Propiconazole; Pesticide Tolerance, 55300-55307 [06-8064]
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Commodity
Parts per million
Banana ...........................
Beet, sugar, dried pulp ...
Beet, sugar, molasses ....
Beet, sugar, roots ...........
Beet, sugar, tops ............
Bushberry subgroup 13B
Cattle, meat byproducts
Citrus, dried pulp ............
Citrus, oil .........................
Cranberry ........................
Fruit, citrus, group 10 .....
Fruit, stone, group 12 .....
Goat, meat byproducts ...
Grain, aspirated fractions
Grape1 ............................
Horse, meat byproducts
Peanut ............................
Pecan ..............................
Sheep, meat byproducts
Wheat, forage .................
Wheat, grain ...................
Wheat, hay .....................
Wheat, straw ...................
0.3
1.0
0.4
0.3
9.0
0.3
0.05
5.0
40.0
0.5
1.0
1.0
0.05
6.0
1.0
0.05
0.1
0.05
0.05
4.0
0.1
8.0
8.0
1There are no United States registrations for
grape as of August 2006.
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[FR Doc. 06–7957 Filed 9–21–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2006–0347; FRL–8092–1]
Propiconazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes or
revises tolerances for combined residues
of propiconazole and its metabolites
containing the dichlorobenzoic acid
(DCBA) moiety expressed as parent
compound in or on various
commodities; and inadvertent residues
in or on alfalfa, forage and alfalfa, hay.
Syngenta Crop Protection, Inc. and
Interregional Research Project No. 4 (IR4), requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective
September 22, 2006. Objections and
requests for hearings must be received
on or before November 21, 2006, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0347. All documents in the
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docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Mary Waller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9354; e-mail address:
waller.mary@epa.gov.
SUPPLEMENTARY 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. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
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the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2006–0347 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before November 21, 2006.
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 that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0347, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
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excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of May 3, 2006
(71 FR 26084) (FRL–8060–2), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP) 2F6371 and
5F4498 by Syngenta Crop Protection,
Inc., and PP 6E4788, 7E4860, and
8E4931 by Interregional Research
Project No. 4 (IR-4). The petitions
requested that 40 CFR 180.434 be
amended by establishing a tolerance for
combined 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 2,4dichlorobenzoic acid and expressed as
parent compound in or on leafy
vegetables (Subgroup 4B) at 5.0 parts
per million (ppm) (PP 6E4788);
cranberry at 1.0 ppm (PP 7E4860); Mint
at.3.0 ppm (PP 8E4931); and under PP
2F6371, almond, hulls and onion, green
at 8.0 ppm; berries (Group 13) and
legume vegetables (Group 6) at 1.0 ppm;
foliage of legume vegetables (Group 7)/
sorghum/soybean, forage and sugar beet,
tops at 10.0 ppm; carrot, roots/
pistachios/nuts, tree (Group 14) at 0.2
ppm; foliage of legume vegetable (Group
7)/soybean, hay at 32.0 ppm; onion, dry
bulb/corn, grain/sugar beet, roots at 0.3
ppm; sorghum, grain/grain cereal group
(except corn, rice, and sorghum), bran at
2.5 ppm; sorghum, stover at 15.0 ppm;
soybean, seed/grain, cereal group
(except corn, rice, and sorghum), hay/
sugar beet, dried pulp at 2.0 ppm;
strawberry at 1.5 ppm; grain, cereal
group (except corn, rice, and sorghum)
(Group 15), forage/sugar beet, molasses
at 3.0 ppm; grain, cereal group (except
corn, rice, and sorghum), straw at 13.0
ppm; grain, cereal group (except corn,
rice, and sorghum)/corn, oil at 0.5 ppm;
rice, bran and hulls at 28.0 ppm; and
aspirated grain fraction at 17.0 ppm.
Further, the petition requested existing
tolerances be amended for corn, forage
at 4.0 ppm; corn, stover at 25.0 ppm;
rice, grain at 7.0 ppm; and rice, straw at
18.0 ppm. Additionally, PP 5F4498,
requested inadvertent residues for
alfalfa, forage and hay at 0.1 ppm. That
notice included a summary of the
petition prepared by Syngenta Crop
Protection, Inc., the registrant. There
were no comments received in response
to the notice of filing.
Upon completing review of the
current propiconazole database, the
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Agency concluded that the appropriate
tolerance levels for propiconazole
residues in or on pending crops and
livestock commodities should be
established as follow: On grain,
aspirated fractions at 30 ppm; almond,
hulls at 7.0 ppm; barley, grain at 0.3
ppm; barley, hay at 1.4 ppm; barley,
straw at 10 ppm; barley, bran at 0.6
ppm; cattle, fat at 0.05 ppm; cattle, meat
at 0.05 ppm; cattle, meat byproducts,
except liver and kidney at 0.05 ppm;
leafy petioles, subgroup 4B at 5.0 ppm;
Berry group 13 at 1.0 ppm; carrot, roots
at 0.25 ppm; corn, field, forage at 12
ppm; corn, sweet, forage at 6.0 ppm;
corn, field, grain at 0.2 ppm; corn, pop,
grain at 0.2 ppm; corn, field, stover at
30 ppm; corn, pop, stover at 30 ppm;
corn, sweet, stover at 30 ppm; goat, fat
at 0.05 ppm; goat, meat at 0.05 ppm;
goat, meat byproducts, except liver and
kidney at 0.05 ppm; hog, kidney at 0.2
ppm; hog, liver at 0.2 ppm; horse, fat at
0.05 ppm; horse, meat at 0.05 ppm;
horse, meat byproducts, except liver and
kidney at 0.05 ppm; spearmint, tops at
3.5 ppm; peppermint, tops at 3.5 ppm;
oat, forage at 1.7 ppm; oat, grain at 0.3
ppm; oat, hay at 1.4 ppm; oat, straw at
10 ppm; onion, bulb at 0.2 ppm; onion,
green at 9.0 ppm; pistachio at 0.1 ppm;
rice, bran at 15 ppm; rice, grain at 7.0
ppm; rice, hulls at 20 ppm; rice, straw
at 18 ppm; rye, grain at 0.3 ppm; rye,
forage at 1.7 ppm; rye, straw at 10 ppm;
rye, bran at 0.6 ppm; sorghum, grain,
forage at 12 ppm; sorghum, grain, grain
at 3.5 ppm; sorghum, grain, stover at 15
ppm; sheep, fat at 0.05 ppm; sheep,
meat at 0.05 ppm; sheep, meat
byproducts, except liver and kidney at
0.05 ppm; soybean, forage at 11 ppm;
soybean, hay at 30 ppm; soybean, seed
at 2.0 ppm; strawberry at 1.3 ppm; beet,
sugar, dried pulp at 1.0 ppm; beet,
sugar, roots at 0.3 ppm; beet, sugar, tops
at 10 ppm; beet, sugar, molasses at 1.5
ppm; nut, tree, group 14 at 0.1 ppm;
wheat, bran at 0.6 ppm; wheat, forage at
1.7 ppm; wheat, grain at 0.3 ppm;
wheat, hay at 1.4 ppm; wheat, straw at
10 ppm; cranberry at 1.0 ppm; and
inadvertent residues in or on alfalfa,
forage at 0.1 ppm and alfalfa, hay at 0.1
ppm. The Agency concluded that there
are insufficient data to establish
tolerances legume vegetables (Group 6);
foliage of legume vegetables (Group 7);
cereal group (except corn, rice, and
sorghum) (Group 15). For additional
information refer to
www.regulations.gov Docket No. EPA–
HQ–OPP–2006–0347–0008.
EPA is also deleting several
established tolerances in 40 CFR
180.434(a), (b), and (c) that are no longer
needed as a result of this action.
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The revisions to 180.434(a) are as
follows:
• Delete celery at 5.0 ppm. Replaced
with leafy petioles, subgroup 4B at 5.0
ppm.
• Delete pecans at 0.1 ppm. Replaced
with nut, tree, group 14 at 0.1 ppm.
The revisions to 180.434(b) are as
follows:
• Delete the time-limited tolerance for
blueberry at 1.0 ppm. Replaced with
Berry group 13 at 1.0 ppm, under 40
CFR 180.434(a).
• Delete the time-limited tolerance for
cranberry; grain, aspirated fractions;
sorghum, grain, grain; sorghum, grain,
stover; soybean; soybean, forage; and
soybean, hay. All are being replaced by
permanent tolerances.
• Delete time-limited tolerance for
dry bean; dry bean forage; and dry bean
hay since these tolerances have expired.
The revisions to 180.434(c) are as
follows:
• Delete mint, tops (leaves and stems)
at 0.3 ppm. Replaced with spearmint,
tops at 3.5 ppm and peppermint, tops at
3.5 ppm under 40 CFR 180.434(a).
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....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
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action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for combined
residues of propiconazole and its
metabolites containing the
dichlorobenzoic acid (DCBA) moiety
expressed as parent compound on grain,
aspirated fractions at 30 ppm; almond,
hulls at 7.0 ppm; barley, grain at 0.3
ppm; barley, hay at 1.4 ppm; barley,
straw at 10 ppm; barley, bran at 0.6
ppm; cattle, fat at 0.05 ppm; cattle, meat
at 0.05 ppm; cattle, meat byproducts,
except liver and kidney at 0.05 ppm;
leafy petioles, subgroup 4B at 5.0 ppm;
Berry group 13 at 1.0 ppm; carrot, roots
at 0.25 ppm; corn, field, forage at 12
ppm; corn, sweet, forage at 6.0 ppm;
corn, field, grain at 0.2 ppm; corn, pop,
grain at 0.2 ppm; corn, field, stover at
30 ppm; corn, pop, stover at 30 ppm;
corn, sweet, stover at 30 ppm; goat, fat
at 0.05 ppm; goat, meat at 0.05 ppm;
goat, meat byproducts, except liver and
kidney at 0.05 ppm; hog, kidney at 0.2
ppm; hog, liver at 0.2 ppm; horse, fat at
0.05 ppm; horse, meat at 0.05 ppm;
horse, meat byproducts, except liver and
kidney at 0.05 ppm; spearmint, tops at
3.5 ppm; peppermint, tops at 3.5 ppm;
oat, forage at 1.7 ppm; oat, grain at 0.3
ppm; oat, hay at 1.4 ppm; oat, straw at
10 ppm; onion, bulb at 0.2 ppm; onion,
green at 9.0 ppm; pistachio at 0.1 ppm;
rice, bran at 15 ppm; rice, grain at 7.0
ppm; rice, hulls at 20 ppm; rice, straw
at 18 ppm; rye, grain at 0.3 ppm; rye,
forage at 1.7 ppm; rye, straw at 10 ppm;
rye, bran at 0.6 ppm; sorghum, grain,
forage at 12 ppm; sorghum, grain, grain
at 3.5 ppm; sorghum, grain, stover at 15
ppm; sheep, fat at 0.05 ppm; sheep,
meat at 0.05 ppm; sheep, meat
byproducts, except liver and kidney at
0.05 ppm; soybean, forage at 11 ppm;
soybean, hay at 30 ppm; soybean, seed
at 2.0 ppm; strawberry at 1.3 ppm; beet,
sugar, dried pulp at 1.0 ppm; beet,
sugar, roots at 0.3 ppm; beet, sugar, tops
at 10 ppm; beet, sugar, molasses at 1.5
ppm; nut, tree, group 14 at 0.1 ppm;
wheat, bran at 0.6 ppm; wheat, forage at
1.7 ppm; wheat, grain at 0.3 ppm;
wheat, hay at 1.4 ppm; wheat, straw at
10 ppm; cranberry at 1.0 ppm; and
inadvertent residues in or on alfalfa,
forage at 0.1 ppm and alfalfa, hay at 0.1
ppm. EPA’s assessment of exposures
and risks associated with establishing
the tolerance 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
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considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
propiconazole as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at www.regulations.gov
Docket No. EPA–HQ–OPP–2006–0347–
0005; pages 35–42.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for propiconazole used for
human risk assessment is discussed at
www.regulations.gov Docket No. EPA–
HQ–OPP–2006–0347–0004; pages 23–
25.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.434) for the
combined residues of propiconazole and
its metabolites containing the
dichlorobenzoic acid (DCBA) moiety
expressed as parent compound, in or on
a variety of raw agricultural
commodities. Tolerances are also
established for residues of
propiconazole and its metabolites
containing the dichlorobenzoic acid
(DCBA) moiety expressed as parent
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compound in or on milk as well as fat,
meat, kidney, liver and meat by
products of cattle, goats, hogs, horse,
and sheep. Some of these existing
tolerances are being revised as a result
of this action. Risk assessments were
conducted by EPA to assess 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.
In conducting the acute dietary
exposure assessment EPA used the
Dietary Exposure Evaluation Model
software with the Food Commodity
Intake Database (DEEM-FCIDTM), which
incorporates food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
exposure to the chemical for each
commodity. The following assumptions
were made for the acute exposure
assessments: Tolerance levels and one
hundred percent of the crops were
treated for all proposed new uses,
revised uses, and existing uses.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the DEEM-FCIDTM, which
incorporates food consumption data as
reported by respondents in the USDA
1994–1996 and 1998 nationwide CSFII,
and accumulated exposure to the
chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments:
Tolerance levels and 100% of the crops
were treated for all proposed new uses,
revised uses, and existing uses.
iii. Cancer. Propiconazole has been
classified as a group C (possible human
carcinogen). The Agency concluded that
the chronic risk assessment, making use
of the chronic population adjusted dose
(cPAD), is protective of any potential
carcinogenic risk.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
propiconazole in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
propiconazole. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
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can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
A registrant drinking water
monitoring study showed very few
detections among a total of 38 selected
community water systems in 12 states.
The Agency concluded that the
sampling scheduling of this monitoring
study is not rigorous enough to be used
for water assessment. Since the
monitoring studies did not provide good
quality data, this drinking water
assessment is based on the model
predicted drinking water
concentrations.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
concentration in Ground Water (SCIGROW) models, the estimated
environmental concentrations (EECs) of
propiconazole for acute exposures are
estimated to be 55.8 parts per billion
(ppb) for surface water and 0.64 ppb for
ground water. The EECs for chronic
exposures are estimated to be 21.6 ppb
for surface water and 0.64 ppb for
ground water.
To estimate surface water for each
specific use, the maximum allowable
label rate was input into PRZM/EXAMS.
The output concentrations were without
percent cropped area (PCA)
consideration. The final estimated
drinking water concentrations were then
adjusted with the proper PCA. Except
the uses of soybean (0.41 ppb) and
wheat (0.56 ppb), other uses assume the
default PCA of 0.87 ppb. Among these
modeling results, turf use gives the
highest acute concentration of 55.78 ppb
(Microgram/liter (µg/L)). For the chronic
exposure, turf use has the highest
concentration of 21.61 ppb (µg/L).
The EECs in ground water were
calculated using the Tier I SCI-GROW
model. SCI-GROW is neither scenarionor crop-specific. The only input
requirements are application rate,
number of applications, Koc, and aerobic
soil metabolism half-life. The higher
estimated concentrations are associated
with the higher rate. Turf use has the
highest concentration of 0.64 µg/L (ppb).
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCID(TM)). For acute dietary risk
assessment, the peak water
concentration value of 55.8 ppb was
used to access the contribution to
drinking water. For chronic dietary risk
assessment, the annual average
concentration of 21.6 ppb was used to
access the contribution to drinking
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to non-
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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 use on the following residential nondietary sites: Ground covers; turf and
ornamentals in lawns and golf courses;
ornamentals trees (injection); shade
trees (outdoor spray); herbaceous plants;
ornamental woody shrubs and vines and
antimicrobial uses in paint and wood
protection treatment. The risk
assessment was conducted using the
following residential exposure
assumptions:
Homeowners can be exposed to
propiconazole through dermal and
inhalation routes while applying home
use products. All risk calculations were
conducted using the maximum turf
application rate (1.8 lb ai/acre). The
anticipated use patterns and current
labeling indicate three major residential
exposure scenarios based on the types of
equipment and techniques that can
potentially be used to make
propiconazole applications. The
quantitative exposure/risk assessment
developed for residential handlers is
based on these scenarios:
• Mixer/Loader/applying liquids and
wettable powder in water soluble
packets via low pressure handwand.
• Mixer/Loader/applying liquids and
wettable powder in water soluble
packets via hose-end sprayer.
• Applying treated paint using airless
sprayer and hose-end spray.
Residential handler exposure
scenarios are considered to be shortterm only due to the infrequent uses
associated with homeowner products.
The existing residential use patterns
result in post application dermal
exposures to adults, and dermal and
oral exposures to infants and children.
These exposure scenarios are
considered short term only, due to the
fact that:
i. Post-application exposures were
calculated using propiconazole as the
parent compound;
ii. Compound specific turf
transferable residue (TTR) data indicate
that at the Indiana, California, and
Pennsylvania test sites, average total
propiconazole residues declined to
below the minimum quantifiable limit
(MQL) by 14, 10 and 8 days after
treatment, respectively. These
dissipation rates, combined with label
specific use rates and frequency of use
specifications, reinforce the hand to
mouth short-term exposure scenario;
iii. For short term exposure to
children 1–2 years old, the driving
factors for this risk assessment are hand
to mouth, object to mouth, and dermal
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exposure. Soil ingestion is insignificant
(margin of exposure (MOE) >300,000)
compared to these factors, indicating
that the post application scenario
should be short term only. Although
both residential and antimicrobial uses
result in incidental oral and dermal
exposure to children, the highest
incidental oral and dermal exposure
scenarios are from residential use on
turf, which were used in the short term
aggregate risk assessment.
In addition to using the EPA’s
Standard Operational Procedure (SOP)
for residential assessment, the study
specific turf transferable residue (TTR)
was used to estimate exposures. The
EPA combined exposures resulting from
separate post-application exposure
scenarios when it is likely they can
occur simultaneously based on the usepattern and the behavior associated with
the exposed population. The
assumptions used for each of the
scenarios separately are considered to
account for potential high levels of
exposure (i.e., time spent outdoors,
dislodgeable residues) therefore,
combining all these activities together is
considered a very high end estimate of
exposure. Propiconazole is classified as
a non-volatile chemical; therefore a
residential inhalation post-application
assessment was not assessed.
The only residential use scenario that
will result in potential intermediate
term exposure to propiconazole is post
application exposure to children from
wood treatment (antimicrobial use) from
incidental oral and dermal contact
activities.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the 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 this 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
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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
website 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 conjugates (triazole alanine and
triazole acetic 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 1,2,4triazole, triazole alanine, and triazole
acetic acid resulting from the use of all
current and pending uses of any
triazole-derived fungicide. The risk
assessment is 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
www.regulations.gov, Docket ID number
EPA–HQ–OPP–2005–0497–0013.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold 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. Margins of safety are
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incorporated into EPA risk assessments
either directly through use of a MOE
analysis or through using uncertainty
(safety) factors in calculating a dose
level that poses no appreciable risk to
humans. In applying this provision,
EPA either retains the default value of
10X when reliable data do not support
the choice of a different factor, or, if
reliable data are available, EPA uses a
different additional safety factor value
based on the use of traditional
uncertainty factors and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There is low concern for pre- and/or
postnatal toxicity resulting from
exposure to propiconazole. In the
developmental toxicity study in rats, the
EPA considered the fetal effects
observed in this study at a dose lower
than that evoking maternal toxicity to be
quantitative evidence of increased
susceptibility of fetuses to in utero
exposure to propiconazole. In the
developmental toxicity study in rabbits,
the Agency determined that 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 preand/or postnatal exposure to
propiconazole was observed in the
study. Since there is quantitative
evidence of increased susceptibility of
the young following exposure to
propiconazole in the developmental rat
study, the Agency performed a Degree of
Concern Analysis to:
i. Determine the LOC for the effects
observed when considered in the
context of all available toxicity data; and
ii. Identify any residual uncertainties
after establishing toxicity endpoints and
traditional uncertainty factors to be used
in the risk assessment of this chemical.
If residual uncertainties are identified,
then EPA examines whether these
residual uncertainties can be addressed
by a special FQPA safety factor and, if
so, the size of the factor needed. In the
developmental rat study, quantitative
susceptibility was evidenced as
increased incidence of rudimentary ribs,
unossified sternebrae, as well as
increased incidence of shortened and
absent renal papillae and increased cleft
palate at (90 mg/kg/day) a dose lower
than that evoking maternal toxicity
(severe clinical toxicity at 300 mg/kg/
day). Considering the overall toxicity
profile and the doses and endpoints
selected for risk assessment for
propiconazole, the EPA characterized
the degree of concern for the effects
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observed in this study as low, noting
that there is a clear no observed adverse
effect level (NOAEL) and wellcharacterized dose response for the
developmental effects observed. No
residual uncertainties were identified.
The NOAEL for developmental effects
in this study (30 mg/kg/day) is used as
the basis for the acute Reference dose
(aRfD) for the female 13–50 population
subgroup as well as for short-term
incidental oral, dermal and inhalation
endpoints. For all other toxicity
endpoints established for
propiconazole, a NOAEL lower than this
developmental NOAEL is used.
3. Conclusion. There is a complete
toxicity data base for propiconazole and
exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. There
is low concern for pre- and/or postnatal
toxicity resulting from exposure to
propiconazole. In the developmental
toxicity study in rats the fetal effects
observed were seen at a dose lower than
that evoking maternal toxicity. These
effects were considered to be
quantitative evidence of increased
susceptibility of fetuses to in utero
exposure to propiconazole. Therefore, as
discussed above a Degree of Concern
Analysis was conducted and the EPA
concluded that the degree of concern for
the effects observed in this study was
low and no residual uncertainties were
identified. EPA determined that the 10X
SF to protect infants and children
should be removed.
E. Aggregate Risks and Determination of
Safety
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 6% of the
acute Population Adjusted Dose (aPAD)
for the U.S. population, 5% of the aPAD
for females 13 years and older, 14% of
the aPAD for all infants (<1 year old),
the subpopulation at greatest exposure,
and 13% of the aPAD for children 1–2
years old. Therefore, EPA does not
expect the aggregate exposure to exceed
100% of the aPAD.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to propiconazole from
food and water will utilize 6% of the
chronic Population Adjusted Dose
(cPAD) for the U.S. population, 14% of
the cPAD for all infants (<1 year old),
and 14% of the cPAD for children 1–2
years old, the subpopulation at greatest
exposure. Based the use pattern, chronic
residential exposure to residues of
propiconazole is not expected.
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Therefore, EPA does not expect the
aggregate exposure to exceed 100% of
the cPAD.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Propiconazole is currently registered
for use that could result in short-term
residential exposure and the Agency has
determined that it is appropriate to
aggregate chronic food and water and
short-term exposures for propiconazole.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded that
food, water and residential exposures
aggregated result in aggregate MOEs for
children 1–2 years old of 1,100 for hand
to mouth activity on turf; 4,500 for
object to mouth activity on turf; 330,000
for soil ingestion; 210 for high contact
turf activities; and 410 from the
antimicrobial use of propiconazole in
treated wood. The food, water and
residential exposures aggregated for
children 1–2 years old following postapplication of propiconazole result in
an aggregate MOE of 160 for high
contact activities. The corresponding
aggregate MOE for adults following
post-application exposure is 330. These
aggregate MOEs do not exceed the
Agency’s LOC for aggregate exposure to
food, water and residential uses.
Therefore, EPA does not expect shortterm aggregate exposure to exceed the
Agency’s LOC.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Propiconazole is currently registered
for use(s) that could result in
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic food
and water and intermediate-term
exposures for propiconazole.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
food, water and residential exposures
aggregated result in an aggregate MOE of
120 for combined exposures from
incidental oral and dermal contact
activities for children 1–2 years old.
These aggregate MOEs do not exceed the
Agency’s LOC for aggregate exposure to
food, water and residential uses.
Therefore, EPA does not expect
intermediate-term aggregate exposure to
exceed the Agency’s LOC.
5. Aggregate cancer risk for U.S.
population. The Agency considers the
chronic aggregate risk assessment,
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16:03 Sep 21, 2006
Jkt 208001
making use of the cPAD, to be protective
of any aggregate cancer risk. See Unit
III.E.2.
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, and to infants and children
from aggregate exposure to
propiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(a gas chromatography (GC) method
using electron capture detection
(Method AG-454) 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
The Codex Alimentarius Commission
has established several maximum
residue limits (MRLs) for propiconazole
in/on various raw agricultural
commodities. The Codex MRLs are
expressed in terms of propiconazole per
se. In addition, both Canada and Mexico
have established MRLs/tolerances on
several commodities which also have
U.S. tolerances. The U.S. tolerance
expression includes all metabolites
determined as 2,4-dichloro-benzoic
acid. In conjunction with the
reregistration process EPA intends to
revise the expression to propiconazole
per se. To the extent possible, for the
present petitions, U.S. tolerances have
been numerically harmonized with
Codex, Canadian, and Mexican MRLs;
however, differences in use patterns and
the supporting residue data have
precluded reducing many tolerances. A
summary of Codex MRLs, Canadian
MRLs, and Mexican tolerances and the
corresponding U.S. tolerances for
propiconazole is discussed at
www.regulations.gov Docket No. EPA–
HQ–OPP–2006–0347–0004; pages 53–
54.
V. Conclusion
Therefore, tolerances are established
for combined residues of propiconazole
and its metabolites containing the
dichlorobenzoic acid (DCBA) moiety
expressed as parent compound in or on
grain, aspirated fractions at 30 ppm;
almond, hulls at 7.0 ppm; barley, grain
at 0.3 ppm; barley, hay at 1.4 ppm;
barley, straw at 10 ppm; barley, bran at
0.6 ppm; cattle, fat at 0.05 ppm; cattle,
meat at 0.05 ppm; cattle, meat
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55305
byproducts, except liver and kidney at
0.05 ppm; leafy petioles, subgroup 4B at
5.0 ppm; Berry group 13 at 1.0 ppm;
carrot, roots at 0.25 ppm; corn, field,
forage at 12 ppm; corn, sweet, forage at
6.0 ppm; corn, field, grain at 0.2 ppm;
corn, pop, grain at 0.2 ppm; corn, field,
stover at 30 ppm; corn, pop, stover at 30
ppm; corn, sweet, stover at 30 ppm;
goat, fat at 0.05 ppm; goat, meat at 0.05
ppm; goat, meat byproducts, except
liver and kidney at 0.05 ppm; hog,
kidney at 0.2 ppm; hog, liver at 0.2 ppm;
horse, fat at 0.05 ppm; horse, meat at
0.05 ppm; horse, meat byproducts,
except liver and kidney at 0.05 ppm;
spearmint, tops at 3.5 ppm; peppermint,
tops at 3.5 ppm; oat, forage at 1.7 ppm;
oat, grain at 0.3 ppm; oat, hay at 1.4
ppm; oat, straw at 10 ppm; onion, bulb
at 0.2 ppm; onion, green at 9.0 ppm;
pistachio at 0.1 ppm; rice, bran at 15
ppm; rice, grain at 7.0 ppm; rice, hulls
at 20 ppm; rice, straw at 18 ppm; rye,
grain at 0.3 ppm; rye, forage at 1.7 ppm;
rye, straw at 10 ppm; rye, bran at 0.6
ppm; sorghum, grain, forage at 12 ppm;
sorghum, grain, grain at 3.5 ppm;
sorghum, grain, stover at 15 ppm; sheep,
fat at 0.05 ppm; sheep, meat at 0.05
ppm; sheep, meat byproducts, except
liver and kidney at 0.05 ppm; soybean,
forage at 11 ppm; soybean, hay at 30
ppm; soybean, seed at 2.0 ppm;
strawberry at 1.3 ppm; beet, sugar, dried
pulp at 1.0 ppm; beet, sugar, roots at 0.3
ppm; beet, sugar, tops at 10 ppm; beet,
sugar, molasses at 1.5 ppm; nut, tree,
group 14 at 0.1 ppm; wheat, bran at 0.6
ppm; wheat, forage at 1.7 ppm; wheat,
grain at 0.3 ppm; wheat, hay at 1.4 ppm;
wheat, straw at 10 ppm; cranberry at 1.0
ppm; and inadvertent residues in or on
alfalfa, forage at 0.1 ppm and alfalfa, hay
at 0.1 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA 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 rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). 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., or impose any
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enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). 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); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, 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. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
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16:03 Sep 21, 2006
Jkt 208001
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. 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 this final
rule in the Federal Register. This final
rule 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: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.434 is revised to read
as follows:
I
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Fmt 4700
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§ 180.434
residue.
Propiconazole; tolerances for
(a) General. Tolerances are
established for the combined residues of
the fungicide 1-[[2-(2,4-dichlorophenyl)4-propyl-1,3-dioxolan-2-yl] methyl]-1H1,2,4-triazole and its metabolites
determined as 2,4-dichlorobenzoic acid
and expressed as parent compound in or
on the following commodities:
Commodity
Almond, hulls ..................
Banana ...........................
Barley, bran ....................
Barley, grain ...................
Barley, hay ......................
Barley, straw ...................
Beet, sugar, dried pulp ...
Beet, sugar, molasses ....
Beet, sugar, roots ...........
Beet, sugar, tops ............
Berry, group 13 ...............
Carrot, roots ....................
Cattle, fat ........................
Cattle, kidney ..................
Cattle, liver ......................
Cattle, meat ....................
Cattle, meat byproducts,
except liver and kidney
Corn, field, forage ...........
Corn, field, grain .............
Corn, field, stover ...........
Corn, pop, grain ..............
Corn, pop, stover ............
Corn, sweet, forage ........
Corn, sweet, kernel plus
cob with husks removed .........................
Corn, sweet, stover ........
Fruit, stone, group 12 .....
Goat, fat ..........................
Goat, kidney ...................
Goat, liver .......................
Goat, meat ......................
Goat, meat byproducts,
except liver and kidney
Grain, aspirated fractions
Grass, forage ..................
Grass, hay ......................
Grass, straw ...................
Hog, kidney .....................
Hog, liver ........................
Horse, fat ........................
Horse, kidney ..................
Horse, liver .....................
Horse, meat ....................
Horse, meat byproducts,
except liver and kidney
Leaf petioles, subgroup
4B ................................
Milk .................................
Mushroom .......................
Nut, tree, group 14 .........
Oat, forage ......................
Oat, grain ........................
Oat, hay ..........................
Oat, straw .......................
Onion, bulb .....................
Onion, green ...................
Peanut ............................
Peanut, hay ....................
Peppermint, tops ............
Pineapple ........................
E:\FR\FM\22SER1.SGM
22SER1
Parts per million
7.0
0.2
0.6
0.3
1.4
10
1.0
1.5
0.3
10
1.0
0.25
0.05
2.0
2.0
0.05
0.05
12
0.2
30
0.2
30
6.0
0.1
30
1.0
0.05
2.0
2.0
0.05
0.05
30
0.5
0.5
40
0.2
0.2
0.05
2.0
2.0
0.05
0.05
5.0
0.05
0.1
0.1
1.7
0.3
1.4
10
0.2
9.0
0.2
20
3.5
0.1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
Commodity
Parts per million
Pistachio .........................
Rice, bran .......................
Rice, grain ......................
Rice, hulls .......................
Rice, straw ......................
Rye, bran ........................
Rye, forage .....................
Rye, grain .......................
Rye, straw .......................
Sheep, fat .......................
Sheep, kidney .................
Sheep, liver .....................
Sheep, meat ...................
Sheep, meat byproducts,
except liver and kidney
Sorghum, grain, forage ...
Sorghum, grain, grain .....
Sorghum, grain, stover ...
Soybean, forage .............
Soybean, hay ..................
Soybean, seed ................
Spearmint, tops ..............
Strawberry ......................
Wheat, bran ....................
Wheat, forage .................
Wheat, grain ...................
Wheat, hay .....................
Wheat, straw ...................
0.1
15
7.0
20
18
0.6
1.7
0.3
10
0.05
2.0
2.0
0.05
40 CFR Part 180
[EPA–HQ–OPP–2006–0170; FRL–8092–2]
Buprofezin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
[FR Doc. 06–8064 Filed 9–21–06; 8:45 am]
SUMMARY: This regulation establishes a
tolerance for combined residues or
residues of buprofezin in or on almond
hulls; cotton, gin byproducts:
Cottonseed; and tomato. Nichino
America, Inc., Linden Park Suite 501,
4550 New Linden Hill Road,
Wilmington, DE 19908 requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of
1996 (FQPA).
DATES: This regulation is effective
September 22, 2006. Objections and
requests for hearings must be received
on or before November 21, 2006, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0170. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Kevin Sweeney, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5063; e-mail address:
sweeney.kevin@epa.gov.
BILLING CODE 6560–50–S
SUPPLEMENTARY INFORMATION:
0.05
12
3.5
15
11
30
2.0
3.5
1.3
0.6
1.7
0.3
1.4
10
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. A tolerance with regional
registration, as defined in §180.1(m), is
established for residues of 1-[[2-(2,4dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its
metabolites determined as 2,4dichlorobenzoic acid and expressed as
parent compound, in or on the
following commodities:
Commodity
Parts per million
Cranberry ........................
Rice, wild ........................
1.0
0.5
(d) Indirect or inadvertent residues.
Tolerances are established for the
combined residues of the fungicide 1[[2-(2,4-dichlorophenyl)-4-propyl-1,3dioxolan-2-yl] methyl]-1H-1,2,4-triazole
and its metabolites determined as 2,4dichlorobenzoic acid and expressed as
parent compound in or on the following
commodities when present therein as a
result of application of propiconazole to
growing crops in paragraphs (a) and (c)
of this section:
Commodity
rwilkins on PROD1PC63 with RULES_1
ENVIRONMENTAL PROTECTION
AGENCY
Parts per million
Alfalfa, forage .................
Alfalfa, hay ......................
VerDate Aug<31>2005
16:03 Sep 21, 2006
0.1
0.1
Jkt 208001
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
55307
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. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
E:\FR\FM\22SER1.SGM
22SER1
Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55300-55307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8064]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0347; FRL-8092-1]
Propiconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes or revises tolerances for combined
residues of propiconazole and its metabolites containing the
dichlorobenzoic acid (DCBA) moiety expressed as parent compound in or
on various commodities; and inadvertent residues in or on alfalfa,
forage and alfalfa, hay. Syngenta Crop Protection, Inc. and
Interregional Research Project No. 4 (IR-4), requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 2006,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0347. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9354; e-mail address: waller.mary@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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0347 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before November 21, 2006.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0347, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday,
[[Page 55301]]
excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket telephone number is (703)
305-5805.
II. Background and Statutory Findings
In the Federal Register of May 3, 2006 (71 FR 26084) (FRL-8060-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of pesticide petitions (PP) 2F6371
and 5F4498 by Syngenta Crop Protection, Inc., and PP 6E4788, 7E4860,
and 8E4931 by Interregional Research Project No. 4 (IR-4). The
petitions requested that 40 CFR 180.434 be amended by establishing a
tolerance for combined 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 leafy vegetables (Subgroup 4B) at
5.0 parts per million (ppm) (PP 6E4788); cranberry at 1.0 ppm (PP
7E4860); Mint at.3.0 ppm (PP 8E4931); and under PP 2F6371, almond,
hulls and onion, green at 8.0 ppm; berries (Group 13) and legume
vegetables (Group 6) at 1.0 ppm; foliage of legume vegetables (Group
7)/ sorghum/soybean, forage and sugar beet, tops at 10.0 ppm; carrot,
roots/pistachios/nuts, tree (Group 14) at 0.2 ppm; foliage of legume
vegetable (Group 7)/soybean, hay at 32.0 ppm; onion, dry bulb/corn,
grain/sugar beet, roots at 0.3 ppm; sorghum, grain/grain cereal group
(except corn, rice, and sorghum), bran at 2.5 ppm; sorghum, stover at
15.0 ppm; soybean, seed/grain, cereal group (except corn, rice, and
sorghum), hay/sugar beet, dried pulp at 2.0 ppm; strawberry at 1.5 ppm;
grain, cereal group (except corn, rice, and sorghum) (Group 15),
forage/sugar beet, molasses at 3.0 ppm; grain, cereal group (except
corn, rice, and sorghum), straw at 13.0 ppm; grain, cereal group
(except corn, rice, and sorghum)/corn, oil at 0.5 ppm; rice, bran and
hulls at 28.0 ppm; and aspirated grain fraction at 17.0 ppm. Further,
the petition requested existing tolerances be amended for corn, forage
at 4.0 ppm; corn, stover at 25.0 ppm; rice, grain at 7.0 ppm; and rice,
straw at 18.0 ppm. Additionally, PP 5F4498, requested inadvertent
residues for alfalfa, forage and hay at 0.1 ppm. That notice included a
summary of the petition prepared by Syngenta Crop Protection, Inc., the
registrant. There were no comments received in response to the notice
of filing.
Upon completing review of the current propiconazole database, the
Agency concluded that the appropriate tolerance levels for
propiconazole residues in or on pending crops and livestock commodities
should be established as follow: On grain, aspirated fractions at 30
ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at
1.4 ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat
at 0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts, except
liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm;
Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field,
forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at
0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm;
corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat
at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except
liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2
ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat
byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5
ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at
0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2
ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15
ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18
ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10
ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum,
grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat
at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except
liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay
at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet,
sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet,
sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree,
group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm;
wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm;
cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage
at 0.1 ppm and alfalfa, hay at 0.1 ppm. The Agency concluded that there
are insufficient data to establish tolerances legume vegetables (Group
6); foliage of legume vegetables (Group 7); cereal group (except corn,
rice, and sorghum) (Group 15). For additional information refer to
www.regulations.gov Docket No. EPA-HQ-OPP-2006-0347-0008.
EPA is also deleting several established tolerances in 40 CFR
180.434(a), (b), and (c) that are no longer needed as a result of this
action.
The revisions to 180.434(a) are as follows:
Delete celery at 5.0 ppm. Replaced with leafy petioles,
subgroup 4B at 5.0 ppm.
Delete pecans at 0.1 ppm. Replaced with nut, tree, group
14 at 0.1 ppm.
The revisions to 180.434(b) are as follows:
Delete the time-limited tolerance for blueberry at 1.0
ppm. Replaced with Berry group 13 at 1.0 ppm, under 40 CFR 180.434(a).
Delete the time-limited tolerance for cranberry; grain,
aspirated fractions; sorghum, grain, grain; sorghum, grain, stover;
soybean; soybean, forage; and soybean, hay. All are being replaced by
permanent tolerances.
Delete time-limited tolerance for dry bean; dry bean
forage; and dry bean hay since these tolerances have expired.
The revisions to 180.434(c) are as follows:
Delete mint, tops (leaves and stems) at 0.3 ppm. Replaced
with spearmint, tops at 3.5 ppm and peppermint, tops at 3.5 ppm under
40 CFR 180.434(a).
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....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this
[[Page 55302]]
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure, consistent with section 408(b)(2)
of FFDCA, for a tolerance for combined residues of propiconazole and
its metabolites containing the dichlorobenzoic acid (DCBA) moiety
expressed as parent compound on grain, aspirated fractions at 30 ppm;
almond, hulls at 7.0 ppm; barley, grain at 0.3 ppm; barley, hay at 1.4
ppm; barley, straw at 10 ppm; barley, bran at 0.6 ppm; cattle, fat at
0.05 ppm; cattle, meat at 0.05 ppm; cattle, meat byproducts, except
liver and kidney at 0.05 ppm; leafy petioles, subgroup 4B at 5.0 ppm;
Berry group 13 at 1.0 ppm; carrot, roots at 0.25 ppm; corn, field,
forage at 12 ppm; corn, sweet, forage at 6.0 ppm; corn, field, grain at
0.2 ppm; corn, pop, grain at 0.2 ppm; corn, field, stover at 30 ppm;
corn, pop, stover at 30 ppm; corn, sweet, stover at 30 ppm; goat, fat
at 0.05 ppm; goat, meat at 0.05 ppm; goat, meat byproducts, except
liver and kidney at 0.05 ppm; hog, kidney at 0.2 ppm; hog, liver at 0.2
ppm; horse, fat at 0.05 ppm; horse, meat at 0.05 ppm; horse, meat
byproducts, except liver and kidney at 0.05 ppm; spearmint, tops at 3.5
ppm; peppermint, tops at 3.5 ppm; oat, forage at 1.7 ppm; oat, grain at
0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10 ppm; onion, bulb at 0.2
ppm; onion, green at 9.0 ppm; pistachio at 0.1 ppm; rice, bran at 15
ppm; rice, grain at 7.0 ppm; rice, hulls at 20 ppm; rice, straw at 18
ppm; rye, grain at 0.3 ppm; rye, forage at 1.7 ppm; rye, straw at 10
ppm; rye, bran at 0.6 ppm; sorghum, grain, forage at 12 ppm; sorghum,
grain, grain at 3.5 ppm; sorghum, grain, stover at 15 ppm; sheep, fat
at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat byproducts, except
liver and kidney at 0.05 ppm; soybean, forage at 11 ppm; soybean, hay
at 30 ppm; soybean, seed at 2.0 ppm; strawberry at 1.3 ppm; beet,
sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3 ppm; beet,
sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm; nut, tree,
group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage at 1.7 ppm;
wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat, straw at 10 ppm;
cranberry at 1.0 ppm; and inadvertent residues in or on alfalfa, forage
at 0.1 ppm and alfalfa, hay at 0.1 ppm. EPA's assessment of exposures
and risks associated with establishing the tolerance 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. Specific information on the studies received and the nature
of the toxic 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
www.regulations.gov Docket No. EPA-HQ-OPP-2006-0347-0005; pages 35-42.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for propiconazole used for
human risk assessment is discussed at www.regulations.gov Docket No.
EPA-HQ-OPP-2006-0347-0004; pages 23-25.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.434) for the combined residues of propiconazole
and its metabolites containing the dichlorobenzoic acid (DCBA) moiety
expressed as parent compound, in or on a variety of raw agricultural
commodities. Tolerances are also established for residues of
propiconazole and its metabolites containing the dichlorobenzoic acid
(DCBA) moiety expressed as parent compound in or on milk as well as
fat, meat, kidney, liver and meat by products of cattle, goats, hogs,
horse, and sheep. Some of these existing tolerances are being revised
as a result of this action. Risk assessments were conducted by EPA to
assess 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.
In conducting the acute dietary exposure assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), which incorporates food consumption
data as reported by respondents in the USDA 1994-1996 and 1998
nationwide Continuing Surveys of Food Intake by Individuals (CSFII),
and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the acute exposure assessments:
Tolerance levels and one hundred percent of the crops were treated for
all proposed new uses, revised uses, and existing uses.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: Tolerance levels and 100% of the crops were
treated for all proposed new uses, revised uses, and existing uses.
iii. Cancer. Propiconazole has been classified as a group C
(possible human carcinogen). The Agency concluded that the chronic risk
assessment, making use of the chronic population adjusted dose (cPAD),
is protective of any potential carcinogenic risk.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for propiconazole in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of propiconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment
[[Page 55303]]
can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
A registrant drinking water monitoring study showed very few
detections among a total of 38 selected community water systems in 12
states. The Agency concluded that the sampling scheduling of this
monitoring study is not rigorous enough to be used for water
assessment. Since the monitoring studies did not provide good quality
data, this drinking water assessment is based on the model predicted
drinking water concentrations.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
propiconazole for acute exposures are estimated to be 55.8 parts per
billion (ppb) for surface water and 0.64 ppb for ground water. The EECs
for chronic exposures are estimated to be 21.6 ppb for surface water
and 0.64 ppb for ground water.
To estimate surface water for each specific use, the maximum
allowable label rate was input into PRZM/EXAMS. The output
concentrations were without percent cropped area (PCA) consideration.
The final estimated drinking water concentrations were then adjusted
with the proper PCA. Except the uses of soybean (0.41 ppb) and wheat
(0.56 ppb), other uses assume the default PCA of 0.87 ppb. Among these
modeling results, turf use gives the highest acute concentration of
55.78 ppb (Microgram/liter ([micro]g/L)). For the chronic exposure,
turf use has the highest concentration of 21.61 ppb ([micro]g/L).
The EECs in ground water were calculated using the Tier I SCI-GROW
model. SCI-GROW is neither scenario- nor crop-specific. The only input
requirements are application rate, number of applications,
Koc, and aerobic soil metabolism half-life. The higher
estimated concentrations are associated with the higher rate. Turf use
has the highest concentration of 0.64 [micro]g/L (ppb). Modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model (DEEM-FCID(\TM\)). For acute dietary risk
assessment, the peak water concentration value of 55.8 ppb was used to
access the contribution to drinking water. For chronic dietary risk
assessment, the annual average concentration of 21.6 ppb was used to
access 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 use on the following
residential non-dietary sites: Ground covers; turf and ornamentals in
lawns and golf courses; ornamentals trees (injection); shade trees
(outdoor spray); herbaceous plants; ornamental woody shrubs and vines
and antimicrobial uses in paint and wood protection treatment. The risk
assessment was conducted using the following residential exposure
assumptions:
Homeowners can be exposed to propiconazole through dermal and
inhalation routes while applying home use products. All risk
calculations were conducted using the maximum turf application rate
(1.8 lb ai/acre). The anticipated use patterns and current labeling
indicate three major residential exposure scenarios based on the types
of equipment and techniques that can potentially be used to make
propiconazole applications. The quantitative exposure/risk assessment
developed for residential handlers is based on these scenarios:
Mixer/Loader/applying liquids and wettable powder in water
soluble packets via low pressure handwand.
Mixer/Loader/applying liquids and wettable powder in water
soluble packets via hose-end sprayer.
Applying treated paint using airless sprayer and hose-end
spray.
Residential handler exposure scenarios are considered to be short-
term only due to the infrequent uses associated with homeowner
products.
The existing residential use patterns result in post application
dermal exposures to adults, and dermal and oral exposures to infants
and children. These exposure scenarios are considered short term only,
due to the fact that:
i. Post-application exposures were calculated using propiconazole
as the parent compound;
ii. Compound specific turf transferable residue (TTR) data indicate
that at the Indiana, California, and Pennsylvania test sites, average
total propiconazole residues declined to below the minimum quantifiable
limit (MQL) by 14, 10 and 8 days after treatment, respectively. These
dissipation rates, combined with label specific use rates and frequency
of use specifications, reinforce the hand to mouth short-term exposure
scenario;
iii. For short term exposure to children 1-2 years old, the driving
factors for this risk assessment are hand to mouth, object to mouth,
and dermal exposure. Soil ingestion is insignificant (margin of
exposure (MOE) >300,000) compared to these factors, indicating that the
post application scenario should be short term only. Although both
residential and antimicrobial uses result in incidental oral and dermal
exposure to children, the highest incidental oral and dermal exposure
scenarios are from residential use on turf, which were used in the
short term aggregate risk assessment.
In addition to using the EPA's Standard Operational Procedure (SOP)
for residential assessment, the study specific turf transferable
residue (TTR) was used to estimate exposures. The EPA combined
exposures resulting from separate post-application exposure scenarios
when it is likely they can occur simultaneously based on the use-
pattern and the behavior associated with the exposed population. The
assumptions used for each of the scenarios separately are considered to
account for potential high levels of exposure (i.e., time spent
outdoors, dislodgeable residues) therefore, combining all these
activities together is considered a very high end estimate of exposure.
Propiconazole is classified as a non-volatile chemical; therefore a
residential inhalation post-application assessment was not assessed.
The only residential use scenario that will result in potential
intermediate term exposure to propiconazole is post application
exposure to children from wood treatment (antimicrobial use) from
incidental oral and dermal contact activities.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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 this 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
[[Page 55304]]
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 website 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 conjugates
(triazole alanine and triazole acetic 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, triazole alanine, and
triazole acetic acid resulting from the use of all current and pending
uses of any triazole-derived fungicide. The risk assessment is 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 www.regulations.gov,
Docket ID number EPA-HQ-OPP-2005-0497-0013.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is low concern for
pre- and/or postnatal toxicity resulting from exposure to
propiconazole. In the developmental toxicity study in rats, the EPA
considered the fetal effects observed in this study at a dose lower
than that evoking maternal toxicity to be quantitative evidence of
increased susceptibility of fetuses to in utero exposure to
propiconazole. In the developmental toxicity study in rabbits, the
Agency determined that 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 pre- and/or postnatal exposure to propiconazole was observed
in the study. Since there is quantitative evidence of increased
susceptibility of the young following exposure to propiconazole in the
developmental rat study, the Agency performed a Degree of Concern
Analysis to:
i. Determine the LOC for the effects observed when considered in
the context of all available toxicity data; and
ii. Identify any residual uncertainties after establishing toxicity
endpoints and traditional uncertainty factors to be used in the risk
assessment of this chemical. If residual uncertainties are identified,
then EPA examines whether these residual uncertainties can be addressed
by a special FQPA safety factor and, if so, the size of the factor
needed. In the developmental rat study, quantitative susceptibility was
evidenced as increased incidence of rudimentary ribs, unossified
sternebrae, as well as increased incidence of shortened and absent
renal papillae and increased cleft palate at (90 mg/kg/day) a dose
lower than that evoking maternal toxicity (severe clinical toxicity at
300 mg/kg/day). Considering the overall toxicity profile and the doses
and endpoints selected for risk assessment for propiconazole, the EPA
characterized the degree of concern for the effects observed in this
study as low, noting that there is a clear no observed adverse effect
level (NOAEL) and well-characterized dose response for the
developmental effects observed. No residual uncertainties were
identified. The NOAEL for developmental effects in this study (30 mg/
kg/day) is used as the basis for the acute Reference dose (aRfD) for
the female 13-50 population subgroup as well as for short-term
incidental oral, dermal and inhalation endpoints. For all other
toxicity endpoints established for propiconazole, a NOAEL lower than
this developmental NOAEL is used.
3. Conclusion. There is a complete toxicity data base for
propiconazole and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. There is low
concern for pre- and/or postnatal toxicity resulting from exposure to
propiconazole. In the developmental toxicity study in rats the fetal
effects observed were seen at a dose lower than that evoking maternal
toxicity. These effects were considered to be quantitative evidence of
increased susceptibility of fetuses to in utero exposure to
propiconazole. Therefore, as discussed above a Degree of Concern
Analysis was conducted and the EPA concluded that the degree of concern
for the effects observed in this study was low and no residual
uncertainties were identified. EPA determined that the 10X SF to
protect infants and children should be removed.
E. Aggregate Risks and Determination of Safety
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 6% of the acute Population Adjusted Dose
(aPAD) for the U.S. population, 5% of the aPAD for females 13 years and
older, 14% of the aPAD for all infants (<1 year old), the subpopulation
at greatest exposure, and 13% of the aPAD for children 1-2 years old.
Therefore, EPA does not expect the aggregate exposure to exceed 100% of
the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
propiconazole from food and water will utilize 6% of the chronic
Population Adjusted Dose (cPAD) for the U.S. population, 14% of the
cPAD for all infants (<1 year old), and 14% of the cPAD for children 1-
2 years old, the subpopulation at greatest exposure. Based the use
pattern, chronic residential exposure to residues of propiconazole is
not expected.
[[Page 55305]]
Therefore, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Propiconazole is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for propiconazole.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential
exposures aggregated result in aggregate MOEs for children 1-2 years
old of 1,100 for hand to mouth activity on turf; 4,500 for object to
mouth activity on turf; 330,000 for soil ingestion; 210 for high
contact turf activities; and 410 from the antimicrobial use of
propiconazole in treated wood. The food, water and residential
exposures aggregated for children 1-2 years old following post-
application of propiconazole result in an aggregate MOE of 160 for high
contact activities. The corresponding aggregate MOE for adults
following post-application exposure is 330. These aggregate MOEs do not
exceed the Agency's LOC for aggregate exposure to food, water and
residential uses. Therefore, EPA does not expect short-term aggregate
exposure to exceed the Agency's LOC.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Propiconazole is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for propiconazole.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food, water and
residential exposures aggregated result in an aggregate MOE of 120 for
combined exposures from incidental oral and dermal contact activities
for children 1-2 years old. These aggregate MOEs do not exceed the
Agency's LOC for aggregate exposure to food, water and residential
uses. Therefore, EPA does not expect intermediate-term aggregate
exposure to exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Unit III.E.2.
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, and to infants and children from aggregate
exposure to propiconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (a gas chromatography (GC) method
using electron capture detection (Method AG-454) 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;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
The Codex Alimentarius Commission has established several maximum
residue limits (MRLs) for propiconazole in/on various raw agricultural
commodities. The Codex MRLs are expressed in terms of propiconazole per
se. In addition, both Canada and Mexico have established MRLs/
tolerances on several commodities which also have U.S. tolerances. The
U.S. tolerance expression includes all metabolites determined as 2,4-
dichloro-benzoic acid. In conjunction with the reregistration process
EPA intends to revise the expression to propiconazole per se. To the
extent possible, for the present petitions, U.S. tolerances have been
numerically harmonized with Codex, Canadian, and Mexican MRLs; however,
differences in use patterns and the supporting residue data have
precluded reducing many tolerances. A summary of Codex MRLs, Canadian
MRLs, and Mexican tolerances and the corresponding U.S. tolerances for
propiconazole is discussed at www.regulations.gov Docket No. EPA-HQ-
OPP-2006-0347-0004; pages 53-54.
V. Conclusion
Therefore, tolerances are established for combined residues of
propiconazole and its metabolites containing the dichlorobenzoic acid
(DCBA) moiety expressed as parent compound in or on grain, aspirated
fractions at 30 ppm; almond, hulls at 7.0 ppm; barley, grain at 0.3
ppm; barley, hay at 1.4 ppm; barley, straw at 10 ppm; barley, bran at
0.6 ppm; cattle, fat at 0.05 ppm; cattle, meat at 0.05 ppm; cattle,
meat byproducts, except liver and kidney at 0.05 ppm; leafy petioles,
subgroup 4B at 5.0 ppm; Berry group 13 at 1.0 ppm; carrot, roots at
0.25 ppm; corn, field, forage at 12 ppm; corn, sweet, forage at 6.0
ppm; corn, field, grain at 0.2 ppm; corn, pop, grain at 0.2 ppm; corn,
field, stover at 30 ppm; corn, pop, stover at 30 ppm; corn, sweet,
stover at 30 ppm; goat, fat at 0.05 ppm; goat, meat at 0.05 ppm; goat,
meat byproducts, except liver and kidney at 0.05 ppm; hog, kidney at
0.2 ppm; hog, liver at 0.2 ppm; horse, fat at 0.05 ppm; horse, meat at
0.05 ppm; horse, meat byproducts, except liver and kidney at 0.05 ppm;
spearmint, tops at 3.5 ppm; peppermint, tops at 3.5 ppm; oat, forage at
1.7 ppm; oat, grain at 0.3 ppm; oat, hay at 1.4 ppm; oat, straw at 10
ppm; onion, bulb at 0.2 ppm; onion, green at 9.0 ppm; pistachio at 0.1
ppm; rice, bran at 15 ppm; rice, grain at 7.0 ppm; rice, hulls at 20
ppm; rice, straw at 18 ppm; rye, grain at 0.3 ppm; rye, forage at 1.7
ppm; rye, straw at 10 ppm; rye, bran at 0.6 ppm; sorghum, grain, forage
at 12 ppm; sorghum, grain, grain at 3.5 ppm; sorghum, grain, stover at
15 ppm; sheep, fat at 0.05 ppm; sheep, meat at 0.05 ppm; sheep, meat
byproducts, except liver and kidney at 0.05 ppm; soybean, forage at 11
ppm; soybean, hay at 30 ppm; soybean, seed at 2.0 ppm; strawberry at
1.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, sugar, roots at 0.3
ppm; beet, sugar, tops at 10 ppm; beet, sugar, molasses at 1.5 ppm;
nut, tree, group 14 at 0.1 ppm; wheat, bran at 0.6 ppm; wheat, forage
at 1.7 ppm; wheat, grain at 0.3 ppm; wheat, hay at 1.4 ppm; wheat,
straw at 10 ppm; cranberry at 1.0 ppm; and inadvertent residues in or
on alfalfa, forage at 0.1 ppm and alfalfa, hay at 0.1 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose
any
[[Page 55306]]
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 this final rule in the Federal Register. This final
rule 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: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.434 is revised to read as follows:
Sec. 180.434 Propiconazole; tolerances for residue.
(a) General. Tolerances are established for the combined residues
of the fungicide 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 the
following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls....................................... 7.0
Banana............................................... 0.2
Barley, bran......................................... 0.6
Barley, grain........................................ 0.3
Barley, hay.......................................... 1.4
Barley, straw........................................ 10
Beet, sugar, dried pulp.............................. 1.0
Beet, sugar, molasses................................ 1.5
Beet, sugar, roots................................... 0.3
Beet, sugar, tops.................................... 10
Berry, group 13...................................... 1.0
Carrot, roots........................................ 0.25
Cattle, fat.......................................... 0.05
Cattle, kidney....................................... 2.0
Cattle, liver........................................ 2.0
Cattle, meat......................................... 0.05
Cattle, meat byproducts, except liver and kidney..... 0.05
Corn, field, forage.................................. 12
Corn, field, grain................................... 0.2
Corn, field, stover.................................. 30
Corn, pop, grain..................................... 0.2
Corn, pop, stover.................................... 30
Corn, sweet, forage.................................. 6.0
Corn, sweet, kernel plus cob with husks removed...... 0.1
Corn, sweet, stover.................................. 30
Fruit, stone, group 12............................... 1.0
Goat, fat............................................ 0.05
Goat, kidney......................................... 2.0
Goat, liver.......................................... 2.0
Goat, meat........................................... 0.05
Goat, meat byproducts, except liver and kidney....... 0.05
Grain, aspirated fractions........................... 30
Grass, forage........................................ 0.5
Grass, hay........................................... 0.5
Grass, straw......................................... 40
Hog, kidney.......................................... 0.2
Hog, liver........................................... 0.2
Horse, fat........................................... 0.05
Horse, kidney........................................ 2.0
Horse, liver......................................... 2.0
Horse, meat.......................................... 0.05
Horse, meat byproducts, except liver and kidney...... 0.05
Leaf petioles, subgroup 4B........................... 5.0
Milk................................................. 0.05
Mushroom............................................. 0.1
Nut, tree, group 14.................................. 0.1
Oat, forage.......................................... 1.7
Oat, grain........................................... 0.3
Oat, hay............................................. 1.4
Oat, straw........................................... 10
Onion, bulb.......................................... 0.2
Onion, green......................................... 9.0
Peanut............................................... 0.2
Peanut, hay.......................................... 20
Peppermint, tops..................................... 3.5
Pineapple............................................ 0.1
[[Page 55307]]
Pistachio............................................ 0.1
Rice, bran........................................... 15
Rice, grain.......................................... 7.0
Rice, hulls.......................................... 20
Rice, straw.......................................... 18
Rye, bran............................................ 0.6
Rye, forage.......................................... 1.7
Rye, grain........................................... 0.3
Rye, straw........................................... 10
Sheep, fat........................................... 0.05
Sheep, kidney........................................ 2.0
Sheep, liver......................................... 2.0
Sheep, meat.......................................... 0.05
Sheep, meat byproducts, except liver and kidney...... 0.05
Sorghum, grain, forage............................... 12
Sorghum, grain, grain................................ 3.5
Sorghum, grain, stover............................... 15
Soybean, forage...................................... 11
Soybean, hay......................................... 30
Soybean, seed........................................ 2.0
Spearmint, tops...................................... 3.5
Strawberry........................................... 1.3
Wheat, bran.......................................... 0.6
Wheat, forage........................................ 1.7
Wheat, grain......................................... 0.3
Wheat, hay........................................... 1.4
Wheat, straw......................................... 10
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. A tolerance with
regional registration, as defined in Sec. 180.1(m), is established for
residues of 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 the
following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cranberry........................................... 1.0
Rice, wild........................................... 0.5
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. Tolerances are established
for the combined residues of the fungicide 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 the following commodities when present therein
as a result of application of propiconazole to growing crops in
paragraphs (a) and (c) of this section:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage..................................... 0.1
Alfalfa, hay......................................... 0.1
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[FR Doc. 06-8064 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S