19130 Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Rules and Regulations 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by May 28, 2013. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Particulate matter, Reporting and 

recordkeeping requirements. 

Dated: February 11, 2013. 

Susan Hedman, 

Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. Section 52.1870 is amended by 

adding paragraph (c)(157) to read as 

follows: 

§ 52.1870 Identification of plan. 

* * * * * 

(c) * * * 

(157) On February 23, 2012, Ohio 

submitted revisions to Ohio 

Administrative Code Chapter 3745–17, 

Rule 3745–17–11. The revisions contain 

particulate matter restriction for 

industrial sources in the State of Ohio 

necessary to attain and maintain the 

2006 24-hour PM2.5, annual PM2.5, and 

24-hour PM10 NAAQS. 

(i) Incorporation by reference. 

(A) Ohio Administrative Code Rule 

3745–17–11 ‘‘Restrictions on particulate 

emissions from industrial processes’’, 

effective December 23, 2011. 

(B) December 13, 2011, ‘‘Director’s 

Final Findings and Orders’’, signed by 

Scott J. Nally, Director, Ohio 

Environmental Protection Agency. 

§ 52.1919 [Amended] 

■ 3. Section 52.1919 is amended by 

removing paragraph (c). 

[FR Doc. 2013–07259 Filed 3–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0860; FRL–9378–6] 

Clothianidin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of clothianidin in 

or on tea, dried and increases the 

tolerance level for pepper to support a 

shorter pre-harvest interval (PHI). These 

tolerances were requested by 

Interregional Research Project Number 4 

(IR–4) and Valent U.S.A. Corporation, 

respectively, under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 29, 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–2011–0860, 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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). 


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• 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 

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–2011–0860 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 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– 

2011–0860, 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 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 December 8, 

2011 (76 FR 76674) (FRL–9328–8) and 

September 28, 2012 (77 FR 59578) 

(FRL–9364–6), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of pesticide petitions ((PP) 1E7923 and 

2F8008) by IR–4, IR–4 Headquarters, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540 and Valent U.S.A. 

Corporation, P.O. Box 8025, Walnut 

Creek, CA 94596, respectively. The 

petitions requested that 40 CFR 180.586 

be amended by establishing tolerances 

for residues of the insecticide 

clothianidin, (E)-1-(2-chloro-1,3-thiazol5-ylmethyl)-3-methyl-2-nitroguanidine, 

in or on fruit, citrus, group 10–10; 

citrus, dried pulp; pistachio; strawberry 

and tea, fresh at 0.60, 1.0, 0.01, 1.50 and 

70 parts per million (ppm), respectively, 

1E7923; and vegetable, fruiting group 

8–10, except pepper/eggplant, subgroup 

8–10B; and pepper/eggplant subgroup 

8–10B at 0.20, and 0.7 ppm, 

respectively, 2F8008. In addition, PP 

2F8008 requested that 40 CFR 

180.586(a) be amended by deleting the 

tolerance for residues of clothianidin in 

or on the vegetable, fruiting group 8 at 

0.2 ppm, upon approval of vegetables, 

fruiting, group 8–10, except pepper/ 

eggplant subgroup 8–10B at 0.2 ppm; 

and replacing the tolerance for residues 

of clothianidin in or on fruit, pome at 

1.0 ppm with fruit, pome group 11–10 

at 1.0 ppm due to EPA expansion of the 

crop group. The above-mentioned 

Federal Register documents referenced 

a summary of the petition prepared by 

Valent U.S.A. Corporation, P.O. Box 

8025, Walnut Creek, CA 94596, the 

registrant, which is available in the 

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

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

At this time, EPA is only establishing 

tolerances for tea, dried and is 

increasing the tolerance level for pepper 

to support PHI for an existing 

registration. In addition, EPA is redefining the crop group tolerance 

expression ‘‘vegetable, fruiting, group 8’’ 

as ‘‘vegetable, fruiting, group 8, except 

pepper.’’ EPA is not prepared to 

establish tolerances for the remaining 

petitioned-for clothianidin tolerances 

until the potential ecological and 

environmental risks can be assessed. 

EPA will make a final determination on 

the other petitioned-for tolerances at a 

later date. The reasons for these changes 

are explained in Unit IV.D. 

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 clothianidin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with clothianidin follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

EPA considered the toxicity of 

clothianidin as well as several 

metabolites and degradates in 

conducting this risk assessment. EPA 

assumed that clothianidin’s metabolites/ 

degradates that are similar in structure 

to clothianidin are toxicologically 

equivalent to clothianidin with respect 

to the endpoints being used for risk 

assessment. 

The available data indicate that there 

are no consistent target organs in 

mammals; however, some effects noted 

in the liver, hematopoietic system and 

kidney are similar to effects from other 

neonicotinoid insecticides. In 


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subchronic oral studies, the dog seemed 

to be more sensitive to clothianidin than 

the rat. In addition to decreases in body 

weight and body weight gains observed 

in both animals, dogs also displayed 

decreased white blood cells, albumin 

and total protein, as well as some 

anemia. Long-term dietary 

administration of clothianidin did not 

result in a wider spectrum of effects in 

the dog; in contrast, the chronic feeding 

studies in rats showed additional effects 

in the liver, ovaries and kidneys. In the 

mouse chronic oral study, increases in 

vocalization and decreases in body 

weight and body weight gain were 

noted. 

Based on the lack of significant tumor 

increases in two adequate rodent 

carcinogenicity studies, EPA has 

classified clothianidin as ‘‘not likely to 

be carcinogenic to humans.’’ A bone 

marrow micronucleus assay in mice 

showed that clothianidin is neither 

clastogenic nor aneugenic up to a toxic 

oral dose. Additionally, a study on the 

livers of Wistar male mice showed no 

induction of unscheduled DNA 

synthesis up to the limit dose; therefore, 

mutagenicity is not of concern. 

Clinical signs of neurotoxicity were 

exhibited in both rats (decreased 

arousal, motor activity and locomotor 

activity) and mice (decreased 

spontaneous motor activity, tremors and 

deep respirations) in acute neurotoxicity 

studies following exposure by gavage; 

however, no indications of 

neurotoxicity were observed following 

dietary exposure in the subchronic 

neurotoxicity study in rats. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

of rat or rabbit fetuses following in utero 

exposure to clothianidin in 

developmental studies; however, 

increased quantitative susceptibility of 

rat pups was seen in both the 

reproduction and developmental 

neurotoxicity studies. In the rat 

reproduction study, offspring toxicity 

(decreased body weight gains and 

absolute thymus weights in pups, 

delayed sexual maturation and an 

increase in stillbirths) was observed in 

the absence of maternal effects. In the 

developmental neurotoxicity study in 

rats, offspring effects (decreased body 

weights, body weight gains, motor 

activity and acoustic startle response 

amplitude) were noted at doses lower 

than those resulting in maternal 

toxicity. 

Decreased absolute and relative 

thymus and spleen weights were 

observed in multiple studies; these 

studies showed possible evidence of 

effects on the immune system. In 

addition, juvenile rats in the rat 

reproduction study appeared to be more 

susceptible to these effects. However, a 

guideline immunotoxicity study showed 

no evidence of clothianidin-mediated 

immunotoxicity in adult rats and a 

developmental immunotoxicity study 

demonstrated no increased 

susceptibility for offspring with regard 

to immunotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by clothianidin 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 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),’’ dated 

September 27, 2012 at page 32, and 

additional information on pome fruit 

can be found in document: 

‘‘Clothianidin—Human Health Risk 

Assessment for Requested Foliar Uses 

on Rice, Seed Treatment on Leafy 

Vegetables, Increased Application Rate 

for Vegetables, and Expanded Uses on 

Fruiting Vegetables and Pome Fruit,’’ 

dated February 1, 2012, in docket ID 

number EPA–HQ–OPP–2011–0860. 

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 clothianidin used for 

human risk assessment is discussed in 

Unit II of the final rule published in the 

Federal Register of August 29, 2012 (77 

FR 52246) (FRL–9360–4). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to clothianidin, EPA 

considered exposure for all of the 

petitioned-for tolerances as well as all 

existing clothianidin tolerances in 40 

CFR 180.586. EPA assessed dietary 

exposures from clothianidin in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

clothianidin. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA used 

maximum field trial values, empirical 

processing factors and assumed 100 

percent crop treated (PCT) for all 

commodities. Clothianidin is a major 

metabolite of thiamethoxam, and there 

are a number of crops for which uses of 

both clothianidin and thiamethoxam 

have been registered. The labels for the 

various end-use products containing 

these active ingredients prohibit the 

application of both active ingredients to 

the same crop during a growing cycle. 

Due to that restriction and the 

assumption of 100 PCT, a single value 

reflecting the greatest clothianidin 

residue from either active ingredient has 

been used for crops listed for use with 

both active ingredients (versus 

combined estimates from clothianidin 

and thiamethoxam). Generally, this 

assessment uses the established or 

recommended clothianidin tolerance for 

crops having tolerances for both 

compounds (the exception being lowgrowing berry, subgroup 13–07G, which 

is based on observed clothianidin 

residues in thiamethoxam strawberry 

field trials). For foods with 

thiamethoxam tolerances but without 

clothianidin tolerances, maximum 

residues of clothianidin observed in 

thiamethoxam field trials have been 

used in these assessments. Foods falling 


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into this category include meats, meat 

by-products, artichoke, tropical fruits, 

coffee, hop, mint, and rice. 

In relying on maximum field trial 

residues of clothianidin, EPA has 

adjusted the field trial values upward to 

account for metabolites of concern for 

leafy and root and tuber vegetables and 

for ruminants and poultry. Details on 

these adjustments are provided in 

document: ‘‘Clothianidin—Human 

Health Risk Assessment for Requested 

Foliar Uses on Rice, Seed Treatment on 

Leafy Vegetables, Increased Application 

Rate for Vegetables, and Expanded Uses 

on Fruiting Vegetables and Pome Fruit,’’ 

dated February 1, 2012, in docket ID 

number EPA–HQ–OPP–2011–0860. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA assessed chronic dietary exposure 

using the same residue information and 

assumptions regarding metabolites/ 

degradates as in the acute exposure 

analysis. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that clothianidin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue information. 

EPA used anticipated residue 

(maximum field trial residues) in the 

dietary assessment for clothianidin. 

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 CallIns 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 clothianidin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

clothianidin. 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. 

The Agency modeled estimated 

drinking water concentrations (EDWC) 

of clothianidin in surface and 

groundwater using the Tier 1 Rice 

Model, the Food Quality Protection Act 

(FQPA) Index Reservoir Screening Tool 

(FIRST), and the Screening 

Concentrations in Groundwater model 

(SCI–GROW). The Tier 1 Rice Model 

produced the greatest value of any of the 

models used to predict EDWCs for acute 

and chronic exposures. The Tier 1 Rice 

Model EDWC of 72 parts per billion 

(ppb) was entered directly into the 

dietary exposure model. 

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). 

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 surfaces, as well as, 

potential for incidental oral postapplication 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 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 hand-to-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 

1,000) 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.’’ 

Clothianidin is a member of the 

neonicotinoid class of pesticides and is 

a metabolite of another neonicotinoid, 

thiamethoxam. 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 

noncompetitive inhibitor. Furthermore, 

even if future research shows that 

neonicotinoids share a common binding 

activity to a specific site on insect 

nAChRs, 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 clothianidin is 

based on unrelated effects in mammals, 

including changes in body and thymus 

weights, delays in sexual maturation, 


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19134 Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Rules and Regulations 

and stillbirths. Additionally, the most 

sensitive toxicological effect in 

mammals differs across the 

neonicotinoids (such as testicular 

tubular atrophy with thiamethoxam, 

and mineralized particles in thyroid 

colloid with imidaclopid). Thus, there is 

currently no evidence to indicate that 

neonicotinoids share common 

mechanisms of toxicity, and EPA is not 

following a cumulative risk approach 

based on a common mechanism of 

toxicity for the neonicotinoids. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see the policy statements 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism 

released by OPP on 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. 

There is no residual concern for 

increased qualitative or quantitative 

susceptibility in the rat or rabbit 

developmental toxicity studies. Since 

there is evidence of increased 

quantitative susceptibility of the young 

following exposure to clothianidin in 

the rat reproduction study and the DNT 

study, EPA performed a degree of 

concern analysis to: 

i. Determine the level of concern for 

the effects observed when considered in 

the context of all available toxicity data; 

and, 

ii. Identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the clothianidin risk assessment. 

Considering the overall toxicity 

profile and the endpoints and doses 

selected for the clothianidin risk 

assessment, EPA characterized the 

degree of concern for the effects 

observed in the clothianidin 2- 

generation reproduction and DNT 

studies as low, noting that there are 

clear NOAELs for the offspring effects 

and regulatory doses were selected to be 

protective of these effects. No other 

residual uncertainties were identified 

with respect to susceptibility. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X in assessing risks 

from dermal and oral exposure 

pathways. However, EPA does not have 

reliable data to support reduction of the 

FQPA SF in assessing risks from the 

inhalation exposure pathway and thus 

is retaining the 10X FQPA SF for these 

assessments. That decision is based on 

the following findings: 

i. The toxicity database for 

clothianidin is complete with the 

exception of a required 28-day 

inhalation study. 

ii. There are no residual concerns 

regarding potential prenatal and 

postnatal toxicity in the young. 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. While the rat multigeneration reproduction study showed 

evidence of increased quantitative 

susceptibility of offspring compared to 

adults, the degree of concern is low 

because the study NOAEL has been 

selected as the POD 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 pre- and postnatal 

toxicity after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment for 

clothianidin. 

iii. 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 maximum field trial residues, 

adjustment factors from metabolism 

data, empirical processing factors, and 

100 PCT for all commodities. The 

exposure databases (dietary food, 

drinking water, and residential) are 

complete. The risk assessment for each 

potential exposure scenario includes all 

metabolites and/or degradates of 

concern and does not underestimate 

potential exposure and risk for infants 

or children. 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 as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by clothianidin. 

In conclusion, there are reliable data 

showing that, with the exception of 

scenarios involving inhalation exposure, 

the risk to infants and children can be 

safely assessed without an additional 

10X safety factor. However, in the 

absence of the required inhalation 

toxicity study, EPA is retaining the 10X 

FQPA factor as a database uncertainty 

factor for assessing inhalation exposure 

and risk only, for both adults and 

children. 

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 

clothianidin will occupy 28% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to clothianidin 

from food and water will utilize 28% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of clothianidin is not expected; 


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Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Rules and Regulations 19135 

therefore, the chronic aggregate risk 

estimates are equivalent to the dietary 

risk estimates and are below EPA’s level 

of concern. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

For purposes of performing an 

aggregate assessment, the EPA selected 

the worst-case adult and children 

exposure scenarios. The treatment of 

tree trunks using a manuallypressurized handwand presents the 

worst-case exposure estimate for adults, 

while the bed bug scenario presents the 

worst-case exposure estimates for 

children 1 to <2 yrs old. 

For short- and intermediate-term 

‘‘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. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

clothianidin was classified as ‘‘not 

likely to be carcinogenic to humans,’’ 

and is not expected to pose a cancer risk 

to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to clothianidin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies, 

based on solvent extraction and Liquid 

chromatography—mass spectrometry/ 

mass spectrometry (LC–MS/MS) 

separation, identification, and 

quantification, are available for plant 

(Morse Method #Meth 164—modified, 

RM–39C–1, or Bayer Method 00552) and 

livestock (Bayer Method 00624) 

matrices. The (LOQ) for clothianidin in 

plant commodities is 0.01 ppm, except 

for wheat straw (0.02 ppm), and the 

validated LOQs are 0.01 ppm in milk 

and 0.02 ppm in animal tissues. 

Clothianidin and its major metabolites 

are not adequately recovered using any 

of the United States Food and Drug 

Administration (FDA) multiresidue 

methods. 

The methods 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 

clothianidin in or on tea, fresh at 0.7 

ppm and fruiting vegetables other than 

cucurbits at 0.050 ppm. The residue 

field trial submitted to support the U.S. 

tolerances results in higher clothianidin 

residues than the maximum residue 

levels established by Codex and 

therefore, the U.S. tolerances cannot be 

harmonized with the Codex MRLs. 

C. Response to Comments 

EPA received one comment on the 

notice of filing for petition, 1E7923, in 

which the commenter requested that 

EPA deny IR–4’s petition to establish a 

tolerance for residues of clothianidin on 

food crops because it is toxic to humans. 

When new or amended tolerances are 

requested for the presence of the 

residues of a pesticide and its 

toxicologically significant metabolite(s) 

in food or feed, the Agency, as is 

required by section 408 of the FFDCA, 

estimates the risk of the potential 

exposure to these residues by 

performing an aggregate risk assessment. 

As discussed in Unit III, EPA’s 

assessment for clothianidin concludes 

that there is a reasonable certainty that 

no harm will result from exposure to 

clothianidin residues of interest. 

Therefore, the tolerances established by 

this action are found to be acceptable. 

The commenter submitted no evidence 

or argument that addresses this statutory 

finding. 

D. Revisions to Petitioned-For 

Tolerances 

In this action EPA is only establishing 

tolerances for tea, dried and pepper and 

will make a final determination on the 

remaining petitioned for tolerances at a 

later date. Though EPA is able to make 

the required safety finding under 

FFDCA and the human health risk 

assessments support all of the 

petitioned-for uses, what must still be 

considered for the additional uses to be 

registered in the United States are 

potential ecological and environmental 

risks associated with clothianidin. 

Therefore, at this time EPA is only 

prepared to establish a tolerance on 

dried tea (without a U.S. registration; 

i.e., an ‘‘import tolerance’’) and to 

increase the tolerance on pepper to 

support a shorter pre-harvest interval 

(PHI). 

EPA is still in the process of assessing 

the potential ecological concerns 

identified with the additional exposures 

expected from the registration of the 

proposed pome fruit group 11–10, 

pepper/eggplant subgroup 8–10B, citrus 

fruit group 10–10, pistachio, and 

strawberry uses. However, in order to 

support an effort to establish tolerances 

for residues of pesticides on tea, to 

ensure a safe supply of tea for the U.S. 

consumer, EPA has determined it will 

move forward with establishing the 

tolerance for clothianidin on tea prior to 

finalizing the decision on the remaining 

petitioned for uses. Additionally, there 

is an existing tolerance for residues of 

clothianidin on fruiting vegetable group 

8 at 0.20 ppm and residue field trial 

data were submitted for pepper to 

support a lower PHI which results in a 

recommended higher tolerance. Though 

EPA is not prepared to allow the 

expansion of the Fruiting Vegetable 

Group 8 at this time to include the 

additional commodities in Pepper/ 

eggplant Subgroup 8–10B, shortening 

the PHI on pepper is not expected to 

result in any additional environmental 

exposure. Therefore, the EPA has 

determined that it will establish a 

higher tolerance for clothianidin on 

pepper in this action and a final 

determination on the petition for the 

pepper/eggplant subgroup 8–10B 

tolerance will be made at a later date. 

As to the tolerance levels, the 

proposed tea, fresh tolerance at 50 ppm 

will be established on tea, dried at 70 

ppm. The commodity listing is changed 

from tea, fresh to tea, dried to reflect the 

commodity from which residue data 

were collected and to reflect the 

principal tea commodity that is in the 

channels of trade. The value of the 

tolerance is changed based on the 


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19136 Federal Register / Vol. 78, No. 61 / Friday, March 29, 2013 / Rules and Regulations 

output from the Organisation for 

Economic Cooperation and 

Development (OECD) calculation 

procedures. EPA is also establishing the 

separate tolerance on pepper at 0.80 

ppm which is different than the 

requested tolerance at 0.7 ppm for 

pepper/eggplant subgroup 8–10B. EPA 

based the 0.80 tolerance level on the 

non-bell-pepper residue data and OECD 

Calculation Procedures. 

Finally, to account for the 

establishment of a ‘‘separate’’ pepper 

tolerance, EPA re-defined the existing 

crop group tolerance expression 

‘‘vegetable, fruiting, group 8’’ as 

‘‘vegetable, fruiting, group 8, except 

pepper’’. 

V. Conclusion 

Therefore, tolerances are established 

for residues of clothianidin, (E)-1-(2- 

chloro-1,3-thiazol-5-ylmethyl)-3-methyl2-nitroguanidine, in or on tea, dried at 

70 ppm, pepper at 0.80 ppm, and 

vegetable, fruiting, group 8, except 

pepper at 0.20 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 tolerances 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. Section 180.586 is amended in 

paragraph (a)(1) by revising the 

commodity ‘‘vegetable, fruiting, group 

8’’, by alphabetically adding the 

commodities ‘‘pepper’’ and ‘‘tea, dried’’, 

and by adding footnote 1 to the table to 

read as follows: 

§ 180.586 Clothianidin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Pepper ...................................... 0.80 

* * * * * 

Tea, dried 1 ............................... 70 

* * * * * 

Vegetable, fruiting, group 8, except pepper ........................... 0.20 

* * * * * 

1 No U.S. registrations. 

* * * * * 

[FR Doc. 2013–07093 Filed 3–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Federal Transit Administration 

49 CFR Part 602 

[Docket No. FTA–2013–0004] 

RIN 2132–AB13 

Emergency Relief Program 

AGENCY: Federal Transit Administration 

(FTA), DOT. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: This action establishes 

procedures governing the 

implementation of the Federal Transit 

Administration’s (FTA) Public 

Transportation Emergency Relief 

Program under 49 U.S.C. 5324, as 

authorized by the Moving Ahead for 

Progress in the 21st Century Act. FTA 

is issuing this interim final rule in order 

to comply with the Disaster Relief 

Appropriations Act of 2013. FTA will 

accept comments on the interim final 

rule and will publish a final rule after 

the comment period closes. 

DATES: This interim final rule becomes 

effective on March 29, 2013. Comments 

on this interim final rule are due May 

28, 2013. Late-filed comments will be 

considered to the extent practicable. In 

compliance with the Paperwork 

Reduction Act, FTA is also seeking 


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