[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]
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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
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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