[Federal Register Volume 71, Number 189 (Friday, September 29, 2006)]
[Rules and Regulations]
[Pages 57431-57436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15931]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0543; FRL-8092-3]


Flufenoxuron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flufenoxuron in or on apple, grape, pear, orange, and livestock 
commodities. BASF Corporation 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 September 29, 2006. Objections and 
requests for hearings must be received on or before November 28, 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-2005-0543. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The 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: Mark Suarez, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0120; e-mail address: [email protected].

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?

    In addition to accessing an electronic copy of this Federal 
Register document

[[Page 57432]]

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. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm

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-2005-0543 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 November 28, 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-2005-0543, 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

    In the Federal Register of April 19, 2006 (71 FR 20097) (FRL-7769-
5), 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 
8E4943) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.623 be amended by establishing tolerances for residues of the 
insecticide flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-
trifluoro-p-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in 
or on apple at 1 parts per million (ppm), pear at 1 ppm, orange at 0.3 
ppm, orange oil at 60 ppm, grape at 0.2 ppm, raisin at 0.8 ppm, meat at 
0.3 ppm, cattle, meat by-products at 1.5 ppm, cattle, fat at 6 ppm, 
milk at 0.6 ppm, and milk, fat at 3 ppm. That notice included a summary 
of the petition prepared by BASF Corporation, the registrant. Comments 
were received on the notice of filing. EPA's response to these comments 
is discussed in Unit IV.C.
    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 tolerances for residues of flufenoxuron, in or 
on apple (0.50 ppm); grape (0.70 ppm); grape, raisin (2.0 ppm); cattle, 
meat (0.10 ppm); cattle, fat (4.5 ppm); cattle, meat byproducts (0.50 
ppm); goat, meat (0.10 ppm); goat, fat (4.5 ppm); goat, meat byproducts 
(0.50 ppm); horse, meat (0.10 ppm); horse, fat (4.5 ppm); horse, meat 
byproducts (0.50 ppm); sheep, meat (0.10 ppm); sheep, fat (4.5 ppm); 
sheep, meat byproducts (0.50 ppm); milk (0.20 ppm); milk, fat (4.0 
ppm); orange (0.30 ppm); orange, oil (60 ppm); and pear (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 their 
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 flufenoxuron 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/opprd001/factsheets.

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.

[[Page 57433]]

    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://wwwepa.gov/oppfead1/trac/science.
    A summary of the toxicological endpoints for flufenoxuron used for 
human risk assessment is shown in Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Flufenoxuron for Use in Human Risk Assessment
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                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
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Acute Dietary (Females 13-50 years of       An end point of concern attributed to single dose effect was not
 age)                                                          identified in the database.
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Acute Dietary (General population           An end point of concern attributed to single dose effect was not
 including infants and children)                               identified in the database.
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Chronic Dietary (All populations)      NOAEL= 3.75 mg/kg/day..  FQPA SF = 1X...........  2-Generation
                                       UF = 100...............  cPAD = chronic RfD/FQPA   Reproduction Toxicity-
                                       Chronic RfD = 0.0375 mg/  SF = 0.0375 mg/kg/day.   Rat
                                        kg/day.                                          LOAEL = 14.33/16.0 (M/
                                                                                          F) mg/kg/day based on
                                                                                          decreased body weights
                                                                                          during lactation
                                                                                          during days 4-21
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Oral-All Durations (Residential)       NOAEL= 3.75 mg/kg/day..  LOC for MOE = 100......  2-Generation
                                                                                          Reproduction Toxicity-
                                                                                          Rat
                                                                                         LOAEL = 14.33/16.0 (M/
                                                                                          F) mg/kg/day based on
                                                                                          decreased body weights
                                                                                          during lactation
                                                                                          during days 4-21
----------------------------------------------------------------------------------------------------------------
Dermal-All Durations (Occupational/    Oral study.............  LOC for MOE = 100        2-Generation
 Residential)                          NOAEL= 3.75 mg/kg/day..   (Occupational).          Reproduction Toxicity-
                                       (dermal absorption rate  LOC for MOE = 100         Rat
                                        = 100%).                 (Residential).          LOAEL = 14.33/16.0 (M/
                                                                                          F) mg/kg/day based on
                                                                                          decreased body weights
                                                                                          during lactation
                                                                                          during days 4-21
----------------------------------------------------------------------------------------------------------------
Inhalation-All Durations               Oral study.............  LOC for MOE = 100        2-Generation
 (Occupational/Residential)            NOAEL= 3.75 mg/kg/day..   (Occupational).          Reproduction Toxicity
                                       (inhalation absorption   LOC for MOE = 100         Rat
                                        rate = 100%).            (Residential).          LOAEL = 14.33/16.0 (M/
                                                                                          F) mg/kg/day based on
                                                                                          decreased body weights
                                                                                          during lactation
                                                                                          during days 4-21
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                     ``Not likely to be carcinogenic to humans''
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. There are currently no 
tolerances established (40 CFR 180) for the residues of flufenoxuron. 
Risk assessments were conducted by EPA to assess dietary exposures from 
flufenoxuron 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 one-day or single exposure.
     No such effects were identified in the toxicological studies for 
flufenoxuron; 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 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: Tolerance level residues and 100% crop treated were 
assumed for all commodities.
    iii. Cancer. Flufenoxuron is classified as ``Not Likely to be 
Carcinogenic to Humans'' based on lack of evidence of carcinogenicity 
in both rats and mice carcinogenicity studies and thus an exposure 
assessment pertaining to cancer risk is unnecessary.
    2. Dietary exposure from drinking water. There is no expectation 
that residues from flufenoxuron use on imported commodities would occur 
in surface or ground water sources of drinking water. No drinking water 
assessment was conducted.
    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).
    Flufenoxuron 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 flufenoxuron and any other 
substances and flufenoxuron does not appear to

[[Page 57434]]

produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
flufenoxuron 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.

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 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. 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 was no evidence of 
increased susceptibility for flufenoxuron in the developmental toxicity 
study in rats. No adverse effects were observed in either dams or 
offspring at the limit dose. Although fetal external examination data 
were not provided in the study report and have been requested, their 
absence does not affect the current risk assessment. Evidence of 
increased susceptibility was observed in the developmental toxicity 
study in rabbits. Specifically, decreased fetal weight was observed in 
the absence of maternal toxicity; however, fetal effects were observed 
at the limit dose, and the NOAEL, which is one order of magnitude 
lower, is considered well characterized and protective of this high-
dose effect. In the 2-generation reproduction study, increased 
susceptibility of offspring was observed in the form of decreased body 
weight, since this effect was observed at a lower dose than the 
maternal NOAEL. However, a NOAEL for this effect in offspring was also 
observed, and it is considered protective of any effects at the 
offspring LOAEL. Based on this analysis, there is no concern for 
increased susceptibility of offspring following exposure to 
flufenoxuron. If adverse effects are observed after submission of fetal 
external examination data for the developmental toxicity study in rats, 
this conclusion may be revised.
    3. Conclusion. There is a complete toxicity database for 
flufenoxuron and exposure data are complete or are estimated based on 
data that reasonably account for potential exposures.
    The establishment of tolerances for flufenoxuron on imported 
commodities include consideration of the fact that: There are no 
residual uncertainties concerning pre- and post-natal toxicity and no 
neurotoxicity concerns; the chronic dietary (food + drinking water) 
exposure assessment is a conservative assessment that is based on 
reliable data and will not underestimate exposure/risk; there is no 
potential for drinking water exposure from the proposed use on imported 
commodities; there is no potential for residential exposure. 
Additionally, the EPA evaluated the quality of the toxicology and 
exposure data; and, based on these data, concluded that the FQPA SF be 
reduced to 1x. The recommendation was based on the following:
    i. There is no evidence of increased susceptibility in the 
developmental study in rats.
    ii. In the rabbit developmental study, there is evidence of 
increased susceptibility; however, the effects are well characterized 
and clear NOAELs and LOAELs are established. Since the effects occurred 
at the limit dose, the delayed fetal growth may be considered a high 
dose effect.
    iii. In the 2-generation reproduction study in rat, there is 
evidence for the increased susceptibility; however, the effects were 
well characterized, clear NOAELs and LOAELs were established for 
offspring toxicities, and the endpoints were used for risk assessment. 
Therefore, there is no residual uncertainty for pre- and/or post-natal 
susceptibility.
    iv. The toxicological database is complete for FQPA assessment.
    v. The chronic dietary food exposure assessment utilizes proposed 
tolerance level residues and assumes 100% CT information for all 
commodities. By using these screening-level assessments, actual 
exposures/risks will not be underestimated.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Because an endpoint of concern attributable to a 
single dose was not identified for flufenoxuron, it 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 
flufenoxuron from food will utilize 14% of the cPAD for the U.S. 
population, 23% of the cPAD for all infants (<1 year), and 63% of the 
cPAD for children 1-2 years. There are no residential uses for 
flufenoxuron that result in chronic residential exposure to 
flufenoxuron. EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD.
    3. Short-term risk, Intermediate-term risk. Flufenoxuron is not 
registered for use on any sites that would result in residential or 
drinking water 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. Based on lack of 
evidence of carcinogenicity in both rats and mice carcinogenicity 
studies, the chemical is considered as ``not likely to be carcinogenic 
to humans.''
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population and to infants and children from aggregate 
exposure to flufenoxuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate HPLC/ultraviolet (UV) method (SAMS 432-3) and liquid 
chromatography (LC)/mass spectrometry (MS)/MS method (BASF Method 544/
0) are available for collecting data on flufenoxuron residues in/on 
plant commodities. The limit of quantification (LOQ) for flufenoxuron 
in/on plant commodities is 0.05 ppm for the HPLC/UV method and 0.01 ppm 
for the LC/MS/MS method. Method SAMS 432-3, which is also the proposed 
enforcement method for plant commodities, has been radio-validated and 
undergone a successful independent laboratory validation (ILV) trial. 
As a successful ILV trail has already been conducted, the method has 
been forwarded to the Analytical Chemistry Branch of the Biological and 
Economics Analysis Division (ACB/BEAD) for a petition method validation 
(PMV) (Memo, J. Tyler, 8/10/05; DP 320112).

[[Page 57435]]

    Adequate HPLC/UV methods are also available for collecting data on 
flufenoxuron residues in milk (Method SAMS 486-1) and livestock tissues 
(Method SAMS 457-2). The validated LOQ for flufenoxuron is 0.01 ppm in 
milk, 0.3 ppm in fat, and 0.1 ppm in other tissues. Method SAMS 486-1, 
which is the proposed enforcement method for milk, does not require 
radio-validation (due to the similarity between the extraction 
procedures in the proposed method and the extraction procedures used in 
the metabolism studies) and has undergone a successful ILV. This method 
has been forwarded to ACB/BEAD for a PMV trial (Memo, J. Tyler, 8/10/
05; DP 320112).

B. International Residue Limits

    There are currently no established or proposed Canadian, Mexican or 
Codex maximum residue limits (MRLs) for flufenoxuron.

C. Response to Comments

    A private citizen responded to PP 8E4943. Comments were received on 
April 19, 2006 objecting to the allowance of any residues of 
flufenoxuron on food commodities. One comment was received from a 
private citizen who opposed the authorization to sell to any pesticide 
that leaves a residue on food. The Agency has received this same 
comment from this commenter on numerous previous occasions and rejects 
it for the reasons previously stated. (January 7, 2005, 70 FR 1349, 
1354; FRL-7691-4).

V. Conclusion

    Therefore, the tolerances are established for residues of 
flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-trifluoro-p-
tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in or on apple 
(0.50 ppm); grape (0.70 ppm); grape, raisin (2.0 ppm); cattle, meat 
(0.10 ppm); cattle, fat (4.5 ppm); cattle, meat byproducts (0.50 ppm); 
goat, meat (0.10 ppm); goat, fat (4.5 ppm); goat, meat byproducts (0.50 
ppm); horse, meat (0.10 ppm); horse, fat (4.5 ppm); horse, meat 
byproducts (0.50 ppm); sheep, meat (0.10 ppm); sheep, fat (4.5 ppm); 
sheep, meat byproducts (0.50 ppm); milk (0.20 ppm); milk, fat (4.0 
ppm); orange (0.30 ppm); orange, oil (60 ppm); and pear (0.50 ppm).
    The petitioner is to provide an amended analytical method, as the 
current method is not adequate for tolerance enforcement in/on plant 
commodities because confirmatory HPLC/UV analysis is not sufficiently 
distinct from the primary analytical method. The petitioner should 
revise the method to include a confirmatory analysis using LC/MS/MS, 
which has been shown to adequately detect and quantify flufenoxuron in 
BASF Method 544/0. In addition, although a successful ILV trial was 
conducted on HPLC/UV method SAMS 458- 1 using fat samples, this method 
is distinct from SAMS 457-2 and is only for the analysis of fat. 
Therefore, a separate ILV trial should be conducted on Method SAMS 457-
2 using samples of liver and muscle. Any proposed HPLC/UV method must 
also be revised to include directions for a confirmatory analysis using 
an analytical method that is distinct from the primary analytical 
method. In addition, radio-labeled method validation data are required 
for the proposed enforcement method using tissue samples from the goat 
metabolism study to ensure that the method will adequately extract 
endogenous flufenoxuron residues.

VI. 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, 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 
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, 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 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

[[Page 57436]]

Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VII. 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: August 20, 2006.
James Jones,
Director, 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 180.623 is added to read as follows:


Sec.  180.623  Flufenoxuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide, flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-
trifluoro-p-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in 
or on the following food commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple\1\.............................................               0.50
Cattle, fat\1\.......................................                4.5
Cattle, meat\1\......................................               0.10
Cattle, meat byproducts\1\...........................               0.50
Goat, fat\1\.........................................                4.5
Goat, meat\1\........................................               0.10
Goat, meat byproducts\1\.............................               0.50
Grape\1\.............................................               0.70
Grape, raisin\1\.....................................                2.0
Horse, fat\1\........................................                4.5
Horse, meat\1\.......................................               0.10
Horse, meat byproducts\1\............................               0.50
Milk.................................................               0.20
Milk, fat\1\.........................................                4.0
Orange\1\............................................               0.30
Orange, oil\1\.......................................                 60
Pear\1\..............................................               0.50
Sheep, fat\1\........................................                4.5
Sheep, meat\1\.......................................               0.10
Sheep, meat byproducts\1\............................               0.50
------------------------------------------------------------------------
\1\There are no U.S. registrations as of September 30, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional restrictions. [Reserved]
    (b) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-15931 Filed 9-28-06; 8:45 am]
BILLING CODE 6560-50-S