[Federal Register Volume 75, Number 22 (Wednesday, February 3, 2010)]
[Rules and Regulations]
[Pages 5522-5526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2144]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0262; FRL-8436-9]


Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY:  This regulation establishes tolerances for the inadvertent or 
indirect combined residues of 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 the following commodities from 
crops grown as rotational crops: bulb vegetables. Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 3, 2010. Objections and 
requests for hearings must be received on or before April 5, 2010, 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-2008-0262. 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: Jennifer Gaines, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5967; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to 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

[[Page 5523]]

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.

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-2008-0262 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 April 5, 2010.
    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-2008-0262, 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 November 5, 2008 (73 FR 65851) (FRL-
8385-1), 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 
8F7398) by Bayer CropScience, P.O. Box 12014, 2 T. W. Alexander Dr., 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.607 be amended by establishing tolerances for the inadvertent or 
indirect combined residues of the insecticide 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 the following commodities from 
crops grown as rotational crops: vegetable, bulb, group 3-07 at 0.07 
parts per million (ppm). That notice is available to the public in the 
docket, http://www.regulations.gov. One comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.

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 inadvertent or indirect combined residues of 
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, on the following 
commodities from crops grown as rotational crops: vegetable, bulb, 
group 3-07. 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.
    Spiromesifen shows low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It was neither an eye nor dermal 
irritant, but showed moderate potential as a contact sensitizer. In 
short- and long-term animal toxicity tests, the critical effects 
observed were loss of body weight, adrenal effects (discoloration, 
decrease in fine vesiculation, and the presence of cytoplasmic 
eosinophilia in zona fasciculata cells), thyroid effects (increased 
thyroid stimulating hormone, increased thyroxine binding capacity, 
decreased T3 and T4 levels, colloidal alteration 
and thyroid follicular cell hypertrophy), liver effects (increased 
alkaline phosphatase, ALT and decreased cholesterol, triglycerides), 
and spleen effects (atrophy, decreased spleen cell count, and increased 
macrophages). Spiromesifen shows no significant developmental or 
reproductive effects, is not likely to be carcinogenic based on 
bioassays in rats and mice, and lacks in vivo and in vitro mutagenic 
effects. Spiromesifen is not considered a neurotoxic chemical based on 
the chemical's mode of action and the available data from multiple 
studies, including acute and subchronic neurotoxicity studies.
    Specific information on the studies received and the nature of the 
adverse 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 at http://www.regulations.gov in the document ``Spiromesifen: Human-Health Risk 
Assessment for Request to Reduce Rotational Crop Plantback Interval 
(PBI) for Bulb Vegetables (Crop Group 3),'' at pages 11-16 in docket ID 
number EPA-HQ-OPP-2008-0262 and memo, D363706, June 11, 2009.

[[Page 5524]]

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 spiromesifen used for 
human risk assessment can be found at http://www.regulations.gov in the 
document ``Spiromesifen: Human-Health Risk Assessment for Request to 
Reduce Rotational Crop Plantback Interval (PBI) for Bulb Vegetables 
(Crop Group 3),'' at page 17 in docket ID number EPA-HQ-OPP-2008-0262.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in (40 
CFR 180.607). EPA assessed 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 food consumption data from the USDA 1994-1996 
and 1998 Cummulative Survey of Food Intake by Individuals. As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities except for the leafy-greens and leafy Brassica greens 
subgroups (4A and 5B). The tolerance values for leafy vegetables were 
adjusted upward to account for the metabolite BSN 2060-4-hydroxymethyl 
(free and conjugated), which is a residue of concern in leafy 
vegetables for risk assessment purposes only. EPA used data from the 
metabolism studies to create a tolerance-equivalent value for the 
parent spiromesifen and the BSN 2060-4-hydroxymethyl metabolite to 
estimate residues in leafy vegetables. Dietary Exposure Evaluation 
Model (DEEM) 7.81 default processing factors and 100% crop treated (CT) 
were assumed for all commodities.
    iii. Cancer. Due to no evidence of carcinogenic effects in the 
submitted rat and mouse cancer studies, spiromesifen has been 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
an exposure assessment to evaluate cancer risk was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for spiromesifen. Tolerance level residues were used 
for all food commodities except for the leafy-greens and leafy Brassica 
greens subgroups (4A and 5B). For these subgroups, the residue values 
were adjusted to account for the metabolite BSN 2060-4-hydroxymethyl 
(free and conjugated), which is a residue of concern in leafy 
vegetables for risk assessment purposes only. The Agency assumed 100% 
CT for all food commodities.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring 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, the 
Agency used screening level water exposure models in the dietary 
exposure analysis and risk assessment for spiromesifen in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport 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.
    Parent spiromesifen is not likely to persist in the environment as 
it readily undergoes both biotic and abiotic degradation; however, its 
primary degradate, BSN2060-enol, is expected to persist. While parent 
spiromesifen strongly sorbs to sediment and is not likely to be mobile, 
its major degradates, BSN2060-enol and BSN2060-carboxy, do not sorb to 
sediment and are expected to leach into groundwater. Spiromesifen has 
limited solubility in water (130 micrograms/Liter ([micro]g/L) at 
25[deg] C) and in some cases has been reported to have a practical 
solubility of 40 to 50 [micro]g/L. The pesticide degrades primarily 
through aerobic soil metabolism and hydrolysis; however, in clear 
shallow water it will readily undergo photolysis. Field studies 
indicate that spiromesifen readily dissipates with field dissipation 
half-lives ranging from 2 to 10 days.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
spiromesifen for chronic exposure are 188 parts per billion (ppb) for 
surface water and 86 ppb for ground water. For chronic dietary risk 
assessment, the water concentration of value 188 ppb was used to assess 
the contribution to drinking water. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model.
    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 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

[[Page 5525]]

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 spiromesifen to share a common mechanism of 
toxicity with 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 assumed that 
spiromesifen 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. There is no evidence of 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to spiromesifen. In the prenatal developmental 
toxicity studies in rats and rabbits and in the two-generation 
reproduction study in rats, developmental toxicity to the offspring 
occurred at equivalent or higher doses than parental 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: 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 spiromesifen is complete and no 
additional immunotoxicity or neurotoxicty testing is required. The 
rationale is described below:
    a. Because spleen effects were seen in several toxicity studies, 
the registrant pursued specialized immunotoxicity studies in rats and 
mice that were both negative. These studies satisfy the revised 40 CFR 
part 158 requirement for immunotoxicity testing. In addition, the 
endpoints selected for the risk assessment are considered protective of 
any possible immunotoxic effects.
    b. There is no concern for 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) at 
high doses (134 and 536 milligrams/kilogram/day (mg/kg/day), 
respectively). These effects were neither reflected in 
neurohistopathology nor in other studies. Because these effects were 
not observed in the acute and subchronic neurotoxicity studies, they 
were not considered reproducible. Thus, based on the chemical's mode of 
action and the available data from multiple studies, the chemical is 
not considered neurotoxic.
    ii. There is no evidence that spiromesifen results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. A developmental neurotoxicity study is not required.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to spiromesifen in drinking water. These assessments 
will not underestimate the exposure and risks posed by spiromesifen.

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, 
spiromesifen 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 
spiromesifen from food and water will utilize 77% of the cPAD for 
infants (<1 year old), the population group receiving the greatest 
exposure.
    3. Short-term risk and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Spiromesifen is not 
registered for any use patterns that would result in residential 
exposure. Therefore, the short-term aggregate risk is the sum of the 
risk from exposure to spiromesifen through food and water and will not 
be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Spiromesifen has been 
classified as ``not likely to be carcinogenic to humans.'' 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, or to infants and children from aggregate 
exposure to spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography/mass spectroscopy (HPLC/MS/MS)/Method 00631/M001 and 
Method 110333) is 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; e-mail address: 
[email protected].

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum Residue Limits have been

[[Page 5526]]

established for residues of spiromesifen and its metabolites on the 
requested crops.

C. Response to Comments

    One comment was received from an anonymous citizen who objected to 
the proposed use of spiromesifen because of the amounts of pesticides 
already approved and being approved. The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned completely. However, under the existing 
legal framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide 
tolerances or exemptions where persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute.

D. Revisions to Petitioned-For Tolerances

    Vegetable, bulb, group 3-07. Due to the detection of residues on 
onion after performing an extensive rotational crop study, Bayer then 
proposed changing the tolerance from 0.07 ppm to 0.09 ppm. The Agency 
concurred with this proposed tolerance. Using the North American Free 
Trade Agreement (NAFTA) Maximum Residue Limits/Tolerance Harmonization 
Workgroup methodology for evaluating field trial data, the Agency 
determined that the requested establishment of permanent tolerances in/
on vegetable, bulb, group 3-07 proposed at 0.09 ppm should be made.

V. Conclusion

    Therefore, tolerances are established for inadvertent or indirect 
combined residues of the insecticide 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 vegetable, bulb, group 3-07 at 
0.09 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, 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: January 25, 2010.
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 by alphabetically adding the following 
commodity to the table in paragraph (d) to read as follows:


Sec.  180.607  Spiromesifen; tolerances for residues.

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Vegetable, bulb, group 3-07..................................       0.09
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-2144 Filed 2-2-10; 8:45 am]
BILLING CODE 6560-50-S