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[Federal Register: April 5, 2006 (Volume 71, Number 65)]
[Rules and Regulations]
[Page 17009-17014]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ap06-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0525; FRL-7756-8]

Novaluron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
novaluron in or on brassica, head and stem, subgroup 5A. Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective April 5, 2006. Objections and
requests for hearings must be received on or before June 5, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0525. All documents are listed on
the http://www.regulations.gov web site. (EDOCKET, EPA's electronic
public docket and comment system was replaced on November 25, 2005, by
an enhanced federal-wide electronic docket management and comment
system located at http://www.regulations.gov/. Follow the on-line
instructions.) Although listed in the index, some information is not
publicly available, i.e., 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 electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket
facility is open 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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 and Other
Related Information?
In addition to using EDOCKET http://www.epa.gov/edocket/, you may
access

[[Page 17010]]

this Federal Register document electronically through the EPA Internet
under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180 is
available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. II. Background and Statutory Findings
In the Federal Register of January 18, 2006 (71 FR 2927) (FRL-7756-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E6834) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ
08902-3390. The petition requested that 40 CFR 180.598 be amended by
establishing a tolerance 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 brassica, head
and stem, subgroup 5A at 0.50 parts per million (ppm). That notice
included a summary of the petition prepared by Makhteshim-Agan of North
America, Inc., the registrant. There were no comments received in
response to the notice of filing.
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. . . .''
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.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of novaluron on
brassica, head and stem, subgroup 5A at 0.50 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance 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. 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.

B. Toxicological Endpoints

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.
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 theFederal Register of June 2, 2004 (69 FR 31013) (FRL-7359-2).

C. 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;
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. 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 Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated

[[Page 17011]]

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 was 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.
Tier 2 Pesticide Root Zone Model/Exposure Analysis Modeling System
(PRZM/EXAMS) modeling was performed to estimate drinking water
concentrations for surface water for novaluron per se. The scenarios
were selected to provide high-end drinking water concentrations for
each crop and represent the geographic locations where the specific
crops are grown in large quantities.
The most-conservative estimates were obtained for airblast
applications to Pennsylvania apples at the maximum annual application
rate of 0.96 pound active ingredient/acre (lb a.i./acre), applied three
times at 0.32 lb a.i./acre with an interval between applications of 10
days.
For surface water, the 1-in-10 year annual mean estimated drinking
water concern (EDWC) for the parent novaluron is 1.8 micrograms/Liter
([mu]g/L) (ppb).
A Tier I drinking water analysis was performed for the chlorophenyl
urea and chloroaniline degradates. The FQPA Index Reservoir Screening
Tool (FIRST) model was used to obtain surface water estimates. As a
conservative assumption, the model assumed chlorophenyl urea was
directly applied, i.e., as granular, to the field, assuming no spray
drift and no foliar interception. The FIRST model estimates a peak and
an annual average value based on the Index Reservoir scenario.
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). Both of these estimates are based upon the maximum
application rate in apples.
For ground water, the screening concentration in ground water (SCI-
GROW) model was used to predict a ground water concentration for
novaluron at the annual application rate of 0.96 lb a.i./acre (i.e.,
three applications of 0.32 lb a.i./acre). The estimate for the parent
novaluron is 5.5 x 10-\3\ [mu]g/L in drinking water from
shallow ground water sources. For the chlorophenyl urea degradate, the
predicted ground water concentration is 4.5 x 10-\3\ [mu]g/
L, and for the chloroaniline degradate the concentration is 9.0 x
10-\3\ [mu]g/L. These concentrations were estimated with the
same assumptions used for surface water modeling, and may be considered
as both the peak and annual average upper bound exposures.
These EDWC values are meant to represent upper-bound estimates of
the concentrations that might be found in surface water and ground
water based upon existing and proposed uses. Of the three EDWC values,
chronic estimates for the terminal metabolite, chloroaniline are the
highest (100% conversion from parent to aniline was assumed). This is
consistent with the expected degradation pattern for novaluron.
Therefore, the EDWC value for the chloroaniline degradate (2.6 ppb) was
used to assess chronic aggregate risk.
Based on the FIRST, PRZM/EXAMS, and SCI-GROW models, the estimated
environmental concentrations (EECs) of novaluron for acute exposures
are estimated to be 1.8 parts per billion (ppb) for novaluron, and 2.6
ppb for the chloroaniline degradate for surface water, respectively.
The EECs for chronic exposures are estimated to be 2.6 ppb surface
water and 0.009 ppb ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For chronic
dietary risk assessment, the annual average concentration of 2.6 ppb
was used to access 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 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/.

[[Page 17012]]

D. Safety Factor for Infants and Children

1. In general. Section 408 of 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 data base on toxicity and exposure
unless EPA determines based on reliable data 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
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.

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% crops
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.

E. 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. The DWLOC values are not
regulatory standards for drinking water, but 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 population adjusted dose (PAD)) is
available for exposure through drinking water e.g., allowable chronic
water exposure milligrams/kilogram/day (mg/kg/day) = chronic PAD -
(average food + residential 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 EPA's 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). 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 ground water are less than the
calculated DWOCs, EPA can conclude with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposures for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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. When new
uses are added, EPA reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate 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 surface water and ground water
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 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 plus water will utilize 20% of the cPAD for the U.S.
population, 33% of the cPAD for infants < 1 year old, and 71% of the
cPAD for children 1-2 years old. There are no residential uses for
novaluron. Therefore, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD.

3. Short-term risk/intermediate-term risk.Short and intermediate-
term aggregate exposures take into account residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level). 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 do not exceed the
Agency's level 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.

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, and to infants and children from aggregate
exposure to novaluron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology Gas Chromatography/Electron
Capture Detection (GC/EDC) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch,

[[Page 17013]]

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 (MRLs) for novaluron.

V. Conclusion

Therefore, the tolerance is 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 brassica, head
and stem, subgroup 5A at 0.50 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0525 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 June 5, 2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described inADDRESSES. Mail your copies,
identified by docket ID number OPP-2005-0525, to: Public Information
and Records Integrity Branch, Information Technology and Resource
Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 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, entitledFederal 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
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. 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, entitledFederalism
(64 FR 43255,

[[Page 17014]]

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 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 (59 FR 22951, 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. 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 theFederal 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: March 27, 2006.
Losi Rossi,
Director, Registration Division, Office of Pesticide Programs.
• Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180.598 is amended by alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *