Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 12731 

the free form of its acide metabolite CG– 

321113 [(E,E)-(methoxyimino)-[2-[1-(3-

(trifluoromethylphenyl)- 

ethylideneaminooxymethyl]-

phenyl]acetic acid, in or on imported 

coffee, green bean 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) (Pub. L. 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: February 17, 2012. 

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 180.555 is amended by 

alphabetically adding the following 

commodity and footnote 2 to the table 

in paragraph (a) to read as follows: 

§ 180.555 Trifloxystrobin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Coffee, green bean 2 ................. 0.02 

Commodity Parts per 

million 

* * * * * 

* * * * * 

2There are no U.S. registrations as of January 18, 2012 for use on coffee, green bean. 

* * * * * 

[FR Doc. 2012–4977 Filed 3–1–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–1079; FRL–9331–8] 

Thiamethoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiamethoxam 

in or on multiple commodities which 

are identified and discussed later in this 

document. Syngenta Crop Protection, 

Inc. requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

March 2, 2012. Objections and requests 

for hearings must be received on or 

before May 1, 2012, 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–2010–1079. 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. 


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FOR FURTHER INFORMATION CONTACT: 

Gene Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0235; email address: 

Benbow.Gene@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 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2010–1079 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before May 1, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–1079, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 26, 

2011 (76 FR 53372) (FRL–8884–9), 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 0F7805) by 

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

18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.565 

be amended by establishing tolerances 

for residues of the insecticide 

thiamethoxam, 3-[(2-chloro-5- 

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

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

yl)methyl]-N’-methyl-N’’-nitroguanidine], in or on: buckwheat, grain at 

0.02 per million (ppm); buckwheat, 

forage at 0.50 ppm; buckwheat, hay at 

0.02 ppm; buckwheat, straw at 0.02 

ppm; oat, grain at 0.02 ppm; oat, forage 

at 0.50 ppm, oat, hay at 0.02 ppm; oat, 

straw at 0.02 ppm; millet, pearl, grain at 

0.02 ppm; millet, pearl, forage at 0.02 

ppm; millet, pearl, stover at 0.02 ppm; 

millet, proso, grain at 0.02 ppm; millet, 

proso, forage at 0.02 ppm; millet, proso, 

stover at 0.02 ppm; millet, proso, straw 

at 0.02 ppm; rye, grain at 0.02 ppm; rye, 

forage at 0.50 ppm; rye, straw at 0.02 

ppm; teosinte, grain at 0.02 ppm; 

teosinte, forage at 0.10 ppm; teosinte, 

stover at 0.05 ppm; triticale, grain at 

0.02 ppm; triticale, forage at 0.05 ppm; 

triticale, hay at 0.02 ppm; triticale, straw 

at 0.02 ppm; wild rice, grain at 0.02 

ppm. That notice referenced a summary 

of the petition prepared by Syngenta 

Crop Protection, Inc., the registrant, 

which is available 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 thiamethoxam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with thiamethoxam 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. 


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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 basis 

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. 

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 can be found at http:// 

www.regulations.gov in section 4.5.1 in 

the document ‘‘Thiamethoxam—Human 

Health Risk Assessement for Crop 

Group 15 (including buckwheat, pearl 

millet, proso millet, oats, rye, teosinte, 

triticale) and Crop Group 16 

Commodities (forage, fodder and straw 

of cereal grains group)’’ in docket ID 

number EPA–HQ–OPP–2010–1079 at 

http://www.regulations.gov. 

Thiamethoxam produces a metabolite 

known as CGA–322704 (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 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, 

is available in the docket EPA–HQ– 

OPP–2008–0945, at http:// 

www.regulations.gov. Refer to the 

document ‘‘Clothianidin: Human Health 

Risk Assessment for the Requested New 

Use on Mustard Seen as well as New 

Uses of Thiamethoxam on Peanuts, 

Alfalfa, in Food-Handling 

Establishments, and as a Seed 

Treatment for Cereal Grains.’’ 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors (U/S F) are used in 

conjunction with the POD to calculate a 

safe exposure level—generally referred 

to as a population-adjusted dose (PAD) 

or a reference dose (RfD)—and a safe 

margin of exposure (MOE). For nonthreshold 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 

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 shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIAMETHOXAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (All populations including infants and children).NOAEL = 34.5 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1 

Acute RfD = 0.35 mg/ 

kg/day.

aPAD = 0.35 mg/kg/day 

Rat Developmental Neurotoxicity study. 

LOAEL = 298.7 mg/kg/day based on delayed sexual maturation 

in male pups, and reduced brain morphometric measurements. 

Chronic dietary (All populations including infants and children).NOAEL = 1.2 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1 

Chronic RfD = 0.012 

mg/kg/day.

cPAD = 0.012 mg/kg/ 

day.

2-Generation reproduction study. 

1. LOAEL = 1.8 mg/kg/day based on increased incidence and 

severity of tubular atrophy in testes of F1 generation males. 

2-Generation reproduction study. 

2. LOAEL = 3 (males), not determined (females) mg/kg/day 

based on sperm abnormalities in F1 males. 

Incidental oral (all durations).NOAEL = 8.23 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1 

MOE = 100 (residential) 90-day Dog study. 

LOAEL = 32 (males) 33.9 (females) mg/kg/day based on slightly 

prolonged prothrombin times and decreased plasma albumin 

and A/G ratio (both sexes); decreased calcium levels and 

ovary weights and delayed maturation in the ovaries (females); decreased cholesterol and phospholipid levels, testis 

weights, spermatogenesis, and spermatic giant cells in testes 

(males). 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIAMETHOXAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Dermal (all durations) 

(Adults).

Oral study NOAEL = 

1.2 mg/kg/day (dermal absorption rate = 

5%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1 

MOE = 100 (residential) 2-Generation reproduction study. 

LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. 

2-Generation reproduction study. 

LOAEL = 3 (males), not determined (females) mg/kg/day based 

on sperm abnormalities in F1 males. 

Dermal (all durations) 

(infants/children 1–6 

yrs).

Dermal study NOAEL = 

60 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1 

MOE = 100 (residential) Rat 28-Day Dermal Toxicity Study. 

LOAEL = 250 (females) mg/kg/day based on increased plasma 

glucose, triglyceride levels, and alkaline phosphatase activity 

and inflammatory cell infiltration in the liver and necrosis of 

single hepatocytes in females. 

Inhalation (all durations) Oral study NOAEL = 

1.2 mg/kg/day (inhalation absorption rate 

= 100% of oral absorption) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1 

MOE = 100 (residential) 2-Generation reproduction study. 

LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. 

2-Generation reproduction study. 

LOAEL = 3 (males), not determined (females) mg/kg/day based 

on sperm abnormalities in F1 males. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. mg/kg/day = milligrams/kilogram/day. 

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 in 

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. Such effects were identified 

for thiamethoxam. 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). For 

residue levels in food, EPA assumed 

tolerance level residues of 

thiamethoxam and clothianidin. It was 

further assumed that 100% of crops 

with registered or requested uses of 

thiamethoxam and 100% of crops with 

registered or requested uses of 

clothianidin were 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. For residue levels 

in food, EPA assumed tolerance level 

and/or anticipated residues (averages) 

from field trial data. It was again 

assumed that 100% of crops with 

registered or requested uses of 

thiamethoxam and 100% of crops with 

registered or requested uses of 

clothianidin were treated. 

A complete listing of the inputs used 

in these assessments can be found in the 

following documents: ‘‘Thiamethoxam. 

Acute and Chronic Aggregate Dietary 

(Food and Drinking Water) Exposure 

and Risk Assessments for the Section 3 

Registration on Crop Group 15/16 

Commodities’’ available in the docket 

EPA–HQ–OPP–2010–1079, at http:// 

www.regulations.gov; and 

‘‘Clothianidin—Acute and Chronic 

Aggregate Dietary (Food and Drinking 

Water) Exposure and Risk Assessments 

to Evaluate Requested Uses on Mustard 

Seed and Requested uses of 

Thiamethoxam on Peanuts, in FoodHandling Establishments, and as a Seed 

Treatment for Cereal Grains,’’ available 

in the docket EPA–HQ–OPP–2008– 

0945, at http://www.regulations.gov. 

iii. Cancer. 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 


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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. 

2. Dietary exposure from drinking 

water. 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 Tier 1 Rice Model for 

surface water and the Screening 

Concentration in Ground Water (SCI– 

GROW) model for ground water, the 

estimated drinking water concentrations 

(EDWCs) of thiamethoxam for acute 

exposures are estimated to be 0.13177 

ppm for surface water and 0.00466 ppm 

for ground water. The chronic exposure 

for surface water and ground water is 

estimated to be 0.01131 ppm and 

0.00466 ppm respectively. Modeled 

estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

Since clothianidin is not a significant 

degradate of thiamethoxam in surface 

water or ground water sources of 

drinking water, it was not included in 

the EDWCs for the thiamethoxam 

dietary assessment. For the clothianidin 

assessments, the EDWC value of 0.0724 

ppm for clothianidin was incorporated 

into the acute and chronic dietary 

assessments. 

A complete listing of the inputs used 

in these assessments can be found in the 

following documents: ‘‘Thiamethoxam. 

Acute and Chronic Aggregate Dietary 

(Food and Drinking Water) Exposure 

and Risk Assessments for the Section 3 

Registration on Crop Group 15/16 

Commodities’’ available in the docket 

EPA–HQ–OPP–2010–1079, at http:// 

www.regulations.gov; and ‘‘Tier I 

Drinking Water Exposure Assessment 

for the Section 3 New Uses of 

Clothianidin on Rice and Leafy 

Vegetables,’’ available in the docket 

EPA–HQ–OPP–2008–0945, at http:// 

www.regulations.gov. 

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, sod farms, and indoor 

crack and crevice or spot treatments to 

control insects in residential settings. 

EPA assessed residential exposure using 

the assumption that thiamethoxam is 

applied by commercial applicators only. 

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 postapplication exposures 

(1 to 30 days of continuous exposure) 

may occur as a result of activities on 

treated turf or entering indoor areas 

previously treated with a thiamethoxam 

indoor crack and crevice product. EPA 

combined all non-dietary sources of 

children’s post application exposure to 

obtain an estimate of potential 

combined exposure. These scenarios 

consisted of dermal postapplication 

exposure and oral (hand-to-mouth) 

exposures for children 3 to 6 years of 

age. 

A complete listing of the inputs used 

in these assessments can be found in the 

document ‘‘Thiamethoxam—Human 

Health Risk Assessment for Crop Group 

15 (including buckwheat, pearl millet, 

proso millet, oats, rye, teosinte, triticale) 

and Crop Group 16 Commodities 

(forage, fodder and straw of cereal grains 

group)’’ in docket ID number EPA–HQ– 

OPP–2010–1079 at http:// 

www.regulations.gov. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

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. 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 

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 Web site 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 


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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. 

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; however, there 

was increased qualitative susceptibility 

because the effects in the pups (reduced 

brain weight and significant changes in 

brain morphometric measurements) 

were considered to be more severe than 

findings in the dams (decreased body 

weight gain and food consumption). 

There is evidence of increased 

quantitative susceptibility for male pups 

in both 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. The 

reproductive effects in males appear in 

the F1 generation in the form of 

increased incidence and severity of 

testicular tubular atrophy (see 

developmental/reproductive section). 

These data are considered to be 

evidence of increased quantitative 

susceptibility for male pups (increased 

incidence of testicular tubular atrophy 

at 1.8 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) for the most sensitive 

subgroup (pups) observed in the 

toxicological database. 

3. Conclusion. i. In the final rule 

published in the Federal Register of 

January 5, 2005 (70 FR 708) (FRL–7689– 

7), EPA had previously determined that 

the FQPA SF should be retained at 10X 

for thiamethoxam, based on the 

following factors: Effects on endocrine 

organs observed across species; 

significant decrease in alanine amino 

transferase levels in companion animal 

studies and in dog studies; the mode of 

action of this chemical in insects 

(interferes with the nicotinic 

acetylcholine receptors of the insect’s 

nervous system); the transient clinical 

signs of neurotoxicity in several studies 

across species; and the suggestive 

evidence of increased quantitative 

susceptibility in the rat reproduction 

study. Since that determination, EPA 

has received and reviewed a 

developmental neurotoxicity (DNT) 

study in rats, and an additional 

reproduction study in rats. Taking the 

results of these studies into account, as 

well as the rest of the data on 

thiamethoxam, 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 (June 23, 2010, 75 FR 35653; FRL– 

8830–4); (June 22, 2007, 72 FR 34401). 

That decision is based on the following 

findings: 

a. The toxicity database for 

thiamethoxam is largely complete, 

including acceptable/guideline 

developmental toxicity, 2-generation 

reproduction, and DNT 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 available 

data for thiamethoxam show the 

potential for immunotoxic effects. 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). 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 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. 

In addition to the previous 

considerations, a 28-day 

immunotoxicity study in female mice 

was recently received and has 

undergone a preliminary review. There 

were no immunotoxic effects observed 

at doses exceeding the limit dose of 

1,000 mg/kg/day. 

b. For the reasons discussed in Unit 

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

increased susceptibility in the young. 

c. 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 14-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. 

In the developmental neurotoxicity 

study (DNT), there was no evidence of 

neurotoxicity in the dams exposed up to 

298.7 mg/kg/day; a dose that was 

associated with decreases in body 

weight gain and food consumption. In 

pups exposed to 298.7 mg/kg/day, there 


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were significant reductions in absolute 

brain weight and size (i.e., length and 

width of the cerebellum was less in 

males on day 12, and there were 

significant decreases in Level 3–5 

measurements in males and in Level 4– 

5 measurements in females on day 63). 

However, there is low concern for this 

increased qualitative susceptibility 

observed in the DNT study because the 

doses and endpoints selected for risk 

assessment are protective of the effects 

in the offspring. As noted previously, 

for risk assessment the Agency selected 

the NOAEL for testicular effects in F1

pups based on two reproductive toxicity 

studies to be protective of all sensitive 

subpopulations. 

d. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed using tolerance-level 

and/or anticipated residues that are 

based on reliable field trial data 

observed in the thiamethoxam field 

trials. 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 

percent crop treated (PCT) was made for 

all foods evaluated in the assessments. 

For the acute and chronic assessments, 

the EDWCs of 131.77 parts per billion 

(ppb) and 11.3 ppb, respectively, were 

used to estimate exposure via drinking 

water. Compared to the results from 

small scale 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 clothianidin, the modeled 

estimates are protective of what actual 

exposures are likely to be. EPA used 

similarly conservative (protective) 

assumptions to assess postapplication 

exposure to children and adults 

including incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by thiamethoxam. 

ii. In the final rule published in the 

Federal Register of February 6, 2008 (73 

FR 6851) (FRL–8346–9), EPA had 

previously determined that the FQPA 

SF for clothianidin should be retained at 

10X because EPA had required the 

submission of a developmental 

immunotoxicity study to address the 

combination of evidence of decreased 

absolute and adjusted organ weights of 

the thymus and spleen in multiple 

studies in the clothianidin database, and 

evidence showing that juvenile rats in 

the 2-generation reproduction study 

appear to be more susceptible to these 

potential immunotoxic effects. In the 

absence of a developmental 

immunotoxicity study, EPA concluded 

that there was sufficient uncertainty 

regarding immunotoxic effects in the 

young that the 10X FQPA factor should 

be retained as a database uncertainty 

factor. 

Since that determination, EPA has 

received and reviewed an acceptable/ 

guideline developmental 

immunotoxicity study, which 

demonstrated no treatment-related 

effects. Taking the results of this study 

into account, as well as the rest of the 

data on clothianidin, EPA has 

determined that reliable data show the 

safety of infants and children would be 

adequately protected if the FQPA SF for 

clothianidin were reduced to 1X 

(February 11, 2011, 76 FR 7712) (FRL– 

8858–3). That decision is based on the 

following findings: 

a. The toxicity database for 

clothianidin is complete. As noted, the 

prior data gap concerning 

developmental immunotoxicity has 

been addressed by the submission of an 

acceptable developmental 

immunotoxicity study. 

b. A rat developmental neurotoxicity 

study is available and shows evidence 

of increased quantitative susceptibility 

of offspring. However, EPA considers 

the degree of concern for the 

developmental neurotoxicity study to be 

low for prenatal and postnatal toxicity 

because the NOAEL and LOAEL were 

well characterized, and the doses and 

endpoints selected for risk assessment 

are protective of the observed 

susceptibility; therefore, there are no 

residual concerns regarding effects in 

the young. 

c. While the rat multi-generation 

reproduction study showed evidence of 

increased quantitative susceptibility of 

offspring compared to adults, the degree 

of concern is low because the study 

NOAEL and LOAEL have been selected 

for risk assessment purposes for relevant 

exposure routes and durations. In 

addition, the potential immunotoxic 

effects observed in the study have been 

further characterized with the 

submission of a developmental 

immunotoxicity study that showed no 

evidence of susceptibility. As a result, 

there are no concerns or residual 

uncertainties for prenatal and postnatal 

toxicity after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment for 

clothianidin. 

d. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on assumptions 

that were judged to be highly 

conservative and health-protective for 

all durations and population subgroups, 

including tolerance-level residues, 

adjustment factors from metabolite data, 

empirical processing factors, and 100 

PCT for all commodities. Additionally, 

EPA made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to clothianidin in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children and adults as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by clothianidin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer 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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

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 9.5% of the 

aPAD for All infants (<1 year), the 

population group receiving the greatest 

exposure. Acute dietary exposure from 

food and water to clothianidin is 

estimated to occupy 23% of the aPAD 

for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. In examining chronic 

aggregate risk, EPA has assumed that the 

only pathway of exposure relevant to 

that time frame is dietary exposure. 

Using this assumption for chronic 

exposure, EPA has concluded that 

chronic exposure to thiamethoxam from 

food and water will utilize 43% of the 

cPAD for Children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Chronic exposure to 

clothianidin from food and water will 

utilize 19% of the cPAD for children 1 

to 2 years old, the population group 

receiving the greatest exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 


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(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 exposure through food 

and water with short-term residential 

exposures to thiamethoxam. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures for thiamethoxam 

result in aggregate MOEs of: 370 for the 

general U.S. population; 490 for all 

infants; 440 for children 1 to 2 years; 

450 for children 3 to 5 years; 370 for 

children 6 to 12 years; 380 for youth 13 

to 19 years, adults 20 to 49 years, adults 

50+ years, and females 13 to 49 years. 

Because EPA’s level of concern for 

thiamethoxam is a MOE of 100 or 

below, these MOEs are not of concern. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures for clothianidin 

result in aggregate MOEs of: 1,200 for 

the general U.S. population; 480 for all 

infants (<1 year); 370 for children 1 to 

2 years; 490 for children 3 to 5 years; 

1,000 for children 6 to 12 years; 1,400 

for youth 13 to 19 years, adults 20–49 

years, and females 13 to 49 years; and 

1,300 for adults 50+ years. Because 

EPA’s level of concern for clothianidin 

is a MOE of 100 or below, these MOEs 

are not of concern. 

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 currently registered 

for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to thiamethoxam. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures for 

thiamethoxam result in aggregate MOEs 

of: 370 for the general U.S. population; 

540 for all infants (<1 year); 470 for 

children 1 to 2 years; 490 for children 

3 to 5 years; 370 for children 6 to 12 

years; 380 for youth 13 to 19 years, 

adults 20 to 49 years, adults 50+ years, 

and females 13 to 49 years. Because 

EPA’s level of concern for 

thiamethoxam is a MOE of 100 or 

below, these MOEs are not of concern. 

Using the exposure assumptions 

described in this unit for intermediate 

exposures, EPA has concluded the 

combined intermediate food, water, and 

residential exposures for clothianidin 

result in aggregate MOEs of: 1,200 for 

the general U.S. population; 480 for all 

infants (<1 year); 370 for children 1 to 

2 years; 490 for children 3 to 5 years; 

1,000 for children 6 to 12 years; 1,400 

for youth 13 to 19 years, adults 20 to 49 

years, and females 13 to 49 years; and 

1,300 for adults 50+ years. Because 

EPA’s level of concern for clothianidin 

is a MOE of 100 or below, these MOEs 

are not of concern. 

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. Therefore, thiamethoxam is 

not expected to pose a cancer risk. 

Clothianidin has been classified as ‘‘not 

likely to be a human carcinogen’’ and 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 

The High Production Liquid 

Chromatography (HPLC) Method AG– 

675 with ultraviolet (UV) or Mass 

Spectrometry (MS) detection was 

previously submitted in conjunction 

with thiamethoxam petitions. Method 

AG–675 has been determined to be 

adequate for enforcing the tolerance 

expression for residues of thiamethoxam 

and CGA–322704 in crop and livestock 

commodities. Syngenta Crop Protection, 

Inc., has submitted a revised Method 

AG–675, i.e., Method GRM.009.04A. 

The full extraction steps for plant and 

livestock commodities, including the 

microwave extraction step for liver, 

have been incorporated. The limits of 

quantitation (LOQs) of Method 

GRM.009.04A have been established at 

0.01 ppm each for residues of 

thiamethoxam, CGA–322704 and CGA– 

265307. Method validation data are 

available for Method GRM.009.04A. 

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. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

EPA is increasing the barley grain 

tolerance to 0.4 ppm in order to 

harmonize with the Codex MRL of 0.4 

ppm. The MRL expressions continue to 

remain different, as the Codex MRL is 

for the parent compound only. 

C. Revisions to Petitioned-For 

Tolerances 

Although the petitioner sought 

tolerances for many of the commodities 

in Crop Groups 15 and 16, the petitioner 

did not request crop group tolerances. 

EPA has determined that a tolerance for 

either Crop Group 15 or Crop Group 16 

commodities is not appropriate except 

for Crop Group 15 grains (except 

barley), because the use pattern is not 

the same for all Crop Group 15 

commodities. Specifically, there is a 

foliar use on barley and there are much 

higher tolerances for barley hay and 

straw associated with this foliar use. It 

is for similar reasons that a Crop Group 

16 tolerance would not be appropriate. 

In addition, there are also significant 

differences in the tolerances for the 

different cereal forages, i.e., wheat 

forage at 0.5 ppm, corn forage at 0.10 

ppm, and sorghum forage at 0.02 ppm. 

Therefore, tolerances for each 

individual commodity have been 

established by translating residue data 

from the most appropriate 

representative commodity, except for 

grains which all have the same tolerance 

(excluding barley). Tolerances are not 

required for triticale and wild rice 

because these commodities are covered 

by the wheat and rice tolerances, as 


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specified in 40 CFR 180.1. Tolerances 

are also not needed for teosinte forage 

and stover as these are not considered 

significant livestock feed items and are 

not consumed by humans. 

V. Conclusion 

Therefore, tolerances are established 

for residues of thiamethoxam, 3-[(2- 

chloro-5-thiazolyl)methyl]tetrahydro-5- 

methyl-N-nitro-4H-1,3,5-oxadiazin-4- 

imine and its metabolite, N-[(2-chlorothiazol-5-yl)methyl]-N ′-methyl-N ′′- 

nitro-guanidine, in or on barley, grain at 

0.4 ppm; buckwheat, forage at 0.50 ppm; 

buckwheat, hay at 0.02 ppm; 

buckwheat, straw at 0.02 ppm; grain, 

cereal, group 15, except barley at 0.02 

ppm; oat, forage at 0.50 ppm, oat, hay 

at 0.02 ppm; oat, straw at 0.02 ppm; 

millet, pearl, forage at 0.02 ppm; millet, 

pearl, stover at 0.02 ppm; millet, proso, 

forage at 0.02 ppm; millet, proso, stover 

at 0.02 ppm; millet, proso, straw at 0.02 

ppm; rye, forage at 0.50 ppm; rye, straw 

at 0.02 ppm. Tolerances are revoked for 

corn, field, grain; corn, pop, grain; rice, 

grain; sorghum, grain; wheat, grain. 

These tolerances are no longer needed, 

since residues on these commodities 

will be covered by the crop group 15 

tolerances being established in this rule. 

In addition, administrative 

corrections are being made to the 

existing tolerances for grain, aspirated 

fractions and soybean, hulls, as follows: 

The tolerance for grain, aspirated 

fractions at 0.08 ppm is being corrected 

to grain, aspirated fractions at 2.0 ppm; 

the tolerance for soybean, hulls at 2.0 

ppm is being corrected to soybean, hulls 

at 0.08 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) (Pub. L. 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: February 17, 2012. 

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 paragraph (a) is 

revised to read as follows: 

§ 180.565 Thiamethoxam; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide thiamethoxam, including its 

metabolites and degradates, in or on the 

following commodities. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only 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-chlorothiazol-5-yl)methyl]-N′-methyl-N′′-nitroguanidine, calculated as the 

stoichiometric equivalent of 

thiamethoxam, in or on the following 

commodities: 

Commodity Parts per 

million 

Alfalfa, forage ......................... 0 .05 

Alfalfa, hay .............................. 0 .12 

Almond, hulls .......................... 1 .2 

Artichoke, globe ...................... 0 .45 

Avocado .................................. 0 .40 

Barley, grain ........................... 0 .4 

Barley, hay .............................. 0 .40 

Barley, straw ........................... 0 .40 

Bean, succulent ...................... 0 .02 

Berry, low growing, subgroup 

13–07G, except cranberry .. 0 .30 

Borage, seed .......................... 0 .02 

Brassica, head and stem, subgroup 5–A ........................... 4 .5 

Brassica, leafy greens, subgroup 5–B ........................... 3 .0 

Buckwheat, forage .................. 0 .50 

Buckwheat, hay ...................... 0 .02 

Buckwheat, straw ................... 0 .02 

Bushberry subgroup 13–07B, 

except lingonberry and 

blueberry, lowbush .............. 0 .20 

Canistel ................................... 0 .40 

Canola, seed .......................... 0 .02 

Cattle, meat ............................ 0 .02 


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12740 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Cattle, meat byproducts ......... 0 .04 

Citrus, dried pulp .................... 0 .60 

Coffee, bean, green 1 ............. 0 .05 

Corn, field, forage ................... 0 .10 

Corn, field, stover ................... 0 .05 

Corn, pop, forage ................... 0 .10 

Corn, pop, stover .................... 0 .05 

Corn, sweet, forage ................ 0 .10 

Corn, sweet, kernel plus cob 

with husks removed ............ 0 .02 

Corn, sweet, stover ................ 0 .05 

Cotton, gin byproducts ........... 1 .5 

Cotton, undelinted seed ......... 0 .10 

Crambe, seed ......................... 0 .02 

Cranberry ................................ 0 .02 

Flax, seed ............................... 0 .02 

Food commodities and feed 

commodities (other than 

those covered by a higher 

tolerance as a result of use 

on growing crops) in food/ 

feed handling establishments .................................. 0 .02 

Fruit, citrus, group 10 ............. 0 .40 

Fruit, pome, group 11 ............. 0 .2 

Fruit, small, vine climbing, 

subgroup 13–07F, except 

fuzzy kiwifruit ....................... 0 .20 

Fruit, stone, group 12 ............. 0 .5 

Goat, meat .............................. 0 .02 

Goat, meat byproducts ........... 0 .04 

Grain, aspirated fractions ....... 2 .0 

Grain, cereal, group 15, except barley .......................... 0 .02 

Grape, raisin ........................... 0 .30 

Hog, meat ............................... 0 .02 

Hog, meat byproducts ............ 0 .02 

Hop, dried cones .................... 0 .10 

Horse, meat ............................ 0 .02 

Horse, meat byproducts ......... 0 .04 

Mango ..................................... 0 .40 

Milk ......................................... 0 .02 

Millet, pearl, forage ................. 0 .02 

Millet, pearl, stover ................. 0 .02 

Millet, proso, forage ................ 0 .02 

Millet, proso, stover ................ 0 .02 

Millet, proso, straw ................. 0 .02 

Oat, forage .............................. 0 .50 

Oat, hay .................................. 0 .02 

Oat, straw ............................... 0 .02 

Peanut .................................... 0 .05 

Peanut, hay ............................ 0 .25 

Peanut, meal .......................... 0 .15 

Peppermint, tops .................... 1 .5 

Pistachio ................................. 0 .02 

Potato ..................................... 0 .25 

Radish, tops ............................ 0 .80 

Rapeseed, seed ..................... 0 .02 

Rye, forage ............................. 0 .50 

Rye, straw ............................... 0 .02 

Sapodilla ................................. 0 .40 

Sapote, black .......................... 0 .40 

Sapote, mamey ...................... 0 .40 

Sheep, meat ........................... 0 .02 

Sheep, meat byproducts ........ 0 .04 

Sorghum, forage ..................... 0 .02 

Sorghum, grain, stover ........... 0 .02 

Soybean, hulls ........................ 0 .08 

Spearmint, tops ...................... 1 .5 

Star apple ............................... 0 .40 

Sunflower ................................ 0 .02 

Tomato, paste ......................... 0 .80 

Vegetable, cucurbit, group 9 .. 0 .2 

Commodity Parts per 

million 

Vegetable, fruiting, group 8 .... 0 .25 

Vegetable, leafy, except brassica, group 4 ....................... 4 .0 

Vegetable, legume, group 6 ... 0 .02 

Vegetable, root, subgroup 1A 0 .05 

Vegetable, tuberous and 

corm, except potato, subgroup 1D ............................. 0 .02 

Wheat, forage ......................... 0 .50 

Wheat, hay ............................. 0 .02 

Wheat, straw ........................... 0 .02 

1There are no U.S. registrations as of September 17, 2003. 

* * * * * 

[FR Doc. 2012–4983 Filed 3–1–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0524; FRL–9337–9] 

Trinexapac-ethyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of trinexapacethyl in or on multiple commodities 

which are identified and discussed later 

in this document. Syngenta Crop 

Protection, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 2, 2012. Objections and requests 

for hearings must be received on or 

before May 1, 2012, 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–2010–0524. 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: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@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 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 


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