[Federal Register Volume 69, Number 57 (Wednesday, March 24, 2004)]
[Notices]
[Pages 13833-13836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6571]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0045; FRL-7347-2]


Fenpropathrin; 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 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-2004-0045, must be 
received on or before April 23, 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: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; 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)
     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-2004-0045. 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.

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 Although, not all docket materials may be available electronically, 
you may still access any of the publicly available docket materials 
through the docket facility identified in Unit I.B. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0045. 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-2004-0045. 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-2004-0045.
    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-2004-0045. 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

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assigned to this action in the subject line on the first page of your 
response. You may also provide the name, date, and Federal Register 
citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: March 15, 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 Interregional Research Project Number 4 (IR-
4) 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.

Interregional Research Project Number 4 (IR-4)

PP 1E6261, PP 1E6331, PP 1E6336, and PP 3E6588

    EPA has received pesticide petitions (PP 1E6261, PP 1E6331, PP 
1E6336, and PP 3E6588) from IR-4, 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 180.466, by establishing tolerances for residues of the 
insecticide fenpropathrin, alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate in or on the following raw 
agricultural commodities: Currant 3.0 parts per million (ppm) (PP 
1E6261), vegetables, fruiting, group 08, except tomato at 1.0 ppm (PP 
1E6331) pea, succulent at 0.02 ppm (PP 1E6336), and bushberry subgroup 
13B, lingonberry, juneberry, and salal at 3.0 ppm (PP 3E6588). 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. This notice includes a 
summary of the petitions prepared by Valent U.S.A. Corporation, P.O. 
Box 8025, Walnut Creek, CA 94596-8025.

A. Residue Chemistry

    1. Plant metabolism. The plant metabolism of fenpropathrin has been 
studied in five different crop plant species: Cotton, apple, tomato, 
cabbage, and bean. Each of the studies involved foliar treatment of the 
plants under either greenhouse or field conditions. In all studies the 
total toxic residue is best defined as parent, fenpropathrin. The 
primary metabolic pathway for fenpropathrin in plants is similar to 
that in mammals. There are no qualitatively unique plant metabolites.
    2. Analytical method. Adequate analytical methodology is available 
to detect and quantify fenpropathrin at residue levels in numerous 
matrices. The methods use solvent extraction and partition and/or 
column chromatography clean-up steps, followed by separation and 
quantitation using capillary gas liquid chromatography (GLC) with FID. 
The extraction efficiency has been validated using radiocarbon samples 
from the plant and animal metabolism studies. The enforcement methods 
have been validated at independent laboratories and by EPA. The limit 
of quantification (LOQ) for fenpropathrin in raw agricultural commodity 
samples is usually 0.01 ppm.
    3. Magnitude of residues. Residue data has been submitted for 
vegetables, fruiting, group 08, except tomato; pea, succulent; 
bushberry subgroup 13B; lingonberry; juneberry; and salal. The 
requested tolerances are adequately supported.

B. Toxicological Profile

     An assessment of the toxic effects caused by fenpropathrin is 
discussed in Unit III.A. and Unit III.B. of the Federal Register dated 
December 3, 1999 (64 FR 67905) (FRL-6392-6).
    1. Animal metabolism. Four metabolites were found in the urine of 
rats dosed with alcohol labeled fenpropathrin. The major metabolites 
were the sulfate conjugate of 3-(4'-hydroxyphenoxy)benzoic acid and 3-
phenoxybenzoic acid (22-44% and 3-9% of the administered dose, 
respectively). The major urinary metabolites of the acid-labeled 
fenpropathrin were TMPA-glucuronic acid and TMPA-CH2OH (11-26% and 6-
10% of the administered dose, respectively). None of the parent 
chemical was found in urine.
     The major elimination products in the feces included the parent 
chemical (13-34% of the administered dose) and four metabolites. The 
fecal metabolites (percentage of administered dose) included CH2OH-
fenpropathrin (9-20%), 4'-OH-fenpropathrin (4-11%), COOH-fenpropathrin 
(2-7%), and 4'-OH-CH2OH-fenpropathrin (2-7%). There are no 
qualitatively unique plant metabolites. The primary aglycones are 
identical in both plants and animals; the only difference is in the 
nature of the conjugating moieties employed.
    2. Metabolite toxicology. The metabolism and potential toxicity of 
the small amounts of terminal plant metabolites have been tested on 
mammals. Glucoside conjugates of 3-phenoxy-benzyl alcohol and 3-
phenoxybenzoic acid, administered orally to rats, were absorbed as the 
corresponding aglycones following cleavage of the glycoside linkage in 
the gut. The free or reconjugated aglycones were rapidly and completely 
eliminated by normal metabolic pathways. The glucose conjugates of 3-
phenoxybenzyl alcohol and 3-phenoxy-benzoic acid are less toxic to mice 
than the corresponding aglycones.
    3. Endocrine disruption. No special studies to investigate the 
potential for estrogenic or other endocrine effects of fenpropathrin 
have been performed. However, as referenced above (see toxicological 
profile), a large and detailed toxicology data base exists for the 
compound including studies acceptable to the Agency in all required 
categories. These studies include evaluations of reproduction and 
reproductive toxicity and detailed pathology and histology of endocrine 
organs following repeated or long-term exposure. These studies are 
considered capable of revealing endocrine effects and no such effects 
were observed.

C. Aggregate Exposure

    1. Dietary exposure. Chronic and acute dietary exposure analyses 
were performed for fenpropathrin using anticipated residues, and 
accounting for proportion of the crop treated. The crops included in 
the analyses are the

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raw agricultural commodities cottonseed, currants, peanuts, 
strawberries, soybeans, lingonberry, juneberry, salal, and grapes, and 
the crop groupings succulent shelled pea (6B), head and stem brassica 
(5A), fruiting vegetables (8), cucurbit vegetables (9), citrus fruits 
(10), bushberry (13B) and pome fruits (11); processed products from 
these crops; and the resulting secondary residues in meat, milk, and 
eggs. Soybeans (and soybean products) were entered into the analyses 
using tolerance-level residues and 1% of the crop treated for chronic 
assessments, and 2% of the crop treated for acute assessments. 
Proportion of crop treated was assumed to be equal for all crops in a 
crop grouping.
    i. Food--a. Acute. Acute dietary exposure was calculated for the 
U.S. population, females (13+), males (20+ years) and five children 
subgroups. At the 99.9th percentile of exposure, the acute 
population adjusted dose (aPAD) of 0.06 milligrams/kilogram body 
weight/day (mg/kg bwt/day) is not exceeded.
    b. Chronic. Chronic dietary exposure was calculated for the U.S. 
population and 25 population subgroups. Chronic dietary exposure was at 
or below 0.6% of the chronic population adjusted dose (cPAD) of 0.025 
mg/kg bwt/day, with apples being the commodity contributing the most to 
chronic exposure. Generally speaking, the Agency has no cause for 
concern if total residue contribution for published and proposed 
tolerances is less than 100% of the cPAD.
    ii. Drinking water. Since fenpropathrin is applied outdoors to 
growing agricultural crops, the potential exists for fenpropathrin to 
reach ground water or surface water that may be used for drinking 
water. To further quantify exposure from drinking water, potential 
surface water and ground water concentrations for fenpropathrin were 
estimated using First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Groundwater (SCI-GROW) modeling. Use on 
citrus, the most intense field use, was modeled. SCI-GROW modeling 
indicated that fenpropathrin would not be detected in ground water. 
FIRST modeling of potential surface water concentrations of 
fenpropathrin yielded annual average parts per billion (0.833 ppb) and 
peak day (1.030 ppb) concentrations. These estimated drinking water 
environmental concentrations (DWEC) can be used for chronic and acute 
exposures, respectively.
    2. Non-dietary exposure. No endpoints of concern were identified by 
the Health Effects Division, Hazard Identification Assessment Review 
Committee for dermal or inhalation exposures of any duration. Thus, no 
risk assessment is needed.

D. Cumulative Effects

     There are numerous other pesticidal compounds, pyrethroids and the 
natural pyrethrins, that are structurally related to fenpropathrin and 
may have similar effects on animals. In consideration of potential 
cumulative effects of fenpropathrin and other substances that may have 
a common mechanism of toxicity, there are currently no available data 
or other reliable information indicating that any toxic effects 
produced by fenpropathrin would be cumulative with those of other 
chemical compounds, or other pyrethroids. Thus, only the potential 
risks of fenpropathrin have been considered in this assessment of 
aggregate exposure and effects.
     Valent will submit information for EPA to consider concerning 
potential cumulative effects of fenpropathrin consistent with the 
schedule established by EPA at 62 FR 42020 (August 4, 1997) (FRL-5734-
6) and other EPA publications pursuant to the Food Quality Protection 
Act.

E. Safety Determination

    1. U.S. population--i. Acute. The potential acute exposure from 
food to the U.S. population and various non-child/infant population 
subgroups provide values well below the aPAD. In a conservative policy, 
the Agency has no cause for concern if total acute exposure calculated 
for the 99.9th percentile is less than 100% of the aPAD. 
Acute DWLOC values are not exceeded by modeled DWEC values. It can be 
concluded that there is a reasonable certainty that no harm will result 
to the overall U.S. population and many non-child/infant subgroups from 
aggregate, acute exposure to fenpropathrin residues.
    ii. Chronic. Using the dietary exposure assessment procedures, the 
calculated chronic dietary exposure resulting from residue exposure 
from existing and proposed uses of fenpropathrin is minimal. The 
estimated chronic dietary exposure from food for the overall U.S. 
population and many non-child/infant subgroups ranges from 0.6% 
(children 1-6 years old, 0.000155 mg/kg bwt/day) to 0.1% (several 
groups) of the cPAD. Generally, the Agency has no cause for concern if 
total residue contribution is less than 100% of the cPAD. Chronic 
drinking water levels of concern (DWLOC) values are not exceeded by 
modeled drinking water estimated concentration (DWEC) values. It can be 
concluded that there is a reasonable certainty that no harm will result 
to the overall U.S. population and many non-child/infant subgroups from 
aggregate, chronic dietary exposure to fenpropathrin residues.
    2. Infants and children. The estimated chronic dietary exposure 
from food to infant and child subgroups ranges from 0.6% children 1-6 
years old, 0.000155 mg/kg bwt/day to 0.1% nursing infants, 0.000026 mg/
kg bwt/day of the cPAD. Generally, the Agency has no cause for concern 
if total residue contribution is less than 100% of the cPAD. Chronic 
DWLOC values are not exceeded by modeled DWEC values. It can be 
concluded that there is a reasonable certainty that no harm will result 
to infant and child subgroups of the U.S. population from aggregate, 
chronic exposure to fenpropathrin residues.

[FR Doc. 04-6571 Filed 3-23-04; 8:45 am]
BILLING CODE 6560-50-S