[Federal Register Volume 69, Number 18 (Wednesday, January 28, 2004)]
[Notices]
[Pages 4143-4147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1240]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0407; FRL-7339-6]


Cyfluthrin; Notice of Filing of Pesticide Petitions 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 pesticide 
petitions 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-2003-0407, must be 
received on or before February 27, 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:  Susan Stanton, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; 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-2003-0407. 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

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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-2003-0407. 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-2003-0407. 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-2003-0407.
    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-2003-0407. 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 pesticide petitions 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: January 7, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner's summary of the pesticide petitions is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions was prepared by Bayer CropScience 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

[[Page 4145]]

pesticide chemical residues or an explanation of why no such method is 
needed.

 Bayer CropScience

 Rutgers State University

 PP 1E6318, PP 1F6290, PP 2F6445, PP 2F6479, PP 3E6776, PP 3E6583

     EPA has received pesticide petitions (PP 1F6290, PP 2F6445, PP 
2F6479) from Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709 and pesticide petitions (PP 1E6318, PP 
3E6583, PP 3E6776) from the Interregional Research Project Number 4 
(IR-4), Technology Centre and Rutgers State University of New Jersey, 
681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390 
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 180.436 by 
establishing a tolerance for residues of cyfluthrin (cyano (4-fluoro-3-
phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-
cyclopropanecarboxylate) in or on raw agricultural commodities as 
follows:
    1. PP 1F6290 proposes tolerances for tree nuts, Crop Group 14 at 
0.01 parts per million (ppm), almond hulls at 1.0 ppm, and pistachio at 
0.01 ppm.
    2. PP 1E6318 proposes tolerances for tuberous and corm vegetable 
subgroup at 0.01 ppm.
    3. PP 2F6445 proposes tolerances for wheat forage, wheat hay and 
wheat straw at 5.0 ppm, wheat shorts at 3.5 ppm, leafy vegetable group 
at 6.0 ppm, leafy brassica greens subgroup at 7.0 ppm, fruiting 
vegetable group at 0.5 ppm, cucurbit vegetable crop group at 0.10 ppm, 
pome fruit group at 0.10 ppm, pome fruit wet pomace at 0.30 ppm, and 
stone fruit group at 0.30 ppm.
    4. PP 2F6479 proposes tolerances for grape at 0.8 ppm, grape, 
raisin at 3.5 ppm, peanut at 0.01 ppm, and peanut, hay at 6.0 ppm.
    5. PP 3E6583 proposes tolerances for turnip greens at 7 ppm.
    6. PP 3E6776 proposes tolerances for grass forage at 6 ppm, grass 
hay at 8 ppm, and pea and bean, dried shelled, except soybean, subgroup 
6C at 0.15 ppm.
     EPA has determined that the petitions contain 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 
petitions. Additional data may be needed before EPA rules on the 
petitions.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of cyfluthrin in plants is 
adequately understood. Studies have been conducted to delineate the 
metabolism of radiolabeled cyfluthrin in various crops all showing 
similar results. The residue of concern is cyfluthrin.
    2. Analytical method. Adequate analytical methodology using GC/EC 
detection is available for enforcement purposes.
    3. Magnitude of residues. Complete residue data are available for 
cyfluthrin on the crops and crop groupings in PP 1F6290, PP 2F6445, and 
PP 2F6479. The data support the requested tolerances.
     Tuberous and corm vegetable subgroup in PP 1E6318. IR-4 received a 
request from the Agricultural Experiment Station of Mississippi for the 
use of cyfluthrin on sweet potato to control numerous insect pests. 
Cyfluthrin is already registered on potato with a tolerance of 0.01 
ppm, and potato is the representative commodity of the tuberous and 
corm vegetable subgroup, 1C. Since sweet potato is a member of subgroup 
1C, IR-4 is proposing that EPA references the registrant's potato data 
to establish a tolerance for the subgroup.
     Turnip greens in PP 3E6583. IR-4 received a request from the 
Agricultural Experiment Stations of Arkansas, Oklahoma, and Tennessee 
for the use of cyfluthrin on turnip greens to control numerous insect 
pests. A tolerance of 7 ppm has been established for cyfluthrin on 
mustard greens. Mustard greens are the sole representative crop for 
Crop Subgroup 5B:
     Leafy Brassica greens. The EPA HED Chemistry Science Advisory 
Council has approved the inclusion of turnip greens in Crop Subgroup 
5B, thus the data on mustard greens are sufficient to establish a 
tolerance on turnip greens.
     Grasses and dried shelled pea and bean (except soybean subgroup 
6C) in PP 3E6776. IR-4 has received requests from the state of 
California for the use of cyfluthrin on grass. To support this 
.request, magnitude of residue data were collected from four supervised 
crop field trials with grass at application rates of 0.024 0.03 lb 
a.i./A with pre-harvest interval(s) of 0 days for grass forage and 6-7 
days for hay. The results from these trials show that the residues of 
cyfluthrin in grass forage ranged from 0.24 ppm to 4.8 ppm after a 
total application rate of 0.024 0.03 lb a.i./A and a PKI of 0 days, and 
the residues of cyfluthrin in grass hay ranged from 0.62 ppm to 6 ppm 
after a total application rate of 0.024 0.03 lb a.i./A and a pre-
harvest interval (PHI) of 6-7 days. The nature of the residues of 
cyfluthrin are adequately understood and an acceptable analytical 
method is available for enforcement purposes. Data on dry peas and 
beans were submitted to EPA in PP 0E6075; however, the tolerance action 
included dry pea only. The data volume that contained dry bean data was 
only reviewed for the dry pea data that it contained. IR-4 requests 
that this data volume be reviewed for the dry bean data it contains and 
that these data, combined with the established dry pea tolerance, be 
used to set a subgroup 6C tolerance for cyfluthrin.

B. Toxicological Profile

    1. Acute toxicity. There is a full battery of acute toxicity 
studies for cyfluthrin supporting an overall toxicity Category II for 
the active ingredient.
    2. Genotoxicty. Based on the results of a complete genotoxicity 
data base, there is no evidence of mutagenicity activity in a battery 
of studies, including several gene mutation assays (reverse mutation 
and recombination assays in bacteria and a Chinese hamster ovary(CHO)/
HGPRT assay), a structural chromosome aberration assay (CHO/sister 
chromatid exchange assay), and an unscheduled DNA synthesis assay in 
rat hepatocytes. All tests were negative for genotoxicity.
    3.  Reproductive and developmental toxicity. A developmental 
toxicity study in rats indicated a maternal no observed adverse effect 
level (NOAEL) of 3 milligrams/kilogram body weight day (mg/kg bwt/day) 
based on reduced body weight gain and food consumption at 10 mg/kg bwt/
day. The developmental NOAEL was 10 mg/kg bwt/day, based on reduced 
fetal body weights and increased skeletal variations at the maternally 
toxic dose of 40 mg/kg bwt/day. An oral developmental toxicity study in 
rabbits with a maternal NOAEL of 20 mg/kg bwt/day and a maternal lowest 
observed adverse effect level (LOAEL) of 60 mg/kg bwt/day, based on 
decreased body weight gain and decreased food consumption during the 
dosing period. A fetal NOAEL of greater than 180 mg/kg bwt/day was also 
observed in this study. A two-generation reproduction study in rats 
indicated parental and offspring NOAELs of 3.0 mg/kg bwt/day, based on 
reductions in body weight and food consumption in the parents and 
course tremors and decreased mean litter weights in the offspring at 
9.0 mg/kg bwt/day. The NOAELs were confirmed in a supplemental two-
generation study.
    4. Subchronic toxicity. In a 28-day oral gavage study in rats, 
cyfluthrin demonstrated a NOAEL of 20 mg/kg bwt/day, based on clinical 
signs of

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neurotoxicity, decreased body weight gain and changes in liver and 
adrenal weights at 80 and 40 mg/kg bwt/day, respectively. In a 90-day 
feeding study in rats, the resulting NOAEL was 9.5 mg/kg bwt/day, based 
on decreased body weight gain, gait abnormalities, skin lesions and 
mortality seen at 37.5 mg/kg bwt/day. A 6-month toxicity feeding study 
in dogs established a NOAEL of 5 mg/kg bwt/day. The LOAEL was 15 mg/kg 
bwt/day based on clinical signs of neurotoxicity and gastrointestinal 
disturbances.
     Two subchronic inhalation studies were conducted with cyfluthrin. 
In the first study, cyfluthrin was administered via inhalation for 5 
days per week for 3 weeks. The resulting NOAEL was 1.4 mg/
m3, based on treatment-related behavioral effects, body 
weight decreases and organ weight changes at 10.5 mg/m3. In 
the second study cyfluthrin was administered via inhalation for 13-
weeks. The resulting NOAEL was 0.09 mg/m3, based treatment-
related behavioral effects in females and increased urinary protein in 
males at 0.71 mg/m3.
    5. Neurotoxicity. An acute neurotoxicity study in rats was 
conducted using beta-cyfluthrin. The NOAEL for this study is 2 mg/kg, 
based on clinical signs, changes in FOB parameters and decreases in 
motor activity noted at 10 mg/kg. In a subchronic neurotoxicity study 
with beta-cyfluthrin the resulting NOAEL was 8 mg/kg, based on clinical 
signs, changes in FOB parameters, and slightly decreased body weight 
gain and food consumption. There is no indication of delayed 
neurotoxicity as a result of exposure to cyfluthrin.
    6. Chronic toxicity. A 12-month chronic feeding study in dogs 
established a NOAEL of 2.4 mg/kg bwt/day (males) and 3.6 mg/kg bwt/day 
(females). The LOAEL for this study is established at 11 mg/kg bwt/day, 
clinical signs, gait abnormalities and abnormal postural reactions in 
males and females. A 24-month chronic feeding/carcinogenicity study in 
rats demonstrated a NOAEL of 2.6 mg/kg bwt/day and LOAEL of 11.6 mg/kg 
bwt/day, based on decreased body weights. A 24-month carcinogenicity 
study in mice was conducted. The NOAEL was 31.9 (males) and 140.6 
(females) mg/kg/bwt/day. The LOAEL was 114.8 mg/kg bwt/day (males) 
based on ear skin lesions and reduced body weight gains, and 309.7 mg/
kg bwt/day (females) based on clinical signs, macroscopic and 
microscopic pathology findings and reduced body weights, body weight 
gains, and food consumption. Under the conditions of these studies, 
there was no evidence of carcinogenic potential.
    7. Animal metabolism. A metabolism study in rats showed that 
cyfluthrin is rapidly absorbed and excreted, mostly as conjugated 
metabolites in the urine, within 48 hours. An enterohepatic circulation 
was observed.
    8. Metabolite toxicology. No toxicology data have been required for 
cyfluthrin metabolites. The residue of concern is cyfluthrin.
    9. Endocrine disruption. There is no evidence of endocrine effects 
in any of the studies conducted with cyfluthrin, thus, there is no 
indication at this time that cyfluthrin causes endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure. The insecticide cyfluthrin has uses on food 
crops in agriculture and also non-dietary uses for homeowners. 
Aggregate exposure for cyfluthrin should consider dietary exposure, 
both food and drinking water and non-dietary exposure both applicator 
and postapplication exposure. For the dietary exposure an acute 
Population Adjusted Dose (PAD) of 0.02 mg/kg bwt/day was selected using 
an uncertainty factor of 100 based on the acute neurotoxicity study. A 
chronic PAD of 0.024 mg/kg bwt/day was based on the chronic toxicity 
test in dogs with an uncertainty factor of 100.
    i. Food. Chronic and acute dietary exposure estimates resulting 
from the above listed proposed and pending uses and the registered uses 
of cyfluthrin are well within acceptable limits for all sectors of the 
population. Potential dietary exposures from food were estimated using 
the Dietary Exposure Evaluation Model (DEEMTM) software 
system (Exponent, Inc.) and the 1994-96 and 1998 USDA consumption data. 
For the chronic analysis, mean residue values were calculated from the 
appropriate field trial studies conducted for cyfluthrin and submitted 
as part of the cyfluthrin petitions. For the acute analysis, the entire 
distribution of field trial residue values was used for non-blended and 
partially blended commodities and the mean value used for blended 
commodities. Processing factors were obtained from GLP processing 
studies for the appropriate commodities. Percent crop treated values 
were obtained from Doane Market Research Data for registered crops, 
using the mean value for the chronic analysis and the maximum value of 
the last 3 years for the acute analysis. Percent crop treated values 
for pending and proposed crops were based on Bayer CropScience market 
projections at market maturity. Using these data and assumptions for 
the chronic analysis, the most highly exposed subpopulation was 
children 1-2 years utilizing 5.4% (0.001288 mg/kg bwt/day) of the 
chronic PAD. The U.S. population utilized 1.5% (0.00037 mg/kg bwt/day) 
of the chronic PAD. For the acute analysis the most highly exposed sub-
population was again children 1-2 years at 52.1% (0.010427 mg/kg bwt/
day) of the acute PAD and the U.S. population at 34.8% (0.006952 mg/kg 
bwt/day) of the acute PAD. Actual exposures are likely to be much less, 
because of the many conservative assumptions incorporated in this 
analysis.
    ii. Drinking water. EPA's Standard Operating Procedure (SOP) for 
Drinking Water Exposure and Risk Assessments was used to perform the 
drinking water assessment. This SOP uses a variety of tools to conduct 
drinking water assessment. These tools include water models such as 
SCI-GROW for potential ground water exposure concentrations, and FIRST 
and/or PRZMS/EXAMS for surface water exposure concentrations, and 
monitoring data. If monitoring data are not available, then the models 
are used to predict potential residues in surface water and ground 
water and the highest is assumed to be the drinking water residue. In 
the case of cyfluthrin, monitoring data do not exist; therefore, SCI-
GROW and FIRST were used to estimate a water residue. The calculated 
drinking water levels of comparison (DWLOC) for chronic exposure for 
all adults and toddlers exceed the drinking water estimated 
concentration (EDWC) from the models. The chronic DWLOC for adults is 
830 ppb. The chronic DWLOC for children 1-2 years is 239 ppb. The 
chronic EDWC for the worst case chronic scenario is 0.16 parts per 
billion (ppb) (FIRST). The acute DWLOC for adults is 467 ppb and for 
children 1-2 years is 96 ppb. The maximum acute EDWC from modeling is 2 
ppb (FIRST). There is no contribution from ground water exposure as 
modeled by SCI-GROW.
    2. Non-dietary exposure. Non-occupational exposure to cyfluthrin 
may occur as a result of inhalation or contact from indoor residential, 
indoor commercial, and outdoor residential uses. Pursuant to the 
requirements of FIFRA as amended by the Food Quality Protection Act of 
1996 non-dietary and aggregate risk analyses for cyfluthrin were 
conducted. The analyses include evaluation of potential non-dietary 
acute application and post-application exposures. Non-occupational, 
non-dietary exposure was assessed based on the assumption that a flea 
infestation control scenario represents a ``worst case'' scenario. For 
the flea control

[[Page 4147]]

infestation scenario indoor fogger, and professional residential turf 
same day treatments were included for cyfluthrin. Deterministic (point 
values) were used to present a worse case upper-bound estimate of non-
dietary exposure. The non-dietary exposure estimates were expressed as 
systemic absorbed doses for a summation of inhalation, dermal, and 
incidental ingestion exposures. These worst case non-dietary exposures 
were aggregated with chronic dietary exposures to evaluate potential 
health risks that might be associated with cyfluthrin products. The 
chronic dietary exposures were expressed as an oral absorbed dose to 
combine with the non-dietary systemic absorbed doses for comparison to 
a systemic absorbed dose no observed effect level (NOEL). Results for 
each potential exposed subpopulation (adults, children 1-6 years, and 
infants <1 year) were compared to the systemic absorbed dose NOEL for 
cyfluthrin to provide estimates of margins of exposure (MOE). The large 
MOEs for cyfluthrin clearly demonstrate a substantial degree of safety. 
The total non-dietary MOEs are 3,800, 2,700, and 2,500 for adults, 
children 1-6 years, and infants (<1 year), respectively. The aggregate 
MOE for adults is approximately 3,700 and the MOEs for infants and 
children exceed 2,400. The non-dietary methods used in the analyses can 
be characterized as highly conservative due to the conservatism 
inherent in the calculation procedures and input assumptions. An 
example of this is the conservatism inherent in the jazzercise 
methodology's over-representation of residential post-application 
exposures. Therefore, it can be concluded that large MOEs associated 
with potential non-dietary and aggregate exposures to cyfluthrin will 
result in little or no health risks to exposed persons. The aggregate 
risk analysis demonstrates compliance with the health-based 
requirements of the Food Quality Protection Act of 1996 for the current 
label uses. The additional use of cyfluthrin on the proposed new uses 
will have no impact on the analysis for non-dietary exposure.

D. Cumulative Effects

     Bayer will submit information for EPA to consider concerning 
potential cumulative effects of cyfluthrin 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 FQPA.

E. Safety Determination

    1. U.S. population. Using the assumptions and data described above, 
based on the completeness and reliability of the toxicity data, it is 
concluded that chronic dietary exposure to the proposed uses of 
cyfluthrin will utilize at most 1.5% of the chronic PAD for the U.S. 
population. The acute dietary exposure to cyfluthrin will utilize at 
most 34.8% of the acute PAD. The actual exposure both acute and chronic 
is likely to be much less as more realistic data and models are 
developed. EPA generally has no concern for exposures below 100% of the 
PAD because the PAD represents the level at or below which daily 
aggregate exposure over a lifetime will not pose appreciable risk to 
human health. Drinking water levels of comparison based on the dietary 
and aggregate exposures are much greater than highly conservative 
estimated levels, and would be expected to be well below the 100% level 
of the PAD, if they occur at all. Large margins of safety exist for the 
non-dietary and aggregate exposure. Therefore, there is a reasonable 
certainty that no harm will occur to the U.S. population from aggregate 
exposure (food, drinking water, and non-dietary) to residues of 
cyfluthrin.
    2. Infants and children. The relevant toxicity studies as discussed 
in the toxicology section above show no extra sensitivity of infants 
and children to cyfluthrin; therefore, the FQPA safety factor can be 
removed. Using the assumptions and data described in the exposure 
section above, the percent of the chronic PAD that will be used for 
exposure to residues of cyfluthrin in food for children 1-2 years (the 
most highly exposed sub-population) is 5.4%. Infants utilize 1.2% 
(0.000056 mg/kg bwt/day) of the chronic PAD. For the acute assessment, 
children 1-2 years utilize 52.1% of the acute PAD and infants utilize 
34.5% of the acute PAD. As in the adult situation, drinking water 
levels of comparison are higher than the worst case drinking water 
estimated concentrations and are expected to use well below 100% of the 
PAD, if they occur at all. As with adults, large margins of safety 
exist for the non-dietary and aggregate exposure for infants and 
children. Therefore, there is a reasonable certainty that no harm will 
occur to infants and children from aggregate exposure to residues of 
cyfluthrin.

F. International Tolerances

    There are no Codex maximum residue levels established for 
cyfluthrin on the commodities proposed in these petitions.
[FR Doc. 04-1240 Filed 1-27-04; 8:45 am]
BILLING CODE 6560-50-S