[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Rules and Regulations]
[Pages 72958-72963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24983]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0309; FRL-8342-8]


Etoxazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on cherry; hop, dried cones; and vegetable, cucurbit 
subgroup 9A. The Interregional Research Project No. 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 26, 2007. Objections and 
requests for hearings must be received on or before February 25, 2008, 
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-2007-0309. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; 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

[[Page 72959]]

not limited to those engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to 
provide 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 EPA's tolerance regulations at 
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 FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. 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-2007-0309 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 as required by 40 CFR part 178 on or 
before February 25, 2008.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2007- 0309, 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'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. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), 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 
6E7150) by the IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.593 be amended by 
establishing a tolerance for residues of the insecticide etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on cherry at 0.70 parts per million (ppm), hops, 
dried cones, at 7.0 ppm, and melon subgroup 9A at 0.15 ppm. That notice 
referenced a summary of the petition prepared by Valent U.S.A. 
Corporation, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon current data supporting the petition, EPA has corrected 
the commodity definition and revised proposed tolerance levels as 
follows:
    1. For commodity cherry, a revised tolerance at 1.0 ppm from 0.70 
ppm; and
    2. For the melon subgroup, the crop definition has been changed 
from ``melon subgroup 9A'' to ``vegetable, cucurbit subgroup 9A'' and 
the tolerance revised from 0.15 to 0.20 ppm.

III. 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 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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and 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 for the petitioned-for tolerance 
for residues of in or on cherry, sweet at 0.60 ppm, cherry, tart at 
0.20 ppm, hop, dried cones, at 5.0 ppm, and vegetable, cucurbit 
subgroup 9A at 0.15 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 adverse effects caused by etoxazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can

[[Page 72960]]

be found at http://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under Docket : EPA-HQ-OPP-2007-0309 and is identified in that 
docket as PP 6E7150; Revised: Etoxazole in/on Cherries, Hops, and Melon 
Subgroup 9A; Health Effects Division (HED) Risk Assessment.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC 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 
risks by comparing aggregate 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 LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for etoxazole used for 
human risk assessment can be found at http://www.regulations.gov in 
document PP: 6E7150. Revised: Etoxazole in/on Cherries, Hops, 
and Melon Subgrou 9A. Health Effects Division (HED) Risk Assessment in 
docket ID number EPA-HQ-OPP-2007-0309.

C. Exposure Assessment

    Dietary exposure from food and feed uses. In evaluating dietary 
exposure to etoxazole, EPA considered exposure under the petitioned-for 
tolerances as well as all existing etoxazole tolerances in (40 CFR 
180.593 EPA assessed dietary exposures from etoxazole in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    An endpoint of concern attributable to a single oral dose was not 
selected for either the general U.S. population (including infants and 
children) or the females 13-50 years old population subgroup for 
etoxazole. The EPA evaluated the suitability of the developmental 
toxicity study in rabbits in which the developmental NOAEL of 200 mg/
kg/day is based upon increased incidences of 27 presacral vertebrae and 
27 presacral vertebrae with 13th ribs (skeletal variations) in the 
fetuses at the LOAEL of 1,000 mg/kg/day (limit dose). Although these 
developmental effects may be attributed to a single dose, the EPA 
concluded that etoxazole is unlikely to pose an acute risk because 
these effects are minor in magnitude and were observed only at the 
limit dose (1000 mg/kg/day). Therefore, an acute dietary exposure 
assessment was not performed .
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID, Version 2.03), which incorporates 
consumption data from United States Department of Agriculture's 
(USDA's) Continuing Surveys of Food Intakes by Individuals (CSFII), 
1994-1996 and 1998. The 1994-96, 1998 data are based on the reported 
consumption of more than 20,000 individuals over two non-consecutive 
survey days. Foods ``as consumed'' (e.g., apple pie) are linked to EPA-
defined food commodities (e.g. apples, peeled fruit - cooked; fresh or 
N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using 
publicly available recipe translation files developed jointly by USDA/
ARS and EPA. Consumption data are averaged for the entire U.S. 
population and within population subgroups for chronic exposure 
assessment.
    An unrefined, chronic dietary exposure assessment was conducted for 
the general U.S. population and various population subgroups using EPA-
calculated residues of concern (parent and metabolites) for livestock 
commodities and tolerance-level residues for all other commodities. For 
all registered and proposed uses, 100% crop treated (CT) information 
was used, as well as DEEM 7.81 default processing factors for all 
commodities other than apple and grape (apple and grape residue data 
showed that there was no concentration in processed commodities; 
therefore; these default values were set to 1).
    iii. Cancer. EPA classified etoxazole as ``not likely to be 
carcinogenic to humans''. This decision was based on the lack of 
carcinogenicity in two studies in mice, lack of carcinogenicity in one 
study in rats, and the lack of hormonal and reproductive effects in 
special studies. Etoxozole is not a mutagen. Therefore, an exposure 
assessment related to cancer risk was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for etoxazole in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
etoxazole. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The Agency conducted Tier 1 estimated drinking water concentrations 
(EDWCs) for etoxazole in assessing water exposure. Environmental fate 
data indicate that parent (etoxazole) has low mobility and relatively 
low persistence in soil. The major route of degradation based on the 
label use pattern will likely be aerobic soil degradation. Based on the 
aerobic soil metabolism study, Metabolite R-8 was found as a major 
degradate in 4 out of 5 soils tested, with a maximum of 38% of the 
applied dose. Metabolite R-8 is mobile and relatively persistent and 
could be available for runoff and leaching for periods of up to months. 
Metabolite R-13 was also found as a major degradate in 3 out of 5 soils 
tested, with a maximum of 30.0% (at 62 days) in an aerobic soil 
metabolism study. Based on submitted mobility data, Metabolite R-13 
appears to be immobile. The Agency believes that metabolites R-8 and R-
13 are likely to have similar toxicity to the parent; and, therefore, 
should be included in the drinking water assessment. Metabolites R-4 
and R-7 were also found in aerobic soil dissipation studies, but less 
frequently. EPA concluded that the

[[Page 72961]]

inclusion of Metabolite R-8 should cover the exposure from R-4 and R-7. 
In summary, the Agency finds that for drinking water risk assessment, 
the residues of concern are parent, Metabolite R-8, and Metabolite R-
13.
    FQPA Index Reservoir Screening Tool (FIRST) and Screening 
Concentrations In Ground Water (SCI-GROW) models were used to calculate 
the chronic surface water and groundwater EDWCs (parent and 
metabolites), respectively. Drinking water was incorporated directly in 
the dietary assessment using the acute concentration for surface water 
generated by the FIRST model. Tier 1 EDWCs results for etoxazole and 
metabolites R-8 and R-13 show annual average surface water 
concentrations of 0.332 parts per billion (ppb), 0.913 ppb and 0.0285 
ppb, respectively. Tier 1 EDWCs results for etoxazole and metabolites 
R-8 and R-13 show ground water concentrations of 0.00173ppb, 0.316 ppb 
and 0.000322 ppb, respectively.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the total sum of the annual average surface water 
concentrations for etoxazole and metabolites R-8 and R-13 of 1.27 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).
    Etoxazole is not registered for use in or 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 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 etoxazole and any other 
substances and etoxazole 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 etoxazole 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 
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 (``10X'') 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. This additional 
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. No quantitative or 
qualitative evidence of increased susceptibility was seen following in 
utero exposure to rats or rabbits in developmental studies. Offspring 
toxicity was more severe (pup mortality) than maternal toxicity 
(increased liver and adrenal weights) at the same dose in the rat 
reproduction study.
    Since there is qualitative evidence of increased susceptibility 
following exposure to etoxazole in the rat reproduction study, the EPA 
performed a Degree-of-Concern Analysis to:
    i. Determine the LOC for the effects observed when considered in 
the context of all available toxicity data; and
    ii. Identify any residual uncertainties after establishing toxicity 
endpoints and traditional uncertainty factors to be used in the risk 
assessment of this chemical. There is evidence of increased qualitative 
susceptibility in the rat reproduction study, but the concern is low 
since:
    a. The effects in pups are well-characterized with a clear NOAEL;
    b. The pup effects occur at the same dose as maternal toxicity; 
and,
    c. The doses selected for various risk assessment scenarios are 
lower than the doses that caused off spring toxicity.
    Therefore, there are no residual uncertainties for pre-/post-natal 
toxicity in this study.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for etoxazole is complete for FQPA 
assessment.
    ii. There is no indication that etoxazole is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. No quantitative or qualitative evidence of increased 
susceptibility was seen following in utero exposure to rats or rabbits 
in developmental studies. Although there is qualitative evidence of 
increased susceptibility in the rat reproduction study, the Agency did 
not identify any residual uncertainties after establishing toxicity 
endpoints and traditional UFs to be used in the risk assessment of 
etoxazole. The degree of concern for prenatal and/or postnatal toxicity 
is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment utilizes EPA-
calculated residues of concern (parent and metabolites) for livestock 
commodities; tolerance-level residues for other commodities; and 100% 
crop treated (CT) information for all proposed uses. By using these 
screening-level assumptions, actual exposures/risks will not be 
underestimated. The dietary drinking water assessment utilized modeling 
results which included conservative assumptions for the parent and all 
degradates of concern. Conservative assumptions were used in the water 
models. Therefore, the water exposure assessment will not underestimate 
the potential risks for infant and children.
    v. There are no registered or proposed residential uses for 
etoxazole.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC 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 was not performed 
because an endpoint of concern attributable to a single oral dose was 
not selected for any population subgroup (including infants

[[Page 72962]]

and children). No acute risk is expected from exposure to etoxazole.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to etoxazole 
from food and water will utilize 8.3% of the cPAD for children 1-2 
years old, the most highly exposed population subgroup. There are no 
residential uses for etoxazole that result in chronic residential 
exposure to etoxazole. Therefore, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Etoxazole is not registered or proposed for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's LOC.
    4. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was not performed because etoxazole is not 
carcinogenic. Etoxazole is not expected to pose a cancer risk 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, or to infants and children from aggregate 
exposure to etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression.
    The following analytical enforcement methods have been validated: 
The gas chromatography/mass-selective detector (GC/MSD) method used to 
determine etoxazole residues in/on cherry matrices is a slightly 
modified version of a previously-validated method (Method RM-37HM). The 
validated limit of quantitation (LOQ) was 0.0037 ppm and the limit of 
detection (LOD) was 0.0012 ppm for etoxazole in/on cherries. The GC 
with nitrogen-phosphorus detector (NPD) method used to determine 
etoxazole residues in/on hop matrices is a modified version of a 
previously-validated method (Method RM-37). The validated LOQ was 0.2 
ppm and the LOD was 0.1 ppm for etoxazole in/on dried hop cones.The 
nitrogen-phosphorus specific flame-ionization detector (NPD) method 
used to determine etoxazole residues in/on cantaloupe matrices is a 
slightly modified version of a previously-validated method (Method RM-
37). The validated LOQ was 0.0046 ppm and the LOD was 0.0015 ppm for 
etoxazole in/on cantaloupe.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
maximum residue limits (MRLs) for etoxazole.
    Therefore, tolerances are established for residues of the 
insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-
2-ethoxyphenyl]-4,5-dihydrooxazole, in or on cherry at 1.0 ppm, hop, 
dried cones at 7.0 ppm, and vegetable, cucurbit subgroup 9A at 0.20 
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, 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) 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 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.
    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 6, 2000) do not apply to this rule. In addition, This 
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).

VII. 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: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 72963]]

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 180.593 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cherry...............................................                1.0
                                * * * * *
Hop, dried cones.....................................                7.0
                                * * * * *
Vegetable, cucurbit subgroup 9A......................               0.20
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-24983 Filed 12-21-07; 8:45 am]
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