8410 Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0311; FRL–9374–9] 

Thiacloprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiacloprid in 

or on pepper; cherry subgroup 12–12A; 

peach subgroup 12–12B; and plum 

subgroup 12–12C. Interregional 

Research Project Number 4 (IR–4) 

requested the stone fruit tolerance and 

Bayer CropScience requested the pepper 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 6, 2013. Objections and 

requests for hearings must be received 

on or before April 8, 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–2010–0311, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0311 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 April 8, 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– 

2010–0311, 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 June 8, 2010 

(75 FR 32463) (FRL–8827–5), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of pesticide 

petitions by IR–4, 681 US Highway #1 

South, North Brunswick, NJ 08902 

(PP0E7704) and Bayer CropScience LLC, 

2 T. W. Alexander Drive, Research 

Triangle Park, NC 27709 (PP0F7706). 

The petitions requested that 40 CFR 

180.594 be amended by establishing 

tolerances for residues of the insecticide 

thiacloprid ([3-[(6-chloro-3- 

pyridinyl)methyl]-2- 

thiazolidinylidene]cyanamide), in or on 

fruit, stone, group 12 at 0.5 parts per 

million (ppm) (PP0E7704) and pepper 

(bell and non-bell) at 1.1 ppm 

(PP0F7706). Bayer, in its petition 

(PP0F7706) also proposed to amend 40 

CFR 180.594 for residues of thiacloprid 

by revising the tolerance expression 

under paragraph (a) to read: Tolerances 

are established for residues of 

thiacloprid, including its metabolites 

and degradates. Compliance with the 

tolerance levels specified is to be 

determined by measuring only 

thiacloprid ([3-[(6-chloro-3- 

pyridinyl)methyl]-2-thiazolidinylidene] 

cyanamide). That document referenced 

a summary of the petition prepared by 

Bayer CropScience, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which the 

tolerances are being established as well 

as some of the nomenclature. The 

reason for these changes is explained in 

Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 


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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 thiacloprid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with thiacloprid 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. 

In mammalian systems, the liver 

appears to be the primary target organ 

of thiacloprid with some relatively 

minor effects in the thyroid. Liver 

effects (enzyme changes, hypertrophy, 

and histopathology) were noted in the 

90-day dog, 2-generation reproduction, 

2-year rat, 2-year mouse, and subchronic 

dermal and inhalation studies. Thyroid 

effects (hormone levels, weights, 

follicular cell hypertrophy) were noted 

in dog, rat, and mouse studies. 

Increased prostate weight and prostatic 

hypertrophy were observed in the 90- 

day dog study, but not in the 1-year dog 

study. Clinical signs were also noted in 

dermal (reduced motility, decreased 

activity, and spastic gait) and 5-day 

inhalation studies (respiratory effects, 

signs of ill health, piloerection, reduced 

mobility, tremors, and increased grip 

strength). 

There was no increase in either 

qualitative or quantitative susceptibility 

of fetal animals or pups in the rabbit 

developmental or the 2-generation rat 

reproduction studies. In the rabbit 

developmental study, decreased fetal 

weights were observed in the presence 

of maternal toxicity (body weight 

changes and decreased food 

consumption and fecal output). In the 

reproduction study in rats, decreased 

body weights were seen in pups at the 

same dose which resulted in thyroid 

and liver effects in maternal animals. 

In the rat developmental toxicity 

study, there was evidence of increased 

qualitative susceptibility. Increased 

resorptions; skeletal retardations and 

variations; dysplastic humerus, radius 

and scapulae; and decreased fetal 

weights were seen in fetuses at the same 

dose resulting in less severe maternal 

effects (decreased body weight, body 

weight gain and food consumption, 

increased urination, and changes in 

water consumption). In the 

developmental neurotoxicity study, 

increased qualitative susceptibility was 

also seen: Decreased body weights in 

both sexes as well as altered 

performance in passive avoidance 

testing were seen in offspring animals, 

while deceased body weight gain and 

food consumption were seen in 

maternal animals. However, there is a 

low degree of concern and no residual 

uncertainties for the increase in 

qualitative susceptibility since there are 

well-characterized dose responses with 

clear NOAELs and LOAELs in the 

studies. Additionally, the endpoints and 

PODs selected for risk assessment are 

protective of potential developmental 

effects. 

Thiacloprid affects nerve function 

through inhibition of nicotinic 

acetylcholine receptors. In the 

neurotoxicity studies in rats, there was 

a reduction in motor and locomotor 

activity, slight tremors and ptosis of the 

eyelids, decreased hind limb grip 

strength, altered performance in passive 

avoidance testing, and altered brain 

morphometrics. Increased grip strength 

was also noted in a 5-day inhalation 

toxicity study. There were no 

indications of neurotoxicity in the 

remainder of the submitted toxicity 

studies. 

A battery of genetic toxicity tests did 

not indicate a mutagenicity or 

clastogenicity concern. Thiacloprid is 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’ based on increased uterine 

tumors in rats, thyroid follicular 

adenomas in rat and ovarian tumors in 

mice. A cancer slope factor of 4.06 × 

10¥2 milligrams/kilogram/day (mg/kg/ 

day)¥1 was calculated based on the 

incidence of combined uterine tumors 

in female rats. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thiacloprid 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 on pages 29–34 of 

the document titled ‘‘Thiacloprid— 

Human Health Risk Assessment of New 

Uses on Stone Fruit and Peppers’’ in 

docket ID number EPA–HQ–OPP–2010– 

0311. 

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 thiacloprid used for 

human risk assessment is shown in the 

Table of this unit. 


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

ASSESSMENT

Exposure/scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (All Populations) ..... NOAEL = 4.4 mg/kg/day ..

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.044 mg/kg/day ....

aPAD = 0.044 mg/kg/day 

Co-Critical Studies Developmental 

Neurotoxicity Study—rat LOAEL = 25.6 

mg/kg bw based on offspring effects of 

altered performance in passive avoidance 

testing. 

Acute Neurotoxicity Study—rat LOAEL = 22 

mg/kg bw based on a reduction of motor 

and locomotor activity in females (NOAEL 

= 3.1 mg/kg bw). 

Chronic dietary (All populations) .. NOAEL = 1.2 mg/kg/day ..

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.012 mg/kg/day

cPAD = 0.012 mg/kg/day 

Chronic/Carcinogenicity Study—rat LOAEL 

= 2.5/3.3 (M/F) mg/kg bw based on liver 

hypertrophy and cytoplasmic changes as 

well as induction of enzymes, thyroid 

epithelial hypertrophy in males and retinal 

degeneration in females. 

Cancer (Oral, dermal, inhalation) ‘‘Likely to be Carcinogenic to Humans’’ based on thyroid tumors in male rats, uterine tumors in rats and 

ovarian tumors in mice. Cancer slope factor = 4.06×10¥2 (mg/kg/day)¥1

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligrams/kilogram/day. 

NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty 

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

(intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thiacloprid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

thiacloprid tolerances in 40 CFR 

180.594. EPA assessed dietary 

exposures from thiacloprid 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 

thiacloprid. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA), 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. The acute assessment was 

based on tolerance-level residues and 

100 percent crop treated (PCT) 

assumptions. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA. This 

dietary survey was conducted from 2003 

to 2008. The chronic assessment was 

based on tolerance-level residues and 

100 PCT assumptions. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the data summarized 

in Unit III.A., EPA has concluded that 

thiacloprid should be classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

and a linear approach has been used to 

quantify cancer risk. 

The cancer analysis is partially 

refined, using average residue field trial 

data, and estimated PCT data for 

existing and proposed new uses as 

appropriate. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

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

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such Data 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. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition A: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition B: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition C: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

In the cancer risk assessment, the 

Agency estimated the PCT for existing 

uses as follows: Apples, 10%; pears, 

5%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 


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use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

In the cancer risk assessment, the 

Agency estimated the PCT for new uses 

as follows: Peaches, 43%; peppers, 45%. 

EPA estimates of the PCT for new 

uses of thiacloprid represent the upper 

bound of use expected during the 

pesticide’s initial 5 years of registration; 

that is, PCT for new uses for thiacloprid 

is a threshold of use that EPA is 

reasonably certain will not be exceeded 

for each registered use site. The PCT for 

new uses recommended for use in the 

chronic dietary assessment is calculated 

as the average PCT of the market leader 

or leaders, (i.e., the one(s) with the 

greatest PCT) on that site over the three 

most recent years of available data. The 

PCT for new uses recommended for use 

in the acute dietary assessment is the 

maximum observed PCT over the same 

period. Comparisons are only made 

among pesticides of the same pesticide 

types (e.g., the market leader for 

insecticides on the use site is selected 

for comparison with a new insecticide). 

The market leader included in the 

estimation may not be the same for each 

year since different pesticides may 

dominate at different times. 

Typically, EPA uses USDA/NASS as 

the source data because it is publicly 

available and directly reports values for 

PCT. When a specific use site is not 

reported by USDA/NASS, EPA uses 

proprietary data and calculates the PCT 

given reported data on acres treated and 

acres grown. If no data are available, 

EPA may extrapolate PCT for new uses 

from other crops, if the production area 

and pest spectrum are substantially 

similar. 

A retrospective analysis to validate 

this approach shows few cases where 

the PCT for the market leaders were 

exceeded. Further review of these cases 

identified factors contributing to the 

exceptionally high use of a new 

pesticide. To evaluate whether the PCT 

for new uses for thiacloprid could be 

exceeded, EPA considered whether 

there may be unusually high pest 

pressure, as indicated in emergency 

exemption requests for thiacloprid; the 

pest spectrum of the new pesticide in 

comparison with the market leaders and 

whether the market leaders are well 

established for that use; and whether 

pest resistance issues with past market 

leaders provide thiacloprid with 

significant market potential. Given 

currently available information, EPA 

concludes that it is unlikely that actual 

PCT for thiacloprid will exceed the 

estimated PCT for new uses during the 

next 5 years. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition A, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions B and C, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which thiacloprid may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for thiacloprid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of thiacloprid. 

The drinking water estimates were also 

refined to account for both percent 

cropped area and for the impact of 

drinking water treatment processes. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

thiacloprid for acute exposures are 

estimated to be 18 parts per billion 

(ppb) for surface water and 0.25 ppb for 

ground water, for chronic exposures for 

non-cancer assessments are estimated to 

be 2.3 ppb for surface water and 0.25 

ppb for ground water, and for chronic 

exposures for cancer assessments are 

estimated to be 1.2 ppb for surface water 

and <0.25 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 18 ppb was used 

to assess the contribution to drinking 

water. For the chronic dietary risk 

assessment, the water concentration of 

value 2.3 ppb was used to assess the 

contribution to drinking water. For the 

cancer dietary risk assessment, the 

water concentration of value 1.2 ppb 

was used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Thiacloprid is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found thiacloprid to 

share a common mechanism of toxicity 

with any other substances, and 

thiacloprid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that thiacloprid does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s 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 


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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 was no increase in either 

qualitative or quantitative susceptibility 

of fetal animals or pups in the rabbit 

developmental or the 2-generation rat 

reproduction studies. In the rabbit 

developmental study, decreased fetal 

weights were observed in the presence 

of maternal toxicity (body weight 

changes and decreased food 

consumption and fecal output). In the 

reproduction study in rats, decreased 

body weights were seen in pups at the 

same dose which resulted in thyroid 

and liver effects in maternal animals. 

In the rat developmental study, there 

was an increase in qualitative 

susceptibility based on an increase in 

resorptions, skeletal retardations and 

variations, dysplastic humerus, radius 

and scapulae, as well as decreased fetal 

weights at the same dose (50 mg/kg/day) 

at which less severe maternal effects 

were noted (decreased body weight, 

body weight gain and food 

consumption, in addition to increased 

urination and changes in water 

consumption). In the developmental 

neurotoxicity study, increased 

qualitative susceptibility was also seen. 

Decreased body weights in both sexes as 

well as altered performance in passive 

avoidance testing were seen in offspring 

animals, while decreased body weight 

gain and food consumption were seen in 

maternal animals. However, there is a 

low degree of concern and no residual 

uncertainties for the increase in 

qualitative susceptibility since there is a 

well-characterized dose response with 

clear NOAELs and LOAELs in the 

studies. Additionally, the endpoints and 

PODs selected for risk assessment are 

protective of potential developmental 

effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicology database concerning 

infants and children is considered to be 

complete with the exception of an 

immunotoxicity study. Submitted 

studies included: Developmental rat and 

rabbit, 2-generation reproduction in rats 

as well as acute, subchronic and 

developmental neurotoxicity in rats. 

Although an immunotoxicity study has 

not been received by the Agency, there 

is relatively little concern as it does not 

appear that thiacloprid directly targets 

the immune system based on available 

studies. Although there were increases 

in the incidence and severity of 

mesenteric and mandibular lymph node 

vacuolization in a cancer study in mice, 

the effects were seen at very high doses 

following long-term treatment. 

Additionally, thiacloprid does not 

belong to a class of chemicals (e.g., the 

organotins, heavy metals, halogenated 

aromatic hydrocarbons) that would be 

expected to be immunotoxic. 

Furthermore, there were no indications 

of immunotoxicity in other studies in 

the toxicology database. The Agency 

does not believe that conducting the 

study will result in a lower POD than 

that currently used for overall risk 

assessment; therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for the lack of the study. 

ii. Acute, subchronic and 

developmental neurotoxicity studies in 

rats are available for thiacloprid. In the 

acute study, there were reductions in 

motor and locomotor activities in 

females and slight tremors and ptosis of 

the eyelids in males. In the subchronic 

neurotoxicity study, decreased hind 

limb grip strength was seen in males. 

Increased grip strength was noted in a 

5-day inhalation toxicity study. In the 

developmental neurotoxicity study, 

altered performance in passive 

avoidance testing and a 4% decrease in 

the size of the corpus striatum region of 

the brain were seen in offspring animals 

at the highest dose tested (HDT). No 

data were received by the Agency 

regarding the mid- and low-dose brain 

measurements. However, the lack of a 

NOAEL for brain morphometric 

measurements in this study does not 

warrant an additional uncertainty factor 

since the decrease in weight at the high 

dose is considered marginal and 

variable, and a lower dose would most 

likely result in less of an effect (the HDT 

was 10x greater than the lowest dose 

tested), and the endpoints and PODs 

selected for risk assessment are 

protective of the slight morphometric 

changes observed at the high dose. Even 

if a 10x factor is applied to the dose 

where the slight morphometric changes 

were seen in the developmental 

neurotoxicity study, the result would be 

a POD comparable to those currently 

selected for risk assessment. Therefore, 

the PODs currently selected are 

protective of any potential effects. There 

were no indications of neurotoxicity in 

the remainder of the submitted toxicity 

studies. 

iii. As noted in Unit III.D.2., although 

there was an increase in qualitative 

susceptibility in the rat developmental 

study and developmental neurotoxicity 

study, there is a low degree of concern 

and no residual uncertainties for the 

increase in qualitative susceptibility 

since there is a well-characterized dose 

response with clear NOAELs and 

LOAELs. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary food 

exposure assessments were performed 

based on 100 PCT and tolerance-level 

residues. The cancer assessment used 

PCT and anticipated residues for new 

and registered uses. This is based on 

reliable data and will not underestimate 

the exposure and risk. The drinking 

water residues used in this assessment 

were partially refined to account for 

PCT area and drinking water treatment 

processes. However, these drinking 

water estimates are still considered to be 

conservative and upper-bound. These 

assessments will not underestimate the 

exposure and risks posed by thiacloprid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

thiacloprid will occupy 19% of the 

aPAD for infants less than 1 year 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 thiacloprid 

from food and water will utilize 26% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for thiacloprid. 

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 


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Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Rules and Regulations 8415 

(considered to be a background 

exposure level). 

Short- and intermediate-term adverse 

effect was identified; however, 

thiacloprid is not registered for any use 

patterns that would result in either 

short- or intermediate-term residential 

exposure. Short- and intermediate-term 

risk is assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or 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 short-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for thiacloprid. 

4. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in this unit for 

cancer, EPA has concluded that the 

cancer risk estimate from exposure to 

thiacloprid through food and water for 

the U.S. population is 2×10 ¥6, which is 

below the Agency’s level of concern. 

EPA generally considers cancer risks 

in the range of 10 ¥6 or less to be 

negligible. The precision which can be 

assumed for cancer risk estimates is best 

described by rounding to the nearest 

integral order of magnitude on the log 

scale; for example, risks falling between 

3 x 10¥7 and 3 x 10 ¥6 are expressed as 

risks in the range of 10 ¥6. Considering 

the precision with which cancer hazard 

can be estimated, the conservativeness 

of low-dose linear extrapolation, and the 

rounding procedure described above, 

cancer risk should generally not be 

assumed to exceed the benchmark level 

of concern of the range of 10 ¥6 until the 

calculated risk exceeds approximately 3 

x 10 ¥6. This is particularly the case 

where some conservatism is maintained 

in the exposure assessment. Here, 

substantial conservatism is incorporated 

by the use of food residue values from 

field trial studies using maximum 

application procedures and upperbound modeled drinking water residues 

in the exposure assessment. 

Accordingly, EPA has concluded the 

cancer risk for all existing thiacloprid 

uses and the uses associated with the 

tolerances established in this action fall 

within the range of 1 x 10 ¥6 and are 

thus negligible. 

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 thiacloprid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography-mass spectrometer/ 

mass spectrometer (HPLC–MS/MS)) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

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 

thiacloprid in or on sweet peppers 

(including pimento or pimiento) at 1 

ppm and stone fruit, crop group 12 at 

0.5 ppm. These MRLs are the same as 

the tolerances being established for 

thiacloprid in the United States on these 

crops. 

C. Revisions to Petitioned-for Tolerances 

The Agency has modified the level at 

which the tolerance is being established 

for pepper from the proposed level of 

1.1 ppm to 1.0 ppm in order to 

harmonize with the Codex MRL. 

EPA has also revised the request for 

a tolerance for thiacloprid on the stone 

fruit group 12. Subsequent to the filing 

of the petition requesting a stone fruit 

group 12 tolerance, EPA issued a final 

rule that revised the crop grouping 

regulations (77 FR 50617, August 22, 

2012) (FRL–9354–3). As part of this 

action, EPA expanded and revised the 

existing stone fruit group 12. Changes to 

crop group 12 included adding the 

following commodities: Japanese 

apricot, capulin, black cherry, nanking 

cherry, Chinese jujube, American plum, 

beach plum, Canada plum, cherry plum, 

Klamath plum, and sloe; creating new 

subgroups (the cherry subgroup 12–12A, 

the peach subgroup 12–12B, and the 

plum subgroup 12–12C); and naming 

the new crop group ‘‘Crop Group 12–12: 

Stone Fruit Group.’’ EPA indicated in 

the August 22, 2012 final rule as well as 

the earlier November 9, 2011 proposed 

rule (76 FR 69693) (FRL–8887–8) that, 

for existing petitions for which a notice 

of filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. Therefore, 

consistent with this rule, and upon 

review of the petition, the Agency 

concluded that it was appropriate to 

establish tolerances for the cherry 

subgroup 12–12A and the peach 

subgroup 12–12B at 0.5 ppm, and the 

plum subgroup 12–12C at 0.05 ppm. A 

single tolerance for the entire stone fruit 

group 12–12 could not be established 

due to the significantly different residue 

levels in the trials with plums as 

compared to the other representative 

commodities in the stone fruit crop 

group and thus tolerances were 

established for each of the three separate 

subgroups. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide 

thiacloprid, including its metabolites 

and degradates, in or on pepper at 1.0 

ppm; cherry subgroup 12–12A at 0.5 

ppm; peach subgroup 12–12B at 0.5 

ppm; plum subgroup 12–12C at 0.05 

ppm. Compliance with the tolerance 

levels is to be determined by measuring 

only thiacloprid, (Z)-[3-[(6-chloro-3- 

pyridinyl)methyl]-2- 

thiazolidinylidene]cyanamide. 

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 


sroberts on DSK5SPTVN1PROD with RULES
8416 Federal Register / Vol. 78, No. 25 / Wednesday, February 6, 2013 / Rules and Regulations 

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: January 29, 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 § 180.594, in paragraph (a) revise 

the introductory text and add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.594 Thiacloprid; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide thiacloprid, including its 

metabolites and degradates in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

thiacloprid ([3-[(6-chloro-3- 

pyridinyl)methyl]-2-thiazolidinylidene] 

cyanamide) in or on the commodity. 

Commodity Parts per 

million 

* * * * * 

Cherry subgroup 12–12A ... 0 .5 

* * * * * 

Peach subgroup 12–12B .... 0 .5 

Pepper ................................ 1 .0 

Plum subgroup 12–12C ...... 0 .05 

* * * * * 

* * * * * 

[FR Doc. 2013–02692 Filed 2–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2013–0002] 

Changes in Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Modified Base (1% annualchance) Flood Elevations (BFEs) are 

finalized for the communities listed 

below. These modified BFEs will be 

used to calculate flood insurance 

premium rates for new buildings and 

their contents. 

DATES: The effective dates for these 

modified BFEs are indicated on the 

following table and revise the Flood 

Insurance Rate Maps (FIRMs) in effect 

for the listed communities prior to this 

date. 

ADDRESSES: The modified BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below of the modified BFEs for 

each community listed. These modified 

BFEs have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Associate 

Administrator for Mitigation has 

resolved any appeals resulting from this 

notification. 

The modified BFEs are not listed for 

each community in this notice. 

However, this final rule includes the 

address of the Chief Executive Officer of 

the community where the modified BFE 

determinations are available for 

inspection. 

The modified BFEs are made pursuant 

to section 206 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4105, 

and are in accordance with the National 

Flood Insurance Act of 1968, 42 U.S.C. 

4001 et seq., and with 44 CFR part 65. 


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