[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Rules and Regulations]
[Pages 3617-3621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1254]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0968; FRL-9334-9]


Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
etoxazole in or on field corn and popcorn. Valent U.S.A. Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective January 25, 2012. Objections and 
requests for hearings must be received on or before March 26, 2012, 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-2010-0968. 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: Autumn Metzger, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5314; email 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 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
harmonized guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2010-0968 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
March 26, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0968, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of February 25, 2011 (76 FR 10584) (FRL-
8863-3), 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 
0F7783) by Valent USA Corporation, 1600 Riviera Avenue, Suite 200, 
Walnut Creek, CA 94596. The petition requested that 40 CFR 180.593 be 
amended by establishing tolerances for residues of the miticide/ovicide 
etoxazole, 2-(2,6-difluorophenyl)-4-[4- (1,1-dimethylethyl)-2-
ethoxyphenyl]-4,5-dihydrooxazole, in or on corn, field, grain at 0.01 
parts per million (ppm); corn, field, forage at 0.6 ppm; corn, field, 
stover at 2.5 ppm; corn, field, refined oil at 0.03 ppm; corn, pop, 
grain at 0.01 ppm; corn, pop, stover at 2.5 ppm; poultry, fat at 0.01 
ppm; and poultry, liver at 0.02 ppm. That notice referenced a summary 
of the petition prepared by Valent, the registrant, which is available 
in the docket, http://www.regulations.gov. There were no comments 
received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some of the tolerances are being set and 
determined tolerances are not needed for poultry.

[[Page 3618]]

The reasons for these changes are 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 etoxazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with etoxazole 
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.
    Etoxazole possesses 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 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 
2-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 studies can be found at http://www.regulations.gov in document titled ``Etoxazole. Human Health Risk 
Assessment for Proposed Uses in/on Field Corn and Pop Corn,'' pp. 24-27 
in docket ID number EPA-HQ-OPP-2010-0968.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 is discussed in Unit III.B., in the Table of the 
final rule published in the Federal Register of April 13, 2011 (76 FR 
20537) (FRL-8867-5) (http://www.gpo.gov/fdsys/pkg/FR-2011-04-13/pdf/2011-8550.pdf.)

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

[[Page 3619]]

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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys 
for Food Intake by Individuals (CSFII). As to residue levels in food, 
an unrefined, chronic dietary exposure assessment was performed for the 
general U.S. population and various population subgroups using 
tolerance-level residues for all agricultural commodities and 100 
percent crop treated (PCT) information.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that etoxazole does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for etoxazole. Tolerance level residues and/or 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), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of etoxazole for 
chronic exposures for non-cancer assessments are estimated to be 4.761 
parts per billion (ppb) for surface water and 0.746 ppb for ground 
water.
    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 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 Web site 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 concerns in this unit, 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 (~3000-fold lower) than the doses that caused offspring toxicity 
in the rat 2-generation reproduction study. Therefore, the endpoints 
selected for risk assessment are protective of the effects seen in the 
rat reproduction study.
    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. 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. Although these studies 
are not yet available for etoxazole, the available data do not show any 
evidence of treatment-related effects on the immune system. Further, 
there is no evidence of neurotoxicity in any study in the toxicity 
database for etoxazole. Therefore, the 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 (mg/kg/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 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

[[Page 3620]]

not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from 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 11% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for etoxazole.
    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).
    A short- and/or intermediate-term adverse effect was identified; 
however, etoxazole is not registered for any use patterns that would 
result in short- and/or intermediate-term residential exposure. Short- 
and/or intermediate-term risk is assessed based on short- and/or 
intermediate term residential exposure plus chronic dietary exposure. 
Because there is no short- and/or intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess short- and/or intermediate-term risk), no 
further assessment of short- and/or intermediate-term risk is 
necessary, and EPA relies on the chronic dietary risk assessment for 
evaluating short- and/or intermediate-term risk for etoxazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, 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 (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) and gas chromatography/mass selective 
detection (GC/MSD) methods) are available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for etoxazole for the 
commodities discussed in this document.

C. Revisions to Petitioned-For Tolerances

    Based upon analysis of the data supporting the petition using the 
Organization for Economic Cooperation and Development tolerance 
calculation procedures, the EPA revised the tolerance levels for corn, 
field, forage from 0.6 ppm to 0.80 ppm; corn, field, stover from 2.5 
ppm, to 4.0 ppm and corn, pop, stover from 2.5 ppm to 4.0 ppm.
    There is no reasonable expectation of finding quantifiable residues 
of etoxazole in poultry commodities based on the calculated maximum 
reasonable dietary burden (MRDB) for poultry (0.0077 ppm) and the 
results from the poultry metabolism study. Therefore, tolerances for 
residues of etoxazole in poultry, fat and poultry, liver were not 
required for this petition.

V. Conclusion

    Therefore, tolerances are established for residues of etoxazole in 
or on corn, field, grain at 0.01 ppm; corn, field, forage at 0.80 ppm; 
corn, field, stover at 4.0 ppm; corn, field, refined oil at 0.03 ppm; 
corn, pop, grain at 0.01 ppm; corn, pop, stover at 4.0 ppm.

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,

[[Page 3621]]

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) (Pub. L. 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: January 13, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 alphabetically adding 
the following commodities to the table to read as follows:


Sec.  180.593  Etoxazole; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, field, forage.......................................          0.80
Corn, field, grain........................................          0.01
Corn, field, refined oil..................................          0.03
Corn, field, stover.......................................          4.0
Corn, pop, grain..........................................          0.01
Corn, pop, stover.........................................          4.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-1254 Filed 1-24-12; 8:45 am]
BILLING CODE 6560-50-P