Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 15869 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

X. 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 20, 2009. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention 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 180.1128 is revised to read 

as follows: 

§ 180.1128 Bacillus subtilis MBI 600; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the biofungicide Bacillus subtilis MBI 

600 in or on all food commodities, 

including residues resulting from postharvest uses, when applied or used in 

accordance with good agricultural 

practices. 

[FR Doc. E9–7172 Filed 4–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0167; FRL–8407–8] 

Thiamethoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

thiamethoxam and its metabolite CGA322704 in or on citrus fruits, citrus 

pulp, tree nuts, almond hulls, and 

pistachios. Syngenta Crop Protection, 

Inc., requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective April 

8, 2009. Objections and requests for 

hearings must be received on or before 

June 8, 2009, 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–2008–0167. 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: Julie 

Chao, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8735; e-mail address: 

chao.julie@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 


rwilkins on PROD1PC63 with RULES
15870 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 

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 e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0167 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 June 8, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0167, 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., N.W., 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 April 16, 

2008 (73 FR 20632) (FRL–8359–1), 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 7F7293) by 

Syngenta Crop Protection, Inc., P.O. Box 

18300, Greensboro, NC 27419–8300. 

The petition requested that 40 CFR 

180.565 be amended by establishing 

tolerances for combined residues of the 

insecticide thiamethoxam [3-[(2-chloro5-thiazolyl)methyl]tetrahydro-5-methylN-nitro-4H-1,3,5-oxadiazin-4-imine] and 

its metabolite CGA-322704 [N-(2-chlorothiazol-5-ylmethyl)-N’-methyl-N’-nitroguanidine], in or on fruit, citrus (crop 

group 10) at 0.3 parts per million (ppm); 

almond, nut, tree (crop group 14) 

including pistachio at 0.02 ppm; and 

almond hulls at 1.2 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Inc., 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 

determined that the tolerance level for 

citrus (crop group 10) needs to be 

raised, and that separate tolerances need 

to be established for pistachios and 

citrus, dried pulp. The reasons for these 

changes are 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. . . .’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for combined residues of 

thiamethoxam and its metabolite CGA322704 on nut, tree (crop group 14) at 

0.02 ppm; almond, hulls at 1.2 ppm; 

fruit, citrus (crop group 10) at 0.40 ppm; 

citrus, dried pulp at 0.60 ppm; pistachio 

at 0.02 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. 

Thiamethoxam shows toxicological 

effects primarily in the liver, kidney, 

testes, and hematopoietic system. In 

addition, developmental neurological 

effects were observed in rats. This 

developmental effect is being used to 

assess risks associated with acute 

exposures to thiamethoxam, and the 

liver and testicular effects are the bases 

for assessing longer term exposures. 

Although thiamethoxam causes liver 

tumors in mice, the Agency has 

classified thiamethoxam as ‘‘not likely 

to be carcinogenic to humans’’ based on 

convincing evidence that a nongenotoxic mode of action for liver 

tumors was established in the mouse 

and that the carcinogenic effects are a 

result of a mode of action dependent on 

sufficient amounts of a hepatotoxic 

metabolite produced persistently. The 

non-cancer (chronic) assessment is 

sufficiently protective of the key events 

(perturbation of liver metabolism, 

hepatotoxicity/regenerative 

proliferation) in the animal mode of 

action for cancer published in the 

Federal Register of June 22, 2007 (72 FR 

34401 (FRL–8133–6). Thiamethoxam 

produces a metabolite known as CGA322704 (referred to in the remainder of 

this rule as clothianidin). Clothianidin 

is also registered as a pesticide. While 

some of the toxic effects observed 

following testing with the 

thiamethoxam and clothianidin are 

similar, the available information 

indicates that thiamethoxam and 

clothianidin have different toxicological 

effects in mammals and should be 

assessed separately. A separate risk 

assessment of clothianidin has been 

completed in conjunction with the 

registration of clothianidin. The most 

recent assessment, which provides 

details regarding the toxicology of 

clothianidin are discussed in the final 

rule published in the Federal Register 

of February 6, 2008 (FRL–8346–9) at 

(http://www.epa.gov/fedrgstr/EPAVerDate Nov<24>2008 16:13 Apr 07, 2009 Jkt 217001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\FR\FM\08APR1.SGM 08APR1

rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 15871 

PEST/2008/February/Day-06/ 

p1784.htm). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thiamethoxam as well 

as the no-observed-adverse-effect-level 

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

toxicity studies are discussed in the 

final rule published in the Federal 

Register of June 22, 2007. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for thiamethoxam used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of June 22, 2007. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thiamethoxam, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing thiamethoxam tolerances in (40 

CFR 180.565). EPA assessed dietary 

exposures from thiamethoxam in food 

as follows: 

For both acute and chronic exposure 

assessments for thiamethoxam, EPA 

combined residues of clothianidin 

coming from thiamethoxam with 

residues of thiamethoxam per se. As 

discussed in this unit, thiamethoxam’s 

major metabolite is CGA-322704, which 

is also the registered active ingredient 

clothianidin. Available information 

indicates that thiamethoxam and 

clothianidin have different toxicological 

effects in mammals and should be 

assessed separately, however, these 

exposure assessments for this action 

incorporated the total residue of 

thiamethoxam and clothianidin from 

use of thiamethoxam because the total 

residue for each commodity for which 

thiamethoxam has a tolerance has not 

been separated between thiamethoxam 

and its clothianidin metabolite. The 

combining of these residues, as was 

done in this assessment, results in 

highly conservative estimates of dietary 

exposure and risk. A separate 

assessment was done for clothianidin. 

The clothianidin assessment included 

clothianidin residues from use of 

clothianidin as a pesticide and 

clothianidin residues from use of 

thiamethoxam on those commodities for 

which the pesticide clothianidin does 

not have a tolerance. As to these 

commodities, EPA has separated total 

residues between thiamethoxam and 

clothianidin. 

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. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed maximum 

residues of thiamethoxam and 

clothianidin observed in the 

thiamethoxam field trials. It was also 

assumed that 100% of crops with 

registered or requested uses of 

thiamethoxam and 100% of crops with 

registered or requested uses of 

clothianidin are treated. 

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 maximum 

residues of thiamethoxam and 

clothianidin observed in the 

thiamethoxam field trials. It was also 

assumed that 100% of crops with 

registered or requested uses of 

thiamethoxam and 100% of crops with 

registered or requested uses of 

clothianidin are treated. 

A complete listing of the inputs used 

in these assessments can be found in the 

following documents: Thiamethoxam 

Acute and Chronic Aggregate Dietary 

and Drinking Water Exposure and Risk 

Assessments for FIFRA Section 3 

Registration on Citrus and Tree Nut 

Crops; Clothianidin. Acute and Chronic 

Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments 

for the Section 3 Registration of 

Thiamethoxam on Citrus and Tree Nut 

Crop Groups. These documents are 

available in the docket EPA–HQ–OPP– 

2008–0167, at http:/// 

www.regulations.gov. 

iii. Cancer. A quantitative cancer 

exposure assessment is not necessary 

because EPA concluded that 

thiamethoxam is ‘‘not likely to be 

carcinogenic to humans’’ based on 

convincing evidence that a nongenotoxic mode of action for liver 

tumors was established in the mouse, 

and that the carcinogenic effects are a 

result of a mode of action dependent on 

sufficient amounts of a hepatotoxic 

metabolite produced persistently. The 

non-cancer (chronic) assessment is 

sufficiently protective of the key events 

(perturbation of liver metabolism, 

hepatotoxicity/regenerative 

proliferation) in the animal mode of 

action for cancer and thus a separate 

exposure assessment pertaining to 

cancer risk is not necessary. Because 

clothianidin is not expected to pose a 

cancer risk, a quantitative dietary 

exposure assessment for the purposes of 

assessing cancer risk was not 

conducted. 

iv. Anticipated residue information. 

EPA did not use percent crop treated 

(PCT) information in the dietary 

assessments for thiamethoxam or 

clothianidin. Maximum field trial 

residues and 100 PCT were assumed for 

all food commodities. 

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 


rwilkins on PROD1PC63 with RULES
15872 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to section 408(f)(1) of 

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

FFDCA and authorized under section 

408(f)(1) of FFDCA. 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. Thiamethoxam is expected to be 

persistent and mobile in terrestrial and 

aquatic environments. These fate 

properties suggest that thiamethoxam 

has a potential to move into surface 

water and shallow ground water. The 

Agency lacks sufficient monitoring data 

to complete a comprehensive dietary 

exposure analysis and risk assessment 

for thiamethoxam in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, the 

Agency used screening level water 

exposure models in the dietary exposure 

analysis and risk assessment for 

thiamethoxam in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 

thiamethoxam. 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 

Concentration in Groundwater (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

thiamethoxam for acute exposures are 

12.26 parts per billion (ppb) for surface 

water and 7.94 ppb for ground water. 

The EDWCs for chronic exposures for 

non-cancer assessments are 1.29 ppb for 

surface water and 7.94 ppb for ground 

water. 

The registrant has conducted smallscale prospective ground water studies 

in several locations in the United States 

to investigate the mobility of 

thiamethoxam in a vulnerable 

hydrogeological setting. A review of 

those data shows that generally residues 

of thiamethoxam, as well as CGA322704, are below the limit of 

quantification (0.05 ppb). When 

quantifiable residues are found, they are 

sporadic and at low levels. The 

maximum observed residue levels from 

any monitoring well were 1.0 ppb for 

thiamethoxam and 0.73 ppb for CGA322704. These values are well below the 

modeled estimates summarized in this 

unit, indicating that the modeled 

estimates are, in fact, protective of what 

actual exposures are likely to be. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

both acute and chronic dietary risk 

assessments for thiamethoxam, the 

upper-bound EDWC value of 12.26 ppb 

was used to assess the contribution to 

drinking water. 

Clothianidin is not a significant 

degradate of thiamethoxam in surface or 

ground water sources of drinking water. 

Clothianidin drinking water residues 

only result from uses of clothianidin. 

The acute EDWC value of 7.3 ppb for 

clothianidin was incorporated into the 

acute dietary assessment and the 

chronic EDWC value of 5.9 ppb for 

clothianidin was incorporated into the 

chronic dietary assessment. 

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). 

Thiamethoxam is currently registered 

for the following uses that could result 

in residential exposures: Turfgrass on 

golf courses, residential lawns, 

commercial grounds, parks, 

playgrounds, athletic fields, landscapes, 

interiorscapes and sod farms. EPA 

assessed residential exposure using the 

following assumptions: 

Thiamethoxam is registered for use on 

turfgrass on golf courses, residential 

lawns, commercial grounds, parks, 

playgrounds, athletic fields, landscapes, 

interiorscapes and sod farms. 

Thiamethoxam is applied by 

commercial applicators only. Therefore, 

exposures resulting from homeowner 

applications were not assessed. 

However, entering areas previously 

treated with thiamethoxam could lead 

to exposures for adults and children. As 

a result, risk assessments have been 

completed for postapplication scenarios. 

Short-term exposures (1 to 30 days of 

continuous exposure) may occur as a 

result of activities on treated turf. There 

are no use patterns for thiamethoxam 

that indicate intermediate-term (1 to 6 

months of continuous exposure) or 

chronic non-dietary exposures are likely 

to occur. 

Dermal exposures were assessed for 

adults and children. Oral non-dietary 

ingestion exposures (i.e. soil ingestion, 

and hand-/object-to-mouth) were 

assessed for children as well. Since all 

postapplication scenarios occur 

outdoors the potential for inhalation 

exposure is negligible and therefore 

does not require an inhalation exposure 

assessment. For purposes of this 

assessment, exposure from residential 

lawns is used to represent the worst 

case scenario for both dermal and oral 

postapplication exposure. 

Postapplication dermal exposure 

resulting from contact with treated turf 

was assessed using the EPA’s Standard 

Operating Procedures for Residential 

Exposure and a chemical-specific turf 

transfer residue study. 

Thiamethoxam use on turf does not 

result in significant residues of 

clothianidin. In addition, clothianidin 

residential and aggregate risks are not of 

concern. Refer to the final rule 

published in the Federal Register of 

February 6, 2008 (http://www.epa.gov/ 

fedrgstr/EPA-PEST/2008/February/Day06/p1784.htm). 

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.’’ 

Thiamethoxam is a member of the 

neonicotinoid class of pesticides and 

produces, as a metabolite, another 

neonicotinoid, clothianidin. Structural 

similarities or common effects do not 

constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same sequence of 

major biochemical events (EPA, 2002). 

Although clothianidin and 

thiamethoxam bind selectively to insect 

nicotinic acetylcholine receptors 

(nAChR), the specific binding site(s)/ 

receptor(s) for clothianidin, 

thiamethoxam, and the other 

neonicotinoids are unknown at this 

time. Additionally, the commonality of 

the binding activity itself is uncertain, 

as preliminary evidence suggests that 

clothianidin operates by direct 

competitive inhibition, while 

thiamethoxam is a non-competitive 

inhibitor. Furthermore, even if future 

research shows that neonicotinoids 

share a common binding activity to a 

specific site on insect nicotinic 

acetylcholine receptors, there is not 

necessarily a relationship between this 

pesticidal action and a mechanism of 

toxicity in mammals. Structural 

variations between the insect and 

mammalian nAChRs produce 

quantitative differences in the binding 

affinity of the neonicotinoids towards 

these receptors, which, in turn, confers 

the notably greater selective toxicity of 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 15873 

this class towards insects, including 

aphids and leafhoppers, compared to 

mammals. While the insecticidal action 

of the neonicotinoids is neurotoxic, the 

most sensitive regulatory endpoint for 

thiamethoxam is based on unrelated 

effects in mammals, including effects on 

the liver, kidney, testes, and 

hematopoietic system. Additionally, the 

most sensitive toxicological effect in 

mammals differs across the 

neonicotinoids (e.g., testicular tubular 

atrophy with thiamethoxam; 

mineralized particles in thyroid colloid 

with imidacloprid). 

Thus, EPA has not found 

thiamethoxam or clothianidin to share a 

common mechanism of toxicity with 

any other substances. For the purposes 

of this tolerance action, therefore, EPA 

has assumed that thiamethoxam and 

clothianidin do not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the developmental studies, there is 

no evidence of increased quantitative or 

qualitative susceptibility of rat or rabbit 

fetuses to in utero exposure to 

thiamethoxam. The developmental 

NOAELs are either higher than or equal 

to the maternal NOAELs. The 

toxicological effects in fetuses do not 

appear to be any more severe than those 

in the dams or does. In the rat 

developmental neurotoxicity study, 

there was no quantitative evidence of 

increased susceptibility. 

There is evidence of increased 

quantitative susceptibility for male pups 

in two 2–generation reproductive 

studies. In one study, there are no 

toxicological effects in the dams 

whereas for the pups, reduced 

bodyweights are observed at the highest 

dose level, starting on day 14 of 

lactation. This contributes to an overall 

decrease in bodyweight gain during the 

entire lactation period. Additionally, 

reproductive effects in males appear in 

the F1 generation in the form of 

increased incidence and severity of 

testicular tubular atrophy. These data 

are considered to be evidence of 

increased quantitative susceptibility for 

male pups (increased incidence of 

testicular tubular atrophy at 1.8 

milligrams/kilogram/day (mg/kg/day) 

when compared to the parents (hyaline 

changes in renal tubules at 61 mg/kg/ 

day; NOAEL is 1.8 mg/kg/day). 

In a more recent 2–generation 

reproduction study, the most sensitive 

effect was sperm abnormalities at 3 mg/ 

kg/day (the NOAEL is 1.2 mg/kg/day) in 

the F1 males. This study also indicates 

increased susceptibility for the offspring 

for this effect. 

Although there is evidence of 

increased quantitative susceptibility for 

male pups in both reproductive studies, 

NOAELs and LOAELs were established 

in these studies and the Agency selected 

the NOAEL for testicular effects in F1 

pups as the basis for risk assessment. 

The Agency has confidence that the 

NOAEL selected for risk assessment is 

protective of the most sensitive effect 

(testicular effects) for the most sensitive 

subgroup (pups) observed in the 

toxicological database. 

Due to the finding of quantitative 

sensitivity in the reproduction studies, 

the EPA conducted a degree of concern 

analysis to assess the residual 

uncertainties for prenatal and/or 

postnatal susceptibility. The Agency 

concluded that there is low concern for 

an increased susceptibility in the young 

given: 

i. There was no increased sensitivity 

(qualitative or quantitative) in the rat 

developmental, rabbit developmental 

and rat developmental neurotoxicity 

studies; 

ii. There was a clear NOAEL 

identified for the effects in pups in the 

rat reproduction studies where 

sensitivity was seen; and 

iii. The Agency selected this NOAEL 

as the basis for risk assessment. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

thiamethoxam is largely complete, 

including acceptable/guideline 

developmental toxicity, 2–generation 

reproduction, and developmental 

neurotoxicity studies designed to detect 

adverse effects on the developing 

organism, which could result from the 

mechanism that may have produced the 

decreased alanine amino transferase 

levels. 

The registrant must submit, as a 

condition of registration, an 

immunotoxicity study. This study is 

now required under 40 CFR part 158. 

The available data for thiamethoxam 

show the potential for immunotoxic 

effects, which are described in more 

detail below: 

a. Subchronic Dog - Leukopenia. In 

the subchronic dog study, leukopenia 

(decreased white blood cells) was 

observed in females only, at the highest 

dose tested (HDT) of 50 mg/kg/day; the 

NOAEL for this effect was 34 mg/kg/ 

day. The overall study NOAEL was 9.3 

mg/kg/day in females (8.2 mg/kg/day in 

males) based on hematology and other 

clinical chemistry findings at the 

LOAEL of 34 mg/kg/day (32 mg/kg/day 

in males). 

b. Subchronic Mouse – Spleen weight 

changes. In the subchronic mouse 

study, decreased spleen weights were 

observed in females at 626 mg/kg/day; 

the NOAEL for this effect was the next 

lowest dose of 231 mg/kg/day. The 

overall study NOAEL was 1.4 mg/kg/ 

day (males) based on increased 

hepatocyte hypertrophy observed at the 

LOAEL of 14.3 mg/kg/day. The 

decreased absolute spleen weights were 

considered to be treatment related, but 

were not statistically significant at 626 

mg/kg/day or at the HDT of 1,163 mg/ 

kg/day. Since spleen weights were not 

decreased relative to body weights, the 

absolute decreases may have been 

related to the decreases in body weight 

gain observed at higher doses. 

Overall, the Agency has a low concern 

for the potential for immunotoxicity 

related to these effects for the following 

reasons: 

• In general, the Agency does not 

consider alterations in hematology 

parameters alone to be a significant 

indication of potential immunotoxicity. 

In the case of thiamethoxam, high-dose 

females in the subchronic dog study had 

slight microcytic anemia as well as 

leukopenia characterized by reductions 

in neutrophils, lymphocytes and 

monocytes; the leukopenia was 

considered to be related to the anemic 

response to exposure. Further, 

endpoints and doses selected for risk 

assessment are protective of the 

observed effects on hematology. 

• Spleen weight decreases, while 

considered treatment-related, were 

associated with decreases in body 


rwilkins on PROD1PC63 with RULES
15874 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 

weight gain, and were not statistically 

significant. In addition, spleen weight 

changes occurred only at very high 

doses, more than 70 times higher than 

the doses selected for risk assessment. 

Therefore, an additional 10x safety 

factor is not warranted at this time. 

ii. For the reasons discussed in Unit 

III.D.2., there is low concern for an 

increased susceptibility in the young. 

iii. Although there is evidence of 

neurotoxicity after acute exposure to 

thiamethoxam at doses of 500 mg/kg/ 

day including drooped palpebral 

closure, decrease in rectal temperature 

and locomotor activity and increase in 

forelimb grip strength, no evidence of 

neuropathology was observed. These 

effects occurred at doses at least 

fourteen-fold and 416-fold higher than 

the doses used for the acute, and 

chronic risk assessments, respectively; 

thus, there is low concern for these 

effects since it is expected that the doses 

used for regulatory purposes would be 

protective of the effects noted at much 

higher doses. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on assumption 

that the maximum residues of 

thiamethoxam and clothianidin 

observed in the thiamethoxam field 

trials were remaining on crops. 

Although there is available information 

indicating that thiamethoxam and 

clothianidin have different toxicological 

effects in mammals and should be 

assessed separately, the residues of each 

have been combined in these 

assessments to ensure that the estimated 

exposures of thiamethoxam do not 

underestimate actual potential 

thiamethoxam exposures. An 

assumption of 100 PCT was made for all 

foods evaluated in the assessments. For 

both the acute and chronic assessments 

the acute EDWC of 12.26 ppb (0.0123 

ppm) was used as a worst-case estimate 

of exposure via drinking water. 

Compared to the results from smallscale prospective ground water studies 

where the maximum observed residue 

levels from any monitoring well were 

1.0 ppb for thiamethoxam and 0.73 ppb 

for CGA-322704, the modeled estimates 

are protective of what actual exposures 

are likely to be. Similarly conservative 

Residential SOPs as well as a chemicalspecific turf transfer residue (TTR) 

study were used to assess postapplication exposure to children and 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by thiamethoxam. 

v. The FQPA safety factor for 

clothianidin has been retained as a 10x 

UFDB for the lack of a developmental 

immunotoxicity study. Refer to the final 

rule published in the Federal Register 

of February 6, 2008 (http:// 

www.epa.gov/fedrgstr/EPA-PEST/2008/ 

February/Day-06/p1784.htm). 

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 

thiamethoxam will occupy 3% of the 

aPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Acute dietary exposure from 

food and water to clothianidin is 

estimated to occupy 45% of the aPAD 

for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to thiamethoxam 

from food and water will utilize 42% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Similarly, chronic 

exposure to clothianidin from food and 

water will occupy 16% of the cPAD for 

children 1 to 2 years old. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

thiamethoxam and clothianidin is not 

expected. 

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). 

Thiamethoxam is currently registered 

for uses that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term residential exposures for 

thiamethoxam. The level of concern for 

the margin of exposure (MOE) is 100 for 

aggregate short-term exposures (i.e., 

MOEs less than 100 indicate potential 

risks of concern). The level of concern 

for clothianidin MOEs is 1,000. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

aggregated short-term food, water, and 

residential exposures to thiamethoxam 

result in MOEs of 730 through 2,800 for 

all exposure scenarios for infants, 

children and adults. Aggregate MOEs 

associated with clothianidin range from 

1,100 to 23,000. 

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). 

Thiamethoxam 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 thiamethoxam or 

clothianidin 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. The Agency has classified 

thiamethoxam as not likely to be a 

human carcinogen based on convincing 

evidence that a non-genotoxic mode of 

action for liver tumors was established 

in the mouse and that the carcinogenic 

effects are a result of a mode of action 

dependent on sufficient amounts of a 

hepatotoxic metabolite produced 

persistently. Thiamethoxam is not 

expected to pose a cancer risk. 

Clothianidin has been classified as a 

‘‘not likely to be a human carcinogen.’’ 

It 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 

thiamethoxam or clothianidin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography/ultraviolet (HPLC/UV) 

or mass spectrometry (MS)) 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; email address: residuemethods@epa.gov. 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 15875 

B. International Residue Limits 

There are no CODEX or Mexican 

maximum residue limits (MRLs) for 

thiamethoxam. A number of Canadian 

MRLs exist for this chemical and are in 

accord with U.S. tolerances. The new/ 

revised tolerances established by this 

rule have been derived using the 

NAFTA Tolerance Harmonization 

Spreadsheet. 

C. Revisions to Petitioned-For 

Tolerances 

Available field trial data support a 

tolerance for combined residues of 

thiamethoxam and CGA-322704 in/on 

citrus (group 10) at 0.40 ppm. Therefore, 

the proposed tolerance of 0.30 ppm 

should be raised to 0.40 ppm. 

The data submitted with the petition 

support the proposed tolerance of 0.02 

ppm for tree nuts (group 14). However, 

because the petitioner is seeking a 

tolerance to cover use on pistachios and 

pistachios are not, pending a proposed 

revision of the tree nut group definition, 

included in the tree nut group, a 

separate tolerance should be established 

for pistachio at 0.02 ppm. 

The data supporting the petition 

indicate that combined residues of 

thiamethoxam and CGA-332704 may 

concentrate in dried citrus pulp. 

Therefore, a tolerance for citrus, dried 

pulp should be established and EPA has 

determined that the appropriate level is 

0.60 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of thiamethoxam, 

[3-[(2-chloro-5- 

thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine], and 

its metabolite, CGA-322704 [N-(2- 

chloro-thiazol-5-ylmethyl)-N’-methylN’-nitro-guanidine], in or on nut, tree 

(crop group 14) at 0.02 ppm; almond, 

hulls at 1.2 ppm; fruit, citrus (crop 

group 10) at 0.40 ppm; citrus, dried 

pulp at 0.60 ppm; pistachio at 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 30, 2009. 

Daniel J. Rosenblatt, 

Acting 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 180.565 is amended by 

revising the introductory text in 

paragraph (a); removing the commodity 

‘‘pecan’’ from the table in paragraph (a); 

alphabetically adding the following 

commodities to the table; and removing 

paragraph (b) and reserving the heading 

to read as follows: 

§ 180.565 Thiamethoxam; tolerances for 

residues. 

(a) General. A tolerance is established 

for the combined residues of the 

insecticide thiamethoxam [3-[(2-chloro5-thiazolyl)methyl]tetrahydro-5-methylN -nitro-4 H -1,3,5-oxadiazin-4-imine] 

(CAS Reg. No. 153719–23–4) and its 

metabolite [N-(2-chloro-thiazol-5- 

ylmethyl) -N ′-methyl- N ′-nitroguanidine], calculated as parent 

equivalents, in or on the following raw 

agricultural commodities: 

Commodity Parts per million 

Almond, hulls .................. 1.2 ppm 

*****

Citrus, dried pulp ............ 0.60 ppm 

*****

Fruit, citrus, group 10 ..... 0.40 ppm 

*****

Nut, tree, group 14) ........ 0.02 ppm 

*****

Pistachio ......................... 0.02 ppm 

*****

* * * * * 


rwilkins on PROD1PC63 with RULES
15876 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. E9–7966 Filed 4–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0361; FRL–8406–8] 

Cyhalofop-butyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

cyhalofop-butyl, cyhalofop acid and the 

di-acid metabolite in or on rice, grain 

and rice, wild, grain. Interregional 

Research Project Number 4 (IR-4) and 

Dow AgroSciences, LLC, requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation also removes the expired, 

time-limited tolerances for residues of 

cyhalofop-butyl, cyhalofop acid and the 

di-acid metabolite in or on on rice, grain 

and rice, straw. 

DATES: This regulation is effective April 

8, 2009. Objections and requests for 

hearings must be received on or before 

June 8, 2009, 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–2008–0361. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0361 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 June 8, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0361, 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 Registers of June 4, 

2008 (73 FR 31862) (FRL–8365–3) and 

August 29, 2008 (73 FR 50963) (FRL– 

8379–2), EPA issued notices pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8E7341) by 

Interregional Research Project Number 4 

(IR-4), 500 College Road East, Suite 

201W, Princeton, NJ, 08540; and a 

pesticide petition (PP 8F7403) by Dow 

AgroSciences, LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268, respectively. 

The petitions requested that 40 CFR 

180.576 be amended by establishing 

tolerances for combined residues of the 

herbicide cyhalofop-butyl, R-(+)-nbutyl-2-(4(4-cyano-2-fluorophenoxy)- 

phenoxy)propionate, plus cyhalofop 

acid, R-(+)-2-(4(4-cyano-2- 

fluorophenoxy)-phenoxy)propionic 

acid) and the di-acid metabolite, (2R)-4- 

[4-(1-carboxyethoxy)phenoxy]-3- 

fluorobenzoic acid, in or on rice, grain 

(PP 8F7403) and rice, wild, grain (PP 

8E7341) at 0.03 parts per million (ppm); 


rwilkins on PROD1PC63 with RULES