[Federal Register Volume 69, Number 37 (Wednesday, February 25, 2004)]
[Notices]
[Pages 8649-8654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3937]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0030; FRL-7344-6]


Novaluron; Notice of Filing a Pesticide Petition to Establish a 
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 identification (ID) number OPP-
2004-0030, must be received on or before March 26, 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: Daniel C. Kenny, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7546; 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-2004-0030. 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

[[Page 8650]]

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 EPA's 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.1. 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 in 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-2004-0030. 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.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2004-0030. 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-2004-0030.
    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-2004-0030. 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.

[[Page 8651]]

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: February 12, 2004.
 Lois Rossi,
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 petitioner 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.

Makhteshim-Agan of North America, Inc.

PP 2F6430

    EPA has received a pesticide petition (2F6430) from Makhteshim-Agan 
of North America, Inc. (MANA), 551 Fifth Avenue, Suite 1100, New York, 
NY 10176 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 
346a(d), to amend 40 CFR part 180 by establishing a tolerance for 
residues of novaluron in or on the raw agricultural commodity pome 
fruits (excluding pears) at 1.0 parts per million (ppm), apple pomace 
at 6.0 ppm, pears at 2 ppm, cottonseed at 0.3 ppm, cotton gin by-
products at 17 ppm, tuberous and corm vegetables (Crop Subgroup 1-C) at 
0.05 ppm, cattle meat at 0.3 ppm, cattle meat-by-products at 6.0 ppm, 
cattle fat at 6.0 ppm, cattle liver at 0.4 ppm, cattle kidney at 0.4 
ppm, and milk at 0.4 ppm. EPA has determined that the petition contains 
data or information regarding the elements set forth in section 
408(d)(2) of 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. The qualitative nature of the residue of 
novaluron in plants is adequately understood based on acceptable apple, 
cabbage, cotton, and potato metabolism studies. These plant metabolism 
studies have demonstrated that novaluron does not metabolize and is 
non-systemic (does not translocate within the plant). The results 
observed in the plant and livestock metabolism studies show similar 
metabolic pathways. The residue of concern, which should be regulated, 
is the parent compound, novaluron, only.
    2. Analytical method. An adequate analytical method, gas 
chromatography/electron capture detector (GC/ECD), is available for 
enforcing tolerances of novaluron residues in or on plant and animal 
commodities. The amount of novaluron in most crop matrices is 
determined using GC with ECD. GC is also used to determine residues of 
novaluron in milk, bovine fat, kidney, liver, and meat.
    3. Magnitude of residues--i. Pome fruits. Field residue trials were 
conducted on pome fruits (total of 23 trials on apples including a 
processing study, and 10 trials on pears), in several locations in the 
U.S. and Canada (2000-2002). In view of the proposed use directions 
(maximum seasonal rate of 1 lb active ingredient per acre, up to 4 
applications, pre-harvest-interval of 14 days), the maximum novaluron 
residue found on apples was 0.876 ppm, which is below the proposed 
tolerance of 1.0 ppm for pome fruit (excluding pears). The highest 
residues measured on pears following 6 applications at a seasonal rate 
of 2 lb active ingredient per acre were 1.9 ppm, which is below the 
proposed tolerance of 2 ppm. Residues in juice from apple processing 
were below 0.05 ppm, demonstrating that there was no concentration in 
juice and therefore no need for proposing a tolerance. The proposed 
tolerance for apple pomace of 6 ppm is supported by using the highest 
average residues measured in the field (0.774 ppm) multiplied by the 
established concentration factor of 7.2 from the available apple 
processing study.
    ii. Cotton. Seventeen residue trials were conducted in the U.S. 
over a 2-year period (2000-2002). The novaluron residues in cottonseed 
ranged from less than 0.05 to 0.23 ppm, and in cotton gin by-products 
the residues ranged from 3.5 ppm to 14.8 ppm, following the proposed 
use directions. Therefore, tolerances of 0.3 ppm for cottonseed and 17 
ppm for cotton gin by-products are being requested.
    iii. Tuberous and corm vegetable subgroup (Crop Subgroup 1-C). A 
series of potato residue trials in support of the tuberous and corm 
vegetable subgroup was conducted over a 2-year period (1999-2000) in 
Europe (Germany, France, Spain, and Italy). Treatments were made twice 
at 0.022 lb active ingredient per acre with the last application 21 
days before harvest, in addition to residue decline studies with 
sampling dates of 0, 3, 7, 14, and 21 days after the last application. 
No residues were detected above 0.01 ppm limit of quantitation (LOQ), 
even at sampling dates right after the last application. Data from 
field trials conducted in Oregon and Pennsylvania (2002), using an 
exaggerated rate of 0.25 lb active ingredient per acre at 21 and 7 days 
before harvest, also indicate that no measurable residues were detected 
(LOQ = 0.05 ppm). Therefore, the generated data set is in full support 
of the proposed tolerance of 0.05 ppm.

B. Toxicological Profile

    1. Acute toxicity. In an acute oral toxicity study in rats, 
novaluron had a lethal dose (LD)50 5,000 mg/kg. A 
dermal toxicity study in rats resulted in an LD50 greater 
than 2,000 mg/kg. The lethal concentration (LC)50 for acute

[[Page 8652]]

inhalation in rats was greater than 5.15 milligrams/Liter (mg/L). In 
rabbits, novaluron is not a skin irritant but it is a mild eye 
irritant. Novaluron is not a sensitizer in guinea pigs.
    2. Genotoxcity. The mutagenic potential of novaluron was 
investigated in several in vivo and in vitro studies. Results in two 
Ames assays, an in vivo mouse micronucleus assay, an in vitro 
unscheduled DNA synthesis (UDS) assay, an in vitro cell mutation assay, 
and an in vitro human lymphocyte clastogenicity test were negative. 
Novaluron is therefore considered to have no potential to induce 
mutagenicity.
    3. Reproductive and developmental toxicity--i. A 2-generation rat 
reproduction study was conducted with dose levels of 1,000, 4,000, and 
12,000 ppm (74.2, 297.5, 894.9 mg/kg/day, and 84, 336.7, 1009.8 mg/kg/
day for males and females, respectively). There were no effects on 
fertility or pregnancy at any dose. The no observed adverse effect 
level (NOAEL) was determined to be 12,000 ppm (894.9 and 1009.8 mg/kg/
day for males and females, respectively).
    ii. Teratology studies were conducted in the rat and rabbit. No 
treatment-related mortalities were observed in either study. No effect 
on survival, development or growth of fetuses was noted in either 
species in either study. The maternal and fetal NOAEL was determined to 
be 1,000 mg/kg/day (highest dose tested (HDT)) in the rat study. In the 
rabbit study the maternal and fetal NOAEL was 1,000 mg/kg/day. The 
fetal effect in the rabbit study was weight gain at 1,000 mg/kg/day. 
These two studies demonstrate that novaluron was not teratogenic in 
either rats or rabbits based on the study results.
    4. Subchronic toxicity. Rats, mice, and dogs all show the same 
toxicologic response. Generally, novaluron induces small increases in 
methemoglobin; red cells are sequestered; and, compensatory 
hematopoiesis occurs. The severity of these changes is well within the 
physiological capacity of the animals and is judged not adverse.
    Rats treated topically with novaluron in a 28-day study at 0, 75, 
400, and 1,000 mg/kg/day did not show signs of systemic toxicity. Small 
treatment-related increases in methemoglobin were seen in both sexes at 
1,000 mg/kg/day and in females at 400 mg/kg/day. The highest 
methemoglobin value seen in females was 1.28% compared with 0.86% in 
controls. Organ weights, macroscopic and microscopic examination of 
organs and tissues did not reveal any treatment-related changes.
    i. Two 13-week rat studies were conducted. In one study, doses were 
administered at 50, 100, 200, 400 ppm (3.52, 6.93, 13.83, 27.77 mg/kg/
day and 4.38, 8.64, 17.54, and 34.39 mg/kg/day for males and females, 
respectively). The NOAEL was 400 ppm, the HDT (27.77 and 34.39 mg/kg/
day for males and females, respectively). In the second 13-week rat 
study, doses were administered at 50, 100, 10,000, and 20,000 ppm (4.2, 
8.3, 818.5, 1666.9 mg/kg/day and 4.7, 8.9, 871, 1820.6 mg/kg/day for 
males and females, respectively). The NOAEL was determined to be 8.3 
mg/kg/day. The lowest observed adverse effect level (LOAEL) of 818.5 
mg/kg/day, is based on histopathological parameters in the spleen.
    ii. A 13-week mouse study was conducted with dose levels of 30, 
100, 1,000, 10,000 ppm (4.2, 12.8, 135.9, 1391.9 mg/kg/day and 4.7, 
15.2, 135.6, 1493.1 mg/kg/day, for males and females, respectively). 
The NOAEL was determined to be 100 ppm (12.8 and 15.2 mg/kg/day, male 
and females, respectively). The LOAEL was 1,000 ppm (135.9 and 135.6 
mg/kg/day, males and females, respectively) based on increased body 
weight gain, low erythrocyte counts, and secondary splenic changes. 
There were no clinical treatment-related signs noted.
    iii. Two 13-week dog studies were conducted. One study resulted in 
an NOAEL of 100 mg/kg/day and a LOAEL of 300 mg/kg/day based on low 
erythrocyte counts and secondary splenic and liver changes. No clinical 
treatment-related signs were noted. Another study, was conducted using 
only one dose level of 10 mg/kg/day. There were no clinical or 
histopathological treatment-related signs and the NOAEL was determined 
to be 10 mg/kg/day.
    5. Chronic toxicity--i. Chronic toxicity and oncogenicity was 
evaluated in the rat, mouse and dog. The rat chronic toxicity and 
oncogenicity was conducted with dose levels of 25, 700, 20,000 ppm 
(1.25, 35, 1,000 mg/kg/day). The no observed effect level (NOEL) was 25 
ppm (1.25 mg/kg/day) based on methemoglobin. There was no evidence of 
carcinogenicity in this study. A mouse chronic toxicity study was 
conducted with dose levels of 30, 450, 7,000 ppm (4.5, 67.5, 1,050 mg/
kg/day). The NOEL was 30 ppm (4.5 mg/kg/day) based on methemoglobin. 
There was also no evidence of carcinogenicity in this study. Chronic 
toxicity was investigated in dogs using dose levels of 10, 100, 1,000 
mg/kg/day. The NOEL of 100 mg/kg/day was based on methemoglobin.
    ii. A reference dose (RfD) of 0.083 mg/kg/day has been established 
for novaluron. The RfD is based on a subchronic rat study with a NOAEL 
of 8.3 mg/kg/day, based on histopathological parameters in the spleen. 
An uncertainty factor (UF) of 100 is used.
    iii. The proposed classification of novaluron is Group E (not 
likely human carcinogen) due to results of oncogenicity studies that 
show no evidence of carcinogenicity.
    6. Animal metabolism. Metabolism studies in rats and goats were 
conducted with the parent material labeled in both the difluorophenyl 
and chlorophenyl moieties.
    Rats absorb little novaluron when it is administered orally. More 
than 90% of the dietary administered chlorophenyl \14\C(U) novaluron is 
recovered in the feces. When the diflurophenyl ring of the molecule is 
labeled, the recovered \14\C activity in the feces is lower but still 
above 75%. The difference is thought to reflect intestinal metabolism 
by microbial flora and the higher absorption of the diflurophenyl 
metabolites.
    The parent molecule as well as its degradates are absorbed from the 
gastrointestinal tract (GI). All parent material is metabolized either 
upon initial entry into the systemic circulation or, if sequestered to 
the fat, upon its depuration back to the systemic circulation. There is 
no intact novaluron found in the urine. Novaluron's high octanol-water 
partition coefficient is responsible for its preferential movement to 
fat. The half-life in fat calculated from the rat metabolism study is 
approximately 55 hours.
    Two groups of metabolites are formed after oral administration of 
novaluron. One group is typified by the aniline metabolite 3-chloro-4-
(1,1,2-trifluoro-2-trifluoromethoxyethoxy) aniline, referred to as 3-
TFA. The other group of metabolites is typified by 2,6-difluorobenzoic 
acid is from the diflurophenyl moiety of the molecule. Nearly all the 
metabolites are formed at a level of 1% or less of the applied dose. 
They are rapidly excreted.
    The metabolism in goats mimics that seen in rats.
    7. Metabolite toxicology. Makhteshim-Agan of North America Inc., 
has determined that there are no metabolites of toxicological concern 
and therefore, no metabolites need to be included in the tolerance 
expression and require regulation.
    8. Endocrine disruption. No special studies investigating potential 
estrogenic or other endocrine effects of novaluron have been conducted.

[[Page 8653]]

 However, inspection of in-life data from toxicology studies does not 
indicate that novaluron is an endocrine disruptor. Specifically, 
endocrine organ weights (e.g., thyroid, testes, ovaries, pituitary from 
the 2-generation study) were not adversely affected by novaluron. 
Milestones of sexual development were not affected by novaluron; and, 
reproduction was not adversely affected. Based on these observations, 
there is no evidence to suggest that novaluron has an adverse effect on 
the endocrine system.

C. Aggregate Exposure

    Dietary exposure. Tolerances are proposed for residues of novaluron 
in or on pome fruit (excluding pears), apple pomace, pears, cottonseed, 
cotton gin by-products, tuberous, and corm vegetables, cattle meat, 
fat, liver, kidney, meat by-products, and milk. For the purpose of 
assessing the potential dietary exposure for these proposed tolerances, 
an exposure assessment was conducted using Exponent's Dietary Exposure 
Evaluation Model (DEEM) software, consumption data derived from the 
1994-1998 United States Department of Agriculture (USDA) Continuing 
Surveys of Food Intake by Individuals (CSFII), residue levels at 
proposed tolerance levels, and projected percent crop treated for 
cotton and pome fruit at market maturity, and assuming 100% crop 
treated for potatoes.
    1. Food--i. Acute dietary exposure. No acute dietary assessments 
were conducted since no toxicological endpoint attributable to a single 
exposure was identified in the available toxicology studies, including 
the rat and rabbit developmental studies.
    ii. Chronic dietary exposure. The appropriate RfD value for 
novaluron is 0.083 mg/kg/day, based upon the NOAEL of 8.3 mg/kg/day 
from the 13-week oral rat study and an UF of 100. The chronic dietary 
exposure estimate for the overall U.S. population is 1.5% of the RfD of 
0.083 mg/kg/day. Children 1 to 2 years old, the most exposed population 
subgroup, utilize 7.6% of the RfD. The chronic exposure estimates for 
the overall U.S. population and 32 population subgroups, including 
infants and children, were less than 8% of the RfD. Based on these 
exposure estimates, Makhteshim-Agan of North America, Inc., concludes 
that there is reasonable certainty of no harm for the use of novaluron 
on pome fruit, cotton, tuberous, and corm vegetables.
    2. Drinking water. A comparison of the calculated drinking water 
level of concern (DWLOC) value to the drinking water estimated 
concentration (DWEC) is made. If the DWLOC exceeds the DWEC value then 
there is reasonable certainty that no harm will result from the short-
term or the intermediate-term aggregate exposure. There are no 
monitoring data for novaluron, so the Food Quality Protection Act 
(FQPA) Index Reservoir Screening Tool (FIRST) model was used to 
estimate a surface water residue. Estimated DWLOC values are 767 parts 
per billion (ppb) for children (1 to 2 years old), 2,470 ppb for adult 
females, and 2,861 ppb for the U.S. population. Since the calculated 
DWLOC values for the U.S. population and all its subgroups considerably 
exceed the modeled DWEC of 0.14 ppb in surface water, Makhteskim-Agan 
of North America Inc., concludes that there is reasonable certainty 
that no harm will result from aggregate (food and water) exposure to 
novaluron residues.

D. Cumulative Effects

    To Makhteskim-Agan of North America's Inc., knowledge, there are 
currently no available data or other reliable information indicating 
that any toxic effects produced by novaluron would be cumulative with 
those of other chemical compounds; thus only the potential risks of 
novaluron have been considered in this assessment of its aggregate 
exposure.

E. Safety Determination

    1. U.S. population. No acute dietary assessment was conducted 
because there is no toxicological endpoint attributable to a single 
exposure. A conservative chronic exposure analysis was conducted, using 
tolerance level residues, with adjustments for percent crop treated at 
product maturity (cotton and pome fruits), and no adjustment for 
potatoes (100% treated). The chronic novaluron exposure is low, 
accounting for 0.8% to 7.6% of the RfD, depending on the population 
subgroup. The chronic exposure for the U.S. population is 0.001243 mg/
kg/day, which uses 1.5% of the RfD. The most sensitive population 
subgroup, children 1 to 2 years old, has a chronic exposure of 0.006339 
mg/kg/day, which utilizes only 7.6% of the RfD. Based on the lack of 
acute toxicity and the chronic exposure analyses, Makhteskim-Agan of 
North America Inc., concludes that there is reasonable certainty that 
no harm will result from acute and chronic exposure to novaluron.
    2. Infants and children--i. General. Data from rat and rabbit 
developmental toxicity studies and a 2-generation rat reproduction 
study have been used to assess the potential for increased sensitivity 
of infants and children. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from pesticide exposure during prenatal development. 
Reproduction studies provide information relating to reproductive and 
other effects on adults and offspring from prenatal and postnatal 
exposure to the pesticide. FFDCA section 408 provides that EPA may 
apply an additional safety factor for infants and children to account 
for prenatal and postnatal toxicity and the completeness of the data 
base. Makhteskim-Agan of North America Inc., concludes that the 
toxicology data base for novaluron regarding potential prenatal and 
postnatal effects in children is complete according to existing Agency 
data requirements and does not indicate any developmental or 
reproductive concerns.
    ii. Developmental toxicity studies. In the rat developmental study, 
the maternal NOAEL was determined to be 1,000 mg/kg/day based on slight 
increase in body weight gain and food consumption and the fetal NOAEL 
was determined to be 1,000 mg/kg/day, the HDT. There was no effect on 
survival, development or growth of the fetuses. There were no 
developmental effects noted in the rabbit study, even at the limit dose 
level (1,000 mg/kg/day), however, slight maternal toxicity (body weight 
effects) was observed at the limit dose level.
    iii. Reproductive toxicity studies. There was no evidence of 
adverse effects on reproductive capability, fertility or pregnancy, 
observed at any dose level in the rat 2-generation reproductive study. 
However, there was increased bodyweight and spleen weight, and 
hemosiderosis of the spleen at the high dose. The NOAEL was 894.9 in 
males and 1009.8 mg/kg/day in females, the HDT.
    iv. Conclusion. Based on the absence of fetal effects and pup 
toxicity in any of the reference studies, Makhteskim-Agan of North 
America Inc., concludes that reliable data support the use of the 
standard 100-fold UF, and that an additional UF is not needed to 
protect the safety of infants and children. In addition, the RfD is 
based on a NOAEL of 8.3 mg/kg/day (from a 13-week rat study), which is 
already more than 120-fold lower than the NOAEL in the rabbit 
developmental toxicity study. Thus, the proposed RfD of 0.083 mg/kg/day 
is considered to be appropriate for assessing potential risks to 
infants and children and an additional FQPA safety factor is not 
warranted. As noted previously, the aggregate chronic exposure 
assessment utilizes less than 8% of the RfD for the entire U.S.

[[Page 8654]]

population and various population subgroups, including the most 
sensitive subgroup, children 1 to 2 years old. Therefore, Makhteskim-
Agan of North America Inc., concludes that there is reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to novaluron residues.

F. International Tolerances

    There are no Canadian, Mexican, or Codex maximum residue limits 
established for novaluron. Therefore, international harmonization is 
not an issue at this time.
[FR Doc. 04-3937 Filed 2-24-04; 8:45 am]
BILLING CODE 6560-50-S