Isoxaben; Pesticide Tolerances, 5307-5312 [2018-02346]
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Dated: January 31, 2018.
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[FR Doc. 2018–02425 Filed 2–6–18; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0650; FRL–9972–75]
Isoxaben; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of isoxaben in or
on apple, the bushberry subgroup 13–
07B, the tree nut group 14–12, and the
small vine climbing fruit (except fuzzy
kiwifruit) subgroup 13–07F.
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
February 7, 2018. Objections and
requests for hearings must be received
on or before April 9, 2018, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0650, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
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SUMMARY:
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Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
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/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–2016–0650 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
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5307
received by the Hearing Clerk on or
before April 9, 2018. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0650, 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 10,
2017 (82 FR 17175) (FRL–9959–61),
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 6E8516) by
Interregional Research Project No. 4
(IR–4) Project Headquarters, Rutgers,
The State University of NJ, 500 College
Road East, Suite 201, W, Princeton, NJ
08540. The petition requested that 40
CFR 180.650 be amended by
establishing tolerances for residues of
the herbicide isoxaben, N-[3-(1-ethyl-1methylpropyl)-5-isoxazolyl]-2, 6dimethoxybenzamide, in or on the raw
agricultural commodities apple at 0.01
parts per million (ppm); the bushberry
subgroup 13–07B at 0.01 ppm; the fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F at 0.01 ppm;
and the nut, tree, group 14–12 at 0.02
ppm. The petition also requested to
remove the tolerances in 40 CFR
180.650 in or on the raw agricultural
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commodities grape at 0.01 ppm; nut,
tree, group 14 at 0.02 ppm; and
pistachio at 0.02 ppm. That document
referenced a summary of the petition
prepared by Dow AgroSciences, the
registrant, which is available in the
docket, https://www.regulations.gov.
Comments were received on the notice
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
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 isoxaben
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with isoxaben 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.
Isoxaben shows low acute toxicity by
all routes. In chronic oral studies, the
liver (mouse) and kidney (rat) were
target organs, and decreased body
weight was observed in the rat, mouse,
and dog. There was no indication of
neurotoxicity or immunotoxicity. No
evidence of increased susceptibility was
observed in the rat or rabbit
developmental toxicity studies, but was
observed in the rat reproductive toxicity
study only at the limit dose.
Isoxaben is currently classified as
having ‘‘suggestive evidence of
carcinogenic potential,’’ based on the
presence of liver tumors in male and
female mice. Because the tumors were
benign and observed at dose levels
exceeding the limit dose of 1,000 mg/kg/
day and there was low concern for
genotoxicity, the cRfD is considered
protective of potential carcinogenicity
and a quantitative assessment of cancer
risk was not conducted.
Specific information on the studies
received and the nature of the adverse
effects caused by isoxaben as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
title ‘‘Isoxaben. Aggregate Human
Health Risk Assessment to Support
Proposed New Uses on Bushberry
Subgroup 13–07B and Apple, Crop
Group Conversion (Tree Nut Group 14–
12), and Crop Group Expansion (Small
Vine Climbing Fruit Except Fuzzy
Kiwifruit Subgroup 13–07F)’’ on pages
26–31 in docket ID number EPA–HQ–
OPP–2016–0650.
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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for isoxaben used for human
risk assessment is shown in Table 1 of
this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISOXABEN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
Acute dietary (All populations) ..
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Chronic dietary (All populations)
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RfD, PAD, LOC for
risk assessment
Study and toxicological effects
An appropriate endpoint for a single exposure was not identified
NOAEL = 5.0 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
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Chronic RfD = 0.05
mg/kg/day.
cPAD = 0.05 mg/kg/
day.
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Chronic combined toxicity/Carcinogenicity (oral)—rat.
LOAEL = 50.7 mg/kg/day, based on renal toxicity in males.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISOXABEN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Incidental oral intermediateterm (1 to 6 months).
NOAEL = 200 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Reproductive toxicity (oral)—rat.
Offspring LOAEL = 1,000 mg/kg/day, based on decreased
body weight gain in F1 females on day 70, decreased F2 pup
weights, gestation survival, live pups/litter, and increased incidence of malformations.
One-year dietary study (co-critical supporting study)—rat.
LOAEL = 625 mg/kg/day, based on decreased body weight
gain in females during the first six months, with a NOAEL of
62.5 mg/kg/day.
Inhalation short-term (1 to 30
days).
NOAEL = 200 mg/
kg/day (inhalation
toxicity assumed
to be equivalent to
oral toxicity).
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Reproductive toxicity (oral)—rat.
Offspring LOAEL = 1,000 mg/kg/day, based on decreased
body weight gain in F1 females on day 70, decreased F2 pup
weights, gestation survival, live pups/litter, and increased incidence of malformations.
Inhalation intermediate-term (1
to 6 months).
NOAEL = 200 mg/
kg/day (inhalation
toxicity assumed
to be equivalent to
oral toxicity).
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
Reproductive toxicity (oral)—rat.
Offspring LOAEL = 1,000 mg/kg/day, based on decreased
body weight gain in F1 females on day 70, decreased F2 pup
weights, gestation survival, live pups/litter, and increased incidence of malformations.
One-year dietary study (co-critical supporting study)—rat.
LOAEL = 625 mg/kg/day, based on decreased body weight
gain in females during the first six months, with a NOAEL of
62.5 mg/kg/day.
Cancer (Oral, dermal, inhalation).
‘‘Suggestive Evidence of Carcinogenic Potential,’’ based on increased incidence of hepatocellular adenomas in
male and female mice. Quantitative assessment of cancer risk using a cancer potency factor is not required.
The chronic RfD is protective of potential cancer risk.
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). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to isoxaben, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
isoxaben tolerances in 40 CFR 180.650.
EPA assessed dietary exposures from
isoxaben in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure.
No such effects were identified in the
toxicological studies for isoxaben;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used 2003–2008 food consumption
data from the US Department of
Agriculture’s (USDA’s) National Health
and Nutrition Examination Survey,
What We Eat in America (NHANES/
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WWEIA). As to residue levels in food,
EPA assumed tolerance-level residues
and 100 percent crop treated (PCT).
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to isoxaben. Cancer risk was
assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for isoxaben.
Tolerance-level residues and 100 PCT
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 isoxaben in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of isoxaben.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
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https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Surface Water
Concentration Calculator (SWCC
v1.106) and Pesticide Root Zone Model
Ground Water (PRZM GW), the
estimated drinking water concentrations
(EDWCs) of isoxaben for chronic
exposures are estimated to be 43.6 parts
per billion (ppb) for surface water and
909 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For the
chronic dietary risk assessment, the
water concentration value of 909 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).
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Isoxaben is currently registered for the
following uses that could result in
residential exposures: Residential turf.
EPA assessed residential exposure using
the following assumptions: Isoxaben
residential uses constitute short- and
intermediate-term exposure scenarios.
For residential handlers, since a dermal
endpoint was not selected, the only
route of exposure quantitatively
assessed for adult handlers is through
inhalation. For post-application
exposures, only intermediate-term
incidental oral exposures for children
were assessed due to the persistence of
isoxaben residues in soil. Neither a
short-term dermal nor short-term
incidental oral endpoint was selected
for children. Although there is potential
for post-application inhalation exposure
of both adults and children, the
estimated exposure is anticipated to be
negligible; therefore, a quantitative postapplication inhalation assessment was
not required.
For the purpose of performing an
aggregate assessment, the Agency
selected only the most conservative, or
worst-case, residential adult and child
scenarios to be included in the
aggregate, based on the lowest overall
MOE (highest exposure estimates). For
adults, handler inhalation exposure
resulting from the application of a
granular formulation of isoxaben to
residential lawns via push-type spreader
has been used to estimate adult
aggregate exposure. (The inhalation
exposure was added to background
exposure from food and water, and
compared to the short-term inhalation
POD.) Post-application risks for adults
in residential settings were not assessed
due to the lack of a dermal endpoint.
For children, an intermediate-term
aggregate assessment was conducted by
adding the incidental soil ingestion
exposure, and average food and water
exposure (chronic dietary exposure).
The incidental oral residential exposure
value selected for the aggregate analysis
is based on children ingesting soil
particles containing pesticide residues
while playing on treated turf. Due to the
persistence of isoxaben in the soil, the
Agency used a conservative approach by
using the maximum seasonal
application rate for estimating soil
ingestion by children rather than the
standard maximum single application
rate. This scenario resulted in the
highest calculated exposure levels;
therefore, it is protective for all other
oral post-application exposure and risk
for children in residential settings.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www2.epa.gov/pesticide-
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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 isoxaben to share
a common mechanism of toxicity with
any other substances, and isoxaben does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
isoxaben does not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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.
No evidence of increased susceptibility
was observed in the rat or rabbit
developmental toxicity studies, but was
observed in the rat reproductive toxicity
study only at the limit dose.
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 isoxaben is
adequately complete to allow the
Agency to assess the toxicological
profile of isoxaben.
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ii. There is no indication that
isoxaben is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. No evidence of increased
susceptibility was observed in the rat or
rabbit developmental toxicity studies,
but was observed in the rat reproductive
toxicity study only at the limit dose;
however, this risk assessment is
protective of the susceptibility observed
at the limit dose in the reproductive
toxicity study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to isoxaben in
drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by isoxaben.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, isoxaben is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to isoxaben from
food and water will utilize 98% of the
cPAD for all infants less than 1-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
isoxaben is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
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short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Isoxaben is currently registered for
uses that could result in short-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to isoxaben.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in an
aggregate MOE of 6,700 for females 13–
49 years old. Because EPA’s level of
concern for isoxaben is a MOE of 100 or
below, this MOE is not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Isoxaben is currently registered for
uses that could result in intermediateterm residential exposure, and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to isoxaben.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures result
in an aggregate MOE of 7,200 for
children 1–2 years old. Because EPA’s
level of concern for isoxaben is a MOE
of 100 or below, this MOE is not of
concern.
5. Aggregate cancer risk for U.S.
population. Based on the discussion in
Unit III.A., EPA considers the chronic
aggregate risk assessment to be
protective of any aggregate cancer risk.
As there is no chronic risk of concern,
EPA does not expect any cancer risk to
the U.S. population from aggregate
exposure to isoxaben.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children,
from aggregate exposure to isoxaben
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate residue analytical
method (RAM) utilizing liquid
chromatography with tandem mass
spectrometric detection (LC/MS/MS),
GRM 02.26.S.1 (a revision of GRM
VerDate Sep<11>2014
17:31 Feb 06, 2018
Jkt 244001
02.26), is available for enforcement of
isoxaben residues in crop commodities.
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 any
MRLs for isoxaben.
C. Response to Comments
Seven comments were received in
response to the notice of filing. All of
the comments were general in nature,
not specific to the chemical isoxaben.
They included statements such as ‘‘I am
not in favor of relaxing requirements on
pesticides,’’ ‘‘I am opposed to this
proposal,’’ and ‘‘My body doesn’t live
well on pesticides.’’
The Agency recognizes that some
individuals believe that pesticides
should be banned on agricultural crops;
however, the existing legal framework
provided by section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA)
states that tolerances may be set when
persons seeking such tolerances or
exemptions have demonstrated that the
pesticide meets the safety standard
imposed by that statute. These citizens’
comments appear to be directed at the
underlying statute and not EPA’s
implementation of it; the citizens have
made no contention that EPA has acted
in violation of the statutory framework
nor have they provided any specific
information or allegation that would
support a finding that these tolerances
are unsafe.
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
5311
V. Conclusion
Therefore, tolerances are established
for residues of isoxaben including its
metabolites and degradates, in or on
apple at 0.01 ppm; the bushberry
subgroup 13–07B at 0.01 ppm; the fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F at 0.01 ppm;
and the nut, tree, group 14–12 at 0.02
ppm. In addition, the following existing
tolerances are removed since they are
superseded by the new tolerances:
Grape, nut, tree, group 14; and
pistachio.
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); Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997); or Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
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
E:\FR\FM\07FER1.SGM
07FER1
5312
Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Rules and Regulations
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: January 19, 2018.
Donna S. Davis,
Acting 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:
sradovich on DSK3GMQ082PROD with RULES
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.650, revise the table in
paragraph (a) to read as follows:
■
§ 180.650 Isoxaben; tolerances for
residues.
(a) * * *
VerDate Sep<11>2014
17:31 Feb 06, 2018
Jkt 244001
Parts per
million
Commodity
Almond, hulls ........................
Apple .....................................
Bushberry subgroup 13–07B
Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–07F ....................
Nut, tree, group 14–12 .........
*
*
*
*
0.40
0.01
0.01
0.01
0.02
*
[FR Doc. 2018–02346 Filed 2–6–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0629; FRL–9972–66]
Fomesafen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fomesafen in
or on the tuberous and corm vegetable
subgroup 1C, the legume vegetable
group 6, and the low growing berry
subgroup 13–07G (except cranberry).
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
February 7, 2018. Objections and
requests for hearings must be received
on or before April 9, 2018, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0629, 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,
ADDRESSES:
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
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/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–2015–0629 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 April 9, 2018. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
E:\FR\FM\07FER1.SGM
07FER1
]]>Agencies
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Rules and Regulations]
[Pages 5307-5312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02346]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0650; FRL-9972-75]
Isoxaben; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
isoxaben in or on apple, the bushberry subgroup 13-07B, the tree nut
group 14-12, and the small vine climbing fruit (except fuzzy kiwifruit)
subgroup 13-07F. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 7, 2018. Objections and
requests for hearings must be received on or before April 9, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0650, 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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0650 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
April 9, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0650, 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 10, 2017 (82 FR 17175) (FRL-9959-
61), 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
6E8516) by Interregional Research Project No. 4 (IR-4) Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201, W, Princeton, NJ 08540. The petition requested that 40
CFR 180.650 be amended by establishing tolerances for residues of the
herbicide isoxaben, N-[3-(1-ethyl-1-methylpropyl)-5-isoxazolyl]-2, 6-
dimethoxybenzamide, in or on the raw agricultural commodities apple at
0.01 parts per million (ppm); the bushberry subgroup 13-07B at 0.01
ppm; the fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 0.01 ppm; and the nut, tree, group 14-12 at 0.02 ppm. The
petition also requested to remove the tolerances in 40 CFR 180.650 in
or on the raw agricultural
[[Page 5308]]
commodities grape at 0.01 ppm; nut, tree, group 14 at 0.02 ppm; and
pistachio at 0.02 ppm. That document referenced a summary of the
petition prepared by Dow AgroSciences, the registrant, which is
available in the docket, https://www.regulations.gov. Comments were
received on the notice 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 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 isoxaben including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with isoxaben 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.
Isoxaben shows low acute toxicity by all routes. In chronic oral
studies, the liver (mouse) and kidney (rat) were target organs, and
decreased body weight was observed in the rat, mouse, and dog. There
was no indication of neurotoxicity or immunotoxicity. No evidence of
increased susceptibility was observed in the rat or rabbit
developmental toxicity studies, but was observed in the rat
reproductive toxicity study only at the limit dose.
Isoxaben is currently classified as having ``suggestive evidence of
carcinogenic potential,'' based on the presence of liver tumors in male
and female mice. Because the tumors were benign and observed at dose
levels exceeding the limit dose of 1,000 mg/kg/day and there was low
concern for genotoxicity, the cRfD is considered protective of
potential carcinogenicity and a quantitative assessment of cancer risk
was not conducted.
Specific information on the studies received and the nature of the
adverse effects caused by isoxaben 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 the document title ``Isoxaben. Aggregate Human
Health Risk Assessment to Support Proposed New Uses on Bushberry
Subgroup 13-07B and Apple, Crop Group Conversion (Tree Nut Group 14-
12), and Crop Group Expansion (Small Vine Climbing Fruit Except Fuzzy
Kiwifruit Subgroup 13-07F)'' on pages 26-31 in docket ID number EPA-HQ-
OPP-2016-0650.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for isoxaben used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Isoxaben 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).. An appropriate endpoint for a single exposure was not identified
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 5.0 mg/kg/ Chronic RfD = 0.05 Chronic combined toxicity/
day. mg/kg/day. Carcinogenicity (oral)--rat.
UFA = 10x........... cPAD = 0.05 mg/kg/ LOAEL = 50.7 mg/kg/day, based on
UFH = 10x........... day.. renal toxicity in males.
FQPA SF = 1x........
[[Page 5309]]
Incidental oral intermediate-term NOAEL = 200 mg/kg/ LOC for MOE = 100.. Reproductive toxicity (oral)--rat.
(1 to 6 months). day. Offspring LOAEL = 1,000 mg/kg/day,
UFA = 10x........... based on decreased body weight
UFH = 10x........... gain in F1 females on day 70,
FQPA SF = 1x........ decreased F2 pup weights,
gestation survival, live pups/
litter, and increased incidence
of malformations.
One-year dietary study (co-
critical supporting study)--rat.
LOAEL = 625 mg/kg/day, based on
decreased body weight gain in
females during the first six
months, with a NOAEL of 62.5 mg/
kg/day.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 NOAEL = 200 mg/kg/ LOC for MOE = 100.. Reproductive toxicity (oral)--rat.
days). day (inhalation Offspring LOAEL = 1,000 mg/kg/day,
toxicity assumed to based on decreased body weight
be equivalent to gain in F1 females on day 70,
oral toxicity). decreased F2 pup weights,
UFA = 10x........... gestation survival, live pups/
UFH = 10x........... litter, and increased incidence
FQPA SF = 1x........ of malformations.
----------------------------------------------------------------------------------------------------------------
Inhalation intermediate-term (1 NOAEL = 200 mg/kg/ LOC for MOE = 100.. Reproductive toxicity (oral)--rat.
to 6 months). day (inhalation Offspring LOAEL = 1,000 mg/kg/day,
toxicity assumed to based on decreased body weight
be equivalent to gain in F1 females on day 70,
oral toxicity). decreased F2 pup weights,
UFA = 10x........... gestation survival, live pups/
UFH = 10x........... litter, and increased incidence
FQPA SF = 1x........ of malformations.
One-year dietary study (co-
critical supporting study)--rat.
LOAEL = 625 mg/kg/day, based on
decreased body weight gain in
females during the first six
months, with a NOAEL of 62.5 mg/
kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) ``Suggestive Evidence of Carcinogenic Potential,'' based on increased
incidence of hepatocellular adenomas in male and female mice. Quantitative
assessment of cancer risk using a cancer potency factor is not required. The
chronic RfD is protective of potential cancer risk.
----------------------------------------------------------------------------------------------------------------
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). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to isoxaben, EPA considered exposure under the petitioned-for
tolerances as well as all existing isoxaben tolerances in 40 CFR
180.650. EPA assessed dietary exposures from isoxaben in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
isoxaben; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the US
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT).
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to isoxaben. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
isoxaben. Tolerance-level residues and 100 PCT 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 isoxaben in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of isoxaben. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Surface Water Concentration Calculator (SWCC v1.106)
and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of isoxaben for chronic exposures
are estimated to be 43.6 parts per billion (ppb) for surface water and
909 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the water concentration value of 909 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).
[[Page 5310]]
Isoxaben is currently registered for the following uses that could
result in residential exposures: Residential turf. EPA assessed
residential exposure using the following assumptions: Isoxaben
residential uses constitute short- and intermediate-term exposure
scenarios. For residential handlers, since a dermal endpoint was not
selected, the only route of exposure quantitatively assessed for adult
handlers is through inhalation. For post-application exposures, only
intermediate-term incidental oral exposures for children were assessed
due to the persistence of isoxaben residues in soil. Neither a short-
term dermal nor short-term incidental oral endpoint was selected for
children. Although there is potential for post-application inhalation
exposure of both adults and children, the estimated exposure is
anticipated to be negligible; therefore, a quantitative post-
application inhalation assessment was not required.
For the purpose of performing an aggregate assessment, the Agency
selected only the most conservative, or worst-case, residential adult
and child scenarios to be included in the aggregate, based on the
lowest overall MOE (highest exposure estimates). For adults, handler
inhalation exposure resulting from the application of a granular
formulation of isoxaben to residential lawns via push-type spreader has
been used to estimate adult aggregate exposure. (The inhalation
exposure was added to background exposure from food and water, and
compared to the short-term inhalation POD.) Post-application risks for
adults in residential settings were not assessed due to the lack of a
dermal endpoint.
For children, an intermediate-term aggregate assessment was
conducted by adding the incidental soil ingestion exposure, and average
food and water exposure (chronic dietary exposure). The incidental oral
residential exposure value selected for the aggregate analysis is based
on children ingesting soil particles containing pesticide residues
while playing on treated turf. Due to the persistence of isoxaben in
the soil, the Agency used a conservative approach by using the maximum
seasonal application rate for estimating soil ingestion by children
rather than the standard maximum single application rate. This scenario
resulted in the highest calculated exposure levels; therefore, it is
protective for all other oral post-application exposure and risk for
children in residential settings.
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.''
EPA has not found isoxaben to share a common mechanism of toxicity
with any other substances, and isoxaben does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that isoxaben does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
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. No evidence of increased
susceptibility was observed in the rat or rabbit developmental toxicity
studies, but was observed in the rat reproductive toxicity study only
at the limit dose.
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 isoxaben is adequately complete to
allow the Agency to assess the toxicological profile of isoxaben.
ii. There is no indication that isoxaben is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. No evidence of increased susceptibility was observed in the
rat or rabbit developmental toxicity studies, but was observed in the
rat reproductive toxicity study only at the limit dose; however, this
risk assessment is protective of the susceptibility observed at the
limit dose in the reproductive toxicity study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to isoxaben in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
isoxaben.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
isoxaben is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
isoxaben from food and water will utilize 98% of the cPAD for all
infants less than 1-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
isoxaben is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account
[[Page 5311]]
short-term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Isoxaben is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to isoxaben.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 6,700 for
females 13-49 years old. Because EPA's level of concern for isoxaben is
a MOE of 100 or below, this MOE is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Isoxaben is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to isoxaben.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 7,200 for children 1-2 years old. Because EPA's level
of concern for isoxaben is a MOE of 100 or below, this MOE is not of
concern.
5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA considers the chronic aggregate risk
assessment to be protective of any aggregate cancer risk. As there is
no chronic risk of concern, EPA does not expect any cancer risk to the
U.S. population from aggregate exposure to isoxaben.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to isoxaben residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate residue analytical method (RAM) utilizing liquid
chromatography with tandem mass spectrometric detection (LC/MS/MS), GRM
02.26.S.1 (a revision of GRM 02.26), is available for enforcement of
isoxaben residues in crop commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established any MRLs for isoxaben.
C. Response to Comments
Seven comments were received in response to the notice of filing.
All of the comments were general in nature, not specific to the
chemical isoxaben. They included statements such as ``I am not in favor
of relaxing requirements on pesticides,'' ``I am opposed to this
proposal,'' and ``My body doesn't live well on pesticides.''
The Agency recognizes that some individuals believe that pesticides
should be banned on agricultural crops; however, the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. These
citizens' comments appear to be directed at the underlying statute and
not EPA's implementation of it; the citizens have made no contention
that EPA has acted in violation of the statutory framework nor have
they provided any specific information or allegation that would support
a finding that these tolerances are unsafe.
V. Conclusion
Therefore, tolerances are established for residues of isoxaben
including its metabolites and degradates, in or on apple at 0.01 ppm;
the bushberry subgroup 13-07B at 0.01 ppm; the fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; and the
nut, tree, group 14-12 at 0.02 ppm. In addition, the following existing
tolerances are removed since they are superseded by the new tolerances:
Grape, nut, tree, group 14; and pistachio.
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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not 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
[[Page 5312]]
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: January 19, 2018.
Donna S. Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.650, revise the table in paragraph (a) to read as
follows:
Sec. 180.650 Isoxaben; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls........................................... 0.40
Apple................................................... 0.01
Bushberry subgroup 13-07B............................... 0.01
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.01
subgroup 13-07F........................................
Nut, tree, group 14-12.................................. 0.02
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-02346 Filed 2-6-18; 8:45 am]
BILLING CODE 6560-50-P
