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Carfentrazone-ethyl (FMC and IR-4). September 29, 2004. Pesticide Tolerance. Final Rule. Federal Register.
Docket identification (ID) number OPP-2004-0256
http://www.epa.gov/fedrgstr/EPA-PEST/2004/September/Day-29/p21586.htm[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Rules and Regulations]
[Page 58071-58079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se04-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0256; FRL-7678-9]
Carfentrazone-ethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of carfentrazone-ethyl and its metabolite in or on certain raw
agricultural commodities. FMC Corporation and Interregional Research
Project Number 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 29, 2004. Objections and
requests for hearings must be received on or before November 29, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0256. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This 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: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address:
miller.joanne@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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.II. Background and Statutory Findings
In the Federal Register of March 31, 2004 (69 FR 16921) (FRL-7348-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP
2F6468 and 3E6746) by FMC Corporation, 1735 Market Street,
Philadelphia, PA 19103 and IR-4, Technology Center, of New Jersey, 681
U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That
notice included a summary of the petition prepared by FMC Corporation,
the registrant. Comments on the petition were filed by B. Sachau, 15
Elm St., Florham Park, NJ 07932. A response to these comments is
provided in Unit V.
In the Federal Register of July 28, 2004 (69 FR 45042) (FRL-7365-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP
2F6468, 3E6746, 4E6814, and 3F6584) by FMC Corporation, 1735 Market
Street, Philadelphia, PA 19103 and IR-4, Technology Center, of New
Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-
3390. That notice included a summary of the petition prepared by FMC
Corporation, the registrant. Comments on the petition were filed by B.
Sachau, 15 Elm St., Florham Park, NJ 07932, and Bonita Poulin, R. R.
#3, Brockville, Ont. A response to these comments is provided in Section V.
The petitions requested that 40 CFR 180.515(a) be amended by
establishing proposed tolerances for combined residues of the herbicide
carfentrazone-ethyl (ethyl-alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-fluorobenzenepropanoate
and the metabolite carfentrazone-ethyl chloropropionic acid (alpha,2-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-
triazol-1-yl]-4-fluorobenzenepropanoic acid), in or on: Acerola at 0.1
parts per million (ppm); almond hulls at 0.20 ppm and grass, forage,
fodder and hay, group 17 at 12 ppm; hops at 0.05 ppm; avocado at 0.1
ppm; atemoya at 0.1 ppm; banana at 0.1 ppm; berry group 13 at 0.1 ppm;
birida at 0.1 ppm; borage, seed at 0.1 ppm; cacao at 0.1 ppm; cactus at
0.1 ppm; canistel at 0.1 ppm; cherimoya at 0.1 ppm; citrus, crop group
10 at 0.1 ppm; citrus cultivars and/or hybrids of grapefruit and
pummelo, including uniq fruit at 0.1 ppm; coconut at 0.1 ppm; coffee at
0.1 ppm; crambe, seed at 0.1 ppm; custard apple at 0.1 ppm; date at
[[Page 58072]]
0.1 ppm; feijoa at 0.1 ppm; fig at 0.1 ppm; fish at 0.2 ppm; flax, seed
at 0.1 ppm; grape at 0.1 ppm; grapefruit at 0.1 ppm; guava at 0.1 ppm;
guayule at 0.1 ppm; herbs and spice group 19 at 0.1 ppm; horseradish at
0.1 ppm; ilama at 0.1 ppm; Indian mulberry at 0.1 ppm; jabotica at 0.1
ppm; Juneberry at 0.1 ppm; kava at 0.1 ppm; kiwi fruit at 0.1 ppm;
lingonberry at 0.1 ppm; lychee at 0.1 ppm; longan at 0.1 ppm; mango at
0.1 ppm; mustard seed, Indian at 0.1 ppm; mustard seed, field at 0.1
ppm; mustard seed, black at 0.1 ppm; okra at 0.1 ppm; olive at 0.1 ppm;
palm heart, leaves at 0.1 ppm; passionfruit at 0.1 ppm; papaya at 0.1
ppm; pawpaw at 0.1 ppm; peanut at 0.1 ppm; persimmon at 0.1 ppm;
pistachio at 0.1 ppm; pome fruit, crop group 11 at 0.1 ppm; pomegranate
at 0.1 ppm; pulasan at 0.1 ppm; pummelo at 0.1 ppm; rambutan at 0.1
ppm; rapeseed, Indian at 0.1 ppm; rapeseed, seed at 0.1 ppm; safflower,
seed at 0.1 ppm; salal at 0.1 ppm; sapodilla at 0.1 ppm; sapote, black
at 0.1 ppm; sapote, mamey at 0.1 ppm; shellfish at 0.2 ppm; sorghum,
sweet, stalks at 0.1 ppm; sorghum, sweet, syrup at 0.1 ppm; soursop at
0.1 ppm; Spanish lime at 0.1 ppm; star apple at 0.1 ppm; starfruit at
0.1 ppm; stone fruit, crop group 12 at 0.1 ppm; strawberry at 0.1 ppm;
strawberrypear at 0.1 ppm; stevia at 0.1 ppm; sugar apple at 0.1 ppm;
sugarcane at 0.1 ppm; sunflower, seed at 0.1 ppm; ti, leaves at 0.1
ppm; tea at 0.1 ppm; tree nut, crop group 14 at 0.1 ppm; tuberous and
corm vegetables, crop subgroup 1C at 0.1 ppm; vanilla at 0.1 ppm;
vegetable, brassica, leafy, group 5 at 0.1 ppm; vegetable, bulb, group
3 at 0.1 ppm; vegetable, cucurbit group 9 at 0.1 ppm; vegetable,
foliage of legume, group 7 at 0.1 ppm; vegetables, fruiting, group,
crop group 8 at 0.1 ppm; vegetable, leaves of root and tuber, group 2
at 0.1 ppm; vegetable, leafy, except brassica, group 4 at 0.1 ppm;
vegetable, legume, group 6 at 0.1 ppm; vegetable, root and tuber, group
1 at 0.1 ppm; wasabi, roots at 0.1 ppm; and wax jambu at 0.1 ppm.
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 FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
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 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
carfentrazone-ethyl and its metabolite, carfentrazone-ethyl
chloropropionic acid, on Vegetable, root and tuber, group 01 at 0.10
ppm; vegetable, leaves of root and tuber, group 2 at 0.10 ppm;
vegetable, bulb, group 3 at 0.10 ppm; vegetable, leafy, except
brassica, group 4 at 0.10 ppm; vegetable, brassica, leafy, group 5 at
0.10 ppm; vegetable, legume, group 6 at 0.10 ppm; vegetable, foliage of
legume (except soybean), group 7 at 0.10 ppm; vegetable, fruiting,
group 8 at 0.10 ppm; vegetable, cucurbit, group 9 at 0.10 ppm; fruit,
citrus, group 10 at 0.10 ppm; fruit, pome, group 14 at 0.10 ppm; fruit,
stone, group 12 at 0.10 ppm; berry, group 13 at 0.10 ppm; nut, tree,
group 14 at 0.10 ppm; herbs and spices, group 19 at 2.0 ppm; almond,
hull at 0.20 ppm; grape at 0.10 ppm; grass, forage at 5.0 ppm; grass,
hay at 8.0 ppm; canola at 0.10 ppm; hop, dried cones at 0.10 ppm;
peanut at 0.10 ppm; peanut, hay at 0.10 ppm; strawberry at 0.10 ppm;
sugarcane at 0.10 ppm; sunflower, seed at 0.10 ppm; okra at 0.10 ppm;
stevia at 0.10 ppm; pistachio at 0.10 ppm; coconut at 0.10 ppm;
strawberrypear at 0.10 ppm; date at 0.10 ppm; fig at 0.10 ppm; papaya
at 0.10 ppm; avocado at 0.10 ppm; sapote, black at 0.10 ppm; canistel
at 0.10 ppm; sapote, mamey at 0.10 ppm; mango at 0.10 ppm; sapodilla at
0.10 ppm; star apple at 0.10 ppm; pummelo at 0.10 ppm; guava at 0.10
ppm; feijoa at 0.10 ppm; jaboticaba at 0.10 ppm; wax jambu at 0.10 ppm;
starfruit at 0.10 ppm; passionfruit at 0.10 ppm; acerola at 0.10 ppm;
lychee at 0.10 ppm; longan at 0.10 ppm; Spanish lime at 0.10 ppm;
rambutan at 0.10 ppm; pulasan at 0.10 ppm; sugar apple at 0.10 ppm;
atemoya at 0.10 ppm; custard apple at 0.10 ppm; cherimoya at 0.10 ppm;
ilama at 0.10 ppm; soursop at 0.10 ppm; biriba at 0.10 ppm; lingonberry
at 0.10 ppm; Juneberry at 0.10 ppm, salal at 0.10 ppm; kiwifruit at
0.10 ppm; pomegranate at 0.10 at ppm; persimmon at 0.10 ppm; pawpaw at
0.10 ppm; palm heart at 0.10 ppm; palm heart, leaves at 0.10 ppm; kava,
kava at 0.10 ppm; ti, leaves at 0.10 ppm; ti, roots at 0.10 ppm;
wasabit, roots at 0.10 ppm; cactus at 0.10 ppm; sorghum, sweet at 0.10
ppm; rapeseed, seed at 0.10 ppm; rapeseed, forage at 0.10 ppm; mustard,
seed at 0.10 ppm; flax, seed at 0.10 ppm; safflower, seed at 0.10 ppm;
crambe, seed at 0.10 ppm; borage at 0.10 ppm; olive at 0.10 ppm; banana
at 0.10 ppm; cacao at 0.10 ppm; tea at 0.10 ppm; mulberry, Indian at
0.10 ppm; vanilla at 0.10 ppm; coffee at 0.10 ppm; horseradish at 0.10
ppm; fish at 0.30 ppm; shellfish at 0.30 ppm; meat, byproducts (cattle,
goat, horse, and sheep) at 0.10 ppm; meat (cattle, goat, horse, and
sheep) at 0.10 ppm; fat (cattle, goat, horse, and sheep) at 0.10 ppm
and milk at 0.05 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. The nature of the toxic effects caused by carfentrazone-ethyl
are discussed in the Unit III.A. of the final rule on carfentrazone-
ethyl published in the Federal Register of August 9, 2000 (65 FR 48620)
(FRL-6597-7).B. Toxicological Endpoints
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
[[Page 58073]]
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. An UF
of 100 is routinely used, 10X to account for interspecies differences
and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-5), one in a million (1 X 10-6), or one in ten
million (1 X 10-7). Under certain specific circumstances,
MOE calculations will be used for the carcinogenic risk assessment. In
this non-linear approach, a ``point of departure'' is identified below
which carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure (MOE
cancer = point of departure/exposures) is calculated.
A summary of the toxicological endpoints for carfentrazone-ethyl
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of August 9, 2000 (65 FR 48620).C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.515(a) for the combined residues of
carfentrazone-ethyl and its metabolite, in or on a variety of raw
agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures from carfentrazone-ethyl in food as follows:
i. Acute exposure. Acute dietary 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 risk 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: For
the acute analyses, conservative estimates of expected residues were
assumed for all food commodities with current or proposed
carfentrazone-ethyl tolerances, and it was assumed that all of the
crops included in the analysis were treated. Percent Crop Treated (PCT)
and/or anticipated residues were not used in the acute risk assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
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: For the chronic analyses, conservative estimates
of expected residues were assumed for all food commodities with current
or proposed carfentrazone-ethyl tolerances, and it was assumed that all
of the crops included in the analysis were treated. PCT and/or
anticipated residues were not used in the chronic risk assessment.
iii. Cancer. Carfentrazone-ethyl is classified as ``not likely'' a
human carcinogen.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for carfentrazone-ethyl 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 carfentrazone-ethyl.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentrations in Groundwater (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water EPA will use FIRST
(a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
driinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the risk
[[Page 58074]]
assessment process, the Agency does not use estimated environmental
concentrations (EECs), which are the model estimates of a pesticide's
concentration in water. EECs derived from these models are used to
quantify drinking water exposure and risk as a %RfD or %PAD. Instead
drinking water levels of comparison (DWLOCs) are calculated and used as
a point of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to carfentrazone-ethyl they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW models, the EECs of carfentrazone-
ethyl for acute exposures are estimated to be 34.3 parts per billion
(ppb) for surface water and 13.4 ppb for ground water. The EECs for
chronic exposures are estimated to be 19.0 ppb for surface water and
13.4 ppb for ground 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).
Carfentrazone-ethyl is currently registered for use on the
following residential non-dietary sites: Ornamental lawns and turf
(application by commercial operators only. There is a proposed aquatic
use under review. The risk assessment was conducted using the following
residential exposure assumptions: Exposures to toddlers in the
residential lawn setting would be higher than that encountered by
toddlers in an institutional setting, such as in schools and parks. It
was anticipated that herbicide application to homeowner lawns is a
seasonal event, thus, only short-term post-application residential
exposures were conducted. A swimmer exposure assessment was conducted
based on the proposed aquatic application. The swimmer assessment
estimates exposures from oral (ingestion) and inhalation routes. No
systemic toxicity was seen at the limit-dose (1,000 milligrams/
kilogram/day (mg/kg/day)) in a 21-day dermal toxicity study in rats,
therefore, these risk assessments are not required. Based on the use
pattern, long-term exposure is not anticipated.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to carfentrazone-ethyl and
any other substances and carfentrazone-ethyl does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that
carfentrazone-ethyl has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site at
http://www.epa.gov/pesticides/cumulative/.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 data base 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 no evidence of
increased susceptibility of rat or rabbit fetuses following in utero
exposure in the developmental studies with carfentrazone-ethyl. There
is no evidence of increased susceptibility of rats in the reproduction
study with carfentrazone-ethyl. EPA concluded there are no residual
uncertainties for prenatal and/or postnatal exposure.
3. Conclusion. EPA concluded that, based on the absence of residual
uncertainties for prenatal and/or postnatal exposure and complete
toxicology, environmental fate, residue chemistry data bases, and the
conservative assumptions used when generating the dietary and
residential exposure estimates, there are reliable data showing that it
is safe for infants and children to remove the additional 10X safety
factor.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female and
youth 13-19, and 1L/10 kg (child). Default body weights and drinking
water consumption values vary on an individual basis. This variation
will be taken into account in more refined screening-level and
quantitative drinking water exposure assessments. Different populations
will have different DWLOCs. Generally, a DWLOC is calculated for each
type of risk assessment used: Acute, short-term, intermediate-term,
chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a
[[Page 58075]]
pesticide's uses, levels of comparison in drinking water may vary as
those uses change. If new uses are added in the future, OPP will
reassess the potential impacts of residues of the pesticide in drinking
water as a part of the aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
carfentrazone-ethyl will occupy less than 1% of the aPAD for the U.S.
population and all population subgroups.
In addition, there is potential for acute dietary exposure to
carfentrazone-ethyl in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
Table 1 of this unit.
Table 1.--Aggregate Risk Assessment for Acute Exposure to Carfentrazone-ethyl Population Subgroup aPAD %aPAD (Food)
Surface Water EDWC\1\ ppbGround Water EDWC\1\ ppb DWLOC\2\ ppb U.S. population - all seasons 5 < 1 34.3 13.4 1.7e + 05 All Infants (< 1 year old) 5 < 1 34.3 13.4 5.0e + 04 Children (1-2 years old) 5 < 1 34.3 13.4 5.0e + 04 Children (3-5 years old) 5 < 1 34.3 13.4 5.0e + 04 Children (6-12 years old) 5 < 1 34.3 13.4 5.0e + 04 Youth (13-19 years old) 5 < 1 34.3 13.4 1.5e + 05 Adults (20-49 years old) 5 < 1 34.3 13.4 1.7e + 05 Adults (50+ years old) 5 < 1 34.3 13.4 1.7e + 05 Females (13-19 years old) 5 < 1 34.3 13.4 1.5e + 05 \1\ EDWCs resulting from maximum registered and proposed application rate (0.4 lbs ai/acre/season - caneberry)
\2\ DWLOC = ((aPAD -food exposure) x (body weigth) x (1,000 [mu]g/mg)) / (water consumption)2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
carfentrazone-ethyl from food will utilize < =75% of the of the cPAD
with children 1-2 years old the population subgroup with the highest
exposures. Based the use pattern, chronic residential exposure to
residues of carfentrazone-ethyl is not expected. In addition, there is
potential for chronic dietary exposure to carfentrazone-ethyl in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Carfentrazone-ethyl Population Subgroup cPAD mg/kg/ day % cPAD (Food)
Surface Water EDWC\1\ ppbGround Water EDWC\1\ ppb DWLOC\2\ ppb U.S. population - all seasons 0.03 24 19.0 13.4 8.1e + 02 All Infants (< 1 year old) 0.03 43 19.0 13.4 1.8e + 02 Children (1-2 years old) 0.03 75 19.0 13.4 8.6e + 01 Children (3-5 years old) 0.03 58 19.0 13.4 1.3e + 02 Children (6-12 years old) 0.03 35 19.0 13.4 2.1e + 02 Youth (13-19 years old) 0.03 21 19.0 13.4 7.3e + 02 Adults (20-49 years old) 0.03 18 19.0 13.4 8.5e + 02 Adults (50+ years old) 0.03 18 19.0 13.4 8.5e + 02 Females (13-19 years old) 0.03 18 19.0 13.4 7.1e + 02 \1\ EDWCs resulting from registered and proposed application rate (0.4 lbs ai/acre/season - caneberry); 56-day
surface water average / 3
\2\ DWLOC = ((cPAD -food exposure) x (body weigth) x (1,000 [mu]g/mg)) / (water consumption)
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).
Carfentrazone-ethyl is currently registered for use that could
result in short-term residential exposure and the
[[Page 58076]]
Agency has determined that it is appropriate to aggregate chronic food
and water and short-term exposures for carfentrazone-ethyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
(including potential aquatic exposure) aggregated result in aggregate
MOEs of 72,875 for the general population and 22,339 for children 1-2
years old. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of carfentrazone-ethyl in ground and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect short-term aggregate
exposure to exceed the Agency's level of concern, as shown in Table 3
of this unit:
Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Carfentrazone-ethyl Population Subgroup Agg. MOE (food and res.)\1\ Aggregate
Level of Concern (LOC)Ground Water EDWC (ppb) Surface Water EDWC (ppb) DWLOC\2\ (ppb) General U.S. population 72875 100 19.0 13.4 1.7e + 05 All Infants (< 1 year old) 37843 100 19.0 13.4 5.0e + 04 Children (1-2 years old) 22339 100 19.0 13.4 5.0e + 04 Children (3-5 years old) 29228 100 19.0 13.4 5.0e + 04 Children (6-12 years old) 51965 100 19.0 13.4 5.0e + 04 Youth (13-19 years old) 85253 100 19.0 13.4 1.5e + 05 Adults (20-49 years old) 87396 100 19.0 13.4 1.7e + 05 Adults (50+ years old) 87457 100 19.0 13.4 1.7e + 05 Females (13-19 years old) 78541 100 19.0 13.4 1.5e + 05 \1\ Aggregate MOE = (NOAEL / (Avg Food Exposure + Residential Exposure))
\2\ DWLOC = ((maximum water exposure) x (body weight) x (1,000 [mu]g/mg)) / (water consumption)
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to carfentrazone-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromotography) 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
There is neither a Codex proposal, nor Canadian or Mexican maximum
residue limits, for residues of carfentrazone-ethyl and F8426-Cl-PAC
in/on the proposed crops, livestock, fish, or shellfish. Therefore,
harmonization is not an issue.
C. Conditions
Residue chemistry: Successful Agency Validation of Proposed
Livestock/Fish/Shellfish Enforcement Method.
V. Comments
Three comments were received in response to the notices of filing.
Two comments from B. Sachau objected to the proposed tolerances because
of the amounts of pesticides already consumed and carried by the
American population. She further indicated that testing conducted on
animals have absolutely no validity and are cruel to the test animals.
Bonita Poulin commented that she doesn't approve of more chemical
contamination of our food when we should be decreasing the residual
poisons building up within us, which are already causing health
problems. She also indicated that there are safe alternatives available.
Ms. Sachau's and Ms. Poulin's comments contained no scientific data
or evidence to rebut the Agency's conclusion that there is a reasonable
certainty that no harm will result from aggregate exposure to
carfentrazone ethyl, including all anticipated dietary exposures and
all other exposures for which there is reliable information.
VI. Conclusion
Therefore, the tolerance is established for combined residues of
carfentrazone-ethyl (ethyl-alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-fluorobenzenepropanoate
and the metabolite carfentrazone-ethyl chloropropionic acid (alpha,2-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-
triazol-1-yl]-4-fluorobenzenepropanoic acid), all expressed as
carfentrazone-ethyl, in or on vegetable, root and tuber, group 01 at
0.10 ppm; vegetable, leaves of root and tuber, group 2 at 0.10 ppm;
vegetable, bulb, group 3 at 0.10 ppm; vegetable, leafy, except
brassica, group 4 at 0.10 ppm; vegetable, brassica, leafy, group 5 at
0.10 ppm; vegetable, legume, group 6 at 0.10 ppm; vegetable, foliage of
legume (except soybean), group 7 at 0.10 ppm; vegetable, fruiting,
group 8 at 0.10 ppm; vegetable, cucurbit, group 9 at 0.10 ppm; fruit,
citrus, group 10 at 0.10 ppm, fruit; pome, group 14 at 0.10 ppm; fruit,
stone, group 12 at 0.10 ppm; berry, group 13 at 0.10 ppm; nut, tree,
group 14 at 0.10 ppm; herbs and spices, group 19 at 2.0 ppm; almond,
hull at 0.20 ppm; grape at 0.10 ppm; grass, forage at 5.0 ppm; grass,
hay at 8.0 ppm; canola at 0.10 ppm, hop, dried cones at
[[Page 58077]]
0.10 ppm; peanut at 0.10 ppm; peanut, hay at 0.10 ppm; strawberry at
0.10 ppm; sugarcane at 0.10 ppm; sunflower, seed at 0.10 ppm; okra at
0.10 ppm; stevia at 0.10 ppm; pistachio at 0.10 ppm; coconut at 0.10
ppm; strawberrypear at 0.10 ppm; date at 0.10 ppm; fig at 0.10 ppm;
papaya at 0.10 ppm; avocado at 0.10 ppm; sapote, black at 0.10 ppm;
canistel at 0.10 ppm; sapote, mamey at 0.10 ppm; mango at 0.10 ppm;
sapodilla at 0.10 ppm; star apple at 0.10 ppm; pummelo at 0.10 ppm;
guava at 0.10 ppm; feijoa at 0.10 ppm; jaboticaba at 0.10 ppm; wax
jambu at 0.10 ppm; starfruit at 0.10 ppm; passionfruit at 0.10 ppm;
acerola at 0.10 ppm; lychee at 0.10 ppm; longan at 0.10 ppm; Spanish
lime at 0.10 ppm; rambutan at 0.10 ppm; pulasan at 0.10 ppm; sugar
apple at 0.10 ppm; atemoya at 0.10 ppm; custard apple at 0.10 ppm;
cherimoya at 0.10 ppm; ilama at 0.10 ppm; soursop at 0.10 ppm; biriba
at 0.10 ppm; lingonberry at 0.10 ppm; Juneberry at 0.10 ppm, salal at
0.10 ppm; kiwifruit at 0.10 ppm; pomegranate at 0.10 at ppm; persimmon
at 0.10 ppm; pawpaw at 0.10 ppm; palm heart at 0.10 ppm; palm heart,
leaves at 0.10 ppm; kava, kava at 0.10 ppm; ti, leaves at 0.10 ppm; ti,
roots at 0.10 ppm; wasabit, roots at 0.10 ppm; cactus at 0.10 ppm;
sorghum, sweet at 0.10 ppm; rapeseed, seed at 0.10 ppm; rapeseed,
forage at 0.10 ppm; mustard, seed at 0.10 ppm; flax, seed at 0.10 ppm;
safflower, seed at 0.10 ppm; crambe, seed at 0.10 ppm; borage at 0.10
ppm; olive at 0.10 ppm; banana at 0.10 ppm; cacao at 0.10 ppm; tea at
0.10 ppm; mulberry, Indian at 0.10 ppm; vanilla at 0.10 ppm; coffee at
0.10 ppm; horseradish at 0.10 ppm; fish at 0.30 ppm; shellfish at 0.30
ppm; meat, byproducts (cattle, goat, horse, and sheep) at 0.10 ppm;
meat (cattle, goat, horse, and sheep) at 0.10 ppm; fat (cattle, goat,
horse, and sheep) at 0.10 ppm and milk at 0.05 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0256 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
29, 2004.
Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector d(40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
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 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 the 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
[[Page 58078]]
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 the 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 (59 FR 22951,
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.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801et 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 16, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.515(a) is amended by alphabetically adding the
following commodities to the table in paragraph (a) to read as follows:
Sec. 180.515 Carfentrazone-ethyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Commodity PPM Commodity PPM Acerola 0.10 Peanut, hay 0.10 Almond, hull 0.20 Persimmon 0.10 Atemoya 0.10 Pistachio 0.10 Avocado 0.10 Pomegranate 0.10 Banana 0.20 Pummelo 0.10 Berry, group 13 0.10 Pusalan 0.10 Birida 0.10 Rambutan 0.10 Borage 0.10 Rapeseed, forage 0.10 Cacao 0.10 Rapeseed, seed 0.10 Cactus 0.10 Safflower, seed 0.10 Canistel 0.10 Salal 0.10 Canola 0.10 Sapodilla 0.10 Cherimoya 0.10 Sapote, black 0.10 Coffee 0.10 Sapote, mamey 0.10 Coconut 0.10 Shellfish 0.30 Crambe, seed
0.10 Sorghum, sweet 0.10 Custard apple 0.10 Soursop, group 0.10 Date 0.10 Spanish lime 0.10 Fat (cattle, goat, horse, and sheep) 0.10 Star apple 0.10 Feijoa 0.10 Starfruit 0.10 Fig 0.10 Stevia 0.10 Fish 0.30 Strawberry 0.10 Flax, seed 0.10 Strawberrypear 0.10 Fruit, citrus, group 10 0.10 Sugar, apple 0.10 Fruit, pome, group 11 0.10 Sugarcane 0.10 Fruit, stone, group 12 0.10 Sunflower, seed 0.10 Grape 0.10 Tea 0.10 Grass, forage 5.0 Ti, leaves 0.10 Grass, hay 8.0 Ti, roots 0.10 Guava 0.10 Vanilla 0.10 Herb and Spices, group 19 2.0 Vegetable, bulb, group 03 0.10 Hops, dried cones 0.10 Vegetable, brassica, leafy, group 05 0.10 Horseradish 0.10 Vegetable, cucurbit, group 09 0.10 Ilama 0.10 Vegetable, foliage of legume (except soybean), group 07 0.10 Jaboticaba 0.10 Vegetable, fruiting, group 8 0.10 Juneberry 0.10 Vegetable, legume, group 06 0.10 Kava, Kava 0.10 Vegetable, leafy, except brassica, group 04 0.10 Kiwi fruit 0.10 Vegetable, leaves of root and tuber, group 02 0.10 Lingonberry 0.10 Vegetable, root and tuber, group 01 0.10 Longan 0.10 Wasabia, roots 0.10 Lychee 0.10 Wax, Jambu 0.10 Mango 0.10 Meat, byproducts, cattle, goat, horse, and sheep) 0.10 Meat, (cattle, goat, horse, and sheep) 0.10 Milk 0.05 Mulberry, Indian 0.10 Mustard, seed 0.10 Nut, tree, group 14
0.10 Okra 0.10 Olive 0.10 Palm heart 0.10 Palm heart, leaves 0.10 Papaya 0.10 Passionfruit 0.10 Pawpaw 0.10 Peanut 0.10 0.10
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-21586 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S