[Federal Register Volume 68, Number 100 (Friday, May 23, 2003)]
[Notices]
[Pages 28218-28222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13005]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0172; FRL-7307-5]


Flonicamid; 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 ID number OPP-2003-0172, must be 
received on or before June 23, 2003.

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: Ann Sibold, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6502]; 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 a 
commercial grower of food or feed crops. Potentially affected entities 
may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] 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. EPA Docket. EPA has established an official public docket for 
this action under docket ID number OPP-2003-0172. 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

[[Page 28219]]

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-2003-0172. 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-2003-0172. 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-2003-0172.
    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-2003-0172. 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.

[[Page 28220]]

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: May 13, 2003.
Debra Edwards,
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 ISK Bioscience Corporation, 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.

ISK Biosciences Corporation

PP 3F6552

     EPA has received a pesticide petition [3F6552] from ISK 
Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio, 
44077, proposing, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 
by establishing tolerances for the combined residues of the insecticide 
flonicamid, (N-cyanomethyl-4-trifluoromethylnicotinamide) and its 
metabolites, TFNA, (4-trifluoromethylnicotinic acid), TFNA-AM, (4-
trifluoromethylnicotinamide) and TFNG, (N-(4-
trifluoromethylnicotinoyl)-glycine) in or on the raw agricultural 
commodities: Celery, at 1.2 parts per million (ppm); cotton, at 0.5 
ppm; cotton, gin trash, at 6.0 ppm; cotton, hulls, at 1.0 ppm; cotton, 
meal, at 1.0 ppm; fruit, pome, group 11, at 0.2 ppm; fruit, stone, 
group 12, except plum and fresh prune plum, at 0.7 ppm; lettuce, head, 
at 1.0 ppm; lettuce, leaf, at 4.0 ppm; plum, at 0.1 ppm; potato, at 0.2 
ppm; potato, flakes, at 0.4 ppm; prune, fresh, at 0.1; spinach, at 9.0 
ppm; tomato, paste, at 2.0 ppm; tomato, puree, at 0.5 ppm; vegetable, 
cucurbit, group 9, at 0.4 ppm; vegetable, fruiting, group 8, at 0.4 
ppm; by establishing tolerances for the combined residues of the 
insecticide flonicamid, (N-cyanomethyl-4-trifluoromethylnicotinamide) 
and its metabolite TFNA-AM, (4-trifluoromethylnicotinamide) in animal 
tissues and poultry meat byproducts: Cattle, fat, at 0.01 ppm; cattle, 
meat, at 0.04 ppm; eggs, at 0.02 ppm; goat, fat, at 0.01 ppm; goat, 
meat, at 0.04 ppm; hog, fat, at 0.01; hog, meat, at 0.01 ppm; horse, 
fat, at 0.01 ppm; horse, meat, at 0.04 ppm; milk, at 0.02 ppm; poultry, 
fat, at 0.01 ppm; poultry, meat, at 0.01 ppm; poultry, meat byproducts, 
at 0.01 ppm; sheep, fat, at 0.01 ppm; sheep, meat, at 0.04 ppm; by 
establishing tolerances for the combined residues of the insecticide 
flonicamid, (N-cyanomethyl-4-trifluoromethylnicotinamide) and its 
metabolites TFNA, (4-trifluoromethylnicotinic acid) and TFNA-AM, (4-
trifluoromethylnicotinamide) in the animal meat byproducts: cattle, 
meat byproducts, at 0.06 ppm; goat, meat byproducts, at 0.06 ppm; hog, 
meat byproducts, at 0.01 ppm; horse, meat byproducts, at 0.06 ppm; and 
sheep, meat byproducts, at 0.06 ppm.

A. Residue Chemistry

    1. Plant metabolism. Wheat, potato and peach metabolism studies 
were conducted using [14C]-pyridyl-flonicamid. The metabolic 
profile was similar for all three matrices. The major metabolites for 
the various crops were: TFNA in peach, TFNA and TFNG in potato, and 
TFNG in wheat. The metabolism of flonicamid in plants shows, the main 
pathway of metabolism involves hydrolysis of -CN and CONH2 
functional groups in the molecule. The metabolism of flonicamid in 
plants is well understood.
    2. Analytical method. Analytical methodology has been developed to 
determine the residues of flonicamid and its three major plant 
metabolites, TFNA, TFNG, and TFNA-AM in various crops. The residue 
analytical method for the majority of crops includes an initial 
extraction with acetonitrile (ACN)/deionized (DI) water, followed by a 
liquid-liquid partition with ethyl acetate. The residue method for 
wheat straw is similar, except that a C18 solid phase 
extraction (SPE) is added prior to the liquid-liquid partition. The 
final sample solution is quantitated using a liquid chromatograph (LC) 
equipped with a reverse phase column and a triple quadruple mass 
spectrometer (MS/MS).
    3. Magnitude of residues. Residue data were collected on various 
crops and crop groups during field trials. Maximum total residues for 
cucurbits (total of 17 field trials) ranged from 0.164 (summer squash) 
to 0.333 ppm (cucumber). Maximum total residues for stone fruits (total 
of 21 field trials) ranged from 0.092 (plum) to 0.520 ppm (cherry). 
Maximum total residues for pome fruits (total of 18 field trials) 
ranged from 0.054 (pears) to 0.169 ppm (apples). Maximum total residues 
for fruiting vegetables (total of 21 field trials) ranged from 0.195 
(bell pepper) to 0.290 ppm (non-bell pepper). Maximum total residues 
for leafy vegetables (total of 24 field trials) ranged from 0.049 (head 
lettuce without wrappers) to 7.978 ppm (spinach). Maximum total 
residues for cottonseed with linters (12 field trials) were 0.343 and 
for gin trash were 5.001 ppm. Maximum total residues for potatoes 
(total of 17 field trials) were 0.119 ppm.

B. Toxicological Profile

    1. Acute toxicity. A battery of acute toxicity studies was 
conducted which placed flonicamid technical in Toxicity Category III 
for oral lethal dose (LD)50, Category IV for dermal 
LD50, inhalation LC50, dermal irritation, and eye 
irritation. Flonicamid technical is not a dermal sensitizer. In an 
acute neurotoxicity study, the no observed adverse effect levels 
(NOAELs) for neurotoxicity were 600 milligrams/kilogram (mg/kg) in 
males and 1,000 mg/kg in female (highest doses tested). The systemic 
NOAELs were 600 mg/kg in males and 300 mg/kg in females.
    2. Genotoxicty. Flonicamid technical did not cause mutations in the 
bacterial reverse mutation or mouse lymphoma tests with or without 
metabolic activation, chromosome damage in the mouse micronucleus or 
cytogenetics tests with and without metabolic activation, an increase 
in DNA damage in the comet assay or in an in vivo rat unscheduled DNA 
synthesis (UDS) study. Based on the weight of evidence, it is concluded 
that, flonicamid technical is not genotoxic.
    3. Reproductive and developmental toxicity. A developmental 
toxicity study in rats resulted in the maternal and developmental no 
observed adverse effect levels (NOAELs) of 100 mg/kg/day. The maternal 
lowest observed adverse effect level (LOAEL) was 500 mg/kg/day based on 
the treatment-related effects observed on the liver and kidney of the 
dams in the highest dose group. The developmental LOAEL was 500 mg/kg/
day based on the increases in placental weights and incidences of fetal 
skeletal variations seen only at maternally toxic doses of 500 mg/kg/
day.
     In the rabbit developmental toxicity study, the maternal and 
developmental NOAELs were 7.5 mg/kg/day and 25 mg/kg/day highest dose 
tested (HDT), respectively. The maternal LOAEL was 25 mg/kg/day based 
on decreased body weights and food consumption. No adverse effects on 
the fetuses were observed at the highest dose.

[[Page 28221]]

     In the multi-generation rat reproduction study, the NOAEL was 300 
ppm for both parental animals (13.5-32.8 and 16.3-67.0 mg/kg/day, 
respectively, for males and females) and their offspring. The effects 
at the highest dose of 1,800 ppm included the following: increased 
kidney weights and gross and histopathological alterations in the 
kidney. Findings noted in the top dose females included delayed vaginal 
opening and increased liver, kidney and spleen weights in the F1 
generation and reduced ovary and adrenal weights in the parental 
generation and decreased uterine weights in the F1 female weanlings. 
There was an increase in the FSH and LH levels in F1 females tested for 
these endpoints. These findings did not affect the reproductive 
performance or survival of offspring in the study.
    4. Subchronic toxicity. The NOAEL for flonicamid technical in the 
rat 28-day dermal toxicity study was 1,000 mg/kg/day, which was the 
highest dose tested.
     In a 90-day rat feeding study the NOAEL was established at 200 ppm 
(12.11 mg/kg/day) for males and 1,000 ppm (72.3 mg/kg/day) for females. 
The NOAELs were based on effects on hematology, triglycerides, and 
pathology in the liver and kidney.
     In a 13-week mouse study, the NOAEL was 100 ppm (15.25 mg/kg/day 
in males and 20.1 mg/kg/day in females). The LOAEL is 1,000 ppm (153.9 
mg/kg/day in males and 191.5 mg/kg/day in females) based on hematology 
effects and changes in glucose, creatinine, bilirubin, sodium, chloride 
and potassium levels, increased liver and spleen weights and 
histopathology findings in the bone marrow, spleen and kidney.
     In a subchronic toxicity study in dogs with capsule 
administration, the NOAEL was 20 mg/kg/day based on findings of severe 
toxicity at a dose exceeding the maximum tolerated dose; symptoms 
included collapse, prostration and convulsions leading to early 
sacrifice at the LOAEL of 50 mg/kg/day.
     In a subchronic neurotoxicity study in rats, the NOAEL for dietary 
administration was 1,000 ppm (67 mg/kg/day in males and 81 mg/kg/day in 
females) for systemic toxicity based on body weight and food 
consumption effects. The NOAEL for neurotoxicity was 10,000 ppm (625 
and 722 mg/kg/day in males and females, respectively (highest dose 
tested).
    5. Chronic toxicity. In the chronic dog study with administration 
via using capsules, the NOAEL was 8 mg/kg/day. The LOAEL was 20 mg/kg/
day based on reduced body weights in females and effects on the 
circulating red blood cells.
     In a rat 24-month combined chronic and oncogenicity study, 
flonicamid technical was not carcinogenic in rats. The NOAEL was 200 
ppm (7.32 mg/kg/day) for males and 1,000 ppm (44.1 mg/kg/day) for 
females. The LOAEL was 1,000 ppm for males and 5,000 ppm for females 
based on histopathology in the kidney, hematology effects, hepatic 
effects including changes in biochemical parameters, increased organ 
weights, and histopathological changes. Atrophy of striated muscle 
fibers, cataract and retinal atrophy observed in the high dose females 
were considered to be due to acceleration of spontaneous age-related 
lesions.
     In the 18-month mouse study, effects were observed in the lung, 
liver, spleen and bone marrow at 250 ppm or higher. Findings included, 
centrilobular hepatocellular hypertrophy, extramedullary hematopoiesis 
and pigment deposition in the spleen and decreased cellularity 
(hypocellularity) in the bone marrow. There were statistically 
significant increases in the incidence of alveolar/bronchiolar adenomas 
in both sexes of treated groups with hyperplasia/hypertrophy of 
epithelial cells in terminal bronchioles. There was a statistically 
significant increase in the incidence of alveolar/bronchiolar 
carcinomas in males at 750 ppm and 2,250 ppm and in females at 2,250 
ppm only. These effects in the lungs of mice were not life threatening 
as most of effects were observed at the terminal sacrifice and there 
was no effect of treatment on mortality in the study. A NOAEL could not 
be determined from the dose levels administered. Mechanism-of-action 
studies have indicated that the lung effects are unique to the mouse 
and are not likely to translate to other species including the rat. 
Flonicamid technical was not carcinogenic in the rat.
    6. Animal metabolism. Rat, goat and poultry metabolism studies were 
conducted using [14C]-pyridyl-flonicamid. The majority of 
the dose was rapidly excreted. Flonicamid was a major component of rat 
urine 48 hours after dosing. TFNA-AM was the major metabolite found in 
rats (urine), goats (milk and tissues), and in laying hens (tissues and 
eggs). TFNG was found between 8-24% of the total radioactive residue 
(TRR) in the livers of rats sacrificed at intervals between 0.5-6 hours 
after dosing. The liver samples at these time intervals had 
14C-residues of 2.3%-4.6% of the dose. TFNA was not a major 
component in animal tissues. The metabolism of flonicamid in animals 
shows the main pathway of metabolism involves hydrolysis of -CN and -
CONH2 functional groups in the molecule, identical to plant 
metabolism. The main metabolic reactions were hydrolysis of cyano to 
the amide function and ring hydroxylation. In rats, flonicamid was 
further metabolized by several routes, including nitrile hydrolysis, 
amide hydrolysis, N-oxidation, and hydroxylation of the pyridine ring, 
leading to multiple metabolites. The metabolism of flonicamid in 
animals is well understood.
    7. Metabolite toxicology. The main metabolites of flonicamid were 
examined in acute oral toxicity studies in rats and bacterial reverse 
mutation tests. All the metabolites were less toxic than flonicamid and 
not mutagenic.
    8. Endocrine disruption. No special studies investigating potential 
estrogenic or other endocrine effects of flonicamid have been 
conducted. Some suggestions of possible endocrine effects were reported 
at the highest dose tested (1,800 ppm) in the multi-generation 
reproduction study which showed increased FSH and LH levels, a delay in 
the time to vaginal opening in the F1 generation, and reduced ovary and 
adrenal weights in the parental generation. However, there were no 
effects on reproductive performance or survival of the offspring in the 
study. At levels that are expected to be found in the environment, 
flonicamid will not cause any endocrine-related effects.

C. Aggregate Exposure

    1. Dietary exposure. Potential dietary exposures from food were 
estimated using the proposed tolerances for all crops using the Dietary 
Exposure Evaluation Model (DEEM) for acute and chronic exposure based 
on U.S. Department of Agriculture's (USDA) Continuing Surveys of Food 
Intake by Individuals (CSFII) conducted in 1994-1998, and percent crop 
treated of 100%. The following raw agricultural commodities were 
included: Leaf lettuce, head lettuce, celery, spinach, cotton, 
potatoes, fruiting vegetables, cucurbits, stone fruits, pome fruits and 
resulting secondary residues in meat, milk, poultry and eggs.
    i. Food. Acute dietary exposure was compared to the acute 
population adjusted dose (aPAD) of 3.0 mg/kg/day based on the NOAEL of 
300 mg/kg from the acute neurotoxicity study in rats and a 100-fold 
uncertainty factor. The U.S. population exposure is 0.26% of the aPAD 
and the most highly exposed subpopulation is children 1-2 with 0.56% of 
the aPAD (95th percentile).
     Based on the available data, an appropriate cPAD is 0.073 mg/kg/
day

[[Page 28222]]

based on the NOEL of 7.32 mg/kg/day from the chronic toxicity study in 
rats and a 100-fold uncertainty factor. The U.S. population exposure is 
3.2% of the cPAD and the most highly exposed subpopulation exposure is 
children 1-6 with 7.4% of the cPAD.
    ii. Drinking water. A drinking water level of comparison (DWLOC) 
was calculated by subtracting the chronic/acute food exposures 
calculated using DEEMTM from the cPAD/aPAD to obtain the 
acceptable chronic/acute exposure to flonicamid in drinking water. The 
estimated average and maximum concentration of flonicamid in surface 
water is 1.20 ppb and 1.64 ppb, respectively. These are both well below 
the lowest chronic (676 ppb) and acute (29,831 ppb) DWLOC values for 
flonicamid. Therefore, taking into account all proposed uses, it can be 
concluded with reasonable certainty that residues of flonicamid in food 
and drinking water will not result in unacceptable levels of human 
health risk.
    2. Non-dietary exposure. There are currently no residential uses of 
flonicamid registered or pending action that need to be added to the 
total risk from exposure.

D. Cumulative Effects

     In consideration of potential cumulative effects of flonicamid and 
other substances that may have a common mechanism of toxicity, to our 
knowledge there are currently no available data or other reliable 
information indicating that any toxic effects produced by flonicamid 
would be cumulative with those of other chemical compounds; thus only 
the potential risks of flonicamid have been considered in this 
assessment of its aggregate exposure. If ISK Biosciences Corporation 
learns of any other compound with the same mechanism of toxicity they 
will submit information for EPA to consider concerning potential 
cumulative effects of flonicamid consistent with the schedule 
established by EPA in the Federal Register of August 4, 1997 (62 FR 
42020) (FRL-5734-6), and other EPA publications pursuant to the Food 
Quality Protection Act (FQPA).

E. Safety Determination

    1. U.S. population. Using conservative exposure assessment 
analyses, the acute dietary exposure estimates are well below the aPAD 
of 3 milligrams/kilogram body weight/day (mg/kg bwt/day) for all 
population subgroups. In addition, the chronic dietary exposure 
estimates for the various population groups are well below the cPAD of 
0.073 mg/kg bwt/day. Based on this information, ISK Biosciences 
Corporation concludes that there is reasonable certainty that no harm 
will result from acute or chronic exposure to flonicamid.
    2. Infants and children. Based on the available developmental and 
reproductive data on flonicamid, ISK Biosciences Corporation, concludes 
that, reliable data support use of the standard 100-fold uncertainty 
factor, and that an additional uncertainty factor is not needed to 
protect the safety of infants and children under the FQPA. Although, 
the reproduction study indicated signs of toxicity to some reproductive 
organs/systems at the high dose of 1,800 ppm in the diet, other signs 
of toxicity such as effects on the kidney accompanied these; there were 
no effects observed at a dose level of 300 ppm. There were no effects 
on reproduction or survival at any dose level. Since acute and chronic 
aggregate exposure assessments are well below the aPAD and cPAD 
respectively, there is reasonable certainty that no harm will result to 
infants and children from aggregate exposure to flonicamid residues.

F. International Tolerances

     There are no Canadian or Mexican residue limits or codex MRLs for 
the insecticide flonicamid and its metabolites TFNA, TFNA-AM, and TFNG.
[FR Doc. 03-13005 Filed 5-22-03; 8:45 am]
BILLING CODE 6560-50-S