Flazasulfuron; Pesticide Tolerances, 24062-24067 [2017-10763]
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[FR Doc. 2017–09536 Filed 5–24–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0112; FRL–9961–54]
Flazasulfuron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of flazasulfuron
in or on olives. ISK Biosciences
Corporation requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May
25, 2017. Objections and requests for
hearings must be received on or before
July 24, 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–2016–0112, is
SUMMARY:
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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 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
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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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
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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–2016–0112 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 July 24, 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–
2016–0112, 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 6F8447) by ISK
Biosciences Corporation, 7470 Auburn
Road, Suite A, Concord, Ohio 44077.
The petition requested that 40 CFR part
180 be amended by establishing
tolerances for residues of the herbicide,
flazasulfuron (N-[[(4,6-dimethoxy-2pyrimidinyl)amino]carbonyl]-3(trifluoromethyl)-2pyridinesulfonamide), in or on olive at
0.01 parts per million (ppm). That
document referenced a summary of the
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petition prepared by ISK Biosciences
Corporation, the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to 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 flazasulfuron
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with flazasulfuron 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 risk assessment for flazasulfuron
is based on a well-characterized and
complete toxicology database. After oral
administration to rats, more than 84% of
the dose of flazasulfuron was excreted
within 72 hours, mostly as parent
compound. Urinary elimination
accounted for about 80–90% of the dose
and fecal elimination for about 10–20%.
Females tended to eliminate more in the
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urine, and slightly more rapidly, than
males. Tissue distribution was rapid but
incomplete. While levels in tissue were
generally low, the tissues with highest
concentrations were the blood, liver,
and muscle.
The liver was the main target organ of
flazasulfuron in most species tested,
with effects ranging from non-adverse
liver hypertrophy to more severe
histopathological findings like
inflammatory cell infiltration,
hepatocellular necrosis and swelling,
and bile duct proliferation. Rats also
showed kidney toxicity (nephropathy)
after chronic exposure. No adverse
effects were observed in most short and
intermediate duration (≤90 days)
studies; only reduced body weight gain
and non-adverse liver effects (increased
weight and hepatocellular hypertrophy)
were observed in some of the
subchronic toxicity studies.
Developmental toxicity was observed
in rats and abortions in rabbits;
however, findings in rats were not
consistent across strains. A small
increase in the incidence of
intraventricular septal defect was
observed in Wistar rats but not in
Sprague-Dawley rats. Significant
decreases in mean fetal body weight
were observed in both rat strains at the
limit dose. In these same studies in the
rat, the maternal animals showed no
adverse effects. A high incidence of
abortion and decreased food
consumption, but no specific fetal
effects, were observed in rabbits. While
the developmental studies indicate
there is offspring susceptibility in rats,
both rat studies provide clear noobserved-adverse-effect levels (NOAELs)
for the adverse fetal effects.
Furthermore, the points of departure
(PODs) used for risk assessment are
lower than doses associated with fetal
effects; therefore, the assessments are
protective of the observed offspring
effects.
No increase in tumor incidence was
seen in rats or mice. Flazasulfuron is not
genotoxic. There was no evidence of
neurotoxicity in the database. The acute
toxicity data indicate that flazasulfuron
has low acute oral, dermal, and
inhalation toxicity. It was not found to
be a skin irritant, but was a moderate
eye irritant. Flazasulfuron was not a
dermal sensitizer. Flazasulfuron is
classified as ‘‘not likely to be
carcinogenic in humans’’ based on the
lack of carcinogenic effects in the rat
and mouse carcinogenicity studies, and
lack of a mutagenicity concern.
Specific information on the studies
received and the nature of the adverse
effects caused by flazasulfuron as well
as the NOAEL and the lowest-observed-
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adverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document titled
‘‘Flazasulfuron. Aggregate Human
Health Risk Assessment for the
Proposed New Use on Olives’’ at page
23 in docket ID number EPA–HQ–OPP–
2016–0112.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for flazasulfuron used for
human risk assessment is discussed in
Unit II. B. of the final rule published in
the Federal Register of September 5,
2014 (79 FR 52985) (FRL–9915–32).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to flazasulfuron, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing flazasulfuron tolerances in 40
CFR 180.655. EPA assessed dietary
exposures from flazasulfuron 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
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occurring as a result of a 1-day or single
exposure.
Such effects were identified for
flazasulfuron. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) under the Continuing Survey of
Food Intake by Individuals (CSFII) and
the CDC under the National Health and
Nutrition Examination Survey/What We
Eat in America (NHANES/WEIA) 2003–
2008. The acute dietary exposure
analyses incorporate tolerance-level
residues of the currently registered and
proposed crops combined with 100%
crop treated (%CT) to determine the
exposure and risk estimates. Residues of
flazasulfuron were all <Level of
Quantification (LOQ) (<0.01 ppm) in/on
olive fruit and olive oil; therefore,
processing factors could not be
calculated. An acceptable method was
used for residue quantitation, and
adequate data were submitted to
support sample storage intervals and
conditions. In the crop field trials, all
residues of parent flazasulfuron in olive
were nondetectable. Since all residues
were <LOQ, residue decline could not
be assessed. Acceptable metabolism
studies on grapes, sugarcane, and
tomatoes are available. Residues of
flazasulfuron were not detected in the
tomato study and were only detected as
a trace or minor component in the grape
and sugarcane studies. Therefore, the
processing factors were set at 1 in the
dietary exposure assessment.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA NHANES/WEIA 2003–
2008. The chronic dietary exposure
analyses incorporate tolerance-level
residues of the currently registered and
proposed crops combined with 100%CT
to determine the exposure and risk
estimates. Processing factors were set at
1 in the dietary exposure assessment.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that flazasulfuron does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for flazasulfuron. 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 flazasulfuron in drinking water.
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These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
flazasulfuron. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
Based on the Pesticide Root Zone
Model Ground Water (PRZM GW) for
ground water and the Pesticide Root
Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for
surface water, the estimated drinking
water concentrations (EDWCs) of
flazasulfuron for acute exposures are
estimated to be 26.9 parts per billion
(ppb) for surface water and 90.8 ppb for
ground water.
For chronic exposures for non-cancer
assessments EDWCs are estimated to be
4.67 ppb for surface water and 55.6 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
For acute dietary risk assessment, the
water concentration value of 90.8 ppb
was used to assess the contribution to
drinking water.
For chronic dietary risk assessment,
the water concentration of value 55.6
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).
Flazasulfuron is currently registered
for use on turf that could result in
residential exposures. Residential
exposure may occur by the dermal, oral,
and inhalation routes of exposures.
Flazasulfuron does not pose a dermal
hazard; therefore, only inhalation
(handler exposure for adults) and oral
(post-application incidental oral for
children) were assessed. Nonoccupational exposures to flazasulfuron
are expected to be for short-term
durations only. The recommended
residential exposure for use in the adult
aggregate assessment reflects inhalation
exposure from applications to turf via
backpack or manually pressurized
handwand. The recommended
residential exposure for use in the
children 1 to <2 years old aggregate
assessment reflects hand-to-mouth
exposures from post-application
exposure to turf treatments. A turf
transferable residues (TTR) study is not
required for flazasulfuron at this time
since there was no dermal hazard
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identified and the hand-to-mouth MOE
is greater than 1,000 based on default
values for the fraction of application
rate available for transfer after a turf
application. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
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.’’
In 2016, EPA’s Office of Pesticide
Programs released a guidance document
entitled, ‘‘Pesticide Cumulative Risk
Assessment: Framework for Screening
Analysis’’ https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/pesticide-cumulativerisk-assessment-framework. This
document provides guidance on how to
screen groups of pesticides for
cumulative evaluation using a two-step
approach beginning with the evaluation
of available toxicological information
and if necessary, followed by a riskbased screening approach. This
framework supplements the existing
guidance documents for establishing
common mechanism groups (CMGs) and
conducting cumulative risk assessments
(CRA). The Agency has utilized this
framework for flazasulfuron and
determined that although flazasulfuron
shares some chemical and/or
toxicological characteristics (e.g.,
chemical structure or apical endpoint)
with other pesticides, the toxicological
database does not support a testable
hypothesis for a common mechanism of
action. No further data is required to
determine that no common mechanism
of toxicity exists for flazasulfuron and
other pesticides and no further
cumulative evaluation is necessary for
flazasulfuron.
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
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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.
The available data indicate that
flazasulfuron produced developmental
effects in the rabbit (increased
abortions), and reproductive effects in
the rat (decreased pup body weight),
only at maternally/parentally toxic dose
levels, and these developmental/
offspring effects were not more severe
than maternal/parental effects
(increased abortions the rabbit,
increased nephropathy and decreased
pup body weight in the rat). While
developmental effects (increased
incidence of interventricular septal
defect and reduced fetal weights) were
seen in rats in the absence of maternal
toxicity, an indication of quantitative
and qualitative susceptibility, clear
NOAELs and LOAELs have been
established for these adverse fetal
effects. Furthermore, the PODs used for
risk assessment are lower than doses
associated with these developmental
effects. Therefore, the assessments are
protective of the observed offspring
effects, and the Agency has no concerns
for quantitative or qualitative
susceptibility.
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
flazasulfuron is complete.
ii. An acute neurotoxicity study was
conducted with flazasulfuron at dose
levels up to 2,000 mg/kg. Mean motor
activity measurements at dose levels of
1,000 and 2,000 mg/kg for males and
females were statistically significantly
decreased from the respective control
groups five hours post-dosing. Animals
were less active with more resting time
than controls. The effect was reversed
by the next scheduled observation (Day
7). Neurohistopathologic evaluation did
not demonstrate any test material
related neurotoxic lesions following the
examination of tissues from the central
and peripheral nervous systems of high
dose and control animals. The NOAEL
was 50 mg/kg. A subchronic
neurotoxicity study was conducted with
flazasulfuron at up to 732 mg/kg bw/day
in the diet for 90 days. No biologically
relevant neurotoxic effects were
observed at the dose levels tested. The
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available neurotoxicity battery,
therefore, did not raise concern for
neurotoxicity. Similarly, the subchronic
and chronic data in the database did not
show any adverse effects that could be
considered as neurotoxicity.
iii. While there is evidence of
increased qualitative and quantitative
susceptibility in the young based on rat
malformations and decreased fetal
weight in two rat developmental
toxicity studies, the FQPA Safety Factor
is reduced to 1X and is protective of the
observed offspring susceptibility
because there are clear NOAELs for the
developmental effects in the two rat
studies developmental toxicity studies
and the PODs selected for risk
assessment are protective of those
effects.
iv. There are no residual uncertainties
identified in the exposure databases.
The exposure databases are complete or
are estimated based on data that
reasonably account for potential
exposures. The acute and chronic
dietary food exposure assessment were
conservatively based on tolerance-level
residues on the currently registered and
proposed crops, 100% CT assumptions,
and conservative ground water drinking
water modeling estimates. The Agency
does not believe that the non-dietary
residential exposures are
underestimated because they are also
based on conservative assumptions. All
of the exposure estimates are based on
conservative assumptions and are not
likely to result in underestimated risk.
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
flazasulfuron will occupy 3.1% of the
aPAD for infants less than one-year old,
the population group receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to flazasulfuron
from food and water will utilize 23% of
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the cPAD for infants less than one-year
old, the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
flazasulfuron is not expected.
3. Short- and intermediate-term
aggregate risk. There is potential shortterm aggregate exposure to flazasulfuron
via the dietary pathway (which is
considered background exposure) and
the residential pathway (which is
considered the primary pathway). Since
intermediate-term residential exposures
are not likely to occur, intermediateterm aggregate risks were not assessed.
Since there is no dermal endpoint, the
short-term aggregate exposure
assessment for adults includes dietary
(food and drinking water) and
inhalation handler exposures and
results in an aggregate MOE of 1,600.
The short-term aggregate exposure
assessment for children 1–2 years old
includes dietary (food and drinking
water) and post-application hand-tomouth exposure from treated turf and
results in an aggregate MOE of 810.
Because EPA’s level of concern for
flazasulfuron is a MOE of 100 or below,
these MOEs are not of concern.
4. Aggregate cancer risk for U.S.
population. A cancer aggregate risk
assessment was not conducted because
there was no evidence of
carcinogenicity to humans based on lack
of carcinogenic effects in the rat and
mouse carcinogenicity studies.
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 flazasulfuron
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement method is
available. The method uses high
performance liquid chromatography/
tandem mass spectrometry with
multiple reaction monitoring (HPLC/
MS–MS/MRM). The LOQ is 0.01 ppm.
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
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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 flazasulfuron.
V. Conclusion
Therefore, tolerances are established
for residues of flazasulfuron, herbicide,
in or on olive at 0.01 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
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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: April 26, 2017.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.655, add alphabetically the
entry ‘‘Olive’’ to the table in paragraph
(a) to read as follows:
■
§ 180.655 Flazasulfuron; tolerances for
residues.
(a) * * *
E:\FR\FM\25MYR1.SGM
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Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations
*
*
*
Olive ......................................
*
*
*
*
*
I. General Information
*
*
0.01
*
*
*
SUPPLEMENTARY INFORMATION:
Parts per
million
Commodity
*
*
[FR Doc. 2017–10763 Filed 5–24–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0029 FRL–9961–99]
Fenazaquin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fenazaquin in
or on hop, dried cones; nuts, tree, group
14–12; pineapple; and tea, dried. Gowan
Company requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May
25, 2017. Objections and requests for
hearings must be received on or before
July 24, 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–2016–0029, 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 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.
SUMMARY:
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15:57 May 24, 2017
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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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2016–0029 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 July 24, 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–
2016–0029, by one of the following
methods:
PO 00000
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Fmt 4700
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24067
• 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
Tolerances
In the Federal Registers of March 16,
2016 (81 FR 14030) (FRL–9942–86);
May 19, 2016 (81 FR 31581) (FRL–9946–
02); and August 12, 2016 (81 FR 53379)
(FRL–9949–53) EPA issued documents
pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing
of pesticide petitions (PP 6F8442, PP
5F8429, and PP 6E8466) by Gowan
Company, P.O. Box 5569, Yuma, AZ
85366–5569. The petitions requested
that 40 CFR 180.632 be amended by
establishing tolerances for residues of
the miticide/insecticide fenazaquin, 4[2-[4-(1,1-dimethylethyl)
phenyl]ethoxy]quinazoline, in or on
hops at 30 parts per million (ppm) (PP
6F8442); nuts, tree, group 14–12 at 0.02
ppm (PP 5F8429); pineapple at 0.2 ppm
(PP 6E8466); and tea at 9 ppm (PP
6E8466). The petitions also requested
that the existing tolerance for almond at
0.2 ppm be removed upon
establishment of the above tolerance for
nut, tree group 14–12. Those documents
referenced summaries of the petitions
prepared by Gowan Company, the
registrant, which are available in the
docket, https://www.regulations.gov.
Comments were received on the Notices
of Filing. EPA’s response to these
comments is discussed in Unit IV.C.
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
E:\FR\FM\25MYR1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24062-24067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10763]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0112; FRL-9961-54]
Flazasulfuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flazasulfuron in or on olives. ISK Biosciences Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective May 25, 2017. Objections and
requests for hearings must be received on or before July 24, 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-2016-0112, 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 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.
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
[[Page 24063]]
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-2016-0112 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 July 24, 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-2016-0112, 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
6F8447) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, Ohio 44077. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide,
flazasulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide), in or on olive at 0.01 parts
per million (ppm). That document referenced a summary of the petition
prepared by ISK Biosciences Corporation, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to 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 flazasulfuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flazasulfuron
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 risk assessment for flazasulfuron is based on a well-
characterized and complete toxicology database. After oral
administration to rats, more than 84% of the dose of flazasulfuron was
excreted within 72 hours, mostly as parent compound. Urinary
elimination accounted for about 80-90% of the dose and fecal
elimination for about 10-20%. Females tended to eliminate more in the
urine, and slightly more rapidly, than males. Tissue distribution was
rapid but incomplete. While levels in tissue were generally low, the
tissues with highest concentrations were the blood, liver, and muscle.
The liver was the main target organ of flazasulfuron in most
species tested, with effects ranging from non-adverse liver hypertrophy
to more severe histopathological findings like inflammatory cell
infiltration, hepatocellular necrosis and swelling, and bile duct
proliferation. Rats also showed kidney toxicity (nephropathy) after
chronic exposure. No adverse effects were observed in most short and
intermediate duration (<=90 days) studies; only reduced body weight
gain and non-adverse liver effects (increased weight and hepatocellular
hypertrophy) were observed in some of the subchronic toxicity studies.
Developmental toxicity was observed in rats and abortions in
rabbits; however, findings in rats were not consistent across strains.
A small increase in the incidence of intraventricular septal defect was
observed in Wistar rats but not in Sprague-Dawley rats. Significant
decreases in mean fetal body weight were observed in both rat strains
at the limit dose. In these same studies in the rat, the maternal
animals showed no adverse effects. A high incidence of abortion and
decreased food consumption, but no specific fetal effects, were
observed in rabbits. While the developmental studies indicate there is
offspring susceptibility in rats, both rat studies provide clear no-
observed-adverse-effect levels (NOAELs) for the adverse fetal effects.
Furthermore, the points of departure (PODs) used for risk assessment
are lower than doses associated with fetal effects; therefore, the
assessments are protective of the observed offspring effects.
No increase in tumor incidence was seen in rats or mice.
Flazasulfuron is not genotoxic. There was no evidence of neurotoxicity
in the database. The acute toxicity data indicate that flazasulfuron
has low acute oral, dermal, and inhalation toxicity. It was not found
to be a skin irritant, but was a moderate eye irritant. Flazasulfuron
was not a dermal sensitizer. Flazasulfuron is classified as ``not
likely to be carcinogenic in humans'' based on the lack of carcinogenic
effects in the rat and mouse carcinogenicity studies, and lack of a
mutagenicity concern.
Specific information on the studies received and the nature of the
adverse effects caused by flazasulfuron as well as the NOAEL and the
lowest-observed-
[[Page 24064]]
adverse-effect-level (LOAEL) from the toxicity studies can be found at
https://www.regulations.gov in document titled ``Flazasulfuron.
Aggregate Human Health Risk Assessment for the Proposed New Use on
Olives'' at page 23 in docket ID number EPA-HQ-OPP-2016-0112.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for flazasulfuron used for
human risk assessment is discussed in Unit II. B. of the final rule
published in the Federal Register of September 5, 2014 (79 FR 52985)
(FRL-9915-32).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flazasulfuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing flazasulfuron
tolerances in 40 CFR 180.655. EPA assessed dietary exposures from
flazasulfuron 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 flazasulfuron. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) under the Continuing Survey of
Food Intake by Individuals (CSFII) and the CDC under the National
Health and Nutrition Examination Survey/What We Eat in America (NHANES/
WEIA) 2003-2008. The acute dietary exposure analyses incorporate
tolerance-level residues of the currently registered and proposed crops
combined with 100% crop treated (%CT) to determine the exposure and
risk estimates. Residues of flazasulfuron were all https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticide Root Zone Model Ground Water (PRZM GW) for
ground water and the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for surface water, the estimated drinking
water concentrations (EDWCs) of flazasulfuron for acute exposures are
estimated to be 26.9 parts per billion (ppb) for surface water and 90.8
ppb for ground water.
For chronic exposures for non-cancer assessments EDWCs are
estimated to be 4.67 ppb for surface water and 55.6 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For acute dietary risk assessment, the water concentration value of
90.8 ppb was used to assess the contribution to drinking water.
For chronic dietary risk assessment, the water concentration of
value 55.6 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).
Flazasulfuron is currently registered for use on turf that could
result in residential exposures. Residential exposure may occur by the
dermal, oral, and inhalation routes of exposures. Flazasulfuron does
not pose a dermal hazard; therefore, only inhalation (handler exposure
for adults) and oral (post-application incidental oral for children)
were assessed. Non-occupational exposures to flazasulfuron are expected
to be for short-term durations only. The recommended residential
exposure for use in the adult aggregate assessment reflects inhalation
exposure from applications to turf via backpack or manually pressurized
handwand. The recommended residential exposure for use in the children
1 to <2 years old aggregate assessment reflects hand-to-mouth exposures
from post-application exposure to turf treatments. A turf transferable
residues (TTR) study is not required for flazasulfuron at this time
since there was no dermal hazard
[[Page 24065]]
identified and the hand-to-mouth MOE is greater than 1,000 based on
default values for the fraction of application rate available for
transfer after a turf application. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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.''
In 2016, EPA's Office of Pesticide Programs released a guidance
document entitled, ``Pesticide Cumulative Risk Assessment: Framework
for Screening Analysis'' https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This document provides guidance on how to screen groups of
pesticides for cumulative evaluation using a two-step approach
beginning with the evaluation of available toxicological information
and if necessary, followed by a risk-based screening approach. This
framework supplements the existing guidance documents for establishing
common mechanism groups (CMGs) and conducting cumulative risk
assessments (CRA). The Agency has utilized this framework for
flazasulfuron and determined that although flazasulfuron shares some
chemical and/or toxicological characteristics (e.g., chemical structure
or apical endpoint) with other pesticides, the toxicological database
does not support a testable hypothesis for a common mechanism of
action. No further data is required to determine that no common
mechanism of toxicity exists for flazasulfuron and other pesticides and
no further cumulative evaluation is necessary for flazasulfuron.
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. The available data indicate
that flazasulfuron produced developmental effects in the rabbit
(increased abortions), and reproductive effects in the rat (decreased
pup body weight), only at maternally/parentally toxic dose levels, and
these developmental/offspring effects were not more severe than
maternal/parental effects (increased abortions the rabbit, increased
nephropathy and decreased pup body weight in the rat). While
developmental effects (increased incidence of interventricular septal
defect and reduced fetal weights) were seen in rats in the absence of
maternal toxicity, an indication of quantitative and qualitative
susceptibility, clear NOAELs and LOAELs have been established for these
adverse fetal effects. Furthermore, the PODs used for risk assessment
are lower than doses associated with these developmental effects.
Therefore, the assessments are protective of the observed offspring
effects, and the Agency has no concerns for quantitative or qualitative
susceptibility.
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 flazasulfuron is complete.
ii. An acute neurotoxicity study was conducted with flazasulfuron
at dose levels up to 2,000 mg/kg. Mean motor activity measurements at
dose levels of 1,000 and 2,000 mg/kg for males and females were
statistically significantly decreased from the respective control
groups five hours post-dosing. Animals were less active with more
resting time than controls. The effect was reversed by the next
scheduled observation (Day 7). Neurohistopathologic evaluation did not
demonstrate any test material related neurotoxic lesions following the
examination of tissues from the central and peripheral nervous systems
of high dose and control animals. The NOAEL was 50 mg/kg. A subchronic
neurotoxicity study was conducted with flazasulfuron at up to 732 mg/kg
bw/day in the diet for 90 days. No biologically relevant neurotoxic
effects were observed at the dose levels tested. The available
neurotoxicity battery, therefore, did not raise concern for
neurotoxicity. Similarly, the subchronic and chronic data in the
database did not show any adverse effects that could be considered as
neurotoxicity.
iii. While there is evidence of increased qualitative and
quantitative susceptibility in the young based on rat malformations and
decreased fetal weight in two rat developmental toxicity studies, the
FQPA Safety Factor is reduced to 1X and is protective of the observed
offspring susceptibility because there are clear NOAELs for the
developmental effects in the two rat studies developmental toxicity
studies and the PODs selected for risk assessment are protective of
those effects.
iv. There are no residual uncertainties identified in the exposure
databases. The exposure databases are complete or are estimated based
on data that reasonably account for potential exposures. The acute and
chronic dietary food exposure assessment were conservatively based on
tolerance-level residues on the currently registered and proposed
crops, 100% CT assumptions, and conservative ground water drinking
water modeling estimates. The Agency does not believe that the non-
dietary residential exposures are underestimated because they are also
based on conservative assumptions. All of the exposure estimates are
based on conservative assumptions and are not likely to result in
underestimated risk.
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 flazasulfuron will occupy 3.1% of the aPAD for infants less than
one-year old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flazasulfuron from food and water will utilize 23% of
[[Page 24066]]
the cPAD for infants less than one-year old, the population group
receiving the greatest exposure. Based on the explanation in Unit
III.C.3., regarding residential use patterns, chronic residential
exposure to residues of flazasulfuron is not expected.
3. Short- and intermediate-term aggregate risk. There is potential
short-term aggregate exposure to flazasulfuron via the dietary pathway
(which is considered background exposure) and the residential pathway
(which is considered the primary pathway). Since intermediate-term
residential exposures are not likely to occur, intermediate-term
aggregate risks were not assessed. Since there is no dermal endpoint,
the short-term aggregate exposure assessment for adults includes
dietary (food and drinking water) and inhalation handler exposures and
results in an aggregate MOE of 1,600. The short-term aggregate exposure
assessment for children 1-2 years old includes dietary (food and
drinking water) and post-application hand-to-mouth exposure from
treated turf and results in an aggregate MOE of 810. Because EPA's
level of concern for flazasulfuron is a MOE of 100 or below, these MOEs
are not of concern.
4. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not conducted because there was no evidence of
carcinogenicity to humans based on lack of carcinogenic effects in the
rat and mouse carcinogenicity studies.
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 flazasulfuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement method is available. The method uses high
performance liquid chromatography/tandem mass spectrometry with
multiple reaction monitoring (HPLC/MS-MS/MRM). The LOQ is 0.01 ppm.
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 flazasulfuron.
V. Conclusion
Therefore, tolerances are established for residues of
flazasulfuron, herbicide, in or on olive at 0.01 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 26, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
0
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. 180.655, add alphabetically the entry ``Olive'' to the
table in paragraph (a) to read as follows:
Sec. 180.655 Flazasulfuron; tolerances for residues.
(a) * * *
[[Page 24067]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Olive................................................... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-10763 Filed 5-24-17; 8:45 am]
BILLING CODE 6560-50-P
