Propiconazole; Pesticide Tolerances, 18461-18467 [2014-07100]
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Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Rules and Regulations
Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995
(NTTAA) (15 U.S.C. 272 note).
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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).
ENVIRONMENTAL PROTECTION
AGENCY
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
SUMMARY:
Dated: March 21, 2014.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
40 CFR Part 180
[EPA–HQ–OPP–2013–0051; FRL–9907–05]
Propiconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of propiconazole
in or on the rapeseed crop subgroup
20A. Syngenta Crop Protection
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective April
2, 2014. Objections and requests for
hearings must be received on or before
June 2, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0051, is
Authority: 21 U.S.C. 321(q), 346a and 371.
available at https://www.regulations.gov
■ 2. Section 180.425 is amended by
or at the Office of Pesticide Programs
removing the entry for ‘‘Cabbage’’ from
Regulatory Public Docket (OPP Docket)
the table in paragraph (a), and by
in the Environmental Protection Agency
alphabetically adding the following
Docket Center (EPA/DC), EPA West
entries
Bldg., Rm. 3334, 1301 Constitution Ave.
‘‘Brassica, head and stem, subgroup
NW., Washington, DC 20460–0001. The
5A’’, ‘‘Cowpea, forage’’, ‘‘Cowpea, hay’’,
Public Reading Room is open from 8:30
‘‘Pea, southern, dry seed’’, ‘‘Pea,
a.m. to 4:30 p.m., Monday through
southern, succulent seed’’, and
Friday, excluding legal holidays. The
‘‘Rhubarb’’ to the table in paragraph (a)
telephone number for the Public
to read as follows.
Reading Room is (202) 566–1744, and
the telephone number for the OPP
§ 180.425 Clomazone; tolerances for
Docket is (703) 305–5805. Please review
residues.
the visitor instructions and additional
(a) General. * * *
information about the docket available
at https://www.epa.gov/dockets.
Parts per
Commodity
million
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
*
*
*
*
*
Environmental Protection Agency, 1200
Brassica, head and stem, subgroup 5A .................................
0.10 Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
*
*
*
*
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(703) 305–7090; email address:
Cowpea, forage ..........................
0.05 RDFRNotices@epa.gov.
Cowpea, hay ...............................
0.05
SUPPLEMENTARY INFORMATION:
1. The authority citation for part 180
continues to read as follows:
ADDRESSES:
*
*
*
*
Pea, southern, dry seed .............
Pea, southern, succulent seed ...
*
0.05
0.05
I. General Information
*
*
*
*
Rhubarb ......................................
*
0.30
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
■
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2014–07008 Filed 4–1–14; 8:45 am]
BILLING CODE 6560–50–P
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A. Does this action apply to me?
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determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2013–0051 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 June 2, 2014. 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–
2013–0051, 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
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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.
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.
II. Summary of Petitioned-for Tolerance
In the Federal Register of February
15, 2013 (78 FR 11126) (FRL–9378–4),
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 2F8135) by
Syngenta Crop Protection, LLC., P.O.
Box 18300, Greensboro, NC 27419–
8300. 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 and expressed as
parent compound, in or on rapeseed
subgroup 20A at 0.3 parts per million
(ppm). That document referenced a
summary of the petition prepared by
Syngenta Crop Protection, the registrant,
which is available in the docket,
https://www.regulations.gov. Comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit IV.C.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
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 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 2-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
resulted in decreased motor activity at
300 mg/kg. The current acute dietary
assessment is based on an endpoint
more sensitive than the neurotoxicity in
the acute neurotoxicity study. Based on
a weight of evidence evaluation by the
Agency, the subchronic neurotoxicity
data requirement (SCN) was waived.
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
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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. Propiconazole 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-observedadverse-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 an Section 3
Registration on Rapeseed Crop
Subgroup 20A,’’ pp. 41–47 in docket ID
number EPA–HQ–OPP–2013–0051.
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
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analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for propiconazole used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of May 11, 2011 (76
FR 27261) (FRL–8873–2).
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
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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. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight of the
evidence from cancer studies and other
relevant data. Cancer risk is quantified
using a linear or nonlinear approach. If
sufficient information on the
carcinogenic mode of action is available,
a threshold or nonlinear approach is
used and a cancer RfD is calculated
based on an earlier noncancer key event.
If carcinogenic mode of action data are
not available, or if the mode of action
data determines a mutagenic mode of
action, a default linear cancer slope
factor approach is utilized. Based on the
data summarized in Unit III.A., EPA has
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.
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://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
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propiconazole for acute exposures are
estimated to be 55.78 parts per billion
(ppb) for surface water and 0.64 ppb for
ground water, and for chronic exposures
are estimated to be 21.61 ppb for surface
water and 0.64 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 55.78 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 21.61ppb was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
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
dermal and incidental oral post
application exposure to children from
wood treatment. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at https://
www.epa.gov/pesticides/trac/science/
trac6a05.pdf.
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
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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://www.epa.gov/pesticides/
cumulative.
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, U.S. 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). In addition, the
Agency retained the additional 10X
FQPA safety factor for the protection of
infants and children. 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
Identification (ID) Number EPA–HQ–
OPP–2005–0497.
An updated dietary exposure and risk
analysis for the common triazole
metabolites 1,2,4-triazole (T),
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triazolylalanine (TA), triazolylacetic
acid (TAA), and triazolylpyruvic acid
(TP) was completed on October 24,
2013, in association with registration
requests for several triazole fungicides
(propiconazole, difenoconazole, and
tebuconazole). 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 Rapeseed Crop
Subgroup 20A; Use of Difenoconazole
on Rapeseed Crop Subgroup 20A; and
Use of Tebuconazole on Imported
Oranges’’ (located in docket ID number
EPA–HQ–OPP–2013–0051).
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity .
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. In the
developmental toxicity study in rabbits,
neither quantitative nor qualitative
evidence of increased susceptibility of
fetuses to in utero exposure to
propiconazole was observed in this
study. In the 2-generation reproduction
study in rats, neither quantitative nor
qualitative evidence of increased
susceptibility of neonates (as compared
to adults) to prenatal and/or postnatal
exposure to propiconazole was
observed. 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 mild neurobehavioral
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effects at 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. The most
recently published Federal Register
notice on April 19, 2013 (78 FR 23497)
(FRL–9381–8) cited an immunotoxicity
study as a data gap, but since the
publication of that final rule, the
Agency has evaluated and granted a
waiver request for this data requirement
for the conazoles as a class based on the
following considerations:
• There was no evidence of adverse
effects on the immune system in mice,
rats, or dogs in the data base for any of
the conazole pesticides.
• The liver, not the immune system,
is generally the target organ for this
chemical class, and hepatotoxicity or
body weight changes are the primary
toxicological endpoints of concern and
were used in risk assessments.
• The conazoles do not belong to a
class of chemicals (e.g., the organotins,
heavy metals, or halogenated aromatic
hydrocarbons) that would be expected
to be immunotoxic.
There was no evidence of
immunotoxicity with six other
structurally-related conazole fungicides,
namely, flutriafol, metconazole,
tebuconazole, tetraconazole,
triadimefon, and triticonazole. For
another conazole fungicide,
triflumizole, the effects on the immune
system occurred only at the highest dose
tested. Immunotoxicity was
demonstrated with difenoconazole,
however it was observed in the presence
of systemic toxicity and at a relatively
high dose. PODs based on the most
sensitive endpoints obtained via the
appropriate routes of exposure in the
most sensitive species are currently
used for dietary and non-dietary risk
assessments.
All these factors indicate that an
immunotoxicity study would most
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likely not result in an adverse effect that
could be used as an endpoint for
conazole risk assessment. Based on a
weight of evidence approach, the
Agency concluded that immunotoxicity
studies are not required for
propiconazole. An immunotoxicity
study is not anticipated to provide a
lower POD or result in a more sensitive
endpoint than those already used. Based
on a weight of the evidence approach,
EPA has waived the requirement for a
subchronic neurotoxicity study for
propiconazole. This data waiver was
based on the following considerations:
i. Other than the mild effects seen at
300 mg/kg in the acute neurotoxicity
study, the lack of neurotoxicity and
neurobehavioral effects seen in the
propiconazole toxicity database;
ii. The liver, not the nervous system,
is the primary target organ of
propiconazole toxicity, and decreased
body weight is the most sensitive
endpoint in repeated-dose studies. EPA
concludes that a subchronic
neurotoxicity study is unlikely to
provide a lower endpoint than those
currently used for risk assessment.
Finally, EPA waived the requirement
for a subchronic inhalation data based
on, among other things, its conclusion
that even if an additional 10X safety
factor was applied, inhalation exposure
would not raise a risk of concern.
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.
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
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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
propiconaozle 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 24% 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. This assessment is considered
conservative since it is based on a
combination of 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.
Additionally, the assessment could be
further refined by using PCT estimates
and anticipated residues for all crops.
Accordingly, even though this MOE for
children 1–2 years old is slightly below
the target MOE of 100, the difference is
small and is more than offset by the
conservative exposure assumptions and
therefore not of concern.
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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. EPA considers the chronic
aggregate risk assessment to be
protective of any aggregate cancer risk.
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.
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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
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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 established MRLs for
propiconazole in or on rapeseed at 0.02
ppm. This MRL is different than the
tolerance being established for
propiconazole in the United States,
which, as noted earlier, is 0.3 ppm. The
approved uses for propiconazole in the
United States will result in residues that
exceed the Codex MRLs.
C. Response to Comments
The Agency received a comment
objecting to the presence of any
pesticide residues on crops and stated
that EPA should set no pesticide
tolerance greater than zero. The
comment also stated that the Agency
should have more information on long
term testing before moving forward. A
second comment also objected to this
petition and stated that this product
should be banned and never used and
never produced in the USA. In addition,
the second comment also noted several
adverse effects seen in animal
toxicology studies with propiconazole
and claims because of these effects no
tolerance should be approved. The
Agency understands the concerns raised
in the comments and recognizes that
some individuals believe that pesticides
should be banned completely. However,
the existing legal framework provided
by section 408 of the Federal Food, Drug
and Cosmetic Act (FFDCA),
contemplates that tolerances greater
than zero may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. The comments appear to be
directed at the underlying statute and
not EPA’s implementation of it; no
contention has been made that EPA has
acted in violation of the statutory
framework. In addition, EPA has found
that there is a reasonable certainty of no
harm to humans after considering these
toxicological studies and the exposure
levels of humans to propiconazole.
A third comment dealt with a
different chemical entirely and thus
needs no response.
V. Conclusion
Therefore, a tolerance is 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 and expressed as
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parent compound, in or on rapeseed
subgroup 20A at 0.30 ppm.
VI. Statutory and Executive Order
Reviews
This final rule 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 final rule
has been exempted from review under
Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, this final
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rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(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 of 1995
(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: March 21, 2014.
Lois Rossi,
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 § 180.434, add alphabetically the
following commodity to the table in
paragraph (a) to read as follows:
■
§ 180.434 Propiconazole; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
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*
*
*
*
Rapeseed subgroup 20A ..........
*
*
*
*
*
*
*
*
*
[FR Doc. 2014–07100 Filed 4–1–14; 8:45 am]
BILLING CODE 6560–50–P
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*
0.30
*
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2013–0011; FRL–9907–47]
Forchlorfenuron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of
forchlorfenuron in or on multiple
commodities which are identified and
discussed later in this document. KIM–
C1, LLC requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April
2, 2014. Objections and requests for
hearings must be received on or before
June 2, 2014, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2013–0011, 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), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
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
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18467
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2013–0011 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 June 2, 2014. 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–
2013–0011, 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.
E:\FR\FM\02APR1.SGM
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Agencies
[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Rules and Regulations]
[Pages 18461-18467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07100]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0051; FRL-9907-05]
Propiconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
propiconazole in or on the rapeseed crop subgroup 20A. Syngenta Crop
Protection requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April 2, 2014. Objections and
requests for hearings must be received on or before June 2, 2014, 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-2013-0051, 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), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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
[[Page 18462]]
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-2013-0051 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
June 2, 2014. 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-2013-0051, 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 February 15, 2013 (78 FR 11126) (FRL-
9378-4), 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
2F8135) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro,
NC 27419-8300. 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
and expressed as parent compound, in or on rapeseed subgroup 20A at 0.3
parts per million (ppm). That document referenced a summary of the
petition prepared by Syngenta Crop Protection, the registrant, which is
available in the docket, https://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for 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 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 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 2-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 resulted in decreased motor activity
at 300 mg/kg. The current acute dietary assessment is based on an
endpoint more sensitive than the neurotoxicity in the acute
neurotoxicity study. Based on a weight of evidence evaluation by the
Agency, the subchronic neurotoxicity data requirement (SCN) was waived.
[[Page 18463]]
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. Propiconazole 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 an Section 3 Registration on Rapeseed Crop Subgroup
20A,'' pp. 41-47 in docket ID number EPA-HQ-OPP-2013-0051.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for propiconazole used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of May 11, 2011 (76 FR 27261) (FRL-
8873-2).
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. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has 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.
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://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
[[Page 18464]]
propiconazole for acute exposures are estimated to be 55.78 parts per
billion (ppb) for surface water and 0.64 ppb for ground water, and for
chronic exposures are estimated to be 21.61 ppb for surface water and
0.64 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 55.78 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 21.61ppb 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 dermal and incidental
oral post application exposure to children from wood treatment. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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://www.epa.gov/pesticides/cumulative.
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, U.S. 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). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. 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
Identification (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 October 24, 2013, in association with registration
requests for several triazole fungicides (propiconazole,
difenoconazole, and tebuconazole). 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 Rapeseed
Crop Subgroup 20A; Use of Difenoconazole on Rapeseed Crop Subgroup 20A;
and Use of Tebuconazole on Imported Oranges'' (located in docket ID
number EPA-HQ-OPP-2013-0051).
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity . 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. In the developmental toxicity study in
rabbits, neither quantitative nor qualitative evidence of increased
susceptibility of fetuses to in utero exposure to propiconazole was
observed in this study. In the 2-generation reproduction study in rats,
neither quantitative nor qualitative evidence of increased
susceptibility of neonates (as compared to adults) to prenatal and/or
postnatal exposure to propiconazole was observed. 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 mild neurobehavioral
[[Page 18465]]
effects at 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. The most
recently published Federal Register notice on April 19, 2013 (78 FR
23497) (FRL-9381-8) cited an immunotoxicity study as a data gap, but
since the publication of that final rule, the Agency has evaluated and
granted a waiver request for this data requirement for the conazoles as
a class based on the following considerations:
There was no evidence of adverse effects on the immune
system in mice, rats, or dogs in the data base for any of the conazole
pesticides.
The liver, not the immune system, is generally the target
organ for this chemical class, and hepatotoxicity or body weight
changes are the primary toxicological endpoints of concern and were
used in risk assessments.
The conazoles do not belong to a class of chemicals (e.g.,
the organotins, heavy metals, or halogenated aromatic hydrocarbons)
that would be expected to be immunotoxic.
There was no evidence of immunotoxicity with six other
structurally-related conazole fungicides, namely, flutriafol,
metconazole, tebuconazole, tetraconazole, triadimefon, and
triticonazole. For another conazole fungicide, triflumizole, the
effects on the immune system occurred only at the highest dose tested.
Immunotoxicity was demonstrated with difenoconazole, however it was
observed in the presence of systemic toxicity and at a relatively high
dose. PODs based on the most sensitive endpoints obtained via the
appropriate routes of exposure in the most sensitive species are
currently used for dietary and non-dietary risk assessments.
All these factors indicate that an immunotoxicity study would most
likely not result in an adverse effect that could be used as an
endpoint for conazole risk assessment. Based on a weight of evidence
approach, the Agency concluded that immunotoxicity studies are not
required for propiconazole. An immunotoxicity study is not anticipated
to provide a lower POD or result in a more sensitive endpoint than
those already used. Based on a weight of the evidence approach, EPA has
waived the requirement for a subchronic neurotoxicity study for
propiconazole. This data waiver was based on the following
considerations:
i. Other than the mild effects seen at 300 mg/kg in the acute
neurotoxicity study, the lack of neurotoxicity and neurobehavioral
effects seen in the propiconazole toxicity database;
ii. The liver, not the nervous system, is the primary target organ
of propiconazole toxicity, and decreased body weight is the most
sensitive endpoint in repeated-dose studies. EPA concludes that a
subchronic neurotoxicity study is unlikely to provide a lower endpoint
than those currently used for risk assessment.
Finally, EPA waived the requirement for a subchronic inhalation
data based on, among other things, its conclusion that even if an
additional 10X safety factor was applied, inhalation exposure would not
raise a risk of concern.
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. 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 propiconaozle 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 24% 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. This assessment is considered
conservative since it is based on a combination of 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. Additionally,
the assessment could be further refined by using PCT estimates and
anticipated residues for all crops. Accordingly, even though this MOE
for children 1-2 years old is slightly below the target MOE of 100, the
difference is small and is more than offset by the conservative
exposure assumptions and therefore not of concern.
[[Page 18466]]
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. EPA considers the
chronic aggregate risk assessment to be protective of any aggregate
cancer risk.
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.
The Codex has established MRLs for propiconazole in or on rapeseed
at 0.02 ppm. This MRL is different than the tolerance being established
for propiconazole in the United States, which, as noted earlier, is 0.3
ppm. The approved uses for propiconazole in the United States will
result in residues that exceed the Codex MRLs.
C. Response to Comments
The Agency received a comment objecting to the presence of any
pesticide residues on crops and stated that EPA should set no pesticide
tolerance greater than zero. The comment also stated that the Agency
should have more information on long term testing before moving
forward. A second comment also objected to this petition and stated
that this product should be banned and never used and never produced in
the USA. In addition, the second comment also noted several adverse
effects seen in animal toxicology studies with propiconazole and claims
because of these effects no tolerance should be approved. The Agency
understands the concerns raised in the comments and recognizes that
some individuals believe that pesticides should be banned completely.
However, the existing legal framework provided by section 408 of the
Federal Food, Drug and Cosmetic Act (FFDCA), contemplates that
tolerances greater than zero may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. The comments appear to be
directed at the underlying statute and not EPA's implementation of it;
no contention has been made that EPA has acted in violation of the
statutory framework. In addition, EPA has found that there is a
reasonable certainty of no harm to humans after considering these
toxicological studies and the exposure levels of humans to
propiconazole.
A third comment dealt with a different chemical entirely and thus
needs no response.
V. Conclusion
Therefore, a tolerance is 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 and expressed as parent compound, in or on
rapeseed subgroup 20A at 0.30 ppm.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final
[[Page 18467]]
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (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 of 1995 (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: March 21, 2014.
Lois Rossi,
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, add alphabetically the following commodity to the
table in paragraph (a) to read as follows:
Sec. 180.434 Propiconazole; tolerances for residues.
(a) * * *
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Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Rapeseed subgroup 20A...................................... 0.30
* * * * *
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* * * * *
[FR Doc. 2014-07100 Filed 4-1-14; 8:45 am]
BILLING CODE 6560-50-P