[Federal Register Volume 75, Number 101 (Wednesday, May 26, 2010)]
[Rules and Regulations]
[Pages 29441-29447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12649]



40 CFR Part 180

[EPA-HQ-OPP-2009-0273; FRL-8825-3]

Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
novaluron in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally revises 
several established tolerances for residues of novaluron. Makhteshim-
Agan of North America, Inc., requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 26, 2010. Objections and 
requests for hearings must be received on or before July 26, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0273. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.


I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).

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     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0273 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 
July 26, 2010. 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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0273, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8417-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9F7547) by Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse 
Road, Raleigh, NC 27609. 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- 
in or on sorghum, grain at 3 parts per million (ppm); sorghum, 
aspirated grain fractions at 25 ppm; sorghum, forage at 6 ppm; and 
sorghum, stover at 40 ppm. Additionally, the petition requested to 
amend existing tolerances of novaluron in or on poultry, fat from 0.40 
ppm to 7.0 ppm; poultry, meat from 0.03 ppm to 0.40 ppm; poultry, meat 
byproducts from 0.04 ppm to 0.80 ppm; hog, fat from 0.05 ppm to 1.5 
ppm; hog, meat from 0.01 ppm to 0.07 ppm; hog, meat byproducts from 
0.01 ppm to 0.15 ppm; and eggs from 0.05 ppm to 1.5 ppm. That notice 
referenced a summary of the petition prepared by Makhteshim-Agan of 
North America, Inc., 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 proposed tolerance for hog, meat byproducts and has 
additionally determined that individual tolerances on poultry, liver; 
poultry, kidney; hog, liver; and hog, kidney are necessary. The reason 
for these changes 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 
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for novaluron including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with novaluron 

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 
    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 (toxicity to blood) 
such as methemoglobinemia, decreased hemoglobin, decreased hematocrit, 
and decreased 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 an immunotoxic effect.

[[Page 29443]]

    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 hematotoxicity.
    Clinical signs of neurotoxicity and neuropathology 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 addition, there 
were no clinical signs of toxicity observed in the acute oral toxicity 
study with novaluron (LD50 >5,000 milligrams/kilogram (mg/
kg)). 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 and no evidence of mutagenic activity 
in the submitted mutagenicity studies, including a bacterial 
(Salmonella, E. coli) reverse mutation assay, an in vitro mammalian 
chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus 
assay and a bacterial DNA damage/repair assay. Based on the results of 
these studies, EPA has classified novaluron 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 Use on Grain Sorghum.'' at pages 27-
30 in docket ID number EPA-HQ-OPP-2009-0273.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
     A summary of the toxicological endpoints for novaluron used for 
human risk assessment is shown in the following Table.

           Summary of Toxicological Doses and Endpoints for novaluron for Use in Human Risk Assessment
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
Acute dietary                          Not applicable           None                     An endpoint of concern
(All populations)....................                                                     attributable to a
                                                                                          single dose was not
                                                                                          identified. An acute
                                                                                          RfD was not
Chronic dietary                        NOAEL = 1.1 mg/kg/day    Chronic RfD = 0.011 mg/  Combined chronic
(All populations)....................  UFA = 10x..............   kg/day                   toxicity/
                                       UFH = 10x..............  cPAD = 0.011 mg/kg/day.   carcinogenicity
                                       FQPA SF = 1x...........                            feeding in rat LOAEL =
                                                                                          30.6 mg/kg/day based
                                                                                          on erythrocyte damage
                                                                                          and turnover resulting
                                                                                          in a regenerative
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose. RfD = reference dose. LOC = level of concern.

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 
    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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys 
of Food Intakes by Individuals (CSFII). As to residue levels in food, 
EPA incorporated average percent crop treated (PCT) data for apples, 
cabbage, cotton, pears, and potatoes and estimated PCT data for the new 
use on sorghum; 100 PCT was assumed for the remaining food commodities. 
The Agency utilized anticipated residues (ARs) for most commodities, 
including meat, milk, hog, and poultry commodities. Average field trial 
residues were used for pome fruit, sugarcane, bushberry, Brassica leafy 
greens, stone fruit, bell pepper, nonbell pepper, cucumber, summer 
squash, cantaloupe, strawberry, succulent snap bean, dry bean seed, and 
Swiss chard, and average greenhouse trial residues for tomato. 
Empirical processing factors

[[Page 29444]]

for apple juice (translated to pear and stone fruit juice), tomato 
paste and puree, and Dietary Exposure Evaluation Model (DEEM) default 
processing factors for the remaining processed commodities were used to 
estimate anticipated residues in processed foods.
    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 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:
    Apples at 15%; cabbage at 10%; cotton at 2.5%; pears at 10%; and 
potatoes at 2.5%.
    In most cases, EPA uses available data from USDA/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 new uses as follows:
    Grain sorghum at 5%.
    EPA utilized estimated PCT data in the chronic dietary risk 
assessment for the new use on grain sorghum, based on the market leader 
approach. The market leader approach is the comparison of the PCT with 
all chemicals of a specific type (i.e., herbicide, insecticide, etc.) 
on a specific crop and choosing the highest PCT (market leader) as the 
PCT for the new use. 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 5 
years of actual use. The predominant factors that bear on whether the 
estimated PCT 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 
    Novaluron has a relatively narrow spectrum of activity compared to 
the market leaders and specifically targets lepidopterous insects, 
which are not key pests of grain sorghum. Additionally, there are no 
resistance or pest pressure issues identified for the use of novaluron 
on grain sorghum. All information currently available has been 
considered for use on grain sorghum, and EPA concludes that it is 
unlikely that the actual grain sorghum PCT with 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 its 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.
    The following models were used to assess residues of concern in 
drinking water: The Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) for parent novaluron in surface water; the 
First Index Reservoir Screening Tool (FIRST) for chlorophenyl urea and 
chloroaniline degradates in surface water; and the Screening 
Concentration in Ground Water (SCI-GROW) model for novaluron, 
chlorophenyl urea and chloroaniline in ground water. The estimated 
drinking water concentrations (EDWCs) of novaluron, chlorophenyl urea, 
and chloroaniline for chronic exposures for non-cancer assessments are 
estimated to be 0.76 parts per billion (ppb), 0.89 ppb and 2.6 ppb, 
respectively, for surface water and 0.0056 ppb, 0.0045 ppb and 0.0090 
ppb, respectively, for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The

[[Page 29445]]

highest drinking water concentrations were estimated for surface water. 
Of the three EDWC values for surface water, the chronic EDWC for the 
terminal metabolite, chloroaniline, is the highest (assuming 100% molar 
conversion from parent to aniline). This is consistent with the 
expected degradation pattern for novaluron. Therefore, for chronic 
dietary risk assessment, the water concentration value for 
chloroaniline of 2.6 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 not 
registered for any specific use patterns that would result in 
residential exposure.
    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 website at 

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 
    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 
reproduction study, 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 
    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 
    i. The toxicity database for novaluron is complete except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Guideline 870.7800) required for 
pesticide registration; however, the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios, and for 
evaluation of the requirements under the FQPA. Although effects were 
seen in the spleen in two studies, as explained in Unit III.A., EPA has 
concluded that novaluron does not directly target the immune system and 
the Agency does not believe that conducting a functional immunotoxicity 
study will result in a NOAEL lower than the regulatory dose for risk 
assessment; therefore, an additional database uncertainty factor is not 
needed to account for potential immunotoxicity.
    ii. There were signs of neurotoxicity in the acute neurotoxicity 
study in rats, including clinical signs (piloerection, fast/irregular 
breathing), functional observation battery (FOB) parameters (head 
swaying, abnormal gait), and neuropathology (sciatic and tibial nerve 
degeneration). However, the signs observed were not severe, were seen 
only at the limit dose (2,000 mg/kg/day) and were not reproducible. No 
signs of neurotoxicity or neuropathology were observed in the 
subchronic neurotoxicity study in rats at doses up to 1,752 mg/kg/day 
in males and 2,000 mg/kg/day in females or in any other subchronic or 
chronic toxicity study in rats, mice or dogs, including the 
developmental and reproduction studies. In addition, no clinical signs 
of toxicity were observed in the acute oral toxicity study 
(LD50 > 5,000 mg/kg). Therefore, novaluron does not appear 
to be a neurotoxicant, 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 
    iv. Although storage stability data has been requested for grain 
sorghum forage, grain, and stover, there are no residual uncertainties 
identified in the exposure databases because acceptable storage 
stability data is available for various commodities which demonstrate 
the stability of novaluron in/or on food commodities for up to 15.3 
months, which exceeds the longest storage time (9.0 months for grain 
sorghum forage) of the grain sorghum commodities in the field trials. 
The chronic dietary food exposure assessment utilized tolerance level 
residues or anticipated residues that are based on reliable field trial 
data, and reliable data from processing studies or worst case 
assumptions. The chronic assessment also utilized PCT data (average PCT 
for several currently registered commodities and estimated PCT data for 
the new use on grain sorghum), which have a valid basis and are 
considered to be reliable. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to novaluron in drinking water. Residential exposures are not 
expected. 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.

[[Page 29446]]

    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 32% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
There are no residential uses for novaluron.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because no short- or 
intermediate-term adverse effect was identified, novaluron is not 
expected to pose a short- or intermediate-term risk.
    4. 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.
    5. 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

     The following adequate enforcement methodologies are available to 
enforce the tolerance expression: A gas chromatography/electron-capture 
detection (GC/ECD) method and a high-performance liquid chromatography/
ultraviolet (HPLC/UV) method. 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; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
(MRLs) established for residues of novaluron in or on grain sorghum 
commodities associated with this petition. There are Codex MRLs 
established for poultry, meat; poultry, edible offal of; and eggs at 
0.01 ppm; and meat (mammalian other than marine) at 10 ppm. 
Additionally, there are Canadian MRLs established for meat of hogs and 
meat byproducts of hogs at 0.01 ppm. EPA's analysis of data used to 
determine the secondary residues in animal commodities, including the 
dietary burden in the United States for registered/proposed uses of 
novaluron, supports establishing tolerances in poultry, meat at 0.40 
ppm; poultry, liver and kidney at 0.8 ppm; hog, meat at 0.07 ppm; and 
egg at 1.5 ppm. Therefore, U.S. tolerances on these animal commodities 
cannot be harmonized with the associated Codex or Canadian MRLs.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the data supporting the petition, EPA has 
revised the proposed tolerance for hog, meat byproducts from 0.15 ppm 
to 0.10 ppm. Additionally, the Agency has determined that individual 
tolerances on poultry, liver at 0.80 ppm; poultry, kidney at 0.80 ppm; 
hog, liver at 0.10 ppm; and hog, kidney at 0.10 ppm are necessary. 
These revisions are based on the following:
    Several tolerances for secondary residues in animal commodities 
have been established for novaluron based on reasonably balanced 
dietary burdens (RBDBs) derived from feedstuff percentages. However, 
new RBDBs have been established based on the proposed/established uses 
of novaluron, thus necessitating revisions in the proposed/established 
tolerances for secondary residues in or on poultry and hog commodities. 
Therefore, the Agency has revised the proposed tolerance for hog, meat 
byproducts from 0.15 ppm to 0.10 ppm and has determined that individual 
tolerances are necessary for hog, liver and hog, kidney at 0.10 ppm; 
and poultry, liver and poultry, kidney at 0.80 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron, N-
in or on sorghum, grain, grain at 3.0 ppm; grain, aspirated fractions 
at 25 ppm; sorghum, grain, forage at 6.0 ppm; sorghum, grain, stover at 
40 ppm; poultry, fat at 7.0 ppm; poultry, meat at 0.40 ppm; poultry, 
liver at 0.80 ppm; poultry, kidney at 0.80 ppm; poultry, meat 
byproducts at 0.80 ppm; hog, fat at 1.5 ppm; hog, meat at 0.07 ppm; 
hog, liver at 0.10 ppm; hog, kidney at 0.10 ppm; hog, meat byproducts 
at 0.10 ppm; and egg at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the

[[Page 29447]]

Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 14, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. Section 180.598 is amended in paragraph (a) as follows:
    i. Add alphabetically ``Grain, aspirated fractions''; ``Hog, 
kidney''; ``Hog, liver''; ``Poultry, kidney''; ``Poultry, liver''; 
``Sorghum, grain, forage''; ``Sorghum, grain, grain''; and ``Sorghum, 
grain, stover'' to the table; and
    ii. Revise the entries for ``Egg''; ``Hog, fat''; ``Hog, meat''; 
``Hog, meat byproducts''; ``Poultry, fat''; ``Poultry, meat''; and 
``Poultry, meat byproducts.'' The added and revised entries to read as 

Sec. 180.598  Novaluron; tolerances for residues.

    (a) * * *

                      Commodity                        Parts per million
                                * * * * *
Egg..................................................                1.5
                                * * * * *
Grain, aspirated fractions...........................                 25
                                * * * * *
Hog, fat.............................................                1.5
Hog, kidney..........................................               0.10
Hog, liver...........................................               0.10
Hog, meat............................................               0.07
Hog, meat byproducts.................................               0.10
                                * * * * *
Poultry, fat.........................................                7.0
Poultry, kidney......................................               0.80
Poultry, liver.......................................               0.80
Poultry, meat........................................               0.40
Poultry, meat byproducts.............................               0.80
                                * * * * *
Sorghum, grain, forage...............................                6.0
Sorghum, grain, grain................................                3.0
Sorghum, grain, stover...............................                 40
                                * * * * *

* * * * *

[FR Doc. 2010-12649 Filed 5-25-10; 8:45 am]