[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Rules and Regulations]
[Page 47013-47022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0100; FRL-7368-8]
Propamocarb hydrochloride; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
propamocarb hydrochloride in or on lettuce, leaf; lettuce, head;
vegetable, cucurbit, group 9; vegetable, fruiting, group 8; and tomato
paste. Bayer CropScience 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 August 4, 2004. Objections and
requests for hearings must be received on or before October 4, 2004.
[[Page 47014]]
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-100. 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 South
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: Mary Waller, Registration Division
7505C, 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 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/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of March 10, 2004 (69 FR 11426-11431) (FRL-
7340-7), 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 petition (PP
0F6123) by Bayer CropScience, 2TW Alexander Drive, Research Triangle
Park, NC 27709. The petition requested that 40 CFR 180.499 be amended
by establishing a tolerance for residues of the fungicide propyl [3-
(dimethylamino) propyl] carbamate mono-hydrochloride, also known as
propamocarb hydrochloride, in or on the raw agricultural commodities
(RACs) lettuce, leaf, at 65 parts per million (ppm), lettuce, head, at
50 ppm, wheat, grain, at 0.05 ppm, wheat, straw, at 0.10 ppm, wheat,
forage, at 0.30 ppm, wheat, hay, at 0.30 ppm, vegetable, cucurbit,
group 9, at 1.5 ppm, vegetable, fruiting, group 8, at 2.0 ppm, and
tomato, paste, at 5.0 ppm. That notice included a summary of the
petition prepared by Bayer CropScience, the registrant. There were no
comments received in response to the notice of filing.
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 tolerances for residues of propamocarb
hydrochloride on vegetable, cucurbit, group 9 at 1.5 ppm; lettuce, head
at 50 ppm; lettuce, leaf at 90 ppm; vegetable, fruiting, group 8 at 2.0
ppm and tomato, paste at 5.0 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 propamocarb
hydrochloride are discussed in Table 1 of this unit as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies reviewed.
[[Page 47015]]
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-day oral NOAEL = 363 mg/kg/
toxicity in day in females
rodents and 646 mg/kg/day
in males
LOAEL = 716 mg/kg/
day in females,
based on
decreased body
weight and body
weight gain and
decreased food
efficiency. LOAEL
in males is 1,363
mg/kg/day based
on decreased food
efficiency
---------------------------------
870.3150 90-day oral NOAEL was not
toxicity in achieved
nonrodents LOAEL = 22.75 mg/
kg/day based upon
body weight gain
depression,
decreased food
efficiency and
focal or multi-
focal chronic
erosive gastritis
---------------------------------
870.3200 21/28-day dermal NOAEL >=150 mg/kg/
toxicity in day for both
rabbits sexes
LOAEL = 525 mg/kg/
day based on dose-
related skin
irritation and
depressed body
weight gain
---------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental 221 mg/kg/day
toxicity in rats Maternal LOAEL =
740 mg/kg/day
based on
mortality
Developmental
NOAEL = 221 mg/kg/
day
Developmental
LOAEL = 740mg/kg/
day based on GD
20 fetal death
and a possible
increase in minor
skeletal
anomalies
---------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental 150 mg /kg/day
toxicity in Maternal LOAEL =
rabbits 300 mg /kg/day
based on
decreased body
weight gains for
GD 6-18 and
possible
increased
abortions
Developmental
NOAEL = 150 mg/kg/
day
Developmental
LOAEL = 300 mg/kg/
day based on
increased post-
implantation loss
---------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL = 65.41 mg/
in rats kg/day for males
and 76.78 mg/kg/
day for females
Parental/Systemic
LOAEL = 406.69 mg/
kg/day for males
and 467.13 mg/kg/
day for females
based on
decreased body
weights
Reproductive/
Offspring NOAEL =
65.41 mg/kg/day
for males and
76.78 mg/kg/day
for females
Reproductive/
Offspring LOAEL =
406.69 mg/kg/day
for males and
467.13 mg/kg/day
for females based
on reduced pup
weights
---------------------------------
870.4100 Chronic toxicity NOAEL = >=25.6 mg/
in rodents kg/day
LOAEL = >25.6 mg/
kg/day. There
were no signs of
toxicity
attributable to
treatment at any
dose level
---------------------------------
870.4100 Chronic toxicity NOAEL was not
in dogs achieved.
LOAEL = 22.75 mg/
kg/day based upon
body weight gain
depression,
decreased food
efficiency and
focal or multi-
focal chronic
erosive gastritis
---------------------------------
870.4200 Carcinogenicity in NOAEL = 84 mg/kg/
rats day in males, 112
mg/kg/day in
females
LOAEL = 682 mg/kg/
day in males, 871
mg/kg/day in
females based on
decreased body
weight and body
weight gain,
decreased food
consumption, and
an increased
incidence of
vacuolation of
choroid plexus
ependymal cells
in the brain in
both sexes and
decreased water
consumption in
the females
no evidence of
carcinogenicity
---------------------------------
870.4200 Carcinogenicity in NOAEL = 12 mg/kg/
mice day in females
and >=690.0 mg/kg/
day in males
LOAEL = 95 mg/kg/
day in females
based on
decreased body
weight and body
weight gains
no evidence of
carcinogenicity
---------------------------------
870.5100 Reverse gene No evidence of
mutation assay in induced mutant
bacteria colonies over
background
---------------------------------
870.5375 Cytogenetics Increases in
in vitro mammalian aberrant
cytogenetics metaphases were
assay. within the
historical
control range
---------------------------------
870.5395 Bone marrow No significant
micronucleus increase in the
assay frequency of
micronucleated
polychromatic
erythrocytes in
bone marrow at
any dose tested
---------------------------------
870.5395 Bone marrow No significant
micronucleus increase in the
assay frequency of
micronucleated
polychromatic
erythrocytes in
bone marrow after
any treatment
time
---------------------------------
[[Page 47016]]
870.5575 Other Genotoxicity No evidence of
Saccharomyces gene conversion
cerevisiae, in the tested
mitotic strains with
recombination, activation
gene conversion
assay
---------------------------------
870.5575 Saccharomyces No evidence of
cerevisiae, gene conversion
mitotic in the tested
recombination, strains without
gene conversion activation
assay
---------------------------------
870.5575 Saccharomyces Under the
cerevisiae, conditions of the
mitotic study, no
recombination, evidence of gene
gene conversion conversion
assay
---------------------------------
870.6200 Acute NOAEL = 200 mg/kg/
neurotoxicity day
screening battery LOAEL =2,000 mg/kg/
in rats day based on
soiled fur coat
(both sexes) and
decreased motor
activity 8 hours
post-dosing
(females only)
---------------------------------
870.6200 Subchronic NOAEL = 1,320.8 mg/
neurotoxicity kg/day in males
screening battery and 1485.6 mg/kg/
in rats day in females
LOAEL = not
observed
---------------------------------
870.7485 Metabolism in rats A higher dose (at
least equivalent
to levels of
human exposure)
should have been
tested, and the
metabolites
should have been
identified
---------------------------------
N/A Special Study - One male and one
cholinesterase female died
inhibition study within 43 min;
exhibited
tremors,
convulsions,
respiratory,
standstill, and
death. ChE
inhibition dead
animals, plasma -
no effect; RBC -
19 - 54%, and
brain decrease 10
X the controls.
No appreciable
decrease in ChE
in the surviving
dog
Conclusion: The
cholinesterase
inhibition
studies were of
questionable
quality. The
chemical does not
cause any
appreciable
inhibition of
cholinesterase
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL)
fromthe 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. 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
(MOEcancer = point of departure/exposures) is calculated.
A summary of the toxicological endpoints for propamocarb
hydrochloride used for human risk assessment is shown in Table 2 of
this unit:
[[Page 47017]]
Table 2.--Summary of Toxicological Dose and Endpoints for propamocarb hydrochloride for Use in Human Risk
Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of NOAEL = 150 mg/kg/day FQPA SF = 1X Developmental toxicity
age) UF = 100............... aPAD = acute RfD / FQPA study - rabbit
Acute RfD = 1.5 mg ai/ SF = 1.5 mg/kg/day. developmental LOAEL =
kg/day. 300 mg/kg/day based on
increased post-
implantation loss
--------------------------------------
Acute dietary general population NOAEL= 200 mg/kg/day FQPA SF = 1X Acute neurotoxicity
including infants and children UF = 100............... aPAD = acute RfD / FQPA screening battery -
Acute RfD = 2.0 mg/kg/ SF = 2.0 mg/kg/day. rat
day. LOAEL = 2000 mg ai/kg/
day, based on
decreased body weight
gain and decreased
motor activity
--------------------------------------
Chronic dietary all populations NOAEL= 12 mg/kg/day FQPA SF = 1X Carcinogenicity study -
UF = 100............... cPAD = chronic RfD / mouse
Chronic RfD = 0.12 mg/ FQPA SF = 0.12 mg/kg/ LOAEL = 95 mg/kg/day,
kg/day. day. based on decreased
body weight and body
weight gain in females
--------------------------------------
Short-term oral (1 - 30 days) NOAEL = 65.41 mg/kg/day Residential LOC for MOE 2-generation
(Residential) = 100 reproduction toxicity
study - rat
Offspring LOAEL = 406.7
mg/kg/day, based on
reduced pup weights in
F0 and F1 during Day
14 - 21 of lactation
--------------------------------------
Intermediate-term oral (1 - 6 NOAEL = 65.41 mg/kg/day Residential LOC for MOE 2-Generation
months)(Residential) = 100 reproduction toxicity
study - rat
Offspring LOAEL = 406.7
mg/kg/day, based on
reduced pup weights in
F0 and F1 during Day
14 - 21 of lactation
--------------------------------------
Cancer (oral, dermal, inhalation) ``not likely to be
carcinogenic to
humans''
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
MOE = margin of exposure.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.499(a)) for the residues of propamocarb
hydrochloride, on potatoes. Risk assessments were conducted by EPA to
assess dietary exposures from propamocarb hydrochloride 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 one-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-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-level residues of propamocarb hydrochloride were assumed for
all plant commodities with current or proposed propamocarb
hydrochloride tolerances. The following residues of propamocarb
hydrochloride and the metabolites of concern in livestock N-oxide
propamocarb, 2-hydroxypropamocarb, and oxazolidine were assumed to be
present in livestock commodities: 0.15 ppm in meat, 0.60 ppm in liver,
0.20 ppm in kidney, 0.15 ppm in meat by-products excluding liver and
kidney, 0.05 ppm in fat and 0.85 ppm in milk. EPA assumed that all of
the crops included in the analysis were treated. Percent crop treated
(PCT) and anticipated residue values were not used in the acute risk
assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
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 chronic exposure
assessments: Tolerance-level residues of propamocarb hydrochloride were
assumed for all plant commodities with current or proposed propamocarb
hydrochloride tolerances. The following residues of propamocarb
hydrochloride and the metabolites of concern in livestock N-oxide
propamocarb, 2-hydroxy propamocarb, and oxazolidine were assumed to be
present in livestock commodities: 0.15 ppm in meat, 0.60 ppm in liver,
0.20 ppm in kidney, 0.15 ppm in meat by-products excluding liver and
kidney, 0.05 ppm in fat and 0.85 ppm in milk. It was assumed that all
of the crops included in the analysis were treated. Percent crop
treated (PCT) and anticipated residue values were not used in the
chronic risk assessment.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for propamocarb hydrochloride 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 propamocarb hydrochloride.
[[Page 47018]]
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 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
drinking 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 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 propamocarb
hydrochloride they are further discussed in the aggregate risk sections
in Unit E., Aggregate Risks and Determination of Safety, below.
Based on the FIRST and SCI-GROW models, the EECs of propamocarb
hydrochloride for acute exposures are estimated to be 972 parts per
billion (ppb) for surface water and 2.99 ppb for ground water. The EECs
for chronic exposures are estimated to be 77 ppb for surface water and
2.99 ppb for ground water. These EEC's are based on application rates
on turf which yield higher projected surfacewater and groundwater
concentrations than the proposed application rates on cucurbit
vegetables; fruiting vegetables and lettuce.
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).
Propamocarb hydrochloride is currently registered for use on the
following residential non-dietary sites: commercial sod farms,
greenhouses growing plants for sale, plant nurseries and golf courses.
There are two end-use products registered for these uses: Banol (EPA
Registration Number 432-942, contains 66.5% propamocarb hydrochloride)
and Banol C (EPA Registration Number 432-961, contains 30.5%
propamocarb hydrochloride and 30.5% chlorothalonil). An MOE of 100 is
assumed to adequately ensure protection from propamocarb hydrochloride
via the dermal and inhalation routes for residential exposures. The
high-end scenario for residential post-application exposure is to
golfers on a course treated with propamocarb hydrochloride. The post-
application risk assessment is based on generic assumptions as
specified by the newly proposed Residential Standard Operating
Procedures (SOPs) and recommended approaches by the Health Effects
Division's (HED's) Exposure Science Advisory Committee. Short-term
post-application exposures are expected for the adult and adolescent
golfer (high end exposure scenario). Golfer exposure is expected
through minimal hand contact with the golf ball and dermal contact to
the lower legs from treated plant surfaces. Since it is assumed that
the adolescent golfer would have a proportionally similar exposure to
adults, a dermal post-application assessment was performed for the
adult golfer only. The calculated MOE for the golfer is 980 and,
therefore, does not exceed EPA's level of concern. Since the short- and
intermediate-term toxicological endpoints are the same, the golfer
post-application exposure assessment is expected to provide adequate
exposure estimates for both the short- and intermediate-term exposure
scenarios. In the event of intermediate-term exposure, propamocarb
hydrochloride residues are expected to dissipate over time. Therefore,
this assessment is expected to present a high-end conservative estimate
of actual exposure.
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 propamocarb hydrochloride
and any other substances and propamocarb hydrochloride 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
propamocarb hydrochloride 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 Office of Pesticide Programs (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. EPA determined that there
are no residual concerns for propamocarb for prenatal and postnatal
toxicology based on the following:
[[Page 47019]]
There is no quantitative or qualitative evidence of
increased susceptibility of rat and rabbit fetuses to in utero exposure
to propamocarb hydrochloride in developmental toxicity studies. There
is no quantitative or qualitative evidence of increased susceptibility
to propamocarb hydrochloride following prenatal/postnatal exposure to a
2-generation reproduction study.
There is no concern for developmental neurotoxicity
resulting from exposure to propamocarb hydrochloride. A developmental
neurotoxicity study (DNT) is not required.
3. Conclusion. There is a complete toxicity data base for
propamocarb hydrochloride and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. Given the completeness of the data base and the lack of
concern for prenatal and postnatal toxicity, EPA concluded that
reliable data shows an additional safety factor of 10X is not needed
for the protection of infants and children.
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
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 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
propamocarb hydrochloride will occupy 4% of the aPAD for the U.S.
population, 6% of the aPAD for females 13 years and older, 2% of the
aPAD for infants < 1 year old, and 5% of the aPAD for children between
1 and 2 years of age. In addition, there is potential for acute dietary
exposure to propamocarb hydrochloride 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 3 of this unit:
Table 3.--Aggregate Risk Assessment for Acute Exposure to propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
Ground Surface
Population Subgroup aPAD (mg/kg/ %aPAD Water EEC Water EEC Acute DWLOC
day) (food) ([mu]g/L) ([mu]g/L) ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population 2.0 4 2.99 972 67,000
------------------------------------------------
All infants (< 1 year old) 2.0 2 2.99 972 19,000
------------------------------------------------
Children (1-2 years old) 2.0 5 2.99 972 19,000
------------------------------------------------
Children (3-5 years old) 2.0 5 2.99 972 19,000
------------------------------------------------
Children (6-12 years old) 2.0 4 2.99 972 19,000
------------------------------------------------
Youth (13-19 years old) 2.0 4 2.99 972 67,000
------------------------------------------------
Adults (20-49 years old) 2.0 4 2.99 972 67,000
------------------------------------------------
Adults (50+ years old) 2.0 4 2.99 972 67,000
------------------------------------------------
Females (13-49 years old) 1.5 6 2.99 972 42,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
propamocarbhydrochloride from food will utilize 18% of the cPAD for the
U.S. population, 11% of the cPAD for infants less than 1 year old, 36%
of the cPAD for children between 1 and 2 years of age and 30% of the
cPAD for children between 3 and 5 years of age. Based on the use
pattern, chronic residential exposure to residues of propamocarb
hydrochloride is not expected. In addition, there is potential for
chronic dietary exposure to propamocarb hydrochloride 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 4 of this unit:
[[Page 47020]]
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
Ground Surface Chronic
Population Subgroup cPAD (mg/kg/ %cPAD Water EEC Water EEC DWLOC
day) (Food) ([mu]g/L) ([mu]g/L) ([mu]g/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.12 18 2.99 77 3,500
------------------------------------------------
All infants (< 1 year old) 0.12 11 2.99 77 1,100
------------------------------------------------
Children (1-2 years old) 0.12 36 2.99 77 760
------------------------------------------------
Children (3-5 years old) 0.12 30 2.99 77 840
------------------------------------------------
Children (6-12 years old) 0.12 22 2.99 77 930
------------------------------------------------
Youth (13-19 years old) 0.12 16 2.99 77 3,500
------------------------------------------------
Adults (20-49 years old) 0.12 16 2.99 77 3,500
------------------------------------------------
Females (13-49 years old) 0.12 17 2.99 77 3,000
------------------------------------------------
Adults (50+ years old) 0.12 14 2.99 77 3,600
----------------------------------------------------------------------------------------------------------------
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).
Propamocarb hydrochloride is currently registered for use on golf
courses 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 propamocarb hydrochloride.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 870 for females 13-50 years old,
1,000 for youth 13-19 years old and 980 for the general U.S.
population. The short-term aggregate risk assessment estimates risks
likely to result from 1-7 day exposure to propamocarb hydrochloride
residues in food, drinking water, and residential pesticide uses. High-
end estimates of the residential exposure are used in the short-term
assessment. Average values are used for food and drinking water
exposure. For short-term aggregate exposure risk, the oral and dermal
exposures can be combined since both are based on the same toxicity
endpoint (decreased body weight). An MOE of 100 is adequate to ensure
protection from propamocarb hydrochloride via the dermal route for
residential exposures. According to the 1995 RED for propamocarb
hydrochloride (Estimated Usage of Pesticide, p. 3), ``almost all usage
of propamocarb hydrochloride in the United States is concentrated on
golf courses with approximately 100,000 to 200,000 lbs ai applied per
year.'' The labels for Banol (EPA Registration Number 432-942) and
Banol C (EPA Registration Number 432-961) both state that only
protected handlers may be present in the treated area during
application. For these reasons, it is assumed that this product will be
used by commercial applicators, mainly on golf courses. The high-end
scenario for residential post-application exposure is the golf course
use of Banol. Therefore, in aggregating short-term risk, the Agency
considered background chronic dietary exposure (food and drinking
water) and short-term golfer dermal exposure.
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 propamocarb hydrochloride 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 5 of this unit:
Table 5.--Aggregate Risk Assessment for Short-Term Exposure to propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground/ Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General US Population 980 100 2.99 77 47,000
-----------------------------------------------
Females 13-49 years old 870 100 2.99 77 40,000
-----------------------------------------------
Youth 13-19 years old 1,000 100 2.99 77 48,000
----------------------------------------------------------------------------------------------------------------
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). The short-
term aggregate assessment adequately addresses both the short- and
intermediate-term golfer dermal exposures. The short- and intermediate-
term dermal endpoints were chosen from the 21-day dermal rabbit
toxicity study. The short-term golfer exposure was calculated assuming
1 to 7 days exposure to propamocarb hydrochloride. The intermediate-
term aggregate risk assessment estimates risks likely to result from 7
days to 3 months of exposure. In the event of intermediate-term
exposure, propamocarb hydrochloride residues are
[[Page 47021]]
expected to dissipate over time. Therefore, the short-term aggregate
assessment is expected to present a high-end conservative estimate of
intermediate-term risk. As the short-term aggregate risk assessment
represents the high-end scenario, an intermediate-term assessment was
not performed.
5. Aggregate cancer risk for U.S. population. A quantitative cancer
risk analysis was not performed since there is no concern for mutagenic
potential and there is no evidence of carcinogenic potential in either
the rat or mouse. Propamocarb has been classified as ``not likely to be
carcinogenic in humans.''
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 propamocarb hydrochloride residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography/nitrogen-phosphorus detection (GC/
NPD) method (Xenos Report Number: XEN97-37) has been submitted. This
method has undergone a successful independent laboratory validation
(ILV) and petition method validation (PMV). The GC/NPD has been sent to
the Food and Drug Administration (FDA) and is currently listed in the
Pesticide Analytical Manual (PAM) Vol. II for determining residues of
propamocarb hydrochloride in plant commodities.
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 (Codex) has established
tolerances (maximum residue levels) for propamocarb hydrochloride in
the following raw agricultural commodities: Beetroot at 0.2 ppm,
brussel sprouts at 1.0 ppm, cabbage (head) at 0.1 ppm, cauliflower at
0.2 ppm, celery at 0.2 ppm, cucumber at 2.0 ppm, lettuce (head) at 10
ppm, pepper (sweet) at 1.0 ppm, radish at 5.0 ppm, strawberry at 0.1
ppm and tomato at 1.0 ppm.
Proposed tolerances for vegetable, cucurbit, Group 9, lettuce head;
vegetables, fruiting, group 8; and tomato paste vary from established
Codex MRL's due to varying agricultural practices and environmental
conditions.
V. Conclusion
Therefore, tolerances are established for residues of propamocarb
hydrochloride on vegetable, cucurbit, group 9 at 1.5 ppm; lettuce, head
at 50 ppm; lettuce, leaf at 90 ppm; vegetable, fruiting, group 8 at 2.0
ppm; tomato, paste at 5.0 ppm.
VI. 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-2004-0100 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 October
4, 2004.
1. 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 (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.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-100, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
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).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in
[[Page 47022]]
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 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.
VIII. 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: July 19, 2004.
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 180.499 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.499 Propamocarb Hydrochloride; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Lettuce, head.............................................. 50
Lettuce, leaf.............................................. 90
* * * * *
Vegetable, cucurbit, group 9............................... 1.5
Vegetable, fruiting, group 8............................... 2.0
Tomato, paste.............................................. 5.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-17510 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S