Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 43323 

part 41)’’ and adding in its place 

‘‘Uniform Administrative Requirements, 

Cost Principles, and Audit 

Requirements for Federal Awards under 

2 CFR part 200’’. 

PART 59—GRANTS TO STATES FOR 

CONSTRUCTION OR ACQUISITION OF 

STATE HOMES 

■ 19. The authority citation for part 59 

continues to read as follows: 

Authority: 38 U.S.C. 101, 501, 1710, 1742, 

8105, 8131–8137. 

§ 59.124 [Amended] 

■ 20. Amend § 59.124(a) by removing 

‘‘Single Audit Act of 1984 (see part 41 

of this chapter)’’ and adding in its place 

‘‘Uniform Administrative Requirements, 

Cost Principles, and Audit 

Requirements for Federal Awards under 

2 CFR part 200’’. 

PART 61—VA HOMELESS PROVIDERS 

GRANT AND PER DIEM PROGRAM 

■ 21. The authority citation for part 61 

continues to read as follows: 

Authority: 38 U.S.C. 501, 2001, 2002, 2011, 

2012, 2061, 2064. 

Subpart B—Capital Grants 

§ 61.16 [Amended] 

■ 22. Amend § 61.16(a) by removing 

‘‘OMB Circular A–122 as codified at 2 

CFR part 230.’’ and adding in its place 

‘‘the Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements for Federal Awards 

under 2 CFR part 200.’’. 

Subpart E—Technical Assistance 

Grants 

■ 23. Amend § 61.50 by revising 

paragraph (b)(3)(i) to read as follows: 

§ 61.50 Technical assistance grantsgeneral. 

* * * * * 

(b) * * * 

(3) * * * 

(i) Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements for Federal Awards 

under 2 CFR part 200; 

* * * * * 

Subpart F—Awards, Monitoring, and 

Enforcement of Agreements 

§ 61.61 [Amended] 

■ 24. Amend § 61.61(a) by removing 

‘‘VA common grant rules at 38 CFR 

parts 43 and 49 and the OMB Circulars, 

including those cited in § 61.66.’’ and 

adding in its place ‘‘Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirements for 

Federal Awards under 2 CFR part 200.’’. 

■ 25. Revise § 61.66 to read as follows: 

§ 61.66 Financial management. 

(a) All recipients must comply with 

applicable requirements of the Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirements for 

Federal Awards under 2 CFR part 200. 

(b) All entities receiving assistance 

under this part must use a financial 

management system that follows 

generally accepted accounting 

principles and meets the requirements 

set forth under 2 CFR part 200. All 

recipients must implement the 

requirements of 2 CFR part 200 when 

determining costs reimbursable under 

all awards issued under this part. 

(Authority: 38 U.S.C. 501) 

§ 61.67 [Amended] 

■ 26. Amend § 61.67: 

■ a. In paragraph (c) by removing ‘‘38 

CFR 49.32’’ and adding in its place ‘‘2 

CFR part 200’’. 

■ b. In paragraph (f) by removing ‘‘38 

CFR 49.34’’ and adding in its place ‘‘2 

CFR part 200’’. 

PART 62—SUPPORTIVE SERVICES 

FOR VETERANS FAMILIES PROGRAM 

■ 27. The authority citation for part 62 

continues to read as follows: 

Authority: 38 U.S.C. 501, 2044, and as 

noted in specific sections. 

■ 28. Amend § 62.70: 

■ a. By revising paragraph (a). 

■ b. In paragraph (b) by removing ‘‘OMB 

Circular A–110, Subpart C, Section 21 

(codified at 2 CFR 215.21) and 38 CFR 

49.21.’’ and adding in its place ‘‘2 CFR 

part 200.’’. 

■ c. In paragraph (c) by removing ‘‘OMB 

Circular A–122, Cost Principles for NonProfit Organizations, codified at 2 CFR 

part 235.’’ and adding in its place ‘‘2 

CFR part 200.’’. 

The revision reads as follows: 

§ 62.70 Financial management and 

administrative costs. 

(a) Grantees must comply with 

applicable requirements of the Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirements for 

Federal Awards under 2 CFR part 200. 

* * * * * 

PART 64—GRANTS FOR THE RURAL 

VETERANS COORDINATION PILOT 

(RVCP) 

■ 29. The authority citation for part 64 

continues to read as follows: 

Authority: 38 U.S.C. 501, 523 note. 

■ 30. Amend § 64.14 by revising 

paragraph (b)(2) to read as follows: 

§ 64.14 RVCP grant agreement. 

* * * * * 

(b) * * * 

(2) Abide by the Uniform 

Administrative Requirements, Cost 

Principles, and Audit Requirements for 

Federal Awards under 2 CFR part 200, 

and 2 CFR parts 25 and 170, if 

applicable. 

* * * * * 

[FR Doc. 2015–17416 Filed 7–21–15; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0354; FRL–9930–84] 

Sedaxane; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sedaxane as a 

seed treatment for cotton, undelinted 

seed; cotton, gin byproducts; and beet, 

sugar. Syngenta Crop Protection, LLC 

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–2014–0354, 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, 


Lhorne on DSK7TPTVN1PROD with RULES
43324 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 

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–2014–0354 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– 

2014–0354, 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 August 1, 

2014 (79 FR 44729) (FRL–9911–67), 

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 4F8263) by 

Syngenta Crop Protection, LLC, 410 

Swing Road, P.O. Box 18300, 

Greensboro, NC 27419. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide sedaxane, N- 

[2-[1,1′-bicyclopropyl]-2-ylphenyl]-3- 

(difluoromethyl)-1-methyl-1H-pyrazole4-carboxamide, as a seed treatment for 

cotton, undelinted seed at 0.01 parts per 

million (ppm); cotton, gin byproducts at 

0.01 ppm; and beet, sugar at 0.01 ppm. 

That document referenced a summary of 

the petition prepared by Syngenta Crop 

Protection, LLC, 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 altered 

the commodity name from ‘‘beet, sugar’’ 

to ‘‘beet, sugar, roots’’. The reason for 

this change is 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 sedaxane 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with sedaxane 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. The toxicological 

effects reported in the submitted animal 

studies such as mitochondrial 

disintegration and glycogen depletion in 

the liver are consistent with the 

pesticidal mode of action also being the 

mode of toxic action in mammals. The 

rat is the most sensitive species tested, 

and the main target tissue for sedaxane 

is the liver. Sedaxane also caused 

thyroid hypertrophy/hyperplasia. In the 

acute neurotoxicity (ACN) and subchronic neurotoxicity (SCN) studies, 

sedaxane caused decreased activity, 

decreased muscle tone, decreased 

rearing, and decreased grip strength. 

There are indications of reproductive 

toxicity in rats such as decreased follicle 

counts, but these effects did not result 

in reduced fertility. Offspring effects in 

the reproduction study occurred at the 

same doses causing parental effects, and 

do not indicate any quantitative or 

qualitative increase in sensitivity in rat 

pups. In the rat, no adverse effects in 

fetuses were seen in developmental 

toxicity studies at maternally toxic 


Lhorne on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 43325 

doses. In the rabbit, fetal toxicity 

(increased unossified sternebrae and 

13th rudimentary ribs, decrease in fetal 

weights, increased numbers of 

abortions) was observed at the same 

doses that produced toxicity in the 

dams (abortions, decreased body weight 

gain/body weight loss, reduced food 

consumption, defecation), and therefore 

does not indicate any increased 

susceptibility. Sedaxane is tumorigenic 

in the liver in the rat and mouse, and 

led to tumors in the thyroid and uterus 

in the rat and was classified as ‘‘likely 

to be carcinogenic to humans.’’ 

Sedaxane was negative in the 

mutagenicity studies. The 28-day 

dermal study did not show systemic 

toxicity at the limit dose of 1,000 

milligrams/kilogram/day (mg/kg/day). 

Sedaxane has low acute toxicity by the 

oral, dermal, and inhalation routes. It is 

not a dermal sensitizer, causes no skin 

irritation and only slight eye irritation. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by sedaxane 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 

‘‘Sedaxane. Human Health Risk 

Assessment to Support New Seed 

Treatment Uses on Cotton and Sugar 

Beet’’ on pages 13–20 in docket ID 

number EPA–HQ–OPP–2014–0354. 

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 (U/SF) 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 nonthreshold risks, the Agency assumes 

that any amount of exposure will lead 

to some degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for sedaxane used for human 

risk assessment is shown in the Table of 

this unit. 

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

ASSESSMENT

Exposure/Scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk 

assessment 

Study and toxicological effects 

Acute dietary (All populations, 

including children and women 

13–49 years of age).

NOAEL = 30 mg/kg/

day.

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

Acute RfD = 0.30 

mg/kg/day.

aPAD = 0.30 mg/kg/

day.

Rat ACN Study. 

LOAEL = 250 mg/kg based on reduced activity, decreased 

rearing, initial inactivity, piloerection, ruffled fur and recumbency, decreased BW, decreased BWG and food consumption (males). In females, weakened condition, swaying gait, 

and decreased activity, reduced muscle tone, decreased locomotor activity and rearing. The weakened condition, 

swaying gait and decreased activity were observed on days 

2–7, while the other effects were on day 1. 

Chronic dietary (All populations) NOAEL= 11 mg/kg/

day.

UFA = 10x ................

UFH = 10x ................

FQPA SF = 1x .........

Chronic RfD = 0.11 

mg/kg/day.

cPAD = 0.11 mg/kg/

day.

Chronic Rat Study. 

NOAEL= 11/14 mg/kg bw/day (male/female). 

LOAEL = 67/86 mg/kg bw/day (male/female) based on decreased hind limb grip strength increased liver weight, increased incidences of hepatocyte hypertrophy and 

eosinophilic foci, and thyroid follicular cell hypertrophy, basophilic colloid, epithelial desquamation and increased phosphate levels (males). In females it was based on decreased 

body weight and body weight gain, increased liver weight 

and the same histopathology noted above for males. 

Cancer (Oral, dermal, inhalation).‘‘Likely to be Carcinogenic to Humans’’ based on significant tumor increases in two adequate rodent carcinogenicity studies. Q1* = 4.64 × 10 ¥ 3 (mg/kg/day)¥1 (linear low-dose extrapolation model). 

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

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

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

(intraspecies). Q1* = Linear cancer slope factor 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sedaxane, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

sedaxane tolerances in 40 CFR 180.665. 

EPA assessed dietary exposures from 

sedaxane in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

sedaxane. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA) conducted 

from 2003–2008. As to residue levels in 


Lhorne on DSK7TPTVN1PROD with RULES
43326 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 

food, EPA conducted a highly 

conservative acute dietary assessment 

using tolerance-level residues and 100% 

crop treated assumptions for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA 

conducted from 2003–2008. As to 

residue levels in food, EPA conducted a 

partially refined chronic dietary 

assessment using anticipated residue 

levels for all commodities and percent 

crop treated data. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that sedaxane should be 

classified as ‘‘Likely to be Carcinogenic 

to Humans’’ and a linear approach has 

been used to quantify cancer risk. 

Cancer risk was quantified using the 

same estimates as discussed in Unit 

III.C.1.ii., Chronic exposure. A linear 

low-dose extrapolation model (Q1*) = 

4.64 × 10¥3 (mg/kg/day)¥1 was used to 

estimate cancer risk. 

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: For 

chronic and cancer dietary exposure 

assessment, 100 PCT was assumed for 

all commodities except for soybeans 

(51%), wheat (32%) and potato (67%), 

which incorporated average PCT 

estimates. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

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

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

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

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which sedaxane may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for sedaxane in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of sedaxane. 

Drinking water accounted for 95% of 

the total dietary exposure to sedaxane. 

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 FQPA Index Reservoir 

Screening Tool (FIRST) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of sedaxane for 

acute exposures are estimated to be 4.1 

parts per billion (ppb) for surface water 

and 22.0 ppb for ground water, for 

chronic exposures and cancer 

assessments are estimated to be 1.2 ppb 

for surface water and 19.3 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 22.0 ppb was 

used to assess the contribution to 

drinking water. For chronic and cancer 

dietary risk assessment, the water 

concentration of value 19.3 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). Sedaxane 

is not registered for any specific use 

patterns that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found sedaxane to share a common 

mechanism of toxicity with any other 

substances, and sedaxane does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

sedaxane does not have a common 

mechanism of toxicity with other 

substances. For information regarding 


Lhorne on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 43327 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http://

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence for increased 

susceptibility following prenatal and/or 

postnatal exposures to sedaxane based 

on effects seen in developmental 

toxicity studies in rabbits or rats. In 

range finding and definitive 

developmental toxicity studies in rats, 

neither quantitative nor qualitative 

evidence of increased susceptibility of 

fetuses to in utero exposure to sedaxane 

was observed. In these studies, there 

were no single-dose effects. There was 

no evidence of increased susceptibility 

in a 2-generation reproduction study in 

rats following prenatal or postnatal 

exposure to sedaxane. Clear NOAELs/

LOAELs were established for the 

developmental effects seen in rats and 

rabbits as well as for the offspring 

effects seen in the 2-generation 

reproduction study. The dose-response 

relationship for the effects of concern is 

well characterized. The NOAEL used for 

the acute dietary risk assessment (30 

mg/kg/day), based on effects observed in 

the ACN study, is protective of the 

developmental and offspring effects 

seen in rabbits and rats (NOAELs of 

100–200 mg/kg/day). In addition, there 

is no evidence of neuropathology or 

abnormalities in the development of the 

fetal nervous system from the available 

toxicity studies conducted with 

sedaxane. 

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 sedaxane 

is complete. 

ii. There is no indication that 

sedaxane is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. Although 

sedaxane caused changes in apical 

endpoints such as decreased activity, 

decreased muscle tone, decreased 

rearing and decreased grip strength in 

the ACN and SCN studies, EPA believes 

these effects do not support a finding 

that sedaxane is a neurotoxicant. The 

observed effects in the ACN and SCN 

studies were likely secondary to 

inhibition of mitochondrial energy 

production caused by sedaxane. 

Furthermore, there was no corroborative 

neuro-histopathology demonstrated in 

any study, even at the highest doses 

tested (i.e., 2,000 mg/kg/day). Therefore, 

based on its chemical structure, its 

pesticidal mode of action, and lack of 

evidence of neuro-histopathology in any 

acute and repeated-dose toxicity study, 

sedaxane does not demonstrate 

potential for neurotoxicity. Since 

sedaxane did not demonstrate increased 

susceptibility to the young or specific 

neurotoxicity, a developmental 

neurotoxicity (DNT) study is not 

required. 

iii. As discussed in Unit III.D.2., there 

is no evidence that sedaxane 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 dietary food exposure assessments 

are highly conservative (acute) or only 

partially refined (chronic), resulting in 

high-end estimates of dietary food 

exposure. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to sedaxane in drinking 

water. These assessments will not 

underestimate the exposure and risks 

posed by sedaxane. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

sedaxane will occupy 1.3% of the aPAD 

for all infants (<1 year old), the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to sedaxane from 

food and water will utilize 1% of the 

cPAD for all infants (<1 year old), the 

population group receiving the greatest 

exposure. There are no residential uses 

for sedaxane. 

3. Short- and Intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

A short- and intermediate-term 

adverse effect was identified; however, 

sedaxane is not registered for any use 

patterns that would result in short- or 

intermediate-term residential exposure. 

Short- and intermediate-term risk is 

assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short- and 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for sedaxane. 

4. Aggregate cancer risk for U.S. 

population. The Agency has classified 

sedaxane as ‘‘Likely to be Carcinogenic 

to Humans’’ based on significant tumor 

increases in two adequate rodent 

carcinogenicity studies. A cancer 

dietary risk assessment was conducted 

using a linear low-dose extrapolation 

model (Q1*) = 4.64 × 10¥3 (mg/kg/

day)¥1 which indicated a risk estimate 

to the U.S. population as 2 × 10¥6. EPA 

generally considers cancer risks in the 

range of 10¥6 or less to be negligible. 

The precision that can be assumed for 

cancer risk estimates is best described 

by rounding to the nearest integral order 

of magnitude on the log scale; for 

example, risks falling between 3 × 10¥7

and 3 × 10¥6 are expressed as risks in 

the range of 10¥6. Considering the 

precision with which cancer hazard can 

be estimated, the conservativeness of 

low-dose linear extrapolation, and the 

rounding procedure described above in 

this unit, cancer risk should generally 

not be assumed to exceed the 


Lhorne on DSK7TPTVN1PROD with RULES
43328 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations 

benchmark level of concern of the range 

of 10¥6 until the calculated risk exceeds 

approximately 3 × 10¥6. This is 

particularly the case where some 

conservatism is maintained in the 

exposure assessment. Based on this 

approach, EPA considers the risks of 

cancer from exposure to sedaxane to be 

negligible. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to sedaxane 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/tandem mass 

spectrometry (LC/MS/MS)) is available 

to enforce the tolerance expression. A 

modification of the Quick, Easy, Cheap, 

Effective, Rugged, and Safe (QuEChERS) 

method was developed for the 

determination of residues of sedaxane 

(as its isomers SYN508210 and 

SYN508211) in/on various crops. The 

sedaxane isomers (SYN508210 and 

SYN508211) are quantitatively 

determined by LC/MS/MS. The 

validated limit of quantitation (LOQ) 

reported in the method is 0.005 ppm for 

both sedaxane isomers. A successful 

independent laboratory validation (ILV) 

study was also conducted on the 

modified QuEChERS method using 

samples of wheat green forage and 

wheat straw fortified with SYN508210 

and SYN508211 at 0.005 and 0.05 ppm. 

The analytical standard for sedaxane, 

with an expiration date of February 28, 

2018, is currently available in the EPA 

National Pesticide Standards 

Repository. 

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 not 

established MRLs for sedaxane. 

C. Revisions to Petitioned-For 

Tolerances 

Although the petitioner sought a 

tolerance for the commodity name 

‘‘beet, sugar’’, EPA is establishing a 

tolerance for ‘‘beet, sugar, roots’’ to be 

consistent with the general food and 

feed commodity vocabulary EPA uses 

for tolerances and exemptions. 

V. Conclusion 

Therefore, tolerances are established 

for residues of sedaxane, N-[2-[1,1′- 

bicyclopropyl]-2-ylphenyl]-3- 

(difluoromethyl)-1-methyl-1H-pyrazole4-carboxamide, as a seed treatment for 

cotton, undelinted seed at 0.01 ppm; 

cotton, gin byproducts at 0.01 ppm; and 

beet, sugar, roots at 0.01 ppm. 

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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 16, 2015. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


Lhorne on DSK7TPTVN1PROD with RULES
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 


Lhorne on DSK7TPTVN1PROD with RULES