60 ppm; vegetable, fruiting, group 8-10 at 1.0 ppm; fruit, 
pome, group 11-10 at 2.0 ppm; cherry subgroup 12-12A at 8.0 ppm; peach

[[Page 43330]]

subgroup 12-12B at 1.9 ppm; and plum subgroup 12-12C at 1.9 ppm.
    Upon approval of the petitioned-for tolerances listed above, the 
petition proposed to remove the following established tolerances for 
residues of novaluron from 40 CFR 180.598: Bean, succulent, snap at 
0.60 ppm; bean, dry, seed at 0.30 ppm; cherry at 8.0 ppm; fruit, pome, 
group 11 at 2.0 ppm; fruit, stone, group 12, except cherry at 1.9 ppm; 
vegetable, fruiting, group 8 at 1.0 ppm; cocona at 1.0 ppm; African 
eggplant at 1.0 ppm; pea eggplant at 1.0 ppm; scarlet eggplant at 1.0 
ppm; goji berry at 1.0 ppm; garden huckleberry at 1.0 ppm; martynia at 
1.0 ppm; naranjilla at 1.0 ppm; okra at 1.0 ppm; roselle at 1.0 ppm; 
sunberry at 1.0 ppm; bush tomato at 1.0 ppm; currant tomato at 1.0 ppm; 
and tree tomato at 1.0 ppm. These tolerances were requested for removal 
because they will be superseded by establishment of the petitioned-for 
tolerances. That document referenced a summary of the petition prepared 
on behalf of IR-4 by Makhteshim-Agan of North America, Inc., the 
registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised several proposed tolerances. EPA has also determined that the 
previously established tolerances in or on vegetable, cucurbit, group 9 
and plum, prune, dried should be revised. Finally, EPA determined that 
establishing a tolerance on bean is not appropriate; rather, a 
tolerance should be established on bean, succulent and the previously 
established tolerance on bean, dry, seed should not be removed. The 
reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with 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 novaluron including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with novaluron 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.
    In subchronic and chronic toxicity studies, novaluron primarily 
produced hematotoxic effects such as methemoglobinemia, decreased 
hemoglobin, decreased hematocrit, decreased red blood cells (RBCs) (or 
erythrocytes) and increased reticulocyte counts that were associated 
with compensatory erythropoiesis. Increased spleen weights or 
hemosiderosis in the spleen were considered to be due to enhanced 
removal of damaged erythrocytes and not to a direct immunotoxic effect.
    There was no maternal or developmental toxicity seen in the rat and 
rabbit developmental toxicity studies up to the limit doses. In the 2-
generation reproductive toxicity study in rats, both parental and 
offspring toxicity (increased spleen weights) were observed at the same 
dose. Reproductive toxicity, including decreases in epididymal sperm 
counts and increased age at preputial separation in the F1 generation, 
was observed at a higher dose than the increased spleen weights and 
were consistent with the primary effects in the database.
    Clinical signs of neurotoxicity (piloerection, irregular 
breathing), changes in functional observational battery (FOB) 
parameters (increased head swaying, abnormal gait), and neuropathology 
(sciatic and tibial nerve degeneration) were seen in the rat acute 
neurotoxicity study at the limit dose. However, no signs of 
neurotoxicity or neuropathology were observed in the subchronic 
neurotoxicity study in rats at similar doses or in any other subchronic 
or chronic toxicity study in rats, mice, or dogs. In the submitted 
immunotoxicity study, the only sign of potential immunotoxicity for 
novaluron was a decreased anti-sheep red blood cell (anti-SRBC) 
response at twice the limit dose in female rats. There was no evidence 
of carcinogenic potential in either the rat or mouse carcinogenicity 
studies, and there was also no concern for genotoxicity or 
mutagenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by novaluron as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``Novaluron: Human Health Risk 
Assessment for the Petition for the Establishment of Permanent 
Tolerances for Residues of Novaluron in/on Avocado; Carrot; Succulent 
Bean; Vegetable, Fruiting, Crop Group 8-10; Fruit, Pome, Crop Group 11-
10; Cherry Subgroup 12-12A; Peach Subgroup 12-12B; and Plum Subgroup 
12-12C; and Revisions to the Label to Include Uses on Greenhouse-Grown 
Cucumber'' at pages 36-40 in docket ID number EPA-HQ-OPP-2014-0232.

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

[[Page 43331]]

EPA uses in risk characterization and a complete description of the 
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for novaluron used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Novaluron for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General              An endpoint of concern attributable to a single dose was not identified, and
 population, including infants                            an acute RfD was not established.
 and children).
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.1 mg/kg/    Chronic RfD = 0.011  Combined chronic toxicity/
                                    day.                  mg/kg/day.           carcinogenicity feeding in rat.
                                   UFA = 10x...........  cPAD = 0.011 mg/kg/  LOAEL = 30.6 mg/kg/day based on
                                   UFH = 10x...........   day.                 erythrocyte damage resulting in a
                                   FQPA SF = 1x........                        compensatory regenerative anemia.
Incidental oral, all durations...  NOAEL = 4.38 mg/kg/   LOC for MOE = 100..  90-day feeding study in rat.
                                    day.                                      LOAEL = 8.64 mg/kg/day based on
                                   UFA = 10x...........                        clinical chemistry (decreased
                                   UFH = 10x...........                        hemoglobin, hematocrit, and RBC
                                   FQPA SF = 1x........                        counts) and histopathology
                                                                               (increased hematopoiesis and
                                                                               hemosiderosis in spleen and
                                                                               liver).
Inhalation, all durations........  Inhalation (or oral)  LOC for MOE = 100..  90-day feeding study in rat.
                                    study NOAEL = 4.38                        LOAEL = 8.64 mg/kg/day based on
                                    mg/kg/day                                  clinical chemistry (decreased
                                    (inhalation                                hemoglobin, hematocrit, and RBC
                                    absorption rate =                          counts) and histopathology
                                    100%).                                     (increased hematopoiesis and
                                   UFA = 10x...........                        hemosiderosis in spleen and
                                   UFH = 10x...........                        liver).
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)              Classified as not likely to be carcinogenic to humans.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to novaluron, EPA considered exposure under the petitioned-for 
tolerances as well as all existing novaluron tolerances in 40 CFR 
180.598. EPA assessed dietary exposures from novaluron in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for novaluron; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA under the 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA); 2003-2008. As to residue levels in food, EPA 
incorporated average field trial residues for the majority of 
commodities; anticipated residues (ARs) for meat, milk, hog, and 
poultry commodities; and average percent crop treated (PCT) data for 
apples, blueberries, cabbage, cauliflower, cotton, dry beans, pears, 
peppers, potatoes, strawberries, and tomatoes. Percent crop treated for 
new use (PCTn) data were incorporated for the recently registered grain 
sorghum and sweet corn uses. For the remaining food commodities, 100 
PCT was assumed. The registered food-handling use was also incorporated 
into the dietary assessment. Empirical processing factors were utilized 
for apple juice (translated to pear and stone fruit juice), cottonseed 
oil, dried plums, and tomato paste and pur[eacute]e. Dietary Exposure 
Evaluation Model (DEEM) (ver. 7.81) default processing factors were 
used for the remaining processed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that novaluron 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

[[Page 43332]]

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 average PCT for existing uses as follows:
    Apple, 10%; blueberry, 1%; cabbage, 5%; cauliflower, 2.5%; cotton, 
2.5%; dry beans, 1%; pear, 15%; pepper, 2.5%; potato, 2.5%; strawberry, 
35%; and tomato, 2.5%.
    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 to 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. 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 estimated the PCT for new uses as follows: Grain 
sorghum, 2%; and sweet corn, 36%.
    EPA estimates PCTn for novaluron based on the PCT of the dominant 
pesticide (i.e., the one with the greatest PCT) on that site over the 
three most recent years of available data. Comparisons are only made 
among pesticides of the same pesticide types (i.e., the dominant 
insecticide on the use site is selected for comparison with a new 
insecticide). The PCTs included in the analysis may be for the same 
pesticide or for different pesticides since the same or different 
pesticides may dominate for each year. Typically, EPA uses USDA/NASS as 
the source for raw PCT data because it is publicly available and does 
not have to be calculated from available data sources. When a specific 
use site is not surveyed by USDA/NASS, EPA uses proprietary data and 
calculates the estimated PCT.
    This estimated PCTn, based on the average PCT of the market leader, 
is appropriate for use in the chronic dietary risk assessment. This 
method of estimating a PCT for a new use of a registered pesticide or a 
new pesticide produces a high-end estimate that is unlikely, in most 
cases, to be exceeded during the initial five years of actual use. The 
predominant factors that bear on whether the estimated PCTn could be 
exceeded are: The extent of pest pressure on the crops in question; the 
pest spectrum of the new pesticide in comparison with the market 
leaders as well as whether the market leaders are well-established for 
this use; and resistance concerns with the market leaders.
    Novaluron specifically targets lepidopterous insects, which are not 
key pests of sorghum but are key pests of sweet corn. However, 
novaluron has a relatively narrow spectrum of pest activity when 
compared to the market leader insecticides. In addition, there are no 
resistance or pest pressure issues as indicated in Section 18 Emergency 
Exemption requests for use of novaluron on sorghum or sweet corn. All 
information currently available has been considered for novaluron use 
on sorghum and sweet corn, and it is the opinion of EPA that it is 
unlikely that actual PCT for novaluron will exceed the estimated PCT 
for new uses during the next five years.
    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 novaluron may be applied in a particular area.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water for risk assessment purposes are novaluron, the 
chlorophenyl urea degradate, and the chloroaniline degradates. The 
estimated drinking water concentrations (EDWCs) for each of these was 
calculated using a molecular weight conversion and then combined for 
each modeled scenario. The degradates are assumed to have equal 
toxicity to the parent. The Agency used screening level water exposure 
models in the dietary exposure analysis and risk assessment for 
novaluron and its degradates in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of novaluron and its degradates. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), the Screening Concentration in Ground Water (SCI-
GROW), and Pesticide Root Zone Model Ground Water (PRZM GW) models, the 
combined EDWCs of novaluron, chlorophenyl urea, and chloroaniline for 
chronic exposures are estimated to be 16.7 ppb for surface water and 
77.8 ppb for groundwater.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 77.8 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Novaluron is currently registered for the following uses that could 
result in residential exposures: Indoor and outdoor crack and crevice 
or perimeter applications in residential areas and their immediate 
surroundings, including homes and apartment buildings; on modes of 
transportation; and as a spot-on use for pets. EPA assessed residential 
exposure using the following assumptions:
    Adult handlers were assessed for potential short-term inhalation 
exposures from mixing, loading, and

[[Page 43333]]

applying novaluron via manually-pressurized hand wand and from liquid 
applications of novaluron to turf. Adults were also assessed for 
potential short-term post-application inhalation exposures to novaluron 
from indoor uses. For children 1 to <2 years old, short-term post-
application inhalation and incidental oral exposures were assessed 
resulting from hand-to-mouth contact with treated residential areas, 
turf, and from contact with treated pets. There is also the potential 
for intermediate-term and long-term post-application hand-to-mouth 
exposures to children 1 to <2 years old from the registered pet spot-on 
use of novaluron. Inhalation exposures are considered negligible for 
this exposure scenario; therefore, the intermediate- and long-term 
aggregate risk estimates do not include inhalation exposures. For 
adults, inhalation exposure is expected to be negligible for 
intermediate- and long-term durations and was not included in the 
aggregate assessment. Additionally, a dermal endpoint has not been 
selected for novaluron, so dermal exposures to adults or children were 
not assessed.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found novaluron to share a common mechanism of toxicity 
with any other substances, and novaluron does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that novaluron does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for novaluron includes rat and rabbit prenatal 
developmental toxicity studies and a two-generation reproduction 
toxicity study in rats. There was no evidence of increased quantitative 
or qualitative susceptibility following in utero exposure to rats or 
rabbits in the developmental toxicity studies and no evidence of 
increased quantitative or qualitative susceptibility of offspring in 
the reproduction study. Neither maternal nor developmental toxicity was 
seen in the developmental studies up to the limit doses (1,000 mg/kg/
day). In the 2-generation reproductive study in rats, offspring and 
parental toxicity (increased absolute and relative spleen weights) were 
similar and occurred at the same dose (74.2 mg/kg/day). Additionally, 
reproductive effects (decreases in epididymal sperm counts and 
increased age at preputial separation in the F1 generation) occurred at 
a higher dose than that which resulted in parental 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 novaluron is complete.
    ii. Acute and subchronic rat neurotoxicity studies were performed 
for novaluron. The clinical signs of neurotoxicity, changes in FOB 
parameters, and neuropathology were seen in the acute neurotoxicity 
study at the limit dose (2,000 mg/kg/day) only and were not reproduced 
at similar, repeated doses in the subchronic neurotoxicity study. In 
addition, no evidence of neuropathology was observed in subchronic and 
chronic toxicity studies in rats, mice, or dogs. Therefore, novaluron 
is not considered a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that novaluron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment was performed 
using average field trial residues, anticipated residues for livestock 
commodities, average PCT and PCTn data for some commodities, and 
empirical and default processing factors. For the remaining food 
commodities, 100 PCT was assumed. The registered food handling use was 
also incorporated into the dietary assessment. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to novaluron 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 novaluron.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
novaluron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
novaluron from food and water will utilize 73% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure.
    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). Novaluron is 
currently

[[Page 43334]]

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 novaluron.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1,560 for adults 
and 350 for children 1 to <2 years old. Because EPA's level of concern 
for novaluron is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate- and long-term risk. Intermediate- and long-term 
aggregate exposure takes into account intermediate- and long-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Novaluron is currently 
registered for uses that could result in intermediate- and long-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
intermediate- and long-term residential exposures to novaluron.
    Using the exposure assumptions described in this unit for 
intermediate- and long-term exposures, EPA has concluded that the 
combined intermediate- and long-term food, water, and residential 
exposures result in an aggregate MOE of 530 for children 1 to <2 years 
old. For adults, since there is no dermal endpoint and inhalation 
exposure is expected to be negligible, the average dietary consumption 
(food and drinking water) exposure estimate is representative of 
intermediate- and long-term aggregate risk, and results in an MOE of 
1640. Because EPA's level of concern for novaluron is a MOE of 100 or 
below, these MOEs are 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, novaluron 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 novaluron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, gas chromatography/electron-
capture detection (GC/ECD) and high-performance liquid chromatography/
ultraviolet (HPLC/UV), are available to enforce the tolerance 
expression.
    The methods 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: 
[email protected].

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 novaluron in or on common beans 
(pods and/or immature seeds) at 0.7 ppm; pome fruit at 3 ppm; cucurbit 
vegetables at 0.2 ppm; and prunes at 3.0 ppm. EPA is establishing 
tolerances in or on succulent bean at 0.70 ppm; pome fruit crop group 
11-10 at 3.0 ppm; cucurbit vegetable crop group 9 at 0.20 ppm; and 
dried prune at 3.0 ppm in order to harmonize with Codex. The Codex has 
additionally established a tolerance in or on fruiting vegetables other 
than cucurbits at 0.7 ppm and stone fruits at 7 ppm. Because EPA is 
recommending a tolerance in or on fruiting vegetables crop group 8-10 
(1.0 ppm) that is higher than Codex, EPA cannot harmonize this 
tolerance. Residue data for greenhouse tomatoes supports the 1.0 ppm 
tolerance for the group 8-10 tolerance.
    The data supporting the EPA petition result in stone fruit 
tolerances that are either higher (cherry subgroup 12-12A at 8.0 ppm) 
or much lower (peach subgroup 12-12B and plum subgroup 12-12C at 1.9 
ppm) than the established Codex MRL for stone fruit at 7 ppm. EPA notes 
that the stone fruit tolerances are not harmonized with associated 
Codex MRLs on these commodities because it has been determined that the 
major export market for these commodities is Canada. Therefore, in 
order to maintain harmonization of U.S. tolerances and Canadian MRLs 
for these commodities, the EPA is establishing these subgroup 
tolerances at the levels that align with the Canadian MRLs. No Codex 
MRLs have been established for residues of novaluron in or on avocado 
or carrot.

C. Response to Comments

    One comment was received to the batched Notice of Filing that 
provided brief and general concerns about toxins and potential impacts 
to bees, but the commenter did not cite a specific petition within the 
Notice. The Agency has received similar comments from this commenter on 
numerous previous occasions. Refer to Federal Register 70 FR 37686 
(June 30, 2005), 70 FR 1354 (January 7, 2005), 69 FR 63096-63098 
(October 29, 2004) for the Agency's response to these objections.

D. Revisions to Petitioned-For Tolerances

    The Agency was petitioned to establish a tolerance of novaluron in 
or on plum subgroup 12-12C. As a part of that request, the Agency 
reviewed the existing tolerance on dried prune, and determined that the 
tolerance should be amended from 2.6 ppm to 3.0 ppm in order to 
harmonize with Codex. Data were also submitted and reviewed by EPA to 
allow the use of novaluron in or on greenhouse-grown cucumbers. During 
review, the Agency determined that the existing tolerance in or on 
cucurbit vegetable group 9 (which includes cucumber) should be amended 
from 0.15 ppm to 0.20 ppm in order to harmonize with Codex.
    EPA was also petitioned to establish a tolerance in or on bean at 
0.60 ppm and to remove the existing tolerance in or on dry bean seed at 
0.30 ppm upon approval of the proposed bean tolerance. However, the 
Agency determined that separate tolerances should be established in or 
on succulent bean and dry bean seed. Therefore, this action will not 
remove the existing tolerance for the use of novaluron in or on dry 
bean seed at 0.30 ppm, and the Agency determined that a tolerance in or 
on succulent bean at 0.70 ppm is appropriate in order to harmonize with 
the established Codex tolerance on beans. Finally, EPA revised the 
proposed pome fruit crop group 11-10 tolerance from 2.0 ppm to 3.0 ppm 
in order to harmonize with the established Codex MRL.

 V. Conclusion

    Therefore, tolerances are established for residues of novaluron, 
(N-[[[3-

[[Page 43335]]

chloro-4-[1,1,2-trifluoro-2- 
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide), 
in or on avocado at 0.60 ppm; bean, succulent at 0.70 ppm; carrot at 
0.05 ppm; cherry subgroup 12-12A at 8.0 ppm; fruit, pome, group 11-10 
at 3.0 ppm; peach subgroup 12-12B at 1.9 ppm; plum subgroup 12-12C at 
1.9 ppm; and vegetable, fruiting, group 8-10 at 1.0 ppm. This 
regulation additionally revises the existing tolerances in or on 
vegetable, cucurbit, group 9 from 0.15 ppm to 0.20 ppm; and plum, 
prune, dried from 2.6 ppm to 3.0 ppm. Finally, this regulation removes 
established tolerances in or on bean, snap, succulent; cherry; cocona; 
fruit, pome, group 11; fruit, stone, group 12, except cherry; eggplant, 
African; eggplant, pea; eggplant, scarlet; goji berry; huckleberry, 
garden; martynia; naranjilla; okra; roselle; sunberry; tomato, bush; 
tomato, currant; tomato, tree; and vegetable, fruiting, group 8.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: July 9, 2015.
Susan Lewis,
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.  180.598:
0
a. Remove the entries in the table in paragraph (a) for ``Bean, snap, 
succulent'', ``Cherry'', ``Cocona'', ``Eggplant, African'', ``Eggplant, 
pea'', ``Eggplant, scarlet'', ``Fruit, pome, group 11'', ``Fruit, 
stone, group 12, except cherry'', ``Goji berry'', ``Huckleberry, 
garden'', ``Martynia'', ``Naranjilla'', ``Okra'', ``Roselle;'' 
``Sunberry'', ``Tomato, bush'', ``Tomato, currant'', ``Tomato, tree'', 
and ``Vegetable, fruiting, group 8''.
0
b. Add alphabetically the entries for ``Avocado'', ``Bean, succulent'', 
``Carrot'', ``Cherry subgroup 12-12A'', ``Fruit, pome, group 11-10'', 
``Peach subgroup 12-12B'', ``Plum subgroup 12-12-C'', and ``Vegetable, 
fruiting, group 8-10'' to the table in paragraph (a).
0
c. Revise the entries for ``Plum, prune, dried'', and ``Vegetable, 
cucurbit, group 9'' in the table in paragraph (a).
    The additions and revisions read as follows:


Sec.  180.598  Novaluron; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Avocado.....................................................        0.60
 
                                * * * * *
Bean, succulent.............................................        0.70
 
                                * * * * *
Carrot......................................................        0.05
 
                                * * * * *
Cherry subgroup 12-12A......................................         8.0
 
                                * * * * *
Fruit, pome, group 11-10....................................         3.0
 
                                * * * * *
Peach subgroup 12-12B.......................................         1.9
 
                                * * * * *
Plum, prune, dried..........................................         3.0
Plum subgroup 12-12C........................................         1.9
 
                                * * * * *
Vegetable, cucurbit, group 9................................        0.20
Vegetable, fruiting, group 8-10.............................         1.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-17676 Filed 7-21-15; 8:45 am]
 BILLING CODE 6560-50-P