Document ID: EPA-HQ-OPP-2009-0166-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Novaluron
Posted Date: 2009-05-06T04:00Z

[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Rules and Regulations]               
[Page 20887-20892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my09-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0166; FRL-8409-8]

 
Novaluron; Pesticide Tolerances for Emergency Exemptions

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 strawberry. 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 strawberries. This regulation establishes a 
maximum permissible level for residues of novaluron in this food 
commodity. The time-limited tolerance expires and is revoked on 
December 31, 2011.

DATES: This regulation is effective May 6, 2009. Objections and 
requests for hearings must be received on or before July 6, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0166. All documents in the 
docket are listed in the docket index available in http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: ertman.andrew@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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
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-
2009-0166 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 July 6, 2009.
    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

[[Page 20888]]

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-2009-0166, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a 
time-limited 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 strawberries at 0.50 parts per million (ppm). This time-
limited tolerance expires and is revoked on December 31, 2011. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerances from the CFR.
    Section 408(l)(6) of 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 time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of 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 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. . . 
.''
    Section 18 of 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.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Novaluron on Strawberries and FFDCA 
Tolerances

    The Florida Department of Agriculture and Consumer Services (FDACS) 
requested the use of novaluron through an emergency exemption to 
control sap beetles on strawberries. According to the FDACS, sap 
beetles are a zero tolerance pest. The presence of larvae in a ripe 
strawberry can lead to the rejection of the entire shipment. The FDACS 
stated that even with the currently available insecticides this pest is 
not adequately controlled as growers have experienced up to 25 percent 
yield loss due to load rejection. After having reviewed the submission, 
EPA determined that emergency conditions exist for this State, and that 
the criteria for an emergency exemption are met. EPA has authorized 
under FIFRA section 18 the use of novaluron on strawberries for control 
of sap beetles in Florida.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of novaluron in 
or on strawberries. In doing so, EPA considered the safety standard in 
section 408(b)(2) of FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of 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 FFDCA. Although 
this time-limited tolerance expires and is revoked on December 31, 
2011, under section 408(l)(5) of FFDCA, residues of the pesticide not 
in excess of the amounts specified in the tolerance remaining in or on 
strawberries after that date will not be unlawful, provided the 
pesticide was applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by this time-limited 
tolerance at the time of that application. EPA will take action to 
revoke this time-limited 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 time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
novaluron meets FIFRA's registration requirements for use on 
strawberries or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision 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 persons in any State 
other than Florida to use this pesticide on this crop under FIFRA 
section 18 absent the issuance of an emergency exemption applicable 
within that State. 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

    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

[[Page 20889]]

give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for residues of novaluron on strawberries 
at 0.50 ppm. EPA's assessment of exposures and risks associated with 
establishing time-limited tolerances follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for novaluron used for 
human risk assessment can be found at http://www.regulations.gov in 
document Novaluron; Human Health Risk Assessment for the Proposed Use 
in/on Strawberry, pages 9-10 in docket ID number EPA-HQ-OPP-2009-0166.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to novaluron, EPA considered exposure under the time-limited 
tolerances established by this action as well as all existing novaluron 
tolerances in 40 CFR 180.598. EPA assessed dietary exposures from 
novaluron in food as follows:
    i. Acute exposure. No acute effects were identified in the 
toxicological studies for novaluron; therefore, a quantitative acute 
dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA incorporated anticipated residues (average field trial residues) 
for some commodities, including strawberries; empirical processing 
factors for apple juice (translated to pear juice), tomato puree and 
tomato paste; and Dietary Exposure Evaluation Model (DEEM) (ver 7.81) 
default processing factors for the remaining processed commodities. In 
estimating dietary exposure from secondary residues in livestock, EPA 
relied on anticipated residues for meat and milk commodities but used 
tolerance-level residues for poultry commodities. 100 percent crop 
treated (PCT) was assumed for all existing and new uses of novaluron.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA has classified novaluron as ``not likely to be 
carcinogenic to humans;'' therefore, a quantitative cancer exposure 
assessment is unnecessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such data call-ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water are novaluron and its chlorophenyl urea and 
chloroaniline degradates. The Agency used screening level water 
exposure models in the dietary exposure analysis and risk assessment 
for novaluron and its degradates in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of novaluron. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
novaluron, chlorophenyl urea and chloroaniline for chronic exposures 
for non-cancer assessments are estimated to be 1.8 parts per billion 
(ppb), 0.86 ppb and 2.6 ppb, respectively, for surface water and 0.0055 
ppb, 0.0045 ppb and 0.0090 ppb, respectively, for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The highest drinking water 
concentrations were estimated for surface water. Of the three EDWC 
values for surface water, the chronic EDWC for the terminal metabolite, 
chloroaniline, is the highest (assuming 100 percent molar 
conversionfrom parent to aniline). This is consistent with the expected 
degradation pattern for novaluron. Therefore, for chronic dietary risk 
assessment, the water concentration value for chloroaniline of 2.6 ppb 
was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 20890]]

    Novaluron is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and`` other substances 
that have a common mechanism of toxicity.''
    EPA has not found novaluron to share a common mechanism of toxicity 
with any other substances, and novaluron does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that novaluron does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see 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(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for novaluron includes rat and rabbit prenatal 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. There was no evidence of increased quantitative or 
qualitative susceptibility following in utero exposure of rats or 
rabbits in the developmental toxicity studies and no evidence of 
increased quantitative or qualitative susceptibility of offspring in 
the reproduction study. Neither maternal nor developmental toxicity was 
seen in the developmental studies up to the limit doses. In the 
reproduction study, offspring and maternal toxicity (increased absolute 
and relative spleen weights) were similar and occurred at the same 
dose; and reproductive effects (decreases in epididymal sperm counts 
and increased age at preputial separation in the F1 
generation) occurred at a higher dose than that which resulted in 
maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for novaluron is complete, except for 
immunotoxicity testing. EPA began requiring functional immunotoxicity 
testing of all food and non-food use pesticides on December 26, 2007. 
Since this requirement went into effect after the tolerance petition 
was submitted, these studies are not yet available for novaluron. In 
the absence of specific immunotoxicity studies, EPA has evaluated the 
available novaluron toxicity data to determine whether an additional 
database uncertainty factor is needed to account for potential 
immunotoxicity. There was no evidence of adverse effects on the organs 
of the immune system at the LOAEL in any study novaluron. In addition, 
novaluron does not belong to a class of chemicals (e.g., the 
organotins, heavy metals, or halogenated aromatic hydrocarbons) that 
would be expected to be immunotoxic. Based on the considerations in 
this Unit, EPA does not believe that conducting a special series 
870.7800 immunotoxicity study will result in a point of departure less 
than the NOAEL of 0.011 mg/kg/day used in calculation the cPAD for 
novaluron, and therefore, an additional database uncertainty factor is 
not needed to account for potential immunotoxicity.
    ii. There were signs of neurotoxicity in the acute neurotoxicity 
study in rats, including clinical signs (piloerection, fast/irregular 
breathing), functional observation battery (FOB) parameters (head 
swaying, abnormal gait) and neuropathology (sciatic and tibial nerve 
degeneration). However, the signs observed were not severe and were 
seen only at the limit dose (2,000 mg/kg/day); further, the 
neuropathological effects that were seen at the limit dose also 
occurred in a few untreated control animals. No signs of neurotoxicity 
or neuropathology were observed in the subchronic neurotoxicity study 
in rats at doses up to 1,752 mg/kg/day in males, and 2,000 mg/kg/day in 
females or in any other subchronic or chronic toxicity study in rats, 
mice or dogs, including the developmental and reproduction studies. 
Therefore, novaluron does not appear to cause significant neurotoxicant 
effects, and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that novaluron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level or anticipated residues derived from 
reliable residue field trials. EPA made conservative (protective) 
assumptions in the ground water and surface water modeling used to 
assess exposure to novaluron in drinking water. Residential exposures 
are not expected. These assessments will not underestimate the exposure 
and risks posed by novaluron.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified, therefore, no acute dietary endpoint was selected. 
Therefore, novaluron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
novaluron from food and water will utilize 76% of the cPAD for children 
1-2 years old, the population group receiving the greatest

[[Page 20891]]

exposure. There are no residential uses for novaluron.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Novaluron is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term aggregate risk is 
the sum of the risk from exposure to novaluron through food and water 
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Novaluron is not registered for any use patterns that would result 
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to novaluron 
through food and water, which has already been addressed, and will not 
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Novaluron has been 
classified as ``not likely to be carcinogenic to humans'' and therefore 
is not expected to pose a cancer risk to humans.
    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, or to infants and children, from aggregate 
exposure to novaluron residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (a gas chromatography/electron- 
capture detection (GC/ECD) method; and a high pressure liquid 
chromatography/ultraviolet detection (HPLC/UV) method)) are available 
to enforce the tolerance expression. The methods may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX residue limits for residues of novaluron on 
strawberry.

VI. Conclusion

    Therefore, a time-limited 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 strawberry at 0.50 ppm. This tolerance expires and is revoked 
on December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under sections 408(e) and 
408(l)(6) of FFDCA in response to a petition submitted to the Agency. 
The Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). Because this final 
rule has been exempted from review under Executive Order 12866, this 
final rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it 
require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: April 28, 2009.
Daniel J. Rosenblatt,
Acting 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 revising paragraph (b) to read as 
follows:

Sec.  180.598  Novaluron; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established 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 the

[[Page 20892]]

specified agricultural commodities, resulting from use of the pesticide 
pursuant to FFIFRA section 18 emergency exemptions. The tolerances 
expire and are revoked on the date specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Strawberry........................               0.50           12/31/11
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-10499 Filed 5-5-09; 8:45 am]

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