Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 18511 

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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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 19, 2013. 

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. § 180.505, is amended by: 

■ i. Revise paragraph (a)(1) introductory 

text and paragraph (a)(2) introductory 

text; 

■ ii. Add alphabetically an entry for 

‘‘Vegetable, cucurbit, group 9’’ to the 

table in paragraph (a)(1). 

The added and revised text read as 

follows: 

§ 180.505 Emamectin; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for emamectin, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of emamectin (a 

mixture of a minimum of 90% 4′-epimethylamino-4′-deoxyavermectin B1a

and maximum of 10% 4′-epimethylamino-4′-deoxyavermectin B1b) 

and its metabolites 8,9-isomer of the B1a

and B1b component of the parent (8,9- 

ZMA), or 4′-deoxy-4′-epi-aminoavermectin B1a and 4’-deoxy-4’-epiamino-avermectin B1b; 4′-deoxy-4′-epiamino avermectin B1a (AB1a); 4′-deoxy4′-epi-(N-formyl-N-methyl)aminoavermectin (MFB1a); and 4′-deoxy-4′- 

epi-(N-formyl)amino-avermectin B1a

(FAB1a), calculated as the stoichiometric 

equivalent of emamectin. 

Commodity Parts per 

million 

* * * * * 

Vegetable, cucurbit, group 9 0.02 

* * * * * 

(2) Tolerances are established for 

emamectin, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of emamectin 

(MAB1a + MAB1b isomers) and the 

associated 8,9-Z isomers (8,9-1a and 8,9- 

ZB1b). 

* * * * * 

[FR Doc. 2013–06758 Filed 3–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0488; FRL–9377–3] 

Thiamethoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of the insecticide 

thiamethoxam in or on tea, and amends 

the existing tolerance for residues of 

thiamethoxam in or on coffee. Syngenta 

Crop Protection, Inc., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 27, 2013. Objections and requests 

for hearings must be received on or 

before May 28, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0488, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

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; email 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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 

Web site at http://www.ecfr.gov/cgi-bin/ 

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 


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18512 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 

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–2012–0488 in the subject line on 

the first Web 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 28, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0488, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2E8036) by Syngenta Crop 

Protection, Inc.; P.O. Box 18300; 

Greensboro, NC 27419. The petition 

requested that 40 CFR 180.565 be 

amended by increasing the tolerance for 

residues of the insecticide 

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

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

its metabolite CGA–322704 [N-(2- 

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

0.05 parts per million (ppm) to 0.2 ppm. 

That document 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. 

In the Federal Register of December 

19, 2012 (77 FR 75082) (FRL–9372–6), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 2E8011) by 

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

18300; Greensboro, NC 27419. The 

petition requested that 40 CFR 180.565 

be amended by establishing a tolerance 

for residues of the insecticide 

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

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

its metabolite CGA–322704 [N-(2- 

chloro-thiazol-5-ylmethyl)-N’-methylN’-nitro-guanidine], in or on tea at 20 

ppm. That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, Inc., the 

registrant, which is available in the 

docket, http://www.regulations.gov. The 

notice of filing mistakenly referenced PP 

2E8011. The correct petition number is 

PP 2E8100. 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. 

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 in the 

mouse. 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 of 

the documents ‘‘Thiamethoxam. Human 

Health Risk Assessment for the Higher 

Tolerance, Use of New Formulations, 

and Increased Maximum Seasonal 

Application Rate on Imported Coffee 

Beans, and Condition-of-Registration 

Data for Leafy Vegetables (Group 4),’’ in 

docket ID number EPA–HQ–OPP–2012– 

0488, and ‘‘Thiamethoxam. Human 

Health Risk Assessment for Residues on 


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Imported Tea Leaves (Dried),’’ in docket 

ID number EPA–HQ–OPP–2012–0858. 

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, which takes into account 

contributions from thiamethoxam, 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–2011–0860, at http:// 

www.regulations.gov. Refer to the 

document ‘‘Clothianidin—Aggregate 

Human Health Risk Assessment of New 

Uses on Strawberry, Pistachio, and 

Citrus; New Tolerance for Tea; and 

Revised PHI and Tolerance for Pepper 

and Eggplant (Crop Subgroup 8–10B).’’ 

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 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 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 

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 March 2, 2012 

(77 FR 12731) (FRL–9331–8). 

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 the previous 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 or clothianidin residues from 

use of thiamethoxam on those 

commodities for which the pesticide 

clothianidin does not have a tolerance. 

The two sources of clothianidin were 

not combined for a given commodity 

because (1) residues of clothianidin are 

greater from clothianidin use than from 

thiamethoxam use; and (2) it was 

assumed that 100% of crops are treated. 

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 U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA). This dietary survey 

was conducted from 2003 to 2008. As to 

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 U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). 

This dietary survey was conducted from 

2003 to 2008. As to 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 Use of Thiamethoxam on 

Imported Coffee Beans and Conditionof-Registration Residue Data for Leaf 

Lettuce,’’ available in the docket EPA– 

HQ–OPP–2012–0488; ‘‘Thiamethoxam. 

Acute and Chronic Aggregate Dietary 

(Food and Drinking Water) Exposure 

and Risk Assessments for Residues of 

Thiamethoxam on Imported Tea,’’ 

available in the docket EPA–HQ–OPP– 

2012–0858; and ‘‘Clothianidin— 

Aggregate Human Health Risk 

Assessment of New Uses on Strawberry, 

Pistachio, and Citrus; New Tolerance for 

Tea; and Revised PHI and Tolerance for 

Pepper and Eggplant (Crop Subgroup 8– 

10B),’’ available in the docket EPA–HQ– 

OPP–2011–0860, 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 in the 

mouse. 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 


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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 and percent 

crop treated (PCT) information. 

Tolerance level residues or anticipated 

residues (average) from the field trial 

data were used for the chronic 

assessment for thiamethoxam. It was 

assumed that 100% of crops were 

treated for all food commodities in both 

the acute and chronic analyses. 

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

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

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

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

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

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

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. 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 

concentrations for surface water and 

ground water are 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 0.072 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 Use of 

Thiamethoxam on Imported Coffee 

Beans and Condition-of-Registration 

Residue Data for Leaf Lettuce,’’ available 

in the docket EPA–HQ–OPP–2012– 

0488; ‘‘Thiamethoxam. Acute and 

Chronic Aggregate Dietary (Food and 

Drinking Water) Exposure and Risk 

Assessments for Residues of 

Thiamethoxam on Imported Tea,’’ 

available in the docket EPA–HQ–OPP– 

2012–0858; and ‘‘Clothianidin— 

Aggregate Human Health Risk 

Assessment of New Uses on Strawberry, 

Pistachio, and Citrus; New Tolerance for 

Tea; and Revised PHI and Tolerance for 

Pepper and Eggplant (Crop Subgroup 8– 

10B),’’ available in the docket EPA–HQ– 

OPP–2011–0860, at http:// 

www.regulations.gov. 

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 show that generally, residues 

of thiamethoxam, as well as 

clothianidin, 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 

clothianidin. 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. 

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 exposures for 

those making applications in residential 

settings as well as for those entering 

areas previously treated with 

thiamethoxam. Exposures are expected 

to be short-term (i.e., up to 30 days) in 

duration. 

Adults were assessed for potential 

short-term dermal and inhalation 

handler exposure from applying 

thiamethoxam to turf/lawns and from 

indoor crack and crevice/spot treatment 

applications. Short-term postapplication 

exposures (1 to 30 days of continuous 

exposure) may also 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 non-dietary 

routes 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 

1 to < 2 years of age. A complete listing 

of the inputs used in these assessments 

can be found in the document 

‘‘Thiamethoxam: Revised Residential 

Exposure Assessment to Support an 

Amended Import Tolerance for Coffee,’’ 

in docket ID number EPA–HQ–OPP– 

2012–0488 at http:// 

www.regulations.gov. 

Clothianidin is currently registered 

for the following uses that could result 

in residential exposures: turf, 

ornamental plants, and/or indoor use to 

control bed bugs. EPA assessed 

residential exposure using the following 

assumptions: exposures may occur 

during application of products 

containing clothianidin (handler 

exposure) as well as following 

application (post-application exposure) 

and are expected to be of short-term (1– 

30 days) duration. 

Adults were assessed for potential 

short-term dermal and inhalation 

handler exposure from applying 

clothianidin to residential turf/home 

lawns and for short-term postapplication dermal exposure from 

contact with treated residential and 

recreational turf home lawns and golf 

courses. There is also potential for postapplication dermal and inhalation 

exposure for adults and children 

resulting from use of clothianidin on 

residential turf, ornamentals (i.e., trees), 

and indoor use to control bed bugs. 

There is also potential for incidental 

oral post-application exposure for 

children. Although there is potential for 

adult exposure resulting from both 

applying the product and post 

application activities, the Agency did 

not combine exposure estimates from 

adult handler and post application 

activities because of the conservative 

assumptions and inputs within each 

exposure scenario. The children’s 


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combined exposure includes only the 

hand-to-mouth exposure for the 

incidental oral exposure component. To 

include exposure from object-to-mouth 

and soil ingestion in addition to handto-mouth would overestimate incidental 

oral exposures for purposes of 

estimating combined residential 

exposure. Further, because the level of 

concern for dermal exposures (MOEs 

less than 100) and inhalation exposure 

(MOEs less than 1000) are different, a 

total aggregate risk index (ARI) 

approach was used instead of the MOE 

approach. ARIs of greater than 1 

indicate risks are not of concern. 

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 

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; 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. 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) 

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 


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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, DNT, and immunotoxicity 

studies. 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 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 


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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 population 

adjusted dose (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 its 

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 28% of its 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 45% of its 

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 28% of its 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 

(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 430 for adults and 450 for 

children 1 to 2 years. Because EPA’s 

level of concern for thiamethoxam is a 

MOE of 100 or below, these MOEs are 

not of concern. 

For the clothianidin aggregate 

assessment, the EPA selected the worstcase adult and children exposure 

scenarios. The treatment of tree trunks 

using a manually-pressurized hand 

wand presents the worst-case exposure 

estimate for adults, while the bed bug 

scenario presents the worst-case 

exposure estimates for children 1 to < 2 

years old. For short- and intermediateterm ‘‘worst-case’’ aggregate exposure 

estimates, the ARI for adults is 6.5 and 

for children 1 to < 2 years old, the ARI 

is estimated at 1.2. ARI estimated values 

greater than 1.0 indicate risks are not of 

concern. 

4. Intermediate-term risk. An 

intermediate-term adverse effect was 

identified; however, intermediate term 

exposures (30 to 180 days of continuous 

exposure) are not expected from the 

registered turf and/or indoor uses of 

thiamethoxam. Intermediate-term risk is 

assessed based on intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

thiamethoxam. 

For purposes of performing a 

clothianidin aggregate assessment, the 

EPA selected the worst-case adult and 

children exposure scenarios. The 

treatment of tree trunks using a 

manually-pressurized hand wand 

presents the worst-case exposure 

estimate for adults, while the bed bug 

scenario presents the worst-case 

exposure estimates for children 1 to < 2 

years old. For short- and intermediateterm ‘‘worst-case’’ aggregate exposure 

estimates, the ARI for adults is 6.5 and 

for children 1 to <2 years old, the ARI 

is estimated at 1.2. ARI estimated values 

greater than 1.0 indicate risks 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. 


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IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(High Production Liquid 

Chromatography (HPLC) Method AG– 

675 with ultraviolet (UV) or Mass 

Spectrometry (MS) detection) 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. 

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 

United Nations 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. 

The Codex has established MRLs for 

thiamethoxam in or on coffee at 0.2 

ppm, and tea at 20 ppm. These MRLs 

are the same as the tolerances 

established for thiamethoxam in the 

United States. 

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 CGA–322704 

N-[(2-chloro-thiazol-5-yl)methyl]-N′- 

methyl-N′′-nitro-guanidine, calculated 

as the stoichiometric equivalent of 

thiamethoxam, in or on coffee, green, 

bean at 0.20 ppm and tea, dried at 20 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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 15, 2013. 

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. In § 180.565, in the table in 

paragraph (a), remove the entry for 

‘‘Coffee, bean, green1,’’ and footnote 1, 

and add alphabetically entries for 

‘‘coffee, green, bean1’’ new footnote 1, 

and ‘‘tea, dried,’’ to read as follows: 

§ 180.565 Thiamethoxam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Coffee, green, bean 1 .............. 0 .20 

* * * * * 

Tea, dried 1 ............................. 20 

* * * * * 

1There are no U.S. registrations as of 

March 27, 2013. 

* * * * * 

[FR Doc. 2013–06759 Filed 3–26–13; 8:45 am] 

BILLING CODE 6560–50–P 


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