5518 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

Commodity Parts per million Expiration/revocation date 

*****

Corn, sweet, plus cobs with husks removed (K+CWHR) ................................... 0.02 12/31/12 

Corn, sweet, forage ............................................................................................. 6.0 12/31/12 

Corn, sweet, stover .............................................................................................. 2.5 12/31/12 

* * * * * 

[FR Doc. 2010–2148 Filed 2–2–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0460; FRL–8808–8] 

Dithianon; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of dithianon in or 

on grapes that are imported. BASF 

requested this tolerance 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–2007–0460 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: Rose 

Kearns, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; e-mail address: 

kearns.rosemary@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 those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 

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–2007–0460 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–2007–0460, 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 

4, 2009 (74 FR 57170) (FRL–8797–7), 

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 6E7103) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.621 be amended by 

establishing a tolerance for residues of 

the fungicide dithianon, 5,10-dihydro-5- 

10-dioxonaptho(2,3-b)-1,4-dithiin-2,3- 

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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 5519 

dicarbonitrile, in or on grapes at 3 parts 

per million (ppm). That notice 

referenced a summary of the petition 

prepared by BASF, 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. 

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 

tolerance, for residues of dithianon on 

grape at 3 ppm. 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. 

The acute toxicity is mild via the oral 

route. The toxicologically significant 

adverse effects of dithianon are similar 

across species. In studies with shorter 

durations of exposure, including the 

subchronic dog and rat studies, the 

developmental toxicity study in rats, 

and the 2-generation reproduction rat 

study, decreases in body weight, body 

weight gain, and/or food consumption 

were noted in adults. However, with 

continued exposure, as in the chronic 

and/or carcinogenicity studies in the rat, 

mouse, and dog, the kidney is the target 

organ for toxicity. Signs of renal toxicity 

include increased absolute and/or 

relative kidney weights in the rat, 

mouse, and dog; non-neoplastic kidney 

lesions in mice and rats; and renal 

adenomas and carcinomas in female 

rats. Post-implantation loss due to early 

resorptions was observed in the 

developmental rat study. 

The available toxicology database 

does not show any indication of 

increased qualitative or quantitative 

susceptibility of the offspring. Dithianon 

did not cause reproductive or 

developmental toxicity in the 2- 

generation reproduction study. In the 

developmental rat study, decreased fetal 

weights were observed only at a dose 

higher than that which produced similar 

maternal effects. The developmental 

toxicity study in rabbits was classified 

unacceptable/guideline. 

Carcinogenicity studies in rats and 

mice do not raise a concern as to 

carcinogenicity. The only treatmentrelated tumors, rare kidney tumors, 

(primarily adenomas), were seen only at 

the highest dose tested (30 milligram/ 

kilogram/day (mg/kg/day)) in one sex 

(females) and in one species (rats). The 

highest dose tested was considered 

adequate, but not excessive, to assess 

the carcinogenicity of dithianon; 

however, significant renal toxicity 

occurred at this dose, which may have 

contributed to the tumor formulation. 

Although the Agency concluded that 

there was not a sufficient or cohesive 

dataset at the time to fully support a 

mode of action, it is biologically 

plausible that the tumors were caused 

by a non-genotoxic mode of action 

involving hephrotoxicity and sustained 

regenerative proliferation. Further, 

dithianon is not mutagenic. Dithianon 

produced positive results in an 

acceptable chromosomal aberration 

assay that was conducted in vitro using 

Chinese hamster lung fibroblasts (V79 

cells); in contrast, a forward gene 

mutation assay tested in this same cell 

line was negative. A second forward 

gene mutation assay with V79 cells was 

also negative, but it was classified 

unacceptable due to inadequate 

cytotoxicity at the highest concentration 

tested. Negative responses were seen in 

bacteria (two acceptable reverse gene 

mutation assays in Salmonella), Wistar 

rat systems (an acceptable in vivo 

cytogenetic assay and an acceptable in 

vitro UDS assay), and NMRI mice (an 

unacceptable in vivo micronucleus 

assay). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by dithianon as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Dithianon-Human Health Risk 

Assessment for Proposed Tolerance on 

Imported Grapes,’’ at pages 9–12 in 

docket ID number EPA–HQ–OPP–2007– 

0460. 

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 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 dithianon used for human 

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5520 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

risk assessment can be found at http:// 

www.regulations.gov in the document 

‘‘Dithianon — Human Health Risk 

Assessment for Proposed Tolerance on 

Imported Grapes,’’ at pages 20–24 in 

docket ID number EPA–HQ–OPP–2007– 

0460. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dithianon, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

dithianon tolerances in (40 CFR 

180.621). EPA assessed dietary 

exposures from dithianon 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 

applicable to the general population in 

the toxicological studies for dithianon; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

However an endpoint was identified for 

females 13–49 years of age. In 

conducting the acute dietary exposure 

assessment EPA used the Dietary 

Exposure Evaluation Model-Food 

Commodity Intake Database (DEEMFCID, version 2.03). EPA assumed that 

dithianon is used on all crops covered 

by tolerances and that all treated crops 

bear tolerance-level residues. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM-FCID, version 2.03. 

EPA assumed that dithianon is used on 

all crops covered by tolerances and that 

all treated crops bear average values 

from crop residue field trials. 

iii. Cancer. For the reasons explained 

in Unit III.A., EPA has concluded that 

dithianon does not pose a cancer risk 

and therefore an exposure assessment 

for the purpose of evaluating cancer risk 

is unnecessary. 

iv. Anticipated residue information. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. Current and proposed tolerances 

for dithianon are intended to support 

imported commodities only and there 

are no existing or proposed U.S. 

registrations. Therefore, there is no 

expectation that dithianon residues 

would occur in surface or ground water 

sources of drinking water. 

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). 

Dithianon is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found dithianon to share 

a common mechanism of toxicity with 

any other substances, and dithianon 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that dithianon 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 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 indication of increased 

quantitative or qualitative susceptibility 

of rats to in utero and/or postnatal 

exposure to dithianon. 

3. Conclusion. The FQPA Safety 

Factor will be retained at 10X as a 

database uncertainty factor for acute and 

chronic assessments. The primary 

reason for retaining the FQPA safety 

factor is residual uncertainty concerning 

lack of an acceptable rabbit 

development study. In deciding to 

retain the safety factor EPA also took 

into account the following 

considerations: 

i. Immunotoxicity testing is required 

as a result of changes made to the 

pesticide data requirements in 

December 2007. Although a study has 

not yet been submitted, there is no 

evidence of immunotoxicity in any 

study in the toxicity database for 

dithianon and the Agency does not 

believe that conducting an 

immunotoxicity study will result in a 

lower POD than that currently used for 

overall risk assessment. Therefore, a 

database uncertainty factor (UFDB ) is 

not needed to account for the lack of 

this study. 

ii. Acute and subchronic 

neurotoxicity testing is required as a 

result of changes made to the pesticide 

data requirements in December 2007. 

Although these studies have not yet 

been submitted, there is no evidence of 

neurotoxicity in any study in the 

toxicity database for dithianon and the 

Agency does not believe that conducting 

these studies will result in a lower POD 

than that currently used for overall risk 

assessment. Therefore, a UFDB is not 

needed to account for the lack of this 

study. For the same reason, EPA has 

determined that there is no need for a 

developmental neurotoxicity study. 

iii. There is no evidence that 

dithianon results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental study 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 for the acute 

analysis and reliable data on average 

field trial residues in the chronic 

analysis. The exposure assessments will 

not understate exposure to dithianon. 

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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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

dithianon will occupy 79% of the aPAD 

for (females 13–49 years of age at the 

95th percentile of exposure) the 

population group receiving the greatest 

exposure. 

2. Chronic risk. The exposure for all 

populations assessed are below the level 

of concern. The exposure for the general 

U.S. population is at 18% of cPAD. The 

most highly exposed sub-group is 

children ( 1–2 years old), whose 

exposure is at 63% of the cPAD. This 

assessment is slightly refined with use 

of average residue values and empirical 

processing factors, but is still highly 

conservative with the assumption of 

100% CT. There are no residential uses 

for dithianon. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Dithianon 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 dithianon through food and 

water and will not be greater than the 

chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Dithianon is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to dithianon through food and 

water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. As described in Unit III.A. 

above, dithianon is not expected to pose 

a cancer risk. 

6. 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 dithianon 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate methodology LC/MS/MS 

method (BASF 244882) is available for 

enforcing the proposed tolerance on 

grapes. Adequate multi-residue method 

testing data are available for dithianon 

and these data have been forwarded to 

the FDA for evaluation. The data 

indicate that FDA multi-residue 

methods are not suitable for 

determining residues of dithianon. 

B. International Residue Limits 

There are currently no established 

Canadian or Mexican maximum residue 

limits (MRLs) for dithianon on grapes. 

There are no harmonization concerns 

with MRL’s on grapes established by 

Codex and the European Union because 

the grape tolerance being established is 

equivalent to these MRLs both in terms 

of residue expression and residue level. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the dithianon 

tolerance expression to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover residues of dithianon 

and its metabolites and degradates but 

that compliance with tolerance levels 

will be determined by measuring only 

dithianon, (5,10-dihydro-5,10- 

dioxonaphtho(2-3-b)-1,4-dithiin-2,3- 

dicarbonitrile), in or on the 

commodities that have an established 

tolerance level. EPA has determined 

that it is reasonable to make this change 

final without prior proposal and 

opportunity for comment, because 

public comment is not necessary, in that 

the change has no substantive effect on 

the tolerance, but rather is merely 

intended to clarify the existing tolerance 

expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of dithianon, 5,10-dihydro5,10-dioxonaphtho(2,3-b)-1,4-dithiin2,3-dicarbonitrile, in or on grapes at 3 

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 

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5522 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

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. 

■ 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 180.621 is revised to read 

as follows: 

§ 180.621 Dithianon; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of dithianon, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

dithianon, 5, 10-dihydro-5,10- 

dioxonaphtho(2,3-b)-1,4-dithiin-2,3- 

dicarbonitrile. 

Commodity Parts per 

million 

Fruit, pome, group 111 ......... 5 

Grape 2 ................................. 3 

Hop, dried cones1 ................. 100 

1No U.S. registration as of September 5, 

2006. 2No U.S. registration as of January 29, 

2010. 

(b)Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2010–2145 Filed 2–2–10; 8:45 am] 

BILLING CODE 6560–50–S 

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: 

gaines.jennifer@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 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 

WReier-Aviles on DSKGBLS3C1PROD with RULES