Fluopicolide; Pesticide Tolerances, 9703-9712 [2018-04533]
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[FR Doc. 2018–04579 Filed 3–6–18; 8:45 am]
BILLING CODE 4510–26–P
PART 1915—[AMENDED]
3. The authority citation for part 1915
continues to read as follows:
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Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), or 1–2012 (77 FR 3912); 29 CFR
part 1911; and 5 U.S.C. 553, as applicable.
Subpart A—General
4. Amend section 1915.8 by adding to
the table, in the proper numerical
sequence, the entry ‘‘1915.1024’’ to read
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PART 1926—[AMENDED]
5. The authority citation for part 1926
is revised to read as follows:
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Authority: 40 U.S.C. 3701 et seq.; 29 U.S.C.
653, 655, 657; Secretary of Labor’s Order No.
12–71 (36 FR 8754), 8–76 (41 FR 25059), 9–
83 (48 FR 35736), 1–90 (55 FR 9033), 6–96
(62 FR 111), 3–2000 (65 FR 50017), 5–2002
(67 FR 65008), 5–2007 (72 FR 31160), 4–2010
(75 FR 55355), or 1–2012 (77 FR 3912), as
applicable; and 29 CFR part 1911.
Subpart A—General
6. Amend § 1926.5 by adding to the
table, in the proper numerical sequence,
the entry ‘‘1926.1124’’ to read as
follows:
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40 CFR Part 82
[EPA–HQ–OAR–2017–0472; FRL–9975–19–
OAR]
RIN 2060–AT53
Protection of Stratospheric Ozone:
Revision to References for
Refrigeration and Air Conditioning
Sector To Incorporate Latest Edition of
Certain Industry, Consensus-Based
Standards; Withdrawal
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
AGENCY:
The Environmental Protection
Agency (EPA) received adverse
comment on the direct final rule titled
‘‘Protection of Stratospheric Ozone:
Revision to References for Refrigeration
and Air Conditioning Sector to
Incorporate Latest Edition of Certain
Industry, Consensus-based Standards,’’
published on December 11, 2017.
Therefore, through this document we
are withdrawing that direct final rule.
DATES: The direct final rule published at
82 FR 58122 on December 11, 2017 is
withdrawn effective March 7, 2018.
FOR FURTHER INFORMATION CONTACT:
Chenise Farquharson, Stratospheric
Protection Division, Office of
Atmospheric Programs (Mail Code
6205T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; telephone
number: (202) 564–7768; email address:
farquharson.chenise@epa.gov.
SUPPLEMENTARY INFORMATION: The EPA
received adverse comment on the direct
final rule ‘‘Protection of Stratospheric
Ozone: Revision to References for
Refrigeration and Air Conditioning
Sector to Incorporate Latest Edition of
Certain Industry, Consensus-based
Standards,’’ published on December 11,
2017 (82 FR 58122). The direct final rule
stated that if the Agency received
adverse comment by January 25, 2018,
the direct final rule would not take
effect and EPA would publish a timely
withdrawal in the Federal Register.
Because we received adverse comment
SUMMARY:
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ENVIRONMENTAL PROTECTION
AGENCY
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on that direct final rule during that
comment period we are withdrawing
the direct final rule in this document.
We will address all significant
comments in any subsequent final
action, which would be based on the
parallel proposed rule also published on
December 11, 2017 (82 FR 58154). As
stated in the direct final rule and the
parallel proposed rule, there will not be
a second comment period on this action.
List of Subjects in 40 CFR Part 82
Environmental protection,
Administrative practice and procedure,
Air pollution control, Incorporation by
reference, Recycling, Reporting and
recordkeeping requirements,
Stratospheric ozone layer.
Dated: February 28, 2018.
E. Scott Pruitt,
Administrator.
Accordingly, the amendments to
appendix R to subpart G of 40 CFR part
82 published on December 11, 2017 (82
FR 58122) are withdrawn effective
March 7, 2018.
[FR Doc. 2018–04521 Filed 3–6–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0257; FRL–9973–44]
Fluopicolide; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fluopicolide in
or on multiple commodities which are
identified and discussed later in this
document. In addition, this regulation
removes several previously established
tolerances that are superseded by 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
March 7, 2018. Objections and requests
for hearings must be received on or
before May 7, 2018, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0257, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
ADDRESSES:
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Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
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identify docket ID number EPA–HQ–
OPP–2016–0257 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 May 7, 2018. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2016–0257, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of Wednesday,
June 22, 2016 (81 FR 40594) (FRL–
9947–32), 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 6E8464) by
IR–4 Headquarters, Rutgers, The State
University of New Jersey, 500 College
Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40
CFR 180.627 be amended by
establishing tolerances for residues of
the fungicide, fluopicolide [2,6dichloro-N-[[3-chloro-5(trifluoromethyl)-2-pyridinyl]methyl]
benzamide], including its metabolites
and degradates, in or on the
commodities: Basil, dried leaves at 200
parts per million (ppm); basil, fresh
leaves at 30 ppm; bean, succulent at 0.9
ppm; citrus, dried pulp at 0.048 ppm;
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citrus, oil at 1.94 ppm; hop, dried cones
at 15 ppm; fruit, citrus, group 10–10 at
0.02 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–07F
at 2.0 ppm; and vegetable, fruiting, crop
group 8–10 at 1.60 ppm. That document
referenced a summary of the petition
prepared by Valent, the registrant,
which is available in the docket, https://
www.regulations.gov. Two similar
anonymous public comments were
received in response to the notice of
filing. The Agency’s response to the
comments is included in Unit IV.C.
Based upon review of the data
supporting the petition, EPA is
establishing certain tolerances that
differ from what the petitioner
requested. The reasons for these changes
are explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of,
and to make a determination on
aggregate exposure for fluopicolide
including exposure resulting from the
tolerances established by this action.
Fluopicolide shares a metabolite, 2,6dichlorobenzamide (BAM), with another
active ingredient, dichlobenil. Residues
of BAM are assessed independently of
fluopicolide and dichlobenil because it
has its own toxicity database and
endpoints of concern. The BAM
assessment considers residues resulting
from both fluopicolide and dichlobenil
uses. EPA’s safety finding for
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fluopicolide considers the aggregate
exposures to fluopicolide alone as well
as the aggregate exposure to BAM from
both fluopicolide and dichlobenil uses.
A. Toxicological Profile
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EPA has evaluated the available
toxicity database and considered its
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Fluopicolide. Fluopicolide has low
acute toxicity by the oral, dermal, and
inhalation routes. Following subchronic
and chronic exposures, increased liver
weights and/or liver hypertrophy were
observed in rats and mice. Additional
liver lesions were seen in mice,
including oval cell proliferation in a 90day oral toxicity study and altered cell
foci in the carcinogenicity study.
Treatment-related effects in rats also
included kidney and thyroid effects;
however, these effects were not seen
consistently across studies in the
fluopicolide database. In the 28-day oral
toxicity study in rats, there were
indications of nephrotoxicity including
pale kidneys and microscopic lesions
(granulation, proteinaceous material,
and hydronephrosis). Kidney effects
were not observed in any other studies,
except the reproduction toxicity study
where slightly increased organ weights
and kidney lesions were observed in
parental animals. Thyroid toxicity was
only observed in the combined chronic/
carcinogenicity study in rats and
consisted of increased thyroid weights,
gross pathological observation of
enlarged thyroids, and increased
incidence of cystic follicular
hyperplasia in males (slight to moderate
severity).
Evidence of increased quantitative
susceptibility was seen in the rat
developmental toxicity study.
Developmental effects (delayed
ossification and fetal growth) were only
seen at a relatively high dose (700 mg/
kg/day) in the absence of maternal
effects. There was no evidence of
susceptibility in the rabbit
developmental toxicity and rat
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reproduction toxicity studies. In the
rabbit developmental toxicity study, late
abortions/premature deliveries were
observed at 60 mg/kg/day. Additional
effects at this dose included late
maternal deaths and decreased crown
rump length in fetuses. In the rat
reproduction toxicity study, offspring
effects (decreased body weight) were
seen in the presence of parental effects
(kidney effects).
There is no evidence of neurotoxicity,
immunotoxicity, or mutagenicity in the
fluopicolide toxicity database. Due to
the absence of treatment-related tumors
in two adequate rodent carcinogenicity
studies, fluopicolide is classified as
‘‘Not Likely to be Carcinogenic to
Humans’’.
BAM. Acute toxicity studies on BAM
demonstrated moderate acute toxicity
via the oral route of exposure. In
subchronic and chronic toxicity studies,
the primary oral effects seen in the rat
and dog were body weight changes.
Adverse liver effects, including
hepatocellular alterations and increased
liver weights, were also observed.
Toxicity to the olfactory sensory
neurons has been observed following
intraperitoneal exposure of mice to
BAM, indicating potential
neurotoxicity; however, no effects on
the olfactory system were observed via
the oral route. There is no evidence that
BAM is either mutagenic or clastogenic
nor is there evidence of endocrine
mediated toxicity. A BAM combined
chronic toxicity/carcinogenicity study
in the rat is available; however, in the
absence of a carcinogenicity study data
for a second species, EPA has assumed
that BAM’s carcinogenic potential is
similar to that of dichlobenil, the parent
compound having the greatest
carcinogenicity potential. Dichlobenil is
classified as ‘‘Group C, possible human
carcinogen.’’ Therefore, EPA has
concluded that quantification of cancer
risk using a non-linear approach (i.e.,
RfD) will adequately account for all
chronic toxicity, including
carcinogenicity, that could result from
exposure to dichlobenil, and therefore,
to BAM.
Specific information on the studies
received and the nature of the adverse
effects caused by fluopicolide and BAM,
as well as the no-observed-adverse-
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effect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
from the toxicity studies can be found
at https://www.regulations.gov in
document: Fluopicolide and 2,6Dichlorobenzamide (BAM). Human
Health Risk Assessment to Support
Registration for Application of
Fluopicolide on Basil, Succulent Bean,
Hops, Small Vine Climbing Subgroup
13–07F, and Citrus Fruit Group 10–10
and Crop Group Conversion for Fruiting
Vegetables 8–10, dated December 5,
2017 at pages 19–25 in docket ID
number EPA–HQ–OPP–2016–0257.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for fluopicolide and BAM
used for human risk assessment is
shown in Table 1 and Table 2,
respectively, of this unit.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPICOLIDE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and
uncertainty/safety
factors
Acute dietary (All populations) ..
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
An endpoint attributable to a single dose was not identified from the available data.
Chronic dietary (All populations)
Maternal NOAEL =
20 mg/kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
cRfD = cPAD = 0.2
mg/kg/day.
Incidental oral short- and intermediate-term (1–30 days,
and 1–6 months).
Maternal NOAEL =
20 mg/kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
Maternal NOAEL =
20 mg/kg/day.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1X
(when applicable).
DAF = 5% ................
LOC for MOE <100
Inhalation short- and intermediate-term (1–30 days,
and 1–6 months).
Maternal NOAEL =
20 mg/kg/day.
Inhalation assumed
equivalent to oral.
UFA = 10x
UFH = 10x
FQPA SF = 1X,
when applicable
LOC for MOE <100
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on the absence of treatment-related tumors in
two adequate rodent carcinogenicity studies.
Dermal short- and intermediateterm (1–30 days, and 1–6
months).
LOC for MOE <100
Developmental Toxicity Study in Rabbits.
LOAEL (maternal) = 60 mg/kg/day based on death, abortions/
premature deliveries, and decreased food consumption.
Co-critical: Chronic/Oncogenicity Study in Rats.
NOAEL = 31.5 mg/kg/day.
LOAEL = 109.4 mg/kg/day based on increased thyroid weight
and increased incidence of thyroid lesions.
Developmental Toxicity Study in Rabbits.
LOAEL (maternal) = 60 mg/kg/day based on death, abortions/
premature deliveries, decreased food consumption and bodyweight gain.
Developmental Toxicity Study in Rabbits.
LOAEL (maternal) = 60 mg/kg/day based on death, abortions/
premature deliveries, decreased food consumption and bodyweight gain.
Co-critical: Chronic/Oncogenicity Study in Rats.
NOAEL = 31.5 mg/kg/day.
LOAEL = 109.4 mg/kg/day based on increased thyroid weight
and increased incidence of thyroid lesions.
Developmental Toxicity Study in Rabbits.
LOAEL (maternal) = 60 mg/kg/day based on death, abortions/
premature deliveries, decreased food consumption.
Co-critical: Chronic/Oncogenicity Study in Rats.
NOAEL = 31.5 mg/kg/day.
LOAEL = 109.4 mg/kg/day based on and increased thyroid
weight and increased incidence of thyroid lesions.
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 associated with lower environmentally relevant human exposures.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2,6-DICHLOROBENZAMIDE (BAM) FOR USE IN
HUMAN HEALTH RISK ASSESSMENT
Exposure/scenario
Acute dietary (All populations) ..
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Chronic dietary (All populations)
Incidental oral short- and intermediate-term (1–30 days,
and 1–6 months).
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Point of departure
and
uncertainty/safety
factors
LOAEL = 100 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF/UFL= 10x
NOAEL = 4.5 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
NOAEL = 14 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
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RfD, PAD, LOC for
risk assessment
Study and toxicological effects
aRfD = aPAD = 0.1
mg/kg/day.
Dose-range finding assay for in vivo mouse erythrocyte micronucleus assay.
LOAEL = 100 mg/kg/day based on lethargy after a single oral
dose.
cRfD = cPAD =
0.045 mg/kg/day.
Chronic toxicity (dog).
LOAEL = 12.5 mg/kg/day based on decreased body weight
and body weight gain.
LOC for MOE <100
90-day oral (rat).
LOAEL = 49 mg/kg/day based on decreased body weight gain
(M) and reduced skeletal muscle tone (day 4 only in males;
days 91 and 92 only in females).
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TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 2,6-DICHLOROBENZAMIDE (BAM) FOR USE IN
HUMAN HEALTH RISK ASSESSMENT—Continued
Exposure/scenario
Dermal short- and intermediateterm (1–30 days and 1–6
months).
Inhalation short- and intermediate-term (1–30 days and
1–6 months).
Cancer .......................................
Point of departure
and
uncertainty/safety
factors
NOAEL = 25 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1X
(when applicable)
NOAEL = 12.1 mg/
m3.
UFA = 3X
UFH = 10X
FQPA SF = 1X
(when applicable)
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
LOC for MOE <100
5-day dermal using dichlobenil (mouse; literature study).
LOAEL = 50 mg/kg/day based on olfactory epithelial damage.
LOC for MOE <100
28-day inhalation using dichlobenil (rat).
LOAEL = 21 mg/m3 based on nasal degeneration.
Classification: unclassified; parent herbicide dichlobenil classified as ‘‘Group C, possible human carcinogen’’
with RfD approach utilized for quantification of human risk
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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, UFL = use of a LOAEL to extrapolate a NOAEL, NOAEL = no-observed
adverse-effect level, LOAEL = lowest-observed adverse-effect level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted
dose, MOE = margin of exposure, LOC = level of concern, N/A = not applicable.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fluopicolide and its
metabolite BAM, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
fluopicolide tolerances in 40 CFR
180.627 and the exposures from BAM
from existing dichlobenil tolerances
under 40 CFR 180.231. EPA assessed
dietary exposures from fluopicolide and
its metabolite BAM in food as follows:
a. 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.
i. Fluopicolide. A toxicity endpoint
attributable to a single dose has not been
identified in the toxicological studies
for fluopicolide; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
ii. BAM. Such effects were identified
for BAM. In estimating acute dietary
exposures to BAM, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). This
dietary survey was conducted from 2003
to 2008. EPA conducted a partially
refined acute dietary exposure
assessment. As to residue levels in food,
EPA assumed maximum BAM residue
from either the fluopicolide or
dichlobenil field trial data. The acute
assessment assumed 100% crop treated
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for all commodities, except apples,
blueberries, cherries, peaches, pears,
and raspberries. These values reflect the
dichlobenil percent crop treated
estimates as fluopicolide is not
registered for application to these crops.
Default processing factors were used for
commodities where empirical
processing data were not available
b. Chronic exposure—i. Fluopicolide.
In estimating chronic dietary exposure,
EPA used Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEM–
FCID, Version 3.16). The software uses
2003–2008 food consumption data from
the U.S. Department of Agriculture
(USDA) National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). The
chronic analysis assumed tolerancelevel residues or maximum field trial
residues, 100% crop treated, default
processing factors, and modeled
drinking water estimates.
ii. BAM. In estimating chronic dietary
exposures, EPA conducted a partially
refined chronic dietary exposure
assessment using DEEM–FCID (ver.
3.16) and USDA’s NHANES/WWEIA
(2003 through 2008). The chronic
dietary assessment assumed the
maximum BAM residue from either the
fluopicolide or dichlobenil field trial
data. The chronic assessment assumed
100% crop treated for all commodities
except apple. These values reflect the
dichlobenil percent crop treated
estimates as fluopicolide is not
registered for application to these crops.
Default processing factors were used for
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commodities where empirical
processing data were not available.
c. Cancer. Fluopicolide has been
classified as ‘‘not likely to be
carcinogenic to humans.’’ Therefore, a
cancer dietary exposure assessment was
not conducted for the parent
fluopicolide. Additionally, EPA has
determined BAM’s potential for
carcinogenicity is similar to that of
dichlobenil, which is classified as
‘‘group C, possible human carcinogen.’’
Quantification of cancer risk is based on
the reference dose (RfD) approach
which requires comparison of the
chronic exposure to the RfD. Using this
methodology will adequately account
for all chronic toxic effects, including
carcinogenicity, likely to result from
exposure to BAM. Hence, a separate
cancer exposure assessment to BAM
was not conducted.
d. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
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submitted no later than 5 years from the
date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states
that the Agency may use data on the
actual percent of food treated for
assessing chronic dietary risk only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, the exposure estimate
does not understate exposure for the
population in such area. In addition, the
Agency must provide for periodic
evaluation of any estimates used. To
provide for the periodic evaluation of
the estimate of PCT as required by
FFDCA section 408(b)(2)(F), EPA may
require registrants to submit data on
PCT.
EPA did not use anticipated residue
or PCT information in the dietary
assessment for fluopicolide. Tolerance
level residues or maximum field trial
residues and 100 PCT were assumed for
all food commodities.
EPA used anticipated residues and
PCT information for the acute and
chronic dietary risk assessments for
BAM. The BAM acute assessment
assumed 100 PCT for all commodities
except apples (2.5%), blueberries
(2.5%), cherries (2.5%), peaches (2.5%),
pears (5%) and raspberries (20%). The
BAM chronic assessment assumed 100
PCT for all commodities except apples
(1%). These values reflect the
dichlobenil percent crop treated
estimates as fluopicolide is not
registered for application to these crops.
Default processing factors were used for
commodities where empirical
processing data were not available.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6–7 years. EPA uses an average
PCT for chronic dietary risk analysis
and a maximum PCT for acute dietary
risk analysis. The average PCT figure for
each existing use is derived by
combining available public and private
market survey data for that use,
averaging across all observations, and
rounding to the nearest 5%, except for
those situations in which the average
PCT is less than 2.5%. The maximum
PCT figure is the highest observed
maximum value reported within the
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most recent 6 years of available public
and private market survey data for the
existing use and rounded up to the
nearest multiple of 5%, except for
situations in which the maximum PCT
is less than 2.5%. In cases where the
estimated value is less than 2.5% but
greater than 1%, the average and
maximum PCT used are 2.5%. If the
estimated value is less than 1%, 1% is
used as the average PCT and 2.5% is
used as the maximum PCT.
The Agency believes that the three
conditions discussed in Unit III.C.1.iv.
have been met. With respect to
Condition a, PCT estimates are derived
from Federal and private market survey
data, which are reliable and have a valid
basis. The Agency is reasonably certain
that the percentage of the food treated
is not likely to be an underestimation.
As to Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which BAM may be found in a
particular area.
2. Dietary exposure from drinking
water. The Agency used screening-level
water exposure models in the dietary
exposure analysis and risk assessment
for fluopicolide in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
fluopicolide. 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.
No monitoring data are available for
fluopicolide or BAM. Drinking water
residues of fluopicolide (parent)
estimates were generated using
maximum annual application rate of
0.375 lbs ai/acre, and the surface water
concentration calculator (SWCC version
1.106) for surface water, and the
pesticide root zone model for
groundwater (PRZM–GW version 1.07).
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The estimated drinking water
concentrations (EDWCs) of fluopicolide
for non-cancer chronic exposures are
12.90 ppb for surface water and 103 ppb
for ground water.
Estimates of BAM residues in
drinking water were generated using the
Provisional Cranberry Model (PCM) and
Pesticide Water Concentration
Calculator (PWC) for surface water, and
the PRZM–GW model for groundwater.
BAM drinking water concentrations can
result from the application of
dichlobenil and fluopicolide. The BAM
estimates resulting from application of
dichlobenil are higher than those
resulting from application of
fluopicolide. The acute and chronic
analyses assumed a BAM drinking water
concentration of 239 ppb and 206 ppb,
respectively, based on the PRZM–GW
model from turf use (worst case
scenario).
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment for BAM,
the water concentration value of 239
ppb was used to assess the contribution
to drinking water. For chronic dietary
risk assessment, the water concentration
of value 206 ppb and 103 ppb were used
to assess the contribution to drinking
water for BAM and fluopicolide,
respectively.
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).
Fluopicolide is currently registered
for the following uses that could result
in residential exposures: Residential turf
grass and recreational sites; however, all
registered fluopicolide product labels
with residential use sites require that
handlers wear specific clothing and/or
use personal protective equipment
(PPE). Therefore, the Agency has
concluded that these products are not
intended to be used by homeowners and
did not conduct residential handler
assessments. There is potential for postapplication exposure for individuals
entering areas that have been previously
treated with fluopicolide. EPA assessed
the following residential exposure
scenarios for fluopicolide:
Post-application exposure to children,
youth, and adults from treated lawns,
turf, gardens, trees, and golf courses.
In the case of BAM, the Agency
considered the potential for residential
exposures to BAM from dichlobenil and
fluopicolide uses. As noted above,
fluopicolide is registered for use on
residential turfgrass and recreational
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sites, such as golf courses. These uses
may also result in short-term dermal
post-application exposure to BAM to
youth and adults from treated gardens.
Post-application exposures from treated
turf is not expected since BAM was not
detected in turf transferable residue
studies with fluopicolide.
As discussed above, residential
handler assessments were not
performed for fluopicolide; therefore, a
residential handler assessment for BAM
is also not required. Residential handler
exposure to BAM resulting from the
application of dichlobenil is not
expected. While dichlobenil is currently
registered for residential uses on
ornamental plants, they are approved
for professional applicator use only.
Post-application exposure of adults and
children to dichlobenil and BAM
exposure from the use of dichlobenil
products on ornamental plants is
expected to be negligible and, therefore,
was not assessed.
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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
fluopicolide and any other substances.
Fluopicolide shares a common
metabolite, BAM, with dichlobenil.
EPA’s assessment of BAM from
pesticide use of fluopicolide and
dichlobenil has been updated for the
current assessment and no risks of
concern were identified. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
fluopicolide (parent) and its metabolite
BAM 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.
For fluopicolide, there is no evidence of
increased susceptibility in the rabbit
developmental or rat reproduction
toxicity studies. There was evidence of
increased quantitative susceptibility in
the rat developmental toxicity study;
however, the developmental effects
were only seen at a relatively high dose
(700 mg/kg/day), the effects are wellcharacterized with a clear NOAEL, and
the selected endpoints are protective of
the observed effects. For BAM, there
was no evidence of increased
susceptibility in the rabbit
developmental study.
3. Conclusion for fluopicolide. 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
fluopicolide is complete.
ii. There is no indication that
fluopicolide is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence of increased
susceptibility in the rabbit
developmental or rat reproduction
toxicity studies. Although there is
evidence of increased quantitative
susceptibility in the rat developmental
toxicity study, the developmental effects
were only seen at a relatively high dose,
the effects are well characterized with a
clear NOAEL, and the selected
endpoints are protective of the observed
effects. There are no residual
uncertainties concerning prenatal and
postnatal toxicity for fluopicolide.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
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9709
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground water and surface water
modeling used to assess exposure to
fluopicolide in drinking water. EPA
used similarly conservative assumptions
to assess post-application exposure of
children. These assessments will not
underestimate the exposure and risks
posed by fluopicolide.
4. Conclusion for BAM: EPA is
retaining the FQPA SF of 10X for the
acute dietary exposure scenario for the
general population to account for the
use of a LOAEL to extrapolate to a
NOAEL. For all other exposure
scenarios, the FQPA SF has been
reduced to 1X. That decision is based on
the following findings:
i. Acute, subchronic, and chronic oral
studies are available for BAM and
utilized for endpoint selection. For the
dermal and inhalation routes of
exposures, the Agency is relying on
dichlobenil toxicity data, where
olfactory toxicity was observed. Based
on a comparison of toxicity via the
intraperitoneal route of exposure, higher
doses of BAM are needed to induce
levels of olfactory toxicity that are
similar to those caused by dichlobenil;
therefore, the endpoints based on
dichlobenil are considered protective of
potential BAM toxicity.
ii. Although there is potential
neurotoxicity in the olfactory system
from BAM exposure, concern is low
since the effects are well-characterized
and selected endpoints based on
dichlobenil are protective of these
effects.
iii. There is no evidence of increased
susceptibility in the developmental
rabbit study.
iv. The assessments of BAM are
unlikely to underestimate exposure and
risks. Acute and chronic dietary
assessments assumed maximum BAM
residues from field trial data as well as
conservative (protective) assumptions of
BAM exposure in drinking water.
Similar conservative assumptions were
used to assess post-application exposure
of children to BAM.
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
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PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected for fluopicolide. Therefore,
fluopicolide is not expected to pose an
acute risk.
In the case of BAM, using the
exposure assumptions discussed in this
unit for acute exposure, the acute
dietary exposure from food and water to
BAM will occupy 81% of the aPAD for
children 1 to <2 years 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 fluopicolide
from food and water will utilize 15% of
the cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. In the case of BAM, chronic
exposure to BAM from food and water
will utilize 26% of the cPAD for all
infants (<1 year old), the population
group receiving the greatest exposure.
Based on the explanation in Unit
III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of fluopicolide or BAM is not
expected.
3. Short-term/intermediate-term risk.
Short-term aggregate exposure takes into
account short-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Fluopicolide is currently registered
for uses that could result in short-term
residential exposure and may result in
post-application exposures of BAM. The
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
fluopicolide and BAM. There are no
intermediate-term exposures expected
for fluopicolide or BAM; however, the
short-term aggregate assessment is
considered protective of intermediateterm since the same endpoints were
selected to evaluate short- and
intermediate-term exposures.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined fluopicolide short-term food,
water, and residential exposures for
children 1–2 years old and children 6–
11 years old result in aggregate MOEs of
490 and 670, respectively. In addition,
an aggregate assessment conducted for
adults resulted in an MOE of 500.
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Because EPA’s level of concern for
fluopicolide is a MOE of 100 or below,
these MOEs are not of concern. For
BAM, dermal and inhalation exposures
may not be combined with oral
exposures due to different toxicological
effects used as the basis of the selected
endpoints. As a result, the aggregate risk
estimates are equivalent to the dietary
risk estimates and are not of concern.
4. Aggregate cancer risk for U.S.
population. Due to the absence of
treatment-related tumors in two
adequate rodent carcinogenicity studies,
fluopicolide is classified as ‘‘not likely
to be carcinogenic to humans’’;
therefore, a quantitative cancer
assessment is not required.
EPA has assumed BAM’s potential for
carcinogenicity is similar to that of
dichlobenil, which is classified as
‘‘group C, possible human carcinogen.’’
Quantification of cancer risk is based
on the RfD approach which requires
comparison of the chronic exposure to
the RfD. Therefore, the chronic risks
discussed in Unit III.E.2. are considered
protective of both non-cancer and
cancer effects.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to fluopicolide
residues, including its metabolite.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography with tandem
mass spectroscopy (LC/MS/MS)
enforcement method RM–43C–2) is
available to enforce the tolerance
expression. Enforcement methodology
(LC/MS/MS Method, Methods 00782,
00782/M001, 00782/M002, and 00782/
M003) is available to adequately enforce
the tolerance expression for BAM.
The methods 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).
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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.
Codex has not established MRLs for
basil, hop, bean, or citrus. The fruit,
small, vine climbing, except fuzzy
kiwifruit, subgroup 13–07F tolerance is
harmonized with Codex grape MRL.
Codex established a tolerance for
‘‘Fruiting vegetables other than
cucurbits’’ at 1.0 ppm. Based on the
field trial data and the Organization for
Economic Cooperation and
Development (OECD) calculator, using
the labeled application scenario may
result in residues greater than 1.0 ppm
in/on fruiting vegetables. As a result,
harmonization of the vegetable, fruiting,
crop group 8–10 tolerance with the
Codex MRL could result in food
containing residues exceeding
tolerances despite legal application of
the pesticide, which would not be
appropriate.
C. Response to Comments on Notice of
Filing
Two anonymous public comments
were received on the notice of filing that
center around opposing IR–4 and the
uses of pesticides (toxic chemicals),
such as fluopicolide, on food
commodities including grape, citrus and
basil, claiming these chemicals are
harmful to human health.
EPA’s Response: Aside from
assertions that chemicals are toxic and
linked to adverse human health effects,
the commenters provided no
information supporting these assertions
that EPA could use to evaluate the
safety of fluopicolide or BAM. The
existing legal framework provided by
section 408 of the Federal Food, Drug
and Cosmetic Act (FFDCA) states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. When new or amended
tolerances are requested for residues of
a pesticide in food or feed, the Agency
evaluates all available data and assesses
the potential for risk from aggregate
exposure to the pesticide. As discussed
in this rule, EPA examined all relevant
data for fluopicolide and BAM and has
concluded that there is a reasonable
certainty that no harm will result from
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aggregate human exposure to
fluopicolide, including residues of its
metabolite BAM. The commenters have
presented no information to support
reconsideration of that conclusion.
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D. Revisions to Petitioned-For
Tolerances
The established tolerances differ from
the petitioner’s requests as follows:
i. EPA is establishing a tolerance for
‘‘basil fresh leaves’’ at 40 ppm, rather
than 30 ppm, as a result of removing
certain inadequate residue data from the
tolerance calculation.
ii. The petitioner requested a
tolerance for residues of fluopicolide for
the general category of ‘‘bean,
succulent’’ at 0.9 ppm. This term is
defined in EPA’s regulations as
including a variety of beans in succulent
form (see 40 CFR 180.1(g)). At this time,
EPA is establishing tolerances for only
those beans included in the succulent
bean definition that are also supported
by the submitted snap bean field trial
data. Those specific succulent beans are
the following: ‘‘bean, moth, succulent’’,
‘‘bean, yardlong, succulent’’ (species of
the Vigna genus), ‘‘bean, runner,
succulent’’, ‘‘bean, snap, succulent’’,
and ‘‘bean, wax, succulent’’ (species of
the Phaseolus genus). Tolerances for the
other beans contained within the
definition of ‘‘bean, succulent’’ as
contained in 180.1(g) are not being
established at this time due to lack of
adequate residue data. In addition, the
Agency has adjusted the tolerance
values for these beans (from 0.9 to 0.90)
to be consistent with its current
guidance on significant figures.
iii. Because all reported residue data
on crops supporting the ‘‘fruit, citrus,
crop group 10–10’’ were below the 0.01
ppm limit of quantitation, EPA is
establishing a tolerance for this group at
0.01 ppm.
iv. The petitioner’s requested
tolerances for ‘‘citrus, dried pulp’’ at
0.048 ppm and ‘‘citrus, oil’’ at 1.94 ppm
were based on the petitioned-for
tolerance level for citrus group 10–10 at
0.02 ppm. Using the 0.01 ppm tolerance
level for group 10–10 as indicated in the
previous paragraph and applying
appropriate processing factors yields
tolerances of 0.03 for citrus, dried pulp
and 1.0 for citrus, oil.
V. Conclusion
Therefore, tolerances are established
for residues of the fungicide
fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2pyridinyl]methyl]benzamide], including
its metabolites and degradates
(determined by measuring the parent
only), in or on Basil, fresh leaves at 40
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ppm; Basil, dried leaves at 200 ppm;
Bean, moth, succulent at 0.90 ppm;
Bean, snap, succulent at 0.90 ppm;
Bean, runner, succulent at 0.90 ppm;
Bean, wax, succulent at 0.90 ppm; Bean,
yardlong, succulent at 0.90 ppm; Citrus,
dried pulp at 0.03 ppm; Citrus, oil at 1.0
ppm; Fruit, citrus, crop group 10–10 at
0.01 ppm; Fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13–07F
at 2.0 ppm; Hop, dried cones at 15 ppm;
and Vegetable, fruiting, crop group 8–10
at 1.6 ppm. Also, the tolerances for
‘‘Grape’’ and ‘‘Vegetable, fruiting, group
8’’ in the table in paragraph (a) and for
‘‘Hop, dried, cones’’ in the table in
paragraph (b) are deleted as they are
superseded by this action. Finally, in an
additional housekeeping measure, the
expired tolerances for ‘‘Potato,
processed potato waste’’ at 1.0 ppm and
‘‘Vegetable, tuberous and corm,
subgroup 1C’’ at 0.3 ppm are deleted
since they have no effect anymore and
have been replaced by lower tolerances
for those commodities as discussed in
the Federal Register of September 26,
2016 (81 FR 65924).
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001); Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997); or Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
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9711
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 20, 2018.
Michael L. Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
E:\FR\FM\07MRR1.SGM
07MRR1
9712
Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Rules and Regulations
PART 180—[AMENDED]
AGENCY FOR INTERNATIONAL
DEVELOPMENT
1. The authority citation for part 180
continues to read as follows:
■
48 CFR Part 752
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.627:
a. In the table to paragraph (a):
i. Add alphabetically the entries
‘‘Basil, dried leaves’’; ‘‘Basil, fresh
leaves’’; ‘‘Bean, moth, succulent’’;
‘‘Bean, runner, succulent’’; ‘‘Bean, snap,
succulent’’; ‘‘Bean, wax, succulent’’;
‘‘Bean, yardlong, succulent’’; ‘‘Citrus,
dried pulp’’; ‘‘Citrus, oil’’; ‘‘Fruit, citrus,
crop group 10–10’’; and ‘‘Fruit, small,
vine climbing, except fuzzy kiwifruit,
subgroup 13–07F’’;
■ ii. Remove the entry for ‘‘Grape’’;
■ iii. Add alphabetically the entry
‘‘Hop, dried cones’’;
■ iv. Remove the entry for ‘‘Potato,
processed potato waste 1 ’’;
■ v. Add alphabetically the entry
‘‘Vegetable, fruiting, crop group 8–10’’;
and
■ vi. Remove the entries for ‘‘Vegetable,
fruiting, group 8’’ and ‘‘Vegetable,
tuberous and corm, subgroup 1C 1 ’’ and
footnote 1 of the table.
■ b. Revise paragraph (b).
The additions and revision read as
follows:
■
■
■
RIN 0412–AA85
USAID Acquisition Regulation (AIDAR)
Regarding Government Property—
USAID Reporting Requirements
U.S. Agency for International
Development.
ACTION: Final rule.
AGENCY:
The U.S. Agency for
International Development (USAID) is
issuing a final rule to amend the USAID
Acquisition Regulation (AIDAR) that
clarifies accountability for all mobile
Information Technology equipment.
DATES: Effective date: April 6, 2018.
FOR FURTHER INFORMATION CONTACT:
Carol Ketrick, Telephone: 202–567–
4676 or Email: cketrick@usaid.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
On November 29, 2016, USAID
published a proposed rule at 81 FR
85916 revising the Agency for
International Development Acquisition
Regulation (AIDAR) to strengthen and
clarify existing policy and procedures
§ 180.627 Fluopicolide; tolerances for
for accountability of all USAID mobile
residues.
Information Technology (IT) equipment
(a) * * *
and access to agency facilities and
information systems. This final rule
Parts per
clarifies the reporting requirements for
Commodity
million
all mobile IT equipment in the AIDAR
Basil, dried, leaves .....................
200 clause section 752.245–70, Government
Basil, fresh leaves ......................
40 Property—USAID reporting
Bean, moth, succulent ................
0.90 requirements. The clause is amended to
Bean, runner, succulent .............
0.90 clarify that all mobile Information
Bean, snap, succulent ................
0.90 Technology (IT) equipment is identified
Bean, wax, succulent .................
0.90 as accountable. This includes both
Bean, yardlong, succulent ..........
0.90
mobile IT equipment that is USAIDowned and furnished to the contractor,
as well as contractor acquired mobile IT
*
*
*
*
*
Citrus, dried pulp ........................
0.03 equipment, title to which vests in the
Citrus, oil .....................................
1.0 U.S. Government.
0.01
*
*
*
*
Hop, dried cones ........................
*
*
*
*
*
Vegetable, fruiting, crop group
8–10 ........................................
daltland on DSKBBV9HB2PROD with RULES
Fruit, citrus, crop group 10–10 ...
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13–07F ....................................
*
*
*
*
*
2.0
15
1.6
*
(b) Section 18 emergency exemptions.
[Reserved]
*
*
*
*
*
[FR Doc. 2018–04533 Filed 3–6–18; 8:45 am]
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16:31 Mar 06, 2018
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II. Discussion and Analysis
One respondent submitted a comment
on the proposed rule.
USAID reviewed and considered the
public comment in the development of
this final rule. A discussion of the
comment received is provided as
follows:
Comment: The respondent suggested
alternative clarifying revisions to the
language in AIDAR section 752.245–70.
Specifically, the comment stated:
It would be clearer if the definition of
‘‘government property’’ in (a)(2) was
updated to include contractor acquired
mobile IT equipment. Either by
updating the clause itself (‘‘The term
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Fmt 4700
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Government property, . . . , shall
mean Government-furnished property,
non-expendable personal property title
to which vests in the U.S. Government,
and all contractor acquired mobile IT
equipment’’) or by updating the
definition of non-expendable personal
property to include mobile IT
equipment regardless of service life or
unit cost (‘‘Non-expendable personal
property, for purposes of this contract,
is defined as personal property . . . and
that has a unit cost of more than $500.
Non-expendable personal property
includes mobile IT equipment
regardless of expected service life or
unit cost’’).
Response: The comment was
considered and revisions have been
made to this final AIDAR rule.
The format of the required Annual
Report of Government Property in
Contractor’s Custody is corrected to read
that all mobile IT equipment is
accountable and must be reported. The
format of the required Annual Report of
Government Property in the Contractor’s
Custody is corrected to read that all
Contractor acquired mobile IT
equipment must be reported.
III. Regulatory Planning and Review
This rule is not an E.O. 13771
regulatory action because this rule is not
significant under E.O. 12866 Regulatory
Planning and Review, dated September
30, 1993. This rule is not a major rule
under 5 U.S.C. 804.
IV. Regulatory Flexibility Act
The rule will not have an impact on
a substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.
Therefore, an Initial Regulatory
Flexibility Analysis has not been
performed.
V. Paperwork Reduction Act
The rule clarifies but does not
establish a new collection of
information that requires the approval
of the Office of Management and Budget
under the Paperwork Reduction Act (44
U.S.C. chapter 35).
List of Subjects in 48 CFR Part 75
Government procurement.
For the reasons discussed in the
preamble, USAID amends 48 CFR
chapter 7 as set forth below:
PART 752—SOLICITATION
PROVISIONS AND CONTRACT
CLAUSES
1. The authority citation for 48 CFR
part 752 continues to read as follows:
■
E:\FR\FM\07MRR1.SGM
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Agencies
[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Rules and Regulations]
[Pages 9703-9712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04533]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0257; FRL-9973-44]
Fluopicolide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fluopicolide in or on multiple commodities which are identified and
discussed later in this document. In addition, this regulation removes
several previously established tolerances that are superseded by 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 March 7, 2018. Objections and
requests for hearings must be received on or before May 7, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0257, is available at https://www.regulations.gov or at the Office of Pesticide Programs
[[Page 9704]]
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0257 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
May 7, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0257, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of Wednesday, June 22, 2016 (81 FR 40594)
(FRL-9947-32), 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 6E8464) by IR-4 Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.627 be
amended by establishing tolerances for residues of the fungicide,
fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], including its metabolites and degradates,
in or on the commodities: Basil, dried leaves at 200 parts per million
(ppm); basil, fresh leaves at 30 ppm; bean, succulent at 0.9 ppm;
citrus, dried pulp at 0.048 ppm; citrus, oil at 1.94 ppm; hop, dried
cones at 15 ppm; fruit, citrus, group 10-10 at 0.02 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and
vegetable, fruiting, crop group 8-10 at 1.60 ppm. That document
referenced a summary of the petition prepared by Valent, the
registrant, which is available in the docket, https://www.regulations.gov. Two similar anonymous public comments were
received in response to the notice of filing. The Agency's response to
the comments is included in Unit IV.C.
Based upon review of the data supporting the petition, EPA is
establishing certain tolerances that differ from what the petitioner
requested. The reasons for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of, and to make a
determination on aggregate exposure for fluopicolide including exposure
resulting from the tolerances established by this action.
Fluopicolide shares a metabolite, 2,6-dichlorobenzamide (BAM), with
another active ingredient, dichlobenil. Residues of BAM are assessed
independently of fluopicolide and dichlobenil because it has its own
toxicity database and endpoints of concern. The BAM assessment
considers residues resulting from both fluopicolide and dichlobenil
uses. EPA's safety finding for
[[Page 9705]]
fluopicolide considers the aggregate exposures to fluopicolide alone as
well as the aggregate exposure to BAM from both fluopicolide and
dichlobenil uses.
A. Toxicological Profile
EPA has evaluated the available toxicity database and considered
its validity, completeness, and reliability as well as the relationship
of the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Fluopicolide. Fluopicolide has low acute toxicity by the oral,
dermal, and inhalation routes. Following subchronic and chronic
exposures, increased liver weights and/or liver hypertrophy were
observed in rats and mice. Additional liver lesions were seen in mice,
including oval cell proliferation in a 90-day oral toxicity study and
altered cell foci in the carcinogenicity study. Treatment-related
effects in rats also included kidney and thyroid effects; however,
these effects were not seen consistently across studies in the
fluopicolide database. In the 28-day oral toxicity study in rats, there
were indications of nephrotoxicity including pale kidneys and
microscopic lesions (granulation, proteinaceous material, and
hydronephrosis). Kidney effects were not observed in any other studies,
except the reproduction toxicity study where slightly increased organ
weights and kidney lesions were observed in parental animals. Thyroid
toxicity was only observed in the combined chronic/carcinogenicity
study in rats and consisted of increased thyroid weights, gross
pathological observation of enlarged thyroids, and increased incidence
of cystic follicular hyperplasia in males (slight to moderate
severity).
Evidence of increased quantitative susceptibility was seen in the
rat developmental toxicity study. Developmental effects (delayed
ossification and fetal growth) were only seen at a relatively high dose
(700 mg/kg/day) in the absence of maternal effects. There was no
evidence of susceptibility in the rabbit developmental toxicity and rat
reproduction toxicity studies. In the rabbit developmental toxicity
study, late abortions/premature deliveries were observed at 60 mg/kg/
day. Additional effects at this dose included late maternal deaths and
decreased crown rump length in fetuses. In the rat reproduction
toxicity study, offspring effects (decreased body weight) were seen in
the presence of parental effects (kidney effects).
There is no evidence of neurotoxicity, immunotoxicity, or
mutagenicity in the fluopicolide toxicity database. Due to the absence
of treatment-related tumors in two adequate rodent carcinogenicity
studies, fluopicolide is classified as ``Not Likely to be Carcinogenic
to Humans''.
BAM. Acute toxicity studies on BAM demonstrated moderate acute
toxicity via the oral route of exposure. In subchronic and chronic
toxicity studies, the primary oral effects seen in the rat and dog were
body weight changes. Adverse liver effects, including hepatocellular
alterations and increased liver weights, were also observed. Toxicity
to the olfactory sensory neurons has been observed following
intraperitoneal exposure of mice to BAM, indicating potential
neurotoxicity; however, no effects on the olfactory system were
observed via the oral route. There is no evidence that BAM is either
mutagenic or clastogenic nor is there evidence of endocrine mediated
toxicity. A BAM combined chronic toxicity/carcinogenicity study in the
rat is available; however, in the absence of a carcinogenicity study
data for a second species, EPA has assumed that BAM's carcinogenic
potential is similar to that of dichlobenil, the parent compound having
the greatest carcinogenicity potential. Dichlobenil is classified as
``Group C, possible human carcinogen.'' Therefore, EPA has concluded
that quantification of cancer risk using a non-linear approach (i.e.,
RfD) will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to dichlobenil, and
therefore, to BAM.
Specific information on the studies received and the nature of the
adverse effects caused by fluopicolide and BAM, as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document: Fluopicolide and 2,6-Dichlorobenzamide
(BAM). Human Health Risk Assessment to Support Registration for
Application of Fluopicolide on Basil, Succulent Bean, Hops, Small Vine
Climbing Subgroup 13-07F, and Citrus Fruit Group 10-10 and Crop Group
Conversion for Fruiting Vegetables 8-10, dated December 5, 2017 at
pages 19-25 in docket ID number EPA-HQ-OPP-2016-0257.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for fluopicolide and BAM
used for human risk assessment is shown in Table 1 and Table 2,
respectively, of this unit.
[[Page 9706]]
Table 1--Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations).. An endpoint attributable to a single dose was not identified from the
available data.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) Maternal NOAEL = 20 cRfD = cPAD = 0.2 Developmental Toxicity Study in
mg/kg/day. mg/kg/day. Rabbits.
UFA = 10x........... LOAEL (maternal) = 60 mg/kg/day
UFH = 10x........... based on death, abortions/
FQPA SF = 1X........ premature deliveries, and
decreased food consumption.
Co-critical: Chronic/Oncogenicity
Study in Rats.
NOAEL = 31.5 mg/kg/day.
LOAEL = 109.4 mg/kg/day based on
increased thyroid weight and
increased incidence of thyroid
lesions.
Incidental oral short- and Maternal NOAEL = 20 LOC for MOE <100... Developmental Toxicity Study in
intermediate-term (1-30 days, mg/kg/day. Rabbits.
and 1-6 months). UFA = 10x........... LOAEL (maternal) = 60 mg/kg/day
UFH = 10x........... based on death, abortions/
FQPA SF = 1X........ premature deliveries, decreased
food consumption and body-weight
gain.
Dermal short- and intermediate- Maternal NOAEL = 20 LOC for MOE <100... Developmental Toxicity Study in
term (1-30 days, and 1-6 months). mg/kg/day. Rabbits.
UFA = 10x........... LOAEL (maternal) = 60 mg/kg/day
UFH = 10x........... based on death, abortions/
FQPA SF = 1X (when premature deliveries, decreased
applicable). food consumption and body-weight
DAF = 5%............ gain.
Co-critical: Chronic/Oncogenicity
Study in Rats.
NOAEL = 31.5 mg/kg/day.
LOAEL = 109.4 mg/kg/day based on
increased thyroid weight and
increased incidence of thyroid
lesions.
Inhalation short- and Maternal NOAEL = 20 LOC for MOE <100... Developmental Toxicity Study in
intermediate-term (1-30 days, mg/kg/day. Rabbits.
and 1-6 months). Inhalation assumed LOAEL (maternal) = 60 mg/kg/day
equivalent to oral. based on death, abortions/
UFA = 10x........... premature deliveries, decreased
UFH = 10x........... food consumption.
FQPA SF = 1X, when Co-critical: Chronic/Oncogenicity
applicable. Study in Rats.
NOAEL = 31.5 mg/kg/day.
LOAEL = 109.4 mg/kg/day based on
and increased thyroid weight and
increased incidence of thyroid
lesions.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
absence of treatment-related tumors in two adequate rodent carcinogenicity
studies.
----------------------------------------------------------------------------------------------------------------
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 associated with lower environmentally
relevant human exposures.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
Table 2--Summary of Toxicological Doses and Endpoints for 2,6-Dichlorobenzamide (BAM) for Use in Human Health
Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations).. LOAEL = 100 mg/kg/ aRfD = aPAD = 0.1 Dose-range finding assay for in
day. mg/kg/day. vivo mouse erythrocyte
UFA = 10x........... micronucleus assay.
UFH = 10x........... LOAEL = 100 mg/kg/day based on
FQPA SF/UFL= 10x.... lethargy after a single oral
dose.
Chronic dietary (All populations) NOAEL = 4.5 mg/kg/ cRfD = cPAD = 0.045 Chronic toxicity (dog).
day. mg/kg/day. LOAEL = 12.5 mg/kg/day based on
UFA = 10x........... decreased body weight and body
UFH = 10x........... weight gain.
FQPA SF = 1X........
Incidental oral short- and NOAEL = 14 mg/kg/day LOC for MOE <100... 90-day oral (rat).
intermediate-term (1-30 days, UFA = 10x........... LOAEL = 49 mg/kg/day based on
and 1-6 months). UFH = 10x........... decreased body weight gain (M)
FQPA SF = 1X........ and reduced skeletal muscle tone
(day 4 only in males; days 91 and
92 only in females).
[[Page 9707]]
Dermal short- and intermediate- NOAEL = 25 mg/kg/day LOC for MOE <100... 5-day dermal using dichlobenil
term (1-30 days and 1-6 months). UFA = 10x........... (mouse; literature study).
UFH = 10x........... LOAEL = 50 mg/kg/day based on
FQPA SF = 1X (when olfactory epithelial damage.
applicable).
Inhalation short- and NOAEL = 12.1 mg/m\3\ LOC for MOE <100... 28-day inhalation using
intermediate-term (1-30 days and UFA = 3X............ dichlobenil (rat).
1-6 months). UFH = 10X........... LOAEL = 21 mg/m\3\ based on nasal
FQPA SF = 1X (when degeneration.
applicable).
----------------------------------------------------------------------------------------------------------------
Cancer........................... Classification: unclassified; parent herbicide dichlobenil classified as
``Group C, possible human carcinogen'' with RfD approach utilized for
quantification of human risk
----------------------------------------------------------------------------------------------------------------
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, UFL = use of a
LOAEL to extrapolate a NOAEL, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect
level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted dose, MOE = margin of
exposure, LOC = level of concern, N/A = not applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluopicolide and its metabolite BAM, EPA considered
exposure under the petitioned-for tolerances as well as all existing
fluopicolide tolerances in 40 CFR 180.627 and the exposures from BAM
from existing dichlobenil tolerances under 40 CFR 180.231. EPA assessed
dietary exposures from fluopicolide and its metabolite BAM in food as
follows:
a. 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.
i. Fluopicolide. A toxicity endpoint attributable to a single dose
has not been identified in the toxicological studies for fluopicolide;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
ii. BAM. Such effects were identified for BAM. In estimating acute
dietary exposures to BAM, EPA used food consumption information from
the United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
This dietary survey was conducted from 2003 to 2008. EPA conducted a
partially refined acute dietary exposure assessment. As to residue
levels in food, EPA assumed maximum BAM residue from either the
fluopicolide or dichlobenil field trial data. The acute assessment
assumed 100% crop treated for all commodities, except apples,
blueberries, cherries, peaches, pears, and raspberries. These values
reflect the dichlobenil percent crop treated estimates as fluopicolide
is not registered for application to these crops. Default processing
factors were used for commodities where empirical processing data were
not available
b. Chronic exposure--i. Fluopicolide. In estimating chronic dietary
exposure, EPA used Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID, Version 3.16). The software
uses 2003-2008 food consumption data from the U.S. Department of
Agriculture (USDA) National Health and Nutrition Examination Survey,
What We Eat in America, (NHANES/WWEIA). The chronic analysis assumed
tolerance-level residues or maximum field trial residues, 100% crop
treated, default processing factors, and modeled drinking water
estimates.
ii. BAM. In estimating chronic dietary exposures, EPA conducted a
partially refined chronic dietary exposure assessment using DEEM-FCID
(ver. 3.16) and USDA's NHANES/WWEIA (2003 through 2008). The chronic
dietary assessment assumed the maximum BAM residue from either the
fluopicolide or dichlobenil field trial data. The chronic assessment
assumed 100% crop treated for all commodities except apple. These
values reflect the dichlobenil percent crop treated estimates as
fluopicolide is not registered for application to these crops. Default
processing factors were used for commodities where empirical processing
data were not available.
c. Cancer. Fluopicolide has been classified as ``not likely to be
carcinogenic to humans.'' Therefore, a cancer dietary exposure
assessment was not conducted for the parent fluopicolide. Additionally,
EPA has determined BAM's potential for carcinogenicity is similar to
that of dichlobenil, which is classified as ``group C, possible human
carcinogen.'' Quantification of cancer risk is based on the reference
dose (RfD) approach which requires comparison of the chronic exposure
to the RfD. Using this methodology will adequately account for all
chronic toxic effects, including carcinogenicity, likely to result from
exposure to BAM. Hence, a separate cancer exposure assessment to BAM
was not conducted.
d. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be
[[Page 9708]]
submitted no later than 5 years from the date of issuance of these
tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit
data on PCT.
EPA did not use anticipated residue or PCT information in the
dietary assessment for fluopicolide. Tolerance level residues or
maximum field trial residues and 100 PCT were assumed for all food
commodities.
EPA used anticipated residues and PCT information for the acute and
chronic dietary risk assessments for BAM. The BAM acute assessment
assumed 100 PCT for all commodities except apples (2.5%), blueberries
(2.5%), cherries (2.5%), peaches (2.5%), pears (5%) and raspberries
(20%). The BAM chronic assessment assumed 100 PCT for all commodities
except apples (1%). These values reflect the dichlobenil percent crop
treated estimates as fluopicolide is not registered for application to
these crops. Default processing factors were used for commodities where
empirical processing data were not available.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis and a
maximum PCT for acute dietary risk analysis. The average PCT figure for
each existing use is derived by combining available public and private
market survey data for that use, averaging across all observations, and
rounding to the nearest 5%, except for those situations in which the
average PCT is less than 2.5%. The maximum PCT figure is the highest
observed maximum value reported within the most recent 6 years of
available public and private market survey data for the existing use
and rounded up to the nearest multiple of 5%, except for situations in
which the maximum PCT is less than 2.5%. In cases where the estimated
value is less than 2.5% but greater than 1%, the average and maximum
PCT used are 2.5%. If the estimated value is less than 1%, 1% is used
as the average PCT and 2.5% is used as the maximum PCT.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which BAM may be found in a particular area.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for fluopicolide in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluopicolide. 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.
No monitoring data are available for fluopicolide or BAM. Drinking
water residues of fluopicolide (parent) estimates were generated using
maximum annual application rate of 0.375 lbs ai/acre, and the surface
water concentration calculator (SWCC version 1.106) for surface water,
and the pesticide root zone model for groundwater (PRZM-GW version
1.07). The estimated drinking water concentrations (EDWCs) of
fluopicolide for non-cancer chronic exposures are 12.90 ppb for surface
water and 103 ppb for ground water.
Estimates of BAM residues in drinking water were generated using
the Provisional Cranberry Model (PCM) and Pesticide Water Concentration
Calculator (PWC) for surface water, and the PRZM-GW model for
groundwater. BAM drinking water concentrations can result from the
application of dichlobenil and fluopicolide. The BAM estimates
resulting from application of dichlobenil are higher than those
resulting from application of fluopicolide. The acute and chronic
analyses assumed a BAM drinking water concentration of 239 ppb and 206
ppb, respectively, based on the PRZM-GW model from turf use (worst case
scenario).
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment for BAM, the water concentration value of 239 ppb was used
to assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 206 ppb and 103 ppb were
used to assess the contribution to drinking water for BAM and
fluopicolide, respectively.
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).
Fluopicolide is currently registered for the following uses that
could result in residential exposures: Residential turf grass and
recreational sites; however, all registered fluopicolide product labels
with residential use sites require that handlers wear specific clothing
and/or use personal protective equipment (PPE). Therefore, the Agency
has concluded that these products are not intended to be used by
homeowners and did not conduct residential handler assessments. There
is potential for post-application exposure for individuals entering
areas that have been previously treated with fluopicolide. EPA assessed
the following residential exposure scenarios for fluopicolide:
Post-application exposure to children, youth, and adults from
treated lawns, turf, gardens, trees, and golf courses.
In the case of BAM, the Agency considered the potential for
residential exposures to BAM from dichlobenil and fluopicolide uses. As
noted above, fluopicolide is registered for use on residential
turfgrass and recreational
[[Page 9709]]
sites, such as golf courses. These uses may also result in short-term
dermal post-application exposure to BAM to youth and adults from
treated gardens. Post-application exposures from treated turf is not
expected since BAM was not detected in turf transferable residue
studies with fluopicolide.
As discussed above, residential handler assessments were not
performed for fluopicolide; therefore, a residential handler assessment
for BAM is also not required. Residential handler exposure to BAM
resulting from the application of dichlobenil is not expected. While
dichlobenil is currently registered for residential uses on ornamental
plants, they are approved for professional applicator use only. Post-
application exposure of adults and children to dichlobenil and BAM
exposure from the use of dichlobenil products on ornamental plants is
expected to be negligible and, therefore, was not assessed.
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluopicolide and any other
substances. Fluopicolide shares a common metabolite, BAM, with
dichlobenil. EPA's assessment of BAM from pesticide use of fluopicolide
and dichlobenil has been updated for the current assessment and no
risks of concern were identified. For the purposes of this tolerance
action, therefore, EPA has not assumed that fluopicolide (parent) and
its metabolite BAM 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. For fluopicolide, there is
no evidence of increased susceptibility in the rabbit developmental or
rat reproduction toxicity studies. There was evidence of increased
quantitative susceptibility in the rat developmental toxicity study;
however, the developmental effects were only seen at a relatively high
dose (700 mg/kg/day), the effects are well-characterized with a clear
NOAEL, and the selected endpoints are protective of the observed
effects. For BAM, there was no evidence of increased susceptibility in
the rabbit developmental study.
3. Conclusion for fluopicolide. 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 fluopicolide is complete.
ii. There is no indication that fluopicolide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence of increased susceptibility in the rabbit
developmental or rat reproduction toxicity studies. Although there is
evidence of increased quantitative susceptibility in the rat
developmental toxicity study, the developmental effects were only seen
at a relatively high dose, the effects are well characterized with a
clear NOAEL, and the selected endpoints are protective of the observed
effects. There are no residual uncertainties concerning prenatal and
postnatal toxicity for fluopicolide.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to fluopicolide in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children. These assessments will not underestimate the exposure and
risks posed by fluopicolide.
4. Conclusion for BAM: EPA is retaining the FQPA SF of 10X for the
acute dietary exposure scenario for the general population to account
for the use of a LOAEL to extrapolate to a NOAEL. For all other
exposure scenarios, the FQPA SF has been reduced to 1X. That decision
is based on the following findings:
i. Acute, subchronic, and chronic oral studies are available for
BAM and utilized for endpoint selection. For the dermal and inhalation
routes of exposures, the Agency is relying on dichlobenil toxicity
data, where olfactory toxicity was observed. Based on a comparison of
toxicity via the intraperitoneal route of exposure, higher doses of BAM
are needed to induce levels of olfactory toxicity that are similar to
those caused by dichlobenil; therefore, the endpoints based on
dichlobenil are considered protective of potential BAM toxicity.
ii. Although there is potential neurotoxicity in the olfactory
system from BAM exposure, concern is low since the effects are well-
characterized and selected endpoints based on dichlobenil are
protective of these effects.
iii. There is no evidence of increased susceptibility in the
developmental rabbit study.
iv. The assessments of BAM are unlikely to underestimate exposure
and risks. Acute and chronic dietary assessments assumed maximum BAM
residues from field trial data as well as conservative (protective)
assumptions of BAM exposure in drinking water. Similar conservative
assumptions were used to assess post-application exposure of children
to BAM.
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
[[Page 9710]]
PODs to ensure that an adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected for
fluopicolide. Therefore, fluopicolide is not expected to pose an acute
risk.
In the case of BAM, using the exposure assumptions discussed in
this unit for acute exposure, the acute dietary exposure from food and
water to BAM will occupy 81% of the aPAD for children 1 to <2 years
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
fluopicolide from food and water will utilize 15% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. In the case of BAM, chronic exposure to BAM from food and
water will utilize 26% of the cPAD for all infants (<1 year old), the
population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of fluopicolide or BAM is not
expected.
3. Short-term/intermediate-term risk. Short-term aggregate exposure
takes into account short-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Fluopicolide is currently registered for uses that could result in
short-term residential exposure and may result in post-application
exposures of BAM. The Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to fluopicolide and BAM. There are no
intermediate-term exposures expected for fluopicolide or BAM; however,
the short-term aggregate assessment is considered protective of
intermediate-term since the same endpoints were selected to evaluate
short- and intermediate-term exposures.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined fluopicolide short-term
food, water, and residential exposures for children 1-2 years old and
children 6-11 years old result in aggregate MOEs of 490 and 670,
respectively. In addition, an aggregate assessment conducted for adults
resulted in an MOE of 500. Because EPA's level of concern for
fluopicolide is a MOE of 100 or below, these MOEs are not of concern.
For BAM, dermal and inhalation exposures may not be combined with oral
exposures due to different toxicological effects used as the basis of
the selected endpoints. As a result, the aggregate risk estimates are
equivalent to the dietary risk estimates and are not of concern.
4. Aggregate cancer risk for U.S. population. Due to the absence of
treatment-related tumors in two adequate rodent carcinogenicity
studies, fluopicolide is classified as ``not likely to be carcinogenic
to humans''; therefore, a quantitative cancer assessment is not
required.
EPA has assumed BAM's potential for carcinogenicity is similar to
that of dichlobenil, which is classified as ``group C, possible human
carcinogen.''
Quantification of cancer risk is based on the RfD approach which
requires comparison of the chronic exposure to the RfD. Therefore, the
chronic risks discussed in Unit III.E.2. are considered protective of
both non-cancer and cancer effects.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluopicolide residues, including its metabolite.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with tandem
mass spectroscopy (LC/MS/MS) enforcement method RM-43C-2) is available
to enforce the tolerance expression. Enforcement methodology (LC/MS/MS
Method, Methods 00782, 00782/M001, 00782/M002, and 00782/M003) is
available to adequately enforce the tolerance expression for BAM.
The methods 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.
Codex has not established MRLs for basil, hop, bean, or citrus. The
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
tolerance is harmonized with Codex grape MRL. Codex established a
tolerance for ``Fruiting vegetables other than cucurbits'' at 1.0 ppm.
Based on the field trial data and the Organization for Economic
Cooperation and Development (OECD) calculator, using the labeled
application scenario may result in residues greater than 1.0 ppm in/on
fruiting vegetables. As a result, harmonization of the vegetable,
fruiting, crop group 8-10 tolerance with the Codex MRL could result in
food containing residues exceeding tolerances despite legal application
of the pesticide, which would not be appropriate.
C. Response to Comments on Notice of Filing
Two anonymous public comments were received on the notice of filing
that center around opposing IR-4 and the uses of pesticides (toxic
chemicals), such as fluopicolide, on food commodities including grape,
citrus and basil, claiming these chemicals are harmful to human health.
EPA's Response: Aside from assertions that chemicals are toxic and
linked to adverse human health effects, the commenters provided no
information supporting these assertions that EPA could use to evaluate
the safety of fluopicolide or BAM. The existing legal framework
provided by section 408 of the Federal Food, Drug and Cosmetic Act
(FFDCA) states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. When new or amended tolerances
are requested for residues of a pesticide in food or feed, the Agency
evaluates all available data and assesses the potential for risk from
aggregate exposure to the pesticide. As discussed in this rule, EPA
examined all relevant data for fluopicolide and BAM and has concluded
that there is a reasonable certainty that no harm will result from
[[Page 9711]]
aggregate human exposure to fluopicolide, including residues of its
metabolite BAM. The commenters have presented no information to support
reconsideration of that conclusion.
D. Revisions to Petitioned-For Tolerances
The established tolerances differ from the petitioner's requests as
follows:
i. EPA is establishing a tolerance for ``basil fresh leaves'' at 40
ppm, rather than 30 ppm, as a result of removing certain inadequate
residue data from the tolerance calculation.
ii. The petitioner requested a tolerance for residues of
fluopicolide for the general category of ``bean, succulent'' at 0.9
ppm. This term is defined in EPA's regulations as including a variety
of beans in succulent form (see 40 CFR 180.1(g)). At this time, EPA is
establishing tolerances for only those beans included in the succulent
bean definition that are also supported by the submitted snap bean
field trial data. Those specific succulent beans are the following:
``bean, moth, succulent'', ``bean, yardlong, succulent'' (species of
the Vigna genus), ``bean, runner, succulent'', ``bean, snap,
succulent'', and ``bean, wax, succulent'' (species of the Phaseolus
genus). Tolerances for the other beans contained within the definition
of ``bean, succulent'' as contained in 180.1(g) are not being
established at this time due to lack of adequate residue data. In
addition, the Agency has adjusted the tolerance values for these beans
(from 0.9 to 0.90) to be consistent with its current guidance on
significant figures.
iii. Because all reported residue data on crops supporting the
``fruit, citrus, crop group 10-10'' were below the 0.01 ppm limit of
quantitation, EPA is establishing a tolerance for this group at 0.01
ppm.
iv. The petitioner's requested tolerances for ``citrus, dried
pulp'' at 0.048 ppm and ``citrus, oil'' at 1.94 ppm were based on the
petitioned-for tolerance level for citrus group 10-10 at 0.02 ppm.
Using the 0.01 ppm tolerance level for group 10-10 as indicated in the
previous paragraph and applying appropriate processing factors yields
tolerances of 0.03 for citrus, dried pulp and 1.0 for citrus, oil.
V. Conclusion
Therefore, tolerances are established for residues of the fungicide
fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], including its metabolites and degradates
(determined by measuring the parent only), in or on Basil, fresh leaves
at 40 ppm; Basil, dried leaves at 200 ppm; Bean, moth, succulent at
0.90 ppm; Bean, snap, succulent at 0.90 ppm; Bean, runner, succulent at
0.90 ppm; Bean, wax, succulent at 0.90 ppm; Bean, yardlong, succulent
at 0.90 ppm; Citrus, dried pulp at 0.03 ppm; Citrus, oil at 1.0 ppm;
Fruit, citrus, crop group 10-10 at 0.01 ppm; Fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; Hop,
dried cones at 15 ppm; and Vegetable, fruiting, crop group 8-10 at 1.6
ppm. Also, the tolerances for ``Grape'' and ``Vegetable, fruiting,
group 8'' in the table in paragraph (a) and for ``Hop, dried, cones''
in the table in paragraph (b) are deleted as they are superseded by
this action. Finally, in an additional housekeeping measure, the
expired tolerances for ``Potato, processed potato waste'' at 1.0 ppm
and ``Vegetable, tuberous and corm, subgroup 1C'' at 0.3 ppm are
deleted since they have no effect anymore and have been replaced by
lower tolerances for those commodities as discussed in the Federal
Register of September 26, 2016 (81 FR 65924).
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 20, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 9712]]
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.627:
0
a. In the table to paragraph (a):
0
i. Add alphabetically the entries ``Basil, dried leaves''; ``Basil,
fresh leaves''; ``Bean, moth, succulent''; ``Bean, runner, succulent'';
``Bean, snap, succulent''; ``Bean, wax, succulent''; ``Bean, yardlong,
succulent''; ``Citrus, dried pulp''; ``Citrus, oil''; ``Fruit, citrus,
crop group 10-10''; and ``Fruit, small, vine climbing, except fuzzy
kiwifruit, subgroup 13-07F'';
0
ii. Remove the entry for ``Grape'';
0
iii. Add alphabetically the entry ``Hop, dried cones'';
0
iv. Remove the entry for ``Potato, processed potato waste \1\ '';
0
v. Add alphabetically the entry ``Vegetable, fruiting, crop group 8-
10''; and
0
vi. Remove the entries for ``Vegetable, fruiting, group 8'' and
``Vegetable, tuberous and corm, subgroup 1C \1\ '' and footnote 1 of
the table.
0
b. Revise paragraph (b).
The additions and revision read as follows:
Sec. 180.627 Fluopicolide; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Basil, dried, leaves........................................ 200
Basil, fresh leaves......................................... 40
Bean, moth, succulent....................................... 0.90
Bean, runner, succulent..................................... 0.90
Bean, snap, succulent....................................... 0.90
Bean, wax, succulent........................................ 0.90
Bean, yardlong, succulent................................... 0.90
------------------------------------------------------------------------
* * * * *
Citrus, dried pulp.......................................... 0.03
Citrus, oil................................................. 1.0
Fruit, citrus, crop group 10-10............................. 0.01
Fruit, small, vine climbing, except fuzzy kiwifruit, 2.0
subgroup 13-07F............................................
* * * * *
Hop, dried cones............................................ 15
* * * * *
Vegetable, fruiting, crop group 8-10........................ 1.6
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2018-04533 Filed 3-6-18; 8:45 am]
BILLING CODE 6560-50-P