Document ID: EPA-HQ-OPP-2006-0815-0001
Agency: epa
Document Type: Rule
Title: Novaluron; Pesticide Tolerance for Emergency Exemption
Posted Date: 2006-10-20T12:54:35Z

[Federal Register: October 20, 2006 (Volume 71, Number 203)]
[Rules and Regulations]               
[Page 61906-61911]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc06-15]                         

[[Page 61906]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0815; FRL-8098-8]

 
Novaluron; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of novaluron in or on sugarcane. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on sugarcane. This regulation establishes a 
maximum permissible level for residues of novaluron in this food 
commodity. The tolerance expires and is revoked on December 31, 2009.

DATES: This regulation is effective October 20, 2006. Objections and 
requests for hearings must be received on or before December 19, 2006, 
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-2006-0815. All documents in the 
docket are listed on the regulations.gov website. 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office 

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9356; e-mail address: conrath.andrea@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:
     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 provides 
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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0815 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 on or 
before December 19, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0815, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the 
insecticide novaluron, 1-[3-chloro-4-(1,1,2-trifluoro-2-
trifluoromethoxyethoxy) phenyl]-3-[2,6-diflurobenzoyl]urea, in or on 
sugarcane, cane at 0.15 parts per million (ppm). This tolerance expires 
and is revoked on December 31, 2009. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section

[[Page 61907]]

408(e) of the FFDCA allows EPA to establish a tolerance or an exemption 
from the requirement of a tolerance on its own initiative, i.e., 
without having received any petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Novaluron on Sugarcane and FFDCA 
Tolerances

    The Applicant claims that sugarcane borer populations have recently 
increased and predator arthropod populations have decreased because of 
tidal surges as a result of Hurricanes Katrina and Rita in 2005. 
Additionally, the applicant states that the sugarcane borer developed 
resistance in some locations to the most commonly used insecticide, 
because of repeated use. Thus the applicant claims that the registered 
alternatives will not be adequate to provide control of the sugarcane 
borer in sugarcane, such that significant economic losses will be 
suffered. EPA has authorized under FIFRA section 18 the use of 
novaluron on sugarcane for control of the sugarcane borer in Louisiana. 
After having reviewed the submission, EPA concurs that emergency 
conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of novaluron in or on 
sugarcane. In doing so, EPA considered the safety standard in section 
408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance 
under section 408(l)(6) of the FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of the FFDCA. 
Although this tolerance expires and is revoked on December 31, 2009, 
under section 408(l)(5) of the FFDCA, residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
sugarcane after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether novaluron 
meets EPA's registration requirements for use on sugarcane or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of novaluron by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than Louisiana to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
novaluron, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the 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 
novaluron and to make a determination on aggregate exposure, consistent 
with section 408(b)(2) of the FFDCA, for a time-limited tolerance for 
residues of novaluron in or on sugarcane, cane at 0.15 parts per 
million (ppm). EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Endpoints

    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. Specific information on the studies received and the nature 
of the toxic 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.epa.gov/EPA-PEST/2004/June/Day-02/p12316.htm
.

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.

[[Page 61908]]

    A summary of the toxicological endpoints for novaluron used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 2, 2004 (69 FR 31013) (FRL-
7359-2).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.598) for the residues of novaluron in or on the 
following raw agricultural commodities: Apple, wet pomace at 8.0 ppm; 
Brassica, head and stem, subgroup 5A at 0.50 ppm; cattle, fat at 11 
ppm; cattle, kidney at 1.0 ppm; cattle, liver at 1.0 ppm; cattle, meat 
at 0.60 ppm; cattle, meat byproducts, except liver and kidney at 0.60 
ppm; cotton, gin byproducts at 30 ppm; cotton, undelinted seed at 0.60 
ppm; eggs at 0.05 ppm; fruit, pome, group 11 at 2.0 ppm; goat, fat at 
11 ppm; goat, kidney at 1.0 ppm; goat, liver at 1.0 ppm; goat, meat at 
0.60 ppm; goat, meat byproducts except liver and kidney at 0.60 ppm; 
hog, fat at 0.05 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 
0.01 ppm; horse, fat at 11 ppm; horse, kidney at 1.0 ppm; horse, liver 
at 1.0 ppm; horse, meat at 0.60 ppm; horse, meat byproducts, except 
liver and kidney at 0.60 ppm; milk at 1.0 ppm; milk, fat at 20 ppm; 
poultry, fat at 0.40 ppm; poultry, meat at 0.03 ppm; poultry, meat 
byproducts at 0.04 ppm; sheep, fat at 11 ppm; sheep, kidney at 1.0 ppm; 
sheep, liver at 1.0 ppm; sheep, meat at 0.60 ppm; sheep, meat 
byproducts, except liver and kidney at 0.60 ppm, and vegetables, 
tuberous and corn, subgroup 1C at 0.05 ppm. Risk assessments were 
conducted by EPA to assess dietary exposures from novaluron in food as 
follows:
    i. Acute exposure. Acute dietary 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 one 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 this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: 100% crops treated for all commodities; average 
field trial residues; empirical processing factors for apple juice 
(translated to pear juice); and DEEM\TM\ (ver 7.76) default processing 
factors for the remaining processed commodities. Furthermore, 
anticipated residues (ARs) were calculated for meat and milk 
commodities and the recommended tolerances were used for poultry 
commodities (partially refined, Tier II analysis).
    iii. Cancer. A cancer dietary exposure assessment was not conducted 
because novaluron is classified as ``not likely to be carcinogenic to 
humans.''
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the 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 chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) require 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. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such data call-ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such data call-ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for novaluron in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
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 Agency uses the First Index Reservoir Screening Tool (FIRST) 
and the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/
EXAMS) to produce estimates of pesticide concentrations in an index 
reservoir. The Screening Concentration in Ground Water (SCI-GROW) model 
is used to predict pesticide concentrations in shallow groundwater. For 
a screening-level assessment for surface water EPA will generally use 
FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    The highest concentrations of novaluron residues in surface water 
and groundwater are associated with the use on apple (0.96 lb active 
ingredient/Acre, the highest registered/proposed use rate). The 
novaluron application scenario associated with apples is higher than 
the application scenario associated with sugarcane; therefore, the 
apple data were used for modeling. In drinking water, EPA concluded 
that the parent compound and degradates chlorophenyl urea, 1-[3-chloro-
4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea and 
chloroaniline, 3-chloro-4-(1,1,2-trifluoro-2-
trifluoromethoxyethoxy)aniline are the residues of concern for risk 
assessment purposes. (Tier 2 PRZM/EXAMS) modeling was used to estimate 
drinking water concentrations for surface water for novaluron per se. 
The estimated drinking water concentration (EDWC: 1-in-10 year annual 
mean) for novaluron per se is 1.8 micrograms/Liter ([mu]g/L) (parts per 
billion (ppb)). For groundwater, the SCI-GROW model was used to predict 
a groundwater concentration for novaluron. The EDWC for novaluron per 
se is 5.5 x 10-3 [mu]g/L in drinking water from shallow 
groundwater sources.
    A Tier I drinking water analysis was performed using the FQPA FIRST 
model to obtain surface water estimates for the chlorophenyl urea and 
chloroaniline degradates. For surface water, the annual average EDWC 
for chlorophenyl urea is 0.86 [mu]g/L(ppb) and the annual average EDWC 
for chloroaniline is 2.6 [mu]g/L(ppb). The SCI-GROW model was

[[Page 61909]]

used to predict groundwater concentrations. The predicted ground water 
EDWC for chlorophenyl urea is 4.5 x 10-3 [mu]g/L, and for 
chloroaniline the EDWC is 9.0 x 10-3 [mu]g/L. These EDWC 
values are meant to represent upper-bound estimates of the 
concentrations that might be found in surface water and groundwater 
based upon novaluron uses. Of the EDWC values for the three different 
compounds (novaluron per se, and its two degradates, chlorophenyl urea 
and chloroaniline), the chronic estimate for chloroaniline is the 
highest (100% conversion from parent to aniline was assumed). This is 
consistent with the expected degradation pattern for novaluron, so the 
EDWC value for chloroaniline (2.6 ppb) was used to assess chronic 
aggregate risk, since it was the highest estimate derived and would 
represent the most conservative exposure scenario. For chronic dietary 
risk assessment, the annual average concentration of 2.6 ppb was 
directly entered into the dietary exposure model (DEEM-FCID\TM\). Since 
an acute dietary risk assessment was not needed, EECs of novaluron for 
acute exposures to surface water and ground water were not used.
    3. 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 use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to novaluron and 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 not assumed that novaluron has 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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold 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 that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure to novaluron in developmental toxicity 
studies. There is no quantitative or qualitative evidence of increased 
susceptibility to novaluron following prenatal/postnatal exposure in a 
2-generation reproduction study. EPA determined that the 10X SF to 
protect infants and children should be reduced to 1X because of the 
following reasons:
     There is no concern for developmental neurotoxicity 
resulting from exposure to novaluron. A developmental neurotoxicity 
study (DNT) study is not required.
     The toxicological database is complete for FQPA 
assessment.
     Dietary assessments are estimated based on data that 
reasonably accounts for potential exposures. The chronic dietary food 
exposure assessment uses the conservative assumption that 100% of the 
crops are treated for all commodities.
     The dietary drinking water assessment utilizes water 
concentration values generated by model and associated modeling 
parameters which are designed to provide conservative, health 
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
     There are no proposed or existing uses for novaluron which 
result in residential exposure.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against EDWCs. DWLOC values are not regulatory 
standards for drinking water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food and residential uses. In calculating a 
DWLOC, the Agency determines how much of the acceptable exposure (i.e., 
the PAD) is available for exposure through drinking water [e.g., 
allowable chronic water exposure (mg/kg/day) = cPAD - (average food + 
chronic non-dietary, non-occupational exposure)]. This allowable 
exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EDWCs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to novaluron in drinking water (when considered along with 
other sources of exposure for which OPP has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because OPP considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, OPP will reassess the potential impacts of 
novaluron on drinking water as a part of the aggregate risk assessment 
process.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surfacewater and groundwater EDWCs 
are directly incorporated into the dietary exposure analysis, along 
with food. This provides a more realistic estimate of exposure because 
actual body weights and water

[[Page 61910]]

consumption from the CSFII are used. The combined food and water 
exposures are then added to estimated exposure from residential sources 
to calculate aggregate risks. The resulting exposure and risk estimates 
are still considered to be high end, due to the assumptions used in 
developing drinking water modeling inputs.
    1. Acute risk. 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, 
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 exposure to novaluron 
from food and drinking water contributions will utilize 20% of the cPAD 
for the U.S. population, 72% of the cPAD for children 1 to 2 years old 
and 34% of the cPAD for infants less than 1 year old. There are no 
residential uses for novaluron that result in chronic residential 
exposure to novaluron. Therefore, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD.
    3. Short- and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account residential exposure plus 
chronic exposure to food and water (considered to be background 
exposure levels.) Novaluron is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which were previously 
addressed and do not exceed the Agency's levels of concern.
    4. Aggregate cancer risk for U.S. population. Novaluron is 
classified as ``not likely to be carcinogenic to humans'' based on the 
lack of evidence for carcinogenicity in mice and rats. Therefore, 
novaluron is not expected to pose a cancer risk.
    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, nor to infants and children from aggregate 
exposure to novaluron residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron 
capture detection) is available to enforce the tolerance expression. 
The method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits for novaluron, so harmonization is not an issue.

VI. Conclusion

    Therefore, the tolerance is established for residues of novaluron, 
1-[3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-[2,6-
diflurobenzoyl]urea, in or on sugarcane, cane at 0.15 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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., or 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). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175.

[[Page 61911]]

Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: October 12, 2006.
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 adding text to paragraph (b) to read 
as follows:

Sec.  180.598  Novaluron; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the fungicide novaluron, 1-[3-chloro-4-
(1,1,2-trifluoro-2-trifluoromethoxyethoxy) phenyl]-3-[2,6-
diflurobenzoyl]urea in connection with use of the pesticide under a 
section 18 emergency exemption granted by EPA. The tolerance will 
expire and is revoked on the date specified in the following table:

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    revocation
                                                million        date
------------------------------------------------------------------------
Sugarcane, cane..............................       0.15        12/31/09
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-17566 Filed 10-19-06; 8:45 am]

BILLING CODE 6560-50-S