Document ID: EPA-HQ-OPP-2006-0667-0004
Agency: epa
Document Type: Rule
Title: Spiromesifen; Pesticide Tolerance
Posted Date: 2007-01-24T05:00Z

[Federal Register: January 24, 2007 (Volume 72, Number 15)]
[Rules and Regulations]               
[Page 3075-3079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja07-19]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0667; FRL-8110-3]

 
Spiromesifen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises a tolerance for combined residues of 
spiromesifen in or on vegetables, fruiting, group 8 and establishes 
tolerances for inadvertent or indirect combined residues in or on oat 
(grain, forage, hay, straw). Interregional Research Project No. 4 (IR-
4) and Bayer CropScience (respectively) requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective January 24, 2007. Objections and 
requests for hearings must be received on or before March 26, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0667. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Thomas C. Harris, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-9423; e-mail address: 
harris.thomas@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0667 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be

[[Page 3076]]

mailed or delivered to the Hearing Clerk on or before March 26, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0667, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of September 13, 2006 (71 FR 54057) (FRL-
8091-7), 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 
5E6901) by Interregional Research Project No. 4 (IR-4), Rutgers, The 
State University of New Jersey, 500 College Road East, Suite 201, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.607 be 
amended by revising a tolerance for combined residues of the 
insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on 
vegetable, fruiting, crop group 8 from 0.30 to 0.45 parts per million 
(ppm). The same notice also announced the filing of a pesticide 
petition (PP 6F7039) by Bayer CropScience, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. That petition requested that 40 CFR 
180.607 be amended by establishing a tolerance for inadvertent or 
indirect combined residues of the insecticide/miticide spiromesifen (2-
oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate), its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), and its metabolites 
containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-
2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), calculated as the 
parent compound equivalents, in or on oat, forage; oat, fodder; and 
oat, straw at 0.25 ppm and in or on the food commodity oat, grain at 
0.03 ppm. The notice included summaries of the petitions prepared by 
Bayer CropScience, the registrant. Comments were received on the notice 
of filing from one private citizen. EPA's response to these comments is 
discussed in Unit IV.C.
    Based on the EPA analysis of the residue chemistry and 
toxicological databases, petition PP 6F7039 was subsequently revised to 
express the oat tolerances as inadvertent or indirect combined residues 
of the insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), 
its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one), and its metabolites containing the 4-
hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)-2,6-
dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), calculated as the 
parent compound equivalents, in or on oat, forage at 0.20 ppm; oat, 
grain at 0.03 ppm; oat, hay at 0.25 ppm; and oat, straw at 0.25 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm and http://

://

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of the 
insecticide/miticide spiromesifen and its enol metabolite, in or on 
vegetable, fruiting, crop group 8 at 0.45 ppm and the inadvertent or 
indirect combined residues of the insecticide/miticide spiromesifen and 
its enol metabolite, in or on oat, forage at 0.20 ppm; oat, grain at 
0.03 ppm; oat, hay at 0.25 ppm; and oat, straw at 0.25 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 its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by spiromesifen 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 in Unit III.A. of 
the final rule published in the Federal Register of April 27, 2005 (70 
FR 21631) (FRL-7705-1) at http://www.epa.gov/fedrgstr/EPAFR-CONTENTS/2005/April/Day-27/contents.htm
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study

[[Page 3077]]

selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk and estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for spiromesifen used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 27, 2005 (70 FR 21631) (FRL-
7705-1) at http://www.epa.gov/fedrgstr/EPAFR-CONTENTS/2005/April/Day-27/contents.htm
.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.607) for the combined residues of spiromesifen, 
in or on a variety of raw agricultural commodities. In addition, 
tolerances have been established for combined residues on several 
livestock (cattle, goat, horse, sheep) commodities which feed on these 
raw agricultural commodities and for inadvertent or indirect combined 
residues on some rotational crop (alfalfa, barley, sugar beet, wheat) 
commodities. Risk assessments were conducted by EPA to assess dietary 
exposures from spiromesifen 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 
spiromesifen. Therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: (1) Established/recommended tolerances for all plant and 
livestock except the leafy-green and leafy-Brassica vegetable 
subgroups; (2) EPA calculated residues of concern (parent and 
metabolites) for the leafy-green and leafy-Brassica vegetable subgroup; 
(3) 100% crop treated (CT) information for all proposed and existing 
uses; and (4) DEEM\TM\ Version 7.81 default processing factors for all 
commodities.
    The metabolism studies show that the hydroxymethyl metabolite is 
formed along with the enol metabolite only in the leafy-green and 
leafy-Brassica vegetable subgroups. EPA determined that these two 
metabolites along with the spiromesifen should be included in the 
chronic dietary risk assessment for these crops. Residue data are 
unavailable for the 4-hydroxymethyl metabolite; to account for this 
metabolite in the risk assessment, the recommended tolerance levels for 
these crops was multiplied by a correction factor of 1.3X, where 1.3 = 
metabolites in risk assessment (ppm) / metabolites in tolerance 
expression (ppm).
    iii. Cancer. A cancer exposure assessment was not performed because 
spiromesifen is classified as ``not likely to be carcinogenic to 
humans.''
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for spiromesifen 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 physical 
characteristics of spiromesifen. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
spiromesifen for chronic exposures are estimated to be 11 ppb for 
surface water and 28 ppb for ground water. Drinking water estimates 
were incorporated directly into the DEEM-FCID\TM\ using the estimated 
drinking water concentration generated by the SCI-GROW (version 2.3) 
model of 28 ppb.
    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).
    Spiromesifen is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency considers ``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 spiromesifen and any other 
substances and spiromesifen 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 spiromesifen has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
Margin of Exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety

[[Page 3078]]

factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rats or rabbits to in utero prenatal or 
postpostnatal exposure to spiromesifen. In a rat developmental toxicity 
study, no developmental toxicity was observed at doses up to 500 
milligrams/kilograms/day (mg/kg/day) (the highest dose tested) in the 
presence of maternal toxicity. The rat maternal LOAEL was determined to 
be 70 mg/kg/day based on decreased body-weight gain and reduced food 
consumption. In the rabbit developmental toxicity study, there was no 
developmental toxicity observed at doses up to 250 mg/kg/day (the 
highest dose tested), but the maternal LOAEL was determined to be 35 
mg/kg/day based on body weight loss and reduced food consumption. There 
is no qualitative and/or quantitative evidence of increased 
susceptibility to spiromesifen following pre/postnatal exposure in a 2-
generation reproduction study in rats.
    There is no concern for developmental neurotoxicity resulting from 
exposure to spiromesifen. Neurotoxic effects such as reduced motility, 
spastic gait, increased reactivity, tremors, clonic-tonic convulsions, 
reduced activity, labored breathing, vocalization, avoidance reaction, 
piloerection, limp, cyanosis, squatted posture, and salivation were 
observed in two studies (5-day inhalation and subchronic oral rat). 
However, these effects were considered as secondary, not neurotoxic, 
effects due to the high dosage. There was no evidence of neurotoxicity 
in the acute or subchronic neurotoxicity or any other studies.
    3. Conclusion. For spiromesifen, EPA determined that the 10X safety 
factor to protect infants and children should be removed. A 1X safety 
factor is appropriate because:
     There is a complete toxicity database for spiromesifen.
     There was no evidence of increased susceptibility of rat 
or rabbit fetuses to in utero exposure in developmental studies, nor 
following prenatal or postnatal exposure by rats in the 2-generation 
reproduction study.
     There are no neurotoxicity concerns based on acute and 
subchronic neurotoxicity studies.
     The dietary food exposure assessment uses proposed 
tolerance levels or higher residues for most commodities and assumed 
100% crop-treated information for all commodities. By using these 
screening-level assessments, chronic exposures and risks will not be 
underestimated. The ``higher residues'' are those that were calculated 
using a modifying factor to account for the lack of spiromesifen-4-
hydroxymethyl residue data.
     The dietary drinking water assessment (Tier 2 estimates) 
uses values generated by model and associated modeling parameters which 
are designed to provide conservative, health protective, and high-end 
estimates of water concentrations.
     Residential exposure is not expected, spiromesifen will be 
registered for agricultural and greenhouse/ornamental uses only.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. As there were no toxic effects attributable to a 
single dose, an endpoint of concern was not identified to quantitate 
acute dietary risk to the general population or any subpopulation. No 
acute risk is expected from exposure to spiromesifen.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
spiromesifen from food and water will utilize 31% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 23% of the 
cPAD for all infants less than 1 year old, and 38% of the cPAD for 
children 1-2 years old, the most highly exposed population subgroups. 
There are no residential uses for spiromesifen that result in chronic 
residential exposure to spiromesifen. Therefore, EPA does not expect 
the aggregate exposure to exceed 100% of the cPAD.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Spiromesifen is not registered 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 
level of concern.
    4. Aggregate cancer risk for U.S. population. Spiromesifen is not 
expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical enforcement methodologies, high-performance 
liquid chromatography (HPLC)/mass spectrometry (MS)/MS, exist and have 
been successfully validated by independent laboratories.

B. International Residue Limits

    There are no international residue limits for spiromesifen listed 
in CODEX.

C. Response to Comments

    Several comments were received from one private citizen objecting 
to pesticide body load, registrant profiteering, establishing 
tolerances, pollution by pesticides, and lack of notification when 
pesticides are applied to neighboring areas. The Agency has received 
similar comments from this commenter on numerous previous occasions. 
Refer to Federal Register 70 FR 37686 (June 30, 2005), 70 FR 1354 
(January 7, 2005), and 69 FR 63096-63098 (October 29, 2004) for the 
Agency's response to these objections.

V. Conclusion

    Therefore, the tolerance is revised for combined residues of the 
insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on 
vegetable, fruiting, crop group 8 to 0.45 ppm. Also, the tolerance is 
established for inadvertent or indirect combined residues of the 
insecticide/miticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate), its enol metabolite 
(4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), 
and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-
[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one), 
calculated as the parent compound equivalents, in or on oat, forage at 
0.20 ppm; oat, grain at 0.03 ppm; oat, hay at 0.25 ppm; and oat, straw 
at 0.25 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,

[[Page 3079]]

October 4, 1993). Because this rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of FFDCA. For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 17, 2007.
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 180.607 is amended in the table to paragraph (a)(1) by 
revising the entry for ``Vegetable, fruiting group 8'' and in the table 
to paragraph (d) by adding alphabetically commodities to read as 
follows:

Sec. 180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Vegetable, fruiting, group 8...............................         0.45
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Oat, forage................................................         0.20
Oat, grain.................................................         0.03
Oat, hay...................................................         0.25
Oat, straw.................................................         0.25
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-990 Filed 1-23-07; 8:45 am]

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