Document ID: EPA-HQ-OPP-2007-0331-0003
Agency: epa
Document Type: Rule
Title: Spiromesifen; Pesticide Tolerance
Posted Date: 2008-03-12T04:00Z

[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]               
[Page 13136-13141]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr08-32]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0331; FRL-8351-7]

 
Spiromesifen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of spiromesifen and its enol metabolite in or on bean, dry; bean, 
succulent; bean, edible podded; and cowpea, forage. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 12, 2008. Objections and 
requests for hearings must be received on or before May 12, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0331. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@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

[[Page 13137]]

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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0331 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 May 12, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0331 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1), 
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 7E7195) 
by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.607 be amended by establishing 
tolerances for 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) and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on bean, edible, 
podded at 1.4 ppm; bean, succulent at 0.10 ppm; bean, dry at 0.02 ppm; 
cowpea, forage at 35 ppm; cattle, fat at 0.20 ppm; cattle, meat at 0.01 
ppm; cattle, meat byproducts at 0.30 ppm; goat, fat at 0.20 ppm; goat, 
meat at 0.01 ppm; goat, meat byproducts at 0.30 ppm; hog, fat at 0.20 
ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.30 ppm; horse, 
fat at 0.20 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at0.30 
ppm; sheep, fat at 0.20 ppm; sheep, meat at 0.01 ppm; sheep, meat 
byproducts at 0.30 ppm; and milk at 0.01 ppm. This notice referenced a 
summary of the petition prepared by Bayer Crop Science, the registrant, 
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised tolerance expressions for bean, edible, podded; cowpea, forage; 
milk, whole; milk, fat; in meat of cattle, goats, horses, and sheep; in 
meat, byproducts, of cattle, goats, horses, and sheep; and in fat of 
cattle, goats, horses, and sheep. A tolerance for cowpea, hay was also 
included. The reason for these changes is explained 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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerances 
for combined residues of spiromesifen on bean, dry at 0.02 ppm; bean, 
succulent at 0.10 ppm; bean, edible podded at 0.80 ppm; cowpea, forage 
at 30 ppm; cowpea, hay at 86 ppm; cattle, fat at 0.10 ppm; cattle, meat 
at 0.02 ppm; cattle, meat byproducts at 0.15 ppm; goat, fat at 0.10 
ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.15 ppm; horse, 
fat at 0.10 ppm; horse, meat at 0.02 ppm; horse, meat

[[Page 13138]]

byproducts at 0.15 ppm; sheep, fat at 0.10 ppm; sheep, meat at 0.02 
ppm; sheep, meat byproducts at 0.15 ppm; milk at 0.01 ppm; and milk, 
fat at 0.20 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerances follow.

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 a 
Magnusson and Kligman maximization assay. Acute dietary-exposure limits 
for all populations, including infants and children, were not necessary 
because an endpoint of concern attributable to a single exposure (dose) 
was not identified from the oral toxicity studies. In addition, there 
are no developmental concerns based on rat and/or rabbit developmental 
toxicity studies. The rat two-generation reproduction study was 
selected for chronic dietary, as well as long-term dermal- and 
inhalation-exposure risk assessments.
    In the 2-generation reproduction study in rat the following effects 
were noted at the lowest observed adverse effect level (LOAEL): 
Significantly decreased spleen weight (absolute and relative in 
parental females and F1 males) and significantly decreased growing 
ovarian follicles in females. Spiromesifen shows no significant 
developmental or reproductive effects, is not likely to be carcinogenic 
based on bioassays in rat and mouse, and lacks in vivo and in vitro 
mutagenic effects. Spiromesifen is not a neurotoxic chemical based on 
results of 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 in the document 
entitled ``Spiromesifen: Human Health Risk Assessment for a Section 3 
Registration on Beans;'' pages 44-52 at www.regulations.gov. The 
referenced document is available in docket EPA-HQ-OPP-2007-0331.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for spiromesifen used for 
human risk assessment can be found at http://www.regulations.gov in the 
document entitled ``Spiromesifen: Human Health Risk Assessment for a 
Section 3 Registration on Beans;'' pages 18-19; docket ID number EPA-
HQ-OPP-2007-0331.

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 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for all commodities with existing and proposed 
tolerances except for the leafy-green and leafy-Brassica vegetable 
subgroups (4A and 5B). An additional metabolite, BSN 2060-4-
hydroxymethyl, was observed in the metabolism studies of lettuce only. 
Since this metabolite's toxicity is expected to be comparable to the 
parent compound, it was included in the risk assessment for leafy crops 
(subgroups 4A and 5B), but not in the tolerance expression. To account 
for this additional toxicity exposure, the recommended tolerance level 
was multiplied by a correction factor of 1.3x. For all commodities, 
100%CT as well as DEEM\TM\ Version 7.81 default processing factors were 
used.
    iii. Cancer. Spiromesifen has been classified as ``not likely to be 
carcinogenic to humans.'' Therefore, a cancer dietary risk assessment 
was not performed.
    2. Dietary exposure from drinking water.The Agency lacks sufficient 
monitoring data to complete a comprehensive dietary exposure analysis 
and risk assessment for 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 environmental fate 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 is expected to persist. While parent 
spiromensifen strongly sorbs to sediment and is not likely to be 
mobile, its enol degradate does not sorb to sediment and is expected to 
leach into groundwater. Spiromesifen has limited solubility in water 
and is some cases has been

[[Page 13139]]

reported to have a practical solubility limit of 40 to 50 [mu]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 dissipation half lives ranging from 2 to 10 days. The compound is 
not likely to bioconcentrate appreciably given its relatively rapid 
degradation and depuration.
    Spiromesifen and BSN 2060-enol are the predominant residues in 
drinking water. BSN 2060-enol may account for 75% of the total acute 
exposure and for over 90% for chronic exposure. Estimated drinking 
water concentrations (EDWCs) were generated for the total toxic residue 
which includes spiromesifen, the -enol and -carboxy metabolites, and 
unextracted material. The highest estimated surface water 
concentrations occurred with the NC sweet potato scenario.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentration (EEC) of 
spiromesifen for chronic exposure is estimated to be 11 parts per 
billion (ppb) for surface water. The EEC for chronic exposure is 
estimated to be 28 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 28 ppb was used to access 
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).
    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 FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to 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 EPA's Web site at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. 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 that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for spiromesifen is complete.
    ii. There is no indication that spiromesifen is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. 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.
    iv. 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 or higher. Conservative ground 
and surface water modeling estimates were used. Residential exposure is 
not expected as spiromesifen will be registered for agricultural and 
greenhouse/ornamental uses only. These assessments will not 
underestimate the exposure and risks posed by spiromesifen.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. No such effects were identified in the toxicological 
studies for spiromesifen; therefore, acute exposure is not expected.
    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 42% of the cPAD for the 
population group children 3-5 years old (the greatest exposure). There 
are no residential uses for spiromesifen that result in chronic 
residential exposure to spiromesifen.
    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.
    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.

[[Page 13140]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high performance liquid 
chromatography/mass spectroscopy (HPLC/MS/MS)/ Method 00631/M001, 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: residuemethods@epa.gov.

B. International Residue Limits

    No Codex, Canadian, or Mexican MRLs have been established for 
residues of spiromesifen and its metabolites.

C. Explanation of Tolerance Revisions

    1. Bean, edible podded and cowpea, forage. The tolerances were 
revised based on analysis with the Agency's tolerance spreadsheet in 
accordance with the Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data SOP.
    2. Cowpea, hay. After reviewing the cowpea residue data, EPA 
determined an additional cowpea tolerance was necessary on cowpea hay.
    3. Livestock feed and milk. Based on the dietary exposure levels 
and the residue data from an available ruminant feeding study, data 
indicate that a tolerance of 0.01 ppm is needed in milk, whole, 0.20 
ppm in milk, fat, 0.02 ppm is needed for residues of spiromesifen in 
the meat of cattle, goats, horses, and sheep, 0.15 ppm in meat, 
byproducts, of cattle, goats, horses, and sheep, and 0.10 in the fat of 
cattle, goats, horses, and sheep. Based on the transfer coefficients 
for livestock tissues and the relatively low dietary burden for swine 
of 0.04 ppm for spiromesifen, tolerances in hogs are not needed.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
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), in or on bean, 
dry at 0.02 ppm; bean, succulent at 0.10 ppm; bean, edible podded at 
0.80 ppm; cowpea, forage at 30 ppm; cowpea, hay at 86 ppm; cattle, fat 
at 0.10 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts at 0.15 
ppm; goat, fat at 0.10 ppm; goat, meat at 0.02 ppm; goat, meat 
byproducts at 0.15 ppm; horse, fat at 0.10 ppm; horse, meat at 0.02 
ppm; horse, meat byproducts at 0.15 ppm; milk at 0.01 ppm; milk, fat at 
0.20 ppm; sheep, fat at 0.10 ppm; sheep, meat at 0.02 ppm; and sheep, 
meat byproducts at 0.15 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: March 4, 2008.
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 commodities to 
the table in paragraph (a)(1), and by revising the table in paragraph 
(a)(2) to read as follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry..................................................         0.02
Bean, edible podded........................................         0.80
Bean, succulent............................................         0.10
                                * * * * *
Cowpea, forage.............................................           30

[[Page 13141]]

Cowpea, hay................................................           86
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.10
Cattle, meat...............................................         0.02
Cattle, meat byproducts....................................         0.15
Goat, fat..................................................         0.10
Goat, meat.................................................         0.02
Goat, meat byproducts......................................         0.15
Horse, fat.................................................         0.10
Horse, meat................................................         0.02
Horse, meat byproducts.....................................         0.15
Milk.......................................................         0.01
Milk, fat..................................................         0.20
Sheep, fat.................................................         0.10
Sheep, meat................................................         0.02
Sheep, meat byproducts.....................................         0.15
------------------------------------------------------------------------

[FR Doc. E8-4920 Filed 3-11-08; 8:45 am]

BILLING CODE 6560-50-S