Urea; Notice of Pesticide Report on FQPA Tolerance Reassessment Progress
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: April 15, 2002 (Volume 67, Number 72)]
[Notices]
[Page 18197-18202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap02-71]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-34255; FRL-6860-6]
Urea; Notice of Pesticide Report on FQPA Tolerance Reassessment
Progress
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice constitutes the Agency's report on the Food
Quality Protection Act (FQPA) tolerance reassessment progress for urea,
announces the Agency's tolerance reassessment decision, and releases
the science assessment for tolerance reassessment decision and related
documents supporting this decision to the public. The Agency's
reassessment of dietary risk, including public exposure through food
and drinking water as required by the Federal Food, Drug, and Cosmetic
Act (FFDCA) as amended by FQPA, indicates that urea poses no risk
concerns within the limits of the existing exemptions; therefore, no
risk mitigation is needed. There will be no changes to the 78 urea
exemptions from the requirement of a tolerance as a result of this
reassessment decision. EPA views this action as noncontroversial and
anticipates no adverse comments. By law, EPA is required by August 2002
to reassess 66% of the tolerances in existence on August 2, 1996, or
about 6,400 tolerances. EPA is counting 78 exemptions from the
requirement of a tolerance as reassessments made toward the August 2002
review deadline.
DATES: Comments, identified by docket control number OPP-34255, must be
received on or before May 15, 2002.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket control
number OPP-34255 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Joseph Nevola, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8037; and e-mail
address: nevola.joseph]@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of interest to persons who are or may be required to
conduct testing of chemical substances under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) or the Federal Food, Drug, and
Cosmetic Act (FFDCA); environmental, human health, and agricultural
advocates; pesticides users; and members of the public interested in
the use of pesticides. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. 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 Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register --Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. In addition, copies of documents
related to the Agency's report on FQPA tolerance reassessment progress
for urea released to the public may also be accessed at http://
www.epa.gov/pesticides/reregistration/status.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-34255. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity
[[Page 18198]]
Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. How Can I Respond to this Action?
A. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-34255 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0/9.0 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-34255. Electronic comments may
also be filed online at many Federal Depository Libraries.
B. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.
III. Report on FQPA Tolerance Reassessment Progress
A new registration for urea was approved on August 23, 1995, with
an approved label date of February 20, 1996, for use as an active
ingredient (frost protectant) to reduce ice formation by ice-nucleating
bacteria which are naturally present on leaf surfaces. Tolerance
exemptions associated with that frost protectant use are codified in 40
CFR 180.1117. Exemptions associated with uses of urea as an inert
ingredient in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest, in pesticide formulations
applied to growing crops only, and in pesticide formulations applied to
animals are codified in 40 CFR 180.1001(c), (d), and (e), respectively.
Therefore, exemptions associated with use of urea as an active and
inert ingredient are subject to reassessment in accordance with FFDCA
as amended by FQPA. FQPA requires EPA to re-evaluate existing
tolerances/exemptions to ensure that children and other sensitive
subpopulations are protected from pesticide risk.
The Agency has completed its assessment of the dietary risk of
urea, and has determined that the level of dietary risk from exposure
as a result of the currently registered uses of urea is not of concern.
Therefore, no mitigation measures are needed and no further actions are
warranted at this time. Urea does not pose unreasonable adverse effects
to the environment when used according to its approved labeling. In
addition, EPA finds that there is a reasonable certainty that no harm
will result from aggregate exposure to the urea residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information. EPA considers a total of 78 exemptions from
the requirement of a tolerance, 75 exemptions in 40 CFR 180.1117 and 3
exemptions in 180.1001, to be reassessed under FQPA. All of those 78
exemptions were found to meet the FQPA safety standard.
The risk assessment and other documents pertaining to the
reassessment of the urea exemptions from a requirement of a tolerance
are available on the Internet at http://www.epa.gov/pesticides/
reregistration/status.htm and the public docket for viewing (see Unit
I.B.2).
This notice of a tolerance reassessment for urea starts a 30-day
public comment period during which the public is encouraged to submit
comments on the Agency's risk assessment and tolerance exemption
reassessment. The Agency is providing an opportunity, through this
notice, for interested parties to comment in accordance with procedures
described in Unit II. of this document. All comments will be carefully
considered by the Agency. If any comment causes the Agency to revise
its decision on reassessment of these exemptions from the requirement
of a tolerance, EPA will publish notice of its amendment in the Federal
Register.
The legal authority for tolerance reassessment is provided by
FFDCA, as amended in 1996. Section 408(q) of FFDCA directs that:
The Administrator shall review tolerances and exemptions for
pesticide chemical residues in effect on the day before the date of
the enactment of the FQPA of 1996, as expeditiously as practicable,
assuring that--66% of such tolerances and exemptions are reviewed
within 6 years (i.e., by August 3, 2002) of the date of enactment of
such Act (i.e., on August 3, 1996), and--shall determine whether the
tolerance or exemption meets the requirements of sections 408(b)(2)
or (c)(2) and shall, by the deadline for the review of the tolerance
or exemption, issue a regulation under section 408(d)(4) or (e)(1)
to modify or revoke the tolerance or revoke the tolerance or
exemption if the tolerance or exemption does not meet such
requirements.
Under section 408 of the FFDCA, a tolerance may only be maintained if
EPA determines that the tolerance is safe based on a number of factors,
including an assessment of the aggregate exposure to the pesticide and
an assessment of the cumulative effects of such pesticide and other
substances that have a common mechanism of toxicity. In section
408(b)(2), the term ``safe,'' with respect to a tolerance for a
pesticide chemical residue, means that the Administrator has determined
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.
IV. Background
Urea is an active ingredient in only one active registration, where
it is used
[[Page 18199]]
as a frost protectant. The exemptions associated with urea use as a
frost protectant are found at 40 CFR 180.1117. For counting purposes,
there are 75 commodities exempt from the requirement of a tolerance
(squash, winter and summer, counts as two; cotton counts as three
because it also includes hay and seed; and casaba, crenshaw, and
persian melon, count as one entry).
Urea is also present in certain pesticide formulations as an inert
ingredient where it is used as a stabilizer, an inhibitor, and as an
adjuvant/intensifier for herbicides. One exemption for urea from the
requirement of a tolerance when used as a stabilizer or inhibitor is
found in 40 CFR 180.1001(c) for inert (or occasionally active)
ingredients in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. Another exemption for urea
when used as an adjuvant/intensifier for herbicides is found in 40 CFR
180.1001(d) for inert (or occasionally active) ingredients in pesticide
formulations applied to growing crops only. In addition, an exemption
for urea when used as a stabilizer or inhibitor is found in 40 CFR
180.1001(e) for inert (or occasionally active) ingredients in pesticide
formulations applied to animals.
Urea is a naturally occurring compound in humans and is approved
for several therapeutic uses in humans with relatively few toxicities.
In addition, urea is considered Generally Recognized As Safe (GRAS) by
the U.S. Food and Drug Administration (FDA) for use in food. Urea is
included in ``Direct Food Substances Affirmed as Generally Recognized
as Safe'' (21 CFR 184.1923), where the affirmation of GRAS as a direct
human food ingredient is based on current good manufacturing practice
and conditions of use as a formulation and fermentation aid.
EPA has reaffirmed data waivers granted for all subchronic,
chronic, developmental, reproduction, mutagenicity, and metabolism
studies based on available data from literature studies concerning
urea. A recent search of the published scientific literature concerning
urea since 1980 showed no basis for toxicological concern.
V. Use Summary
Urea was registered by EPA in 1995 for use as a frost protectant
pesticide under the trade name Enfrost. Enfrost is a 43% liquid
formulation of urea that can be applied commercially to a wide variety
of field crops, vegetables, fruit trees and ornamentals to reduce frost
damage. There are currently no residential uses for urea as a pesticide
product. Enfrost is the only currently registered pesticide product
containing urea as an active ingredient. Enfrost provides frost
protection by modifying the protein produced by ice-nucleating
bacteria. Enfrost has not been actively produced or sold by the
registrant, Entek Corporation, since 1995. However, the registrant
wishes to maintain active registration of Enfrost for potential future
production and use.
In addition to its use as a frost protectant, urea is used as an
inert pesticide ingredient as a stabilizer, inhibitor, or intensifier.
Also, several million tons of urea are produced annually for use in
fertilizer and as an animal feed supplement. Moreover, urea is used in
the manufacture of dyes, fire retardant paints, plasticizers, and
stabilizers for explosives.
VI. Hazard Characterization
With the exception of six acute toxicity studies submitted by the
registrant, the urea toxicity data base is comprised of the available
literature data. These data are considered by the Agency to be
sufficient to assess the potential hazard to humans, including special
sensitivity of infants and children.
1. Acute toxicity. The six acute toxicological studies indicate
that the frost protectorant is a slight eye irritant and has a low
toxicity to animals when administered via the oral, dermal, or
inhalation routes of exposure.
2. Subchronic toxicity. Urea produced no severe toxicity in dogs
injected subcutaneously with 30-40 milliliters/kilograms/day (mL/kg/
day) of 10% urea solution for 45 days. With plasma levels ranging from
200-700 mg/100 mL (10 to 30-fold above normal), the only clinical
symptoms observed were drowsiness and diuresis. Necropsy indicated no
adverse organ pathology.
3. Chronic toxicity and carcinogenicity. Animal studies provide no
evidence of adverse chronic or carcinogenic effects. One year feeding
studies in male and female C57B1/6 mice and Fisher 344 rats reported no
evidence of treatment-related cancer at doses up to 4.5% of the diet.
Studies in the susceptible mouse strain (Strain A) also indicate no
evidence of urea tumorigenicity.
4. Developmental and reproductive toxicity. In a developmental
toxicity study, pregnant Wistar rats produced healthy offspring with no
reported evidence of teratogenic effects. A study of pregnant cows
receiving 0.44 grams/kilograms urea showed no effects on reproductive
performance nor were the calves affected.
Urea has also been evaluated in monkeys for its ability to induce
abortion. The mode of action is similar to the hyperosmolar effect of
large doses of hypertonic saline and dextrose. However, such high
intrauterine exposures would not be expected to occur from exposure to
urea used as a frost protectant or inert pesticide ingredient. Urea is
currently classified by FDA in category C for therapeutic use, ``Safety
for use during pregnancy has not been established.''
5. Absorption, metabolism, and excretion. Urea is extremely soluble
in water and oral doses are rapidly absorbed and distributed in humans.
Urea is a normal human body constituent and is constantly being
produced through amino acid and protein metabolism where urea is formed
through a cyclic mechanism.
Urea has long been used as a dietary supplement for ruminants as a
source of nitrogen for protein synthesis. Urea nitrogen can also
contribute part of the amino acid requirements in humans. Utilization
of urea nitrogen has been demonstrated both in malnourished children
and adults.
6. Therapeutic uses. Urea is approved for several therapeutic uses
in humans with relatively few toxicities. Urea is used primarily as an
osmotic agent for inducing diuresis and reducing intraoccular and
intracranial pressure. Urea has also been used as a topical anesthetic
for the treatment of mouth and throat inflammation (10-15% urea gel,
liquid or solution), to debride necrotic and infected tissues, i.e.
fingernails and toenails. It is also used in the treatment of sickle-
cell anemia and to ammoniate dentrifices as well as a basic ingredient
in the synthesis of medically important compounds such as barbiturates
and urethanes.
7. FQPA considerations. EPA evaluated the available hazard and
exposure data for urea and concluded that the data provide no
indication of increased sensitivity of infants and children from
exposure to urea. Due to the expected low toxicity of urea, the Agency
has not used a safety factor analysis to assess the risk. For the same
reasons, the additional ten-fold (FQPA 10X) safety factor to account
for enhanced sensitivity of infants and children is not necessary.
VII. Exposure Assessment
Based on the hazard assessment of urea, exposures to this compound
resulting from reasonably anticipated patterns of usage present a
reasonable certainty of no harm to human health. Given the low toxicity
of urea, a more detailed assessment of risks resulting
[[Page 18200]]
from exposure to urea, when used either as a frost protectant or
pesticide inert ingredient, is not necessary.
VIII. Environmental Fate and Transport
Available data from literature reviews show that urea degrades
rapidly in most soils, generally hydrolyzed to ammonium through soil
urease activity. In various soils, the hydrolysis may near completion
within 24 hours; however, the rate of hydrolysis can be much slower
depending upon soil type, moisture content, and urea formulation. Soil
adsorption studies show that urea adsorbs very weakly to soil;
therefore, leaching is possible. Ultimate urea degradation produces
ammonia and carbon dioxide as volatile products. Biodegradation is
expected to be the major fate process in the aquatic ecosystem. The
rate of biodegradation generally decreases with decreasing
temperatures. Naturally-occurring phytoplankton increases the
degradation rate because phytoplankton use urea as a nitrogen source.
In phytoplankton-rich waters, degradation occurs much faster in
sunlight than in the dark. Abiotic hydrolysis of urea occurs very
slowly in relation to biotic hydrolysis.
IX. Summary of Risk Assessment Findings
From the available animal studies and other data, EPA has concluded
that urea exhibits a low toxicity and exposures to urea used either as
an active or inert pesticide ingredient present a reasonable certainty
of no harm to human health. The Agency's analysis of extensive
toxicological data in numerous species supports the 1995 decision to
grant permanent exemptions from the requirement of a tolerance for
residues of the frost protectant when used before harvest in the
production of raw agricultural commodities.
X. Tolerance Reassessment Summary
Based on reevaluation of existing data, EPA believes there is
sufficient basis to maintain exemption from the requirement of a
tolerance for residues of the frost protectant urea when used before
harvest in the production of the raw agricultural commodities listed in
40 CFR 180.1117 and inert uses of urea listed in 40 CFR 180.1001.
Urea Inert Ingredient Exemptions
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Inert Ingredient Current Tolerance Reassessment Decision Uses
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Exemption listed in 40 CFR
180.1001(c)
Urea Exempt Same Stabilizer, inhibitor
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Exemption listed in 40 CFR
180.1001(d)
Urea (CAS 57-13-6) Exempt Same Adjuvant/intensifier
for herbicides
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Exemption listed in 40 CFR
180.1001(e)
Urea Exempt Same Stabilizer, inhibitor
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Urea Active Ingredient Exemptions (40 CFR 180.1117)
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Corrected Commodity
Commodity Current Tolerance Reassessment Decision Definition
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Alfalfa Exempt Same
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Almonds Exempt Same Almond
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Apples Exempt Same Apple
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Apricots Exempt Same Apricot
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Artichokes Exempt Same Artichoke, globe
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Asparagus Exempt Same
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Avocados Exempt Same Avocado
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Beans Exempt Same Bean
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Bell peppers Exempt Same Pepper, bell
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Blackberries Exempt Same Blackberry
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Blueberries Exempt Same Blueberry
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Boysenberries Exempt Same Boysenberry
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Broccoli Exempt Same
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Brussels sprouts Exempt Same
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Caneberries Exempt Same Caneberry
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Canola Exempt Same
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[[Page 18201]]
Cantaloupes Exempt Same Cantaloupe
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Carrots Exempt Same Carrot
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Cauliflower Exempt Same
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Casaba Exempt Same Muskmelon
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Celery Exempt Same
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Cherries Exempt Same Cherry, sweet and
cherry, tart
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Chili peppers Exempt Same Pepper, nonbell
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Chinese cabbage (bok choy, napa) Exempt Same Cabbage, Chinese, bok
choy
Cabbage, Chinese, napa
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Cooking peppers Exempt Same Pepper, nonbell sweet
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Corn Exempt Same
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Cotton Exempt Same
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Crenshaw Exempt Same Muskmelon
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Cucumbers Exempt Same Cucumber
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Figs Exempt Same Fig
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Grapefruit Exempt Same
----------------------------------------------------------------------------------------------------------------
Grapes Exempt Same Grape
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Honeydew melon Exempt Same
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Hops Exempt Same Hop, dried cones
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Kiwifruit Exempt Same
----------------------------------------------------------------------------------------------------------------
Kohlrabi Exempt Same
----------------------------------------------------------------------------------------------------------------
Lemons Exempt Same Lemon
----------------------------------------------------------------------------------------------------------------
Lentils Exempt Same Lentil
----------------------------------------------------------------------------------------------------------------
Lettuce Exempt Same
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Limes Exempt Same Lime
----------------------------------------------------------------------------------------------------------------
Macadamia nuts Exempt Same Nut, macadamia
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Musk melon Exempt Same Muskmelon
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Nectarines Exempt Same Nectarine
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Olives Exempt Same Olive
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Onions Exempt Same Onion, dry bulb
Onion, green
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Oranges Exempt Same Orange, sweet
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Peaches Exempt Same Peach
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Pears Exempt Same Pear
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Peanuts Exempt Same Peanut
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Peas Exempt Same Pea
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Persian melon Exempt Same Muskmelon
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Pistachios Exempt Same Pistachio
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[[Page 18202]]
Plums Exempt Same Plum
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Potatoes Exempt Same Potato
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Pumpkin Exempt Same
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Prunes Exempt Same Plum, prune
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Radish Exempt Same
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Raspberries Exempt Same Raspberry
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Rice Exempt Same
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Safflower Exempt Same
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Sorghum Exempt Same Sorghum, grain
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Spinach Exempt Same
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Spinach (New Zealand) Exempt Same Spinach, New Zealand
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Squash (winter and summer) Exempt Same Squash, summer
Squash, winter
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Strawberries Exempt Same Strawberry
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Sugar beets Exempt Same Beet, sugar
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Sunflower Exempt Same
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Sweet pepper Exempt Same Pepper, nonbell, sweet
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Table beets Exempt Same Beet, garden
----------------------------------------------------------------------------------------------------------------
Tangerines Exempt Same Tangerine
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Tomatoes Exempt Same Tomato
----------------------------------------------------------------------------------------------------------------
Walnuts Exempt Same Walnut
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Watermelon Exempt Same
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Zucchini Exempt Same Squash, summer
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List of Subjects
Environmental protection.
Dated: March 28, 2002.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 02-9071 Filed 4-12-02; 8:45 a.m.]
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