Sethoxydim; Pesticide Tolerances, 34070-34078 [2015-14642]
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Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Pesticide chemical
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0161; FRL–9928–20]
Sethoxydim; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
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Solvent.
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Dated: June 5, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
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Limits
Uses
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Solvent.
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2. In § 180.910, add alphabetically the
inert ingredient to the table to read as
follows:
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§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
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4. In § 180.940(a), add alphabetically
the inert ingredient to the table to read
as follows:
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§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
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(a) * * *
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Limits
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When ready for use, the end-use concentration is not to exceed 15,000 ppm.
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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).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0161, is
available at https://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
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Di-n-butyl carbonate (CAS
Reg. No. 542–52–9).
Authority: 21 U.S.C. 321(q), 346a and 371.
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
1. The authority citation for part 180
continues to read as follows:
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3. In § 180.930, add alphabetically the
inert ingredient to the table to read as
follows:
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Inert ingredients
PART 180—[AMENDED]
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Therefore, 40 CFR chapter I is
amended as follows:
ADDRESSES:
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
SUMMARY:
Uses
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Di-n-butyl carbonate (CAS
Reg. No. 542–52–9).
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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[FR Doc. 2015–14647 Filed 6–12–15; 8:45 am]
Limits
List of Subjects in 40 CFR Part 180
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542–52–9
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Inert ingredients
CAS Reg. No.
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Di-n-butyl carbonate ..................................
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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).
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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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0161 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before August 14, 2015. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0161, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://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-2cyclohexen-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, https://
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
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levels, setting meal tolerances for
various oilseed crop subgroups to cover
potential processed commodities, and
updating crop definitions as well as the
tolerance expression for sethoxydim to
conform to current EPA policies. The
reasons for these changes are explained
in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue . . . . ’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for sethoxydim
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with sethoxydim follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Toxicological tests in animals (rats,
mice, and dog) show that the target
organ of sethodydim toxicity is the liver.
Toxic effects are characterized by
increased liver weight; hypertrophy;
fatty degeneration; hepatocyte swelling;
increased serum bilirubin, alkaline
phosphatase, aspartate
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aminotransferase, and alanine
aminotransferase levels; focal
granulomatous inflammation; and
eosinophilic foci. Liver toxicity was
observed by exposure through both the
oral and inhalation routes.
Findings other than liver toxicity
were also observed. In a subchronic rat
study, decreased body weight, body
weight gain, and food efficiency were
noted at a lower dose than liver toxicity.
In a chronic dog toxicity study,
increased hemosiderosis in the spleen
and depressed myeloid erythropoiesis
in the sternal bone marrow were
observed. Interstitial fibrosis and heart
failure cells in lung in female rats were
observed in the chronic toxicity/
carcinogenicity study in rats.
In the developmental rat study,
maternal toxicity was observed, as
evidenced by an irregular gait,
decreased activity, excessive salivation,
and anogenital staining at a dose greater
than half the limit dose and at the limit
dose. All clinical signs reported were
transient, with the exception of the
anogenital staining, which did not
reverse.
Developmental toxicity occurred at
the same dose as maternal toxicity in
rats and included decreased fetal
weights, filamentous tail, and lack of
tail due to the absence of sacral and/or
caudal vertebrae, and delayed
ossification in the hyoids, vertebral
centrum and/or transverse processes,
sternebrae and/or metatarsals, and
pubes. No maternal toxicity was noted
in rabbits at 400 milligrams per
kilogram (mg/kg)/day, and
developmental toxicity was noted at 400
mg/kg/day (NOAEL = 320 mg/kg/day) as
an increase in the incidence of
incompletely ossified 6th sternebrae. In
the reproduction study, no parental or
reproductive toxicity was observed at
150 mg/kg/day (highest dose tested), but
offspring toxicity was noted at this dose
as decreased pup weight in the F1a, F1b,
and F2b generation during lactation (noobserved-adverse-effect-level (NOAEL)
= 30 mg/kg/day). There is a low concern
for these findings, since the selected
points of departure are protective; there
is low concern for pre- and/or postnatal
toxicity resulting from exposure to
sethoxydim.
Dermal toxicity was not observed at
the limit dose in a 21-day dermal study
in rabbits. Based on the lack of
sensitization in treated guinea pigs,
sethoxydim is not a skin sensitizer. No
eye or dermal irritation were noted in
rabbits. No neurotoxicity or other
toxicity was observed at the highest
dose tested (207 mg/kg/day) in the
subchronic neurotoxicity test in rats.
There was no evidence of
carcinogenicity in rats and mice, and no
evidence of genotoxicity. Sethoxydim is
classified as ‘‘Not Likely to Be
Carcinogenic to Humans.’’ Specific
information on the studies received and
the nature of the adverse effects caused
by sethoxydim, as well as the NOAEL
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies,
can be found at https://
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 https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for sethoxydim used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SETHOXYDIM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (females 13–49
years of age).
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Acute dietary (general population including infants and
children).
Chronic dietary (all populations)
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Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL = 180 mg/
kg/day.
UFA = 10x ................
UFH = 10x ................
FQPA SF =1x ..........
NOAEL = 180 mg/
kg/day.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1x .........
NOAEL = 14 mg/kg/
day.
UFA = 10x ................
UFH =10x .................
FQPA SF =1x ..........
Acute RfD = aPAD =
1.8 mg/kg/day.
Rat Developmental Toxicity
Developmental LOAEL = 650 mg/kg/day based on decreased
fetal body weight, tail abnormalities, and delayed ossification
Tail abnormalities were considered an acute effect.
Acute RfD = aPAD =
1.8 mg/kg/day.
Rat Developmental Toxicity
Maternal LOAEL = 650 mg/kg/day based on irregular gait that
was observed in 12/34 dams on the first day of dosing.
Chronic RfD = cPAD
= 0.14 mg/kg/day.
Mouse Carcinogenicity Study
LOAEL = 41 mg/kg/day based on liver hypertrophy and fatty
degeneration.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SETHOXYDIM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Incidental oral short-term (1 to
30 days).
Short- and Intermediate term
Inhalation.
Cancer (oral, dermal, inhalation).
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL = 180 mg/
kg/day.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1x .........
Inhalation study
NOAEL = 0.3 mg/
L.
UFA = 3x ..................
UFH = 10x ................
FQPA SF = 1x .........
HEC = 0.932 mg/L/
day (residential
handler).
HED = 26.7 mg/kg/
day (residential
handler) or 39.8–
138.9 mg/kg/day
(occupational handler).
Residential LOC for
MOE = 100.
Rat Developmental Toxicity
Maternal LOAEL = 650 mg/kg/day based on irregular gait, decreased activity, excessive salivation, and anogenital staining.
Residential LOC for
MOE = 30.
Occupational LOC
for MOE = 30.
Rat 28-day Inhalation Study
LOAEL = 2.4 mg/L based on increased liver weight, increased
total serum bilirubin, and increased incidence of slight
centrilobular hepatocyte swelling.
‘‘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
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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
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been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area. In addition, the
Agency must provide for periodic
evaluation of any estimates used. To
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provide for the periodic evaluation of
the estimate of PCT as required by
FFDCA section 408(b)(2)(F), EPA may
require registrants to submit data on
PCT.
The Agency estimated the PCT for
existing uses. For acute dietary risk
assessment for sethoxydim the
following maximum PCT estimates were
used: Alfalfa 2.5%; almonds 5%; apples
2.5%; apricots 10%; artichokes 2.5%;
asparagus 10%; beans, green 15%;
blueberries 10%; broccoli 5%; cabbage
10%; caneberries 10%; canola 2.5%;
cantaloupes 25%; carrots 5%;
cauliflower 10%; celery 2.5%; cherries
2.5%; corn 2.5%; cotton 2.5%;
cucumbers 10%; dry beans/peas 35%;
eggplant 10%; fallow 2.5%; garlic 5%;
grapefruit 2.5%; grapes 5%; hazelnuts
2.5%; lettuce 10%; oats 2.5%; onions
15%; oranges 5%; peaches 2.5%;
peanuts 10%; pears 2.5%; peas, green
15%; pecans 2.5%; peppers 15%;
pistachios 2.5%; plums/prunes 2.5%;
potatoes 5%; pumpkins 10%; soybeans
2.5%; spinach 2.5%; squash 10%;
strawberries 10%; sugar beets 5%;
sunflowers 10%; sweet corn 5%;
tobacco 10%; tomatoes 5%; walnuts
5%; watermelons 20%; wheat 2.5%.
For chronic dietary risk assessment,
the following average PCT estimates for
sethoxydim were used: Alfalfa 1%;
almonds 2.5%; apples 1%; apricots
2.5%; artichokes 2.5%; asparagus 5%;
beans, green 10%; blueberries 5%;
broccoli 2.5%; cabbage 5%; caneberries
5%; canola 2.5%; cantaloupes 5%;
carrots 2.5%; cauliflower 5%; celery
2.5%; cherries 2.5%; corn 1%; cotton
1%; cucumbers 5%; dry beans/peas
30%; eggplant 5%; fallow 1%; garlic
2.5%; grapefruit 2.5%; grapes 2.5%;
hazelnuts 2.5%; lettuce 2.5%; oats 1%;
onions 5%; oranges 2.5%; peaches 1%;
peanuts 5%; pears 2.5%; peas, green
5%; pecans 2.5%; peppers 5%;
pistachios 1%; plums/prunes 1%;
potatoes 2.5%; pumpkins 5%; soybeans
1%; spinach 2.5%; squash 5%;
strawberries 2.5%; sugar beets 2.5%;
sunflowers 5%; sweet corn 2.5%;
tobacco 5%; tomatoes 2.5%; walnuts
2.5%; watermelons 10%; wheat 1%.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
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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
https://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.
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For chronic exposures for non-cancer
assessments are estimated to be 13.9
ppb for surface water and 0.51 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
For acute dietary risk assessment, the
water concentration value of 79.6 ppb
was used to assess the contribution to
drinking water.
For chronic dietary risk assessment,
the water concentration of value 13.9
ppb was used to assess the contribution
to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Sethoxydim is currently registered for
the following uses that could result in
residential exposures: Turf (including
lawns, golf courses, recreational parks,
and sod farms) and ornamentals. Shortterm exposure to sethoxydim may occur
via the dermal and inhalation routes for
adults using sethoxydim products in
residential settings. Since no dermal
hazard was identified, only inhalation
exposures were assessed for residential
applicators. In addition, children may
potentially be exposed orally in postapplication turf scenarios. Intermediateor long-term exposures are not expected
due to the intermittent nature of
applications by homeowners.
EPA assessed residential exposure
using the following assumptions: Since
no dermal hazard was identified in the
toxicity database for sethoxydim, a
quantitative residential post-application
dermal risk assessment is not required
and was not completed. Postapplication inhalation exposures while
performing activities in previously
treated turf or ornamentals are not
expected, primarily due to the very low
vapor pressure (1.6 × 10¥7 mm Hg at 25
°C) and the expected dilution in outdoor
air after an application has occurred.
Therefore, post-application inhalation
exposures were not assessed. The
residential post-application assessment
considers non-dietary incidental oral
exposures only. Residential postapplication exposures are generally
considered to be intermittent and shortterm in duration.
For the residential turf use scenario,
post-application incidental oral
exposure is assessed for children (1 to
< 2 years old as the sentinel
population). The turf use site assessed
was residential lawn turf as exposures
from that use are expected to be higher
than any potential exposures from other
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turf uses (i.e., recreational parks, golf
courses, or treated sod). The assessment
was conducted assuming the maximum
application rate (0.47 lbs ai/acre) and
used unit exposure values and estimates
for area treated or amount handled.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://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
https://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
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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
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underestimate the exposure and risks
posed by sethoxydim.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. Using the exposure assumptions
described in this unit for acute
exposure, acute dietary risk estimates
for the registered and proposed uses of
sethoxydim will occupy 5.4% of the
aPAD for the general U.S. population.
The risk estimate for the most highly
exposed subgroup, children 1–2 year
old, was 8.6% of the aPAD.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to sethoxydim
from food and water will utilize 27% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of sethoxydim is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Sethoxydim is currently registered for
uses that could result in short-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to sethoxydim. The shortterm aggregate assessment for children
1–2 years old, the most exposed
subpopulation group, includes postapplication oral residential exposures
from treated turf and chronic dietary
exposure.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 4,000 that are below the EPA’s
level of concern for sethoxydim.
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4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Because there is no intermediate-term
exposure, sethoxydim is not expected to
pose an intermediate-term risk.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
sethoxydim is not expected to pose a
cancer risk to humans.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to sethoxydim
residues.
IV. Other Considerations
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A. Analytical Enforcement Methodology
An adequate gas chromatography/
flame photometric detection GC/FPD
method is available (Method I in PAM
Vol. II) for determining the combined
residues of sethoxydim and its
metabolites containing the 3-alkyl
substituted pentanedioic acid moiety in
plant and livestock commodities which
provides a 0.05 ppm limit of
quantitation (LOQ).
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
There are no Codex MRLs established
for the residues of sethoxydim in/on
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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
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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-2cyclohexen-1-one (CAS Reg. No. 74051–
80–2) and its metabolites containing the
2-cyclohexen-1-one moiety, calculated
as the stoichiometric equivalent of
sethoxydim, in or on the commodities
listed in the subsections.
E. Trade Considerations
Establishing a tolerance at 4.0 ppm for
the expanded crop subgroup 13–07B
results in reductions of the existing
sethoxydim tolerance level for
juneberry, lingonberry, and salal, which
are each set individually at 5.0 ppm. In
order to allow a reasonable interval for
producers in the exporting member
countries of the World Trade
Organization’s Sanitary and
Phytosanitary Measures Agreement to
adapt to the requirements of these
modified tolerances, EPA is establishing
an expiration date for those higher
individual tolerances (for juneberry,
lingonberry, and salal) of December 15,
2015. Those tolerances will remain in
place for six months after the
publication of this rule—and residues of
sethoxydim may be present on
juneberry, lingonberry, and salal at
levels up to 5.0 ppm until their
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expiration date—in order to allow a
reasonable interval for producers in
exporting member countries to adapt to
the reduced tolerances. After that 6month 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-2cyclohexen-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;
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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
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34077
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 4, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. § 180.412 is revised to read as
follows:
■
§ 180.412 Sethoxydim; tolerances for
residues.
(a) Tolerances are established for the
herbicide sethoxydim, including its
metabolites and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
E:\FR\FM\15JNR1.SGM
15JNR1
34078
Federal Register / Vol. 80, No. 114 / Monday, June 15, 2015 / Rules and Regulations
measuring only the sum of the herbicide
2-[1-(ethoxyimino)butyl]-5-[2(ethylthio)propyl]-3-hydroxy-2cyclohexen-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
illion
wreier-aviles on DSK5TPTVN1PROD with RULES
Commodity
Alfalfa, forage ...............................
Alfalfa, hay ....................................
Almond, hulls ................................
Apricot ...........................................
Apple, wet pomace .......................
Asparagus .....................................
Bean, succulent ............................
Beet, sugar, molasses ..................
Beet, sugar, tops ..........................
Berry, low growing, subgroup 13–
07H, except strawberry .............
Borage, meal ................................
Buckwheat, flour ...........................
Buckwheat, grain ..........................
Bushberry subgroup 13–07B ........
Calendula, meal ............................
Caneberry subgroup 13–07A .......
Canola, meal ................................
Castor oil plant, meal ...................
Cattle, fat ......................................
Cattle, meat ..................................
Cattle, meat byproducts ...............
Cherry, sweet ...............................
Cherry, tart ....................................
Chinese tallowtree, meal ..............
Citrus, dried pulp ..........................
Clover, forage ...............................
Clover, hay ...................................
Coriander, leaves .........................
Corn, field, forage .........................
Corn, field, grain ...........................
Corn, field, stover .........................
Corn, sweet, forage ......................
Corn, sweet, kernel plus cob with
husk removed ...........................
Corn, sweet, stover ......................
Cottonseed subgroup 20C ...........
Cowpea, forage ............................
Cowpea, hay .................................
Crambe, meal ...............................
Cuphea, meal ...............................
Dillweed, fresh leaves ..................
Echium, meal ................................
Egg ...............................................
Euphorbia, meal ...........................
Evening primrose, meal ................
Flax seed, meal ............................
Fruit, citrus, group 10–10 .............
Fruit, pome, group 11–10 .............
Fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13–
07F ............................................
Goat, fat ........................................
Goat, meat ....................................
Goat, meat byproducts .................
Gold of pleasure, meal .................
Grape, raisin .................................
Hare’s ear mustard, meal .............
Hog, fat .........................................
Hog, meat .....................................
Hog, meat byproducts ..................
Horse, fat ......................................
Horse, meat ..................................
VerDate Sep<11>2014
15:17 Jun 12, 2015
Jkt 235001
40
40
2.0
0.2
0.8
4.0
15
10
3.0
2.5
40
25
19
4.0
20
5.0
40
20
0.2
0.2
1.0
0.2
0.2
20
1.5
35
55
4.0
2.0
0.5
2.5
3.0
0.4
3.5
5.0
15
50
40
40
10
40
2.0
20
20
40
0.5
0.2
1.0
0.2
0.2
1.0
40
2.0
40
0.2
0.2
1.0
0.2
0.2
Parts per
illion
Commodity
Horse, meat byproducts ...............
Jojoba, meal .................................
Juneberry 1 ....................................
Lesquerella, meal .........................
Lingonberry 1 .................................
Lunaria, meal ................................
Meadowfoam, meal ......................
Milk ...............................................
Milkweed, meal .............................
Mustard, meal ...............................
Nectarine ......................................
Niger seed, meal ..........................
Nut, tree, group 14 .......................
Oil radish, meal ............................
Pea and bean, dried shelled, except soybean, subgroup 6C ......
Pea, field, hay ...............................
Pea, field, vines ............................
Pea, succulent ..............................
Peach ............................................
Peanut ..........................................
Peppermint, tops ..........................
Pistachio .......................................
Poppy seed, meal .........................
Potato granules/flakes ..................
Potato waste, processed ..............
Poultry, fat ....................................
Poultry, meat ................................
Poultry, meat byproducts ..............
Radish, tops ..................................
Rapeseed, meal ...........................
Rapeseed subgroup 20A ..............
Rose hip, meal .............................
Safflower, seed .............................
Salal 1 ............................................
Sesame, meal ...............................
Sheep, fat .....................................
Sheep, meat .................................
Sheep, meat byproducts ..............
Soybean, hay ................................
Soybean, seed ..............................
Spearmint, tops ............................
Strawberry ....................................
Stokes aster, meal ........................
Sunflower, meal ............................
Sunflower subgroup 20B, except
safflower ....................................
Sweet rocket, meal .......................
Tallowwood, meal .........................
Tea oil plant, meal ........................
Turnip, tops ...................................
Vegetable, brassica, leafy, group
5 ................................................
Vegetable, bulb, group 3–07 ........
Vegetable, cucurbit, group 9 ........
Vegetable, fruiting, group 8–10 ....
Vegetable, leafy, except brassica,
group 4 ......................................
Vegetable, root and tuber, group
1 ................................................
Vernonia, meal .............................
1.0
20
5.0
40
5.0
40
40
0.5
40
40
0.2
20
0.2
40
25
40
20
10
0.2
25
30
0.2
40
8.0
8.0
0.2
0.2
2.0
4.5
40
35
20
15
5.0
40
0.2
0.2
1.0
10
16
30
10
20
20
5.0
1.0
4.0
4.0
4.0
20
(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.
Fmt 4700
Sfmt 9990
Parts per
million
Artichoke, globe ............................
Fescue, forage ..............................
Fescue, hay ..................................
Rhubarb ........................................
5.0
7.0
4.0
0.3
(d) Indirect and inadvertent residues.
[Reserved]
[FR Doc. 2015–14642 Filed 6–12–15; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 216
Types of Contracts
CFR Correction
In Title 48 of the Code of Federal
Regulations, Chapter 2, Parts 200 to 299,
revised as of October 1, 2014, on page
111, redesignate section 216.405–270 as
section 216.405–2–70.
[FR Doc. 2015–14527 Filed 6–12–15; 8:45 am]
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 217
Special Contracting Methods
4.0
individual tolerances for Juneberry,
Lingonberry, and Salal expire on December
15, 2015.
Frm 00056
Commodity
BILLING CODE 1505–01–D
7.0
40
20
20
5.0
1 The
PO 00000
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-2cyclohexen-1-one) and its metabolites
containing the 2-cyclohexen-1-one
moiety, calculated as the stoichiometric
equivalent of sethoxydim, in or on the
commodity.
CFR Correction
In Title 48 of the Code of Federal
Regulations, Chapter 2, Parts 200 to 299,
revised as of October 1, 2014, on page
117, in section 217.171, redesignate
paragraph (c)(2)(C)(2) as paragraph
(c)(2)(i).
[FR Doc. 2015–14528 Filed 6–12–15; 8:45 am]
BILLING CODE 1505–01–D
E:\FR\FM\15JNR1.SGM
15JNR1
Agencies
[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]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0161; FRL-9928-20]
Sethoxydim; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
sethoxydim in or on multiple commodities that are identified and
discussed later in this document. In addition, this regulation removes
existing tolerances for residues of sethoxydim in or on several
commodities identified later in this document that are superseded by
this action. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective June 15, 2015. Objections and
requests for hearings must be received on or before August 14, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0161, is available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
[[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 https://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: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://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, https://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 https://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 https://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
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
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 https://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 https://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 https://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:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no Codex MRLs established for the residues of sethoxydim
in/on raw agricultural or processed commodities.
C. Response to Comments
One comment was received from a private citizen objecting to
establishment of petitioned-for tolerances for residues of sethoxydim
and a number of other pesticides on food items as these are ``dangerous
chemicals'' and children are disproportionately exposed to health risks
from their use. In addition, the commenter expressed concern about the
potential for increased cancer rates in children due to pesticide
exposures. The Agency understands the commenters' concerns regarding
chemicals and their potential effects on humans. Pursuant to its
authority under the FFDCA, and as discussed further in this preamble,
EPA conducted a comprehensive assessment of sethoxydim, which included
an assessment on the carcinogenic potential of sethoxydim. Based on its
assessment of the available data, EPA has found that there is a
reasonable certainty of no harm to humans, with special emphases on
infants and children sensitivity, from aggregate exposure to sethoxydim
based on a complete toxicological database and the potential exposure
levels.
D. Revisions to Petitioned-For Tolerances
The tolerance for the bushberry subgroup 13-07B is based on the
residue data on blueberry, the representative crop at 4.0 ppm and not
the previously established tolerances for juneberry, lingonberry, and
salal at 5.0 ppm. The juneberry, lingonberry, and salal tolerances were
based on the translation of caneberry data, which are no longer
relevant to these crops following updated crop grouping realignment.
Moreover, EPA has determined that available data support a reduction in
sethoxydim residue tolerance level for these crops from 5.0 ppm to 4.0
ppm.
Based on available data and the application of the OECD calculation
procedures, EPA is establishing a tolerance of 7.0 ppm for fescue,
forage, rather than 6.0 ppm as requested by the petitioner. This
difference stems from the conclusion that only 4 independent grass
trials were conducted instead of 5 (as assumed by IR-4).
In addition, for the requested rapeseed subgroup 20A and sunflower
subgroup 20B crop group conversions, each RAC could potentially be
processed into meal. Therefore, following the established meal
tolerance of the representative crop, canola meal at 40 ppm for
subgroup 20A and sunflower meal at 20 ppm for subgroup 20B, tolerances
for the residues of sethoxydim are also required for translation to the
following commodities: Calendula, meal at 20 ppm; castor oil plant,
meal at 20 ppm; Chinese tallowtree, meal at 20 ppm; cuphea, meal at 40
ppm; echium, meal 40 ppm; euphoriba, meal at 20 ppm; evening primrose,
meal at 20 ppm; flax seed, meal at 40 ppm; hare's ear mustard, meal at
40 ppm; jojoba, meal at 20 ppm; lesquerella, meal at 40 ppm; lunaria,
meal at 40 ppm; meadowfoam, meal at 40 ppm; milkweed, meal at 40 ppm;
mustard, meal at 40 ppm; niger seed, meal at 20 ppm; oil radish, meal
at 40 ppm; poppy seed, meal at 40 ppm; rose hip, meal at 20 ppm;
sesame, meal at 40 ppm; stokes aster, meal at 20 ppm; sweet rocket,
meal at 40 ppm; tallowwood, meal at 20 ppm; tea oil plant, meal at 20
ppm; and vernonia, meal at 20 ppm. Additionally, an existing borage,
meal tolerance at 10 ppm is being raised to 40 ppm.
Lastly, the Agency is updating the tolerance expressions for
sethoxydim as follows to reflect current EPA policies: Tolerances are
established for the herbicide sethoxydim, including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels specified below is to be determined by
measuring only the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-
2) and its metabolites containing the 2-cyclohexen-1-one moiety,
calculated as the stoichiometric equivalent of sethoxydim, in or on the
commodities listed in the subsections.
E. Trade Considerations
Establishing a tolerance at 4.0 ppm for the expanded crop subgroup
13-07B results in reductions of the existing sethoxydim tolerance level
for juneberry, lingonberry, and salal, which are each set individually
at 5.0 ppm. In order to allow a reasonable interval for producers in
the exporting member countries of the World Trade Organization's
Sanitary and Phytosanitary Measures Agreement to adapt to the
requirements of these modified tolerances, EPA is establishing an
expiration date for those higher individual tolerances (for juneberry,
lingonberry, and salal) of December 15, 2015. Those tolerances will
remain in place for six months after the publication of this rule--and
residues of sethoxydim may be present on juneberry, lingonberry, and
salal at levels up to 5.0 ppm until their
[[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