Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 43329 

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 § 180.665, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.665 Sedaxane; tolerances for 

residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Beet, sugar, roots ......................... 0.01 

* * * * * 

Cotton, undelinted seed ............... 0.01 

Cotton, gin byproducts ................. 0.01 

* * * * * 

* * * * * 

[FR Doc. 2015–17999 Filed 7–21–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0232; FRL–9929–57] 

Novaluron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of novaluron in 

or on multiple commodities and 

removes several existing tolerances 

which are identified and discussed later 

in this document. This regulation 

additionally revises existing tolerances 

in or on vegetable, cucurbit, group 9; 

and plum, prune, dried. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

22, 2015. Objections and requests for 

hearings must be received on or before 

September 21, 2015, 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–2014–0232, 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 

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 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–2014–0232 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 September 21, 2015. 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– 

2014–0232, 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 December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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 4E8241) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 201 

W., Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the insecticide novaluron, 

(N-[[[3-chloro-4-[1,1,2-trifluoro-2- 

(trifluoromethoxy)ethoxy]

phenyl]amino]carbonyl]-2,6-difluoro

benzamide), in or on avocado at 0.60 

parts per million (ppm); carrot at 0.05 

ppm; bean at 0.60 ppm; vegetable, 

fruiting, group 8–10 at 1.0 ppm; fruit, 

pome, group 11–10 at 2.0 ppm; cherry 

subgroup 12–12A at 8.0 ppm; peach 


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subgroup 12–12B at 1.9 ppm; and plum 

subgroup 12–12C at 1.9 ppm. 

Upon approval of the petitioned-for 

tolerances listed above, the petition 

proposed to remove the following 

established tolerances for residues of 

novaluron from 40 CFR 180.598: Bean, 

succulent, snap at 0.60 ppm; bean, dry, 

seed at 0.30 ppm; cherry at 8.0 ppm; 

fruit, pome, group 11 at 2.0 ppm; fruit, 

stone, group 12, except cherry at 1.9 

ppm; vegetable, fruiting, group 8 at 1.0 

ppm; cocona at 1.0 ppm; African 

eggplant at 1.0 ppm; pea eggplant at 1.0 

ppm; scarlet eggplant at 1.0 ppm; goji 

berry at 1.0 ppm; garden huckleberry at 

1.0 ppm; martynia at 1.0 ppm; naranjilla 

at 1.0 ppm; okra at 1.0 ppm; roselle at 

1.0 ppm; sunberry at 1.0 ppm; bush 

tomato at 1.0 ppm; currant tomato at 1.0 

ppm; and tree tomato at 1.0 ppm. These 

tolerances were requested for removal 

because they will be superseded by 

establishment of the petitioned-for 

tolerances. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by Makhteshim-Agan of 

North America, Inc., the registrant, 

which is available in the docket, 

http://www.regulations.gov. Comments 

were received on the notice of filing. 

EPA’s response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

several proposed tolerances. EPA has 

also determined that the previously 

established tolerances in or on 

vegetable, cucurbit, group 9 and plum, 

prune, dried should be revised. Finally, 

EPA determined that establishing a 

tolerance on bean is not appropriate; 

rather, a tolerance should be established 

on bean, succulent and the previously 

established tolerance on bean, dry, seed 

should not be removed. The reasons for 

these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for novaluron 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with novaluron 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 subchronic and chronic toxicity 

studies, novaluron primarily produced 

hematotoxic effects such as 

methemoglobinemia, decreased 

hemoglobin, decreased hematocrit, 

decreased red blood cells (RBCs) (or 

erythrocytes) and increased reticulocyte 

counts that were associated with 

compensatory erythropoiesis. Increased 

spleen weights or hemosiderosis in the 

spleen were considered to be due to 

enhanced removal of damaged 

erythrocytes and not to a direct 

immunotoxic effect. 

There was no maternal or 

developmental toxicity seen in the rat 

and rabbit developmental toxicity 

studies up to the limit doses. In the 2- 

generation reproductive toxicity study 

in rats, both parental and offspring 

toxicity (increased spleen weights) were 

observed at the same dose. Reproductive 

toxicity, including decreases in 

epididymal sperm counts and increased 

age at preputial separation in the F1 

generation, was observed at a higher 

dose than the increased spleen weights 

and were consistent with the primary 

effects in the database. 

Clinical signs of neurotoxicity 

(piloerection, irregular breathing), 

changes in functional observational 

battery (FOB) parameters (increased 

head swaying, abnormal gait), and 

neuropathology (sciatic and tibial nerve 

degeneration) were seen in the rat acute 

neurotoxicity study at the limit dose. 

However, no signs of neurotoxicity or 

neuropathology were observed in the 

subchronic neurotoxicity study in rats at 

similar doses or in any other subchronic 

or chronic toxicity study in rats, mice, 

or dogs. In the submitted 

immunotoxicity study, the only sign of 

potential immunotoxicity for novaluron 

was a decreased anti-sheep red blood 

cell (anti-SRBC) response at twice the 

limit dose in female rats. There was no 

evidence of carcinogenic potential in 

either the rat or mouse carcinogenicity 

studies, and there was also no concern 

for genotoxicity or mutagenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by novaluron as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Novaluron: Human Health Risk 

Assessment for the Petition for the 

Establishment of Permanent Tolerances 

for Residues of Novaluron in/on 

Avocado; Carrot; Succulent Bean; 

Vegetable, Fruiting, Crop Group 8–10; 

Fruit, Pome, Crop Group 11–10; Cherry 

Subgroup 12–12A; Peach Subgroup 12– 

12B; and Plum Subgroup 12–12C; and 

Revisions to the Label to Include Uses 

on Greenhouse-Grown Cucumber’’ at 

pages 36–40 in docket ID number EPA– 

HQ–OPP–2014–0232. 

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 


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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 novaluron used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NOVALURON 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).

An endpoint of concern attributable to a single dose was not identified, and an acute RfD was not established. 

Chronic dietary (All populations) NOAEL = 1.1 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.011 

mg/kg/day.

cPAD = 0.011 mg/

kg/day.

Combined chronic toxicity/carcinogenicity feeding in rat. 

LOAEL = 30.6 mg/kg/day based on erythrocyte damage resulting in a compensatory regenerative anemia. 

Incidental oral, all durations ...... NOAEL = 4.38 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day feeding study in rat. 

LOAEL = 8.64 mg/kg/day based on clinical chemistry (decreased hemoglobin, hematocrit, and RBC counts) and 

histopathology (increased hematopoiesis and hemosiderosis 

in spleen and liver). 

Inhalation, all durations ............. Inhalation (or oral) 

study NOAEL = 

4.38 mg/kg/day 

(inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day feeding study in rat. 

LOAEL = 8.64 mg/kg/day based on clinical chemistry (decreased hemoglobin, hematocrit, and RBC counts) and 

histopathology (increased hematopoiesis and hemosiderosis 

in spleen and liver). 

Cancer (Oral, dermal, inhalation).Classified as not likely to be carcinogenic to humans. 

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 novaluron, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

novaluron tolerances in 40 CFR 180.598. 

EPA assessed dietary exposures from 

novaluron 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 novaluron; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA under the National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA); 2003–2008. As to 

residue levels in food, EPA incorporated 

average field trial residues for the 

majority of commodities; anticipated 

residues (ARs) for meat, milk, hog, and 

poultry commodities; and average 

percent crop treated (PCT) data for 

apples, blueberries, cabbage, 

cauliflower, cotton, dry beans, pears, 

peppers, potatoes, strawberries, and 

tomatoes. Percent crop treated for new 

use (PCTn) data were incorporated for 

the recently registered grain sorghum 

and sweet corn uses. For the remaining 

food commodities, 100 PCT was 

assumed. The registered food-handling 

use was also incorporated into the 

dietary assessment. Empirical 

processing factors were utilized for 

apple juice (translated to pear and stone 

fruit juice), cottonseed oil, dried plums, 

and tomato paste and pure ́e. Dietary 

Exposure Evaluation Model (DEEM) 

(ver. 7.81) default processing factors 

were used for the remaining processed 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that novaluron does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue 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 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 


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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. 

The Agency estimated the average 

PCT for existing uses as follows: 

Apple, 10%; blueberry, 1%; cabbage, 

5%; cauliflower, 2.5%; cotton, 2.5%; 

dry beans, 1%; pear, 15%; pepper, 

2.5%; potato, 2.5%; strawberry, 35%; 

and tomato, 2.5%. 

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 to 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 estimated the PCT for 

new uses as follows: Grain sorghum, 

2%; and sweet corn, 36%. 

EPA estimates PCTn for novaluron 

based on the PCT of the dominant 

pesticide (i.e., the one with the greatest 

PCT) on that site over the three most 

recent years of available data. 

Comparisons are only made among 

pesticides of the same pesticide types 

(i.e., the dominant insecticide on the use 

site is selected for comparison with a 

new insecticide). The PCTs included in 

the analysis may be for the same 

pesticide or for different pesticides 

since the same or different pesticides 

may dominate for each year. Typically, 

EPA uses USDA/NASS as the source for 

raw PCT data because it is publicly 

available and does not have to be 

calculated from available data sources. 

When a specific use site is not surveyed 

by USDA/NASS, EPA uses proprietary 

data and calculates the estimated PCT. 

This estimated PCTn, based on the 

average PCT of the market leader, is 

appropriate for use in the chronic 

dietary risk assessment. This method of 

estimating a PCT for a new use of a 

registered pesticide or a new pesticide 

produces a high-end estimate that is 

unlikely, in most cases, to be exceeded 

during the initial five years of actual 

use. The predominant factors that bear 

on whether the estimated PCTn could 

be exceeded are: The extent of pest 

pressure on the crops in question; the 

pest spectrum of the new pesticide in 

comparison with the market leaders as 

well as whether the market leaders are 

well-established for this use; and 

resistance concerns with the market 

leaders. 

Novaluron specifically targets 

lepidopterous insects, which are not key 

pests of sorghum but are key pests of 

sweet corn. However, novaluron has a 

relatively narrow spectrum of pest 

activity when compared to the market 

leader insecticides. In addition, there 

are no resistance or pest pressure issues 

as indicated in Section 18 Emergency 

Exemption requests for use of novaluron 

on sorghum or sweet corn. All 

information currently available has been 

considered for novaluron use on 

sorghum and sweet corn, and it is the 

opinion of EPA that it is unlikely that 

actual PCT for novaluron will exceed 

the estimated PCT for new uses during 

the next five 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 novaluron may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The residues of concern in 

drinking water for risk assessment 

purposes are novaluron, the 

chlorophenyl urea degradate, and the 

chloroaniline degradates. The estimated 

drinking water concentrations (EDWCs) 

for each of these was calculated using a 

molecular weight conversion and then 

combined for each modeled scenario. 

The degradates are assumed to have 

equal toxicity to the parent. The Agency 

used screening level water exposure 

models in the dietary exposure analysis 

and risk assessment for novaluron and 

its degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of novaluron 

and its degradates. 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), the Screening 

Concentration in Ground Water (SCI– 

GROW), and Pesticide Root Zone Model 

Ground Water (PRZM GW) models, the 

combined EDWCs of novaluron, 

chlorophenyl urea, and chloroaniline 

for chronic exposures are estimated to 

be 16.7 ppb for surface water and 77.8 

ppb for groundwater. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 77.8 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). 

Novaluron is currently registered for 

the following uses that could result in 

residential exposures: Indoor and 

outdoor crack and crevice or perimeter 

applications in residential areas and 

their immediate surroundings, 

including homes and apartment 

buildings; on modes of transportation; 

and as a spot-on use for pets. EPA 

assessed residential exposure using the 

following assumptions: 

Adult handlers were assessed for 

potential short-term inhalation 

exposures from mixing, loading, and 


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applying novaluron via manuallypressurized hand wand and from liquid 

applications of novaluron to turf. Adults 

were also assessed for potential shortterm post-application inhalation 

exposures to novaluron from indoor 

uses. For children 1 to <2 years old, 

short-term post-application inhalation 

and incidental oral exposures were 

assessed resulting from hand-to-mouth 

contact with treated residential areas, 

turf, and from contact with treated pets. 

There is also the potential for 

intermediate-term and long-term postapplication hand-to-mouth exposures to 

children 1 to <2 years old from the 

registered pet spot-on use of novaluron. 

Inhalation exposures are considered 

negligible for this exposure scenario; 

therefore, the intermediate- and longterm aggregate risk estimates do not 

include inhalation exposures. For 

adults, inhalation exposure is expected 

to be negligible for intermediate- and 

long-term durations and was not 

included in the aggregate assessment. 

Additionally, a dermal endpoint has not 

been selected for novaluron, so dermal 

exposures to adults or children were not 

assessed. 

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 novaluron to share 

a common mechanism of toxicity with 

any other substances, and novaluron 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that novaluron 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 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. 

The prenatal and postnatal toxicology 

database for novaluron includes rat and 

rabbit prenatal developmental toxicity 

studies and a two-generation 

reproduction toxicity study in rats. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

following in utero exposure to rats or 

rabbits in the developmental toxicity 

studies and no evidence of increased 

quantitative or qualitative susceptibility 

of offspring in the reproduction study. 

Neither maternal nor developmental 

toxicity was seen in the developmental 

studies up to the limit doses (1,000 mg/ 

kg/day). In the 2-generation 

reproductive study in rats, offspring and 

parental toxicity (increased absolute and 

relative spleen weights) were similar 

and occurred at the same dose (74.2 mg/ 

kg/day). Additionally, reproductive 

effects (decreases in epididymal sperm 

counts and increased age at preputial 

separation in the F1 generation) 

occurred at a higher dose than that 

which resulted in parental toxicity. 

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 novaluron 

is complete. 

ii. Acute and subchronic rat 

neurotoxicity studies were performed 

for novaluron. The clinical signs of 

neurotoxicity, changes in FOB 

parameters, and neuropathology were 

seen in the acute neurotoxicity study at 

the limit dose (2,000 mg/kg/day) only 

and were not reproduced at similar, 

repeated doses in the subchronic 

neurotoxicity study. In addition, no 

evidence of neuropathology was 

observed in subchronic and chronic 

toxicity studies in rats, mice, or dogs. 

Therefore, novaluron is not considered 

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 

novaluron 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 dietary food exposure 

assessment was performed using 

average field trial residues, anticipated 

residues for livestock commodities, 

average PCT and PCTn data for some 

commodities, and empirical and default 

processing factors. For the remaining 

food commodities, 100 PCT was 

assumed. The registered food handling 

use was also incorporated into the 

dietary assessment. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to novaluron 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 novaluron. 

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, novaluron 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 novaluron from 

food and water will utilize 73% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Novaluron is currently 


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43334 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 

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 

novaluron. 

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 1,560 for adults and 350 for 

children 1 to <2 years old. Because 

EPA’s level of concern for novaluron is 

a MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate- and long-term risk. 

Intermediate- and long-term aggregate 

exposure takes into account 

intermediate- and long-term residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). Novaluron 

is currently registered for uses that 

could result in intermediate- and longterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate- and long-term residential 

exposures to novaluron. 

Using the exposure assumptions 

described in this unit for intermediateand long-term exposures, EPA has 

concluded that the combined 

intermediate- and long-term food, water, 

and residential exposures result in an 

aggregate MOE of 530 for children 1 to 

<2 years old. For adults, since there is 

no dermal endpoint and inhalation 

exposure is expected to be negligible, 

the average dietary consumption (food 

and drinking water) exposure estimate 

is representative of intermediate- and 

long-term aggregate risk, and results in 

an MOE of 1640. Because EPA’s level of 

concern for novaluron is a MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

novaluron is not expected to pose a 

cancer risk to humans. 

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 novaluron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies, 

gas chromatography/electron-capture 

detection (GC/ECD) and highperformance liquid chromatography/

ultraviolet (HPLC/UV), are available to 

enforce the tolerance expression. 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

novaluron in or on common beans (pods 

and/or immature seeds) at 0.7 ppm; 

pome fruit at 3 ppm; cucurbit vegetables 

at 0.2 ppm; and prunes at 3.0 ppm. EPA 

is establishing tolerances in or on 

succulent bean at 0.70 ppm; pome fruit 

crop group 11–10 at 3.0 ppm; cucurbit 

vegetable crop group 9 at 0.20 ppm; and 

dried prune at 3.0 ppm in order to 

harmonize with Codex. The Codex has 

additionally established a tolerance in 

or on fruiting vegetables other than 

cucurbits at 0.7 ppm and stone fruits at 

7 ppm. Because EPA is recommending 

a tolerance in or on fruiting vegetables 

crop group 8–10 (1.0 ppm) that is higher 

than Codex, EPA cannot harmonize this 

tolerance. Residue data for greenhouse 

tomatoes supports the 1.0 ppm tolerance 

for the group 8–10 tolerance. 

The data supporting the EPA petition 

result in stone fruit tolerances that are 

either higher (cherry subgroup 12–12A 

at 8.0 ppm) or much lower (peach 

subgroup 12–12B and plum subgroup 

12–12C at 1.9 ppm) than the established 

Codex MRL for stone fruit at 7 ppm. 

EPA notes that the stone fruit tolerances 

are not harmonized with associated 

Codex MRLs on these commodities 

because it has been determined that the 

major export market for these 

commodities is Canada. Therefore, in 

order to maintain harmonization of U.S. 

tolerances and Canadian MRLs for these 

commodities, the EPA is establishing 

these subgroup tolerances at the levels 

that align with the Canadian MRLs. No 

Codex MRLs have been established for 

residues of novaluron in or on avocado 

or carrot. 

C. Response to Comments 

One comment was received to the 

batched Notice of Filing that provided 

brief and general concerns about toxins 

and potential impacts to bees, but the 

commenter did not cite a specific 

petition within the Notice. The Agency 

has received similar comments from this 

commenter on numerous previous 

occasions. Refer to Federal Register 70 

FR 37686 (June 30, 2005), 70 FR 1354 

(January 7, 2005), 69 FR 63096–63098 

(October 29, 2004) for the Agency’s 

response to these objections. 

D. Revisions to Petitioned-For 

Tolerances 

The Agency was petitioned to 

establish a tolerance of novaluron in or 

on plum subgroup 12–12C. As a part of 

that request, the Agency reviewed the 

existing tolerance on dried prune, and 

determined that the tolerance should be 

amended from 2.6 ppm to 3.0 ppm in 

order to harmonize with Codex. Data 

were also submitted and reviewed by 

EPA to allow the use of novaluron in or 

on greenhouse-grown cucumbers. 

During review, the Agency determined 

that the existing tolerance in or on 

cucurbit vegetable group 9 (which 

includes cucumber) should be amended 

from 0.15 ppm to 0.20 ppm in order to 

harmonize with Codex. 

EPA was also petitioned to establish 

a tolerance in or on bean at 0.60 ppm 

and to remove the existing tolerance in 

or on dry bean seed at 0.30 ppm upon 

approval of the proposed bean 

tolerance. However, the Agency 

determined that separate tolerances 

should be established in or on succulent 

bean and dry bean seed. Therefore, this 

action will not remove the existing 

tolerance for the use of novaluron in or 

on dry bean seed at 0.30 ppm, and the 

Agency determined that a tolerance in 

or on succulent bean at 0.70 ppm is 

appropriate in order to harmonize with 

the established Codex tolerance on 

beans. Finally, EPA revised the 

proposed pome fruit crop group 11–10 

tolerance from 2.0 ppm to 3.0 ppm in 

order to harmonize with the established 

Codex MRL. 

V. Conclusion 

Therefore, tolerances are established 

for residues of novaluron, (N-[[[3- 


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Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 43335 

chloro-4-[1,1,2-trifluoro-2- (trifluoro

methoxy)ethoxy]phenyl]amino]

carbonyl]-2,6-difluorobenzamide), in or 

on avocado at 0.60 ppm; bean, succulent 

at 0.70 ppm; carrot at 0.05 ppm; cherry 

subgroup 12–12A at 8.0 ppm; fruit, 

pome, group 11–10 at 3.0 ppm; peach 

subgroup 12–12B at 1.9 ppm; plum 

subgroup 12–12C at 1.9 ppm; and 

vegetable, fruiting, group 8–10 at 1.0 

ppm. This regulation additionally 

revises the existing tolerances in or on 

vegetable, cucurbit, group 9 from 0.15 

ppm to 0.20 ppm; and plum, prune, 

dried from 2.6 ppm to 3.0 ppm. Finally, 

this regulation removes established 

tolerances in or on bean, snap, 

succulent; cherry; cocona; fruit, pome, 

group 11; fruit, stone, group 12, except 

cherry; eggplant, African; eggplant, pea; 

eggplant, scarlet; goji berry; huckleberry, 

garden; martynia; naranjilla; okra; 

roselle; sunberry; tomato, bush; tomato, 

currant; tomato, tree; and vegetable, 

fruiting, group 8. 

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: July 9, 2015. 

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 § 180.598: 

■ a. Remove the entries in the table in 

paragraph (a) for ‘‘Bean, snap, 

succulent’’, ‘‘Cherry’’, ‘‘Cocona’’, 

‘‘Eggplant, African’’, ‘‘Eggplant, pea’’, 

‘‘Eggplant, scarlet’’, ‘‘Fruit, pome, group 

11’’, ‘‘Fruit, stone, group 12, except 

cherry’’, ‘‘Goji berry’’, ‘‘Huckleberry, 

garden’’, ‘‘Martynia’’, ‘‘Naranjilla’’, 

‘‘Okra’’, ‘‘Roselle;’’ ‘‘Sunberry’’, 

‘‘Tomato, bush’’, ‘‘Tomato, currant’’, 

‘‘Tomato, tree’’, and ‘‘Vegetable, 

fruiting, group 8’’. 

■ b. Add alphabetically the entries for 

‘‘Avocado’’, ‘‘Bean, succulent’’, 

‘‘Carrot’’, ‘‘Cherry subgroup 12–12A’’, 

‘‘Fruit, pome, group 11–10’’, ‘‘Peach 

subgroup 12–12B’’, ‘‘Plum subgroup 12– 

12–C’’, and ‘‘Vegetable, fruiting, group 

8–10’’ to the table in paragraph (a). 

■ c. Revise the entries for ‘‘Plum, prune, 

dried’’, and ‘‘Vegetable, cucurbit, group 

9’’ in the table in paragraph (a). 

The additions and revisions read as 

follows: 

§ 180.598 Novaluron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Avocado ...................................... 0.60 

* * * * * 

Bean, succulent .......................... 0.70 

* * * * * 

Carrot .......................................... 0.05 

* * * * * 

Cherry subgroup 12–12A ........... 8.0 

* * * * * 

Fruit, pome, group 11–10 ........... 3.0 

* * * * * 

Peach subgroup 12–12B ............ 1.9 

* * * * * 

Plum, prune, dried ...................... 3.0 

Plum subgroup 12–12C .............. 1.9 

* * * * * 

Vegetable, cucurbit, group 9 ...... 0.20 

Vegetable, fruiting, group 8–10 .. 1.0 

* * * * * 

* * * * * 

[FR Doc. 2015–17676 Filed 7–21–15; 8:45 am] 

BILLING CODE 6560–50–P 


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