80 FR 34070 - Sethoxydim; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 114 (June 15, 2015)

Page Range		34070-34078
FR Document		2015-14642
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existing tolerances for residues of sethoxydim in or on several commodities identified later in this document that are superseded by this action.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).
Federal Register, Volume 80 Issue 114 (Monday, June 15, 2015)
[Federal Register Volume 80, Number 114 (Monday, June 15, 2015)]
[Rules and Regulations]
[Pages 34070-34078]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14642]


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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.

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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commodities identified later in this document that are superseded by 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: [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 34071]]

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/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0161 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

[[Page 34072]]

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 (no-observed-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-effect-level (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
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (females 13-49       NOAEL = 180 mg/kg/    Acute RfD = aPAD =   Rat Developmental Toxicity
 years of age).                     day.                  1.8 mg/kg/day.      Developmental LOAEL = 650 mg/kg/
                                   UFA = 10x...........                        day based on decreased fetal body
                                   UFH = 10x...........                        weight, tail abnormalities, and
                                   FQPA SF =1x.........                        delayed ossification
                                                                              Tail abnormalities were considered
                                                                               an acute effect.
Acute dietary (general population  NOAEL = 180 mg/kg/    Acute RfD = aPAD =   Rat Developmental Toxicity
 including infants and children).   day.                  1.8 mg/kg/day.      Maternal LOAEL = 650 mg/kg/day
                                   UFA = 10x...........                        based on irregular gait that was
                                   UFH = 10x...........                        observed in 12/34 dams on the
                                   FQPA SF = 1x........                        first day of dosing.
Chronic dietary (all populations)  NOAEL = 14 mg/kg/day  Chronic RfD = cPAD   Mouse Carcinogenicity Study
                                   UFA = 10x...........   = 0.14 mg/kg/day.   LOAEL = 41 mg/kg/day based on
                                   UFH =10x............                        liver hypertrophy and fatty
                                   FQPA SF =1x.........                        degeneration.

[[Page 34073]]

 
Incidental oral short-term (1 to   NOAEL = 180 mg/kg/    Residential LOC for  Rat Developmental Toxicity
 30 days).                          day.                  MOE = 100.          Maternal LOAEL = 650 mg/kg/day
                                   UFA = 10x...........                        based on irregular gait,
                                   UFH = 10x...........                        decreased activity, excessive
                                   FQPA SF = 1x........                        salivation, and anogenital
                                                                               staining.
Short- and Intermediate term       Inhalation study      Residential LOC for  Rat 28-day Inhalation Study
 Inhalation.                        NOAEL = 0.3 mg/L.     MOE = 30.           LOAEL = 2.4 mg/L based on
                                   UFA = 3x............  Occupational LOC      increased liver weight, increased
                                   UFH = 10x...........   for MOE = 30.        total serum bilirubin, and
                                   FQPA SF = 1x........                        increased incidence of slight
                                   HEC = 0.932 mg/L/day                        centrilobular hepatocyte
                                    (residential                               swelling.
                                    handler).
                                   HED = 26.7 mg/kg/day
                                    (residential
                                    handler) or 39.8-
                                    138.9 mg/kg/day
                                    (occupational
                                    handler).
                                  ------------------------------------------------------------------------------
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

[[Page 34074]]

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 non-occupational, 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. Short-term 
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 post-application turf scenarios. Intermediate- or 
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. Post-application 
inhalation exposures while performing activities in previously treated 
turf or ornamentals are not expected, primarily due to the very low 
vapor pressure (1.6 x 10^-7 mm Hg at 25 [deg]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 post-application exposures 
are generally considered to be intermittent and short-term 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

[[Page 34075]]

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 short-term 
aggregate assessment for children 1-2 years old, the most exposed 
subpopulation group, includes post-application 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.

[[Page 34076]]

    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: 
[email protected].

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

[[Page 34077]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Sec.  180.412 is revised to read as follows:


Sec.  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

[[Page 34078]]

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.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
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        1.0
 13-07F......................................................
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
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
------------------------------------------------------------------------
\1\ The 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.

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

has determined that this action will not Senate, the U.S. House of Inert ingredients Limits Uses
have a substantial direct effect on States Representatives, and the Comptroller
or tribal governments, on the General of the United States prior to
relationship between the national publication of the rule in the Federal * * * * *
government and the States or tribal Register. This action is not a ‘‘major Di-n-butyl carbonate (CAS .......... Solvent.
governments, or on the distribution of rule’’ as defined by 5 U.S.C. 804(2). Reg. No. 542–52–9).
power and responsibilities among the * * * * *
various levels of government or between List of Subjects in 40 CFR Part 180
the Federal Government and Indian Environmental protection,
tribes. Thus, the Agency has determined ■ 3. In § 180.930, add alphabetically the
Administrative practice and procedure, inert ingredient to the table to read as
that Executive Order 13132, entitled Agricultural commodities, Pesticides
‘‘Federalism’’ (64 FR 43255, August 10, follows:
and pests, Reporting and recordkeeping
1999) and Executive Order 13175, requirements. § 180.930 Inert ingredients applied to
entitled ‘‘Consultation and Coordination animals; exemptions from the requirement
with Indian Tribal Governments’’ (65 FR Dated: June 5, 2015. of a tolerance.
67249, November 9, 2000) do not apply Susan Lewis, * * * * *
to this action. In addition, this action Director, Registration Division, Office of
does not impose any enforceable duty or Pesticide Programs. Inert ingredients Limits Uses
contain any unfunded mandate as Therefore, 40 CFR chapter I is
described under Title II of the Unfunded amended as follows:
Mandates Reform Act (UMRA) (2 U.S.C. * * * * *
1501 et seq.). Di-n-butyl carbonate (CAS .......... Solvent.
PART 180—[AMENDED] Reg. No. 542–52–9).
This action does not involve any
technical standards that would require ■ 1. The authority citation for part 180 * * * * *
Agency consideration of voluntary continues to read as follows:
consensus standards pursuant to section ■ 4. In § 180.940(a), add alphabetically
Authority: 21 U.S.C. 321(q), 346a and 371.
12(d) of the National Technology the inert ingredient to the table to read
Transfer and Advancement Act ■ 2. In § 180.910, add alphabetically the as follows:
(NTTAA) (15 U.S.C. 272 note). inert ingredient to the table to read as
follows: § 180.940 Tolerance exemptions for active
VIII. Congressional Review Act and inert ingredients for use in
Pursuant to the Congressional Review § 180.910 Inert ingredients used pre- and antimicrobial formulations (Food-contact
Act (5 U.S.C. 801 et seq.), EPA will post-harvest; exemptions from the surface sanitizing solutions).
submit a report containing this rule and requirement of a tolerance. * * * * *
other required information to the U.S. * * * * * (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.

* * * * * * *

* * * * * commodities identified later in this Constitution Ave. NW., Washington, DC
[FR Doc. 2015–14647 Filed 6–12–15; 8:45 am] document that are superseded by this 20460–0001.
BILLING CODE 6560–50–P action. Interregional Research Project The Public Reading Room is open
Number 4 (IR–4) requested these from 8:30 a.m. to 4:30 p.m., Monday
tolerances under the Federal Food, through Friday, excluding legal
ENVIRONMENTAL PROTECTION Drug, and Cosmetic Act (FFDCA).
AGENCY holidays. The telephone number for the
DATES: This regulation is effective June Public Reading Room is (202) 566–1744,
40 CFR Part 180 15, 2015. Objections and requests for and the telephone number for the OPP
hearings must be received on or before Docket is (703) 305–5805. Please review
[EPA–HQ–OPP–2014–0161; FRL–9928–20] August 14, 2015, and must be filed in the visitor instructions and additional
accordance with the instructions
Sethoxydim; Pesticide Tolerances information about the docket available
provided in 40 CFR part 178 (see also
at http://www.epa.gov/dockets.
Unit I.C. of the SUPPLEMENTARY
AGENCY: Environmental Protection
INFORMATION). FOR FURTHER INFORMATION CONTACT:
Agency (EPA).
ADDRESSES: The docket for this action, Susan Lewis, Registration Division
ACTION: Final rule.
identified by docket identification (ID) (7505P), Office of Pesticide Programs,
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SUMMARY: This regulation establishes number EPA–HQ–OPP–2014–0161, is Environmental Protection Agency, 1200
tolerances for residues of sethoxydim in available at http://www.regulations.gov Pennsylvania Ave. NW., Washington,
or on multiple commodities that are or at the Office of Pesticide Programs DC 20460–0001; main telephone
identified and discussed later in this Regulatory Public Docket (OPP Docket) number: (703) 305–7090; email address:
document. In addition, this regulation in the Environmental Protection Agency RDFRNotices@epa.gov.
removes existing tolerances for residues Docket Center (EPA/DC), West William SUPPLEMENTARY INFORMATION:
of sethoxydim in or on several Jefferson Clinton Bldg., Rm. 3334, 1301

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34074 Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations

provide for the periodic evaluation of nearest 5%, except for those situations For chronic exposures for non-cancer
the estimate of PCT as required by in which the average PCT is less than assessments are estimated to be 13.9
FFDCA section 408(b)(2)(F), EPA may one. In those cases, 1% is used as the ppb for surface water and 0.51 ppb for
require registrants to submit data on average PCT and 2.5% is used as the ground water.
PCT. maximum PCT. EPA uses a maximum Modeled estimates of drinking water
The Agency estimated the PCT for PCT for acute dietary risk analysis. The concentrations were directly entered
existing uses. For acute dietary risk maximum PCT figure is the highest into the dietary exposure model.
assessment for sethoxydim the observed maximum value reported For acute dietary risk assessment, the
following maximum PCT estimates were within the recent 6 years of available water concentration value of 79.6 ppb
used: Alfalfa 2.5%; almonds 5%; apples public and private market survey data was used to assess the contribution to
2.5%; apricots 10%; artichokes 2.5%; for the existing use and rounded up to drinking water.
asparagus 10%; beans, green 15%; the nearest multiple of 5%. For chronic dietary risk assessment,
blueberries 10%; broccoli 5%; cabbage The Agency believes that the three the water concentration of value 13.9
10%; caneberries 10%; canola 2.5%; conditions discussed in Unit III.C.1.iv. ppb was used to assess the contribution
cantaloupes 25%; carrots 5%; have been met. With respect to to drinking water.
cauliflower 10%; celery 2.5%; cherries Condition a, PCT estimates are derived 3. From non-dietary exposure. The
2.5%; corn 2.5%; cotton 2.5%; from Federal and private market survey term ‘‘residential exposure’’ is used in
cucumbers 10%; dry beans/peas 35%; data, which are reliable and have a valid this document to refer to non-
eggplant 10%; fallow 2.5%; garlic 5%; basis. The Agency is reasonably certain occupational, non-dietary exposure
grapefruit 2.5%; grapes 5%; hazelnuts that the percentage of the food treated (e.g., for lawn and garden pest control,
2.5%; lettuce 10%; oats 2.5%; onions is not likely to be an underestimation. indoor pest control, termiticides, and
15%; oranges 5%; peaches 2.5%; As to Conditions b and c, regional flea and tick control on pets).
peanuts 10%; pears 2.5%; peas, green consumption information and Sethoxydim is currently registered for
15%; pecans 2.5%; peppers 15%; consumption information for significant the following uses that could result in
pistachios 2.5%; plums/prunes 2.5%; subpopulations is taken into account residential exposures: Turf (including
potatoes 5%; pumpkins 10%; soybeans through EPA’s computer-based model lawns, golf courses, recreational parks,
2.5%; spinach 2.5%; squash 10%; for evaluating the exposure of and sod farms) and ornamentals. Short-
strawberries 10%; sugar beets 5%; significant subpopulations including term exposure to sethoxydim may occur
sunflowers 10%; sweet corn 5%; several regional groups. Use of this via the dermal and inhalation routes for
tobacco 10%; tomatoes 5%; walnuts consumption information in EPA’s risk adults using sethoxydim products in
5%; watermelons 20%; wheat 2.5%. assessment process ensures that EPA’s residential settings. Since no dermal
For chronic dietary risk assessment, exposure estimate does not understate hazard was identified, only inhalation
the following average PCT estimates for exposure for any significant exposures were assessed for residential
sethoxydim were used: Alfalfa 1%; subpopulation group and allows the applicators. In addition, children may
almonds 2.5%; apples 1%; apricots Agency to be reasonably certain that no potentially be exposed orally in post-
2.5%; artichokes 2.5%; asparagus 5%; regional population is exposed to application turf scenarios. Intermediate-
beans, green 10%; blueberries 5%; residue levels higher than those or long-term exposures are not expected
broccoli 2.5%; cabbage 5%; caneberries estimated by the Agency. Other than the due to the intermittent nature of
5%; canola 2.5%; cantaloupes 5%; data available through national food applications by homeowners.
carrots 2.5%; cauliflower 5%; celery consumption surveys, EPA does not EPA assessed residential exposure
2.5%; cherries 2.5%; corn 1%; cotton have available reliable information on using the following assumptions: Since
1%; cucumbers 5%; dry beans/peas the regional consumption of food to no dermal hazard was identified in the
30%; eggplant 5%; fallow 1%; garlic which Sethoxydim may be applied in a toxicity database for sethoxydim, a
2.5%; grapefruit 2.5%; grapes 2.5%; particular area. quantitative residential post-application
hazelnuts 2.5%; lettuce 2.5%; oats 1%; 2. Dietary exposure from drinking dermal risk assessment is not required
onions 5%; oranges 2.5%; peaches 1%; water. The Agency used screening level and was not completed. Post-
peanuts 5%; pears 2.5%; peas, green water exposure models in the dietary application inhalation exposures while
5%; pecans 2.5%; peppers 5%; exposure analysis and risk assessment performing activities in previously
pistachios 1%; plums/prunes 1%; for sethoxydim in drinking water. These treated turf or ornamentals are not
potatoes 2.5%; pumpkins 5%; soybeans simulation models take into account expected, primarily due to the very low
1%; spinach 2.5%; squash 5%; data on the physical, chemical, and fate/ vapor pressure (1.6 × 10¥7 mm Hg at 25
strawberries 2.5%; sugar beets 2.5%; transport characteristics of sethoxydim. °C) and the expected dilution in outdoor
sunflowers 5%; sweet corn 2.5%; Further information regarding EPA air after an application has occurred.
tobacco 5%; tomatoes 2.5%; walnuts drinking water models used in pesticide Therefore, post-application inhalation
2.5%; watermelons 10%; wheat 1%. exposure assessment can be found at exposures were not assessed. The
In most cases, EPA uses available data http://www.epa.gov/oppefed1/models/ residential post-application assessment
from United States Department of water/index.htm. considers non-dietary incidental oral
Agriculture/National Agricultural Based on the Pesticide Root Zone exposures only. Residential post-
Statistics Service (USDA/NASS), Model/Exposure Analysis Modeling application exposures are generally
proprietary market surveys, and the System (PRZM/EXAMS) Surface Water considered to be intermittent and short-
National Pesticide Use Database for the Calculator (SWCC Version 1.106), term in duration.
chemical/crop combination for the most Surface Water Provisional Cranberry For the residential turf use scenario,
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recent 6–7 years. EPA uses an average Model and Tier 1 mode of the Pesticide post-application incidental oral
PCT for chronic dietary risk analysis. Root Zone Model Ground Water (PRZM exposure is assessed for children (1 to
The average PCT figure for each existing GW), the estimated drinking water < 2 years old as the sentinel
use is derived by combining available concentrations (EDWCs) of sethoxydim population). The turf use site assessed
public and private market survey data for acute exposures are estimated to be was residential lawn turf as exposures
for that use, averaging across all 79.6 parts per billion (ppb) for surface from that use are expected to be higher
observations, and rounding to the water and 0.565 ppb for ground water. than any potential exposures from other

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4. Intermediate-term risk. raw agricultural or processed at 40 ppm for subgroup 20A and
Intermediate-term aggregate exposure commodities. sunflower meal at 20 ppm for subgroup
takes into account intermediate-term 20B, tolerances for the residues of
C. Response to Comments
residential exposure plus chronic sethoxydim are also required for
exposure to food and water (considered One comment was received from a translation to the following
to be a background exposure level). private citizen objecting to commodities: Calendula, meal at 20
Because there is no intermediate-term establishment of petitioned-for ppm; castor oil plant, meal at 20 ppm;
exposure, sethoxydim is not expected to tolerances for residues of sethoxydim Chinese tallowtree, meal at 20 ppm;
pose an intermediate-term risk. and a number of other pesticides on cuphea, meal at 40 ppm; echium, meal
5. Aggregate cancer risk for U.S. food items as these are ‘‘dangerous 40 ppm; euphoriba, meal at 20 ppm;
population. Based on the lack of chemicals’’ and children are evening primrose, meal at 20 ppm; flax
evidence of carcinogenicity in two disproportionately exposed to health seed, meal at 40 ppm; hare’s ear
adequate rodent carcinogenicity studies, risks from their use. In addition, the mustard, meal at 40 ppm; jojoba, meal
sethoxydim is not expected to pose a commenter expressed concern about the at 20 ppm; lesquerella, meal at 40 ppm;
cancer risk to humans. potential for increased cancer rates in lunaria, meal at 40 ppm; meadowfoam,
6. Determination of safety. Based on children due to pesticide exposures. meal at 40 ppm; milkweed, meal at 40
these risk assessments, EPA concludes The Agency understands the ppm; mustard, meal at 40 ppm; niger
that there is a reasonable certainty that commenters’ concerns regarding seed, meal at 20 ppm; oil radish, meal
no harm will result to the general chemicals and their potential effects on at 40 ppm; poppy seed, meal at 40 ppm;
population, or to infants and children humans. Pursuant to its authority under rose hip, meal at 20 ppm; sesame, meal
from aggregate exposure to sethoxydim the FFDCA, and as discussed further in at 40 ppm; stokes aster, meal at 20 ppm;
residues. this preamble, EPA conducted a sweet rocket, meal at 40 ppm;
comprehensive assessment of tallowwood, meal at 20 ppm; tea oil
IV. Other Considerations
sethoxydim, which included an plant, meal at 20 ppm; and vernonia,
A. Analytical Enforcement Methodology assessment on the carcinogenic meal at 20 ppm. Additionally, an
An adequate gas chromatography/ potential of sethoxydim. Based on its existing borage, meal tolerance at 10
flame photometric detection GC/FPD assessment of the available data, EPA ppm is being raised to 40 ppm.
method is available (Method I in PAM has found that there is a reasonable Lastly, the Agency is updating the
Vol. II) for determining the combined certainty of no harm to humans, with tolerance expressions for sethoxydim as
residues of sethoxydim and its special emphases on infants and follows to reflect current EPA policies:
metabolites containing the 3-alkyl children sensitivity, from aggregate Tolerances are established for the
substituted pentanedioic acid moiety in exposure to sethoxydim based on a herbicide sethoxydim, including its
plant and livestock commodities which complete toxicological database and the metabolites and degradates, in or on the
provides a 0.05 ppm limit of potential exposure levels. commodities in the table below.
quantitation (LOQ). Compliance with the tolerance levels
D. Revisions to Petitioned-For
The method may be requested from: specified below is to be determined by
Tolerances
Chief, Analytical Chemistry Branch, measuring only the sum of the herbicide
Environmental Science Center, 701 The tolerance for the bushberry 2-[1-(ethoxyimino)butyl]-5-[2-
Mapes Rd., Ft. Meade, MD 20755–5350; subgroup 13–07B is based on the (ethylthio)propyl]-3-hydroxy-2-
telephone number: (410) 305–2905; residue data on blueberry, the cyclohexen-1-one (CAS Reg. No. 74051–
email address: residuemethods@ representative crop at 4.0 ppm and not 80–2) and its metabolites containing the
epa.gov. the previously established tolerances for 2-cyclohexen-1-one moiety, calculated
juneberry, lingonberry, and salal at 5.0 as the stoichiometric equivalent of
B. International Residue Limits ppm. The juneberry, lingonberry, and sethoxydim, in or on the commodities
In making its tolerance decisions, EPA salal tolerances were based on the listed in the subsections.
seeks to harmonize U.S. tolerances with translation of caneberry data, which are
international standards whenever no longer relevant to these crops E. Trade Considerations
possible, consistent with U.S. food following updated crop grouping Establishing a tolerance at 4.0 ppm for
safety standards and agricultural realignment. Moreover, EPA has the expanded crop subgroup 13–07B
practices. EPA considers the determined that available data support a results in reductions of the existing
international maximum residue limits reduction in sethoxydim residue sethoxydim tolerance level for
(MRLs) established by the Codex tolerance level for these crops from 5.0 juneberry, lingonberry, and salal, which
Alimentarius Commission (Codex), as ppm to 4.0 ppm. are each set individually at 5.0 ppm. In
required by FFDCA section 408(b)(4). Based on available data and the order to allow a reasonable interval for
The Codex Alimentarius is a joint application of the OECD calculation producers in the exporting member
United Nations Food and Agriculture procedures, EPA is establishing a countries of the World Trade
Organization/World Health tolerance of 7.0 ppm for fescue, forage, Organization’s Sanitary and
Organization food standards program, rather than 6.0 ppm as requested by the Phytosanitary Measures Agreement to
and it is recognized as an international petitioner. This difference stems from adapt to the requirements of these
food safety standards-setting the conclusion that only 4 independent modified tolerances, EPA is establishing
organization in trade agreements to grass trials were conducted instead of 5 an expiration date for those higher
individual tolerances (for juneberry,
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which the United States is a party. EPA (as assumed by IR–4).
may establish a tolerance that is In addition, for the requested lingonberry, and salal) of December 15,
different from a Codex MRL; however, rapeseed subgroup 20A and sunflower 2015. Those tolerances will remain in
FFDCA section 408(b)(4) requires that subgroup 20B crop group conversions, place for six months after the
EPA explain the reasons for departing each RAC could potentially be publication of this rule—and residues of
from the Codex level. processed into meal. Therefore, sethoxydim may be present on
There are no Codex MRLs established following the established meal tolerance juneberry, lingonberry, and salal at
for the residues of sethoxydim in/on of the representative crop, canola meal levels up to 5.0 ppm until their

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expiration date—in order to allow a flax, seed; fruit, citrus group 10; fruit, government and the States or tribal
reasonable interval for producers in pome, group 11; gold of pleasure, seed; governments, or on the distribution of
exporting member countries to adapt to grape; hare’s ear mustard, seed; power and responsibilities among the
the reduced tolerances. After that 6- lesquerella, seed; lunaria, seed; various levels of government or between
month period, those individual meadowfoam, seed; milkweed, seed; the Federal Government and Indian
tolerances will expire, and residues of mustard, seed; oil radish, seed; okra; Tribes. Thus, the Agency has
sethoxydim on juneberry, lingonberry, poppy, seed; rapeseed, seed; sesame, determined that Executive Order 13132,
and salal will need to comply with the seed; sunflower, seed; sweet rocket, entitled ‘‘Federalism’’ (64 FR 43255,
bushberry subgroup 13–07B tolerance, seed; vegetable, bulb group 3; and August 10, 1999) and Executive Order
which includes those commodities and vegetable, fruiting group 8. 13175, entitled ‘‘Consultation and
limits residues to 4.0 ppm. Finally, the individual tolerances for Coordination with Indian Tribal
juneberry, lingonberry, and salal at 5.0 Governments’’ (65 FR 67249, November
V. Conclusion ppm will expire 6 months from the date 9, 2000) do not apply to this action. In
Tolerances are established for the of publication of this final rule in the addition, this action does not impose
herbicide sethoxydim, including its Federal Register. any enforceable duty or contain any
metabolites and degradates, in or on the unfunded mandate as described under
commodities listed below. Compliance VI. Statutory and Executive Order
Reviews Title II of the Unfunded Mandates
with the tolerance levels specified Reform Act (UMRA) (2 U.S.C. 1501 et
below is to be determined by measuring This action establishes tolerances seq.).
only the sum of the herbicide 2-[1- under FFDCA section 408(d) in This action does not involve any
(ethoxyimino)butyl]-5-[2- response to a petition submitted to the technical standards that would require
(ethylthio)propyl]-3-hydroxy-2- Agency. The Office of Management and Agency consideration of voluntary
cyclohexen-1-one (CAS Reg. No. 74051– Budget (OMB) has exempted these types consensus standards pursuant to section
80–2) and its metabolites containing the of actions from review under Executive 12(d) of the National Technology
2-cyclohexen-1-one moiety, calculated Order 12866, entitled ‘‘Regulatory
Transfer and Advancement Act
as the stoichiometric equivalent of Planning and Review’’ (58 FR 51735,
(NTTAA) (15 U.S.C. 272 note).
sethoxydim, in or on commodities: October 4, 1993). Because this action
Berry, low growing, subgroup 13–07H, has been exempted from review under VII. Congressional Review Act
except strawberry at 2.5 ppm; borage, Executive Order 12866, this action is Pursuant to the Congressional Review
meal at 40 ppm; bushberry, subgroup not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will
13–07B at 4.0 ppm; calendula, meal at entitled ‘‘Actions Concerning submit a report containing this rule and
20 ppm; caneberry, subgroup 13–07A at Regulations That Significantly Affect other required information to the U.S.
5.0 ppm; castor oil plant, meal at 20 Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
ppm; Chinese tallowtree, meal at 20 FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller
ppm; cottonseed, subgroup 20C at 5.0 Order 13045, entitled ‘‘Protection of General of the United States prior to
ppm; cuphea, meal at 40 ppm; echium, Children from Environmental Health publication of the rule in the Federal
meal 40 ppm; euphorbia, meal at 20 Risks and Safety Risks’’ (62 FR 19885,
Register. This action is not a ‘‘major
ppm; evening primrose, meal at 20 ppm; April 23, 1997). This action does not
rule’’ as defined by 5 U.S.C. 804(2).
fescue, forage at 7.0 ppm; fescue, hay at contain any information collections
4.0 ppm; flax seed, meal at 40 ppm; subject to OMB approval under the List of Subjects in 40 CFR Part 180
fruit, citrus, group 10–10 at 0.5 ppm; Paperwork Reduction Act (PRA) (44 Environmental protection,
fruit, pome, group 11–10 at 0.2 ppm; U.S.C. 3501 et seq.), nor does it require Administrative practice and procedure,
fruit, small, vine climbing, subgroup any special considerations under Agricultural commodities, Pesticides
13–07F, except fuzzy kiwifruit at 1.0 Executive Order 12898, entitled and pests, Reporting and recordkeeping
ppm; hare’s ear mustard, meal at 40 ‘‘Federal Actions to Address requirements.
ppm; jojoba, meal at 20 ppm; Environmental Justice in Minority
lesquerella, meal at 40 ppm; lunaria, Populations and Low-Income Dated: June 4, 2015.
meal at 40 ppm; meadowfoam, meal at Populations’’ (59 FR 7629, February 16, Susan Lewis,
40 ppm; milkweed, meal at 40 ppm; 1994). Director, Registration Division, Office of
mustard, meal at 40 ppm; niger seed, Since tolerances and exemptions that Pesticide Programs.
meal at 20 ppm; oil radish, meal at 40 are established on the basis of a petition Therefore, 40 CFR chapter I is
ppm; poppy seed, meal at 40 ppm; under FFDCA section 408(d), such as amended as follows:
rapeseed, subgroup 20A at 35 ppm; rose the tolerances in this final rule, do not
hip, meal at 20 ppm; sesame, meal at 40 require the issuance of a proposed rule, PART 180—[AMENDED]
ppm; stokes aster, meal at 20 ppm; the requirements of the Regulatory
■ 1. The authority citation for part 180
sunflower subgroup 20B, except Flexibility Act (RFA) (5 U.S.C. 601 et
continues to read as follows:
safflower at 7.0 ppm; sweet rocket, meal seq.), do not apply.
at 40 ppm; tallowwood, meal at 20 ppm; This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371.
tea oil plant, meal at 20 ppm; vegetable, food processors, food handlers, and food ■ 2. § 180.412 is revised to read as
bulb, group 3–07 at 1.0 ppm; vegetable, retailers, not States or tribes, nor does follows:
fruiting, group 8–10 to 4.0 ppm; and this action alter the relationships or
vernonia, meal at 20 ppm. In addition, distribution of power and § 180.412 Sethoxydim; tolerances for
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upon establishment of the above responsibilities established by Congress residues.
tolerances, remove the following entries in the preemption provisions of FFDCA (a) Tolerances are established for the
that are superseded by this action section 408(n)(4). As such, the Agency herbicide sethoxydim, including its
including: Blueberry; borage, seed; has determined that this action will not metabolites and degradates, in or on the
caneberry subgroup 13A; canola, seed; have a substantial direct effect on States commodities in the table below.
cotton, undelinted seed; crambe, seed; or tribal governments, on the Compliance with the tolerance levels
cranberry; cuphea, seed; echium, seed; relationship between the national specified below is to be determined by

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34078 Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations

measuring only the sum of the herbicide Parts per Compliance with the tolerance levels
Commodity
2-[1-(ethoxyimino)butyl]-5-[2- illion specified below is to be determined by
(ethylthio)propyl]-3-hydroxy-2- measuring only the sum of the herbicide
cyclohexen-1-one (CAS Reg. No. 74051– Horse, meat byproducts ............... 1.0
2-[1-(ethoxyimino)butyl]-5-[2-
80–2) and its metabolites containing the Jojoba, meal ................................. 20
Juneberry 1 .................................... 5.0 (ethylthio)propyl]-3-hydroxy-2-
2-cyclohexen-1-one moiety, calculated Lesquerella, meal ......................... 40 cyclohexen-1-one) and its metabolites
as the stoichiometric equivalent of Lingonberry 1 ................................. 5.0 containing the 2-cyclohexen-1-one
sethoxydim, in or on the commodity. Lunaria, meal ................................ 40 moiety, calculated as the stoichiometric
Meadowfoam, meal ...................... 40 equivalent of sethoxydim, in or on the
Parts per Milk ............................................... 0.5
Commodity illion commodity.
Milkweed, meal ............................. 40
Mustard, meal ............................... 40
Alfalfa, forage ............................... 40 Parts per
Nectarine ...................................... 0.2 Commodity
Alfalfa, hay .................................... 40 million
Niger seed, meal .......................... 20
Almond, hulls ................................ 2.0 Nut, tree, group 14 ....................... 0.2
Apricot ........................................... 0.2 Artichoke, globe ............................ 5.0
Oil radish, meal ............................ 40
Apple, wet pomace ....................... 0.8 Fescue, forage .............................. 7.0
Pea and bean, dried shelled, ex-
Asparagus ..................................... 4.0 cept soybean, subgroup 6C ...... 25 Fescue, hay .................................. 4.0
Bean, succulent ............................ 15 Pea, field, hay ............................... 40 Rhubarb ........................................ 0.3
Beet, sugar, molasses .................. 10 Pea, field, vines ............................ 20
Beet, sugar, tops .......................... 3.0 Pea, succulent .............................. 10
Berry, low growing, subgroup 13– (d) Indirect and inadvertent residues.
Peach ............................................ 0.2 [Reserved]
07H, except strawberry ............. 2.5 Peanut .......................................... 25
Borage, meal ................................ 40 Peppermint, tops .......................... 30 [FR Doc. 2015–14642 Filed 6–12–15; 8:45 am]
Buckwheat, flour ........................... 25 Pistachio ....................................... 0.2 BILLING CODE 6560–50–P
Buckwheat, grain .......................... 19 Poppy seed, meal ......................... 40
Bushberry subgroup 13–07B ........ 4.0 Potato granules/flakes .................. 8.0
Calendula, meal ............................ 20 Potato waste, processed .............. 8.0
Caneberry subgroup 13–07A ....... 5.0 Poultry, fat .................................... 0.2
Canola, meal ................................ 40 DEPARTMENT OF DEFENSE
Poultry, meat ................................ 0.2
Castor oil plant, meal ................... 20 Poultry, meat byproducts .............. 2.0
Cattle, fat ...................................... 0.2 Radish, tops .................................. 4.5 Defense Acquisition Regulations
Cattle, meat .................................. 0.2 Rapeseed, meal ........................... 40 System
Cattle, meat byproducts ............... 1.0 Rapeseed subgroup 20A .............. 35
Cherry, sweet ............................... 0.2 Rose hip, meal ............................. 20 48 CFR Part 216
Cherry, tart .................................... 0.2 Safflower, seed ............................. 15
Chinese tallowtree, meal .............. 20 Salal 1 ............................................ 5.0
Citrus, dried pulp .......................... 1.5
Types of Contracts
Sesame, meal ............................... 40
Clover, forage ............................... 35 Sheep, fat ..................................... 0.2 CFR Correction
Clover, hay ................................... 55 Sheep, meat ................................. 0.2
Coriander, leaves ......................... 4.0 Sheep, meat byproducts .............. 1.0 In Title 48 of the Code of Federal
Corn, field, forage ......................... 2.0 Soybean, hay ................................ 10 Regulations, Chapter 2, Parts 200 to 299,
Corn, field, grain ........................... 0.5 Soybean, seed .............................. 16
Corn, field, stover ......................... 2.5 revised as of October 1, 2014, on page
Spearmint, tops ............................ 30 111, redesignate section 216.405–270 as
Corn, sweet, forage ...................... 3.0 Strawberry .................................... 10
Corn, sweet, kernel plus cob with Stokes aster, meal ........................ 20
section 216.405–2–70.
husk removed ........................... 0.4 Sunflower, meal ............................ 20 [FR Doc. 2015–14527 Filed 6–12–15; 8:45 am]
Corn, sweet, stover ...................... 3.5 Sunflower subgroup 20B, except BILLING CODE 1505–01–D
Cottonseed subgroup 20C ........... 5.0 safflower .................................... 7.0
Cowpea, forage ............................ 15 Sweet rocket, meal ....................... 40
Cowpea, hay ................................. 50 Tallowwood, meal ......................... 20
Crambe, meal ............................... 40 DEPARTMENT OF DEFENSE
Tea oil plant, meal ........................ 20
Cuphea, meal ............................... 40 Turnip, tops ................................... 5.0
Dillweed, fresh leaves .................. 10 Defense Acquisition Regulations
Vegetable, brassica, leafy, group
Echium, meal ................................ 40 5 ................................................ 5.0 System
Egg ............................................... 2.0 Vegetable, bulb, group 3–07 ........ 1.0
Euphorbia, meal ........................... 20 Vegetable, cucurbit, group 9 ........ 4.0 48 CFR Part 217
Evening primrose, meal ................ 20 Vegetable, fruiting, group 8–10 .... 4.0
Flax seed, meal ............................ 40 Vegetable, leafy, except brassica, Special Contracting Methods
Fruit, citrus, group 10–10 ............. 0.5 group 4 ...................................... 4.0
Fruit, pome, group 11–10 ............. 0.2 Vegetable, root and tuber, group CFR Correction
Fruit, small, vine climbing, except 1 ................................................ 4.0
fuzzy kiwifruit, subgroup 13– Vernonia, meal ............................. 20 In Title 48 of the Code of Federal
07F ............................................ 1.0 Regulations, Chapter 2, Parts 200 to 299,
Goat, fat ........................................ 0.2 1 Theindividual tolerances for Juneberry,
Goat, meat .................................... 0.2 Lingonberry, and Salal expire on December revised as of October 1, 2014, on page
Goat, meat byproducts ................. 1.0 15, 2015. 117, in section 217.171, redesignate
wreier-aviles on DSK5TPTVN1PROD with RULES

Gold of pleasure, meal ................. 40 paragraph (c)(2)(C)(2) as paragraph
(b) Section 18 emergency exemptions.
Grape, raisin ................................. 2.0
[Reserved] (c)(2)(i).
Hare’s ear mustard, meal ............. 40 [FR Doc. 2015–14528 Filed 6–12–15; 8:45 am]
Hog, fat ......................................... 0.2 (c) Tolerances with regional
Hog, meat ..................................... 0.2 registration. Tolerances are established BILLING CODE 1505–01–D

Hog, meat byproducts .................. 1.0 for the herbicide sethoxydim, including
Horse, fat ...................................... 0.2 its metabolites and degradates, in or on
Horse, meat .................................. 0.2 the commodities in the table below.

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Document Created: 2015-12-15 15:13:25
Document Modified: 2015-12-15 15:13:25
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 34070
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements