[Federal Register Volume 80, Number 114 (Monday, June 15, 2015)]
[Rules and Regulations]
[Pages 34070-34078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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commodities identified later in this document that are superseded by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).
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Cancer (oral, dermal, inhalation) ``Not Likely to Be Carcinogenic to Humans'' based on the lack of evidence of
carcinogenicity in rats and mice.
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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