[Federal Register Volume 69, Number 18 (Wednesday, January 28, 2004)]
[Notices]
[Pages 4147-4151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1241]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0372; FRL-7335-9]


Tebufenozide; 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-2003-0372, 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:  Joseph M. Tavano, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6411; 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

[[Page 4148]]

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-2003-0372. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although, not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although, not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0372. 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-2003-0372. 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),

[[Page 4149]]

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0372.
    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-2003-0372. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

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

List of Subjects

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

    Dated: January 5, 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 Dow AgroSciences 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.

 Dow AgroSciences

 PP 7F4824

     EPA has received a pesticide petition (PP 7F4824) from Dow 
AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268 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, to reestablish 
the time-limited tolerance for indirect or inadvertent residues of 
tebufenozide and its metabolite benzoic acid, 3,5-dimethyl-1-(1,1-
dimethylethyl)-2-4-(hydroxyethyl) benzoyl benzoyl in or on the raw 
agricultural commodity foliage of legume vegetables at 0.1 parts per 
million (ppm), forage, fodder, hay and straw of cereal grains at 0.5 
ppm, grass forage, fodder and hay at 0.5 ppm, and forage, fodder, straw 
and hay of nongrass animals feeds at 0.5 ppm. Rohm and Haas Company 
requested these tolerances under the Federal Food, Drug and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. A Notice of 
Filing was submitted and published in the Federal Register of July 2, 
1999 (64 FR 35999) (FRL-6085-6). Based on the data submitted by Rohm 
and Haas Company, the Agency determined that only time-limited 
tolerances for these residues could be established. The final rule was 
published on October 21, 1999 (64 FR 56690; FRL-6382-6) with the time-
limited tolerances expiring on September 30, 2003. To establish 
permanent tolerances, 12 additional trials were requested to establish 
the requested tolerances in cereal grains and legumes for a 30-day 
plantback interval. Rohm and Haas committed to fulfill these data gaps. 
The data were submitted to the Agency on March 25, 2003. An extension 
of the tolerance which expired September 30, 2003 is needed to allow 
for Agency review of the additional rotational crop data. 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 tebufenozide 
residues in plants and animals is adequately understood and was 
previously published in the Federal Register of October 21, 1999 (64 FR 
56690) (FRL-6382-6).
    2. Analytical method. Adequate enforcement methods are available 
for determination of tebufenozide in rotational crops. The available 
Analytical Enforcement Methodology was previously reviewed in the 
Federal Register of October 21, 1999 (FR 64 56690). Dow AgroSciences 
has also submitted method validation/concurrent recovery studies for a 
proposed enforcement method. The high performance liquid 
chromotography/mass spectroscopy (HPLC/MS) method (GRM 02.20) is to be

[[Page 4150]]

used for determining residues of tebufenozide in/on rotated crops.
    3. Magnitude of residues. Twelve field rotation crops residue 
trials were conducted and residues of tebufenozide and its metabolite 
were measured. The requested tolerances are adequately supported.

B. Toxicological Profile

     The toxicological profile and endpoints for tebufenozide which 
supports this petition to reestablish time-limited tolerances were 
previously published in the Federal Register of October 21, 1999 (64 FR 
56690).

C. Aggregate Exposure

    1. Dietary exposure. Assessments were conducted to evaluate 
potential risks due to chronic and acute dietary exposure of the U.S. 
population subgroups to residues of tebufenozide. These analysis cover 
all registered crops, as well as, uses pending with the Agency, active 
and proposed Section 18 uses, and proposed IR-4 minor uses. There are 
no registered residential nonfood uses of tebufenozide.
    i. Food.--a. Acute exposure and risk. Acute dietary risk 
assessments are performed for a food-use pesticide if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Neither neurotoxicity nor 
systemic toxicity was observed in rats given a single oral 
administration of tebufenozide at 0, 500, 1,000 or 2,000 milligrams/
kilogram (mg/kg). No maternal or developmental toxicity was observed 
following oral administration of tebufenozide at 1,000 mg/kg/day limit-
dose during gestation to pregnant rabbits. This risk is considered to 
be negligible.
    b. Chronic exposure and risk. In conducting a chronic dietary risk 
assessment, reference is made to the conservative assumptions made by 
EPA: tebufenozide time-limited tolerances (64 FR 56690, October 21, 
1999), tolerance level residues, and some percent crop tested (Tier 2). 
The analysis was determined using Dietary Exposure Evaluation Model 
(DEEM) software and the U.S. Department of Agriculture (USDA) 
Nationwide Continuing Surveys of Food Intake by Individuals (SCFII) 
that was conducted from 1989 through 1992.
    ii. Drinking water--a. Acute exposure and risk. Because no acute 
dietary endpoint was determined, Dow AgroSciences concludes that there 
is a reasonable certainty of no harm from acute exposure from drinking 
water.
    b. Chronic exposure and risk. The Agency calculated the Tier I 
Estimated Environmental Concentrations (EECs) for tebufenozide using 
generic expected environmental concentration (GENEEC) (surface water) 
and screening concentration in ground water (SCI-GROW) (ground water) 
models for use in the human health risk assessment. For chronic 
exposure, the worst case EECs for surface water and ground water were 
16.5 parts per billion (ppb) and 1.04 ppb, respectively. These values 
represent upper-bound estimates of the concentrations that might be 
found in surface and ground water. These modeling data were compared to 
the chronic drinking water levels of comparison (DWLOC) for 
tebufenozide in ground water, and surface water.
     For purposes of chronic risk assessment, the estimated maximum 
concentration for tebufenozide in surface water and ground waters (16.5 
ppb) was compared to the back-calculated human health DWLOCs for the 
chronic (non-cancer) endpoint. These DWLOCs for various population 
categories are summarized below in Table:

                                   Table--Drinking Water Levels of Comparison for Chronic Exposure to Tebufenozide\1\
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                                                                                                   Exposure max.                       EEC\7\ calc. max.
                  Population Category\2\                    Chronic RfD (mg/  Food exposure (mg/   water (mg/kg/      (DWLOC) [mu]g/      [mu]g/L (in
                                                                kg/day)            kg/day)            day)\3\          L)\4, 5, 6\          percent)
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U.S. population (48 contiguous states)                                 0.018             0.0038             0.0142                497               16.5
Females (13 + years)                                                   0.018             0.0043             0.0137                411               16.5
Children (1-6 years)                                                   0.018             0.0092             0.0088                 88              16.5
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\1\ Values are expressed to two significant figures.
\2\ Within each of these categories, the subgroup with the highest food exposure was selected.
\3\ Maximum water exposure chronic milligrams/kilogram/day (mg/kg/day) = Chronic PAD mg/kg/day.
\4\ Drinking water levels of concern (DWLOC) [mu]g/L) = Max. water exposure mg/kg/day x bodyweight kg divided by 10-3 mg/[mu]g) x water consumed daily
  (L/day).
\5\ HED default body weights are: General U.S. population, 70 kg; females (13+ years old), 60 kg; other adult populations, 70 kg; and, all infants/
  children, 10 kg.
\6\ HED default daily drinking rates are 2 liter/day (L/day) for adults and 1 L/day for children.
\7\ Estimates Environmental Concentration (EEC). Chronic 56-day value.

    2. Non-dietary exposure. There is a potential for occupational 
exposure to tebufenozide during mixing, loading and application 
activities. However, the Agency did not identify dermal or inhalation 
endpoints for tebufenozide and determined that risks from these routes 
of exposure are negligible.

D. Cumulative Effects

     Cumulative exposure to substances with a common mechanism of 
toxicity, Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' EPA does not have, at this time, 
available data to determine whether tebufenozide has a common mechanism 
of toxicity with other substances or how to include this pesticide in a 
cumulative risk assessment. Unlike other pesticides for which EPA has 
followed a cumulative risk approach based on a common mechanism of 
toxicity, tebufenozide does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
petition, Dow AgroSciences has not assumed that tebufenozide has a 
common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Using the exposure assumptions described above, 
and taking into account the completeness and reliability of the 
toxicity data, Dow AgroSciences has concluded that dietary (food only) 
exposure to tebufenozide will utilize 21% of the chronic population 
adjusted dose (cPAD) for the U.S. population, and 51% of the cPAD for 
the most

[[Page 4151]]

highly exposed population subgroup (children 1-6 years old). EPA 
generally has no concern for exposures below 100% of the cPAD. 
Submitted environmental fate studies suggest that tebufenozide is 
moderately persistent to persistent and mobile; thus, tebufenozide 
could potentially leach to ground water and run off to surface water 
under certain environmental conditions. The modeling data for 
tebufenozide indicate levels less than the Agency's DWLOCs. There are 
no chronic non-occupational/residential exposures expected for 
tebufenozide. Therefore, Dow AgroSciences concludes that there is a 
reasonable certainty that no harm will result to adults, infants and 
children from chronic aggregate exposure to tebufenozide residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of tebufenozide, EPA 
considered data from developmental toxicity studies in the rat and 
rabbit and a 2-generation reproduction study in the rat. The 
developmental toxicity studies are designed to evaluate adverse effects 
on the developing organism resulting from maternal pesticide exposure 
gestation. Reproduction studies provide information relating to effects 
from exposure to the pesticide on the reproductive capability of mating 
animals and data on systematic toxicity.
     FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans. EPA believes that reliable data 
support using the standard uncertainty factor (usually 100 for combined 
inter- and intra-species variability) and not the additional tenfold 
MOE/uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
     There is a complete toxicity data base for tebufenozide and 
exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. For the reasons summarized 
above, Dow AgroSciences concludes that an additional safety factor is 
not needed to protect the safety of infants and children.
     Using the exposure assumptions described above, and taking into 
account the completeness and reliability of the toxicity data, the 
Agency has concluded that dietary (food only) exposure to tebufenozide 
will utilize 21% of the cPAD for the U.S. population, and 51% of the 
cPAD for the most highly exposed population subgroup (children 1-6 
years old). EPA generally has no concern for exposures below 100% of 
the cPAD. Despite the potential for exposure to tebufenozide in 
drinking water and from non-dietary non-occupational exposure, Dow 
AgroSciences does not expect the aggregate exposure to exceed 100% of 
the RfD.

F. International Tolerances

     Codex MRLs have been established for residues of tebufenozide in/
on pome fruit 1.0 ppm, husked rice 0.1 ppm and walnut 0.05 ppm. 
Tebufenozide is registered in Canada, and a tolerance for residues in/
on apples is established at 1.0 ppm. EPA has set the pome fruit 
tolerance at 1.5 ppm based on U.S. field residue trials.
[FR Doc. 04-1241 Filed 1-27-04; 8:45am]
BILLING CODE 6560-50-S