52240 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

sulfonyl]-2-thiophenecarboxylate, in or 

on chicory roots at 0.01 ppm and 

chicory tops at 0.01 ppm.) 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 17, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.439 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.439 Thifensulfuron methyl; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Chicory, roots ....................... 0.01 

Chicory, tops ......................... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2012–21356 Filed 8–28–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0521; FRL–9360–5] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pendimethalin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 29, 2012. Objections and 

requests for hearings must be received 

on or before October 29, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0521, 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, 

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 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52241 

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://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–2011–0521 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 October 29, 2012. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit the nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0521, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1E7878) by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.361 be 

amended by establishing tolerances for 

residues of the herbicide pendimethalin, 

N-(1-ethylpropyl)-3,4-dimethyl2,6dinitrobenzenamine, and its 3, 5- 

dinitrobenzyl alcohol metabolite (CL 

202347), in or on lettuce, leaf at 3.0 

parts per million (ppm); Brassica, leafy 

greens, subgroup 5B at 0.2 ppm; turnip 

greens at 0.2 ppm; melons subgroup 9A 

at 0.1 ppm; vegetable, soybean, 

succulent at 0.1 ppm; and small fruit 

vine climbing subgroup 13–07E, except 

grape at 0.1 ppm. That notice referenced 

a summary of the petition prepared by 

BASF, 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 level for which the 

tolerance is being established for leaf 

lettuce. The reason for this change 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 

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 pendimethalin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pendimethalin 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. 

Pendimethalin has low acute oral, 

dermal, and inhalation toxicity, and is 

not a dermal sensitizer. The thyroid is 

a target organ for pendimethalin. 

Thyroid toxicity in chronic and 

subchronic rat and mouse studies was 

manifested as alterations in thyroid 

hormones, increased thyroid weight, 

and microscopic thyroid lesions. Due to 

these effects, the Agency required that a 

developmental thyroid assay be 

conducted to evaluate the impact of 

pendimethalin on thyroid hormones, 

structure, and/or thyroid hormone 

homeostasis during development. A 

developmental thyroid study was 

submitted and demonstrated that there 

is no potential thyroid toxicity 

following pre- and/or post-natal 

exposure to pendimethalin. The 

available prenatal and postnatal 

developmental toxicity data provided 

no indication of qualitative or 

quantitative susceptibility to the young. 

The overall weight of evidence suggests 

that this chemical does not directly 

target the immune system. There is no 

evidence of neurotoxicity for 

pendimethalin exposure. 

The points of departure (PODs) used 

for the chronic and short-term risk 

assessments were based on a 92-day 

thyroid function study in rats, a 56-day 

thyroid study in rats, and a 14-day intra 

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52242 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

thyroid metabolism study in rats. Due to 

several important quantitative dynamic 

differences between rats and humans 

with respect to thyroid function, the 

interspecies uncertainty factor ((UF); 

used to account for animal to human 

differences in toxicokinetics and 

toxicodynamics) was reduced to 3X for 

the chronic and short-term risk 

assessments. A 10X interspecies UF was 

used in the acute risk assessment 

because the POD was based on an acute 

neurotoxicity study, not a thyroid study. 

The use of an oral POD, assuming 100 

percent inhalation absorption is 

considered protective for assessing 

short-term inhalation exposure since 

pendimethalin has a low vapor pressure 

(1.24 x 10¥8 Millimeter (mm) mercury 

(Hg) at 20°C) and is not likely to 

volatilize substantially. It also has a 

relatively low solubility in water (0.275 

ppm at 25 °C). Further, the EPA has 

determined a subchronic inhalation 

study is not needed at this time. 

Pendimethalin is considered a 

possible human carcinogen based on a 

statistically significant increased trend 

and pair-wise comparison between the 

high dose group and controls for thyroid 

folliculate cell adenomas in male and 

female rats. A threshold approach is 

being used to evaluate cancer risk 

because mode of action studies are 

available demonstrating that the thyroid 

tumors are due to a thyroid-pituitary 

imbalance (a threshold effect), and also 

because pendimethalin was shown to be 

non-mutagenic in mammalian somatic 

cells and germ cells. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pendimethalin 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 pp. 51–54 in 

the document titled ‘‘Revised 

Pendimethalin: Human Health Risk 

Assessment for Proposed Use on Leaf 

lettuce; Leafy brassica greens; Melons; 

Edamame; Kiwi and other small fruit 

vines’’ in docket ID number EPA–HQ– 

OPP–2011–0521. 

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 pendimethalin used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENDIMETHALIN 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 (General population including infants and children).NOAEL = 100 mg/ 

kg/day 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 1 mg/ 

kg/day 

aPAD = 1 mg/kg/ 

day 

Acute neurotoxicity study 

LOAEL = 300 mg/kg, based on reduced motor activity for 

males and females on Day 0 

Chronic dietary (All populations) ............ NOAEL= 10 mg/kg/ 

day 

UFA = 3X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.3 

mg/kg/day 

cPAD = 0.3 mg/kg/ 

day 

92-Day thyroid function study in rats; 56-day thyroid study 

in rats; 14-day intra thyroid metabolism study in rats 

LOAEL = 31 mg/kg/day based on hormonal and 

histopathological changes in the thyroid 

Incidental oral short-term (1 to 30 days) NOAEL= 10 mg/kg/ 

day 

UFA = 3X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 30 92-Day thyroid function study in rats; 56-day thyroid study 

in rats; 14-day intra thyroid metabolism study in rats 

LOAEL = 31 mg/kg/day based on hormonal and 

histopathological changes in the thyroid 

Dermal short-term (1 to 30 days) ........... Oral study NOAEL 

= 10 mg/kg/day 

(dermal absorption rate = 3% 

UFA = 3X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 30 92-Day thyroid function study in rats; 56-day thyroid study 

in rats; 14-day intra thyroid metabolism study in rats 

LOAEL = 31 mg/kg/day based on hormonal and 

histopathological changes in the thyroid 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52243 

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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation short-term (1 to 30 days) ....... Oral study 

NOAEL= 10 mg/ 

kg/day (inhalation absorption 

rate = 100%) 

UFA = 3X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 30 92-Day thyroid function study in rats; 56-day thyroid study 

in rats; 14-day intra thyroid metabolism study in rats 

LOAEL = 31 mg/kg/day based on hormonal and 

histopathological changes in the thyroid 

Cancer (Oral, dermal, inhalation) ........... Pendimethalin has been classified as a possible human carcinogen based on a statistically significant 

increased trend and pair-wise comparison between the high dose group and controls for thyroid follicular cell adenomas in male and female rats. A non-quantitative approach (i.e., non-linear, RfD approach) was used since mode of action studies are available 

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

milligram/kilogram/day. MOE = margin of exposure. 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 pendimethalin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pendimethalin tolerances in 40 

CFR 180.361. EPA assessed dietary 

exposures from pendimethalin 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 

pendimethalin. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT) and 

tolerance-level residues for all current 

and proposed crops. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed 100 PCT and tolerance-level 

residues for all current and proposed 

crops. 

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. Cancer risk is 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 a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to pendimethalin. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

pendimethalin. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pendimethalin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pendimethalin. 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 

pendimethalin for acute exposures are 

estimated to be 80.5 parts per billion 

(ppb) for surface water and 0.036 ppb 

for ground water; and for chronic 

exposures are estimated to be 6.2 ppb 

for surface water and 0.036 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 80.5 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 6.2 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). 

Pendimethalin is currently registered 

for the following uses that could result 

in residential exposures: Turf and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: For handlers, it is 

assumed that most residential use will 

result in short-term (1 to 30 days) 

dermal and inhalation exposures. 

Residential handlers are assumed to be 

wearing short-sleeved shirts, short 

pants, shoes and socks during 

application of pendimethalin. 

Residential post-application exposure 

is assumed to be short-term (1–30 days) 

in duration, resulting from the 

following: physical activities on turf: 

adults (dermal) and children 1–2 years 

old (dermal and incidental oral); 

mowing: adults (dermal) and children 

11 < 16 years old (dermal); and golfing: 

adults (dermal), children 11 < 16 years 

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52244 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

old (dermal), and children 6 < 11 years 

old (dermal). 

EPA did not combine exposure 

resulting from adult handler and postapplication exposure resulting from 

treated lawns and/or golfing because of 

the conservative assumptions and 

inputs within each estimated exposure 

scenario. The Agency believes that 

combining exposures resulting from 

handler and post-application activities 

would result in an overestimate of adult 

exposure. EPA selected the most 

conservative adult residential scenario 

(adults 50+ years old; dermal postapplication exposure) as the 

contributing source of residential 

exposure to be combined with the 

dietary exposure for the aggregate 

assessment. 

The children’s oral exposure is based 

on post-application hand-to-mouth 

exposures. To include exposure from 

object-to-mouth and soil ingestion in 

addition to hand-to-mouth could result 

in a very conservative estimation of 

exposure, as it would overestimate the 

potential for oral exposure. However, 

there is potential for co-occurrence of 

the dermal and oral exposure based on 

the use pattern and combining them is 

appropriate because risk estimated from 

the dermal and oral routes of exposure 

are based on the same toxicological 

study. As a result, the children’s 

aggregate assessment combines postapplication dermal and oral exposure 

along with dietary exposure from food 

and water. 

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.’’ 

EPA has not found pendimethalin to 

share a common mechanism of toxicity 

with any other substances, and 

pendimethalin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pendimethalin 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 

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 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 indication of pre- and/or 

post-natal qualitative or quantitative 

increased susceptibility in the 

developmental studies in rats and 

rabbits or the 2-generation reproduction 

studies in rats. In addition, a 

developmental thyroid toxicity study 

demonstrated that there is no potential 

thyroid toxicity following pre- and/or 

post-natal exposure to pendimethalin. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

pendimethalin is complete. 

ii. There is no indication that 

pendimethalin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

pendimethalin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. In addition, a 

developmental thyroid toxicity study 

demonstrated that there is no potential 

thyroid toxicity following pre- and/or 

post-natal exposure to pendimethalin. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

pendimethalin in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by pendimethalin. 

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 aPAD and 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 

pendimethalin will occupy 2.0% of the 

aPAD for all 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 pendimethalin 

from food and water will utilize 1.6% 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 pendimethalin is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Pendimethalin is currently registered 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to pendimethalin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 125 for adults and 93 for 

children 1–2 years old, the two 

population subgroups receiving the 

greatest combined dietary and nondietary exposure. Because EPA’s level of 

concern for pendimethalin is a MOE of 

30 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52245 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, pendimethalin 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

pendimethalin. 

5. Aggregate cancer risk for U.S. 

population. Pendimethalin is 

considered a ‘‘possible human 

carcinogen’’ based on a statistically 

significant increased trend and pairwise comparison between the high dose 

group and controls for thyroid follicular 

cell adenomas in male and female rats. 

A non-quantitative approach (i.e., nonlinear, RfD approach) was used since 

mode of action studies are available to 

demonstrate that the thyroid tumors are 

due to a thyroid-pituitary imbalance, 

and also since pendimethalin was 

shown to be non-mutagenic in 

mammalian somatic cells and germ 

cells. The chronic dietary risk 

assessment is considered to be 

protective of any cancer effects. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

pendimethalin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

PAM Volume II lists four Gas 

Chromatography/Electron Capture 

Detector (GC/ECD), methods for the 

determination of pendimethalin and its 

3,5-dinitrobenzyl alcohol metabolite in 

plant commodities. Methods I and III 

determine residues of the parent, 

whereas Methods II and IV determine 

residues of the 3,5-dinitrobenzyl alcohol 

metabolite. 

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 not established MRLs 

for pendimethalin on any of these new 

uses. 

C. Revisions to Petitioned-For 

Tolerances 

The proposed tolerance of 3.0 ppm on 

leaf lettuce is being increased to 4.0 

ppm. This is because the Agency used 

the Organization of Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures in 

determining appropriate tolerance 

levels, whereas the petitioner used the 

North American Free Trade Agreement 

(NAFTA) tolerance calculation 

procedures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl2,6dinitrobenzenamine, and its 3, 5- 

dinitrobenzyl alcohol metabolite (CL 

202347), in or on lettuce, leaf at 4.0 

ppm; Brassica, leafy greens, subgroup 

5B at 0.20 ppm; turnip greens at 0.20 

ppm; melon subgroup 9A at 0.10 ppm; 

vegetable, soybean (edamame) at 0.10 

ppm; and fruit, small vine climbing 

subgroup 13–07E, except grape at 0.10 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

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52246 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

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: August 17, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.361 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Brassica, leafy greens, subgroup 5B ......................... 0 .20 

* * * * * 

Fruit, small vine climbing, 

except grape, subgroup 

13–07E ............................ 0 .10 

* * * * * 

Lettuce, leaf ........................ 4 .0 

Melon subgroup 9A ............ 0 .10 

* * * * * 

Turnip greens ..................... 0 .20 

* * * * * 

Vegetable, soybean, succulent ............................... 0 .10 

* * * * * 

* * * * * 

[FR Doc. 2012–21361 Filed 8–28–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0217; FRL–9360–4] 

Clothianidin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clothianidin in 

or on rice, grain at 0.01 ppm. Valent 

U.S.A. Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 29, 2012. Objections and 

requests for hearings must be received 

on or before October 29, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2010–0217, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Marianne Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8043; email address: 

lewis.marianne@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I access electronic copies of 

this document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I file an objection or hearing 

request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0217 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before October 29, 2012. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2010–0217, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

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