
[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
[Pages 40027-40033]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15869]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0291; FRL-9389-7]


Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
novaluron in or on peanut and soybean, seed. Makhteshim-Agan of North 
America requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA). This regulation additionally deletes the time-
limited tolerance for strawberry, as that tolerance expired on December 
31, 2011.

DATES: This regulation is effective July 3, 2013. Objections and 
requests for hearings must be received on or before September 3, 2013, 
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-2012-0291, 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), 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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Jennifer Gaines, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5967; email address: gaines.jennifer@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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-2012-0291 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 3, 2013. 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

[[Page 40028]]

by docket ID number EPA-HQ-OPP-2012-0291, 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.htm. 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 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 
2F7999) by Makhteshim-Agan of North America, 3120 Highwoods Blvd., 
Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR 
180.598 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 peanuts at 0.01 parts per million (ppm) and soybean, seed at 
0.06 ppm. That document referenced a summary of the petition prepared 
by Makhteshim-Agan of North America, the registrant, which is available 
in the docket, http://www.regulations.gov. There were no comments 
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance level for soybean, seed. The reason for this 
change is 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 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.
    Novaluron has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. It is not an eye or skin irritant and is 
not a dermal sensitizer. In subchronic and chronic toxicity studies, 
novaluron primarily produced hematotoxic effects such as 
methemoglobinemia, decreased hemoglobin, decreased hematocrit, and 
decreased red blood cells (RBCs) (or erythrocytes) associated with 
increased erythropoiesis. Increased spleen weights and/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 (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.
    Signs of neurotoxicity (piloerection, irregular breathing), changes 
in functional observational batter 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. Therefore, there is no concern for neurotoxicity resulting from 
exposure to novaluron.
    There was no evidence of carcinogenic potential in either the rat 
or mouse carcinogenicity studies. There was no concern for genotoxicity 
or mutagenicity. Therefore novaluron was classified as ``not likely to 
be carcinogenic to humans.''
    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 Proposed Section 3 Uses on Peanut and Soybean at pp. 37-40 in 
docket ID number EPA-HQ-OPP-2012-0291.

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 the NOAEL and the LOAEL are indentified. 
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 40029]]

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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  None................  None...............  An endpoint of concern
 including infants and children).                                              attributable to a single dose was
                                                                               not identified. An acute RfD was
                                                                               not established.
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 short-term.......  NOAEL = 4.38 mg/kg/   LOC for MOE = 100..  90-day feeding study in rat.
(1 to 30 days) and Intermediate-    day.                                      LOAEL = 8.64 mg/kg/day based on
 Term (1 to 6 months).             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).
Dermal short-term (1 to 30 days).  Not applicable and    None...............  No toxicity was observed at the
                                    none.                                      limit dose in the dermal study
                                                                               and there were no developmental
                                                                               toxicity concerns at the limit-
                                                                               dose; therefore, quantification
                                                                               of short-term dermal risk is not
                                                                               necessary.
Dermal intermediate-term (1 to 6   Dermal (or oral)      LOC for MOE = 100..  90-day feeding study in rat.
 months).                           study NOAEL = 4.38                        LOAEL = 8.64 mg/kg/day based on
                                    mg/kg/day (dermal                          clinical chemistry (decreased
                                    absorption rate =                          hemoglobin, hematocrit, and RBC
                                    10% when                                   counts) and histopathology
                                    appropriate).                              (increased hematopoiesis and
                                   UFA = 10X...........                        hemosiderosis in spleen and
                                   UFH = 10X...........                        liver).
                                   FQPA SF = 1X........
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  90-day feeding study in rat.
 days) and Intermediate Term (1     study NOAEL = 4.38                        LOAEL = 8.64 mg/kg/day based on
 to 6 months).                      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)             Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
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 percent crop treated (PCT) data for apples, 
cabbage, cauliflower, cotton, pears, potatoes, strawberries, and 
tomatoes and utilized estimates for PCT for recently registered uses 
for grain sorghum and sweet corn. 100 PCT was assumed for the remaining 
food commodities. Anticipated residues (ARs) for meat, milk, hog, and 
poultry commodities were calculated based on the proposed/registered 
uses, and incorporated average field trial residues, percent crop 
treated for new uses (PCTn) data for grain sorghum and sweet corn, 
average PCT data for apple and cotton, and an assumption of 100 PCT for 
sugarcane, aspirated grain fractions (AGF), and cowpea seed.
    The chronic analysis also incorporated average field trial 
residues, tolerance-level residues for the proposed commodities, 
average greenhouse trial residue for tomatoes, and half-limit of 
quantitation (LOQ) residues for food commodities other than those 
covered by a higher tolerance

[[Page 40030]]

as a result of use on growing crops from the registered use in food and 
feed handling establishments. Additionally, empirical processing 
factors for apple juice (translated to pear and stone fruit juice), 
cottonseed oil, dried plums, and tomato paste and pur[eacute]e, and 
Dietary Exposure Evaluation Model (DEEM) (ver. 7.81) default processing 
factors for the remaining processed commodities, where provided were 
incorporated.
    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 percent crop treated (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: Apples 
at 10%; cabbage at 10%; cauliflower at < 2.5%, cotton at < 2.5%, pears 
at 15%, potatoes at < 2.5%, strawberries at 35%, and tomatoes at < 1%.
    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. 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 recently approved uses as follows: 
Sweet corn at 36% and grain sorghum at 2%.
    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 doesn 
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.
    The estimated PCT for new uses, 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 PCT for new uses could be exceeded are:
    1. The extent of pest pressure on the crops in question;
    2. 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
    3. 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.
    All information currently available has been considered for 
novaluron use on sorghum and sweet corn, and it is the opinion of the 
Agency that it is unlikely that actual PCT for novaluron will exceed 
the estimated PCT for new uses during the next 5 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 are novaluron and it chlorophenyl urea and chloroaniline 
degradates. 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. 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.
    EPA utilized the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) for estimating

[[Page 40031]]

parent novaluron in surface water, the Tier 1 FQPA Index Reservoir 
Screening Tool (FIRST) model for surface water estimates for 
chlorophenyl urea and chloroaniline degradates, and the Screening 
Concentration in Ground Water (SCI-GROW) model for novaluron, 
chorophenyl urea, and chloroaniline in ground water. Based on these 
models, the estimated drinking water concentrations (EDWCs) of 
novaluron, chlorophenyl urea, and chloroaniline for chronic exposures 
for non-cancer assessments are estimated to be 0.41 parts per billion 
(ppb), 0.375 ppb, and 3.301 ppb respectively, for surface water and 
0.00137 ppb, 0.00149 ppb, and 0.00658 ppb respectively for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The highest 1-in-10 year 
annual mean surface water EDWCs were combined to estimate drinking 
water exposures. For chronic dietary risk assessment, the water 
concentration of value 4.086 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 uses for the control of 
crickets (cracks and crevice and spot treatments) in residential areas 
such as homes and apartment buildings, and their immediate 
surroundings, and on modes of transportation. There is a potential for 
exposure in residential settings during the application process for 
homeowners who use products containing novaluron.
    Additionally, exposure routes were assessed for post-application 
exposures for adults and children via inhalation routes and post-
application incidental oral (hand-to-mouth) exposure for children (1 to 
< 2 years old). Additionally, a combined residential assessment that 
consisted of children (1 to < 2 years old) inhalation and oral (hand-
to-mouth) post-application exposure was included. Details of the 
residential risk exposure and risk assessment are contained in the EPA 
public docket EPA-HQ-OPP-2010-0466 at http://www.regulations.gov in 
document ``Novaluron: Human-Health Risk Assessment for Proposed Section 
3 Uses on Sweet Corn and in Food-or Feed-Handling Establishments'' on 
pp. 21-26.
    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 2-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. 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; 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. There is minimal indication that novaluron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that 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 anticipated residues derived from reliable residue field trials, 
tolerance-level residues for proposed commodities, average PCT data for 
some commodities, and PCTn data for grain sorghum and sweet corn. 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 post-
application 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

[[Page 40032]]

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 55% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
The residential exposure assessment was conducted using high-end 
estimates of use and potential exposure providing a conservative, 
health protective estimate of risk.
    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 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 2,520 for adults 
and 480 for children 1-2 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-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). An intermediate-term aggregate exposure (food+drinking 
water+residential) assessment was not conducted since residential 
intermediate-term exposures are not likely due to the intermittent 
nature of applications by homeowners.
    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 methodology (gas chromatography/electron-
capture detection (GC/ECD) method and a high-performance liquid 
chromatography/ultraviolet (HPLC/UV) method) are 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 an MRL for residues of novaluron in or on 
immature soybean seed at 0.01 ppm. Immature soybean seed (edamame) is 
not covered by soybean, seed; therefore, harmonization is not an issue 
for the proposed soybean use. There is no Codex MRL for peanut.

C. Revisions to Petitioned-for Tolerances

    Based on analysis from the residue field trial data supporting the 
petition and use of the Organization for Economic Cooperation and 
Development tolerance calculation procedures, EPA revised the proposed 
tolerance on soybean, seed from 0.06 ppm to 0.07 ppm. Additionally, the 
commodity term for peanuts is being revised.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron, N-
[[[3-chloro-4-[1,1,2-trifluoro-2-
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide, 
in or on peanut and soybean, seed at 0.01 and 0.07 ppm, respectively.
    This regulation additionally deletes the time-limited tolerance for 
strawberry, as that tolerance expired on December 31, 2011.

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, 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

[[Page 40033]]

``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: June 25, 2013.
G. Jeffrey Herndon,
Acting 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. Add alphabetically the commodities to the table in paragraph (a).
0
b. Remove and reserve paragraph (b).


Sec.  180.598  Novaluron; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Peanut..................................................            0.01
 
                                * * * * *
Soybean, seed...........................................            0.07
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2013-15869 Filed 7-2-13; 8:45 am]
BILLING CODE 6560-50-P


