34070 Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations 

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). 

VIII. 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 5, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Di-n-butyl carbonate (CAS 

Reg. No. 542–52–9).

.......... Solvent. 

* * * * * 

■ 3. In § 180.930, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Di-n-butyl carbonate (CAS 

Reg. No. 542–52–9).

.......... Solvent. 

* * * * * 

■ 4. In § 180.940(a), add alphabetically 

the inert ingredient to the table to read 

as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Di-n-butyl carbonate .................................. 542–52–9 When ready for use, the end-use concentration is not to exceed 15,000 ppm. 

*******

* * * * * 

[FR Doc. 2015–14647 Filed 6–12–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0161; FRL–9928–20] 

Sethoxydim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sethoxydim in 

or on multiple commodities that are 

identified and discussed later in this 

document. In addition, this regulation 

removes existing tolerances for residues 

of sethoxydim in or on several 

commodities identified later in this 

document that are superseded by this 

action. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

15, 2015. Objections and requests for 

hearings must be received on or before 

August 14, 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–2014–0161, 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: 


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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–2014–0161 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 14, 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– 

2014–0161, 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 May 23, 

2014 (79 FR 29729) (FRL–9910–29), 

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 4E8239) by 

Interregional Research Project Number 4 

(IR–4), IR–4 Project Headquarters, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.412 be 

amended by establishing tolerances for 

combined residues of the herbicide 

sethoxydim 2-[1-(ethoxyimino)butyl]-5- 

[2-(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one and its metabolites 

containing the 2-cyclohexen-1-one 

moiety (calculated as the herbicide 

sethoxydim) in or on raw agricultural 

commodities (RACs): Bushberry 

subgroup 13–07B at 5.0 parts per 

million (ppm); caneberry subgroup 13– 

07A at 5.0 ppm; berry, low growing 

subgroup 13–07H, except strawberry at 

2.5 ppm; fescue forage at 6.0 ppm; 

fescue, hay at 4.0 ppm; fruit, citrus 

group 10–10 at 0.5 ppm; fruit, pome 

group 11–10 at 0.2 ppm; fruit, small, 

vine climbing subgroup 13–07F, except 

fuzzy kiwifruit at 1.0 ppm; rapeseed 

subgroup 20A at 35 ppm; sunflower 

subgroup 20B, except safflower, seed at 

7.0 ppm; cottonseed subgroup 20C at 5.0 

ppm; vegetable, bulb group 3–07 at 1.0 

ppm; and vegetable, fruiting group 8–10 

at 4.0 ppm. That document referenced a 

summary of the petition prepared by 

BASF Corporation, the registrant, which 

is available in the docket, http://

www.regulations.gov. One comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has made 

certain modifications, including 

revising certain petitioned-for tolerance 

levels, setting meal tolerances for 

various oilseed crop subgroups to cover 

potential processed commodities, and 

updating crop definitions as well as the 

tolerance expression for sethoxydim to 

conform to current EPA policies. The 

reasons for these changes are explained 

in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . . ’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for sethoxydim 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with sethoxydim follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Toxicological tests in animals (rats, 

mice, and dog) show that the target 

organ of sethodydim toxicity is the liver. 

Toxic effects are characterized by 

increased liver weight; hypertrophy; 

fatty degeneration; hepatocyte swelling; 

increased serum bilirubin, alkaline 

phosphatase, aspartate 


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aminotransferase, and alanine 

aminotransferase levels; focal 

granulomatous inflammation; and 

eosinophilic foci. Liver toxicity was 

observed by exposure through both the 

oral and inhalation routes. 

Findings other than liver toxicity 

were also observed. In a subchronic rat 

study, decreased body weight, body 

weight gain, and food efficiency were 

noted at a lower dose than liver toxicity. 

In a chronic dog toxicity study, 

increased hemosiderosis in the spleen 

and depressed myeloid erythropoiesis 

in the sternal bone marrow were 

observed. Interstitial fibrosis and heart 

failure cells in lung in female rats were 

observed in the chronic toxicity/

carcinogenicity study in rats. 

In the developmental rat study, 

maternal toxicity was observed, as 

evidenced by an irregular gait, 

decreased activity, excessive salivation, 

and anogenital staining at a dose greater 

than half the limit dose and at the limit 

dose. All clinical signs reported were 

transient, with the exception of the 

anogenital staining, which did not 

reverse. 

Developmental toxicity occurred at 

the same dose as maternal toxicity in 

rats and included decreased fetal 

weights, filamentous tail, and lack of 

tail due to the absence of sacral and/or 

caudal vertebrae, and delayed 

ossification in the hyoids, vertebral 

centrum and/or transverse processes, 

sternebrae and/or metatarsals, and 

pubes. No maternal toxicity was noted 

in rabbits at 400 milligrams per 

kilogram (mg/kg)/day, and 

developmental toxicity was noted at 400 

mg/kg/day (NOAEL = 320 mg/kg/day) as 

an increase in the incidence of 

incompletely ossified 6th sternebrae. In 

the reproduction study, no parental or 

reproductive toxicity was observed at 

150 mg/kg/day (highest dose tested), but 

offspring toxicity was noted at this dose 

as decreased pup weight in the F1a, F1b, 

and F2b generation during lactation (noobserved-adverse-effect-level (NOAEL) 

= 30 mg/kg/day). There is a low concern 

for these findings, since the selected 

points of departure are protective; there 

is low concern for pre- and/or postnatal 

toxicity resulting from exposure to 

sethoxydim. 

Dermal toxicity was not observed at 

the limit dose in a 21-day dermal study 

in rabbits. Based on the lack of 

sensitization in treated guinea pigs, 

sethoxydim is not a skin sensitizer. No 

eye or dermal irritation were noted in 

rabbits. No neurotoxicity or other 

toxicity was observed at the highest 

dose tested (207 mg/kg/day) in the 

subchronic neurotoxicity test in rats. 

There was no evidence of 

carcinogenicity in rats and mice, and no 

evidence of genotoxicity. Sethoxydim is 

classified as ‘‘Not Likely to Be 

Carcinogenic to Humans.’’ Specific 

information on the studies received and 

the nature of the adverse effects caused 

by sethoxydim, as well as the NOAEL 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies, 

can be found at http://

www.regulations.gov in document 

‘‘Sethoxydim: Human Health Risk 

Assessment for Registration Review and 

to Support the Section 3 Registration of 

Proposed Uses on High Bush Blueberry 

and Fine Fescue Grasses’’, dated 

February 3, 2015 at page 40 in docket 

ID number EPA–HQ–OPP–2014–0161– 

000x. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for sethoxydim used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SETHOXYDIM 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 (females 13–49 

years of age).

NOAEL = 180 mg/

kg/day.

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

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

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

Acute RfD = aPAD = 

1.8 mg/kg/day.

Rat Developmental Toxicity 

Developmental LOAEL = 650 mg/kg/day based on decreased 

fetal body weight, tail abnormalities, and delayed ossification 

Tail abnormalities were considered an acute effect. 

Acute dietary (general population including infants and 

children).

NOAEL = 180 mg/

kg/day.

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

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

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

Acute RfD = aPAD = 

1.8 mg/kg/day.

Rat Developmental Toxicity 

Maternal LOAEL = 650 mg/kg/day based on irregular gait that 

was observed in 12/34 dams on the first day of dosing. 

Chronic dietary (all populations) NOAEL = 14 mg/kg/

day.

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

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

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

Chronic RfD = cPAD 

= 0.14 mg/kg/day.

Mouse Carcinogenicity Study 

LOAEL = 41 mg/kg/day based on liver hypertrophy and fatty 

degeneration. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SETHOXYDIM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Incidental oral short-term (1 to 

30 days).

NOAEL = 180 mg/

kg/day.

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

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

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

Residential LOC for 

MOE = 100.

Rat Developmental Toxicity 

Maternal LOAEL = 650 mg/kg/day based on irregular gait, decreased activity, excessive salivation, and anogenital staining. 

Short- and Intermediate term 

Inhalation.

Inhalation study 

NOAEL = 0.3 mg/

L.

UFA = 3x ..................

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

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

HEC = 0.932 mg/L/

day (residential 

handler).

HED = 26.7 mg/kg/

day (residential 

handler) or 39.8– 

138.9 mg/kg/day 

(occupational handler).

Residential LOC for 

MOE = 30.

Occupational LOC 

for MOE = 30.

Rat 28-day Inhalation Study 

LOAEL = 2.4 mg/L based on increased liver weight, increased 

total serum bilirubin, and increased incidence of slight 

centrilobular hepatocyte swelling. 

Cancer (oral, dermal, inhalation).‘‘Not Likely to Be Carcinogenic to Humans’’ based on the lack of evidence of carcinogenicity in rats and mice. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. 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). UFDB = to account for the absence of data or other data deficiency. UFH = 

potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS =

use of a short-term study for long-term risk assessment. Human equivalent concentrations (HECs), Human equivalent dose (HED). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sethoxydim, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing sethoxydim tolerances in 40 

CFR 180.412. EPA assessed dietary 

exposures from sethoxydim 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 sethoxydim. In conducting the acute 

dietary exposure assessment for 

sethoxydim, EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM–FCID) Version 3.16. 

This software uses 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). A 

partially refined acute analysis was 

performed based on tolerance-level 

residues; percent crop treated (PCT) 

estimates for most agricultural uses of 

sethoxydim were applied, and DEEM TM

default processing factors were applied 

to account for processed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

for sethoxydim, EPA used DEEM–FCID 

Version 3.16 in which the software uses 

2003–2008 food consumption data from 

the USDA’s NHANES/WWEIA. A 

partially refined chronic dietary 

exposure assessment was conducted, 

which used PCT data, but the overall 

dietary assessment represents high-end 

exposure because tolerance-level 

residues were used for food and 

bounding modeled residues for drinking 

water. Anticipated residues (based on 

maximum theoretical diets) were used 

for livestock commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that sethoxydim is not likely 

to 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 


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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. For acute dietary risk 

assessment for sethoxydim the 

following maximum PCT estimates were 

used: Alfalfa 2.5%; almonds 5%; apples 

2.5%; apricots 10%; artichokes 2.5%; 

asparagus 10%; beans, green 15%; 

blueberries 10%; broccoli 5%; cabbage 

10%; caneberries 10%; canola 2.5%; 

cantaloupes 25%; carrots 5%; 

cauliflower 10%; celery 2.5%; cherries 

2.5%; corn 2.5%; cotton 2.5%; 

cucumbers 10%; dry beans/peas 35%; 

eggplant 10%; fallow 2.5%; garlic 5%; 

grapefruit 2.5%; grapes 5%; hazelnuts 

2.5%; lettuce 10%; oats 2.5%; onions 

15%; oranges 5%; peaches 2.5%; 

peanuts 10%; pears 2.5%; peas, green 

15%; pecans 2.5%; peppers 15%; 

pistachios 2.5%; plums/prunes 2.5%; 

potatoes 5%; pumpkins 10%; soybeans 

2.5%; spinach 2.5%; squash 10%; 

strawberries 10%; sugar beets 5%; 

sunflowers 10%; sweet corn 5%; 

tobacco 10%; tomatoes 5%; walnuts 

5%; watermelons 20%; wheat 2.5%. 

For chronic dietary risk assessment, 

the following average PCT estimates for 

sethoxydim were used: Alfalfa 1%; 

almonds 2.5%; apples 1%; apricots 

2.5%; artichokes 2.5%; asparagus 5%; 

beans, green 10%; blueberries 5%; 

broccoli 2.5%; cabbage 5%; caneberries 

5%; canola 2.5%; cantaloupes 5%; 

carrots 2.5%; cauliflower 5%; celery 

2.5%; cherries 2.5%; corn 1%; cotton 

1%; cucumbers 5%; dry beans/peas 

30%; eggplant 5%; fallow 1%; garlic 

2.5%; grapefruit 2.5%; grapes 2.5%; 

hazelnuts 2.5%; lettuce 2.5%; oats 1%; 

onions 5%; oranges 2.5%; peaches 1%; 

peanuts 5%; pears 2.5%; peas, green 

5%; pecans 2.5%; peppers 5%; 

pistachios 1%; plums/prunes 1%; 

potatoes 2.5%; pumpkins 5%; soybeans 

1%; spinach 2.5%; squash 5%; 

strawberries 2.5%; sugar beets 2.5%; 

sunflowers 5%; sweet corn 2.5%; 

tobacco 5%; tomatoes 2.5%; walnuts 

2.5%; watermelons 10%; wheat 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 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 Sethoxydim 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 sethoxydim in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of sethoxydim. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) Surface Water 

Calculator (SWCC Version 1.106), 

Surface Water Provisional Cranberry 

Model and Tier 1 mode of the Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of sethoxydim 

for acute exposures are estimated to be 

79.6 parts per billion (ppb) for surface 

water and 0.565 ppb for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 13.9 

ppb for surface water and 0.51 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 79.6 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 13.9 

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). 

Sethoxydim is currently registered for 

the following uses that could result in 

residential exposures: Turf (including 

lawns, golf courses, recreational parks, 

and sod farms) and ornamentals. Shortterm exposure to sethoxydim may occur 

via the dermal and inhalation routes for 

adults using sethoxydim products in 

residential settings. Since no dermal 

hazard was identified, only inhalation 

exposures were assessed for residential 

applicators. In addition, children may 

potentially be exposed orally in postapplication turf scenarios. Intermediateor long-term exposures are not expected 

due to the intermittent nature of 

applications by homeowners. 

EPA assessed residential exposure 

using the following assumptions: Since 

no dermal hazard was identified in the 

toxicity database for sethoxydim, a 

quantitative residential post-application 

dermal risk assessment is not required 

and was not completed. Postapplication inhalation exposures while 

performing activities in previously 

treated turf or ornamentals are not 

expected, primarily due to the very low 

vapor pressure (1.6 × 10¥7 mm Hg at 25 

°C) and the expected dilution in outdoor 

air after an application has occurred. 

Therefore, post-application inhalation 

exposures were not assessed. The 

residential post-application assessment 

considers non-dietary incidental oral 

exposures only. Residential postapplication exposures are generally 

considered to be intermittent and shortterm in duration. 

For the residential turf use scenario, 

post-application incidental oral 

exposure is assessed for children (1 to 

< 2 years old as the sentinel 

population). The turf use site assessed 

was residential lawn turf as exposures 

from that use are expected to be higher 

than any potential exposures from other 


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turf uses (i.e., recreational parks, golf 

courses, or treated sod). The assessment 

was conducted assuming the maximum 

application rate (0.47 lbs ai/acre) and 

used unit exposure values and estimates 

for area treated or amount handled. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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 sethoxydim to 

share a common mechanism of toxicity 

with any other substances, and 

sethoxydim does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that sethoxydim 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. 

There is evidence of increased 

susceptibility of the young following 

exposure to sethoxydim in the rat and/ 

or rabbit developmental and 

reproduction studies. To further assess 

these effects, the EPA performed a 

Degree of Concern Analysis in which 

sethoxydim was evaluated for potential 

developmental effects in the rat and 

rabbit. Maternal toxicity included 

transient clinical signs (irregular gait, 

decreased activity, excessive salivation, 

and anogenital staining) in rats at 650 

mg/kg/day and at the limit dose. 

Decreased fetal body weight, delayed 

ossification, and malformations 

(filamentous tail; lack of tail) were 

observed in the rat at 650 mg/kg/day 

and at the limit dose. Maternal toxicity 

was not observed in rabbits, whereas an 

increased incidence of incompletely 

ossified 6th sternebrae was noted in 

fetuses at the high dose (400 mg/kg/

day). Decreased body weight was 

observed in F1a, F1b, and F2b pups 

during lactation in the 2-generation 

reproduction study at 150 mg/kg/day 

(highest dose tested), while parental 

toxicity was not observed. The Agency 

concluded from the Degree of Concern 

Analysis that there was low concern for 

pre- and/or post-natal toxicity resulting 

from exposure to sethoxydim, because 

the chosen points of departure for risk 

assessment for each exposure scenario 

are protective for these effects. 

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 

sethoxydim is complete. 

ii. There was no clear evidence of 

neurotoxicity or neuropathology in the 

available studies, which include a 

subchronic neurotoxicity study. The 

acute neurotoxicity study and 

developmental neurotoxicity study 

requirements have been waived. 

iii. There is evidence that sethoxydim 

results in increased susceptibility in in 

utero exposure to sethoxydim in the 

rabbit developmental toxicity study and 

following in utero and/or pre-/post-natal 

exposure in the 2-generation 

reproduction study in rats. However, 

there is low concern because the chosen 

points of departure for risk assessment 

for each exposure scenario are 

protective for these effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary exposure estimates were 

partially refined by incorporation of 

percent of crop treated assumptions; 

however, tolerance-level residue in food 

and upper-bound drinking water 

estimates based on modeling were used 

which are conservative assumptions. 

EPA used similarly conservative 

assumptions to assess post-application 

exposure of children, as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by sethoxydim. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

described in this unit for acute 

exposure, acute dietary risk estimates 

for the registered and proposed uses of 

sethoxydim will occupy 5.4% of the 

aPAD for the general U.S. population. 

The risk estimate for the most highly 

exposed subgroup, children 1–2 year 

old, was 8.6% of the aPAD. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to sethoxydim 

from food and water will utilize 27% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of sethoxydim is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Sethoxydim 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 sethoxydim. The shortterm aggregate assessment for children 

1–2 years old, the most exposed 

subpopulation group, includes postapplication oral residential exposures 

from treated turf and chronic dietary 

exposure. 

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 4,000 that are below the EPA’s 

level of concern for sethoxydim. 


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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). 

Because there is no intermediate-term 

exposure, sethoxydim is not expected to 

pose an intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

sethoxydim 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 sethoxydim 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography/

flame photometric detection GC/FPD 

method is available (Method I in PAM 

Vol. II) for determining the combined 

residues of sethoxydim and its 

metabolites containing the 3-alkyl 

substituted pentanedioic acid moiety in 

plant and livestock commodities which 

provides a 0.05 ppm limit of 

quantitation (LOQ). 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There are no Codex MRLs established 

for the residues of sethoxydim in/on 

raw agricultural or processed 

commodities. 

C. Response to Comments 

One comment was received from a 

private citizen objecting to 

establishment of petitioned-for 

tolerances for residues of sethoxydim 

and a number of other pesticides on 

food items as these are ‘‘dangerous 

chemicals’’ and children are 

disproportionately exposed to health 

risks from their use. In addition, the 

commenter expressed concern about the 

potential for increased cancer rates in 

children due to pesticide exposures. 

The Agency understands the 

commenters’ concerns regarding 

chemicals and their potential effects on 

humans. Pursuant to its authority under 

the FFDCA, and as discussed further in 

this preamble, EPA conducted a 

comprehensive assessment of 

sethoxydim, which included an 

assessment on the carcinogenic 

potential of sethoxydim. Based on its 

assessment of the available data, EPA 

has found that there is a reasonable 

certainty of no harm to humans, with 

special emphases on infants and 

children sensitivity, from aggregate 

exposure to sethoxydim based on a 

complete toxicological database and the 

potential exposure levels. 

D. Revisions to Petitioned-For 

Tolerances 

The tolerance for the bushberry 

subgroup 13–07B is based on the 

residue data on blueberry, the 

representative crop at 4.0 ppm and not 

the previously established tolerances for 

juneberry, lingonberry, and salal at 5.0 

ppm. The juneberry, lingonberry, and 

salal tolerances were based on the 

translation of caneberry data, which are 

no longer relevant to these crops 

following updated crop grouping 

realignment. Moreover, EPA has 

determined that available data support a 

reduction in sethoxydim residue 

tolerance level for these crops from 5.0 

ppm to 4.0 ppm. 

Based on available data and the 

application of the OECD calculation 

procedures, EPA is establishing a 

tolerance of 7.0 ppm for fescue, forage, 

rather than 6.0 ppm as requested by the 

petitioner. This difference stems from 

the conclusion that only 4 independent 

grass trials were conducted instead of 5 

(as assumed by IR–4). 

In addition, for the requested 

rapeseed subgroup 20A and sunflower 

subgroup 20B crop group conversions, 

each RAC could potentially be 

processed into meal. Therefore, 

following the established meal tolerance 

of the representative crop, canola meal 

at 40 ppm for subgroup 20A and 

sunflower meal at 20 ppm for subgroup 

20B, tolerances for the residues of 

sethoxydim are also required for 

translation to the following 

commodities: Calendula, meal at 20 

ppm; castor oil plant, meal at 20 ppm; 

Chinese tallowtree, meal at 20 ppm; 

cuphea, meal at 40 ppm; echium, meal 

40 ppm; euphoriba, meal at 20 ppm; 

evening primrose, meal at 20 ppm; flax 

seed, meal at 40 ppm; hare’s ear 

mustard, meal at 40 ppm; jojoba, meal 

at 20 ppm; lesquerella, meal at 40 ppm; 

lunaria, meal at 40 ppm; meadowfoam, 

meal at 40 ppm; milkweed, meal at 40 

ppm; mustard, meal at 40 ppm; niger 

seed, meal at 20 ppm; oil radish, meal 

at 40 ppm; poppy seed, meal at 40 ppm; 

rose hip, meal at 20 ppm; sesame, meal 

at 40 ppm; stokes aster, meal at 20 ppm; 

sweet rocket, meal at 40 ppm; 

tallowwood, meal at 20 ppm; tea oil 

plant, meal at 20 ppm; and vernonia, 

meal at 20 ppm. Additionally, an 

existing borage, meal tolerance at 10 

ppm is being raised to 40 ppm. 

Lastly, the Agency is updating the 

tolerance expressions for sethoxydim as 

follows to reflect current EPA policies: 

Tolerances are established for the 

herbicide sethoxydim, 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 the herbicide 

2-[1-(ethoxyimino)butyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one (CAS Reg. No. 74051– 

80–2) and its metabolites containing the 

2-cyclohexen-1-one moiety, calculated 

as the stoichiometric equivalent of 

sethoxydim, in or on the commodities 

listed in the subsections. 

E. Trade Considerations 

Establishing a tolerance at 4.0 ppm for 

the expanded crop subgroup 13–07B 

results in reductions of the existing 

sethoxydim tolerance level for 

juneberry, lingonberry, and salal, which 

are each set individually at 5.0 ppm. In 

order to allow a reasonable interval for 

producers in the exporting member 

countries of the World Trade 

Organization’s Sanitary and 

Phytosanitary Measures Agreement to 

adapt to the requirements of these 

modified tolerances, EPA is establishing 

an expiration date for those higher 

individual tolerances (for juneberry, 

lingonberry, and salal) of December 15, 

2015. Those tolerances will remain in 

place for six months after the 

publication of this rule—and residues of 

sethoxydim may be present on 

juneberry, lingonberry, and salal at 

levels up to 5.0 ppm until their 


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expiration date—in order to allow a 

reasonable interval for producers in 

exporting member countries to adapt to 

the reduced tolerances. After that 6- 

month period, those individual 

tolerances will expire, and residues of 

sethoxydim on juneberry, lingonberry, 

and salal will need to comply with the 

bushberry subgroup 13–07B tolerance, 

which includes those commodities and 

limits residues to 4.0 ppm. 

V. Conclusion 

Tolerances are established for the 

herbicide sethoxydim, including its 

metabolites and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only the sum of the herbicide 2-[1- 

(ethoxyimino)butyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one (CAS Reg. No. 74051– 

80–2) and its metabolites containing the 

2-cyclohexen-1-one moiety, calculated 

as the stoichiometric equivalent of 

sethoxydim, in or on commodities: 

Berry, low growing, subgroup 13–07H, 

except strawberry at 2.5 ppm; borage, 

meal at 40 ppm; bushberry, subgroup 

13–07B at 4.0 ppm; calendula, meal at 

20 ppm; caneberry, subgroup 13–07A at 

5.0 ppm; castor oil plant, meal at 20 

ppm; Chinese tallowtree, meal at 20 

ppm; cottonseed, subgroup 20C at 5.0 

ppm; cuphea, meal at 40 ppm; echium, 

meal 40 ppm; euphorbia, meal at 20 

ppm; evening primrose, meal at 20 ppm; 

fescue, forage at 7.0 ppm; fescue, hay at 

4.0 ppm; flax seed, meal at 40 ppm; 

fruit, citrus, group 10–10 at 0.5 ppm; 

fruit, pome, group 11–10 at 0.2 ppm; 

fruit, small, vine climbing, subgroup 

13–07F, except fuzzy kiwifruit at 1.0 

ppm; hare’s ear mustard, meal at 40 

ppm; jojoba, meal at 20 ppm; 

lesquerella, meal at 40 ppm; lunaria, 

meal at 40 ppm; meadowfoam, meal at 

40 ppm; milkweed, meal at 40 ppm; 

mustard, meal at 40 ppm; niger seed, 

meal at 20 ppm; oil radish, meal at 40 

ppm; poppy seed, meal at 40 ppm; 

rapeseed, subgroup 20A at 35 ppm; rose 

hip, meal at 20 ppm; sesame, meal at 40 

ppm; stokes aster, meal at 20 ppm; 

sunflower subgroup 20B, except 

safflower at 7.0 ppm; sweet rocket, meal 

at 40 ppm; tallowwood, meal at 20 ppm; 

tea oil plant, meal at 20 ppm; vegetable, 

bulb, group 3–07 at 1.0 ppm; vegetable, 

fruiting, group 8–10 to 4.0 ppm; and 

vernonia, meal at 20 ppm. In addition, 

upon establishment of the above 

tolerances, remove the following entries 

that are superseded by this action 

including: Blueberry; borage, seed; 

caneberry subgroup 13A; canola, seed; 

cotton, undelinted seed; crambe, seed; 

cranberry; cuphea, seed; echium, seed; 

flax, seed; fruit, citrus group 10; fruit, 

pome, group 11; gold of pleasure, seed; 

grape; hare’s ear mustard, seed; 

lesquerella, seed; lunaria, seed; 

meadowfoam, seed; milkweed, seed; 

mustard, seed; oil radish, seed; okra; 

poppy, seed; rapeseed, seed; sesame, 

seed; sunflower, seed; sweet rocket, 

seed; vegetable, bulb group 3; and 

vegetable, fruiting group 8. 

Finally, the individual tolerances for 

juneberry, lingonberry, and salal at 5.0 

ppm will expire 6 months from the date 

of publication of this final rule in the 

Federal Register. 

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: June 4, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. § 180.412 is revised to read as 

follows: 

§ 180.412 Sethoxydim; tolerances for 

residues. 

(a) Tolerances are established for the 

herbicide sethoxydim, 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 


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measuring only the sum of the herbicide 

2-[1-(ethoxyimino)butyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one (CAS Reg. No. 74051– 

80–2) and its metabolites containing the 

2-cyclohexen-1-one moiety, calculated 

as the stoichiometric equivalent of 

sethoxydim, in or on the commodity. 

Commodity Parts per 

illion 

Alfalfa, forage ............................... 40 

Alfalfa, hay .................................... 40 

Almond, hulls ................................ 2 .0 

Apricot ........................................... 0 .2 

Apple, wet pomace ....................... 0 .8 

Asparagus ..................................... 4 .0 

Bean, succulent ............................ 15 

Beet, sugar, molasses .................. 10 

Beet, sugar, tops .......................... 3 .0 

Berry, low growing, subgroup 13– 

07H, except strawberry ............. 2 .5 

Borage, meal ................................ 40 

Buckwheat, flour ........................... 25 

Buckwheat, grain .......................... 19 

Bushberry subgroup 13–07B ........ 4 .0 

Calendula, meal ............................ 20 

Caneberry subgroup 13–07A ....... 5 .0 

Canola, meal ................................ 40 

Castor oil plant, meal ................... 20 

Cattle, fat ...................................... 0 .2 

Cattle, meat .................................. 0 .2 

Cattle, meat byproducts ............... 1 .0 

Cherry, sweet ............................... 0 .2 

Cherry, tart .................................... 0 .2 

Chinese tallowtree, meal .............. 20 

Citrus, dried pulp .......................... 1 .5 

Clover, forage ............................... 35 

Clover, hay ................................... 55 

Coriander, leaves ......................... 4 .0 

Corn, field, forage ......................... 2 .0 

Corn, field, grain ........................... 0 .5 

Corn, field, stover ......................... 2 .5 

Corn, sweet, forage ...................... 3 .0 

Corn, sweet, kernel plus cob with 

husk removed ........................... 0 .4 

Corn, sweet, stover ...................... 3 .5 

Cottonseed subgroup 20C ........... 5 .0 

Cowpea, forage ............................ 15 

Cowpea, hay ................................. 50 

Crambe, meal ............................... 40 

Cuphea, meal ............................... 40 

Dillweed, fresh leaves .................. 10 

Echium, meal ................................ 40 

Egg ............................................... 2 .0 

Euphorbia, meal ........................... 20 

Evening primrose, meal ................ 20 

Flax seed, meal ............................ 40 

Fruit, citrus, group 10–10 ............. 0 .5 

Fruit, pome, group 11–10 ............. 0 .2 

Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F ............................................ 1 .0 

Goat, fat ........................................ 0 .2 

Goat, meat .................................... 0 .2 

Goat, meat byproducts ................. 1 .0 

Gold of pleasure, meal ................. 40 

Grape, raisin ................................. 2 .0 

Hare’s ear mustard, meal ............. 40 

Hog, fat ......................................... 0 .2 

Hog, meat ..................................... 0 .2 

Hog, meat byproducts .................. 1 .0 

Horse, fat ...................................... 0 .2 

Horse, meat .................................. 0 .2 

Commodity Parts per 

illion 

Horse, meat byproducts ............... 1 .0 

Jojoba, meal ................................. 20 

Juneberry 1 .................................... 5 .0 

Lesquerella, meal ......................... 40 

Lingonberry 1 ................................. 5 .0 

Lunaria, meal ................................ 40 

Meadowfoam, meal ...................... 40 

Milk ............................................... 0 .5 

Milkweed, meal ............................. 40 

Mustard, meal ............................... 40 

Nectarine ...................................... 0 .2 

Niger seed, meal .......................... 20 

Nut, tree, group 14 ....................... 0 .2 

Oil radish, meal ............................ 40 

Pea and bean, dried shelled, except soybean, subgroup 6C ...... 25 

Pea, field, hay ............................... 40 

Pea, field, vines ............................ 20 

Pea, succulent .............................. 10 

Peach ............................................ 0 .2 

Peanut .......................................... 25 

Peppermint, tops .......................... 30 

Pistachio ....................................... 0 .2 

Poppy seed, meal ......................... 40 

Potato granules/flakes .................. 8 .0 

Potato waste, processed .............. 8 .0 

Poultry, fat .................................... 0 .2 

Poultry, meat ................................ 0 .2 

Poultry, meat byproducts .............. 2 .0 

Radish, tops .................................. 4 .5 

Rapeseed, meal ........................... 40 

Rapeseed subgroup 20A .............. 35 

Rose hip, meal ............................. 20 

Safflower, seed ............................. 15 

Salal 1 ............................................ 5 .0 

Sesame, meal ............................... 40 

Sheep, fat ..................................... 0 .2 

Sheep, meat ................................. 0 .2 

Sheep, meat byproducts .............. 1 .0 

Soybean, hay ................................ 10 

Soybean, seed .............................. 16 

Spearmint, tops ............................ 30 

Strawberry .................................... 10 

Stokes aster, meal ........................ 20 

Sunflower, meal ............................ 20 

Sunflower subgroup 20B, except 

safflower .................................... 7 .0 

Sweet rocket, meal ....................... 40 

Tallowwood, meal ......................... 20 

Tea oil plant, meal ........................ 20 

Turnip, tops ................................... 5 .0 

Vegetable, brassica, leafy, group 

5 ................................................ 5 .0 

Vegetable, bulb, group 3–07 ........ 1 .0 

Vegetable, cucurbit, group 9 ........ 4 .0 

Vegetable, fruiting, group 8–10 .... 4 .0 

Vegetable, leafy, except brassica, 

group 4 ...................................... 4 .0 

Vegetable, root and tuber, group 

1 ................................................ 4 .0 

Vernonia, meal ............................. 20 

1The individual tolerances for Juneberry, 

Lingonberry, and Salal expire on December 

15, 2015. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registration. Tolerances are established 

for the herbicide sethoxydim, 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 the herbicide 

2-[1-(ethoxyimino)butyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one) and its metabolites 

containing the 2-cyclohexen-1-one 

moiety, calculated as the stoichiometric 

equivalent of sethoxydim, in or on the 

commodity. 

Commodity Parts per 

million 

Artichoke, globe ............................ 5.0 

Fescue, forage .............................. 7.0 

Fescue, hay .................................. 4.0 

Rhubarb ........................................ 0.3 

(d) Indirect and inadvertent residues. 

[Reserved] 

[FR Doc. 2015–14642 Filed 6–12–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 216 

Types of Contracts 

CFR Correction 

In Title 48 of the Code of Federal 

Regulations, Chapter 2, Parts 200 to 299, 

revised as of October 1, 2014, on page 

111, redesignate section 216.405–270 as 

section 216.405–2–70. 

[FR Doc. 2015–14527 Filed 6–12–15; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 217 

Special Contracting Methods 

CFR Correction 

In Title 48 of the Code of Federal 

Regulations, Chapter 2, Parts 200 to 299, 

revised as of October 1, 2014, on page 

117, in section 217.171, redesignate 

paragraph (c)(2)(C)(2) as paragraph 

(c)(2)(i). 

[FR Doc. 2015–14528 Filed 6–12–15; 8:45 am] 

BILLING CODE 1505–01–D 


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