Document ID: EPA-HQ-OPP-2008-0554-0004
Agency: epa
Document Type: Rule
Title: Etoxazole; Pesticide Tolerances
Posted Date: 2009-05-27T04:00Z

[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Rules and Regulations]               
[Page 25156-25161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my09-5]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0554; FRL-8413-5]

 
Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on stone fruit; plum; prune; spearmint tops and oil; 
peppermint tops and oil; tomato; and cucumber. This regulation also 
deletes the existing cherry tolerance, as it will be superseded by 
inclusion in the stone fruit crop group. The Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 27, 2009. Objections and 
requests for hearings must be received on or before July 27, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0554. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather 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 electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

[[Page 25157]]

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2008-0554 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 July 27, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
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-2008-0554, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of August 13, 2008 (73 FR 47186) (FRL-8375-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7347) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W., Princeton, NJ 08540. The petition 
requested that 40 CFR 180.593 be amended by establishing tolerances for 
residues of the insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-
(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on fruit, 
stone, group 12, except plum at 1.0 parts per million (ppm); plum at 
0.12 ppm; plum, prune, dried at 0.4 ppm; cucumber at 0.02 ppm; tomato 
at 0.25; spearmint, tops at 10 ppm; peppermint, tops at 10 ppm; 
peppermint, oil at 20 ppm; and spearmint, oil at 20 ppm. The petition 
additionally requested to delete the tolerance for residues of 
etoxazole in or on the food commodity cherry at 1.0 ppm. That notice 
referenced a summary of the petition prepared on behalf of IR-4 by 
Valent U.S.A. Corporation, the registrant, which is available to the 
public in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance levels for plum; plum, prune, dried; and 
tomato. The reason for these changes is explained in Unit IV.D.

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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for 
tolerances for residues of etoxazole on fruit, stone, group 12, except 
plum at 1.0 ppm; plum at 0.15 ppm; plum, prune, dried at 0.30 ppm; 
cucumber at 0.02 ppm; tomato at 0.20; spearmint, tops at 10 ppm; 
peppermint, tops at 10 ppm; peppermint, oil at 20 ppm; and spearmint, 
oil at 20 ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The existing etoxazole data indicate that it possess low acute 
toxicity via all routes of exposure. It is not an eye or dermal 
irritant or a dermal sensitizer. No toxicity was seen at the limit dose 
in a 28-day dermal toxicity study in rats.
    The liver is the main target organ in mice, rats and dogs. In a 90-
day toxicity study in dogs, increased liver weights and centrilobular 
hepatocellular swelling in the liver were observed. Similar effects 
were observed in a chronic toxicity study in dogs at similar doses, 
indicating that systemic effects (mainly liver effects) occur at 
similar dose levels following short- through long-term exposure without 
increasing in severity. In a 90-day toxicity study in mice, 
hepatotoxicity (increased relative liver weight, liver enlargement, and 
centrilobular hepatocellular swelling) was observed at high doses. 
Similar effects were observed at the high dose in a mouse 
carcinogenicity study. Subchronic and chronic toxicity studies in rats 
produced similar effects (increased liver weights, centrilobular 
hepatocellular swelling, etc.) to those seen in mice and dogs. In 
addition, slight increases in thyroid weights and incisors were 
observed in subchronic and chronic toxicity studies in rats at high 
doses and at terminal stages of the study. Toxicity was not observed at 
the highest dose tested (HDT) in another carcinogenicity study in mice. 
There is no evidence of immunotoxicity or neurotoxicity in any of the 
submitted studies.
    Two studies in mice showed no evidence of carcinogenicity up to the 
HDT. In a rat carcinogenicity study, which was deemed unacceptable due 
to inadequate dosing, benign interstitial cell tumors (testis) and 
pancreas benign islet cell adenomas were observed (in females) at the 
high dose. These effects were not observed in an acceptable 
carcinogenicity study in rats at higher doses. In special mechanistic 
male rat studies there were no observable

[[Page 25158]]

changes in serum hormone levels (estradiol, luteinizing hormone (LH), 
prolactin and testosterone) or reproductive effects (interstitial cell 
proliferation or spermatogenesis) noted. EPA classified etoxazole as 
``not likely to be carcinogenic to humans.'' Etoxazole is not 
mutagenic.
    The toxicology data for etoxazole provides no indication of 
increased susceptibility, as compared to adults, of rat and rabbit 
fetuses to in utero exposure in developmental studies. The rabbit 
developmental toxicity study included maternal toxic effects (liver 
enlargement, decreased weight gain, and decreased food consumption) at 
the same dose as developmental effects (increased incidences of 27 
presacral vertebrae and 27 presacral vertebrae with 13th ribs). In the 
two-generation reproduction study conducted with rats, offspring 
toxicity was more severe (pup mortality) than parental toxicity 
(increased liver and adrenal weights) at the same dose, indicating 
increased qualitative susceptibility.
    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 studiescan be found at http://
www.regulations.gov in document ``Etoxazole; Human Health Risk 
Assessment for Proposed Uses on Stone Fruits, Cucumber, Tomato, and 
Mint,'' pages 29-31 in docket ID number EPA-HQ-OPP-2008-0554.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for etoxazole used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Etoxazole; Human Health Risk Assessment for Proposed Uses on 
Stone Fruits, Cucumber, Tomato, and Mint,'' page 15 in docket ID number 
EPA-HQ-OPP-2008-0554.

C. Exposure Assessment

    1. 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.
    No such effects were identified in the toxicological studies for 
etoxazole; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level 
residues and empirically determined (when available) or DEEM default 
processing factors. Additionally, EPA assumed 100 percent crop treated 
(PCT) for all commodities covered by proposed or existing tolerances.
    iii. Cancer. Two mouse studies showed no evidence of 
carcinogenicity at the high dose. While benign interstitial cell tumors 
in the testis and pancreas benign islet cell adenomas were observed in 
an unacceptable rat carcinogenicity study, these effects were not seen 
in a repeat study at higher doses. Furthermore, special mechanistic 
male rat studies resulted in no observable changes in serum hormone 
levels (estradiol, luteinizing hormone, prolactin and testosterone) or 
reproductive effects (interstitial cell proliferation or 
spermatogenesis). EPA determined that cancer risk concerns due to long-
term consumption of etoxazole residues are adequately addressed by the 
chronic dietary exposure analysis; therefore, etoxazole was classified 
as ``not likely to be carcinogenic to humans,'' and a quantitative 
exposure assessment to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
etoxazole. Tolerance level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for etoxazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
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.
    Based on the First Index Reservoir Screening Tool (FIRST) model for 
surface water, and Screening Concentration in Ground Water (SCI-GROW) 
model for ground water, the estimated drinking water concentrations 
(EDWCs) of etoxazole and its major metabolites (R-8 and R-13) for 
surface water are estimated to be 15.73 parts per billion (ppb) for 
acute exposures and 4.761 ppb for chronic exposures. For ground water, 
the estimated drinking water concentration is estimated to be 0.746 
ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 4.761 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

[[Page 25159]]

is not registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found etoxazole to share a common mechanism of toxicity 
with 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 assumed that etoxazole does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The toxicology data for 
etoxazole provides no indication of increased susceptibility, as 
compared to adults, of rat and rabbit fetuses to in utero exposure in 
developmental studies. In a rat reproduction study, offspring toxicity 
was more severe (pup mortality) than parental toxicity (increased liver 
and adrenal weights) at the same dose; thereby indicating increased 
qualitative susceptibility. Based on the above concerns, a Degree of 
Concern Analysis was performed by EPA, which concluded that concern is 
low since:
    i. The effects in pups are well-characterized with a clear NOAEL;
    ii. The pup effects occur at the same dose as parental toxicity; 
and
    iii. The doses selected for various risk assessment scenarios are 
lower than the doses that caused offspring toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for etoxazole is complete except for acute 
and subchronic neurotoxicity and immunotoxicity studies. Recent changes 
to 40 CFR 180.158 make acute and subchronic neurotoxicity testing 
(OPPTS Guideline 870.6200), and immunotoxicity testing (OPPTS Guideline 
870.7800) required for pesticide registration. Because these testing 
requirements went into effect shortly before the tolerance petition was 
submitted, these studies are not yet available for etoxazole. However, 
the available data for etoxazole do not show potential for 
immunotoxicity. Further, there is no evidence of neurotoxicity in any 
study in the toxicity database for etoxazole. Therefore, EPA does not 
believe that conducting neurotoxicity and immunotoxicity studies will 
result in a NOAEL lower than the NOAEL of 4.62 milligrams/kilograms/day 
already established for etoxazole. Consequently, an additional database 
uncertainty factor does not need to be applied.
    ii. There is no indication that etoxazole is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional Uncertainity Factors (UFs) to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased 
susceptibility of offspring (pup mortality) compared to less severe 
parental effects (increased liver and adrenal weights) at the same dose 
in the rat multi-generation reproduction study, the Agency did not 
identify any residual uncertainties after establishing toxicity 
endpoints and traditional UFs (10X for interspecies variation and 10X 
for intraspecies variation) to be used in the risk assessment. 
Therefore, there are no residual concerns regarding developmental 
effects in the young.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to etoxazole in drinking water. These assessments 
will not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
etoxazole from food and water will utilize 10% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for etoxazole to consider.
    3. Short-, and intermediate-term risk. Short-, and intermediate-
term aggregate exposure takes into account short-, and intermediate-
term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Etoxazole is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-, and intermediate-term 
aggregate risk is the sum of the risk from exposure to etoxazole 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.C.1.iii., EPA has classified etoxazole as ``not likely to be 
carcinogenic to humans,'' and it 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.

[[Page 25160]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) and gas chromatography/mass selective 
detection (GC/MSD) methods) are available to enforce the tolerance 
expression. The methods may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    Currently, there are no Codex, Canadian, or Mexican maximum residue 
limits (MRLs) established for residues of etoxazole in or on the 
subject commodities.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a 
general objection to the presence of any pesticide residues on crops 
and stated that EPA should set no pesticide tolerance greater than 
zero. The Agency understands the commenter's concerns and recognizes 
that some individuals believe that pesticides should be banned 
completely. However, the existing legal framework provided by section 
408 of FFDCA states that tolerances greater than zero may be set when 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA revised 
tolerances for certain proposed commodities, as follows: Plum from 0.12 
ppm to 0.15 ppm; plum, prune, dried from 0.40 ppm to 0.30 ppm; and 
tomato from 0.25 ppm to 0.20 ppm. EPA revised the tolerance levels 
based on analysis of the residue field trial data using the Agency's 
Tolerance Spreadsheet in accordance with the Agency's Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data.

V. Conclusion

    Therefore, tolerances are established for residues of etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on fruit, stone, group 12, except plum at 1.0 
ppm; plum at 0.15 ppm; plum, prune, dried at 0.30 ppm; cucumber at 0.02 
ppm; tomato at 0.20 ppm; spearmint, tops at 10 ppm; peppermint, tops at 
10 ppm; spearmint, oil at 20 ppm; and peppermint, oil at 20 ppm. This 
regulation also deletes the existing tolerance in or on cherry at 1.0 
ppm, as it is superseded by inclusion in fruit, stone, group 12.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established 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 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

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: May 15, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.593 is amended in paragraph (a), by removing the 
commodity ``Cherry'' and by alphabetically adding the following 
commodities to the table to read as follows:

Sec.  180.593  Etoxazole; tolerances for residues.

     (a) General. * * *

[[Page 25161]]

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cucumber.............................................               0.02
                                * * * * *
Fruit, stone, group 12, except plum..................                1.0
                                * * * * *
Peppermint, oil......................................                 20
Peppermint, tops.....................................                 10
                                * * * * *
Plum.................................................               0.15
Plum, prune, dried...................................               0.30
                                * * * * *
Spearmint, oil.......................................                 20
Spearmint, tops......................................                 10
                                * * * * *
Tomato...............................................               0.20
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-12292 Filed 5-26-09; 8:45 am]

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