Document ID: EPA-HQ-OPP-2008-0769-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Novaluron
Posted Date: 2009-12-09T05:00Z

[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Rules and Regulations]               
[Page 65029-65034]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de09-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0769; FRL-8799-6]

 
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 bushberry subgroup 13-07B; Brassica, leafy greens, 
subgroup 5B; turnip, greens; fruit, stone, group 12, except cherry; 
cherry; and plum, prune, dried. This regulation additionally revises an 
existing tolerance in or on egg and revises terminology for an existing 
tolerance. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 9, 2009. Objections and 
requests for hearings must be received on or before February 8, 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-2008-0769. 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) 
305-5805.

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.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    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 OPPTS Harmonized Test Guidelines referenced in this 
document, go directly to the guidelines at http://www.epa.gov/oppts and 
select ``Test Methods & Guidelines'' on the left side navigation menu.

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-2008-0769 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before February 8, 2010.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0769, 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.

[[Page 65030]]

II. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
8E7425 and PP 8E7426) by IR-4, 500 College Road East, Suite 201 W., 
Princeton, NJ 08540. The petitions 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 bushberry, subgroup 13-07B at 7 parts per million (ppm) (PP 
8E7425); fruit, stone, group 12 at 8 ppm (PP 8E7426); Brassica, leafy 
greens, subgroup 5B at 25 ppm (PP 8E7426); and turnip, greens at 25 ppm 
(PP 8E7426). PP 8E7426 additionally requested to increase the existing 
tolerance for residues of novaluron in or on egg from 0.05 ppm to 0.07 
ppm; however, the petition number associated with this request was 
incorrectly reported. The correct petition number for the request to 
increase the existing egg tolerance is PP 9F7630. The notice referenced 
summaries of the petitions prepared on behalf of IR-4 by Makhteshim-
Agan of North America, Inc., the registrant, which are available to the 
public 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 on stone fruit and has determined that individual 
tolerances in or on cherry; and plum, prune, dried are necessary. The 
reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of novaluron on bushberry subgroup 13-07B at 
7.0 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; turnip, greens 
at 25 ppm; fruit, stone, group 12, except cherry at 1.9 ppm; cherry at 
8.0 ppm; plum, prune, dried at 2.6 ppm; and egg at 0.07 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    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 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.
    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 maternal and 
offspring toxicity were evidenced by enlargement of the spleen. 
Reproductive toxicity (decreases in epididymal sperm counts and 
increased age at preputial separation in the F1 generation) 
was observed only in males.
    Signs of neurotoxicity were seen in the rat acute neurotoxicity 
study at the limit dose, including clinical signs (piloerection, fast/
irregular breathing), functional observation battery (FOB) parameters 
(head swaying, abnormal gait) and neuropathology (sciatic and tibial 
nerve degeneration). No signs of neurotoxicity or neuropathology were 
observed in the subchronic neurotoxicity study in rats 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 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 or 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 Uses on Bushberry Crop Subgroup 13-
07B; Brassica, Leafy Greens, Crop Subgroup 5B; Turnip, Greens; and 
Fruit, Stone, Crop Group 12,'' pages 28-31 in docket ID number EPA-HQ-
OPP-2008-0769.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic

[[Page 65031]]

population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for novaluron used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Novaluron: Human-Health Risk Assessment for Proposed Section 
3 Uses on Bushberry Crop Subgroup 13-07B; Brassica, Leafy Greens, Crop 
Subgroup 5B; Turnip, Greens; and Fruit, Stone, Crop Group 12,'' pages 
13-14 in docket ID number EPA-HQ-OPP-2008-0769.

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 1994-1996 
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As 
to residue levels in food, EPA incorporated anticipated residues from 
average field trial residues for pome fruit, sugarcane, bushberries, 
Brassica leafy greens, stone fruit and greenhouse tomatoes; empirical 
processing factors for apple juice (translated to pear and stone fruit 
juice), tomato paste and pur[eacute]e, and dried plums; and DEEM 
default processing factors for the remaining processed commodities. In 
estimating dietary exposure from secondary residues in livestock, EPA 
relied on anticipated residues for meat and milk commodities but used 
tolerance-level residues for poultry commodities. 100 percent crop 
treated (PCT) was assumed for all existing and new uses of novaluron.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in 
two adequate rodent carcinogenicity studies, EPA has classified 
novaluron as ``not likely to be carcinogenic to humans.'' Therefore, a 
quantitative exposure assessment to evaluate cancer risk is 
unnecessary.
    iv. Anticipated residue 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.
    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 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 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

[[Page 65032]]

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 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 
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 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 except for 
immunotoxicity testing. Recent changes to 40 CFR part 158 make 
immunotoxicity testing (OPPTS Test 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), 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. 
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 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level or anticipated residues derived from 
reliable residue field trials. 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
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 83% of the cPAD for children 
1-2 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). Novaluron is not 
registered for any use patterns that would result in residential 
exposure. Therefore, the short- and intermediate-term aggregate risk is 
the sum of the risk from exposure to novaluron through food and water 
and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. 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; therefore, 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

    No Codex, Canadian or Mexican maximum residue limits (MRLs) have 
been established for novaluron on bushberries; Brassica, leafy greens; 
turnip greens; or stone fruit. Canada has reviewed the use of novaluron 
on Brassica, leafy greens and stone fruit

[[Page 65033]]

(including cherry and plum, prune, dried). Canadian and U.S. 
recommendations have been harmonized and MRLs for Brassica, leafy 
greens, subgroup 5B at 7.0 ppm; stone fruit, group 12, except cherry at 
1.9 ppm; cherry at 8.0 ppm; and plum, prune, dried at 2.6 ppm are 
expected to be established in Canada.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the residue field trial data using the 
Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance 
for Setting Pesticide Tolerances Based on Field Trial Data, EPA revised 
the proposed tolerance on fruit, stone, group 12 (excluding cherry; and 
plum, prune, dried) from 8.0 ppm to 1.9 ppm and determined that 
individual tolerances on cherry at 8.0 ppm and plum, prune, dried at 
2.6 ppm are necessary. For peaches, fresh plums and cherries (the 
representative commodities for fruit, stone, group 12) the tolerance 
spreadsheet recommends tolerances of 1.8 ppm, 1.9 ppm, and 8.0 ppm, 
respectively. For plum, prune, dried, the tolerance spreadsheet 
recommends a tolerance of 2.6 ppm. Therefore, tolerances of novaluron 
in or on fruit, stone, group 12, except cherry at 1.9 ppm; cherry at 
8.0 ppm; and plum, prune, dried at 2.6 ppm are appropriate. EPA has 
also revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of novaluron not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

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 bushberry subgroup 13-07B at 7.0 ppm; Brassica, leafy greens, 
subgroup 5B at 25 ppm; turnip, greens at 25 ppm; fruit, stone, group 
12, except cherry at 1.9 ppm; cherry at 8.0 ppm; plum, prune, dried at 
2.6 ppm; and egg at 0.07 ppm. EPA also revised the commodity definition 
for vegetables, tuberous and corn, subgroup 1C to vegetable, tuberous 
and corm, subgroup 1C to reflect the correct commodity definition.

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

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: November 13, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.598 is amended by:
    i. Revising the introductory text in paragraph (a);
    ii. Revising the existing entries for ``Egg'' and ``Vegetables, 
tuberous and corn, subgroup 1C'' in the table in paragraph (a) and 
alphabetically adding ``Brassica, leafy greens, subgroup 5B''; 
``Bushberry subgroup 13-07B''; ``Cherry''; ``Fruit, stone, group 12, 
except cherry''; ``Plum, prune, dried''; and ``Turnip, greens'' to the 
table in paragraph (a); and
    iii. Revising the introductory text in paragraph (b).
    The amendments read as follows:

Sec.  180.598  Novaluron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide novaluron, including its metabolites and degradates, in or 
on the following commodities. Compliance with the tolerance levels 
specified in the following table is to be determined by

[[Page 65034]]

measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-trifluoro-2- 
(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-difluorobenzamide), 
in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Brassica, leafy greens, subgroup 5B........................           25
Bushberry subgroup 13-07B..................................          7.0
                                * * * * *
Cherry.....................................................          8.0
                                * * * * *
Egg........................................................         0.07
                                * * * * *
Fruit, stone, group 12, except cherry......................          1.9
                                * * * * *
Plum, prune, dried.........................................          2.6
                                * * * * *
Turnip, greens.............................................           25
Vegetable, tuberous and corm, subgroup 1C..................         0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide novaluron, including its 
metabolites and degradates, in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. Compliance with 
the tolerance levels specified in the following table is to be 
determined by measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-
trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-
difluorobenzamide). These tolerances will expire and are revoked on the 
dates specified in the following table:
* * * * *

[FR Doc. E9-29212 Filed 12-8-09; 8:45 am]

BILLING CODE 6560-50-S