Isoxaben; Pesticide Tolerances, 29340-29345 [2020-08962]
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Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for acequinocyl in or on the bushberry
subgroup 13–07B.
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V. Conclusion
Therefore, a tolerance is established
for residues of acequinocyl, including
its metabolites and degradates in or on
the bushberry subgroup 13–07B at 3
ppm.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under 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
have a substantial direct effect on States
or Tribal Governments, on the
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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 1, 2020.
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 § 180.599, amend the table in
paragraph (a) by adding in alphabetical
order an entry for ‘‘Bushberry subgroup
13–07B’’ to read as follows:
■
§ 180.599 Acequinocyl; tolerances for
residues.
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[FR Doc. 2020–09451 Filed 5–14–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0070; FRL–10001–14]
Isoxaben; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of isoxaben in or
on the caneberry subgroup 13–07A and
hop, dried cones. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
15, 2020. Objections and requests for
hearings must be received on or before
July 14, 2020, 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–2019–0070, 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:
SUMMARY:
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Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s eCFR 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–2019–0070 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
14, 2020. 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–
2019–0070, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of June 7, 2019
(84 FR 26630) (FRL–9993–93), 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 8E8731) by IR–4, IR–4
Project Headquarters, Rutgers, The State
University of New Jersey, 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
isoxaben, N-[3-(1-ethyl-1-methylpropyl)5-isoxazolyl]-2, 6-dimethoxybenzamide
in or on the raw agricultural
commodities Hop, dried cones at 0.01
parts per million (ppm) and Caneberry
subgroup 13–07A at 0.01 ppm. That
document referenced a summary of the
petition prepared by the Dow Chemical
Company, the registrant, which is
available in the docket, https://
www.regulations.gov. A comment was
received on the notice of filing. EPA’s
response to this comment 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
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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. There
was no evidence of increased
quantitative susceptibility for pre- and/
or post-natal effects in the rat and rabbit
developmental toxicity studies, nor in
the rat multigeneration reproductive
toxicity study. Increased qualitative
susceptibility was observed in the rat
reproductive toxicity study; however,
concern for qualitative susceptibility is
low because these effects were only
observed at the limit dose of 1,000 mg/
kg/day in the presence of maternal
effects.
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 chronic reference dose
is considered protective of potential
carcinogenicity and a separate
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
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(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
titled ‘‘Isoxaben. Human Health Risk
Assessment to Support Proposed New
Uses on Caneberry Subgroup 13–07A
and Hops’’ on page numbers 32–37 in
docket ID number EPA–HQ–OPP–2019–
0070.
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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 discussed in Unit
III.B. of the final rule published in the
Federal Register of February 7, 2018 (83
FR 5307) (FRL–9972–75).
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
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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 U.S.
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.,
chronic exposure.
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-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: Landscape
ornamentals, lawns/turf, and trees. 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 applications of isoxabentreated mulch by hand 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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science-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-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-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
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D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased
quantitative susceptibility for pre- and/
or post-natal effects in the rat and rabbit
developmental toxicity studies, nor in
the rat multigeneration reproductive
toxicity study. Increased qualitative
susceptibility was observed in the rat
reproductive toxicity study, however,
concern for qualitative susceptibility is
low because these effects were only
observed at the limit dose of 1,000 mg/
kg/day in the presence of maternal
effects. The NOAEL/LOAEL for these
effects is well-defined, and risk
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assessment PODs were selected to be
protective for these effects.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1x. That decision is
based on the following findings:
i. The toxicity database for isoxaben is
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. There was no evidence of
increased quantitative susceptibility for
pre- and/or post-natal effects in the rat
and rabbit developmental toxicity
studies, nor in the rat multigeneration
reproductive toxicity study. Increased
qualitative susceptibility was observed
in the rat reproductive toxicity study,
however, concern for qualitative
susceptibility is low because these
effects were only observed at the limit
dose of 1,000 mg/kg/day in the presence
of maternal effects. The regulatory
endpoint is protective of the offspring
effects.
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
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29343
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
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 10,500 for females 13
to 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 to 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
E:\FR\FM\15MYR1.SGM
15MYR1
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Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations
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 analytical method
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: 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.
jbell on DSKJLSW7X2PROD with RULES
C. Response to Comments
One comment was received that
stated in part that isoxaben ‘‘should (sic)
not be allowed to be used on hop, etc.’’
Although the Agency recognizes that
some individuals believe that pesticides
should be banned on agricultural crops,
the existing legal framework provided
by section 408 of the Federal Food, Drug
and Cosmetic Act (FFDCA) authorizes
EPA to establish tolerances when it
determines that the tolerance is safe.
Upon consideration of the validity,
completeness, and reliability of the
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16:12 May 14, 2020
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available data as well as other factors
the FFDCA requires EPA to consider,
EPA has determined that these isoxaben
tolerances are safe. The commenter has
provided no information supporting a
contrary conclusion.
V. Conclusion
Therefore, tolerances are established
for residues of isoxaben in or on the
caneberry subgroup 13–07A at 0.01 ppm
and hop, dried cones 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); 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 tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the National
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
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 3, 2020.
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 § 180.650, add alphabetically the
entries ‘‘Caneberry subgroup 13–07A’’
and ‘‘Hop, dried cones’’ to the table in
paragraph (a) to read as follows:
■
§ 180.650 Isoxaben; tolerances for
residues.
(a) * * *
E:\FR\FM\15MYR1.SGM
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Federal Register / Vol. 85, No. 95 / Friday, May 15, 2020 / Rules and Regulations
Commodity
Parts per million
*
*
*
Caneberry subgroup 13– 0.01
07A.
*
*
*
*
*
Hop, dried cones ............ 0.01
*
*
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2020–08962 Filed 5–14–20; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 200420–0118]
RIN 0648–XH043
Fisheries of the Northeastern United
States; Summer Flounder, Scup, and
Black Sea Bass Fisheries; Revised
2020 and Projected 2021 Black Sea
Bass and Scup Specifications
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule.
AGENCY:
This action approves revised
2020 and projected 2021 specifications
for the scup and black sea bass fisheries.
Changes to the specifications are
necessary to better achieve optimum
yield within the fishery while
controlling overfishing, consistent with
recent stock assessment updates and the
Magnuson-Stevens Fishery
Conservation and Management Act.
This rule informs the public of the
changes to the specifications for the
remainder of the 2020 fishing year and
announces projected 2021
specifications.
SUMMARY:
Effective May 15, 2020, through
December 31, 2020.
ADDRESSES: Copies of the revised
specifications, including the
DATES:
Environment Assessment, and other
supporting documents for the action, are
available upon request from Dr.
Christopher M. Moore, Executive
Director, Mid-Atlantic Fishery
Management Council, Suite 201, 800 N
State Street, Dover, DE 19901. These
documents are also accessible via the
internet at https://www.mafmc.org.
FOR FURTHER INFORMATION CONTACT:
Emily Keiley, Fishery Policy Analyst,
(978) 281–9116.
SUPPLEMENTARY INFORMATION:
Background
The Mid-Atlantic Fishery
Management Council and the Atlantic
States Marine Fisheries Commission
jointly manage the scup and black sea
bass fisheries as part of the Summer
Flounder, Scup, and Black Sea Bass
Fishery Management Plan (FMP). Scup
and black sea bass annual catch and
landings limits do not roll over from one
year to the next. To meet the FMP
objectives and requirements of the
Magnuson-Stevens Act, commercial
quotas and recreational harvest limits
(RHL) must be in place by January 1 of
each year. At a joint meeting in October
2019, the Council and the Commission’s
Summer Flounder, Scup, and Black Sea
Bass Board adopted interim 2020 catch
and landings limits for scup and black
sea bass in late 2019 (84 FR 54041,
October 9, 2019). The interim limits
were identical to 2019 limits and
intended to be replaced as soon as
possible following operational stock
assessments for both species conducted
in the fall of 2019. Interim 2020
specifications were necessary because
there was not sufficient time to
complete the specification development
and rulemaking between the stock
assessment peer review and January 1,
2020. This action implements the
updated 2020 specifications replacing
the interim measures and announces
projected 2021 specifications for scup
and black sea bass.
The Council’s Scientific and
Statistical Committee (SSC) and the
Summer Flounder, Scup, and Black Sea
Bass Monitoring Committee (MC) met in
October 2019 to review the operational
29345
stock assessment results and make
recommendations to the Council for
revised catch and landings limits. The
SSC applied the Council’s risk policy
and acceptable biological catch (ABC)
control rule to derive recommended
overfishing limits (OFL) and ABC values
for fishing years 2020 and 2021.
The Council and Board reviewed the
new operational stock assessment
information and the SSC and MCrecommended specifications at their
joint meeting in October 2019, and took
final action on revised 2020 and
projected 2021 specifications. This
action implements the Council and
Board’s preferred alternatives.
This action is being published
without prior notice and a formal public
comment period. The revised 2020 scup
and black sea bass specifications
included in this action were anticipated
during development of the interim
specifications, which were the subject of
a notice and comment rulemaking
process. Prior to our rulemaking, the
Council and Board discussed that the
interim measures would be replaced as
quickly as possible once the operational
stock assessment process was complete.
The public was also notified of our
intent to publish revised specifications
in the proposed and final rules of the
interim scup and black sea bass
specifications action (84 FR 54041,
October 9, 2019).
Revised Specifications
Black Sea Bass Specifications
The Council and Board recommended
2020–2021 black sea bass catch and
landings limits are shown in Table 1.
The recommendations are based on the
averaged 2020–2021 ABCs
recommended by the SSC. This
approach allows for constant catch and
landings limits across both years. The
ABCs are based on an SSC-modified
OFL and the Council’s risk policy for a
species with a typical life history and
biomass level above BMSY, resulting in
a 40-percent probability of overfishing.
The final 2020 commercial quota and
RHL are 59 percent higher than the
interim 2020 limits.
TABLE 1—2020–2021 BLACK SEA BASS CATCH AND LANDINGS LIMITS *
Measure
Mil lb.
jbell on DSKJLSW7X2PROD with RULES
OFL ..........................................................................................................................................................................
ABC ..........................................................................................................................................................................
ABC Landings Portion .............................................................................................................................................
ABC Discards Portion ..............................................................................................................................................
Expected Commercial Discards ..............................................................................................................................
Expected Recreational Discards .............................................................................................................................
Commercial ACL = ACT ..........................................................................................................................................
Commercial Quota ...................................................................................................................................................
VerDate Sep<11>2014
16:12 May 14, 2020
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Fmt 4700
Sfmt 4700
E:\FR\FM\15MYR1.SGM
15MYR1
2020: 19.39
2021: 17.68
15.07
11.39
3.68
1.4
2.28
6.98
5.58
Metric ton
2020: 8,795
2021: 8,021
6,835
5,164
1,671
637
1,034
3,167
2,530
]]>Agencies
[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Rules and Regulations]
[Pages 29340-29345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08962]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0070; FRL-10001-14]
Isoxaben; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
isoxaben in or on the caneberry subgroup 13-07A and hop, dried cones.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 15, 2020. Objections and
requests for hearings must be received on or before July 14, 2020, 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-2019-0070, 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:
[[Page 29341]]
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
Publishing 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-2019-0070 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 14, 2020. 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-2019-0070, 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 June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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
8E8731) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 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 isoxaben, N-[3-(1-
ethyl-1-methylpropyl)-5-isoxazolyl]-2, 6-dimethoxybenzamide in or on
the raw agricultural commodities Hop, dried cones at 0.01 parts per
million (ppm) and Caneberry subgroup 13-07A at 0.01 ppm. That document
referenced a summary of the petition prepared by the Dow Chemical
Company, the registrant, which is available in the docket, https://www.regulations.gov. A comment was received on the notice of filing.
EPA's response to this comment 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. There was no
evidence of increased quantitative susceptibility for pre- and/or post-
natal effects in the rat and rabbit developmental toxicity studies, nor
in the rat multigeneration reproductive toxicity study. Increased
qualitative susceptibility was observed in the rat reproductive
toxicity study; however, concern for qualitative susceptibility is low
because these effects were only observed at the limit dose of 1,000 mg/
kg/day in the presence of maternal effects.
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 chronic reference dose is considered
protective of potential carcinogenicity and a separate 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
[[Page 29342]]
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies can be found at https://www.regulations.gov in the
document titled ``Isoxaben. Human Health Risk Assessment to Support
Proposed New Uses on Caneberry Subgroup 13-07A and Hops'' on page
numbers 32-37 in docket ID number EPA-HQ-OPP-2019-0070.
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 discussed in Unit III.B. of the final rule
published in the Federal Register of February 7, 2018 (83 FR 5307)
(FRL-9972-75).
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 U.S.
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., chronic exposure.
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).
Isoxaben is currently registered for the following uses that could
result in residential exposures: Landscape ornamentals, lawns/turf, and
trees. 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 applications of isoxaben-treated
mulch by hand 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-
[[Page 29343]]
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. There was no evidence of
increased quantitative susceptibility for pre- and/or post-natal
effects in the rat and rabbit developmental toxicity studies, nor in
the rat multigeneration reproductive toxicity study. Increased
qualitative susceptibility was observed in the rat reproductive
toxicity study, however, concern for qualitative susceptibility is low
because these effects were only observed at the limit dose of 1,000 mg/
kg/day in the presence of maternal effects. The NOAEL/LOAEL for these
effects is well-defined, and risk assessment PODs were selected to be
protective for these effects.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for isoxaben is 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. There was no evidence of increased quantitative susceptibility
for pre- and/or post-natal effects in the rat and rabbit developmental
toxicity studies, nor in the rat multigeneration reproductive toxicity
study. Increased qualitative susceptibility was observed in the rat
reproductive toxicity study, however, concern for qualitative
susceptibility is low because these effects were only observed at the
limit dose of 1,000 mg/kg/day in the presence of maternal effects. The
regulatory endpoint is protective of the offspring effects.
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 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 10,500 for
females 13 to 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 to 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
[[Page 29344]]
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 analytical method 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]ov.
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
One comment was received that stated in part that isoxaben ``should
(sic) not be allowed to be used on hop, etc.'' Although the Agency
recognizes that some individuals believe that pesticides should be
banned on agricultural crops, the existing legal framework provided by
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA)
authorizes EPA to establish tolerances when it determines that the
tolerance is safe. Upon consideration of the validity, completeness,
and reliability of the available data as well as other factors the
FFDCA requires EPA to consider, EPA has determined that these isoxaben
tolerances are safe. The commenter has provided no information
supporting a contrary conclusion.
V. Conclusion
Therefore, tolerances are established for residues of isoxaben in
or on the caneberry subgroup 13-07A at 0.01 ppm and hop, dried cones 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); 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 tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the National Government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 3, 2020.
Michael Goodis,
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, add alphabetically the entries ``Caneberry
subgroup 13-07A'' and ``Hop, dried cones'' to the table in paragraph
(a) to read as follows:
Sec. 180.650 Isoxaben; tolerances for residues.
(a) * * *
[[Page 29345]]
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Caneberry subgroup 13-07A................. 0.01
* * * * *
Hop, dried cones.......................... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-08962 Filed 5-14-20; 8:45 am]
BILLING CODE 6560-50-P
