Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40027 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 21, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.480 revise paragraph (a) 

introductory text and revise the entry 

‘‘Pepper’’ in the table in paragraph (a) to 

read as follows: 

§ 180.480 Fenbuconazole; tolerances for 

residues. 

(a) Tolerances are established for 

residues of the fungicide fenbuconazole, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of fenbuconazole, alpha-[2-(4- 

chlorophenyl)-ethyl]-alpha-phenyl-3- 

(1H-1,2,4-triazole)-1-propanenitrile, and 

its metabolites RH-9129, cis-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, and RH-9130, trans-5-(4- 

chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3 Hfuranone, calculated as the 

stoichiometric equivalent of 

fenbuconazole, in or on the following 

agricultural commodities. 

Commodity Parts per 

million 

* * * * * 

Pepper .................................. 1.0 

* * * * * 

* * * * * 

[FR Doc. 2013–15867 Filed 7–2–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0291; FRL–9389–7] 

Novaluron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of novaluron in 

or on peanut and soybean, seed. 

Makhteshim-Agan of North America 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). This regulation additionally 

deletes the time-limited tolerance for 

strawberry, as that tolerance expired on 

December 31, 2011. 

DATES: This regulation is effective July 

3, 2013. Objections and requests for 

hearings must be received on or before 

September 3, 2013, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0291, 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: 

Jennifer Gaines, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5967; email address: 

gaines.jennifer@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–2012–0291 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 3, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

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40028 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

by docket ID number EPA–HQ–OPP– 

2012–0291, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

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

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), 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 2F7999) by MakhteshimAgan of North America, 3120 

Highwoods Blvd., Suite 100, Raleigh, 

NC 27604. The petition requested that 

40 CFR 180.598 be amended by 

establishing tolerances for residues of 

the insecticide novaluron, N-[[[3-chloro4-[1,1,2-trifluoro-2-(trifluoromethoxy)

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

difluorobenzamide, in or on peanuts at 

0.01 parts per million (ppm) and 

soybean, seed at 0.06 ppm. 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. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance level for soybean, seed. 

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 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. 

Novaluron has low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. It is not an eye or skin 

irritant and is not a dermal sensitizer. In 

subchronic and chronic toxicity studies, 

novaluron primarily produced 

hematotoxic effects such as 

methemoglobinemia, decreased 

hemoglobin, decreased hematocrit, and 

decreased red blood cells (RBCs) (or 

erythrocytes) associated with increased 

erythropoiesis. Increased spleen weights 

and/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 (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. 

Signs of neurotoxicity (piloerection, 

irregular breathing), changes in 

functional observational batter 

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. Therefore, there is no concern for 

neurotoxicity resulting from exposure to 

novaluron. 

There was no evidence of 

carcinogenic potential in either the rat 

or mouse carcinogenicity studies. There 

was no concern for genotoxicity or 

mutagenicity. Therefore novaluron was 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

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 Proposed Section 3 Uses 

on Peanut and Soybean at pp. 37–40 in 

docket ID number EPA–HQ–OPP–2012– 

0291. 

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 the NOAEL and the 

LOAEL are indentified. 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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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40029 

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).None ..................... None ..................... An endpoint of concern attributable to a single dose was 

not identified. 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 short-term .......................

(1 to 30 days) and Intermediate-Term (1 

to 6 months).

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). 

Dermal short-term (1 to 30 days) ........... Not applicable and 

none.

None ..................... No toxicity was observed at the limit dose in the dermal 

study and there were no developmental toxicity concerns at the limit-dose; therefore, quantification of shortterm dermal risk is not necessary. 

Dermal intermediate-term (1 to 6 

months).

Dermal (or oral) 

study NOAEL = 

4.38 mg/kg/day 

(dermal absorption rate = 10% 

when appropriate).

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 short-term (1 to 30 days) and 

Intermediate Term (1 to 6 months).

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) ........... Classification: 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 percent crop treated (PCT) data 

for apples, cabbage, cauliflower, cotton, 

pears, potatoes, strawberries, and 

tomatoes and utilized estimates for PCT 

for recently registered uses for grain 

sorghum and sweet corn. 100 PCT was 

assumed for the remaining food 

commodities. Anticipated residues 

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

commodities were calculated based on 

the proposed/registered uses, and 

incorporated average field trial residues, 

percent crop treated for new uses 

(PCTn) data for grain sorghum and 

sweet corn, average PCT data for apple 

and cotton, and an assumption of 100 

PCT for sugarcane, aspirated grain 

fractions (AGF), and cowpea seed. 

The chronic analysis also 

incorporated average field trial residues, 

tolerance-level residues for the 

proposed commodities, average 

greenhouse trial residue for tomatoes, 

and half-limit of quantitation (LOQ) 

residues for food commodities other 

than those covered by a higher tolerance 

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40030 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

as a result of use on growing crops from 

the registered use in food and feed 

handling establishments. Additionally, 

empirical processing factors for apple 

juice (translated to pear and stone fruit 

juice), cottonseed oil, dried plums, and 

tomato paste and pure ́e, and Dietary 

Exposure Evaluation Model (DEEM) 

(ver. 7.81) default processing factors for 

the remaining processed commodities, 

where provided were incorporated. 

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 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. 

The Agency estimated the PCT for 

existing uses as follows: Apples at 10%; 

cabbage at 10%; cauliflower at < 2.5%, 

cotton at < 2.5%, pears at 15%, potatoes 

at < 2.5%, strawberries at 35%, and 

tomatoes at < 1%. 

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 estimated the PCT for 

recently approved uses as follows: 

Sweet corn at 36% and grain sorghum 

at 2%. 

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 doesn 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. 

The estimated PCT for new uses, 

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 PCT for 

new uses could be exceeded are: 

1. The extent of pest pressure on the 

crops in question; 

2. 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 

3. 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. 

All information currently available 

has been considered for novaluron use 

on sorghum and sweet corn, and it is the 

opinion of the Agency that it is unlikely 

that actual PCT for novaluron will 

exceed the estimated PCT for new uses 

during the next 5 years. 

The Agency believes that the three 

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

have been met. With respect to 

Condition A, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which novaluron may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The residues of concern in 

drinking water are novaluron and it 

chlorophenyl urea and chloroaniline 

degradates. The Agency used screeninglevel 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. 

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. 

EPA utilized the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) for estimating 

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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40031 

parent novaluron in surface water, the 

Tier 1 FQPA Index Reservoir Screening 

Tool (FIRST) model for surface water 

estimates for chlorophenyl urea and 

chloroaniline degradates, and the 

Screening Concentration in Ground 

Water (SCI–GROW) model for 

novaluron, chorophenyl urea, and 

chloroaniline in ground water. Based on 

these models, the estimated drinking 

water concentrations (EDWCs) of 

novaluron, chlorophenyl urea, and 

chloroaniline for chronic exposures for 

non-cancer assessments are estimated to 

be 0.41 parts per billion (ppb), 0.375 

ppb, and 3.301 ppb respectively, for 

surface water and 0.00137 ppb, 0.00149 

ppb, and 0.00658 ppb respectively for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

highest 1-in-10 year annual mean 

surface water EDWCs were combined to 

estimate drinking water exposures. For 

chronic dietary risk assessment, the 

water concentration of value 4.086 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 uses for 

the control of crickets (cracks and 

crevice and spot treatments) in 

residential areas such as homes and 

apartment buildings, and their 

immediate surroundings, and on modes 

of transportation. There is a potential for 

exposure in residential settings during 

the application process for homeowners 

who use products containing novaluron. 

Additionally, exposure routes were 

assessed for post-application exposures 

for adults and children via inhalation 

routes and post-application incidental 

oral (hand-to-mouth) exposure for 

children (1 to < 2 years old). 

Additionally, a combined residential 

assessment that consisted of children (1 

to < 2 years old) inhalation and oral 

(hand-to-mouth) post-application 

exposure was included. Details of the 

residential risk exposure and risk 

assessment are contained in the EPA 

public docket EPA–HQ–OPP–2010– 

0466 at http://www.regulations.gov in 

document ‘‘Novaluron: Human-Health 

Risk Assessment for Proposed Section 3 

Uses on Sweet Corn and in Food-or 

Feed-Handling Establishments’’ on pp. 

21–26. 

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 2-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. 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; 

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. There is minimal indication that 

novaluron 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 

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 

anticipated residues derived from 

reliable residue field trials, tolerancelevel residues for proposed 

commodities, average PCT data for some 

commodities, and PCTn data for grain 

sorghum and sweet corn. 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 

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40032 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 

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 55% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. The residential exposure 

assessment was conducted using highend estimates of use and potential 

exposure providing a conservative, 

health protective estimate of risk. 

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 

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 2,520 for adults and 480 for 

children 1–2 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-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). An 

intermediate-term aggregate exposure 

(food+drinking water+residential) 

assessment was not conducted since 

residential intermediate-term exposures 

are not likely due to the intermittent 

nature of applications by homeowners. 

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 methodology 

(gas chromatography/electron-capture 

detection (GC/ECD) method and a highperformance liquid chromatography/ 

ultraviolet (HPLC/UV) method) are 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established an MRL for 

residues of novaluron in or on immature 

soybean seed at 0.01 ppm. Immature 

soybean seed (edamame) is not covered 

by soybean, seed; therefore, 

harmonization is not an issue for the 

proposed soybean use. There is no 

Codex MRL for peanut. 

C. Revisions to Petitioned-for Tolerances 

Based on analysis from the residue 

field trial data supporting the petition 

and use of the Organization for 

Economic Cooperation and 

Development tolerance calculation 

procedures, EPA revised the proposed 

tolerance on soybean, seed from 0.06 

ppm to 0.07 ppm. Additionally, the 

commodity term for peanuts is being 

revised. 

V. Conclusion 

Therefore, tolerances are established 

for residues of novaluron, N-[[[3-chloro4-[1,1,2-trifluoro-2-(trifluoromethoxy)

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

difluorobenzamide, in or on peanut and 

soybean, seed at 0.01 and 0.07 ppm, 

respectively. 

This regulation additionally deletes 

the time-limited tolerance for 

strawberry, as that tolerance expired on 

December 31, 2011. 

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 

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Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Rules and Regulations 40033 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 25, 2013. 

G. Jeffrey Herndon, 

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. In § 180.598: 

■ a. Add alphabetically the 

commodities to the table in paragraph 

(a). 

■ b. Remove and reserve paragraph (b). 

§ 180.598 Novaluron; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Peanut .................................. 0.01 

* * * * * 

Soybean, seed ...................... 0.07 

Commodity Parts per 

million 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2013–15869 Filed 7–2–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 121 

RIN 0906–AA73 

Organ Procurement and 

Transplantation Network 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: HHS is issuing this final rule 

(herein referred to as ‘‘this rule’’) to add 

vascularized composite allografts 

(VCAs) as specified herein to the 

definition of organs covered by the rules 

governing the operation of the Organ 

Procurement and Transplantation 

Network (OPTN) (herein referred to as 

the OPTN final rule). When it enacted 

the National Organ Transplant Act in 

1984, Congress included a definition of 

the term organ and authorized the 

Secretary to expand this definition by 

regulation. The Secretary has previously 

exercised this authority and expanded 

the statutory definition of organ. Prior to 

this rule, the OPTN final rule defined 

covered organs as ‘‘a human kidney, 

liver, heart, lung, or pancreas, or 

intestine (including the esophagus, 

stomach, small and/or large intestine, or 

any portion of the gastrointestinal tract). 

Blood vessels recovered from an organ 

donor during the recovery of such 

organ(s) are considered part of an organ 

with which they are procured for 

purposes of this part if the vessels are 

intended for use in organ 

transplantation and labeled ‘For use in 

organ transplantation only.’ ’’ This rule 

also includes a corresponding change to 

the definition of human organs covered 

by section 301 of the National Organ 

Transplant Act of 1984, as amended 

(NOTA). 

DATES: The final rule is effective July 3, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

James Bowman, M.D., Medical Director, 

Division of Transplantation, Healthcare 

Systems Bureau (HSB), Health 

Resources and Services Administration 

(HRSA), 5600 Fishers Lane, Room 12C– 

06, Rockville, Maryland 20857, or by 

telephone (301) 443–7577. 

SUPPLEMENTARY INFORMATION: On 

December 16, 2011, HHS published a 

notice of proposed rulemaking (NPRM) 

in the Federal Register (76 FR 78216) to 

include VCAs within the definition of 

organs covered by the OPTN final rule 

and to make a corresponding change to 

the definition of human organs covered 

by section 301 of NOTA. The NPRM 

provided for a 60-day comment period 

and HHS received 29 comment letters 

raising a variety of issues. HHS has 

carefully considered all comments in 

developing this rule, as outlined in 

Section III below, presenting a summary 

of all major comments and 

Departmental responses. 

I. Background 

As discussed in the NPRM, the 

transplant community has referred to 

the transplants of intact vascularized 

body parts such as hands and faces as 

composite tissue allograft transplants. 

As tissues, these components have been 

under the regulatory jurisdiction of the 

Food and Drug Administration (FDA). 

For the reasons outlined in the NPRM, 

the Secretary believes that these 

components, based on their clinical 

characteristics, are more characteristic 

of organs as defined specifically in 

NOTA and subsequently by regulation 

in the case of intestines and blood 

vessels used in conjunction with organ 

transplantation. For the purpose of this 

regulation, these components are 

described as vascularized composite 

allografts (VCAs). 

Human cells or tissue intended for 

implantation, transplantation, infusion, 

or transfer into a human recipient are 

regulated as human cells, tissues, and 

cellular and tissue-based products (or 

HCT/Ps). FDA regulates HCT/Ps under 

section 361 of the Public Health Service 

Act (42 U.S.C. 264) and 21 CFR parts 

1270 and 1271. Examples of such 

tissues are bone, skin, corneas, 

ligaments, tendons, dura mater, heart 

valves, hematopoietic stem/progenitor 

cells derived from peripheral and cord 

blood, oocytes, and semen. FDA does 

not regulate the transplantation of 

vascularized human organ transplants 

such as kidney, liver, heart, lung, or 

pancreas. FDA regulations provide that 

‘‘vascularized human organs for 

transplantation’’ are not considered 

HCT/Ps. 21 CFR 1271.3(d)(1). HRSA 

oversees the transplantation of 

vascularized human organs. 

At present, face and hand allografts, 

and other body parts meeting the 

proposed definition of VCAs, are not 

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