[Federal Register: April 7, 2004 (Volume 69, Number 67)]
[Notices]
[Page 18375-18380]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap04-52]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0073; FRL-7349-9]
Forchlorfenuron; Notice of Filing a Pesticide Petition to
Establish an Extension of a Time-Limited Tolerance for a Certain
Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket ID number OPP-2004-0073, must be
received on or before May 7, 2004.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Cynthia Giles-Parker, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone
[[Page 18376]]
number: (703) 305-7740; e-mail address: giles-parker.cynthia@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)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0073. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1921 Jefferson Davis Hwy., 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.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although, not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also, include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0073. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
[[Page 18377]]
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP-2004-0073. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0073.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2004-0073. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is 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 docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also, provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 22, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the KIM-C1, LLC, c/o Siemer & Associates, Inc., and
represents the view of the petitioner. The petition summary announces
the availability of a description of the analytical methods available
to EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
KIM-C1, LLC, c/o Siemer & Associates, Inc.,
PP 7G4906
EPA has received a pesticide petition (PP 7G4906) from KIM-C1, LLC,
c/o Siemer & Associates, Inc., 4672 W. Jennifer, Street, Suite 103,
Fresno, CA 93722, proposing, pursuant to section 408(d) the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40
CFR part 180 by establishing an extension of a time-limited tolerance
for forchlorfenuron (CPPU) in or on the raw agricultural commodities
almonds, apples, blueberries, figs, grapes, kiwi fruit, pears, and
plums at 0.01 parts per million (ppm). EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408(d)(2) or the FFDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
support granting of the petition. Additional data may be needed before
EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. 14C radiolabel studies were
conducted on apples, grapes, and kiwi fruit. Results of these three
studies showed that the metabolism of CPPU in apples, grapes, and kiwi
fruit is similar, if not identical. Metabolism of CPPU in these crops
involved hydroxylation of the phenyl-ring to form 3-hydroxy-CPPU or 4-
hydroxy-CPPU followed by conjugation with glucose to form B-glycosides.
These studies were conducted using CPPU at 15 parts per million (ppm)
and 75 ppm. Most of the residue remained on the treated surface and was
primarily associated with the pulp tissue. Very little radioactivity
was found in the juice.
[[Page 18378]]
2. Analytical method. Two analytical methods both based on high
performance liquid chromotography (HPLC) procedures have been
developed. The first used a visible ultraviolet (UV) detector while the
second used a mass spec detector. Since the mass spec detector is
capable of both qualitative as well as quantitative measurement it is
the preferred method. The level of quantification (LOQ) in whole grape
fruit was 0.01 ppm; the level of detection (LOD) was 0.003 ppm. In
grape juice, the LOQ was 0.002 ppm and the LOD 0.0007 ppm (0.7 parts
per billion (ppb)). In raisins the LOQ was 0.01 ppm and the LOD was
0.003 ppm.
3. Magnitude of residues. The magnitude of the residues in the
crops are anticipated to be below the level of quantification which,
based on whole fruit, will be 0.01 ppm.
B. Toxicological Profile
A full battery of toxicology testing including studies of acute,
subchronic, chronic, oncogenicity, developmental, reproductive and
genotoxicity effects is available for CPPU. The acute toxicity of CPPU
is low by all routes. The lowest subchronic study no observable adverse
effect level (NOAEL) value is 16.8 milligrams/kilogram/day (mg/kg/day)
obtained from the dog 90-day toxicity study. Chronic studies indicate
that CPPU is not carcinogenic. The lowest chronic dietary NOAEL is 7
mg/kg/day from male rats fed CPPU for 104 weeks. CPPU showed no
evidence of developmental toxicity in rats and rabbits. In a rat
reproduction study, reproductive effects were only observed at
maternally toxic doses. Finally, genetic toxicity studies indicate that
CPPU is not genotoxic. For the purpose of dietary risk analysis, 0.07
mg/kg/day is proposed for the chronic population adjusted dose (cPAD).
The cPAD is based on a chronic endpoint of 7 mg/kg/day which is the
NOAEL for males from the rat chronic/oncogenicity feeding study and an
uncertainty factor of 100. No acute toxicity endpoint could be
identified and, therefore, an acute dietary risk assessment is
considered unnecessary.
1. Acute toxicity. The acute toxicity of CPPU is low by all routes.
The battery of acute toxicity studies place CPPU into Toxicity Category
III. CPPU has low acute toxicity when administered orally, dermally or
via inhalation to rats. It is not a skin irritant and is only a mild
eye irritant. CPPU is not a skin sensitizer.
2. Genotoxicity. The genotoxic potential of CPPU was studied in
vitro in bacteria and mammalian cells and in vivo in the unscheduled
DNA synthesis test. The test systems assayed did not show any evidence
of genotoxicity except in the bacterial mutagenicity assay, strain
TA1535, without metabolic activation. The weight of the evidence
indicates that CPPU does not possess significant genotoxicity concerns.
3. Reproductive and developmental toxicity. Developmental effects
of CPPU were studied in rats and rabbits and multigenerational effects
on reproduction were studied in rats.
i. Rat developmental. In the developmental toxicity study conducted
with rats, CPPU was administered by gavage at levels of 0, 100, 200,
and 400 mg/kg/day. The maternal and developmental NOAELs are 200 mg/kg/
day based on reduced body weights, body weight gain and food
consumption and an increased incidence of alopecia in dams. There were
no developmental effects.
ii. Rabbit developmental.. In the rabbit developmental toxicity
study, gavage doses of 0, 25, 50, 100 mg/kg/day were administered.
Maternal toxicity (decreased body weight and body weight gains) was
observed at 50 mg/kg/day and above. The maternal NOAEL is 25 mg/kg/day
and the developmental NOAEL is 100 mg/kg/day. There were no
developmental effects.
iii. Reproduction. In the rat reproduction study, CPPU was
administered in the diet at levels of 0, 150, 2,000 and 7,500 ppm for
two generations. There were no adverse effects of CPPU on reproductive
success. Parental toxicity consisted of clinical signs, inhibition of
body weight gain, reduced food consumption, and macroscopic and
microscopic effects in the kidney. Reproductive toxicity in the highest
dose consisted of slightly reduced live litter sizes in the
F2 litters. In the pups, body weights and survival (late
lactation period) were reduced and at the high dose, pup mortality and
emaciation were increased. The parental, pup and reproductive NOAELs
are 150 ppm, 150 ppm and 2,000 ppm, respectively.
4. Subchronic toxicity. Subchronic studies have been conducted with
CPPU in the rat, mouse and dog.
i. Rats: CPPU technical was tested in rats in a 3-month study at
dietary levels of 0, 200, 1,000 and 5,000 ppm. Observations were
decreased body weight, body weight gain and food efficiency. The NOAEL
males is 5,000 ppm (400 mg/kg/day) and in females is 1,000 ppm (84 mg/
kg/day).
ii. Mice. A 13-week feeding study in mice was conducted at dose
levels of 0, 900, 1,800, 3,500 and 7,000 ppm. Effects included
decreased body weight and food consumption, increased relative liver
weight and lymphocytic cell infiltration in the kidneys. The NOAEL is
3,500 ppm (609 mg/kg/day in males and 788 mg/kg/day in females).
iii. Dogs: A 13-week dietary toxicity study was conducted in beagle
dogs at dose levels of 0, 50, 500, and 5,000 ppm. Effects included
decreased body weight gain, food consumption and food efficiency. The
NOAEL for both sexes was 500 ppm (16.8 mg/kg/day in males and 19.1 mg/
kg/day in females).
5. Chronic toxicity. CPPU has been tested in chronic studies with
dogs, rats, and mice.
i. Rats. In a 104-week combined chronic/oncogenicity study in rats,
CPPU was administered at dose levels of 0, 150, 2,000, and 7,500 ppm in
the diet. Findings were decreased body weight, body histopathological
effects in the kidney. No oncogenicity was found. The NOAEL for this
study is 150 ppm (7 mg/kg/day in males and 9 mg/kg/day in females).
ii. Mice. CPPU was administered in the diet to mice for 78-weeks at
dose levels of 0, 10, and 1,000 mg/kg/day. Observations were decreased
body weight and body weight gain, food consumption, increased kidney
weights and incidence of chronic kidney histopathological lesions. The
NOAEL for both sexes is 10 mg/kg/day.
iii. Dogs. In a 12-month study, CPPU was administered in the diet
to dogs at dose levels of 0, 150, 3,000 and 7,500 ppm. Observations
included reduced body weight, body weight gain and food consumption and
various hematology changes. The NOAEL for both sexes was 3,000 ppm (87
mg/kg/day in males and 91 mg/kg/day in females).
iv. Carcinogenicity. CPPU did not produce carcinogenicity in
chronic studies with rats or mice. The oncogenicity classification of
CPPU will be ``E'' (no evidence of carcinogenicity for humans).
6. Animal metabolism. A rat metabolism study indicates that CPPU is
almost completely absorbed and most of the 14C-CPPU-derived
radioactivity is rapidly eliminated primarily via the urine. The
majority of the metabolism of CPPU was via hydroxylation of the phenyl
ring. The sulfate conjugate of hydroxyl CPPU was the major metabolite
excreted in the urine, accounting for as much as approximately 96% of
the urinary radioactivity. Tissue residues accounted for less than 1%
of the administered dose at 168 hours post-dosing.
7. Metabolite toxicology. Metabolites occur at levels below 0.1 ppm
and, therefore, are below levels required to be assayed in animal
testing.
8. Endocrine disruption. Potential endocrine effects. No special
studies to
[[Page 18379]]
investigate the potential for endocrine effects of CPPU have been
performed. However, as summarized above, a large and detailed
toxicology data base exists for the compound including studies in all
required categories. These studies include acute, sub-chronic, chronic,
developmental, and reproductive toxicology studies including detailed
histology and histopathology of numerous tissues, including endocrine
organs, following repeated or long-term exposures. These studies are
considered capable of revealing endocrine effects. The results of all
of these studies show no evidence of any endocrine-mediated effects and
no pathology of the endocrine organs. Consequently, it is concluded
that CPPU does not possess estrogenic or endocrine disrupting
properties.
C. Aggregate Exposure
1. Dietary exposure. The dietary exposure assessment was conducted
by Environs for foods containing forchlorfenuron: CAS Number: 68157-60-
8 (CPPU).
i. Food. A reference dose (RfD) was calculated using the most
sensitive species data available from the toxicological testing. This
RfD 0.08 mg/kg/day/based on a temporary tolerance of 0.01 ppm, was used
to calculate the impact of the estimated residue levels with results
from treatment of the indicated crops. The table below shows the
theoretical maximum residue concentrations (TMRC) of CPPU on or in the
listed crops requested in the EUP request.
Theoretical maximum residue concentrations for CPPU for the crops
listed in the EUP request
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Total Exposure
All - Apples All + Apples -------------------------------------
Mg/kg bwt/day Percent of RfD
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General U.S. populations (all .000005 .000011 .000016 .02
seasons)
----------------------------------------------------------------------------------------------------------------
Non-nursing infants .000029 .000064 .000093 .12
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Children (1 to 6 years of age) .000010 .000048 .000058 .07
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Children (7 to 12 years of age) .000005 .000017 .000022 .03
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The anticipated use rate of 17 grams of CPPU per acre applied once
per year yielding residue levels in the very low ppb range indicates
that less than 1% of the RfD would be consumed in aggregate with all of
these crops. The crop contributing greatest to the percent of the RfD
related to the most sensitive of the population, i.e., all nursing
infants (less than 1-year old) would represent 1/10\th\ of 1% of the
RfD. Making the same risk exposure calculations, it is shown that there
is no significant impact on reducing the RfD by using almonds, apples,
blueberries, figs, grapes, kiwi fruit, pears, and plums in aggregate.
Combining the RfD consumption from the large group of crops with that
of apples would exceed 1% of the reference dose only slightly if the
total acreage of all these crops were treated. The intention of this
experimental use permit is not to treat all of the various crops
listed; the following table shows the requested acreage of each crop.
----------------------------------------------------------------------------------------------------------------
Crop Acreage Requested % Total Acreage
----------------------------------------------------------------------------------------------------------------
Grape 3,500 0.53
----------------------------------------------------------------------------------------------------------------
Kiwi fruit 250 0.05
----------------------------------------------------------------------------------------------------------------
Almond 50 0.01
----------------------------------------------------------------------------------------------------------------
Apple 50 0.14
----------------------------------------------------------------------------------------------------------------
Blueberries 50 --
----------------------------------------------------------------------------------------------------------------
Figs 50 0.40
----------------------------------------------------------------------------------------------------------------
Plums 50 0.03
----------------------------------------------------------------------------------------------------------------
Pears 20 0.15
----------------------------------------------------------------------------------------------------------------
This program would permit development of requisite data to assure
safe and efficacious use and, yet, not subject any segment of the
public to a health risk.
Acute (1-day) exposure would not represent any hazard since no
acute exposure was identified in this risk assessment.
ii. Drinking water. The very low use rate of CPPU, i.e., 17 grams
active ingredient (a.i.) or less per acre if used constantly for 20
years would apply less than a pound of CPPU per acre during that 20
year period. Computer modeling, using the conservative pesticide root
zone model (PRZM) means of analysis has shown that no CPPU would reach
ground water, even in sandy loam soils. The results of this risk
analysis supported an unambiguous conclusion of ``essentially zero risk
to ground water'' even under reasonable worst-case assumptions.
Concentrations are not predicted to exceed 15 to 20 ppb of CPPU in the
soil in the upper soil horizons, even following yearly applications for
as long as 30 years. No secondary exposure is anticipated as a result
of contamination of drinking water.
2. Non-dietary exposure. No non-dietary exposure is expected since
CPPU is not anticipated to be found in the drinking water. This
material does not translocate in plants and thus secondary exposure
through plants growing in soil receiving CPPU is not anticipated. The
extremely low
[[Page 18380]]
application rates will not result in significant buildup in the
environment. Data indicate that any parent material of CPPU left in the
soil will be strongly bound to soil particles and will not move.
D. Cumulative Effects
There are no cumulative effects expected since CPPU is not taken up
by plants from the soil. It slowly degrades to mineral end points. Its
low use rates and infrequent applications are not conducive to buildup
in the environment.
E. Safety Determination
1. U.S. population. As pointed out above in dietary exposure-food,
the percentage of the RfD consumed by treating the subject crops
represents only slightly more than 1% of the estimated safe level for
the most sensitive segment of the population, non-nursing infants.
2. Infants and children. No developmental, reproductive or
fetotoxic effects have been associated with CPPU. The calculation of
safety margins with respect to these segments of the population were
taken into consideration in the TMRC estimates with respect to the risk
associated with the percentage of the reference dose being consumed.
F. International Tolerances
There is no Codex maximum residue level established for CPPU.
However, CPPU is registered for use on grapes and other crops in Japan,
Chile, Mexico, and South Africa.
[FR Doc. 04-7651 Filed 4-6-04; 8:45 am]
BILLING CODE 6560-50-S