Triflumezopyrim; Pesticide Tolerances, 48000-48005 [2017-22356]
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
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
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).
Dated: September 6, 2017.
Richard P. Keigwin, Jr.,
Acting Director, Office of Pesticide Programs.
DATES:
*There are no U.S. registrations for use of
fenpicoxamid on this commodity.
I. General Information
This regulation is effective
October 16, 2017. Objections and
requests for hearings must be received
on or before December 15, 2017, and
Therefore, 40 CFR chapter I is
must be filed in accordance with the
amended as follows:
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
PART 180—[AMENDED]
SUPPLEMENTARY INFORMATION).
■ 1. The authority citation for part 180
ADDRESSES: The docket for this action,
continues to read as follows:
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0142, is
Authority: 21 U.S.C. 321(q), 346a and 371.
available at https://www.regulations.gov
■ 2. Add § 180.109 to subpart C to read
or at the Office of Pesticide Programs
as follows:
Regulatory Public Docket (OPP Docket)
§ 180.109 Fenpicoxamid; Tolerances for
in the Environmental Protection Agency
residues.
Docket Center (EPA/DC), West William
(a) General. Tolerances are
Jefferson Clinton Bldg., Rm. 3334, 1301
established for residues of fenpicoxamid Constitution Ave. NW., Washington, DC
including its metabolites and
20460–0001. The Public Reading Room
degradates, in or on the commodities in is open from 8:30 a.m. to 4:30 p.m.,
the table below. Compliance with the
Monday through Friday, excluding legal
tolerance levels for fenpicoxamid is to
holidays. The telephone number for the
be determined by measuring only
Public Reading Room is (202) 566–1744,
fenpicoxamid ([[4-methoxy-2and the telephone number for the OPP
[[[(3S,7R,8R,9S)-9-methyl-8-(2-methyl-1- Docket is (703) 305–5805. Please review
oxopropoxy)-2,6-dioxo-7the visitor instructions and additional
(phenylmethyl)-1,5-dioxonan-3information about the docket available
yl]amino]carbonyl]-3at https://www.epa.gov/dockets.
pyridinyl]oxy]methyl 2FOR FURTHER INFORMATION CONTACT:
methylpropanoate) in or on the
Michael L. Goodis, Registration Division
commodity.
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Parts per
Pennsylvania Ave. NW., Washington,
Commodity
million
DC 20460–0001; main telephone
Banana* ................................
0.15 number: (703) 305–7090; email address:
Wheat, grain* ........................
0.60 RDFRNotices@epa.gov.
Rye, grain* ............................
0.60 SUPPLEMENTARY INFORMATION:
AGENCY:
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).
This regulation establishes
tolerances for residues of
triflumezopyrim in or on rice, grain and
rice, hulls. E.I. Dupont de Nemours and
Company requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
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. To access the OCSPP test
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 2017–22357 Filed 10–13–17; 8:45 am]
BILLING CODE 6560–50–P
VII. Congressional Review Act
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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
16:21 Oct 13, 2017
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40 CFR Part 180
[EPA–HQ–OPP–2016–0142; FRL–9966–13]
Triflumezopyrim; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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AGENCY
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
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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–2016–0142 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 December 15, 2017. 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–
2016–0142, 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 April 25,
2016 (81 FR 24044) (FRL–9944–86),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
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pesticide petition (PP 6E8448) by E.I.
Dupont de Nemours and Company, 974
Centre Road, Wilmington, DE 19805.
The petition requested that 40 CFR part
180 be amended by establishing
tolerances for residues of the insecticide
triflumezopyrim (2,4-dioxo-1-(5pyrimidinylmethyl)-3-[3(trifluoromethyl)phenyl]-2H-pyrido[1,2a]pyrimidinium inner salt), in or on
rice, grain at 0.20 parts per million
(ppm). That document referenced a
summary of the petition prepared by E.I.
Dupont de Nemours and Company, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the tolerance for rice, grain to 0.40 ppm
based on the OECD tolerance
calculation procedure. Additionally,
EPA is requiring a tolerance for rice,
hull at 1.0 ppm. The reason 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 triflumezopyrim
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with triflumezopyrim
follows.
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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. The most common
adverse effect observed across the
triflumezopyrim toxicological database
was a decrease in absolute bodyweight
in dogs and rats in both sexes following
subchronic and chronic exposures. No
additional non-cancer effects relevant
for human health risk assessment were
noted in the subchronic rat and dog oral
toxicity studies. No effects were seen in
the mice and rabbit studies, including
the dermal toxicity study.
Chronic exposures in rats resulted in
an increased incidence of bile duct
hyperplasia in the presence of decreases
in absolute bodyweight (∼70 milligrams/
kilogram/day (mg/kg/day)). Additional
lesions were seen in the liver, testes,
and uterus at a higher dose (∼400 mg/
kg/day). The rat combined chronic/
carcinogenicity study showed an
increase in uterine and liver tumors at
a dose of ∼400 mg/kg/day, which is
considered excessive for evaluating
carcinogenic potential. The remaining
doses were not considered excessive
and did not show treatment-related
tumors in either sex. Liver tumors in
male mice during the mouse
carcinogenicity study were considered
treatment-related. The proposed mode
of action (constitutive androstane
receptor (CAR)-mediated proliferation)
for the liver tumors in male mice was
adequately supported by mechanistic
data that clearly identified the sequence
of events, dose-response concordance
and temporal relationship for this tumor
type. Triflumezopyrim is classified as
‘‘not likely to be carcinogenic to humans
at dose levels that do not cause a
significant induction in CYP2B
activity.’’ Based on the mechanistic
studies provided, significant induction
in CYP2B only occurred at 7,000 ppm
(727 mg/kg/day in male mice); the
chronic reference dose used for the
Agency’s safety assessment is based on
a no observed adverse effect level of 17
mg/kg/day. As a result, the Agency
concludes that the chronic reference
dose will be protective of potential
carcinogenicity, which can be assessed
through a non-linear approach. There is
no mutagenicity concern based on the
results from the in vitro and in vivo
genetic toxicity studies.
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Evidence of increased quantitative
susceptibility in the rat developmental
toxicity study was observed in the form
of incomplete ossification of the parietal
skull in the fetuses of dams treated with
a relatively high dose (200 mg/kg/day)
in the absence of any maternal toxicity.
There was no evidence of susceptibility
in the rat reproduction toxicity or rabbit
developmental toxicity study.
Possible signs of neurotoxicity were
observed in the acute neurotoxicity
(ACN) in rats as well as in the 28-day
subchronic oral toxicity study in dogs.
An overall decrease in motor activity
was observed in the ACN study on the
day of dosing. Animals also showed
slight decreases in body temperature
and number of rearing movements, as
well as increases in the incidence of
high posture, at a dose 4x higher than
what elicited the decrease in motor
activity. The 28-day subchronic oral
toxicity study in dogs showed
neurobehavioral signs such as slight
impairment of forelimb and/or hindlimb
strength and effects on pupil
constriction. However, the
neurobehavioral signs were not seen in
studies of longer duration in dogs.
Although evidence of neurotoxicity
was seen in the ACN study in rats and
28-day oral toxicity study in dogs,
concern is low since: (1) Effects are
well-characterized with clearly
established NOAEL/LOAEL values; (2)
no additional neurotoxic effects were
seen in the toxicological database
including the subchronic neurotoxicity
study (SCN); (3) there were no
corroborating neuropathological
findings; (4) the neurobehavioral signs
in the dog were not observed in studies
of longer durations in dogs; and (5) the
selected endpoints for risk assessment
are protective of these effects.
Specific information on the studies
received and the nature of the adverse
effects caused by Triflumezopyrim as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
Triflumezopyrim: Human Health Risk
Assessment to Establish Tolerances for
Rice Without U.S. Registration at page
21 in docket ID number EPA–HQ–OPP–
2016–0142.
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/pesticide-science-andassessing-pesticide-risks/guidancehuman-health-risk-assessmentspesticides.
A summary of the toxicological
endpoints for Triflumezopyrim used for
human risk assessment is shown in the
Table below.
SUMMARY TABLE OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFLUMEZOPYRIM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (All populations) ..
NOAEL = 100 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
aPAD = 1.0 mg/kg/
day.
Acute neurotoxicity study (rats). LOAEL = 500 mg/kg/day
based on decreased motor activity on day of dosing.
Chronic dietary (All populations)
NOAEL = 17 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
cPAD = 0.17 mg/kg/
day.
Combined chronic/carcinogenicity study (rats). LOAEL = 71/74
(M/F) mg/kg/day based on decreased absolute bodyweights
in females and increased incidence of bile duct hyperplasia
in males.
Cancer (Oral, dermal, inhalation).
Not likely to be carcinogenic to humans at dose levels that do not cause a significant induction in CYP2B activity. Quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity.
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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.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to triflumezopyrim, EPA
considered exposure under the
petitioned-for tolerances. EPA assessed
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dietary exposures from triflumezopyrim
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
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possibility of an effect of concern
occurring as a result of a 1-day or single
exposure.
Such effects were identified for
triflumezopyrim. In estimating acute
dietary exposure, EPA used food
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consumption information from the
United States Department of Agriculture
(USDA) 2003–2008 National Health and
Nutrition Examination Survey, What We
Eat In America (NHANES/WWEIA). As
to residue levels in food, EPA used an
unrefined dietary analysis and
incorporated tolerance-level residues
and assumed 100% of all rice was
treated.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 2003–2008 National
Health and Nutrition Examination
Survey, What We Eat In America
(NHANES/WWEIA). As to residue levels
in food, EPA used an unrefined dietary
analysis and incorporated tolerancelevel residues and assumed 100% of all
rice was treated.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that triflumezopyrim is not
likely to cause cancer to humans at dose
levels that do not cause a significant
increase in CYP2B activity.
Additionally, there is no chronic risk
from exposure to triflumezopyrim and
the chronic reference dose is protective
of potential carcinogenicity. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for triflumezopyrim. Tolerance-level
residues and/or 100% CT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. Because there are no domestic
registrations for triflumezopyrim in the
United States, dietary exposure (acute
and chronic) from imported
commodities is the only source of
exposure assessed. Residues from
imported commodities are not expected
to reach drinking water sources.
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).
Triflumezopyrim is not registered for
any specific use patterns that would
result in residential exposure.
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
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substances that have a common
mechanism of toxicity.’’
EPA has not found triflumezopyrim to
share a common mechanism of toxicity
with any other substances, and
triflumezopyrim does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that triflumezopyrim 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 was no evidence of increased
susceptibility in the rabbit
developmental or the rat reproduction
toxicity studies; however, there was
evidence of increased quantitative
susceptibility in the rat developmental
study in rats where an increased
incidence of incomplete ossification of
the parietal skull was seen in the
absence of maternal toxicity. Concern is
low since: (1) The effect is wellcharacterized with clearly established
NOAEL/LOAEL values; and (2) the
selected endpoints for this chemical are
protective of 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 for assessing risks
for all populations. That decision is
based on the following findings:
i. The toxicity database for
triflumezopyrim is complete.
ii. Although there is evidence of
neurotoxicity in the ACN study in rats
and 28-day oral toxicity study in dogs
for triflumezopyrim, the concern is low
since: (1) The effects are well-
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characterized with clearly established
NOAEL/LOAEL values; (2) no
additional neurotoxic effects were seen
in the toxicological database including
the SCN; (3) there were no corroborating
neuropathological findings; (4) the
neurobehavioral signs in the dog were
not observed in studies of longer
durations in dogs; and (5) the selected
endpoints for this chemical are
protective of these effects. As a result,
there is no need to require a
developmental neurotoxicity study or
retain the 10X to account for potential
neurotoxic effects.
iii. Although there was evidence of
increased quantitative susceptibility in
the rat developmental toxicity study
where incomplete ossification of the
parietal skull in the fetuses of dams
treated with a relatively high dose (200
mg/kg/day) was observed in the absence
of any maternal toxicity, concern is low
since: (1) The effect is wellcharacterized with clearly established
NOAEL/LOAEL values and (2) the
selected endpoints for this chemical are
protective of these effects. There was no
evidence of increased susceptibility in
the rabbit developmental or the rat
reproduction toxicity studies.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on considering
that 100% of all rice was treated and
using tolerance-level residues. Since the
metabolites were found at insignificant
levels in the metabolism studies,
triflumezopyrim is considered the only
residue of concern. These assessments
will not underestimate the exposure and
risks posed by triflumezopyrim.
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. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
triflumezopyrim will occupy <1% of the
aPAD for all infants <1 year old, the
population group receiving the greatest
exposure.
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to
triflumezopyrim from food will utilize
<1% of the cPAD for all infants <1 year
old, the population group receiving the
greatest exposure. There are no
residential uses for triflumezopyrim.
3. Short-term and Intermediate-term
risk. Triflumezopyrim is not registered
for any use patterns that would result in
short-term or intermediate-term
residential exposure. Because there are
no residential uses for triflumezopyrim,
as a result, aggregate risk estimates for
short- and intermediate-term exposure
are equivalent to the chronic dietary risk
estimates and are not of concern.
4. Aggregate cancer risk for U.S.
population. As discussed in Unit III.A.,
EPA has determined that
triflumezopyrim is not likely to be
carcinogenic to humans at doses that do
not cause a significant induction in
CYP2B activity. Because there is no
chronic risk from exposure to
triflumezopyrim and the chronic
reference dose is protective of potential
carcinogenicity, triflumezopyrim is not
expected to pose a cancer risk.
5. 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
triflumezopyrim residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(DuPont Liquid chromatography Mass
spectrometry/mass spectrometry (LC/
MS/MS) methods 36348 and 45170) is
available to enforce the tolerance
expression. 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.
jstallworth on DSKBBY8HB2PROD with RULES
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
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14:58 Oct 13, 2017
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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 triflumezopyrim.
C. Revisions to Petitioned-For
Tolerances
EPA is establishing a tolerance for
rice, grain at 0.40 ppm, rather than at
0.20 ppm as requested, in addition to
establishing a tolerance for rice, hulls of
1.0 ppm. The rice grain tolerance is
based on the OECD tolerance
calculation procedure with the inputted
residues adjusted proportionally to
reflect the maximum application rate.
The raw agricultural commodity of
‘‘rice, grain’’ consists of the rice kernel,
as well as the rice hull. The rice hull is
considered a processed commodity for
rice, and where residues concentrate in
processed commodities, a higher
tolerance to cover those residues is
warranted. Because the available data
indicates a higher level of residues on
the rice hull, EPA is establishing a
separate tolerance to cover those
residues.
V. Conclusion
Therefore, tolerances are established
for residues of triflumezopyrim, (2,4dioco-1-(5-pyrimidinylmethyl)-3-[3(trifluoromethyl)phenyl]-2H-pyrido[1,2a]pyrimidinium inner salt), in or on
rice, grain at 0.40 and rice, hulls at 1.0
ppm.
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
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
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
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).
E:\FR\FM\16OCR1.SGM
16OCR1
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: September 7, 2017.
Richard P. Keigwin, Jr.,
Director, 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. Add § 180.107 to subpart C to read
as follows:
■
§ 180.107
residues.
Triflumezopyrim; tolerance for
jstallworth on DSKBBY8HB2PROD with RULES
(a) General. Tolerances are
established for residues of the
insecticide triflumezopyrim, including
its metabolites and degradates, in or on
the following food commodities in the
table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
triflumezopyrim (2,4-dioxo-1-(5pyrimidinylmethyl)-3-[3(trifluoromethyl)phenyl]-2H-pyrido[1,2a] pyrimidinium inner salt) in or on the
commodity.
In this document, the
Commission announces that the Office
of Management and Budget (OMB) has
approved, for a period of six months,
the information collection associated
with the Commission’s Procedures for
Commission Review of State Opt-Out
Request from the FirstNet Radio Access
Network, Report and Order (Report and
Order)’s rules and procedures for
administering the state opt-out process
as provided under the Middle Class Tax
Relief and Job Creation Act of 2012, as
well delineating the specific standards
by which the Commission will evaluate
state opt-out applications. This
document is consistent with the Report
and Order, which stated that the
Commission would publish a document
in the Federal Register announcing the
effective date of those rules.
SUMMARY:
The amendments to 47 CFR
90.532(b) and (c) published at 82 FR
46690, October 6, 2017, are effective
November 6, 2017.
DATES:
For
additional information about the
information collection, contact Nicole
Ongele, FCC, at (202) 418–2991 or via
email PRA@fcc.gov and to
Nicole.Ongele@fcc.gov.
FOR FURTHER INFORMATION CONTACT:
This
document announces that, on October 6,
2017, OMB approved this information
collection under the emergency
processing of the Paperwork Reduction
Parts per
Act (PRA), 5 CFR 1320.13, for a period
Commodity
million
of six months, the information
Rice, grain * ..........................
0.40 collection requirements relating to the
Rice, hulls * ...........................
1.0 State opt-out rules contained in the
Commission’s Report and Order, FCC
* There are no U.S. registrations for the use
17–75, published at 82 FR 46690,
of triflumezopyrim on these commodities.
October 6, 2017. The OMB Control
(b) Section 18 emergency exemptions. Number is 3060–1245. The Commission
[Reserved]
publishes this document as an
(c) Tolerances with regional
announcement of the effective date of
registrations. [Reserved]
the rules. If you have any comments on
(d) Indirect or inadvertent residues.
the burden estimates listed below, or
[Reserved]
how the Commission can improve the
[FR Doc. 2017–22356 Filed 10–13–17; 8:45 am]
collections and reduce any burdens
BILLING CODE 6560–50–P
caused thereby, please contact Nicole
Ongele, Federal Communications
Commission, Room 1–A620, 445 12th
FEDERAL COMMUNICATIONS
Street SW., Washington, DC 20554.
COMMISSION
Please include the OMB Control
Number, 3060–1245, in your
47 CFR Part 90
correspondence. The Commission will
also accept your comments via email at
[PS Docket No. 16–269, FCC 17–75]
PRA@fcc.gov.
Procedures for Commission Review of
To request materials in accessible
State Opt-Out Request From the
formats for people with disabilities
FirstNet Radio Access Network
(Braille, large print, electronic files,
audio format), send an email to fcc504@
AGENCY: Federal Communications
fcc.gov or call the Consumer and
Commission.
Governmental Affairs Bureau at (202)
ACTION: Final rule; announcement of
418–0530 (voice), (202) 418–0432
effective date.
(TTY).
VerDate Sep<11>2014
16:21 Oct 13, 2017
Jkt 244001
SUPPLEMENTARY INFORMATION:
PO 00000
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48005
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the FCC is notifying the public that it
received final OMB approval on October
6, 2017, for the information collection
requirements contained in the
modifications to the Commission’s rules
in 47 CFR 90.532. Under 5 CFR part
1320, an agency may not conduct or
sponsor a collection of information
unless it displays a current, valid OMB
Control Number.
No person shall be subject to any
penalty for failing to comply with a
collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number. The OMB Control Number is
3060–1245.
The foregoing notice is required by
the Paperwork Reduction Act of 1995,
Public Law 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
OMB Control Number: 3060–1245.
OMB Approval Date: October 6, 2017.
OMB Expiration Date: April 30, 2018.
Title: Procedures for Commission
Review of State Opt-Out Request from
the FirstNet Radio Access Network.
Form Number: N/A.
Respondents: State, local or tribal
governments.
Number of Respondents and
Responses: 55 respondents; 110
responses.
Estimated Time per Response: 0.25
hours per initial notification.
Frequency of Response: One-time
reporting requirement.
Obligation to Respond: Required to
obtain or retain benefits. Statutory
authority for requiring licensees to
submit this information enter into the
written agreements is contained in the
Middle Class Tax Relief and Job
Creation Act of 2012, Public Law 112
96, 126 Stat. 156 §§ 6001–6303, 6413
(codified at 47 U.S.C. 1401–1443, 1457).
Total Annual Burden: 26,414 hours.
Total Annual Cost: No cost.
Nature and Extent of Confidentiality:
Alternative state plans are very likely to
contain proprietary information as well
as information whose disclosure could
compromise network security. Parties
may therefore seek confidential
treatment of any filing under our Part 0
rules, including the use of a protective
order process to allow other those
granted party status to the restricted
proceeding access to the information on
a confidential basis.
Privacy Act: No impact(s).
Needs and Uses: The purpose of
requiring this collection is to comply
E:\FR\FM\16OCR1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 48000-48005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22356]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0142; FRL-9966-13]
Triflumezopyrim; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
triflumezopyrim in or on rice, grain and rice, hulls. E.I. Dupont de
Nemours and Company requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 16, 2017. Objections and
requests for hearings must be received on or before December 15, 2017,
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-2016-0142, 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:
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. To access the OCSPP
test
[[Page 48001]]
guidelines referenced in this document electronically, please go to
https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
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-2016-0142 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
December 15, 2017. 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-2016-0142, 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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), 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
6E8448) by E.I. Dupont de Nemours and Company, 974 Centre Road,
Wilmington, DE 19805. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the insecticide
triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3-
(trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in
or on rice, grain at 0.20 parts per million (ppm). That document
referenced a summary of the petition prepared by E.I. Dupont de Nemours
and Company, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the tolerance for rice, grain to 0.40 ppm based on the OECD
tolerance calculation procedure. Additionally, EPA is requiring a
tolerance for rice, hull at 1.0 ppm. The reason 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 triflumezopyrim including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with triflumezopyrim
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. The most common adverse effect observed across the
triflumezopyrim toxicological database was a decrease in absolute
bodyweight in dogs and rats in both sexes following subchronic and
chronic exposures. No additional non-cancer effects relevant for human
health risk assessment were noted in the subchronic rat and dog oral
toxicity studies. No effects were seen in the mice and rabbit studies,
including the dermal toxicity study.
Chronic exposures in rats resulted in an increased incidence of
bile duct hyperplasia in the presence of decreases in absolute
bodyweight (~70 milligrams/kilogram/day (mg/kg/day)). Additional
lesions were seen in the liver, testes, and uterus at a higher dose
(~400 mg/kg/day). The rat combined chronic/carcinogenicity study showed
an increase in uterine and liver tumors at a dose of ~400 mg/kg/day,
which is considered excessive for evaluating carcinogenic potential.
The remaining doses were not considered excessive and did not show
treatment-related tumors in either sex. Liver tumors in male mice
during the mouse carcinogenicity study were considered treatment-
related. The proposed mode of action (constitutive androstane receptor
(CAR)-mediated proliferation) for the liver tumors in male mice was
adequately supported by mechanistic data that clearly identified the
sequence of events, dose-response concordance and temporal relationship
for this tumor type. Triflumezopyrim is classified as ``not likely to
be carcinogenic to humans at dose levels that do not cause a
significant induction in CYP2B activity.'' Based on the mechanistic
studies provided, significant induction in CYP2B only occurred at 7,000
ppm (727 mg/kg/day in male mice); the chronic reference dose used for
the Agency's safety assessment is based on a no observed adverse effect
level of 17 mg/kg/day. As a result, the Agency concludes that the
chronic reference dose will be protective of potential carcinogenicity,
which can be assessed through a non-linear approach. There is no
mutagenicity concern based on the results from the in vitro and in vivo
genetic toxicity studies.
[[Page 48002]]
Evidence of increased quantitative susceptibility in the rat
developmental toxicity study was observed in the form of incomplete
ossification of the parietal skull in the fetuses of dams treated with
a relatively high dose (200 mg/kg/day) in the absence of any maternal
toxicity. There was no evidence of susceptibility in the rat
reproduction toxicity or rabbit developmental toxicity study.
Possible signs of neurotoxicity were observed in the acute
neurotoxicity (ACN) in rats as well as in the 28-day subchronic oral
toxicity study in dogs. An overall decrease in motor activity was
observed in the ACN study on the day of dosing. Animals also showed
slight decreases in body temperature and number of rearing movements,
as well as increases in the incidence of high posture, at a dose 4x
higher than what elicited the decrease in motor activity. The 28-day
subchronic oral toxicity study in dogs showed neurobehavioral signs
such as slight impairment of forelimb and/or hindlimb strength and
effects on pupil constriction. However, the neurobehavioral signs were
not seen in studies of longer duration in dogs.
Although evidence of neurotoxicity was seen in the ACN study in
rats and 28-day oral toxicity study in dogs, concern is low since: (1)
Effects are well-characterized with clearly established NOAEL/LOAEL
values; (2) no additional neurotoxic effects were seen in the
toxicological database including the subchronic neurotoxicity study
(SCN); (3) there were no corroborating neuropathological findings; (4)
the neurobehavioral signs in the dog were not observed in studies of
longer durations in dogs; and (5) the selected endpoints for risk
assessment are protective of these effects.
Specific information on the studies received and the nature of the
adverse effects caused by Triflumezopyrim 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 Triflumezopyrim: Human Health Risk
Assessment to Establish Tolerances for Rice Without U.S. Registration
at page 21 in docket ID number EPA-HQ-OPP-2016-0142.
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/pesticide-science-and-assessing-pesticide-risks/guidance-human-health-risk-assessments-pesticides.
A summary of the toxicological endpoints for Triflumezopyrim used
for human risk assessment is shown in the Table below.
Summary Table of Toxicological Doses and Endpoints for Triflumezopyrim 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).. NOAEL = 100 mg/kg/ aPAD = 1.0 mg/kg/ Acute neurotoxicity study (rats).
day. day. LOAEL = 500 mg/kg/day based on
UFA = 10x........... decreased motor activity on day
UFH = 10x........... of dosing.
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 17 mg/kg/day cPAD = 0.17 mg/kg/ Combined chronic/carcinogenicity
UFA = 10x........... day. study (rats). LOAEL = 71/74 (M/F)
UFH = 10x........... mg/kg/day based on decreased
FQPA SF = 1x........ absolute bodyweights in females
and increased incidence of bile
duct hyperplasia in males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Not likely to be carcinogenic to humans at dose levels that do not cause a
significant induction in CYP2B activity. Quantification of risk using a non-
linear approach (i.e., RfD) will adequately account for all chronic
toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
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.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triflumezopyrim, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
triflumezopyrim 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 triflumezopyrim. In estimating
acute dietary exposure, EPA used food
[[Page 48003]]
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat In America (NHANES/WWEIA). As to residue levels in
food, EPA used an unrefined dietary analysis and incorporated
tolerance-level residues and assumed 100% of all rice was treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat In
America (NHANES/WWEIA). As to residue levels in food, EPA used an
unrefined dietary analysis and incorporated tolerance-level residues
and assumed 100% of all rice was treated.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that triflumezopyrim is not likely to cause cancer to humans
at dose levels that do not cause a significant increase in CYP2B
activity. Additionally, there is no chronic risk from exposure to
triflumezopyrim and the chronic reference dose is protective of
potential carcinogenicity. Therefore, a dietary exposure assessment for
the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for triflumezopyrim. Tolerance-level residues and/or
100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. Because there are no
domestic registrations for triflumezopyrim in the United States,
dietary exposure (acute and chronic) from imported commodities is the
only source of exposure assessed. Residues from imported commodities
are not expected to reach drinking water sources.
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). Triflumezopyrim is
not registered for any specific use patterns that would result in
residential exposure.
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 triflumezopyrim to share a common mechanism of
toxicity with any other substances, and triflumezopyrim does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
triflumezopyrim 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 was no evidence of
increased susceptibility in the rabbit developmental or the rat
reproduction toxicity studies; however, there was evidence of increased
quantitative susceptibility in the rat developmental study in rats
where an increased incidence of incomplete ossification of the parietal
skull was seen in the absence of maternal toxicity. Concern is low
since: (1) The effect is well-characterized with clearly established
NOAEL/LOAEL values; and (2) the selected endpoints for this chemical
are protective of 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 for assessing risks for all populations.
That decision is based on the following findings:
i. The toxicity database for triflumezopyrim is complete.
ii. Although there is evidence of neurotoxicity in the ACN study in
rats and 28-day oral toxicity study in dogs for triflumezopyrim, the
concern is low since: (1) The effects are well-characterized with
clearly established NOAEL/LOAEL values; (2) no additional neurotoxic
effects were seen in the toxicological database including the SCN; (3)
there were no corroborating neuropathological findings; (4) the
neurobehavioral signs in the dog were not observed in studies of longer
durations in dogs; and (5) the selected endpoints for this chemical are
protective of these effects. As a result, there is no need to require a
developmental neurotoxicity study or retain the 10X to account for
potential neurotoxic effects.
iii. Although there was evidence of increased quantitative
susceptibility in the rat developmental toxicity study where incomplete
ossification of the parietal skull in the fetuses of dams treated with
a relatively high dose (200 mg/kg/day) was observed in the absence of
any maternal toxicity, concern is low since: (1) The effect is well-
characterized with clearly established NOAEL/LOAEL values and (2) the
selected endpoints for this chemical are protective of these effects.
There was no evidence of increased susceptibility in the rabbit
developmental or the rat reproduction toxicity studies.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on considering that 100% of all rice was treated and using tolerance-
level residues. Since the metabolites were found at insignificant
levels in the metabolism studies, triflumezopyrim is considered the
only residue of concern. These assessments will not underestimate the
exposure and risks posed by triflumezopyrim.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to triflumezopyrim will occupy <1% of the aPAD for all infants <1 year
old, the population group receiving the greatest exposure.
[[Page 48004]]
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
triflumezopyrim from food will utilize <1% of the cPAD for all infants
<1 year old, the population group receiving the greatest exposure.
There are no residential uses for triflumezopyrim.
3. Short-term and Intermediate-term risk. Triflumezopyrim is not
registered for any use patterns that would result in short-term or
intermediate-term residential exposure. Because there are no
residential uses for triflumezopyrim, as a result, aggregate risk
estimates for short- and intermediate-term exposure are equivalent to
the chronic dietary risk estimates and are not of concern.
4. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has determined that triflumezopyrim is not likely to be
carcinogenic to humans at doses that do not cause a significant
induction in CYP2B activity. Because there is no chronic risk from
exposure to triflumezopyrim and the chronic reference dose is
protective of potential carcinogenicity, triflumezopyrim is not
expected to pose a cancer risk.
5. 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 triflumezopyrim residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (DuPont Liquid chromatography Mass
spectrometry/mass spectrometry (LC/MS/MS) methods 36348 and 45170) is
available to enforce the tolerance expression. 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.
The Codex has not established a MRL for triflumezopyrim.
C. Revisions to Petitioned-For Tolerances
EPA is establishing a tolerance for rice, grain at 0.40 ppm, rather
than at 0.20 ppm as requested, in addition to establishing a tolerance
for rice, hulls of 1.0 ppm. The rice grain tolerance is based on the
OECD tolerance calculation procedure with the inputted residues
adjusted proportionally to reflect the maximum application rate. The
raw agricultural commodity of ``rice, grain'' consists of the rice
kernel, as well as the rice hull. The rice hull is considered a
processed commodity for rice, and where residues concentrate in
processed commodities, a higher tolerance to cover those residues is
warranted. Because the available data indicates a higher level of
residues on the rice hull, EPA is establishing a separate tolerance to
cover those residues.
V. Conclusion
Therefore, tolerances are established for residues of
triflumezopyrim, (2,4-dioco-1-(5-pyrimidinylmethyl)-3-[3-
(trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in
or on rice, grain at 0.40 and rice, hulls at 1.0 ppm.
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 tolerance 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).
[[Page 48005]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 7, 2017.
Richard P. Keigwin, Jr.,
Director, 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. Add Sec. 180.107 to subpart C to read as follows:
Sec. [emsp14]180.107 Triflumezopyrim; tolerance for residues.
(a) General. Tolerances are established for residues of the
insecticide triflumezopyrim, including its metabolites and degradates,
in or on the following food commodities in the table below. Compliance
with the tolerance levels specified below is to be determined by
measuring only triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3-
(trifluoromethyl)phenyl]-2H-pyrido[1,2-a] pyrimidinium inner salt) in
or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Rice, grain *........................................... 0.40
Rice, hulls *........................................... 1.0
------------------------------------------------------------------------
* There are no U.S. registrations for the use of triflumezopyrim on
these commodities.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2017-22356 Filed 10-13-17; 8:45 am]
BILLING CODE 6560-50-P
