Thiencarbazone-methyl; Pesticide Tolerance, 29028-29033 [2018-13453]
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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations
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).
i. Add alphabetically the entries
‘‘Alfalfa, forage’’; ‘‘Alfalfa, hay’’; ‘‘Cattle,
fat’’; ‘‘Cattle, kidney’’; ‘‘Cattle, meat’’;
‘‘Cattle, meat byproducts, except
kidney’’; ‘‘Goat, fat’’; ‘‘Goat, kidney’’;
‘‘Goat, meat’’; ‘‘Goat, meat byproducts,
except kidney’’; ‘‘Hog, kidney’’; ‘‘Horse,
fat’’; ‘‘Horse, kidney’’; ‘‘Horse, meat’’;
‘‘Horse, meat byproducts, except
kidney’’; ‘‘Milk’’; ‘‘Sheep, fat’’; ‘‘Sheep,
kidney’’; ‘‘Sheep, meat‘‘; ‘‘Sheep, meat
byproducts, except kidney’’; to the table
in paragraph (a) and
■ ii. Revise the commodities ‘‘Animal
feed, nongrass, group 18, except alfalfa,
forage’’, and ‘‘Animal feed, nongrass,
group 18, except alfalfa, hay’’ in the
table in paragraph (d).
The additions and revisions read as
follows:
■
§ 180.470 Acetochlor; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
Alfalfa, forage .......................
Alfalfa, hay ............................
*
Cattle,
Cattle,
Cattle,
Cattle,
cept
8.0
20
*
*
fat ..............................
kidney ........................
meat ..........................
meat byproducts, exkidney ........................
*
*
*
*
Goat, fat ................................
Goat, kidney .........................
Goat, meat ............................
Goat, meat byproducts, except kidney ........................
Hog, kidney ...........................
Horse, fat ..............................
Horse, kidney ........................
Horse, meat ..........................
Horse, meat byproducts, except kidney ........................
Milk .......................................
*
*
*
*
Sheep, fat .............................
Sheep, kidney .......................
Sheep, meat .........................
Sheep, meat byproducts, except kidney ........................
*
*
0.02
0.03
0.02
0.02
*
0.02
0.03
0.02
0.02
0.02
0.02
0.03
0.02
0.02
0.02
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 5, 2018.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
*
*
*
*
(d) * * *
Therefore, 40 CFR chapter I is
amended as follows:
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*
*
*
0.02
*
*
*
Parts per
million
Commodity
PART 180—[AMENDED]
*
0.02
0.03
0.02
Animal feed, nongrass, group
18, except alfalfa, forage ..
Animal feed, nongrass, group
18, except alfalfa, hay .......
1. The authority citation for part 180
continues to read as follows:
■
1.3
3.5
Authority: 21 U.S.C. 321(q), 346a and 371.
■
*
2. In § 180.470,
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[FR Doc. 2018–13459 Filed 6–21–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0448; FRL–9978–50]
Thiencarbazone-methyl; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of thiencarbazonemethyl in or on wheat forage. Bayer
CropScience requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective June
22, 2018. Objections and requests for
hearings must be received on or before
August 21, 2018, 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–2017–0448, 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:
Michael L. Goodis, 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:
SUMMARY:
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
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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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2017–0448 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 21, 2018. 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–
2017–0448, 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/
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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.
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 thiencarbazonemethyl including exposure resulting
from the tolerances established by this
action. EPA’s assessment of exposures
and risks associated with
thiencarbazone-methyl follows.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of March 6,
2018 (83 FR 9471) (FRL–9973–27), 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 7F8583) by Bayer
CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709. The
petition requested that the existing
wheat, forage tolerance in 40 CFR
180.645 for residues of the herbicide
thiencarbazone-methyl, methyl 4-[[[(4,5dihydro-3-methoxy-4-methyl-5-oxo-1H–
1,2,4-triazol-1-yl)carbonyl]
amino]sulfonyl]-5-methyl-3thiophenecarboxylate, be amended from
0.10 parts per million (ppm) to 0.15
ppm. That document referenced a
summary of the petition prepared by
Bayer CropScience, the registrant,
which is available in the docket, https://
www.regulations.gov. No comments
related to this tolerance action were
received on the notice of filing.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Thiencarbazone-methyl has low acute
toxicity via the oral, dermal, and
inhalation routes of exposure.
Thiencarbazone-methyl is not an eye
nor a skin irritant and it is not a skin
sensitizer.
The most toxicologically significant
effect of thiencarbazone-methyl occurs
in the urothelial system including the
kidney, bladder, and urinary tract.
Across species, the dog is more sensitive
than the rat or the mouse. Common
effects observed throughout the database
included sulfonamide crystals in the
urine, eosinophilic urolithiasis (kidney,
ureter and bladder stones), pelvic
dilation, thickening of the kidney,
bladder, or ureter, collecting duct
hyperplasia, urothelial hyperplasia,
submucosal inflammatory cell
infiltration, bladder hemorrhage,
inflammation, and ulceration.
There is no evidence of susceptibility
in the thiencarbazone-methyl database.
Offspring effects occurred at the same
doses as those which caused maternal
toxicity. In rats, maternal toxicity was
indicated by decreased body and
placenta weight and yellowish sediment
in the urinary bladder. Developmental
toxicity was indicated by delayed
ossification of several locations. In
rabbits, maternal toxicity consisted of
decreased body weight, deaths, reduced
food consumption and sediment in the
kidney and urinary bladder.
Developmental toxicity consisted of
more runt fetuses and lower body
weight in female offspring. There were
no effects on reproductive parameters in
either males or females in a
reproductive study in rats. Systemically,
there were effects on the urothelial
system at the high dose in the parents
and decreases in body weight in females
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
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toward the end of lactation. There was
also evidence of reduced absolute and
relative liver weight in males in the high
dose F1 group. The pups also
demonstrated evidence of urothelial
effects as indicated by the presence of
stones in the kidneys and urinary
bladder in a few F2 weanlings at the
highest dose tested.
There is no evidence of
immunotoxicity, neurotoxicity, or
mutagenicity in the thiencarbazonemethyl database. There were no
treatment-related increases in neoplasia
in the rat carcinogenicity study. In mice,
calculi in the urothelial system as well
as transitional cell epithelium tumors in
the urinary bladder (1 male/3 females)
and in the prostatic urethra (1 male)
were observed at the highest dose tested
(599 mg/kg/day in males and 758 mg/
kg/day in females). Since the neoplasia
occurred only in the high dose group,
thiencarbazone-methyl was classified as
‘‘not likely to be a carcinogen to humans
at doses that do not cause urothelial
cytotoxicity.’’ The formation of the
tumors is considered to be related to the
secondary effects of the urothelial
toxicity (irritation) and regenerative
proliferation associated with the
formation of urinary tract crystals/
calculi.
Specific information on the studies
received and the nature of the adverse
effects caused by thiencarbazone-methyl
as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
from the toxicity studies can be found
at https://www.regulations.gov in
document, Thiencarbazone-methyl
Human Health Risk Assessment, at
pages 39–42 in docket ID number EPA–
HQ–OPP–2017–0448.
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 thiencarbazone-methyl
used for human risk assessment is
shown in Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIENCARBAZONE-METHYL FOR USE IN HUMAN
HEALTH RISK ASSESSMENT
Exposure/scenario
Point of departure
and
uncertainty/safety
factors
Acute dietary (All populations) ..
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
No selection because no indication of significant toxicity following a single dose.
NOAEL= 117 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 1.17
mg/kg/day.
cPAD = 1.17 mg/kg/
day.
Dog chronic feeding.
LOAEL = 117 mg/kg/day based on urothelial effects.
Oral short-term (adult and incidental oral for children) (1 to
30 days).
NOAEL= 159 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential MOE =
100.
Dog subchronic study.
LOAEL = 335 mg/kg/day in males and 351 mg/kg/day in females based on urothelial effects.
Dermal short-term (1 to 30
days).
NOAEL = 159 mg/
kg/day.
DAF = 100%
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential MOE =
100.
Dog subchronic study.
LOAEL = 335 mg/kg/day in males and 351 mg/kh/day in females based on urothelial effects.
Inhalation short-term (1 to 30
days).
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Chronic dietary (All populations)
NOAEL= 159 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential MOE =
100.
Dog subchronic study.
LOAEL = 335 mg/kg/day in males and 351 mg/kg/day in females based on urothelial effects.
Cancer (oral, dermal, inhalation).
Classification ‘‘not likely to be carcinogenic to humans at doses that do not cause urothelium cytotoxicity.’’
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. 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). UFH = potential variation in sensitivity among
members of the human population (intraspecies). DAF= dermal absorption factor.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to thiencarbazone-methyl,
EPA considered exposure under the
petitioned-for tolerances as well as all
existing thiencarbazone-methyl
tolerances in 40 CFR 180.180.645. EPA
assessed dietary exposures from
thiencarbazone-methyl 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.
No such effects were identified in the
toxicological studies for thiencarbazonemethyl; therefore, a quantitative acute
dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the dietary model Dietary
Exposure Evaluation Model-Food
Commodity Intake Database (DEEM–
FCID). The modeled exposure estimates
for the chronic assessment are based on
tolerance level residues and assume
100% of the crops are treated.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to thiencarbazone-methyl
because the chronic reference dose is
protective of any cancer or precancerous effect observed in
carcinogenicity studies. Cancer risk was
assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for thiencarbazone-methyl. Tolerancelevel residues and/or 100% CT were
assumed for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening-level
water exposure models in the dietary
exposure analysis and risk assessment
for thiencarbazone-methyl in drinking
water. These simulation models take
into account data on the physical,
chemical, and fate/transport
characteristics of thiencarbazonemethyl. 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 First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCI–
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GROW) models, the estimated drinking
water concentrations (EDWCs) of
thiencarbazone-methyl for chronic
exposures for non-cancer assessments
are estimated to be 0.36 ppb for surface
water and 0.00079 ppb for ground
water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 0.36 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).
Thiencarbazone-methyl is currently
registered for the following uses that
could result in residential exposures:
Application to residential turfgrass and
ornamentals. EPA assessed residential
exposure using the following
assumptions:
• Residential handler exposure is
expected to be short-term in duration.
Intermediate-term exposures are not
likely because of the intermittent nature
of applications by homeowners. There is
a potential for inhalation and dermal
exposure for adult handlers.
• Post-application exposure is
expected to be short-term in nature.
There is a potential for dermal exposure
to adults and children and incidental
oral exposure to children ages 1 <2
years old through contact with treated
areas after treatment.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
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 thiencarbazonemethyl to share a common mechanism
of toxicity with any other substances,
and thiencarbazone-methyl does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
thiencarbazone-methyl does not have a
common mechanism of toxicity with
other substances. For information
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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 website 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 no evidence of increased
qualitative or quantitative susceptibility
in the young. Offspring effects occurred
at the same doses as those which caused
maternal toxicity.
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
thiencarbazone-methyl is considered
complete. There are available
developmental studies in rats and
rabbits, a reproductions study in rats,
and acute and subchronic neurotoxicity
battery studies. The requirement for a
subchronic inhalation study was waived
because thiencarbazone-methyl has low
volatility, low acute inhalation toxicity
and the use of a POD from an oral study
to estimate inhalation exposures results
in MOEs that are >100 times higher than
the MOEs of concern.
ii. There is no indication that
thiencarbazone-methyl is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
thiencarbazone-methyl results in
increased susceptibility in in utero rats
or rabbits in the prenatal developmental
studies or in young rats in the 2generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
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tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
thiencarbazone-methyl in drinking
water. EPA used similarly conservative
assumptions to assess postapplication
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by thiencarbazone-methyl.
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. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, thiencarbazonemethyl is not expected to pose an acute
risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to
thiencarbazone-methyl from food and
water will utilize less than 1% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure.
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).
Thiencarbazone-methyl 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
thiencarbazone-methyl. 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 9,200 to
adults, 140,000 for children 11–16 years
old, 13,000 for children 6–11 years old,
VerDate Sep<11>2014
16:09 Jun 21, 2018
Jkt 244001
and 7,500 for children 1–2 years old.
Because EPA’s level of concern for
thiencarbazone-methyl is a MOE of 100
or below, these MOEs are not of
concern.
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 no intermediate-term adverse
effect was identified, thiencarbazonemethyl is not expected to pose a
intermediate-term risk.
5. Aggregate cancer risk for U.S.
population. As explained in section
III.A., thiencarbazone-methyl is
considered ‘‘not likely to be
carcinogenic to humans at doses that do
not cause urothelial cytotoxicity.’’
Because the Agency is regulating
exposure to thiencarbazone-methyl to
ensure that the U.S. population will not
be exposed to levels that cause
urothelial cytotoxicity, EPA concludes
that thiencarbazone-methyl will not
pose an aggregate cancer risk.
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
thiencarbazone-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(LC/MS/MS) is available to enforce the
tolerance expression.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for thiencarbazone-methyl.
PO 00000
Frm 00056
Fmt 4700
Sfmt 4700
V. Conclusion
Therefore, the tolerance is amended
for residues of thiencarbazone-methyl,
methyl 4-[[[(4,5-dihydro-3-methoxy-4methyl-5-oxo-1H–1,2,4-triazol-1yl)carbonyl] amino]sulfonyl]-5-methyl3-thiophenecarboxylate, in or on wheat
forage at 0.15 ppm. In addition, EPA is
revising the tolerance expression to
clarify (1) that, as provided in FFDCA
section 408(a)(3), the tolerance covers
metabolites and degradates of
thiencarbazone-methyl not specifically
mentioned; and (2) that compliance
with the specified tolerance levels is to
be determined by measuring only the
specific compounds mentioned in the
tolerance expression. EPA has
determined that it is reasonable to make
this change final without prior proposal
and opportunity for comment, because
public comment is not necessary, in that
the change has no substantive effect on
the tolerance, but rather is merely
intended to clarify the existing tolerance
expression.
VI. Statutory and Executive Order
Reviews
This action amends a tolerance 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), nor is it considered a
regulatory action subject to Executive
Order 13771, entitled ‘‘Reducing
Regulations and Controlling Regulatory
Costs’’ (82 FR 9339, February 3, 2017).
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 tolerance in this final rule, do not
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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations
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
daltland on DSKBBV9HB2PROD with RULES
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 1, 2018.
Daniel J. Rosenblatt,
Deputy Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
VerDate Sep<11>2014
16:09 Jun 21, 2018
Jkt 244001
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.645,
a. Revise paragraph (a)(1) introductory
text;
■ b. Revise the entry for ‘‘wheat, forage’’
in the table in paragraph (a)(1);
■ c. Revise paragraph (a)(2) introductory
text; and
■ d. Revise paragraph (d) introductory
text.
The revisions read as follows:
■
■
§ 180.645 Thiencarbazone-methyl;
tolerances for residues.
(a)(1) General. Tolerances are
established for residues of the
thiencarbazone-methyl, 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 only thiencarbazonemethyl [methyl 4-[[[(4,5-dihydro-3methoxy-4-methyl-5-oxo-1H-1,2,4triazol-1-yl)-carbonyl]amino]sulfonyl]-5methyl-3-thiophenecarboxylate] in or on
the following food and feed
commodities.
29033
measuring only the sum of
thiencarbazone-methyl [methyl 4-[[[(4,5dihydro-3-methoxy-4-methyl-5-oxo-1H1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]-5-methyl-3thiophenecarboxylate] and its
metabolite BYH 18636–MMT-glucoside
[2-hexopyranosyl-5-methoxy-4-methyl2,4-dihydro-3H-1,2,4-triazol-3-one],
calculated as the stoichiometric
equivalent of thiencarbazone-methyl, in
or on the following food commodities:
*
*
*
*
*
[FR Doc. 2018–13453 Filed 6–21–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0167; FRL–9977–94]
Benzovindiflupyr; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
In response to a petition filed
by Syngenta Crop Protection, LLC under
the Federal Food, Drug, and Cosmetic
Act (FFDCA), this regulation establishes
tolerances for residues of
Parts per
Commodity
benzovindiflupyr in or on bluegrass,
million
forage at 0.15 parts per million (ppm),
bluegrass, hay at 7.0 ppm, bluegrass,
*
*
*
*
*
straw at 6.0 ppm, bromegrass, forage at
Wheat, forage .......................
0.15 0.15 ppm, bromegrass, hay at 7.0 ppm,
bromegrass, straw at 6.0 ppm, fescue,
*
*
*
*
*
forage at 0.15 ppm, fescue, hay at 7.0
ppm, fescue, straw at 6.0 ppm,
(2) Tolerances are established for
orchardgrass, forage at 0.15 ppm,
residues of thiencarbazone-methyl,
orchardgrass, hay at 7.0 ppm,
including its metabolites and
degradates, in or on the commodities in orchardgrass, straw at 6.0 ppm, and
ryegrass, forage at 0.15 ppm, ryegrass,
the table below. Compliance with the
tolerance levels specified below is to be hay at 7.0 ppm, and ryegrass, straw at
6.0 ppm.
determined by measuring only the sum
DATES: This regulation is effective June
of thiencarbazone-methyl [methyl 422, 2018. Objections and requests for
[[[(4,5-dihydro-3-methoxy-4-methyl-5hearings must be received on or before
oxo-1H-1,2,4-triazol-1-yl)August 21, 2018, and must be filed in
carbonyl]amino]sulfonyl]-5-methyl-3accordance with the instructions
thiophenecarboxylate] and its
provided in 40 CFR part 178 (see also
metabolite BYH 18636–MMT [5Unit I.C. of the SUPPLEMENTARY
methoxy-4-methyl-2,4-dihydro-3HINFORMATION).
1,2,4-triazol-3-one], calculated as the
stoichiometric equivalent of
ADDRESSES: The docket for this action,
thiencarbazone-methyl, in or on the
identified by docket identification (ID)
following food commodities of animal
number EPA–HQ–OPP–2017–0167, is
origin:
available at https://www.regulations.gov
*
*
*
*
*
or at the Office of Pesticide Programs
(d) Indirect or inadvertent residues.
Regulatory Public Docket (OPP Docket)
Tolerances are established for residues
in the Environmental Protection Agency
of thiencarbazone-methyl, including its
Docket Center (EPA/DC), West William
metabolites and degradates, in or on the Jefferson Clinton Bldg., Rm. 3334, 1301
commodities in the table below.
Constitution Ave. NW, Washington, DC
Compliance with the tolerance levels
20460–0001. The Public Reading Room
specified below is to be determined by
is open from 8:30 a.m. to 4:30 p.m.,
PO 00000
Frm 00057
Fmt 4700
Sfmt 4700
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 29028-29033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13453]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0448; FRL-9978-50]
Thiencarbazone-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
thiencarbazone-methyl in or on wheat forage. Bayer CropScience
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective June 22, 2018. Objections and
requests for hearings must be received on or before August 21, 2018,
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-2017-0448, 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: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
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
[[Page 29029]]
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-2017-0448 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 21, 2018. 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-2017-0448, 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 March 6, 2018 (83 FR 9471) (FRL-9973-
27), 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
7F8583) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that the existing wheat, forage
tolerance in 40 CFR 180.645 for residues of the herbicide
thiencarbazone-methyl, methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-
oxo-1H-1,2,4-triazol-1-yl)carbonyl] amino]sulfonyl]-5-methyl-3-
thiophenecarboxylate, be amended from 0.10 parts per million (ppm) to
0.15 ppm. That document referenced a summary of the petition prepared
by Bayer CropScience, the registrant, which is available in the docket,
https://www.regulations.gov. No comments related to this tolerance
action were received on the notice of filing.
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 thiencarbazone-methyl including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with thiencarbazone-
methyl follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Thiencarbazone-methyl has low acute toxicity via the oral, dermal,
and inhalation routes of exposure. Thiencarbazone-methyl is not an eye
nor a skin irritant and it is not a skin sensitizer.
The most toxicologically significant effect of thiencarbazone-
methyl occurs in the urothelial system including the kidney, bladder,
and urinary tract. Across species, the dog is more sensitive than the
rat or the mouse. Common effects observed throughout the database
included sulfonamide crystals in the urine, eosinophilic urolithiasis
(kidney, ureter and bladder stones), pelvic dilation, thickening of the
kidney, bladder, or ureter, collecting duct hyperplasia, urothelial
hyperplasia, submucosal inflammatory cell infiltration, bladder
hemorrhage, inflammation, and ulceration.
There is no evidence of susceptibility in the thiencarbazone-methyl
database. Offspring effects occurred at the same doses as those which
caused maternal toxicity. In rats, maternal toxicity was indicated by
decreased body and placenta weight and yellowish sediment in the
urinary bladder. Developmental toxicity was indicated by delayed
ossification of several locations. In rabbits, maternal toxicity
consisted of decreased body weight, deaths, reduced food consumption
and sediment in the kidney and urinary bladder. Developmental toxicity
consisted of more runt fetuses and lower body weight in female
offspring. There were no effects on reproductive parameters in either
males or females in a reproductive study in rats. Systemically, there
were effects on the urothelial system at the high dose in the parents
and decreases in body weight in females
[[Page 29030]]
toward the end of lactation. There was also evidence of reduced
absolute and relative liver weight in males in the high dose F1 group.
The pups also demonstrated evidence of urothelial effects as indicated
by the presence of stones in the kidneys and urinary bladder in a few
F2 weanlings at the highest dose tested.
There is no evidence of immunotoxicity, neurotoxicity, or
mutagenicity in the thiencarbazone-methyl database. There were no
treatment-related increases in neoplasia in the rat carcinogenicity
study. In mice, calculi in the urothelial system as well as
transitional cell epithelium tumors in the urinary bladder (1 male/3
females) and in the prostatic urethra (1 male) were observed at the
highest dose tested (599 mg/kg/day in males and 758 mg/kg/day in
females). Since the neoplasia occurred only in the high dose group,
thiencarbazone-methyl was classified as ``not likely to be a carcinogen
to humans at doses that do not cause urothelial cytotoxicity.'' The
formation of the tumors is considered to be related to the secondary
effects of the urothelial toxicity (irritation) and regenerative
proliferation associated with the formation of urinary tract crystals/
calculi.
Specific information on the studies received and the nature of the
adverse effects caused by thiencarbazone-methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document, Thiencarbazone-methyl Human Health
Risk Assessment, at pages 39-42 in docket ID number EPA-HQ-OPP-2017-
0448.
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 thiencarbazone-methyl
used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Thiencarbazone-Methyl 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 (All populations).. No selection because no indication of significant toxicity following a single
dose.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 117 mg/kg/day Chronic RfD = 1.17 Dog chronic feeding.
UFA = 10x........... mg/kg/day. LOAEL = 117 mg/kg/day based on
UFH = 10x........... cPAD = 1.17 mg/kg/ urothelial effects.
FQPA SF = 1x........ day..
----------------------------------------------------------------------------------------------------------------
Oral short-term (adult and NOAEL= 159 mg/kg/day Residential MOE = Dog subchronic study.
incidental oral for children) (1 UFA = 10x........... 100. LOAEL = 335 mg/kg/day in males and
to 30 days). UFH = 10x........... 351 mg/kg/day in females based on
FQPA SF = 1x........ urothelial effects.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days). NOAEL = 159 mg/kg/ Residential MOE = Dog subchronic study.
day. 100. LOAEL = 335 mg/kg/day in males and
DAF = 100%.......... 351 mg/kh/day in females based on
UFA = 10x........... urothelial effects.
UFH = 10x...........
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 NOAEL= 159 mg/kg/day Residential MOE = Dog subchronic study.
days). UFA = 10x........... 100. LOAEL = 335 mg/kg/day in males and
UFH = 10x........... 351 mg/kg/day in females based on
FQPA SF = 1x........ urothelial effects.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification ``not likely to be carcinogenic to humans at doses that do not
cause urothelium cytotoxicity.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. 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). UFH = potential variation in sensitivity among members of the human
population (intraspecies). DAF= dermal absorption factor.
[[Page 29031]]
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiencarbazone-methyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing thiencarbazone-methyl
tolerances in 40 CFR 180.180.645. EPA assessed dietary exposures from
thiencarbazone-methyl 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.
No such effects were identified in the toxicological studies for
thiencarbazone-methyl; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the dietary model Dietary Exposure Evaluation
Model-Food Commodity Intake Database (DEEM-FCID). The modeled exposure
estimates for the chronic assessment are based on tolerance level
residues and assume 100% of the crops are treated.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to thiencarbazone-methyl because the chronic reference dose
is protective of any cancer or pre-cancerous effect observed in
carcinogenicity studies. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for thiencarbazone-methyl. Tolerance-level residues
and/or 100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for thiencarbazone-methyl in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of thiencarbazone-methyl. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of thiencarbazone-
methyl for chronic exposures for non-cancer assessments are estimated
to be 0.36 ppb for surface water and 0.00079 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.36 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). Thiencarbazone-methyl
is currently registered for the following uses that could result in
residential exposures: Application to residential turfgrass and
ornamentals. EPA assessed residential exposure using the following
assumptions:
Residential handler exposure is expected to be short-term
in duration. Intermediate-term exposures are not likely because of the
intermittent nature of applications by homeowners. There is a potential
for inhalation and dermal exposure for adult handlers.
Post-application exposure is expected to be short-term in
nature. There is a potential for dermal exposure to adults and children
and incidental oral exposure to children ages 1 <2 years old through
contact with treated areas after treatment.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 thiencarbazone-methyl to share a common mechanism
of toxicity with any other substances, and thiencarbazone-methyl does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that thiencarbazone-methyl 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 website 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 no evidence of
increased qualitative or quantitative susceptibility in the young.
Offspring effects occurred at the same doses as those which caused
maternal toxicity.
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 thiencarbazone-methyl is considered
complete. There are available developmental studies in rats and
rabbits, a reproductions study in rats, and acute and subchronic
neurotoxicity battery studies. The requirement for a subchronic
inhalation study was waived because thiencarbazone-methyl has low
volatility, low acute inhalation toxicity and the use of a POD from an
oral study to estimate inhalation exposures results in MOEs that are
>100 times higher than the MOEs of concern.
ii. There is no indication that thiencarbazone-methyl is a
neurotoxic chemical and there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that thiencarbazone-methyl results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and
[[Page 29032]]
tolerance-level residues. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to thiencarbazone-methyl in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by thiencarbazone-
methyl.
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. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
thiencarbazone-methyl is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
thiencarbazone-methyl from food and water will utilize less than 1% of
the cPAD for children 1-2 years old, the population group receiving the
greatest exposure.
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).
Thiencarbazone-methyl 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 thiencarbazone-
methyl. 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 9,200 to
adults, 140,000 for children 11-16 years old, 13,000 for children 6-11
years old, and 7,500 for children 1-2 years old. Because EPA's level of
concern for thiencarbazone-methyl is a MOE of 100 or below, these MOEs
are not of concern.
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 no intermediate-term adverse effect was identified,
thiencarbazone-methyl is not expected to pose a intermediate-term risk.
5. Aggregate cancer risk for U.S. population. As explained in
section III.A., thiencarbazone-methyl is considered ``not likely to be
carcinogenic to humans at doses that do not cause urothelial
cytotoxicity.'' Because the Agency is regulating exposure to
thiencarbazone-methyl to ensure that the U.S. population will not be
exposed to levels that cause urothelial cytotoxicity, EPA concludes
that thiencarbazone-methyl will not pose an aggregate cancer risk.
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 thiencarbazone-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (LC/MS/MS) is available to enforce
the tolerance expression.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for thiencarbazone-methyl.
V. Conclusion
Therefore, the tolerance is amended for residues of thiencarbazone-
methyl, methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-
triazol-1-yl)carbonyl] amino]sulfonyl]-5-methyl-3-thiophenecarboxylate,
in or on wheat forage at 0.15 ppm. In addition, EPA is revising the
tolerance expression to clarify (1) that, as provided in FFDCA section
408(a)(3), the tolerance covers metabolites and degradates of
thiencarbazone-methyl not specifically mentioned; and (2) that
compliance with the specified tolerance levels is to be determined by
measuring only the specific compounds mentioned in the tolerance
expression. EPA has determined that it is reasonable to make this
change final without prior proposal and opportunity for comment,
because public comment is not necessary, in that the change has no
substantive effect on the tolerance, but rather is merely intended to
clarify the existing tolerance expression.
VI. Statutory and Executive Order Reviews
This action amends a tolerance 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), nor is it considered a
regulatory action subject to Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 tolerance in this
final rule, do not
[[Page 29033]]
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 1, 2018.
Daniel J. Rosenblatt,
Deputy 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. In Sec. 180.645,
0
a. Revise paragraph (a)(1) introductory text;
0
b. Revise the entry for ``wheat, forage'' in the table in paragraph
(a)(1);
0
c. Revise paragraph (a)(2) introductory text; and
0
d. Revise paragraph (d) introductory text.
The revisions read as follows:
Sec. 180.645 Thiencarbazone-methyl; tolerances for residues.
(a)(1) General. Tolerances are established for residues of the
thiencarbazone-methyl, 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 only
thiencarbazone-methyl [methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-
oxo-1H-1,2,4-triazol-1-yl)-carbonyl]amino]sulfonyl]-5-methyl-3-
thiophenecarboxylate] in or on the following food and feed commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Wheat, forage........................................... 0.15
* * * * *
------------------------------------------------------------------------
(2) Tolerances are established for residues of thiencarbazone-
methyl, 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
thiencarbazone-methyl [methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-
oxo-1H-1,2,4-triazol-1-yl)-carbonyl]amino]sulfonyl]-5-methyl-3-
thiophenecarboxylate] and its metabolite BYH 18636-MMT [5-methoxy-4-
methyl-2,4-dihydro-3H-1,2,4-triazol-3-one], calculated as the
stoichiometric equivalent of thiencarbazone-methyl, in or on the
following food commodities of animal origin:
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for residues of thiencarbazone-methyl, 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 thiencarbazone-methyl [methyl 4-[[[(4,5-
dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-
carbonyl]amino]sulfonyl]-5-methyl-3-thiophenecarboxylate] and its
metabolite BYH 18636-MMT-glucoside [2-hexopyranosyl-5-methoxy-4-methyl-
2,4-dihydro-3H-1,2,4-triazol-3-one], calculated as the stoichiometric
equivalent of thiencarbazone-methyl, in or on the following food
commodities:
* * * * *
[FR Doc. 2018-13453 Filed 6-21-18; 8:45 am]
BILLING CODE 6560-50-P
