[Federal Register Volume 69, Number 67 (Wednesday, April 7, 2004)]
[Notices]
[Pages 18375-18380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7651]


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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: [email protected].

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 [email protected], 
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

----------------------------------------------------------------------------------------------------------------
                                                                                       Total Exposure
                                         All - Apples       All + Apples   -------------------------------------
                                                                              Mg/kg bwt/day      Percent of RfD
----------------------------------------------------------------------------------------------------------------
General U.S. populations (all                   .000005            .000011            .000016                .02
 seasons)
----------------------------------------------------------------------------------------------------------------
Non-nursing infants                             .000029            .000064            .000093                .12
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years of age)                  .000010            .000048            .000058                .07
----------------------------------------------------------------------------------------------------------------
Children (7 to 12 years of age)                 .000005            .000017            .000022                .03
----------------------------------------------------------------------------------------------------------------

    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