Penthiopyrad; Pesticide Tolerances, 26352-26359 [2019-11676]
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Federal Register / Vol. 84, No. 109 / Thursday, June 6, 2019 / Rules and Regulations
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David Gray was designated the Acting
Regional Administrator on May 28, 2019
through the order of succession outlined
in Regional Order R6–1110.13, a copy of
which is included in the docket for this
action.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Ozone, Volatile organic
compounds.
Dated: May 28, 2019.
David Gray,
Acting Regional Administrator, Region 6.
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart SS—Texas
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§ 52.2270
[Amended]
2. In § 52.2270 the table in paragraph
(c) entitled ‘‘EPA Approved Regulations
in the Texas SIP’’ is amended by
removing the entry for ‘‘Section 114.86’’
under Chapter 114 (Reg 4)—Control of
Air Pollution from Motor Vehicles.
■
[FR Doc. 2019–11760 Filed 6–5–19; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0674; FRL–9994–08]
Penthiopyrad; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of penthiopyrad
in or on multiple commodities that are
identified and discussed later in this
document. In addition, this regulation
removes certain established
penthiopyrad tolerances that are
superseded by new tolerances
established in this final rule.
Interregional Research Project Number 4
(IR–4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective June
6, 2019. Objections and requests for
hearings must be received on or before
August 5, 2019, 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–2017–0674, 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:
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
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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 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–2017–0674 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before August 5, 2019. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0674, 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.
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• 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.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of July 24,
2018 (83 FR 34968) (FRL–9980–31),
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 7E8616) by
Interregional Research Project Number 4
(IR–4), IR–4 Project Headquarters,
Rutgers, The State University of New
Jersey, 500 College Road East, Suite
201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.658 be
amended by establishing tolerances for
residues of the fungicide penthiopyrad,
(N-[2-(1,3-dimethylbutyl)-3-thienyl]-1methyl-3-(trifluoromethyl)-1H-pyrazole4-carboxamide), in or on Brassica, leafy
greens, subgroup 4–16B at 50 parts per
million (ppm); Bushberry subgroup 13–
07B at 6 ppm; Caneberry subgroup 13–
07A at 10 ppm; Celtuce at 30 ppm;
Fennel, Florence at 30 ppm; Fruit,
stone, group 12–12 at 4.0 ppm; Kohlrabi
at 5.0 ppm; Leaf petiole vegetable
subgroup 22B at 30 ppm; Leafy greens
subgroup 4–16A at 30 ppm; Nut, tree,
group 14–12 at 0.06 ppm; Oilseed group
20 at 1.5 ppm; and Vegetable, brassica,
head and stem, group 5–16 at 5.0 ppm.
The petitioner also requested that the
following established tolerances be
removed upon establishment of the
petitioned-for tolerances: Brassica, head
and stem, subgroup 5A at 5.0 ppm;
Brassica, leafy greens, subgroup 5B at 50
ppm; Canola at 1.5 ppm; Cotton, seed at
1.5 ppm; Fruit, stone, group 12 at 4.0
ppm; Nut, tree, group 14 at 0.06 ppm;
Pistachio at 0.06 ppm; Sunflower, seed
at 1.5 ppm and Vegetable, leafy, except
Brassica, group 4 at 30 ppm. That
document referenced a summary of the
petition prepared by DuPont, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Based upon review of the data
supporting the petition, EPA has made
certain corrections and modifications to
petitioned-for tolerances. The reasons
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for these changes are explained 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 penthiopyrad
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with penthiopyrad follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
The liver and thyroid are target organs
for penthiopyrad toxicity. Metabolism
studies show higher radioactive
residues in the liver, compared to other
tissues. Short-term oral exposure
resulted in liver alterations (weight
increases, enzyme changes,
hypertrophy, and/or histopathology) in
rats and mice at similar doses, and dogs
at higher doses. Of the three species, the
liver effects observed in rats were more
significant (fatty change, hepatocellular
degeneration, and Kupffer cell
proliferation) than the liver effects in
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the other species (e.g., increased liver
weight, hepatocellular hypertrophy).
Short-term exposure also resulted in
thyroid changes in mice (hypertrophy)
and rats (decreased weight,
hypertrophy/proliferation, and hormone
changes). Other effects observed were
body weight changes and hematological
alterations in rats and dogs, along with
gallbladder effects (inflammation and
edema) in dogs. Short-term dermal
exposure did not result in dermal
irritation or systemic effects up to the
limit dose.
Subchronic rat studies are also
available for penthiopyrad metabolites
PCA and DM–PCA. Short-term exposure
to PCA did not result in treatmentrelated effects up to the limit dose.
Short-term exposure to DM–PCA
resulted in decreased body weight gain
and food consumption at high doses.
However, the effects with DM–PCA
were seen at higher doses than the
effects observed in subchronic rat
studies with the technical grade active
ingredient.
Long-term exposure in rats (at lower
doses) resulted in liver effects
comparable to those seen in subchronic
studies, as well as adrenal and thyroid
hypertrophy. Higher doses resulted in
more progressive liver effects
(vacuolation, periportal cell swelling,
and necrosis), thyroid tumors (males),
and ovarian hypertrophy. No effects
were observed in the ovaries in other
toxicity studies. In mice, chronic
exposure led to liver and thyroid effects
and liver tumors (males). Alveolar
foamy cell accumulation was also seen
in mice, but it was not considered to be
an adverse effect. In dogs, effects noted
(liver, gallbladder, and adrenal gland)
were similar to those seen in subchronic
dog studies, with the addition of
gallbladder hypertrophy/hyperplasia.
In the developmental toxicity study in
rats, comparable toxicity was noted in
fetal and maternal animals. Effects
observed were decreased body weight
gain and food consumption, increased
resorptions (resulting in decreased postimplantation survival), decreased litter
size, and decreased gravid uterine
weight at the limit dose. No effects were
noted in a preliminary study in rats up
to the limit dose. In the developmental
toxicity study in rabbits, decreased fetal
body weight was seen in the presence of
maternal toxicity. Abortion was noted in
one maternal animal, preceded by a
period of markedly reduced food
consumption and body weight loss, at
the highest dose tested. In a preliminary
study, decreased fetal body weight was
seen at the limit dose. At lower doses,
maternal effects including decreased
water and food consumption, body
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weight loss, and abnormal feces were
seen. At the limit dose, increased
abortions and mortality were noted in
maternal animals. In the reproductive
toxicity study in rats, body weight
changes, liver, adrenal, and thyroid
effects were seen in maternal animals in
preliminary and definitive studies.
Offspring effects included body weight
changes, delay in preputial separation,
and decreased thymus weights at
similar doses. Decreased spleen weights
were seen in offspring animals in the
preliminary reproduction study. No
reproductive toxicity was observed.
In the developmental neurotoxicity
study in rats (definitive study),
decreased body weight, increased motor
activity, and tremors were seen in
offspring animals in the absence of
maternal toxicity. In the preliminary
study, decreased pup weight,
deterioration, and mortality were seen
in offspring animals in the absence of
maternal toxicity. Clinical signs were
observed in the acute neurotoxicity
study with penthiopyrad. Transient
functional alterations (hunched posture,
unsteady gait, reduced body
temperature, and increased landing
footsplay) and decreased motor activity
were seen at the estimated time-to-peakeffect (4 hours). In a subchronic
neurotoxicity study, decreased body
weight gain was seen at the highest dose
tested; however, no clinical signs were
observed, and there was no evidence of
neurotoxicity.
Immunotoxicity studies were
conducted in both mice and rats for
penthiopyrad. In the immunotoxicity
study in mice, decreased plaque forming
ability was observed at the limit dose.
However, in the immunotoxicity study
in rats, no evidence of immunotoxicity
was observed up to the highest dose
tested. General toxicity noted in the rat
study included decreased body weight
gain and food consumption, increased
liver weight, and decreased spleen
weight.
A mutagenicity battery is available for
penthiopyrad technical ingredient and
the majority of the studies were
negative; however, chromosome
aberrations were observed at cytotoxic
concentrations in an in vitro assay.
Mutagenicity studies are also available
for several penthiopyrad metabolites
(PCA, DM–PCA, PAM, and 753–A–OH).
These studies were usually negative;
however, the PAM metabolite induced
chromosome aberrations (-S9 after 24
hours) and PCA induced a weakly
positive mutant frequency (after 24
hours); however, based on the overall
analysis of the available data,
penthiopyrad is not considered to be
mutagenic.
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EPA classified penthiopyrad as
having ‘‘suggestive evidence of
carcinogenicity,’’ based on an increased
incidence of treatment-related liver
tumors in male mice. Thyroid tumors
were observed in male rats but were not
considered to be treatment related. In
accordance with the EPA’s Final
Guidelines for Carcinogen Risk
Assessment (March 2005), the Agency
has determined that the quantification
of risk using a non-linear approach
based on the chronic reference dose (i.e.,
cRfD) which is 7x lower than the dose
at which tumors were observed will
adequately account for all chronic
toxicity, including carcinogenicity, that
could result from penthiopyrad
exposure.
Specific information on the studies
received and the nature of the adverse
effects caused by penthiopyrad as well
as the no-observed-adverse-effects-level
(NOAEL) and the lowest-observedadverse-effects-level (LOAEL) identified
from the toxicity studies can be found
at https://www.regulations.gov in
document SUBJECT: Penthiopyrad.
Human Health Risk Assessment for
Proposed New Use on Caneberry
Subgroup 13–07A and Bushberry
Subgroup 13–07B; and Crop Group/
Subgroup Conversions and Expansions
at page 39 in docket ID number EPA–
HQ–OPP–2017–0674.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (PODs)
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
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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 previously applied
penthiopyrad toxicological endpoints
for human risk assessment is discussed
in Unit III of the final rule published in
the Federal Register of March 9, 2012
(77 FR 14291) (FRL–9335–7). That
database was recently re-evaluated/
updated based on current practices and
includes updated dermal endpoints and
PODs selected for adults and children.
As a result of the database update, one
endpoint and POD based on the 28-day
oral toxicity study in the dog is used for
all populations, and also used to derive
the endpoints/PODs for the incidental
oral and inhalation routes of exposure.
The updated NOAELs, LOAELs, and the
PODs are summarized below for the
affected exposure/scenarios:
i. Children and adult dermal
exposures. Children and adult dermal
exposures were previously assessed
with separate endpoints/PODs. Dermal
exposure is now being evaluated using
the same endpoint and POD for all ages,
from the 28-day dog study. The revised
dermal NOAEL is 80 milligrams per
kilogram (mg/kg/day), based on mucosal
edema in gall bladder as well as clinical
chemistry and increased organ weight/
histopathology in the livers of females at
the LOAEL of 269 mg/kg/day.
ii. Previous adult dermal assessment.
The developmental rabbit study was
previously used for the adult dermal
assessment with a NOAEL of 75 mg/kg/
day based on abortions in one animal at
the LOAEL of 225 mg/kg/day. The
endpoint is not strong, and the dose
spacing is comparable to the selected
28-day dog study.
iii. Previous children’s dermal
assessment. Previously the
developmental neurotoxicity (DNT) was
selected for the children’s dermal
assessment. The respective NOAEL and
LOAEL for that study are 100 mg/kg/day
and 250 mg/kg/day. Again, due to dose
spacing, the study is comparable to the
28-dog study, whose NOAEL is
protective of the DNT NOAEL. In
addition, the effects seen in the 28-day
dog study include gallbladder effects, an
organ rats do not have, which is a
potentially human-relevant effect.
iv. Inhalation and incidental oral
assessments. The 28-day dog study,
which previously was used and
continues to also be used for the
inhalation and incidental oral
assessments was also updated. The
NOAEL is now 80 mg/kg/day, based on
mucosal edema in the gallbladder; as
well as clinical chemistry, increased
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organ weight and histopathology in the
liver of females at the LOAEL of 269
mg/kg/day. The updated NOAEL is
comparable to or protective of other
NOAEL and LOAEL values in the
database, including those relating to
susceptibility.
v. Residential incidental oral,
inhalation, and dermal exposures. The
28-day dog study is now being used to
assess residential incidental oral,
inhalation, and dermal exposures.
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A summary of the toxicological
endpoints for penthiopyrad used for
dietary and non-occupational human
health risk assessment is shown in the
Table of this unit.
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PENTHIOPYRAD FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, level of
concern for risk
assessment
Acute dietary (All populations) ..
NOAEL = 125 mg/
kg/day.
UFA = 10x
UFH =10x
FQPA SF = 1x
Acute RfD = 1.25
mg/kg/day.
aPAD = 1.25
mg/kg/day
Chronic dietary (All populations)
NOAEL = 27 mg/kg/
day.
UFA = 10x
UFH =10x
FQPA SF = 1x
Chronic RfD = 0.27
mg/kg/day.
cPAD = 0.27
mg/kg/day
Incidental oral short-term (1–30
days) and Intermediate-term
(1–6 months).
NOAEL = 80 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL = 80 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
DAF = 40%
NOAEL = 80 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Residential LOC for
MOE = 100.
Dermal short-term (1–30 days);
Intermediate-term (1–6
months).
Inhalation short-term (1–30
days); Intermediate-term (1–6
months).
Cancer (oral, dermal, inhalation).
Study and toxicological effects
Acute Neurotoxicity in Rats.
LOAEL = 500 mg/kg/day, based on transient functional alterations (e.g., hunched posture, unsteady gait, reduced body
temperature, and increased landing footsplay) and decreased
motor activity at the estimated time-to-peak-effect (4 hours)
on the day of administration.
Co-Critical Studies:
Chronic Toxicity/Carcinogenicity in Rats LOAEL = 83 mg/kg/
day, based on decreased body weight gain and adrenal effects in females and hepatic periportal fatty degeneration in
males (NOAEL = 27 mg/kg/day).
Chronic Toxicity in Rats.
LOAEL = 100 mg/kg/day, based on altered plasma chemistry
profile, increased liver weight and alterations in the adrenal
and thyroid glands. (NOAEL = 25 mg/kg/day).
28-Day Oral Toxicity in Dogs.
LOAEL = 269 mg/kg/day, based on mucosal edema in the gall
bladder; clinical chemistry, increased organ weight and
histopathology in the liver of females.
Residential LOC for
MOE = 100.
28-Day Oral Toxicity in Dogs.
LOAEL = 269 mg/kg/day, based on mucosal edema in the gall
bladder; clinical chemistry, increased organ weight and
histopathology in the liver of females.
Residential LOC for
MOE = 100.
28-Day Oral Toxicity in Dogs.
LOAEL = 269 mg/kg/day, based on mucosal edema in the gall
bladder; clinical chemistry, increased organ weight and
histopathology in the liver of females.
Classification: ‘‘Suggestive Evidence of Carcinogenicity’’ based on liver tumors in male mice. The Agency has
determined that a nonlinear approach based on the chronic reference dose will be protective of potential carcinogenicity.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk estimates associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD =
population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. DAF = dermal absorption factor. IAF = inhalation absorption factor.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to penthiopyrad, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing penthiopyrad tolerances in 40
CFR 180.658. EPA assessed dietary
exposures from penthiopyrad in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
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occurring as a result of a 1-day or single
exposure.
Such effects were identified for
penthiopyrad. In estimating acute
dietary exposure, EPA used 2003–2008
food consumption information from the
United States Department of Agriculture
(USDA) National Health and Nutrition
Survey/What We Eat in America
(NHANES/WWEIA). The acute dietary
(food and drinking water) exposure
assessment was conducted using the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM–FCID), Version
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3.16. As to residue levels in food, EPA
assumed 100 percent crop treated (PCT)
and tolerance-level residues for all
existing and proposed commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the 2003–2008 food
consumption information from the
USDA NHANES/WWEIA. The chronic
dietary (food and drinking water)
exposure assessment was conducted
using DEEM–FCID, Version 3.16. As to
residue levels in food, EPA assumed 100
PCT and tolerance-level residues for all
existing and proposed commodities.
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iii. Cancer. EPA classified
penthiopyrad as having ‘‘suggestive
evidence of carcinogenicity,’’ based on
an increased incidence of treatmentrelated liver tumors in male mice and
determined that the quantification of
risk using a non-linear approach (i.e.,
RfD) will adequately account for all
chronic toxicity, including
carcinogenicity, that could result from
penthiopyrad exposure.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for
penthiopyrad. 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 penthiopyrad in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
penthiopyrad. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
Based on the First Index Reservoir
Screening Tool (FIRST) and Pesticide
Root Zone Model Ground Water (PRZM
GW), the estimated drinking water
concentrations (EDWCs) of
penthiopyrad are based on the use
pattern of highest exposure, which is
the currently labeled use on turf at 2.9
lbs active ingredient per acre per year.
The residues of concern assessed in
drinking water included penthiopyrad
and its cleavage product PAM. For acute
exposures, EDWCs are estimated to be
240 parts per billion (ppb) for surface
water and 1,330 ppb for ground water.
For chronic exposures for non-cancer
assessments, EDWCs are estimated to be
131 ppb for surface water and 978 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 1,330 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 978 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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Although the proposed new uses do
not include any residential use,
registered residential uses including
turf, lawn, and sod could result in
residential exposure and have been
reassessed in support of this rulemaking
to reflect updates to new dermal,
inhalation, and incidental oral PODs.
There is the potential for postapplication exposure for individuals
exposed as a result of being in an
environment that has been previously
treated with penthiopyrad. The
quantitative exposure/risk assessment
for residential post-application
exposures is based on the following
scenarios:
i. Adult dermal post-application
exposure resulting from contact with
treated turf;
ii. Dermal post-application exposure
to youth 11–16 yrs. old resulting from
mowing and playing golf on turf;
iii. Dermal post-application exposure
to children 6–11 yrs. old resulting from
playing golf on turf;
iv. Dermal post-application exposure
to children 1 to <2 yrs. old resulting
from playing on turf; and
v. Incidental oral post-application
exposure to children 1 to <2 yrs. old
resulting from playing on turf.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www2.epa.gov/pesticidescience-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 penthiopyrad to
share a common mechanism of toxicity
with any other substances, and
penthiopyrad does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that penthiopyrad 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.
No evidence of increased quantitative or
qualitative susceptibility was observed
in developmental toxicity studies in rats
or rabbits or in a reproduction toxicity
study in rats. However, increased
quantitative susceptibility was seen in
DNT studies in rats. Decreased body
weight (250 mg/kg/day), and increased
motor activity and tremors were seen in
offspring animals at 500 mg/kg/day.
Decreased body weight was seen at 300
mg/kg/day, and mortality was noted at
1,000 mg/kg/day in offspring animals.
The effects observed in offspring
animals in the DNT studies were seen
in the absence of maternal toxicity.
EPA concluded that there is a low
concern and no residual uncertainties
for prenatal and/or postnatal toxicity
effects of penthiopyrad,
notwithstanding observed increased
susceptibility seen in the preliminary
and definitive DNT studies, based on
the following data:
i. The pup body weight changes noted
in the definitive and preliminary DNT
studies were also observed in
developmental and reproduction studies
at similar doses. Additionally, the body
weight changes in these studies
occurred in the presence of significant
maternal toxicity. Although clinical
signs (tremors and increased motor
activity) were noted in offspring animals
in the definitive study, the neurotoxic
potential of penthiopyrad has been
adequately characterized in the
available neurotoxicity studies. Tremors
and changes in motor activity were
observed at very high doses in the acute
neurotoxicity study and were not
present in the subchronic neurotoxicity
study. In the preliminary DNT study,
mortality was observed in the offspring
animals at the limit dose. However, this
finding is attributed to the poor
condition (body weight loss, under
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activity, pallor) of the offspring animals
in this dose group.
ii. A clear NOAEL has been identified
for all offspring effects in the DNT
studies, and the PODs used in the risk
assessments are protective of the
observed 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
penthiopyrad is complete.
ii. There is no concern for
neurotoxicity after exposure to
penthiopyrad. A complete neurotoxicity
battery is available for penthiopyrad.
The database includes acute
neurotoxicity, subchronic neurotoxicity,
and DNT studies in rats. As a result, the
neurotoxic potential of penthiopyrad is
well characterized, and no additional
data are needed.
iii. As discussed in Unit IV.D.2., EPA
has concluded that there are no residual
uncertainties concerning prenatal and
postnatal effects, that would warrant
retaining the 10X FQPA safety factor.
iv. There are no residual uncertainties
identified in the exposure databases.
There are no residual uncertainties with
regard to dietary and residential
exposure. The dietary food exposure
assessments were performed based on
conservative assumptions that ensure
that exposures to penthiopyrad are not
underestimated, including tolerancelevel residues and 100 PCT estimates for
all registered commodities. The use of
default assumptions did not result in
risk estimates of concern for the
proposed new uses. Actual exposures
and risk estimates from penthiopyrad
will likely be lower. Furthermore,
conservative, upper-bound assumptions
were used to determine exposure
through drinking water and residential
sources, such that these exposures have
not been underestimated. 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 penthiopyrad.
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
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are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
penthiopyrad will occupy 21% of the
aPAD for all infants (<1-year-old), the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to penthiopyrad
from food and water will utilize 29% of
the cPAD for all infants (<1-year-old),
the population group receiving the
greatest exposure.
3. Short-and Intermediate-term risk.
Short- and intermediate-term risk
aggregate exposure takes into account
short- and intermediate-term risk
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). The
short- and intermediate-term
toxicological endpoints for
penthiopyrad are the same for each
route of exposure. Therefore, for
residential exposure scenarios, only
short-term exposures were assessed, and
are protective of intermediate-term
exposure and risk.
Penthiopyrad is proposed for
registration for uses that could result in
short-/intermediate-term residential
exposures, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short -term residential
exposures to penthiopyrad. These
assessments include exposure through
the dermal route for adults and youth,
and from dermal and incidental oral
exposure for children (1 to <2 yrs.).
EPA selected the following two
residential exposure scenarios which
represent the highest exposure and risk
scenarios for each population: (1) Adult
post-application exposure and (2)
children’s (1 to <2 yrs.) post-application
exposure resulting from contact with
treated turf. The level of concern for
these assessments is 100. The chronic
dietary exposure estimate for adults was
the background exposure added to the
dermal residential post-application
exposure estimates. The adult shortterm aggregate risk assessment resulted
in estimated MOEs of 440. The chronic
dietary exposure estimate for the
subgroup children 1 to <2 years old was
the background exposure added to the
children’s dermal and incidental oral
residential post-application exposure
estimates. The children’s short-term
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Fmt 4700
Sfmt 4700
26357
aggregate risk assessment resulted in
estimated MOEs of 220. These risk
estimates are not of concern to EPA.
5. Aggregate cancer risk for U.S.
population. EPA classified
penthiopyrad as having ‘‘suggestive
evidence of carcinogenicity’’ based on
liver tumors in male mice. The
quantification of risk using a non-linear
approach (i.e., the RfD) adequately
accounts for all chronic toxicity,
including carcinogenicity, therefore
cancer risk is not of concern.
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
penthiopyrad residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(a Liquid chromatography-tandem mass
spectrometry (LC/MS/MS) method
known as Method CEM 3399–001) is
available to enforce the tolerance
expression.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The U.S. tolerance definition for
penthiopyrad is harmonized with those
of Canada and Codex and most relevant
established tolerance levels are
harmonized with Canadian and Codex
MRLs. There are currently no
established Canadian or Codex MRLs for
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the proposed new uses for bushberries
or caneberries.
C. Revisions to Petitioned-For
Tolerances
In accordance with its authority in
FFDCA section 408(d)(4)(A)(i), EPA is
establishing tolerances in this rule that
vary slightly from what the petitioner
sought. These variations are explained
below.
1. The petitioner requested tolerances
in Fruit, stone, group 12–12 at 4.0 ppm,
Kohlrabi at 5.0 ppm, and Vegetable,
brassica, head and stem, group 5–16 at
5.0 ppm; EPA is establishing those
tolerances without the additional zero to
be consistent with OECD calculation
procedures.
2. The petitioner requested a tolerance
for ‘‘Fennel, Florence’’; EPA is
establishing a tolerance for the
commodity ‘‘Fennel, Florence, fresh
leaves and stalk’’ to be consistent with
commodity terms the Agency uses in
tolerances.
3. EPA is establishing a tolerance for
the Nut, tree group 14–12 tolerance at
0.05 ppm instead of 0.06 ppm as
requested in order to harmonize with
Codex MRL. The established tolerance
level is appropriate as the highest
average field trial residue was 0.037
ppm while other residues were below
LOQ (0.01 ppm).
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D. International Trade Considerations
In this final rule, EPA is reducing the
existing tolerances for the commodities
in the nut, tree group 14–12 from 0.06
ppm to 0.05 ppm. The Agency is
reducing these tolerances to harmonize
with Codex MRLs, and available residue
data demonstrates that tolerances at 0.05
ppm are sufficient to cover residues on
these commodities.
In accordance with the World Trade
Organization’s (WTO) Sanitary and
Phytosanitary Measures (SPS)
Agreement, EPA intends to notify the
WTO of this revision. In addition, the
SPS Agreement requires that members
provide a ‘‘reasonable interval’’ between
the publication of a regulation subject to
the agreement and its entry into force to
allow time for producers in exporting
member countries to adapt to the new
requirement. At this time, EPA is
establishing an expiration date for the
existing tolerances to allow those
tolerances to remain in effect for a
period of six months after the effective
date of this final rule, in order to
address the requirement to provide a
reasonable interval. After the six-month
period expires, residues of penthiopyrad
on commodities included in the nut,
tree group 14–12 cannot exceed the
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newly established tolerances of 0.05
ppm.
This reduction in tolerance levels is
not discriminatory; the same food safety
standard contained in the FFDCA
applies equally to domestically
produced and imported foods. The new
tolerance levels are supported by
available residue data.
V. Conclusion
Therefore, tolerances are established
for residues of penthiopyrad, (N-[2-(1,3dimethylbutyl)-3-thienyl]-1-methyl-3(trifluoromethyl)-1H-pyrazole-4carboxamide), in or on Brassica, leafy
greens, subgroup 4–16B at 50 ppm;
Bushberry subgroup 13–07B at 6 ppm;
Caneberry subgroup 13–07A at 10 ppm;
Celtuce at 30 ppm; Fennel, Florence,
fresh leaves and stalk at 30 ppm; Fruit,
stone, group 12–12 at 4 ppm; Kohlrabi
at 5 ppm; Leaf petiole vegetable
subgroup 22B at 30 ppm; Leafy greens
subgroup 4–16A at 30 ppm; Nut, tree,
group 14–12 at 0.05 ppm; Oilseed group
20 at 1.5 ppm; and Vegetable, brassica,
head and stem, group 5–16 at 5 ppm. In
addition, EPA is removing the following
tolerances from paragraph (a)(1) because
they are superseded by the new
tolerances being established in this
rulemaking: Brassica, head and stem,
subgroup 5A at 5.0 ppm; Brassica, leafy
greens, subgroup 5B at 50 ppm; Canola
at 1.5 ppm; Cotton, seed at 1.5 ppm;
Fruit, stone, group 12 at 4.0 ppm;
Sunflower, seed at 1.5 ppm; and
Vegetable, leafy, except brassica, group
4 at 30 ppm. Finally, EPA is establishing
a six-month expiration date for the
established pistachio and tree nut group
tolerances.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
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Sfmt 4700
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).
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List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 29, 2019.
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 the table in § 180.658(a)(1):
a. Remove the entries ‘‘Brassica, head
and stem, subgroup 5A’’ and ‘‘Brassica,
leafy greens, subgroup 5B’’;
■ b. Add alphabetically the
commodities ‘‘Brassica, leafy greens,
subgroup 4–16B’’, ‘‘Bushberry subgroup
13–07B’’, and ‘‘Caneberry subgroup 13–
07A’’;
■ c. Remove the entry ‘‘Canola’’;
■ d. Add alphabetically the commodity
‘‘Celtuce’’;
■ e. Remove the entry ‘‘Cotton, seed’’;
■ f. Add alphabetically the commodity
‘‘Fennel, Florence, fresh leaves and
stalk’’;
■ g. Remove the entry ‘‘Fruit, stone,
group 12’’;
■ h. Add alphabetically the
commodities ‘‘Fruit, stone, group 12–
12’’, ‘‘Kohlrabi’’, ‘‘Leaf petiole vegetable
subgroup 22B’’, and ‘‘Leafy greens
subgroup 4–16A’’;
■ i. Revise the entry ‘‘Nut, tree, group
14’’;
■ j. Add alphabetically the commodities
‘‘Nut, tree, group 14–12’’ and ‘‘Oilseed
group 20’’;
■ k. Revise the entry ‘‘Pistachio’’;
■ l. Remove the entry ‘‘Sunflower,
seed’’;
■ m. Add alphabetically the commodity
‘‘Vegetable, brassica, head and stem,
group 5–16’’;
■ n. Remove the entry ‘‘Vegetable, leafy,
except brassica, group 4’’; and
■ o. Add footnote 1 to the table.
The additions and revisions read as
follows:
■
■
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§ 180.658 Penthiopyrad; tolerances for
residues.
(a) * * *
(1) * * *
Parts per
million
Commodity
*
*
*
*
Brassica, leafy greens, subgroup
4–16B ......................................
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*
50
Parts per
million
Commodity
26359
This final authorization is
effective June 6, 2019.
DATES:
The EPA has established a
docket for this action under Docket ID
No. EPA–R05–RCRA–2018–0228. The
Docket ID No. was identified as EPA–
R05–RCRA–2017–0381 in the proposed
rule published in the October 10, 2018,
Federal Register at 83 FR 50868, but
that Docket ID No. was incorrect. All
documents in the docket are listed on
the https://www.regulations.gov website.
Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
ADDRESSES:
*
*
*
*
Bushberry subgroup 13–07B ......
Caneberry subgroup 13–07A .....
Celtuce ........................................
*
*
*
*
*
Fennel, Florence, fresh leaves
and stalk ..................................
*
*
*
*
*
Fruit, stone, group 12–12 ...........
*
*
*
*
*
Kohlrabi .......................................
Leaf petiole vegetable subgroup
22B ..........................................
Leafy greens subgroup 4–16A ...
*
*
*
*
*
Nut, tree, group 14 1 ...................
Nut, tree, group 14–12 ...............
*
0.06
0.05
*
*
*
*
Oilseed group 20 ........................
*
*
*
*
*
Pistachio 1 ...................................
*
0.06
6
10
30
30
4
5
30
30
1.5
Judith Greenberg, RCRA C and D
Section, Land and Chemicals Branch,
Land, Chemicals and Redevelopment
Division, U.S. Environmental Protection
*
Agency, 77 W Jackson Blvd., Chicago, IL
5 60604, phone number: (312) 886–4179,
email: greenberg.judith@epa.gov.
*
*
*
*
Vegetable, brassica, head and
stem, group 5–16 ....................
*
*
1 This
*
*
*
tolerance expires on December 6,
2019.
*
*
*
*
*
[FR Doc. 2019–11676 Filed 6–5–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[EPA–R05–RCRA–2018–0228; FRL–9994–
75–Region 5]
Michigan: Final Authorization of State
Hazardous Waste Management
Program Revisions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is granting Michigan final
authorization for changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). The Agency published a
proposed rule on October 10, 2018, and
provided for public comment. No
comments were received on the
proposed revisions. No further
opportunity for comment will be
provided.
SUMMARY:
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
A. What changes to Michigan’s
hazardous waste program is EPA
authorizing with this action?
On March 2, 2018, Michigan
submitted a complete program revision
application seeking authorization of
changes to its hazardous waste program
in accordance with 40 CFR 271.21. EPA
now makes a final decision that
Michigan’s hazardous waste program
revisions that are being authorized are
equivalent to, consistent with, and no
less stringent than the Federal program,
and therefore satisfy all the
requirements necessary to qualify for
final authorization. For a list of State
rules being authorized with this final
rule, please see the proposed rule
published in the October 10, 2018,
Federal Register at 83 FR 50869.
B. Which revised state rules are
different from the federal rules?
See the October 10, 2018, proposed
rule for a description of which state
rules are different from the federal rules,
with one exception. The proposed rule
incorrectly stated that Michigan has
proposed additions to its Universal
Wastes that will add Antifreeze, Aerosol
Cans and Paint Wastes that are not
already regulated as hazardous waste.
This statement should be disregarded.
E:\FR\FM\06JNR1.SGM
06JNR1
Agencies
[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Rules and Regulations]
[Pages 26352-26359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11676]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0674; FRL-9994-08]
Penthiopyrad; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
penthiopyrad in or on multiple commodities that are identified and
discussed later in this document. In addition, this regulation removes
certain established penthiopyrad tolerances that are superseded by new
tolerances established in this final rule. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 6, 2019. Objections and
requests for hearings must be received on or before August 5, 2019, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0674, 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
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-2017-0674 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 5, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0674, 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.
[[Page 26353]]
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 July 24, 2018 (83 FR 34968) (FRL-9980-
31), 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
7E8616) by Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters, Rutgers, The State University of New Jersey, 500 College
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that
40 CFR 180.658 be amended by establishing tolerances for residues of
the fungicide penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-
methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide), in or on
Brassica, leafy greens, subgroup 4-16B at 50 parts per million (ppm);
Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup 13-07A at 10
ppm; Celtuce at 30 ppm; Fennel, Florence at 30 ppm; Fruit, stone, group
12-12 at 4.0 ppm; Kohlrabi at 5.0 ppm; Leaf petiole vegetable subgroup
22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut, tree, group
14-12 at 0.06 ppm; Oilseed group 20 at 1.5 ppm; and Vegetable,
brassica, head and stem, group 5-16 at 5.0 ppm.
The petitioner also requested that the following established
tolerances be removed upon establishment of the petitioned-for
tolerances: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica,
leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at
1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; Nut, tree, group 14 at 0.06
ppm; Pistachio at 0.06 ppm; Sunflower, seed at 1.5 ppm and Vegetable,
leafy, except Brassica, group 4 at 30 ppm. That document referenced a
summary of the petition prepared by DuPont, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has made
certain corrections and modifications to petitioned-for tolerances. The
reasons for these changes are explained 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 penthiopyrad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with penthiopyrad follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The liver and thyroid are target organs for penthiopyrad toxicity.
Metabolism studies show higher radioactive residues in the liver,
compared to other tissues. Short-term oral exposure resulted in liver
alterations (weight increases, enzyme changes, hypertrophy, and/or
histopathology) in rats and mice at similar doses, and dogs at higher
doses. Of the three species, the liver effects observed in rats were
more significant (fatty change, hepatocellular degeneration, and
Kupffer cell proliferation) than the liver effects in the other species
(e.g., increased liver weight, hepatocellular hypertrophy).
Short-term exposure also resulted in thyroid changes in mice
(hypertrophy) and rats (decreased weight, hypertrophy/proliferation,
and hormone changes). Other effects observed were body weight changes
and hematological alterations in rats and dogs, along with gallbladder
effects (inflammation and edema) in dogs. Short-term dermal exposure
did not result in dermal irritation or systemic effects up to the limit
dose.
Subchronic rat studies are also available for penthiopyrad
metabolites PCA and DM-PCA. Short-term exposure to PCA did not result
in treatment-related effects up to the limit dose. Short-term exposure
to DM-PCA resulted in decreased body weight gain and food consumption
at high doses. However, the effects with DM-PCA were seen at higher
doses than the effects observed in subchronic rat studies with the
technical grade active ingredient.
Long-term exposure in rats (at lower doses) resulted in liver
effects comparable to those seen in subchronic studies, as well as
adrenal and thyroid hypertrophy. Higher doses resulted in more
progressive liver effects (vacuolation, periportal cell swelling, and
necrosis), thyroid tumors (males), and ovarian hypertrophy. No effects
were observed in the ovaries in other toxicity studies. In mice,
chronic exposure led to liver and thyroid effects and liver tumors
(males). Alveolar foamy cell accumulation was also seen in mice, but it
was not considered to be an adverse effect. In dogs, effects noted
(liver, gallbladder, and adrenal gland) were similar to those seen in
subchronic dog studies, with the addition of gallbladder hypertrophy/
hyperplasia.
In the developmental toxicity study in rats, comparable toxicity
was noted in fetal and maternal animals. Effects observed were
decreased body weight gain and food consumption, increased resorptions
(resulting in decreased post-implantation survival), decreased litter
size, and decreased gravid uterine weight at the limit dose. No effects
were noted in a preliminary study in rats up to the limit dose. In the
developmental toxicity study in rabbits, decreased fetal body weight
was seen in the presence of maternal toxicity. Abortion was noted in
one maternal animal, preceded by a period of markedly reduced food
consumption and body weight loss, at the highest dose tested. In a
preliminary study, decreased fetal body weight was seen at the limit
dose. At lower doses, maternal effects including decreased water and
food consumption, body
[[Page 26354]]
weight loss, and abnormal feces were seen. At the limit dose, increased
abortions and mortality were noted in maternal animals. In the
reproductive toxicity study in rats, body weight changes, liver,
adrenal, and thyroid effects were seen in maternal animals in
preliminary and definitive studies. Offspring effects included body
weight changes, delay in preputial separation, and decreased thymus
weights at similar doses. Decreased spleen weights were seen in
offspring animals in the preliminary reproduction study. No
reproductive toxicity was observed.
In the developmental neurotoxicity study in rats (definitive
study), decreased body weight, increased motor activity, and tremors
were seen in offspring animals in the absence of maternal toxicity. In
the preliminary study, decreased pup weight, deterioration, and
mortality were seen in offspring animals in the absence of maternal
toxicity. Clinical signs were observed in the acute neurotoxicity study
with penthiopyrad. Transient functional alterations (hunched posture,
unsteady gait, reduced body temperature, and increased landing
footsplay) and decreased motor activity were seen at the estimated
time-to-peak-effect (4 hours). In a subchronic neurotoxicity study,
decreased body weight gain was seen at the highest dose tested;
however, no clinical signs were observed, and there was no evidence of
neurotoxicity.
Immunotoxicity studies were conducted in both mice and rats for
penthiopyrad. In the immunotoxicity study in mice, decreased plaque
forming ability was observed at the limit dose. However, in the
immunotoxicity study in rats, no evidence of immunotoxicity was
observed up to the highest dose tested. General toxicity noted in the
rat study included decreased body weight gain and food consumption,
increased liver weight, and decreased spleen weight.
A mutagenicity battery is available for penthiopyrad technical
ingredient and the majority of the studies were negative; however,
chromosome aberrations were observed at cytotoxic concentrations in an
in vitro assay. Mutagenicity studies are also available for several
penthiopyrad metabolites (PCA, DM-PCA, PAM, and 753-A-OH). These
studies were usually negative; however, the PAM metabolite induced
chromosome aberrations (-S9 after 24 hours) and PCA induced a weakly
positive mutant frequency (after 24 hours); however, based on the
overall analysis of the available data, penthiopyrad is not considered
to be mutagenic.
EPA classified penthiopyrad as having ``suggestive evidence of
carcinogenicity,'' based on an increased incidence of treatment-related
liver tumors in male mice. Thyroid tumors were observed in male rats
but were not considered to be treatment related. In accordance with the
EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), the
Agency has determined that the quantification of risk using a non-
linear approach based on the chronic reference dose (i.e., cRfD) which
is 7x lower than the dose at which tumors were observed will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from penthiopyrad exposure.
Specific information on the studies received and the nature of the
adverse effects caused by penthiopyrad as well as the no-observed-
adverse-effects-level (NOAEL) and the lowest-observed-adverse-effects-
level (LOAEL) identified from the toxicity studies can be found at
https://www.regulations.gov in document SUBJECT: Penthiopyrad. Human
Health Risk Assessment for Proposed New Use on Caneberry Subgroup 13-
07A and Bushberry Subgroup 13-07B; and Crop Group/Subgroup Conversions
and Expansions at page 39 in docket ID number EPA-HQ-OPP-2017-0674.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (PODs) 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 previously applied penthiopyrad toxicological
endpoints for human risk assessment is discussed in Unit III of the
final rule published in the Federal Register of March 9, 2012 (77 FR
14291) (FRL-9335-7). That database was recently re-evaluated/updated
based on current practices and includes updated dermal endpoints and
PODs selected for adults and children. As a result of the database
update, one endpoint and POD based on the 28-day oral toxicity study in
the dog is used for all populations, and also used to derive the
endpoints/PODs for the incidental oral and inhalation routes of
exposure. The updated NOAELs, LOAELs, and the PODs are summarized below
for the affected exposure/scenarios:
i. Children and adult dermal exposures. Children and adult dermal
exposures were previously assessed with separate endpoints/PODs. Dermal
exposure is now being evaluated using the same endpoint and POD for all
ages, from the 28-day dog study. The revised dermal NOAEL is 80
milligrams per kilogram (mg/kg/day), based on mucosal edema in gall
bladder as well as clinical chemistry and increased organ weight/
histopathology in the livers of females at the LOAEL of 269 mg/kg/day.
ii. Previous adult dermal assessment. The developmental rabbit
study was previously used for the adult dermal assessment with a NOAEL
of 75 mg/kg/day based on abortions in one animal at the LOAEL of 225
mg/kg/day. The endpoint is not strong, and the dose spacing is
comparable to the selected 28-day dog study.
iii. Previous children's dermal assessment. Previously the
developmental neurotoxicity (DNT) was selected for the children's
dermal assessment. The respective NOAEL and LOAEL for that study are
100 mg/kg/day and 250 mg/kg/day. Again, due to dose spacing, the study
is comparable to the 28-dog study, whose NOAEL is protective of the DNT
NOAEL. In addition, the effects seen in the 28-day dog study include
gallbladder effects, an organ rats do not have, which is a potentially
human-relevant effect.
iv. Inhalation and incidental oral assessments. The 28-day dog
study, which previously was used and continues to also be used for the
inhalation and incidental oral assessments was also updated. The NOAEL
is now 80 mg/kg/day, based on mucosal edema in the gallbladder; as well
as clinical chemistry, increased
[[Page 26355]]
organ weight and histopathology in the liver of females at the LOAEL of
269 mg/kg/day. The updated NOAEL is comparable to or protective of
other NOAEL and LOAEL values in the database, including those relating
to susceptibility.
v. Residential incidental oral, inhalation, and dermal exposures.
The 28-day dog study is now being used to assess residential incidental
oral, inhalation, and dermal exposures.
A summary of the toxicological endpoints for penthiopyrad used for
dietary and non-occupational human health risk assessment is shown in
the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Penthiopyrad for Use in Dietary and Non-Occupational
Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure RfD, PAD, level of
Exposure/scenario and uncertainty/ concern for risk Study and toxicological effects
safety factors assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations).. NOAEL = 125 mg/kg/ Acute RfD = 1.25 mg/ Acute Neurotoxicity in Rats.
day. kg/day. LOAEL = 500 mg/kg/day, based on
UFA = 10x........... aPAD = 1.25........ transient functional alterations
UFH =10x............ mg/kg/day.......... (e.g., hunched posture, unsteady
FQPA SF = 1x........ gait, reduced body temperature,
and increased landing footsplay)
and decreased motor activity at
the estimated time[dash]to-peak-
effect (4 hours) on the day of
administration.
Chronic dietary (All populations) NOAEL = 27 mg/kg/day Chronic RfD = 0.27 Co-Critical Studies:
UFA = 10x........... mg/kg/day. Chronic Toxicity/Carcinogenicity
UFH =10x............ cPAD = 0.27........ in Rats LOAEL = 83 mg/kg/day,
FQPA SF = 1x........ mg/kg/day.......... based on decreased body weight
gain and adrenal effects in
females and hepatic periportal
fatty degeneration in males
(NOAEL = 27 mg/kg/day).
Chronic Toxicity in Rats.
LOAEL = 100 mg/kg/day, based on
altered plasma chemistry profile,
increased liver weight and
alterations in the adrenal and
thyroid glands. (NOAEL = 25 mg/kg/
day).
Incidental oral short-term (1-30 NOAEL = 80 mg/kg/day Residential LOC for 28-Day Oral Toxicity in Dogs.
days) and Intermediate-term (1-6 UFA = 10x........... MOE = 100. LOAEL = 269 mg/kg/day, based on
months). UFH = 10x........... mucosal edema in the gall
FQPA SF = 1x........ bladder; clinical chemistry,
increased organ weight and
histopathology in the liver of
females.
Dermal short-term (1-30 days); NOAEL = 80 mg/kg/day Residential LOC for 28-Day Oral Toxicity in Dogs.
Intermediate-term (1-6 months). UFA = 10x........... MOE = 100. LOAEL = 269 mg/kg/day, based on
UFH = 10x........... mucosal edema in the gall
FQPA SF = 1x........ bladder; clinical chemistry,
DAF = 40%........... increased organ weight and
histopathology in the liver of
females.
Inhalation short-term (1-30 NOAEL = 80 mg/kg/day Residential LOC for 28-Day Oral Toxicity in Dogs.
days); Intermediate-term (1-6 UFA = 10x........... MOE = 100. LOAEL = 269 mg/kg/day, based on
months). UFH = 10x........... mucosal edema in the gall
FQPA SF = 1x........ bladder; clinical chemistry,
increased organ weight and
histopathology in the liver of
females.
------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Suggestive Evidence of Carcinogenicity'' based on liver
tumors in male mice. The Agency has determined that a nonlinear approach
based on the chronic reference dose will be protective of potential
carcinogenicity.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk estimates associated with lower
environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed
adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety
Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of
exposure. LOC = level of concern. DAF = dermal absorption factor. IAF = inhalation absorption factor.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to penthiopyrad, EPA considered exposure under the petitioned-
for tolerances as well as all existing penthiopyrad tolerances in 40
CFR 180.658. EPA assessed dietary exposures from penthiopyrad in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for penthiopyrad. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the United States Department of Agriculture (USDA) National Health and
Nutrition Survey/What We Eat in America (NHANES/WWEIA). The acute
dietary (food and drinking water) exposure assessment was conducted
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance-level residues for all existing and proposed commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the 2003-2008 food consumption information from the
USDA NHANES/WWEIA. The chronic dietary (food and drinking water)
exposure assessment was conducted using DEEM-FCID, Version 3.16. As to
residue levels in food, EPA assumed 100 PCT and tolerance-level
residues for all existing and proposed commodities.
[[Page 26356]]
iii. Cancer. EPA classified penthiopyrad as having ``suggestive
evidence of carcinogenicity,'' based on an increased incidence of
treatment-related liver tumors in male mice and determined that the
quantification of risk using a non-linear approach (i.e., RfD) will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from penthiopyrad exposure.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
penthiopyrad. 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 penthiopyrad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of penthiopyrad. 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 First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of penthiopyrad are based on the
use pattern of highest exposure, which is the currently labeled use on
turf at 2.9 lbs active ingredient per acre per year. The residues of
concern assessed in drinking water included penthiopyrad and its
cleavage product PAM. For acute exposures, EDWCs are estimated to be
240 parts per billion (ppb) for surface water and 1,330 ppb for ground
water. For chronic exposures for non-cancer assessments, EDWCs are
estimated to be 131 ppb for surface water and 978 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1,330 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 978 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).
Although the proposed new uses do not include any residential use,
registered residential uses including turf, lawn, and sod could result
in residential exposure and have been reassessed in support of this
rulemaking to reflect updates to new dermal, inhalation, and incidental
oral PODs. There is the potential for post-application exposure for
individuals exposed as a result of being in an environment that has
been previously treated with penthiopyrad. The quantitative exposure/
risk assessment for residential post-application exposures is based on
the following scenarios:
i. Adult dermal post-application exposure resulting from contact
with treated turf;
ii. Dermal post-application exposure to youth 11-16 yrs. old
resulting from mowing and playing golf on turf;
iii. Dermal post-application exposure to children 6-11 yrs. old
resulting from playing golf on turf;
iv. Dermal post-application exposure to children 1 to <2 yrs. old
resulting from playing on turf; and
v. Incidental oral post-application exposure to children 1 to <2
yrs. old resulting from playing on turf.
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 penthiopyrad to share a common mechanism of
toxicity with any other substances, and penthiopyrad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
penthiopyrad 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
quantitative or qualitative susceptibility was observed in
developmental toxicity studies in rats or rabbits or in a reproduction
toxicity study in rats. However, increased quantitative susceptibility
was seen in DNT studies in rats. Decreased body weight (250 mg/kg/day),
and increased motor activity and tremors were seen in offspring animals
at 500 mg/kg/day. Decreased body weight was seen at 300 mg/kg/day, and
mortality was noted at 1,000 mg/kg/day in offspring animals. The
effects observed in offspring animals in the DNT studies were seen in
the absence of maternal toxicity.
EPA concluded that there is a low concern and no residual
uncertainties for prenatal and/or postnatal toxicity effects of
penthiopyrad, notwithstanding observed increased susceptibility seen in
the preliminary and definitive DNT studies, based on the following
data:
i. The pup body weight changes noted in the definitive and
preliminary DNT studies were also observed in developmental and
reproduction studies at similar doses. Additionally, the body weight
changes in these studies occurred in the presence of significant
maternal toxicity. Although clinical signs (tremors and increased motor
activity) were noted in offspring animals in the definitive study, the
neurotoxic potential of penthiopyrad has been adequately characterized
in the available neurotoxicity studies. Tremors and changes in motor
activity were observed at very high doses in the acute neurotoxicity
study and were not present in the subchronic neurotoxicity study. In
the preliminary DNT study, mortality was observed in the offspring
animals at the limit dose. However, this finding is attributed to the
poor condition (body weight loss, under
[[Page 26357]]
activity, pallor) of the offspring animals in this dose group.
ii. A clear NOAEL has been identified for all offspring effects in
the DNT studies, and the PODs used in the risk assessments are
protective of the observed 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 penthiopyrad is complete.
ii. There is no concern for neurotoxicity after exposure to
penthiopyrad. A complete neurotoxicity battery is available for
penthiopyrad. The database includes acute neurotoxicity, subchronic
neurotoxicity, and DNT studies in rats. As a result, the neurotoxic
potential of penthiopyrad is well characterized, and no additional data
are needed.
iii. As discussed in Unit IV.D.2., EPA has concluded that there are
no residual uncertainties concerning prenatal and postnatal effects,
that would warrant retaining the 10X FQPA safety factor.
iv. There are no residual uncertainties identified in the exposure
databases. There are no residual uncertainties with regard to dietary
and residential exposure. The dietary food exposure assessments were
performed based on conservative assumptions that ensure that exposures
to penthiopyrad are not underestimated, including tolerance-level
residues and 100 PCT estimates for all registered commodities. The use
of default assumptions did not result in risk estimates of concern for
the proposed new uses. Actual exposures and risk estimates from
penthiopyrad will likely be lower. Furthermore, conservative, upper-
bound assumptions were used to determine exposure through drinking
water and residential sources, such that these exposures have not been
underestimated. 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 penthiopyrad.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to penthiopyrad will occupy 21% of the aPAD for all infants (<1-year-
old), the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
penthiopyrad from food and water will utilize 29% of the cPAD for all
infants (<1-year-old), the population group receiving the greatest
exposure.
3. Short-and Intermediate-term risk. Short- and intermediate-term
risk aggregate exposure takes into account short- and intermediate-term
risk residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). The short- and
intermediate-term toxicological endpoints for penthiopyrad are the same
for each route of exposure. Therefore, for residential exposure
scenarios, only short-term exposures were assessed, and are protective
of intermediate-term exposure and risk.
Penthiopyrad is proposed for registration for uses that could
result in short-/intermediate-term residential exposures, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short -term residential exposures
to penthiopyrad. These assessments include exposure through the dermal
route for adults and youth, and from dermal and incidental oral
exposure for children (1 to <2 yrs.).
EPA selected the following two residential exposure scenarios which
represent the highest exposure and risk scenarios for each population:
(1) Adult post-application exposure and (2) children's (1 to <2 yrs.)
post-application exposure resulting from contact with treated turf. The
level of concern for these assessments is 100. The chronic dietary
exposure estimate for adults was the background exposure added to the
dermal residential post-application exposure estimates. The adult
short-term aggregate risk assessment resulted in estimated MOEs of 440.
The chronic dietary exposure estimate for the subgroup children 1 to <2
years old was the background exposure added to the children's dermal
and incidental oral residential post-application exposure estimates.
The children's short-term aggregate risk assessment resulted in
estimated MOEs of 220. These risk estimates are not of concern to EPA.
5. Aggregate cancer risk for U.S. population. EPA classified
penthiopyrad as having ``suggestive evidence of carcinogenicity'' based
on liver tumors in male mice. The quantification of risk using a non-
linear approach (i.e., the RfD) adequately accounts for all chronic
toxicity, including carcinogenicity, therefore cancer risk is not of
concern.
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 penthiopyrad residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (a Liquid chromatography-tandem
mass spectrometry (LC/MS/MS) method known as Method CEM 3399-001) is
available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[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 U.S. tolerance definition for penthiopyrad is harmonized with
those of Canada and Codex and most relevant established tolerance
levels are harmonized with Canadian and Codex MRLs. There are currently
no established Canadian or Codex MRLs for
[[Page 26358]]
the proposed new uses for bushberries or caneberries.
C. Revisions to Petitioned-For Tolerances
In accordance with its authority in FFDCA section 408(d)(4)(A)(i),
EPA is establishing tolerances in this rule that vary slightly from
what the petitioner sought. These variations are explained below.
1. The petitioner requested tolerances in Fruit, stone, group 12-12
at 4.0 ppm, Kohlrabi at 5.0 ppm, and Vegetable, brassica, head and
stem, group 5-16 at 5.0 ppm; EPA is establishing those tolerances
without the additional zero to be consistent with OECD calculation
procedures.
2. The petitioner requested a tolerance for ``Fennel, Florence'';
EPA is establishing a tolerance for the commodity ``Fennel, Florence,
fresh leaves and stalk'' to be consistent with commodity terms the
Agency uses in tolerances.
3. EPA is establishing a tolerance for the Nut, tree group 14-12
tolerance at 0.05 ppm instead of 0.06 ppm as requested in order to
harmonize with Codex MRL. The established tolerance level is
appropriate as the highest average field trial residue was 0.037 ppm
while other residues were below LOQ (0.01 ppm).
D. International Trade Considerations
In this final rule, EPA is reducing the existing tolerances for the
commodities in the nut, tree group 14-12 from 0.06 ppm to 0.05 ppm. The
Agency is reducing these tolerances to harmonize with Codex MRLs, and
available residue data demonstrates that tolerances at 0.05 ppm are
sufficient to cover residues on these commodities.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of this revision. In addition, the SPS Agreement requires that
members provide a ``reasonable interval'' between the publication of a
regulation subject to the agreement and its entry into force to allow
time for producers in exporting member countries to adapt to the new
requirement. At this time, EPA is establishing an expiration date for
the existing tolerances to allow those tolerances to remain in effect
for a period of six months after the effective date of this final rule,
in order to address the requirement to provide a reasonable interval.
After the six-month period expires, residues of penthiopyrad on
commodities included in the nut, tree group 14-12 cannot exceed the
newly established tolerances of 0.05 ppm.
This reduction in tolerance levels is not discriminatory; the same
food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods. The new tolerance levels are
supported by available residue data.
V. Conclusion
Therefore, tolerances are established for residues of penthiopyrad,
(N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide), in or on Brassica, leafy greens, subgroup 4-
16B at 50 ppm; Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup
13-07A at 10 ppm; Celtuce at 30 ppm; Fennel, Florence, fresh leaves and
stalk at 30 ppm; Fruit, stone, group 12-12 at 4 ppm; Kohlrabi at 5 ppm;
Leaf petiole vegetable subgroup 22B at 30 ppm; Leafy greens subgroup 4-
16A at 30 ppm; Nut, tree, group 14-12 at 0.05 ppm; Oilseed group 20 at
1.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 5 ppm.
In addition, EPA is removing the following tolerances from paragraph
(a)(1) because they are superseded by the new tolerances being
established in this rulemaking: Brassica, head and stem, subgroup 5A at
5.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; Canola at 1.5
ppm; Cotton, seed at 1.5 ppm; Fruit, stone, group 12 at 4.0 ppm;
Sunflower, seed at 1.5 ppm; and Vegetable, leafy, except brassica,
group 4 at 30 ppm. Finally, EPA is establishing a six-month expiration
date for the established pistachio and tree nut group tolerances.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), 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 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).
[[Page 26359]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 29, 2019.
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 the table in Sec. 180.658(a)(1):
0
a. Remove the entries ``Brassica, head and stem, subgroup 5A'' and
``Brassica, leafy greens, subgroup 5B'';
0
b. Add alphabetically the commodities ``Brassica, leafy greens,
subgroup 4-16B'', ``Bushberry subgroup 13-07B'', and ``Caneberry
subgroup 13-07A'';
0
c. Remove the entry ``Canola'';
0
d. Add alphabetically the commodity ``Celtuce'';
0
e. Remove the entry ``Cotton, seed'';
0
f. Add alphabetically the commodity ``Fennel, Florence, fresh leaves
and stalk'';
0
g. Remove the entry ``Fruit, stone, group 12'';
0
h. Add alphabetically the commodities ``Fruit, stone, group 12-12'',
``Kohlrabi'', ``Leaf petiole vegetable subgroup 22B'', and ``Leafy
greens subgroup 4-16A'';
0
i. Revise the entry ``Nut, tree, group 14'';
0
j. Add alphabetically the commodities ``Nut, tree, group 14-12'' and
``Oilseed group 20'';
0
k. Revise the entry ``Pistachio'';
0
l. Remove the entry ``Sunflower, seed'';
0
m. Add alphabetically the commodity ``Vegetable, brassica, head and
stem, group 5-16'';
0
n. Remove the entry ``Vegetable, leafy, except brassica, group 4''; and
0
o. Add footnote 1 to the table.
The additions and revisions read as follows:
Sec. 180.658 Penthiopyrad; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Brassica, leafy greens, subgroup 4-16B...................... 50
* * * * *
Bushberry subgroup 13-07B................................... 6
Caneberry subgroup 13-07A................................... 10
Celtuce..................................................... 30
* * * * *
Fennel, Florence, fresh leaves and stalk.................... 30
* * * * *
Fruit, stone, group 12-12................................... 4
* * * * *
Kohlrabi.................................................... 5
Leaf petiole vegetable subgroup 22B......................... 30
Leafy greens subgroup 4-16A................................. 30
* * * * *
Nut, tree, group 14 \1\..................................... 0.06
Nut, tree, group 14-12...................................... 0.05
* * * * *
Oilseed group 20............................................ 1.5
* * * * *
Pistachio \1\............................................... 0.06
* * * * *
Vegetable, brassica, head and stem, group 5-16.............. 5
* * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on December 6, 2019.
* * * * *
[FR Doc. 2019-11676 Filed 6-5-19; 8:45 am]
BILLING CODE 6560-50-P