38604 Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: May 31, 2016. 

Susan Lewis, 

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 § 180.628, in the table in 

paragraph (a): 

■ a. Remove the entries for ‘‘Cherry, 

sweet,’’ ‘‘Cherry, tart,’’ ‘‘Plum, 

chickasaw,’’ and ‘‘Plum, damson;’’ 

■ b. Revise the entry for ‘‘Egg;’’ 

■ c. Amend the existing entries by 

adding a footnote for ‘‘Artichoke, 

globe,’’ ‘‘Fruit, stone, group 12–12, 

except cherry, chickasaw plum, and 

damson plum,’’ ‘‘Hop, dried cones,’’ 

‘‘Nut, tree, group 14,’’ and ‘‘Pistachio;’’ 

and 

■ d. Add alphabetically the entries for 

‘‘Artichoke, globe,’’ ‘‘Fruit, stone, group 

12–12,’’ ‘‘Hop, dried cones,’’ and ‘‘Nut, 

tree, group 14–12.’’ 

The additions and revisions read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke, globe 1 .................. 4.0 

Artichoke, globe .................... 2.0 

* * * * * 

Egg ....................................... 1.0 

* * * * * 

Fruit, stone, group 12–12 ..... 2.5 

Fruit, stone, group 12–12, 

except cherry, chickasaw 

plum, and damson plum 1 4.0 

* * * * * 

Hop, dried cones 1 ................ 90 

Commodity Parts per 

million 

Hop, dried cones .................. 40 

* * * * * 

Nut, tree, group 14 1 ............. 0.04 

Nut, tree, group 14–12 ......... 0.02 

* * * * * 

Pistachio 1 ............................. 0.04 

* * * * * 

1This tolerance expires on December 14, 

2016. 

* * * * * 

[FR Doc. 2016–13910 Filed 6–13–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0749; FRL–9942–23] 

Clofentezine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clofentezine in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

14, 2016. Objections and requests for 

hearings must be received on or before 

August 15, 2016, 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–2014–0749, 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), West William 

Jefferson Clinton 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 


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the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

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

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

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–2014–0749 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 August 15, 2016. 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– 

2014–0749, 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.html. 

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 February 

11, 2015 (80 FR 7559) (FRL–9921–94), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 4E8312) by IR–4, 

IR–4 Project Headquarters, Rutgers, The 

State University of New Jersey, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.446 be 

amended by establishing tolerances for 

residues of the acaricide clofentezine in 

or on avocado at 0.3 parts per million 

(ppm); papaya at 0.3 ppm; fruit, pome, 

group 11–10 at 0.5 ppm; cherry, 

subgroup 12–12A at 1.0 ppm; peach, 

subgroup 12–12B at 1.0 ppm; and fruit, 

small, vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 1.0 ppm. 

Upon the approval of the 

aforementioned tolerances, IR–4 

proposed that the existing tolerances for 

apple at 0.5 ppm; pear at 0.5 ppm; 

cherry at 1.0 ppm; nectarine at 1.0 ppm; 

peach at 1.0 ppm; and grape at 1.0 ppm 

be removed as unnecessary. That 

document referenced a summary of the 

petition prepared by Makhteshim Agan 

of North America, the registrant, which 

is available in the docket, http://

www.regulations.gov. One comment was 

received in response to the notice of 

filing, however it related to a different 

chemical. 

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 clofentezine 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with clofentezine 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. 

Subchronic and chronic studies 

indicate the liver is the primary target 

organ for clofentezine with secondary 

effects on the thyroid. Body weight and 

body weight gain were decreased 

whereas liver weights were increased 

and hepatocellular enlargement was 

reported along with other observations 

(increases in plasma cholesterol and 

triglyceride levels). The induction of the 

liver enzyme, uridine diphosphate 

glucuronyltransferase (UDPGT) and the 

subsequent increase in the metabolism 

and the excretion of the thyroid 


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hormone T4 reduced the availability of 

T4 required for the general metabolism 

and the maintenance of homeostasis. 

The decreased levels of plasma T4 

resulted in the stimulation of the 

thyroid by the pituitary gland to raise 

the plasma T4 levels. Thyroid changes 

in the form of colloid depletion, thyroid 

follicular cell hypertrophy and 

hyperplasia were observed as a means to 

regain the homeostasis. 

Two pre-natal developmental toxicity 

studies are available, one in the rat and 

one in the rabbit. No evidence 

(quantitative or qualitative) of increased 

susceptibility was seen in either study 

(developmental NOAELs were set at or 

above the limit dose for both studies). 

There was no evidence (quantitative or 

qualitative) of increased susceptibility 

seen following pre-and/or post-natal 

exposure in rats for 2-generations in the 

reproduction study (NOAEL set at the 

highest dose tested). 

Clofentezine does cause thyroid 

tumors in male rats after long-term high 

exposure resulting in progressive effects 

on the thyroid that leads to hyperplasia 

and eventual tumor formation. No 

mechanism or mode of action has been 

submitted to the Agency at this time for 

clofentezine. As a result, clofentezine 

has been classified as a possible human 

carcinogen based on male rat thyroid 

follicular cell adenoma and/or 

carcinoma combined tumor rates. The 

Q1* value for use in clofentezine risk 

assessment using the 3⁄4 inter species 

scaling factor is 3.76 × 10¥2 (mg/kg/

day)¥1. Clofentezine is not considered 

to be a mutagen. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by clofentezine as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Clofentezine.’’ Human-Health 

Risk Assessment to Support a Section 3 

Registration Request to Add New Uses 

on Avocado and Papaya, and New Uses 

for Pome Fruit Group 11–10, Cherry 

sub-group 12–12A, Peach sub-group 12– 

12B, and Small Fruit Vine Climbing 

except Fuzzy Kiwifruit Subgroup 13– 

07F based on Existing Tolerances on 

Representative Commodities’’ on page 

38 in docket ID number EPA–HQ–OPP– 

2014–0749. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for clofentezine used for 

human risk assessment is shown in 

Table 1 of this Unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CLOFENTEZINE 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) .. No appropriate endpoint was identified including developmental toxicity studies in rats and rabbits. 

Chronic dietary (All populations) NOAEL= 1.25 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.013 

mg/kg/day.

cPAD = 0.013 mg/

kg/day 

1-year chronic dog study—LOAEL = 25 mg/kg based on increased liver weights, hepatocellular enlargement, and increased serum cholesterol, triglycerides and alkaline phosphatase levels. 

Cancer (Oral, dermal, inhalation).Classification: Possible human carcinogen (classification of C), Q* using the 3⁄4 interspecies scaling factor is 

3.76 × 10¥2 (mg/kg/day)¥1. 

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

milligram/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 clofentezine, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing clofentezine tolerances in 40 

CFR 180.446. EPA assessed dietary 

exposures from clofentezine 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. No such effects were 

identified in the toxicological studies 

for clofentezine; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, a partially refined 

chronic dietary exposure and risk 

assessment was performed that directly 


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incorporated average field trial residues 

and used percent crop treated 

information. 

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 

non cancer 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 

clofentezine should be classified as 

possible human carcinogen and a linear 

approach has been used to quantify 

cancer risk. Cancer risk was quantified 

using the same estimates as discussed in 

Unit III.C.1.ii. 

iv. Anticipated residue and percent 

crop treated (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 call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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. 

Average percent crop treated 

estimates were used in the chronic and 

cancer dietary risk assessments for the 

following crops that are currently 

registered for clofentezine: Almonds: 

5%; apples: 2.5%; apricots: 2.5%; 

cherries: 5%; grapes: 1%; nectarines: 

5%; peaches: 5%; pears: 5%; and 

walnuts: 5%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/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 

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%. 

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 clofentezine 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 clofentezine in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

clofentezine. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

clofentezine for chronic exposures for 

non-cancer and cancer assessments are 

estimated to be 0.062 parts per billion 

(ppb) for surface water and 0.041 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic and cancer dietary risk 

assessment, the water concentration of 

value 0.062 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). 

Clofentezine 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 clofentezine to 

share a common mechanism of toxicity 

with any other substances, and 

clofentezine does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that clofentezine 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 


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the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Two pre-natal developmental toxicity 

studies were available, one in the rat 

and one in the rabbit. No evidence 

(quantitative or qualitative) of increased 

susceptibility was seen in either study 

(developmental NOAELs were set at or 

above the limit dose for both studies). 

There was no evidence (quantitative or 

qualitative) of increased susceptibility 

seen following pre-and/or post-natal 

exposure in rats for 2-generations in the 

reproduction study (NOAEL set at the 

highest dose tested). 

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 

clofentezine is complete. 

ii. There is no indication that 

clofentezine 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 

clofentezine 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. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic and cancer analyses 

incorporated anticipated residues 

(average residues from available field 

trial data) for all registered and 

proposed commodities and the latest 

PCT data available. The highest 

estimated drinking water concentrations 

of clofentezine were incorporated 

directly into the chronic and cancer 

assessments. These assessments will not 

underestimate the exposure and risks 

posed by clofentezine. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, clofentezine is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to clofentezine 

from food and water will utilize <1% of 

the cPAD for all population groups. 

There are no residential uses for 

clofentezine. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

A short- and intermediate-term 

adverse effect was identified; however, 

clofentezine is not registered for any use 

patterns that would result in 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- or 

intermediate-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for clofentezine. 

4. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions described in this unit for 

cancer exposure, EPA has concluded 

that by applying the Q1* of 3.76 × 10¥2

mg/kg/day to the exposure value results 

in a cancer risk estimate of 3.8 × 10¥7

to the general U.S. population. EPA 

generally considers cancer risks 

(expressed as the probability of an 

increased cancer case) in the range of 1 

in 1 million (or 1 × 10¥6) or less to be 

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 clofentezine 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography (HPLC)) 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. 

There are no Codex MRLs for residues 

on avocado and papaya. 

The U.S. pome fruit tolerance of 0.5 

ppm is harmonized with the Codex 

MRL. 

The U.S. tolerance is 1.0 ppm in/on 

stone fruit (12–12A and 12–12B). The 

Codex MRL for stone fruit is 0.5 ppm. 

The clofentezine residues in/on 

representative stone fruit crops, cherry 

and peach, from the submitted U.S. field 

trial data are greater than 0.5 ppm and 


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Federal Register / Vol. 81, No. 114 / Tuesday, June 14, 2016 / Rules and Regulations 38609 

setting the tolerances for 12–12A and 

12–12B at 0.5 ppm to harmonize with 

Codex could result a tolerance 

exceedance for U.S. growers. Therefore, 

the U.S. tolerance cannot be harmonized 

with Codex MRL for stone fruit at this 

time. 

The U.S. tolerance of 1.0 ppm for the 

crop subgroup fruit, small, vine 

climbing, except fuzzy kiwifruit, 13–07F 

does not harmonize with the Codex 

MRL of 2.0 ppm. The petitioner 

requested a 13–07F subgroup tolerance 

at 1.0 ppm, which would maintain the 

existing tolerance on grapes at 1.0 ppm 

consistent with the MRL at 1.0 ppm 

maintained by several countries 

including Japan and Korea. EPA is not 

harmonizing with Codex in order to 

maintain MRL harmony with several 

other countries to avoid potential export 

issues. 

V. Conclusion 

Therefore, tolerances are established 

for residues of clofentezine in or on 

avocado at 0.30 ppm; papaya at 0.30 

ppm; fruit, pome, group 11–10 at 0.50 

ppm; cherry, subgroup 12–12A at 1.0 

ppm; peach, subgroup 12–12B at 1.0 

ppm; and fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

at 1.0 ppm. In addition, the existing 

tolerances for apple at 0.5 ppm; pear at 

0.5 ppm; cherry at 1.0 ppm; nectarine at 

1.0 ppm; peach at 1.0 ppm; and grape 

at 1.0 ppm are removed as unnecessary. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: May 31, 2016. 

Susan Lewis, 

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 § 180.446, in the table in 

paragraph (a)(1): 

■ a. Remove the entries for ‘‘Apple’’, 

‘‘Cherry’’, ‘‘Grape’’, ‘‘Nectarine’’, 

‘‘Peach’’, and ‘‘Pear’’; and 

■ b. Add alphabetically the entries for 

‘‘Avocado’’, ‘‘Cherry, subgroup 12– 

12A’’, ‘‘Fruit, pome, group 11–10’’, 

‘‘Fruit, small, vine climbing, except 

fuzzy kiwifruit, Subgroup 13–07F’’, 

‘‘Papaya’’, and ‘‘Peach, subgroup 12– 

12B’’. 

The additions read as follows: 

§ 180.446 Clofentezine; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Avocado .................................... 0.30 

Cherry, subgroup 12–12A ........ 1.0 

Fruit, pome, group 11–10 ......... 0.50 

Fruit, small, vine climbing, except fuzzy kiwifruit, Subgroup 

13–07F .................................. 1.0 

* * * * * 

Papaya ...................................... 0.30 

Peach, subgroup 12–12B ......... 1.0 

* * * * * 

* * * * * 

[FR Doc. 2016–13911 Filed 6–13–16; 8:45 am] 

BILLING CODE 6560–50–P 


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