[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Rules and Regulations]
[Pages 49364-49368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13761]



[[Page 49364]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0216; FRL-8087-6]


Fenpyroximate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of fenpyroximate and its z-isomer in or on hop, dried cones; almond 
hulls; nut, tree, group 14; pistachio; fruit, citrus, group 10; citrus, 
dried pulp; citrus, oil; peppermint, tops; and spearmint, tops. 
Interregional Project Number 4 (IR-4) requested these tolerances 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 August 23, 2006. Objections and 
requests for hearings must be received on or before October 23, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0216. 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: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-308-3194; 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., cattleranchers 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 through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0216 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 October 23, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0216, 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 August 10, 2005 (70 FR 46444) (FRL-7729-
3), 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 
5E6943) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 
08902-3390. The petition requested that 40 CFR 180.566 be amended by 
establishing tolerances for combined residues of the insecticide/
miticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]benzoate and its Z-
isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-
4-yl)methylene]amino]oxy] methyl]benzoate, in or on almond hulls at 1.8 
parts per million (ppm); nut, tree, group 14 at 0.1 ppm; pistachio at 
0.1 ppm; fruit, citrus, group 10; citrus at 0.4 ppm, fruit, citrus, 
dried pulp at 2.5

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ppm; citrus, oil at 15 ppm; hop at 4.5 ppm; peppermint, tops at 3.0 
ppm; and spearmint, tops at 3.0 ppm. That notice included a summary of 
the petition prepared by Nichino America, the registrant. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C. below.
    Following review of the residue chemistry data, EPA determined that 
the commodity terms and tolerance levels should be revised to the 
following: Almond, hulls at 3.0 ppm; hop, dried cones at 10 ppm ; nut, 
tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; fruit, citrus, group 
10 at 0.60 ppm; fruit, citrus, dried pulp revised to read citrus, 
dried, pulp at 2.5 ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0 
ppm; and spearmint, tops at 7.0 ppm.
    Time-limited tolerances for grape, wine and hop (currently revised 
to hop, dried cones) have expired under 40 CFR 180.566(a)(1). Permanent 
tolerances have been established for these commodities; therefore, 
grape, wine and hop, dried cones will be added to 40 CFR 180.566(a)(2). 
The petitioner for hop, dried cones has requested a domestic 
registration; therefore, footnote 1 to the table in Sec.  180.566(a)(2) 
which reads ``There are no U.S. registration on hops'' has been 
removed. In addition, registrations for citrus fruits, hops, mint, tree 
nuts (including pistachio) have been deemed as conditional and are 
contingent upon submission of required additional data.
    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 combined residues of 
fenpyroximate and its z-isomer on almond, hulls at 3.0 ppm; hop, dried 
cones at 10 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 
ppm; fruit, citrus, group 10 at 0.60 ppm; citrus, dried, pulp at 2.5 
ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0 ppm; and spearmint, 
tops at 7.0 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerances follow.

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 fenpyroximate 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.regulations.gov, Docket No. EPA-HQ-OPP-2004-0174-0001, pages 2-4.

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 fenpyroximate used for 
human risk assessment is discussed at http://www.regulations.gov, 
Docket No. EPA-HQ-OPP- 2005-0216-0001; pages 14-15.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established in 40 CFR 180.566(a)(2) for the combined residues of 
fenpyroximate and its z-isomer, in or on a variety of raw agricultural 
commodities. Risk assessments were conducted by EPA to assess dietary 
exposures from fenpyroximate 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.
     An unrefined, Tier I acute dietary-exposure assessment was 
conducted for females 13 to 49 years old. The unrefined, Tier I acute 
analyses assumed that fenpyroximate residues were present in all 
commodities at tolerance levels and that 100% of all commodities 
(registered and proposed uses) are treated. Adequate processing data on 
apples, grapes, oranges and mint are available. Modified processing 
factors based on these data were used for apple juice, pear juice, 
grape juice, raisins, citrus juice (orange, grapefruit, lemon and lime) 
and mint oils (peppermint and spearmint). The Dietary Exposure 
Evaluation Model (DEEMTM) default processing factors were 
used for all other processed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Data base (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

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following assumptions were made for the chronic exposure assessments: 
An unrefined, Tier I chronic dietary exposure assessment was conducted 
for the general U.S. population, and various population subgroups. The 
unrefined, Tier I chronic analyses assumed that fenpyroximate residues 
were present in all commodities at tolerance levels and that 100% of 
all commodities (registered and proposed uses) are treated. Adequate 
processing data on apples, grapes, oranges and mint are available. 
Modified processing factors based on these data were used for apple 
juice, pear juice, grape juice, raisins, citrus juice (orange, 
grapefruit, lemon and lime) and mint oils (peppermint and spearmint). 
DEEM\TM\ default processing factors were used for all other processed 
commodities.
    iii. Cancer. Fenpyroximate is classified as ``not likely to be a 
human carcinogen.'' Therefore, a cancer dietary exposure assessment was 
not performed.
    2. Dietary exposure from drinking water. The Agency determined in 
addition to the parent compound (M-1), the M-3 metabolite should be 
included in the drinking water assessment for fenpyroximate. Based on 
the proposed application rates and the environmental fate properties of 
fenpyroximate, some surface and ground water contamination may occur. 
However, the risk of water contamination from parent compound is 
relatively low, based on its high sorption potential. Unlike parent 
compound, the sorption of the M-3 metabolite is much less, and it may 
move into water resources more readily. Environmental fate data 
indicate that parent and its Z-isomer are stable to photolysis in soil 
and immobile in soil. Major degradates formed in the aqueous layer were 
M-3 (50%), M-8 (36%), M-16 (4-hydroxymethylbenzoic acid, 58%) and M-11 
(25 to 30%), and M-3 (>10%), M-11 (25 to 30%) and M8 (16 to 19%) in the 
soil. However, data from a field dissipation study showed M3 (32%) 
being the only significant degradate found in the field. Based on the 
structural similarity between parent and M-3, the Agency concluded that 
parent and M-3 be included in the risk assessment.
     Based on Tier II screening-level surface water modeling for 
drinking water, the Agency estimated concentrations in surface water to 
be used for acute, chronic non-cancer, and cancer exposure assessment. 
Tier II surface water concentrations for parent fenpyroximate and M-3 
were calculated using the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM-EXAMS). The acute, and chronic non-cancer 
concentrations for GA pecan (highest exposure) are 12.9 and 1.8 
microgram/liter, respectively. EPA used the Screening Concentration in 
Ground Water model (SCI-GROW2) to estimate a groundwater concentration 
of 0.059 parts per billion (ppb). These results for both surface water 
and ground water are consistent with the fate and transport properties 
of fenpyroximate.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID). For the acute 
assessment, the peak concentration of 12.9 ppb was used to access the 
contribution to drinking water; for the chronic assessment, the annual 
mean value of 1.8 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). Fenpyroximate 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 fenpyroximate and any other substances and fenpyroximate 
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 fenpyroximate 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 Web site 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 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. The rat and rabbit 
developmental-toxicity studies were tested at doses that produced 
minimal maternal toxicity at best. These doses were supported partly by 
range finding data. The two generation reproductive-toxicity study 
indicated that maternal (decreased body weight) and offspring toxicity 
(decreased lactational weight gain) occurred at the same dose, 
suggesting no evidence of sensitivity or susceptibility. Reproductive 
parameters were not affected in this 2-generation reproduction study. 
There are no neurotoxicity studies other than a negative delayed acute-
neurotoxicity study in the hen. There was no indication of 
neurotoxicity present in any of the existing subchronic or chronic 
toxicity studies. The toxicology data base is complete for FQPA 
purposes and that there are no residual uncertainties for prenatal/
postnatal toxicity.
    3. Conclusion. There is a complete toxicity data base for 
fenpyroximate and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be changed to 1X 
for the following reasons:
    i. There are no concerns or residual uncertainties for prenatal or 
postnatal toxicity.
    ii. The toxicological data base is complete for the assessment of 
toxicity and susceptibility following prenatal and/or postnatal 
exposures. No clinical

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signs of neurotoxicity or neuropathology were observed in the data 
base.
    iii. There are no residual concerns regarding completeness of the 
exposure data base.
    iv. The dietary food exposure assessment is Tier I, screening 
level, which is based on tolerance level residues and assumes 100% of 
all crops will be treated with fenpyroximate. By using these screening-
level assessments, actual exposures/risks will not be underestimated.
    v. The dietary drinking water assessment utilizes water 
concentration values generated by models and associated modeling 
parameters which are designed to provide conservative, health-
protective, high-end estimates of water concentrations which will not 
likely be exceeded.
    vi. There are currently no registered or proposed residential uses 
of fenpyroximate.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An unrefined, acute dietary-exposure assessment was 
conducted for females 13 to 49 years old. Since an effect of concern 
attributable to a single dose in toxicity studies was not identified 
for the general U.S. population, an acute dietary-exposure assessment 
was not performed for this population. Using the exposure assumptions 
discussed in this unit for acute exposure, the acute dietary exposure 
from food and water to fenpyroximate will occupy 6.8% of the acute 
population adjusted dose (aPAD) for females 13 years and older. EPA 
does not expect the aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenpyroximate from food and water will utilize 9.8% of the chronic 
adjusted population dose (cPAD) for the U.S. population, 20% of the 
cPAD for all infants < 1 year old, and 34% of the cPAD for children 1 
to 2 years old. There are no residential uses for fenpyroximate that 
result in chronic residential exposure to fenpyroximate. Therefore, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD.
    3. Aggregate cancer risk for U.S. population. Fenpyroximate has 
been classified as not likely to be carcinogenic to humans. Therefore, 
fenpryroximate is expected to pose at most a negligible cancer risk.
    4. 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An enforcement method has been developed which involves extraction 
of fenpyroximate from crops with acetone, filtration, partitioning and 
cleanup, and analysis by gas chromatography using a nitrogen/
phosphorous detector. This method allows detection of residues at or 
above the proposed tolerances. The method has undergone independent 
laboratory validation.

B. International Residue Limits

    Codex maximum residue limits (MRLs) are established for residues of 
fenpyroximate per se in/on apple, grapes, hops, oranges, and cattle 
commodities. The Codex MRLs differ from the proposed and established 
tolerances for all commodities except hops. Harmonization with the 
other Codex MRLs is not possible because the U.S. tolerance expressions 
include additional metabolites/isomers. There are currently no 
established Canadian or Mexican MRLs.

C. Response to Comments

    Comments were received from a private citizen in Florham Park, New 
Jersey. The comments were in response to the notice of filing published 
in the Federal Register of August 10, 2005 (70 FR 46444) (FRL-7729-3). 
The commenter opposes the establishment of any food tolerances (greater 
than zero) and exemptions. However, under the existing legal framework 
provided by section 408 of the FFDCA, EPA is authorized to establish 
pesticide tolerances or exemptions where persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. The commenter also believes 
IR-4 and Rutgers University are profiteering, and expressed concerns 
about the Agency's partnership with IR-4. This comment was earlier 
addressed in the Federal Register of June 30, 2005 (70 FR 37683) (FRL-
7718-3).

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene] amino]oxy]methyl]benzoate and its Z-isomer, 
(Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene] amino]oxy]methyl]benzoate, in or on almond, hulls at 3.0 
ppm; hop, dried cones at 10 ppm; nut, tree, group 14 at 0.10 ppm; 
pistachio at 0.10 ppm; fruit, citrus, group 10 at 0.60 ppm; citrus, 
dried, pulp at 2.5 ppm; citrus, oil at 10 ppm; peppermint, tops at 7.0 
ppm; and spearmint, tops at 7.0 ppm.

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

[[Page 49368]]

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 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 11, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.


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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


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2. Section 180.566 is amended by removing paragraph (a)(1), by 
redesignating paragraph (a)(2) as paragraph (a)(1), by revising the 
table in newly redesignated paragraph (a)(1), and by redesignating 
paragraphs (a)(3) and (a)(4) as paragraphs (a)(2) and (a)(3), 
respectively, to read as follows:


Sec.  180.566   Fenpyroximate; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................             3.0
Citrus, dried pulp......................................             2.5
Citrus, oil.............................................              10
Cotton, gin byproducts..................................              10
Cotton undelinted seed..................................            0.10
Fruit, citrus, group 10.................................            0.60
Fruit, pome, group 11...................................            0.40
Grape...................................................             1.0
Hop, dried cones........................................              10
Nut, tree, group 14.....................................            0.10
Peppermint, tops........................................             7.0
Pistachio...............................................            0.10
Spearmint, tops.........................................             7.0
------------------------------------------------------------------------

* * * * *

[FR Doc. E6-13761 Filed 8-22-06; 8:45 am]
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