Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Rules and Regulations 3075 

ARIZONA—SO2—Continued 

Designated area 

Does not meet 

primary 

standards 

Does not meet 

secondary 

standards 

Cannot be 

classified 

Better than 

national 

standards 

T1S, R141⁄2E ............................................................................................. ........................ ........................ ........................ X 

T1S, R15E ................................................................................................. ........................ ........................ ........................ X 

T2N, R13E1 .............................................................................................. ........................ ........................ X ........................

T2N, R16E ................................................................................................ ........................ ........................ X ........................

T1N, R16E ................................................................................................ ........................ ........................ X ........................

T1S, R13E1 .............................................................................................. ........................ ........................ X ........................

T1S, R16E ................................................................................................. ........................ ........................ X ........................

T2S, R14E1 .............................................................................................. ........................ ........................ X ........................

T2S, R15E ................................................................................................. ........................ ........................ X ........................

* * * * * * * 

1Only that portion in Gila County. 

* * * * * 

[FR Doc. E7–996 Filed 1–23–07; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


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3076 Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Rules and Regulations 

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 (IR4), 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://www.epa.gov/fedrgstr/EPA-PEST/ 

2003/July/Day-30/p19357.htm. 

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-observedadverse-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 


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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 nonthreshold 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/EPAFRCONTENTS/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-FCIDTM), 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) 

DEEMTM 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 (SCIGROW) 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-FCIDTM using 

the estimated drinking water 

concentration generated by the SCIGROW (version 2.3) model of 28 ppb. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, 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 


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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% croptreated 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, 


rmajette on PROD1PC67 with RULES
Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 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: 

§180.607 Spiromesifen; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Vegetable, fruiting, group 8 ...... 0.45 

* * * * * 

* * * * * 

(d) * * * 

Commodity Parts per 

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] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

42 CFR Part 51a 

RIN # 0906–AA70 

Healthy Tomorrows Partnership for 

Children Program (HTPC) 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Final rule. 

SUMMARY: This Final Rule sets forth the 

Secretary’s proposal to require HTPC 

grant recipients to contribute nonFederal matching funds in years 2 

through 5 of the project period equal to 

two times the amount of the Federal 

Grant Award or such lesser amount 


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