Propiconazole; Pesticide Tolerances, 79711-79718 [2015-32327]
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food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for 2-propenoic acid, homopolymer,
ester with a-[2,4,6-tris(1phenylethyl)phenyl]-whydroxypoly(oxy-1,2-ethanediyl),
compd. with 2,2′,2″-nitrilotris[ethanol].
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IX. Conclusion
Accordingly, EPA finds that
exempting residues of 2-propenoic acid,
homopolymer, ester with a-[2,4,6-tris(1phenylethyl)phenyl]-whydroxypoly(oxy-1,2-ethanediyl),
compd. with 2,2′,2″-nitrilotris[ethanol]
from the requirement of a tolerance will
be safe.
X. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). 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
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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).
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
XI. 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).
SUMMARY:
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 11, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, add alphabetically the
following polymer to the table to read as
follows:
■
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*
*
*
*
*
Polymer
CAS No.
*
*
*
2-propenoic acid,
homopolymer, ester with
a-[2,4,6-tris(1phenylethyl)phenyl]-whydroxypoly(oxy-1,2ethanediyl), compd. with
2,2′,2″-nitrilotris[ethanol]),
minimum number average
molecular weight (in amu),
10,000 ...............................
*
*
*
*
*
1477613–46–9
*
*
[FR Doc. 2015–32176 Filed 12–22–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0788; FRL–9939–83]
Propiconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of propiconazole
in or on multiple commodities which
are identified and discussed later in this
document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 23, 2015. Objections and
requests for hearings must be received
on or before February 22, 2016, 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–2014–0788, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
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information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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–2014–0788 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 February 22, 2016. 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
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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–
2014–0788, 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 October 21,
2015 (80 FR 63731) (FRL–9935–29),
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 4E8321) by IR–4,
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.434 be
amended by establishing tolerances for
residues of the fungicide,
propiconazole, 1-[[2-(2,4dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole and its
metabolites determined as 2,4,dichlorobenzoic acid (2,4–DCBA),
expressed as the stoichiometric
equivalent of propiconazole, in or on
the following raw agricultural
commodities: Dill, dried at 80 parts per
million (ppm); dill, fresh at 30 ppm;
dill, seed at 15 ppm; fruit, stone, group
12–12, except plum at 4 ppm and nut,
tree, group 14–12 at 0.1 ppm; leafy
Brassica greens, subgroup 5B at 20 ppm;
quinoa, grain, at 3.0 ppm; radish, roots
at 0.04 ppm; radish, tops at 0.2 ppm; ti
palm, leaves at 10 ppm; ti palm, roots
at 0.3 ppm, and watercress at 6 ppm.
IR–4 also requested that upon
establishment of the above tolerances,
that the existing tolerances for ‘‘fruit,
stone, group 12, except plum’’ and ‘‘nut,
tree, group 14’’ be removed. That
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document referenced a summary of the
petition prepared by Syngenta, the
registrant, which is available in the
docket, https://www.regulations.gov. The
October 21, 2015 notice supersedes a
notice of filing published in the Federal
Register on February 11, 2015 (80 FR
7559) (FRL–9921–94). The October 21,
2015 notice includes the commodity
‘‘quinoa, grain’’ as well as the other
commodities that were originally
requested in the February 11, 2015
notice. Two comments were received in
response to the October 21, 2015 notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
modified some of the commodity
vocabulary and rounded the significant
figures of some of the tolerances. The
reason 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 propiconazole
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with propiconazole follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
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the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
The primary target organ for
propiconazole toxicity in animals is the
liver. Increased liver weights were seen
in mice after subchronic or chronic oral
exposures to propiconazole. Liver
lesions such as vacuolation of
hepatocytes, ballooned liver cells, foci
of enlarged hepatocytes, hypertrophy,
and necrosis are characteristic of
propiconazole toxicity in rats and mice.
Decreased body weight gain was also
seen in subchronic, chronic,
developmental and reproductive studies
in animal studies. Dogs appeared to be
more sensitive to the localized toxicity
of propiconazole as manifested by
stomach irritations at 6 milligram/
kilogram/day (mg/kg/day) and above.
In rabbits, developmental toxicity
occurred at a higher dose than the
maternally toxic dose, while in rats,
developmental toxicity occurred at
lower doses than maternal toxic doses.
Increased incidences of rudimentary
ribs occurred in rat and rabbit fetuses.
Increased cleft palate malformations
were noted in two studies in rats. In one
published study in rats, developmental
effects (malformations of the lung and
kidneys, incomplete ossification of the
skull, caudal vertebrae and digits, extra
rib (14th rib) and missing sternbrae)
were reported at doses that were not
maternally toxic. In the two generation
reproduction study in rats, offspring
toxicity occurred at a higher dose than
the parental toxic dose suggesting lower
susceptibility of the offspring to the
toxic doses of propiconazole.
The acute neurotoxicity study
produced severe clinical signs of
toxicity (decreased activity, cold, pale,
decreased motor activity, etc.) in rats at
the high dose of 300 milligram/kilogram
(mg/kg). Limited clinical signs
(piloerection, diarrhea, tip toe gait) were
observed in the mid-dose animals (100
mg/kg), while no treatment related signs
were observed at 30 mg/kg. The current
acute dietary assessment for the general
population is based on the NOAEL of 30
mg/kg from the acute neurotoxicity
study. A subchronic neurotoxicity study
in rats did not produce neurotoxic signs
at the highest dose tested that was
associated with decreased body weight.
Propiconazole was negative for
mutagenicity in the in vitro BALB/3T3
cell transformation assay, bacterial
reverse mutation assay, Chinese hamster
bone marrow chromosomal aberration
assay, unscheduled DNA synthesis
studies in human fibroblasts and
primary rat hepatocytes, mitotic gene
conversion assay, and the dominant
lethal assay in mice. It caused
proliferative changes in the rat liver
with or without pretreatment with an
initiator, like phenobarbital, a known
liver tumor promoter. Liver enzyme
induction studies with propiconazole in
mice demonstrated that propiconazole
is a strong phenobarbital type inducer of
xenobiotic metabolizing enzymes.
Hepatocellular proliferation studies in
mice suggest that propiconazole induces
cell proliferation followed by treatmentrelated hypertrophy in a manner similar
to the known hypertrophic agent
phenobarbital.
Propiconazole was carcinogenic to
male mice but was not carcinogenic to
rats or to female mice. The Agency
classified propiconazole as a possible
human carcinogen and recommended
that, for the purpose of risk
characterization, the reference dose
(RfD) approach be used for
quantification of human risk.
Propiconazole is not genotoxic and this
fact, together with special mechanistic
studies, indicates that propiconazole is
a threshold carcinogen. Propiconazole
produced liver tumors in male mice
only at a high dose that was toxic to the
liver. At doses below the RfD, liver
toxicity is not expected; therefore,
tumors are also not expected.
Specific information on the studies
received and the nature of the adverse
effects caused by propiconazole as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-
79713
adverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
titled, ‘‘Propiconazole Human Health
Risk Assessment for the New Uses of
Propiconazole on dill, leafy brassicas
crop subgroup 5B, ti palm, watercress,
and quinoa, along with expansion to
fruit, stone, group 12–12; except plum,
and nut, tree, group 14–12’’ on pp. 37
in docket ID number EPA–HQ–OPP–
2014–0788.
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 the NOAEL and the
LOAEL are identified. 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
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-assessingpesticide-risks/assessing-human-healthrisk-pesticides.
A summary of the toxicological
endpoints for propiconazole used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPICONAZOLE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
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Exposure/scenario
Acute dietary (Females 13–50
years of age).
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Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL = 30 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.3 mg/
kg/day.
aPAD = 0.3 mg/kg/
day
Developmental Study—Rat
LOAEL = 90 mg/kg/day based on increased incidence of rudimentary ribs, un-ossified sternebrae, as well as increased incidence of shortened and absent renal papillae and increased cleft palate.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPICONAZOLE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Acute dietary (General population including infants and
children).
Chronic dietary (Adult Males
and Females 50+ yrs).
Incidental oral short-term (1 to
30 days).
Incidental oral intermediateterm (1 to 6 months).
Dermal short-term (1 to 30
days).
Dermal intermediate-term (1 to
6 months).
Inhalation short-term (1 to 30
days).
Cancer (Oral, dermal, inhalation).
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
NOAEL = 30 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 10 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 30 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 10 mg/kg/
day.
UFA= 10x
UFH= 10x
FQPA SF = 1x
Oral study NOAEL =
30 mg/kg/day (dermal absorption
rate = 40%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Oral study NOAEL=
10 mg/kg/day (dermal absorption
rate = 40%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Oral study NOAEL=
30 mg/kg/day (inhalation absorption
rate = 100%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.3 mg/
kg/day.
aPAD = 0.3 mg/kg/
day
Acute neurotoxicity study—Rat
LOAEL = 100 mg/kg/day based on clinical signs of toxicity
(piloerection in one male, diarrhea in one female, tip toe gait
in 3 females).
Chronic RfD = 0.1
mg/kg/day.
cPAD = 0.1 mg/kg/
day
24-Month carcinogenicity study on CD–1 mice. MRID
00129918
LOAEL = 50 mg/kg/day based on non-neoplastic liver effects
(increased liver weight in males and increase in liver lesions:
Masses/raised areas/swellings/nodular areas mainly).
Acute Neurotoxicity Study—Rats
LOAEL = 100 mg/kg/day based on clinical signs of toxicity
(piloerection in one male, diarrhea in one female, tip toe gait
in 3 females).
LOC for MOE = 100
LOC for MOE = 100
24-Month carcinogenicity Study—Mice
LOAEL = 50 mg/kg/day based on non-neoplastic liver effects
(increased liver weight in males and increase in liver lesions:
Masses/raised areas/swellings/nodular areas mainly).
LOC for MOE = 100
Acute Neurotoxicity Study—Rats
LOAEL = 100 mg/kg/day based on clinical signs of toxicity
(piloerection in one male, diarrhea in one female, tip toe gait
in 3 females).
LOC for MOE = 100
24-Month carcinogenicity Study—Mice
LOAEL = 50 mg/kg/day based on non-neoplastic liver effects
(increased liver weight in males and increase in liver lesions:
Masses/raised areas/swellings/nodular areas mainly).
LOC for MOE = 100
Acute Neurotoxicity Study—Rats
LOAEL = 100 mg/kg/day based on clinical signs of toxicity
(piloerection in one male, diarrhea in one female, tip toe gait
in 3 females).
Classification: Group C, possible human carcinogen, RfD approach for risk characterization.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to propiconazole, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing propiconazole tolerances in 40
CFR 180.434. EPA assessed dietary
exposures from propiconazole in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
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occurring as a result of a 1-day or single
exposure.
Such effects were identified for
propiconazole. In estimating acute
dietary exposure, 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. As to residue levels in food,
EPA conducted an acute dietary
analysis for propiconazole residues of
concern using tolerance levels and 100
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percent crop treated (PCT) for all
existing and proposed uses.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA’s NHANES/WWEIA.
This dietary survey was conducted from
2003 to 2008. As to residue levels in
food, EPA conducted a chronic dietary
analysis for propiconazole residues of
concern using tolerance levels for some
commodities, average field trial residues
for the remaining commodities, and 100
PCT for all existing and proposed uses.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
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concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to propiconazole. Cancer
risk was assessed using the same
exposure estimates as discussed in Unit
III.C.1.ii., chronic exposure.
iv. Anticipated residue 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 submitted no later than
5 years from the date of issuance of
these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for propiconazole in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
propiconazole. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Surface Water
Concentration Calculator (SWCC) and
Pesticide Root Zone Model—Ground
Water (PRZM–GW) models, the
estimated drinking water concentrations
(EDWCs) of propiconazole for acute
exposures are estimated to be 35.2 parts
per billion (ppb) for surface water and
37.9 ppb for ground water, and for
chronic exposures are estimated to be
18.6 ppb for surface water and 35.1 ppb
for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 37.9 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 35.1 ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
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indoor pest control, termiticides, and
flea and tick control on pets).
Propiconazole is currently registered
for the following uses that could result
in residential exposures: Turf,
ornamentals, and in paint. The highest
incidental oral and dermal exposure
scenarios are expected from residential
use on turf. EPA assessed short-term
risk to toddlers from incidental oral and
dermal exposure and short-term risk to
adults from dermal and inhalation
residential handler exposure as well as
from post-application dermal exposure.
The highest post-application exposure
from residential use on turf was used to
assess risk to short-term aggregate
exposures.
The only residential use scenario that
will result in potential intermediate
term exposure to propiconazole is wood
treatment, which the Agency assumes
may result in dermal and incidental oral
post-application exposures to children.
No chronic exposures are expected.
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.’’
Propiconazole is a member of the
triazole-containing class of pesticides.
Although conazoles act similarly in
plants (fungi) by inhibiting ergosterol
biosynthesis, there is not necessarily a
relationship between their pesticidal
activity and their mechanism of toxicity
in mammals. Structural similarities do
not constitute a common mechanism of
toxicity. Evidence is needed to establish
that the chemicals operate by the same,
or essentially the same, sequence of
major biochemical events (EPA, 2002).
In conazoles, however, a variable
pattern of toxicological responses is
found; some are hepatotoxic and
hepatocarcinogenic in mice. Some
induce thyroid tumors in rats. Some
induce developmental, reproductive,
and neurological effects in rodents.
Furthermore, the conazoles produce a
diverse range of biochemical events
including altered cholesterol levels,
stress responses, and altered DNA
methylation. It is not clearly understood
whether these biochemical events are
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directly connected to their toxicological
outcomes. Thus, there is currently no
evidence to indicate that conazoles
share common mechanisms of toxicity
and EPA is not following a cumulative
risk approach based on a common
mechanism of toxicity for the conazoles.
For information regarding EPA’s
procedures for cumulating effects from
substances found to have a common
mechanism of toxicity, see EPA’s Web
site at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
cumulative-assessment-risk-pesticides.
Propiconazole is a triazole-derived
pesticide. This class of compounds can
form the common metabolite 1,2,4triazole and two triazole conjugates
(triazolylalanine and triazolylacetic
acid). To support existing tolerances
and to establish new tolerances for
triazole-derivative pesticides, including
propiconazole, EPA conducted a human
health risk assessment for exposure to
1,2,4-triazole, triazolylalanine, and
triazolylacetic acid resulting from the
use of all current and pending uses of
any triazole-derived fungicide. The risk
assessment is a highly conservative,
screening-level evaluation in terms of
hazards associated with common
metabolites (e.g., use of a maximum
combination of uncertainty factors) and
potential dietary and non-dietary
exposures (i.e., high end estimates of
both dietary and non-dietary exposures).
The Agency retained a 3X for the
LOAEL to NOAEL safety factor when
the reproduction study was used. In
addition, the Agency retained a 10X for
the lack of studies including a DNT. The
assessment includes evaluations of risks
for various subgroups, including those
comprised of infants and children. The
Agency’s complete risk assessment is
found in the propiconazole
reregistration docket at https://
www.regulations.gov, Docket ID Number
EPA–HQ–OPP–2005–0497.
An updated dietary exposure and risk
analysis for the common triazole
metabolites 1,2,4-triazole (T),
triazolylalanine (TA), triazolylacetic
acid (TAA), and triazolylpyruvic acid
(TP) was completed on April 9, 2015, in
association with registration requests for
several triazole fungicides,
propiconazole, difenoconazole, and
flutriafol. That analysis concluded that
risk estimates were below the Agency’s
level of concern for all population
groups. This assessment may be found
on https://www.regulations.gov by
searching for the following title and
docket number: ‘‘Common Triazole
Metabolites: Updated Aggregate Human
Health Risk Assessment to Address The
New Section 3 Registrations For Use of
Propiconazole on Tea, Dill, Mustard
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Greens, Radish, and Watercress; Use of
Difenoconazole on Globe Artichoke,
Ginseng and Greenhouse Grown
Cucumbers and Conversion of the
Established Foliar Uses/Tolerances for
Stone Fruit and Tree Nut Crop Groups
to Fruit, Stone, Group 12–12 and the
Nut, Tree, Group 14–12.; and Use of
Flutriafol on Hops’’ (located in docket
ID number EPA–HQ–OPP–2014–0788).
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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
Food Quality Protection Act Safety
Factor (FQPA 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.
In the developmental toxicity study in
rats, fetal effects observed in this study
at a dose lower than that evoking
maternal toxicity are considered to be
quantitative evidence of increased
susceptibility of fetuses to in utero
exposure to propiconazole. Neither
quantitative nor qualitative evidence of
increased susceptibility was observed in
utero or postnatally in either the rabbit
developmental or 2-generation
reproduction rat study. There is no
evidence of neuropathology or
abnormalities in the development of the
fetal nervous system from the available
toxicity studies conducted with
propiconazole. In the rat acute
neurotoxicity study, there was evidence
of clinical toxicity at the high dose of
300 mg/kg, but no evidence of
neuropathology from propiconazole
administration.
Although there was quantitative
evidence of increased susceptibility of
the young following exposure to
propiconazole in the developmental rat
study, the Agency determined there is a
low degree of concern for this finding
and no residual uncertainties because
the increased susceptibility was based
on minimal toxicity at high doses of
administration, clear NOAELs and
LOAELs have been identified for all
effects of concern, and a clear doseresponse has been well defined.
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3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1x. That decision is
based on the following findings:
i. The toxicity database for
propiconazole is complete.
ii. Other than the mild effects seen at
300 mg/kg in the acute neurotoxicity
study, neurotoxicity and
neurobehavioral effects were not seen in
the propiconazole toxicity database. The
liver, not the nervous system, is the
primary target organ of propiconazole
toxicity.
iii. Although an apparent increased
quantitative susceptibility was observed
in fetuses and offspring, for the reasons
noted in this Unit residual uncertainties
or concerns for prenatal and/or
postnatal toxicity are minimal.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute dietary food exposure
assessments were performed based on
100 PCT and tolerance-level residues,
while the chronic used a combination of
tolerance-level residues and reliable
data on average field trial residues and
100 PCT. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to propiconazole in
drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children as well
as incidental oral exposure of toddlers.
A turf transferable residue study is
unavailable but being requested from
the registrant for registration review of
propiconazole. In all probability this
study will reduce exposure estimates for
both the incidental oral and postapplication exposure to children. These
assessments will not underestimate the
exposure and risks posed by
propiconazole.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
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propiconazole will occupy 84% of the
aPAD for children 1–2 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 propiconazole
from food and water will utilize 25% of
the cPAD for children 1–2 years 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 propiconazole is not
expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Propiconazole is
currently registered for uses that could
result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to propiconazole.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs from post-application activities
(the highest exposure scenario) of 200
for adults and 96 for children 1–2 years
old. Although the MOE for children 1–
2 years old is slightly below the target
MOE of 100, the Agency does not
believe that propiconazole poses shortterm risks of concern because the
difference is small and more than offset
by the use of conservative endpoints
and conservative exposure assumptions.
This assessment is considered
conservative since the short-term
endpoints are based on a conservative
LOAEL that is 3x higher than the
NOAEL. Therefore, the true NOAEL is
likely higher and would result in MOEs
greater than 100. Further, the
assessment combines conservative
assumptions by using tolerance-level
residues and reliable data on average
field-trial residues and 100 PCT,
conservative assumptions in the ground
and surface water modeling, and
conservative assumptions to assess postapplication exposure of children as well
as incidental oral exposure of toddlers.
Refining any one of these conservatisms
would result in MOEs for this age group
that are not of concern. Although
dietary (food and water) is not the
aggregate exposure driver, incorporating
PCT would likely increase the aggregate
MOE further above 100. For example,
using the Agency’s highest average PCT
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reported for propiconazole residues on
crops (i.e., 55%), which is
approximately half the currently
assumed dietary exposure, the MOE for
this age group would exceed the target
MOE of 100 and not be of concern.
Therefore, the Agency has determined
that there is no short-term risk of
concern from exposure to
propiconazole.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Propiconazole is currently registered
for use as a wood treatment that could
result in intermediate-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with intermediate-term
residential exposures to propiconazole.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures result
in an aggregate MOE of 110 for children
1–2 years old. Because EPA’s level of
concern for propiconazole is a MOE of
100 or below, this MOE is not of
concern.
5. Aggregate cancer risk for U.S.
population. Based on the discussion in
Unit III.A., EPA considers the chronic
aggregate risk assessment to be
protective of any aggregate cancer risk.
As there is no chronic risk of concern,
EPA does not expect any cancer risk to
the U.S. population from aggregate
exposure to propiconazole.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
propiconazole residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
a high performance liquid
chromatography with ultraviolet
detection method (HPLC/UV Method
AG–671A) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
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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.
There are no Codex MRLs for
dillweed (fresh or dried), dill seed, the
brassica leafy greens subgroup 5B, ti
palm, watercress, quinoa or radish.
Codex does have MRLs in place for
peach and plums (part of the U.S. stone
fruit group), and pecans (part of the U.S.
tree nut group) that are different than
the U.S. tolerances. The U.S. tolerance
expression is not harmonized with the
Codex expression, which is expressed in
terms of propiconazole per se, and
therefore, the U.S. tolerance level for
stone fruit and tree nuts cannot be
harmonized with the Codex MRLs that
are currently established.
C. Response to Comments
Two comments were received in
response to the October 21, 2015 notice
of filing. The first comment asserted that
no residues should be allowed and that
the pesticide should not be approved for
sale or use. The Agency understands the
commenter’s concerns and recognizes
that some individuals believe that
pesticides should be banned on
agricultural crops. However, the existing
legal framework provided by section
408 of the 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. The comment appears to be
directed at the underlying statute and
not EPA’s implementation of it; the
citizen has made no contention that
EPA has acted in violation of the
statutory framework.
The second comment was from the
Center for Biological Diversity and
concerned endangered species;
specifically stating that EPA cannot
approve this new use prior to
completion of consultations with the
U.S. Fish and Wildlife Service and the
National Marine Fisheries Service (‘‘the
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79717
Services’’). This comment is not
relevant to the Agency’s evaluation of
safety of the propiconazole tolerances;
section 408 of the FFDCA focuses on
potential harms to human health and
does not permit consideration of effects
on the environment.
D. Revisions to Petitioned-for
Tolerances
The Agency is revising the petitionedfor tolerance requests for ‘‘dill, fresh’’
and ‘‘dill, dried’’ to ‘‘dillweed, fresh
leaves’’ and ‘‘dillweed, dried leaves’’,
respectively, for consistency with the
Agency’s commodity vocabulary for
those commodities. For the same reason,
the Agency is revising the petitioned-for
tolerance request for ‘‘leafy Brassica
greens, subgroup 5B’’ to ‘‘Brassica leafy
greens, subgroup 5B’’. In addition, EPA
is revising the tolerance values for
radish, tops; ti palm, roots; and
watercress to be consistent with EPA’s
policy on significant figures for
tolerances.
V. Conclusion
Therefore, tolerances are established
for residues of propiconazole, 1-[[2-(2,4dichlorophenyl)-4-propyl-1,3-dioxolan2-yl] methyl]-1H-1,2,4-triazole and its
metabolites determined as 2,4,dichlorobenzoic acid (2,4-DCBA),
expressed as the stoichiometric
equivalent of propiconazole, in or on
brassica leafy greens, subgroup 5B at 20
ppm; dill seed at 15 ppm; dillweed,
dried leaves at 80 ppm; dillweed, fresh
leaves at 30 ppm; quinoa, grain at 3.0
ppm; radish, roots at 0.04 ppm; radish,
tops at 0.20 ppm; ti palm, leaves at 10
ppm; ti palm, roots at 0.30 ppm; and
watercress at 6.0 ppm. In addition, the
existing fruit, stone, group 12, except
plum and nut, tree, group 14 tolerances
are modified to read ‘‘fruit, stone, group
12–12, except plum’’ and ‘‘nut, tree,
group 14–12,’’ respectively.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
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asabaliauskas on DSK5VPTVN1PROD with RULES
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
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: December 14, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
*
*
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Parts 591 and 592
Allowing Importers To Provide
Information to U.S. Customs and
Border Protection in Electronic Format
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Final rule.
AGENCY:
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.434:
a. Revise the entries for ‘‘Fruit, stone,
group 12, except plum’’ and ‘‘Nut, tree,
group 14.’’
■ b. Add alphabetically the following
commodities to the table in paragraph
(a).
The revisions and additions read as
follows:
■
■
On September 2, 2015, the
National Highway Traffic Safety
Administration (NHTSA) published an
interim final rule and request for
comment entitled ‘‘Allowing Importers
to Provide Information to U.S. Customs
and Border Protection in Electronic
Format.’’ No comments were received in
response to the interim final rule.
Accordingly, this final rule confirms
§ 180.434 Propiconazole; tolerances for
that the September 2, 2015 interim final
residues.
rule will not be changed and its
(a) * * *
effective date is September 2, 2015.
Parts per milDATES: Effective December 23, 2015.
Commodity
lion
FOR FURTHER INFORMATION CONTACT:
Arija Flowers, Trial Attorney, Office of
the Chief Counsel, National Highway
*
*
*
*
*
Traffic Safety Administration, 1200 New
Brassica leafy greens, subgroup 5B .........................
20
Jersey Avenue SE., Washington, DC
20590 (telephone: 202–366–5263).
*
*
*
*
*
SUPPLEMENTARY INFORMATION: As
Dill, seed .............................
15
NHTSA received no comments on its
Dillweed, dried leaves ........
80
interim final rule published on
Dillweed, fresh leaves ........
30
September 2, 2015 (80 FR 53011), the
*
*
*
*
*
agency is making no changes to the rule
Fruit, stone, group 12–12,
and its effective date is September 2,
except plum .....................
4.0
2015. For regulatory analyses and
notices associated with this action,
*
*
*
*
*
please see the interim final rule
Nut, tree, group 14–12 .......
0.10
published at 80 FR 53011.
Accordingly, the interim rule
*
*
*
*
*
amending 49 CFR parts 591 and 592,
Quinoa, grain ......................
3.0
Radish, roots ......................
0.04 published at 80 FR 53011 on September
Radish, tops ........................
0.20 2, 2015, is adopted as final without
change.
*
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
*
10
0.30
*
*
*
Watercress ..........................
*
*
6.0
*
*
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*
RIN 2127–AL63
*
*
*
Ti palm, leaves ...................
Ti palm, roots ......................
16:43 Dec 22, 2015
*
[FR Doc. 2015–32327 Filed 12–22–15; 8:45 am]
[Docket No. NHTSA–2015–0076]
VII. Congressional Review Act
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*
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*
*
*
SUMMARY:
Issued in Washington, DC, on December
17, 2015 under authority delegated in 49 CFR
part 1.95.
Mark R. Rosekind,
Administrator.
[FR Doc. 2015–32260 Filed 12–22–15; 8:45 am]
BILLING CODE 4910–59–P
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[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Rules and Regulations]
[Pages 79711-79718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32327]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0788; FRL-9939-83]
Propiconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
propiconazole in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective December 23, 2015. Objections and
requests for hearings must be received on or before February 22, 2016,
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-2014-0788, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional
[[Page 79712]]
information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection 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-2014-0788 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
February 22, 2016. 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-2014-0788, 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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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
4E8321) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.434 be
amended by establishing tolerances for residues of the fungicide,
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-
dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric
equivalent of propiconazole, in or on the following raw agricultural
commodities: Dill, dried at 80 parts per million (ppm); dill, fresh at
30 ppm; dill, seed at 15 ppm; fruit, stone, group 12-12, except plum at
4 ppm and nut, tree, group 14-12 at 0.1 ppm; leafy Brassica greens,
subgroup 5B at 20 ppm; quinoa, grain, at 3.0 ppm; radish, roots at 0.04
ppm; radish, tops at 0.2 ppm; ti palm, leaves at 10 ppm; ti palm, roots
at 0.3 ppm, and watercress at 6 ppm. IR-4 also requested that upon
establishment of the above tolerances, that the existing tolerances for
``fruit, stone, group 12, except plum'' and ``nut, tree, group 14'' be
removed. That document referenced a summary of the petition prepared by
Syngenta, the registrant, which is available in the docket, https://www.regulations.gov. The October 21, 2015 notice supersedes a notice of
filing published in the Federal Register on February 11, 2015 (80 FR
7559) (FRL-9921-94). The October 21, 2015 notice includes the commodity
``quinoa, grain'' as well as the other commodities that were originally
requested in the February 11, 2015 notice. Two comments were received
in response to the October 21, 2015 notice of filing. EPA's response to
these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
modified some of the commodity vocabulary and rounded the significant
figures of some of the tolerances. The reason 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 propiconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with propiconazole
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as
[[Page 79713]]
the relationship of the results of the studies to human risk. EPA has
also considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
The primary target organ for propiconazole toxicity in animals is
the liver. Increased liver weights were seen in mice after subchronic
or chronic oral exposures to propiconazole. Liver lesions such as
vacuolation of hepatocytes, ballooned liver cells, foci of enlarged
hepatocytes, hypertrophy, and necrosis are characteristic of
propiconazole toxicity in rats and mice. Decreased body weight gain was
also seen in subchronic, chronic, developmental and reproductive
studies in animal studies. Dogs appeared to be more sensitive to the
localized toxicity of propiconazole as manifested by stomach
irritations at 6 milligram/kilogram/day (mg/kg/day) and above.
In rabbits, developmental toxicity occurred at a higher dose than
the maternally toxic dose, while in rats, developmental toxicity
occurred at lower doses than maternal toxic doses. Increased incidences
of rudimentary ribs occurred in rat and rabbit fetuses. Increased cleft
palate malformations were noted in two studies in rats. In one
published study in rats, developmental effects (malformations of the
lung and kidneys, incomplete ossification of the skull, caudal
vertebrae and digits, extra rib (14th rib) and missing sternbrae) were
reported at doses that were not maternally toxic. In the two generation
reproduction study in rats, offspring toxicity occurred at a higher
dose than the parental toxic dose suggesting lower susceptibility of
the offspring to the toxic doses of propiconazole.
The acute neurotoxicity study produced severe clinical signs of
toxicity (decreased activity, cold, pale, decreased motor activity,
etc.) in rats at the high dose of 300 milligram/kilogram (mg/kg).
Limited clinical signs (piloerection, diarrhea, tip toe gait) were
observed in the mid-dose animals (100 mg/kg), while no treatment
related signs were observed at 30 mg/kg. The current acute dietary
assessment for the general population is based on the NOAEL of 30 mg/kg
from the acute neurotoxicity study. A subchronic neurotoxicity study in
rats did not produce neurotoxic signs at the highest dose tested that
was associated with decreased body weight.
Propiconazole was negative for mutagenicity in the in vitro BALB/
3T3 cell transformation assay, bacterial reverse mutation assay,
Chinese hamster bone marrow chromosomal aberration assay, unscheduled
DNA synthesis studies in human fibroblasts and primary rat hepatocytes,
mitotic gene conversion assay, and the dominant lethal assay in mice.
It caused proliferative changes in the rat liver with or without
pretreatment with an initiator, like phenobarbital, a known liver tumor
promoter. Liver enzyme induction studies with propiconazole in mice
demonstrated that propiconazole is a strong phenobarbital type inducer
of xenobiotic metabolizing enzymes. Hepatocellular proliferation
studies in mice suggest that propiconazole induces cell proliferation
followed by treatment-related hypertrophy in a manner similar to the
known hypertrophic agent phenobarbital.
Propiconazole was carcinogenic to male mice but was not
carcinogenic to rats or to female mice. The Agency classified
propiconazole as a possible human carcinogen and recommended that, for
the purpose of risk characterization, the reference dose (RfD) approach
be used for quantification of human risk. Propiconazole is not
genotoxic and this fact, together with special mechanistic studies,
indicates that propiconazole is a threshold carcinogen. Propiconazole
produced liver tumors in male mice only at a high dose that was toxic
to the liver. At doses below the RfD, liver toxicity is not expected;
therefore, tumors are also not expected.
Specific information on the studies received and the nature of the
adverse effects caused by propiconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled, ``Propiconazole Human
Health Risk Assessment for the New Uses of Propiconazole on dill, leafy
brassicas crop subgroup 5B, ti palm, watercress, and quinoa, along with
expansion to fruit, stone, group 12-12; except plum, and nut, tree,
group 14-12'' on pp. 37 in docket ID number EPA-HQ-OPP-2014-0788.
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 the NOAEL and the LOAEL are identified.
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 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 propiconazole used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Propiconazole for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-50 NOAEL = 30 mg/kg/day Acute RfD = 0.3 mg/ Developmental Study--Rat
years of age). UFA = 10x........... kg/day. LOAEL = 90 mg/kg/day based on
UFH = 10x........... aPAD = 0.3 mg/kg/ increased incidence of
FQPA SF = 1x........ day. rudimentary ribs, un-ossified
sternebrae, as well as increased
incidence of shortened and absent
renal papillae and increased
cleft palate.
[[Page 79714]]
Acute dietary (General population NOAEL = 30 mg/kg/day Acute RfD = 0.3 mg/ Acute neurotoxicity study--Rat
including infants and children). UFA = 10x........... kg/day. LOAEL = 100 mg/kg/day based on
UFH = 10x........... aPAD = 0.3 mg/kg/ clinical signs of toxicity
FQPA SF = 1x........ day. (piloerection in one male,
diarrhea in one female, tip toe
gait in 3 females).
Chronic dietary (Adult Males and NOAEL= 10 mg/kg/day. Chronic RfD = 0.1 24-Month carcinogenicity study on
Females 50+ yrs). UFA = 10x........... mg/kg/day. CD-1 mice. MRID 00129918
UFH = 10x........... cPAD = 0.1 mg/kg/ LOAEL = 50 mg/kg/day based on non-
FQPA SF = 1x........ day. neoplastic liver effects
(increased liver weight in males
and increase in liver lesions:
Masses/raised areas/swellings/
nodular areas mainly).
Incidental oral short-term (1 to NOAEL= 30 mg/kg/day. LOC for MOE = 100.. Acute Neurotoxicity Study--Rats
30 days). UFA = 10x........... LOAEL = 100 mg/kg/day based on
UFH = 10x........... clinical signs of toxicity
FQPA SF = 1x........ (piloerection in one male,
diarrhea in one female, tip toe
gait in 3 females).
Incidental oral intermediate-term NOAEL= 10 mg/kg/day. LOC for MOE = 100.. 24-Month carcinogenicity Study--
(1 to 6 months). UFA= 10x............ Mice
UFH= 10x............ LOAEL = 50 mg/kg/day based on non-
FQPA SF = 1x........ neoplastic liver effects
(increased liver weight in males
and increase in liver lesions:
Masses/raised areas/swellings/
nodular areas mainly).
Dermal short-term (1 to 30 days). Oral study NOAEL = LOC for MOE = 100.. Acute Neurotoxicity Study--Rats
30 mg/kg/day LOAEL = 100 mg/kg/day based on
(dermal absorption clinical signs of toxicity
rate = 40%). (piloerection in one male,
UFA = 10x........... diarrhea in one female, tip toe
UFH = 10x........... gait in 3 females).
FQPA SF = 1x........
Dermal intermediate-term (1 to 6 Oral study NOAEL= 10 LOC for MOE = 100.. 24-Month carcinogenicity Study--
months). mg/kg/day (dermal Mice
absorption rate = LOAEL = 50 mg/kg/day based on non-
40%). neoplastic liver effects
UFA = 10x........... (increased liver weight in males
UFH = 10x........... and increase in liver lesions:
FQPA SF = 1x........ Masses/raised areas/swellings/
nodular areas mainly).
Inhalation short-term (1 to 30 Oral study NOAEL= 30 LOC for MOE = 100.. Acute Neurotoxicity Study--Rats
days). mg/kg/day LOAEL = 100 mg/kg/day based on
(inhalation clinical signs of toxicity
absorption rate = (piloerection in one male,
100%). diarrhea in one female, tip toe
UFA = 10x........... gait in 3 females).
UFH = 10x...........
FQPA SF = 1x........
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Cancer (Oral, dermal, inhalation) Classification: Group C, possible human carcinogen, RfD approach for risk
characterization.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propiconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing propiconazole
tolerances in 40 CFR 180.434. EPA assessed dietary exposures from
propiconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for propiconazole. In estimating acute
dietary exposure, 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. As to residue levels in
food, EPA conducted an acute dietary analysis for propiconazole
residues of concern using tolerance levels and 100 percent crop treated
(PCT) for all existing and proposed uses.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. As to
residue levels in food, EPA conducted a chronic dietary analysis for
propiconazole residues of concern using tolerance levels for some
commodities, average field trial residues for the remaining
commodities, and 100 PCT for all existing and proposed uses.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
[[Page 79715]]
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to propiconazole. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue 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 submitted no later than 5 years from the date of issuance of these
tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propiconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propiconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Surface Water Concentration Calculator (SWCC) and
Pesticide Root Zone Model--Ground Water (PRZM-GW) models, the estimated
drinking water concentrations (EDWCs) of propiconazole for acute
exposures are estimated to be 35.2 parts per billion (ppb) for surface
water and 37.9 ppb for ground water, and for chronic exposures are
estimated to be 18.6 ppb for surface water and 35.1 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 37.9 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 35.1 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Propiconazole is currently registered for the following uses that
could result in residential exposures: Turf, ornamentals, and in paint.
The highest incidental oral and dermal exposure scenarios are expected
from residential use on turf. EPA assessed short-term risk to toddlers
from incidental oral and dermal exposure and short-term risk to adults
from dermal and inhalation residential handler exposure as well as from
post-application dermal exposure. The highest post-application exposure
from residential use on turf was used to assess risk to short-term
aggregate exposures.
The only residential use scenario that will result in potential
intermediate term exposure to propiconazole is wood treatment, which
the Agency assumes may result in dermal and incidental oral post-
application exposures to children. No chronic exposures are expected.
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.''
Propiconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
Propiconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including propiconazole, EPA conducted
a human health risk assessment for exposure to 1,2,4-triazole,
triazolylalanine, and triazolylacetic acid resulting from the use of
all current and pending uses of any triazole-derived fungicide. The
risk assessment is a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high end estimates of both dietary and
non-dietary exposures). The Agency retained a 3X for the LOAEL to NOAEL
safety factor when the reproduction study was used. In addition, the
Agency retained a 10X for the lack of studies including a DNT. The
assessment includes evaluations of risks for various subgroups,
including those comprised of infants and children. The Agency's
complete risk assessment is found in the propiconazole reregistration
docket at https://www.regulations.gov, Docket ID Number EPA-HQ-OPP-2005-
0497.
An updated dietary exposure and risk analysis for the common
triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA),
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP) was
completed on April 9, 2015, in association with registration requests
for several triazole fungicides, propiconazole, difenoconazole, and
flutriafol. That analysis concluded that risk estimates were below the
Agency's level of concern for all population groups. This assessment
may be found on https://www.regulations.gov by searching for the
following title and docket number: ``Common Triazole Metabolites:
Updated Aggregate Human Health Risk Assessment to Address The New
Section 3 Registrations For Use of Propiconazole on Tea, Dill, Mustard
[[Page 79716]]
Greens, Radish, and Watercress; Use of Difenoconazole on Globe
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.;
and Use of Flutriafol on Hops'' (located in docket ID number EPA-HQ-
OPP-2014-0788).
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 Food Quality
Protection Act Safety Factor (FQPA 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. In the developmental
toxicity study in rats, fetal effects observed in this study at a dose
lower than that evoking maternal toxicity are considered to be
quantitative evidence of increased susceptibility of fetuses to in
utero exposure to propiconazole. Neither quantitative nor qualitative
evidence of increased susceptibility was observed in utero or
postnatally in either the rabbit developmental or 2-generation
reproduction rat study. There is no evidence of neuropathology or
abnormalities in the development of the fetal nervous system from the
available toxicity studies conducted with propiconazole. In the rat
acute neurotoxicity study, there was evidence of clinical toxicity at
the high dose of 300 mg/kg, but no evidence of neuropathology from
propiconazole administration.
Although there was quantitative evidence of increased
susceptibility of the young following exposure to propiconazole in the
developmental rat study, the Agency determined there is a low degree of
concern for this finding and no residual uncertainties because the
increased susceptibility was based on minimal toxicity at high doses of
administration, clear NOAELs and LOAELs have been identified for all
effects of concern, and a clear dose-response has been well defined.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for propiconazole is complete.
ii. Other than the mild effects seen at 300 mg/kg in the acute
neurotoxicity study, neurotoxicity and neurobehavioral effects were not
seen in the propiconazole toxicity database. The liver, not the nervous
system, is the primary target organ of propiconazole toxicity.
iii. Although an apparent increased quantitative susceptibility was
observed in fetuses and offspring, for the reasons noted in this Unit
residual uncertainties or concerns for prenatal and/or postnatal
toxicity are minimal.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues, while the chronic used a
combination of tolerance-level residues and reliable data on average
field trial residues and 100 PCT. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to propiconazole in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. A turf
transferable residue study is unavailable but being requested from the
registrant for registration review of propiconazole. In all probability
this study will reduce exposure estimates for both the incidental oral
and post-application exposure to children. These assessments will not
underestimate the exposure and risks posed by propiconazole.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to propiconazole will occupy 84% of the aPAD for children 1-2 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
propiconazole from food and water will utilize 25% of the cPAD for
children 1-2 years 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
propiconazole is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Propiconazole
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to propiconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs from post-
application activities (the highest exposure scenario) of 200 for
adults and 96 for children 1-2 years old. Although the MOE for children
1-2 years old is slightly below the target MOE of 100, the Agency does
not believe that propiconazole poses short-term risks of concern
because the difference is small and more than offset by the use of
conservative endpoints and conservative exposure assumptions. This
assessment is considered conservative since the short-term endpoints
are based on a conservative LOAEL that is 3x higher than the NOAEL.
Therefore, the true NOAEL is likely higher and would result in MOEs
greater than 100. Further, the assessment combines conservative
assumptions by using tolerance-level residues and reliable data on
average field-trial residues and 100 PCT, conservative assumptions in
the ground and surface water modeling, and conservative assumptions to
assess post-application exposure of children as well as incidental oral
exposure of toddlers. Refining any one of these conservatisms would
result in MOEs for this age group that are not of concern. Although
dietary (food and water) is not the aggregate exposure driver,
incorporating PCT would likely increase the aggregate MOE further above
100. For example, using the Agency's highest average PCT
[[Page 79717]]
reported for propiconazole residues on crops (i.e., 55%), which is
approximately half the currently assumed dietary exposure, the MOE for
this age group would exceed the target MOE of 100 and not be of
concern. Therefore, the Agency has determined that there is no short-
term risk of concern from exposure to propiconazole.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Propiconazole is currently registered for use as a wood treatment
that could result in intermediate-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with intermediate-term residential
exposures to propiconazole.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 110 for children 1-2 years old. Because EPA's level of
concern for propiconazole is a MOE of 100 or below, this MOE is not of
concern.
5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA considers the chronic aggregate risk
assessment to be protective of any aggregate cancer risk. As there is
no chronic risk of concern, EPA does not expect any cancer risk to the
U.S. population from aggregate exposure to propiconazole.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to propiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, a high performance liquid
chromatography with ultraviolet detection method (HPLC/UV Method AG-
671A) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no Codex MRLs for dillweed (fresh or dried), dill seed,
the brassica leafy greens subgroup 5B, ti palm, watercress, quinoa or
radish.
Codex does have MRLs in place for peach and plums (part of the U.S.
stone fruit group), and pecans (part of the U.S. tree nut group) that
are different than the U.S. tolerances. The U.S. tolerance expression
is not harmonized with the Codex expression, which is expressed in
terms of propiconazole per se, and therefore, the U.S. tolerance level
for stone fruit and tree nuts cannot be harmonized with the Codex MRLs
that are currently established.
C. Response to Comments
Two comments were received in response to the October 21, 2015
notice of filing. The first comment asserted that no residues should be
allowed and that the pesticide should not be approved for sale or use.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that pesticides should be banned on
agricultural crops. However, the existing legal framework provided by
section 408 of the 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. The
comment appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.
The second comment was from the Center for Biological Diversity and
concerned endangered species; specifically stating that EPA cannot
approve this new use prior to completion of consultations with the U.S.
Fish and Wildlife Service and the National Marine Fisheries Service
(``the Services''). This comment is not relevant to the Agency's
evaluation of safety of the propiconazole tolerances; section 408 of
the FFDCA focuses on potential harms to human health and does not
permit consideration of effects on the environment.
D. Revisions to Petitioned-for Tolerances
The Agency is revising the petitioned-for tolerance requests for
``dill, fresh'' and ``dill, dried'' to ``dillweed, fresh leaves'' and
``dillweed, dried leaves'', respectively, for consistency with the
Agency's commodity vocabulary for those commodities. For the same
reason, the Agency is revising the petitioned-for tolerance request for
``leafy Brassica greens, subgroup 5B'' to ``Brassica leafy greens,
subgroup 5B''. In addition, EPA is revising the tolerance values for
radish, tops; ti palm, roots; and watercress to be consistent with
EPA's policy on significant figures for tolerances.
V. Conclusion
Therefore, tolerances are established for residues of
propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]
methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-
dichlorobenzoic acid (2,4-DCBA), expressed as the stoichiometric
equivalent of propiconazole, in or on brassica leafy greens, subgroup
5B at 20 ppm; dill seed at 15 ppm; dillweed, dried leaves at 80 ppm;
dillweed, fresh leaves at 30 ppm; quinoa, grain at 3.0 ppm; radish,
roots at 0.04 ppm; radish, tops at 0.20 ppm; ti palm, leaves at 10 ppm;
ti palm, roots at 0.30 ppm; and watercress at 6.0 ppm. In addition, the
existing fruit, stone, group 12, except plum and nut, tree, group 14
tolerances are modified to read ``fruit, stone, group 12-12, except
plum'' and ``nut, tree, group 14-12,'' respectively.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of
[[Page 79718]]
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 14, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.434:
0
a. Revise the entries for ``Fruit, stone, group 12, except plum'' and
``Nut, tree, group 14.''
0
b. Add alphabetically the following commodities to the table in
paragraph (a).
The revisions and additions read as follows:
Sec. 180.434 Propiconazole; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Brassica leafy greens, subgroup 5B...................... 20
* * * * *
Dill, seed.............................................. 15
Dillweed, dried leaves.................................. 80
Dillweed, fresh leaves.................................. 30
* * * * *
Fruit, stone, group 12-12, except plum.................. 4.0
* * * * *
Nut, tree, group 14-12.................................. 0.10
* * * * *
Quinoa, grain........................................... 3.0
Radish, roots........................................... 0.04
Radish, tops............................................ 0.20
* * * * *
Ti palm, leaves......................................... 10
Ti palm, roots.......................................... 0.30
* * * * *
Watercress.............................................. 6.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2015-32327 Filed 12-22-15; 8:45 am]
BILLING CODE 6560-50-P
