[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38911-38918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13175]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0145; FRL-7721-5]


Boscalid; Notice of Filing a Pesticide Petition to Establish a 
Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0145, must be received on or before August 5, 2005.

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: Dennis McNeilly, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-6742; 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 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-2005-0145. 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, 1801 S. Bell St., 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.

[[Page 38912]]

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-2005-0145. 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-2005-0145. 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-2005-0145.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2005-0145. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

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

[[Page 38913]]

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: June 27, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

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

 BASF CORPORATION

 PP 4F6875, 3E6791, 5E6933

     EPA has received pesticide petitions PP 4F6875, 3E6791, 5E6933 
from BASF Corporation, Research Triangle Park, NC 27709 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 residues of boscalid (3-pyridinecarboxamide, 2-chloro-N-
(4'-chloro(1,1'-biphenyl)-2-yl) in or on the raw agricultural commodity 
almond, hulls at 15 parts per million (ppm), vegetable, leafy, except 
brassica, group 4 at 50 ppm, and banana at 0.5 ppm. EPA has determined 
that the petition contains data or information regarding the elements 
set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data support granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. Nature of the residue studies (OPPTS 
Harmonized Guideline 860.1300) were conducted in grapes, lettuce and 
beans as representative crops in order to characterize the fate of 
boscalid (BAS 510F) in all crop matrices. In all three crops the 
boscalid BAS 510F Residues of Concern (ROC) were characterized as 
parent boscalid (BAS 510F). A confined rotational crop study also 
determined that parent was the residue of concern in the representative 
crops of radish, lettuce and wheat.
    2. Analytical method. In plants, the parent residue is extracted 
using an aqueous organic solvent mixture followed by liquid/liquid 
partitioning and a column clean up. Quantitation is by gas 
chromatography using mass spectrometry (GC/MS). In livestock, the 
residues are extracted with methanol. The extract is treated with 
enzymes in order to release the conjugated glucuronic acid metabolite. 
The residues are then isolated by liquid/liquid partition followed by 
column chromatography. The hydroxylated metabolite is acetylated 
followed by a column clean-up. The parent and acetylated metabolite are 
quantitated by gas chromatography with electron capture detection.
    3. Magnitude of residues. Field trials were carried out in order to 
determine the magnitude of the residue in/on almond hulls, leafy 
vegetables (celery and spinach), and banana. Field trials were 
conducted in the United States in the required regions for almonds and 
leafy vegetables. A total of 12 trials were conducted on bananas during 
the growing season in the principal banana growing regions represented 
by the countries of Costa Rica, Colombia, Ecuador, Guatemala, Honduras, 
Martinique, and Mexico. The number and locations of field trials are in 
accordance with (OPPTS Harmonized Guideline 860.1500). Field trials 
were carried out using the maximum label rate, the maximum number of 
applications, and the minimum pre-harvest interval for each crop or 
crop group.

B. Toxicological Profile

    1. Acute toxicity. Based on available acute toxicity data, BAS 510F 
and its formulated products do not pose acute toxicity risks. The acute 
toxicity studies place technical Boscalid (BAS 510F) in toxicity 
category IV for acute oral; category III for acute dermal and category 
IV for acute inhalation. BAS 510F is category IV for both eye and skin 
irritation, and it is not a dermal sensitizer. For almonds, the 
formulated end use product proposed is as follows: A water dispersible 
granule (WG) termed Pristine (BAS 516 02/04F) containing a 2:1 mixture 
of boscalid (BAS 510F) and pyraclostrobin (BAS 500F). BAS 516 02F has 
an acute oral toxicity category of III, acute dermal of category III, 
acute inhalation of category IV, eye irritation of category III, skin 
irritation of category IV, and is not a dermal sensitizer.
     For leafy vegetables (except brassica vegetables), crop group 4, 
two formulated end use products are proposed as follows: a water 
dispersible granule (WG) termed Endura (BAS 510 02/04F) containing 70% 
boscalid (BAS 510F) and a water dispersible granule (WG) termed 
Pristine (BAS 516 02/04F) containing a 2:1 mixture of boscalid (BAS 
510F) and pyraclostrobin (BAS 500F). BAS 510 02F has an acute oral 
toxicity category of III, acute dermal of category III, acute 
inhalation of category IV, eye irritation of category III, skin 
irritation of category IV, and is not a dermal sensitizer. BAS 516 02F 
has an acute oral toxicity category of III, acute dermal of category 
III, acute inhalation of category IV, eye irritation of category III, 
skin irritation of category IV, and is not a dermal sensitizer.
     For banana, the formulated end use product used in the studies is 
a water dispersible granule (WG) with various proposed trade names such 
as Cantus, banastar, etc. containing 50% Boscalid

[[Page 38914]]

(BAS 510F). BAS 510F has an acute oral toxicity category of III, acute 
dermal of category III, acute inhalation of category IV, eye irritation 
of category III, skin irritation of category IV, and is not a dermal 
sensitizer.
    2. Genotoxicity. Ames test 1 study; gene point mutation: Negative; 
in vitro CHO/HGPRT Locus Mammalian Cell Mutation Assay (1 study; point 
gene mutation): Negative; in vitro V79 Cell cytogenetic assay 1 study; 
chromosome damage: Negative; in vivo mouse micronucleus (1 study; 
chromosome damage): Negative; in vitro rat hepatocyte (1 study; DNA 
damage and repair): Negative. BAS 510F has been tested in a total of 5 
genetic toxicology assays consisting of in vitro and in vivo studies. 
It can be stated that BAS 510F did not show any mutagenic, clastogenic 
or other genotoxic activity when tested under the conditions of the 
studies mentioned above. Therefore, BAS 510F does not pose a genotoxic 
hazard to humans.
    3. Reproductive and developmental toxicity. The reproductive and 
developmental toxicity of BAS 510F was investigated in a 2-generation 
rat reproduction study as well as in rat and rabbit teratology studies.
     There were no adverse effects on reproduction in the 2-generation 
study at any dose tested. The reproductive no observed adverse effect 
level (NOAEL) is 10,000 ppm 1,165 and 1,181 milligrams/kilogram/body 
weight/day (mg/kg/bwt/day) for males and females, respectively), the 
highest dose tested (HDT). Pup effects were observed, at the HDT. In 
males of the F1 generation, reduced body weight and reduced body weight 
gain were observed at 10,000 ppm. Additionally, hepatocyte degeneration 
was observed in males in animals of both the F0 and F1 generations at 
10,000 ppm. The parental systemic NOAEL is 1,000 and 10,000 113 and 
1,181 mg/kg bwt/day) for males and females, respectively. Toxicity to 
the offspring was seen at 1,000 ppm in the form of decreased pup 
weights in the F2 males, and at 10,000 ppm in the form of decreased pup 
weights for both males and females of both the F1 and F2 generations. 
The offspring NOAEL is 100 and 1,000 ppm (12 and 116 mg/kg bwt/day) for 
males and females, respectively.
     The Agency concluded that there are no residual uncertainties for 
prenatal and postnatal toxicity as the degree of concern is low for the 
susceptibility seen in the above studies, and the dose and endpoints 
selected for the overall risk assessments will address the concerns for 
the body weight effects seen in the offspring. Although, the dose 
selected for overall risk assessments (21.8 mg/kg bwt/day) is higher 
than the NOAELs in the 2-generation reproduction study (10.1 mg/kg bwt/
day) and the developmental neurotoxicity study (14 mg/kg bwt/day), 
these differences are considered to be an artifact of the dose 
selection process in these studies. For example, there is a 10-fold 
difference between the lowest observed adverse effect level (LOAEL). 
(106.8 mg/kg bwt/day) and the NOAEL (10.1 mg/kg bwt/day) in the 2-
generation reproduction study. A similar pattern was seen with regard 
to the developmental neurotoxicity study, where there is also a 10-fold 
difference between the LOAEL (147 mg/kg bwt/day) and the NOAEL (14 mg/
kg bwt/day). There is only a 2-3-fold difference between the LOAEL (57 
mg/kg bwt/day) and the NOAEL (21.8 mg/kg bwt/day) in the critical study 
used for risk assessment. Because the gap between the NOAEL and LOAEL 
in the 2-generation reproduction and developmental neurotoxicity 
studies was large and the effects at the LOAELs were minimal, the true 
no observed adverse effect level was probably considerably higher. 
Therefore, the selection of the NOAEL of 21.8 mg/kg bwt/day from the 1-
year dog study is conservative and appropriate for the overall risk 
assessments. In addition, the endpoints for risk assessment are based 
on thyroid effects seen in multiple species (mice, rats and dogs) and 
after various exposure durations (subchronic and chronic exposures) 
which were not observed at the LOAELs in either the 2-generation 
reproduction or the developmental neurotoxicity studies. Based on these 
data, the Agency concluded that there are no residual uncertainties for 
prenatal and postnatal toxicity.
     No teratogenic effects were noted in either the rat or rabbit 
developmental studies. In the rat study, evidence of maternal or 
developmental toxicity was not observed at any dose (highest dose 
tested of 1,000 mg/kg bwt/day). Neither a maternal nor developmental 
LOAEL were found since the highest dose tested was the NOAEL in both 
studies. In the rabbit teratology study, maternal toxicity observed at 
the mid dose of 300 mg/kg bwt/day consisted of discolored/reduced feces 
in one dam and an abortion in one dam. This finding is not necessarily 
indicative of a definitive test substance related adverse effect. The 
dam which displayed the fecal alterations and abortion also displayed 
decreased body weight and body weight gain, compared to the group mean 
during gestation. These decreases occurred even prior to compound 
administration. Food consumption was also dramatically decreased in 
this dam compared to the other animals in the group. Every day from 
gestation day (GD) 1-12, this dam had food consumption values which 
were less than half the mean for the group (compound administration 
began on GD 7). From GD 13 to 26 (when the animal aborted and was 
sacrificed) this dam ate essentially nothing (food consumption during 
this time period was less than or equal to 1.5 grams food/day). These 
decreases in body weight, body weight gain, and food consumption, prior 
to compound administration, all indicate an animal in poor health and 
this poor state of health, rather than compound exposure, was likely 
the reason for the fecal alterations and abortion.
     At the high dose of 1,000 mg/kg bwt/day a maternal body weight 
gain decrease compared to controls of 81% was observed during the 
treatment period. Reduced food consumption, reduced body weight and 
abortions in three dams, were also seen at 1,000 mg/kg bwt/day. 
Evidence of developmental toxicity was not seen at any dose tested. 
Developmental neurotoxicity was not observed at any dose in the 
developmental neurotoxicity study. No maternal toxic effects were noted 
at any dose in this study. No developmental toxicity was seen at the 
low dose of 12 mg/kg bwt/day parts per million (100 ppm). Reduced body 
weights and body weight gains were seen at 118 mg/kg bwt/day 1,000 ppm 
during post natal day (PND) 1 4. Reduced body weights and body weight 
gains were seen at 1,183 mg/kg bwt/day (10,000 ppm) as well as 
decreased absolute pup brain weight at day PND 11 (both sexes) and 
decreased brain length (males only) at PND. The reduced pup brain 
weights and decreased brain length go hand-in-hand and both are due to 
the decreased pup weights seen at this dose. In this respect, it should 
be noted that pup brain weights relative to body weight at PND 11 were 
not significantly different from controls at this dose. Though no 
maternal toxicity was seen in this study, other studies using similar 
doses of BAS 510F resulted in maternal toxicity. A dose of 118 mg/kg 
bwt/day in female rats of the same strain in the multigeneration study, 
resulted in an increased incidence of hepatic centrilobular 
hypertrophy, a parameter which could not have been detected in the 
developmental neurotoxicity (DNT) study as liver histopathology on 
parental animals was not performed in the DNT study.
    4. Subchronic toxicity. The subchronic toxicity of BAS 510F was

[[Page 38915]]

investigated in a 90 day feeding studies with rats, mice and dogs, and 
in a 28 day dermal administration study in rats. Additonally a 90 day 
neurotoxicity study in rats was performed. Generally, mild toxicity was 
observed. At high dose levels (doses above the LOAELs) in feeding 
studies, all three species displayed alterations in various clinical 
chemistry parameters. These clinical chemistry alterations were likely 
secondary to general toxicity. Statistically significant increased 
absolute and relative thyroid weights were observed in male rats only 
at doses at and above the LOAEL. Increased absolute and relative liver 
weights were observed in both sexes at doses above the LOAEL in rats 
and dogs. Increased absolute and relative liver weights were seen in 
both sexes of the mouse at lower doses. However, the increases in liver 
weights at these lower doses in the mouse were not deemed to be 
compound related due to the unusually low concurrent control liver 
weight values. At doses above the LOAELs, liver weight increases were 
supported by histopathology alterations in the rat and mouse, but not 
in the dog. Overall, only mild toxicity was observed in oral subchronic 
testing.
     In the 28 day repeat dose dermal study, no systemic effects were 
noted up to the HDT of 1,000 mg/kg bwt/day. In a 90 day rat 
neurotoxicity study, there was no mortality, signs of clinical 
toxicity, or adverse effects on food consumption or body weight at any 
dose level in either sex. No signs of neurotoxicity were observed 
during clinical observations, functional observation batteries, motor 
activity measurements of neuropathology. Therefore, there were no 
selective neurotoxic effects. Adverse effects were not seen even at the 
highest dose level tested. A LOAEL was not found and the NOAEL is the 
highest tested of 15,000 ppm (1,050 mg/kg bwt/day in males; 1,272 mg/kg 
bwt/day in females).
    5. Chronic toxicity. Based on review of the available data, the 
Reference Dose (RfD) for BAS 510F will be based on a 1-year feeding 
study in dogs with a NOAEL of 21.8 mg/kg bwt/day. Using an uncertainty 
factor of 100, the RfD is calculated to be 0.218 mg/kg bwt/day. The 
following are summaries of chronic toxicity studies submitted to EPA.
     The chronic toxicity/oncogenicity studies with BAS 510F include a 
12-month feeding study with Beagle dogs, an 18-month B63CF1 mouse 
feeding study, a 24 month Wistar rat chronic feeding study and a 24- 
month Wistar rat oncogenicity study.
     At the HDT in dogs, effects observed consisted primarily of 
increased liver and thyroid weights and some serum clinical chemistry 
changes. The NOAEL was 800 ppm (21.8 mg/kg bwt/day males; 22.1 mg/kg 
bwt/day females.)
     Decreased body weights were seen in males in the mouse chronic 
study at doses of 8,000 ppm (1,804 mg/kg bwt/day) and above. Decreased 
female body weight was seen at doses of 2,000 ppm (331 mg/kg bwt/day) 
and above. The target organ in this study was the liver. The NOAEL was 
65 and 443 mg/kg bwt/day 8,000 and 2,000 ppm for male and female mice, 
respectively. In both the rat chronic and oncogenicity studies, the HDT 
of 15,000 ppm exceeded a maximum tolerated dose (MTD) and was 
discontinued after 17 months. Effects observed at the next highest dose 
of 2,500 ppm primarily centered around the thyroid and liver. The NOAEL 
was 23 and 30 mg/kg bwt/day 2,500 ppm for male and female rats, 
respectively.
     Overall, mild toxicity was observed with chronic exposure to BAS 
510F. No evidence of treatment-induced oncogenicity was observed in the 
mouse or dog studies. A slight increase in thyroid follicular cell 
adenomas was seen in both sexes at the high dose when the data from 
both rat bioassays are combined.
     A mode of action (MOA) for the thyroid follicular cell adenomas 
has been proposed. This MOA is based on the EPA publication 
``Assessment of Thyroid Follicular Cell Tumors,'' March 1998, EPA/630/R 
97/002. This document describes the criteria which must be met in order 
for a compound to be considered under the MOA described in that 
publication. BASF Corporation believes that BAS 510F has met the cited 
criteria.
     Threshold effects. Based on a review of the available chronic 
toxicity data, BASF believes EPA will establish the RfD for BAS 510F at 
0.218 mg/kg bwt/day. This RfD for BAS 510F is based on the 2 year 
chronic and 2-year oncogenicity studies in rats and the 1-year dog 
study with the lowest threshold NOAEL of 21.8 mg/kg bwt/day for males. 
Using an uncertainty factor of 100, the RfD is calculated to be 0.218 
mg/kg bwt/day. Based on the acute toxicity data, BASF believes that BAS 
510F does not pose any acute dietary risks.
     BAS 510F was shown to be noncarcinogenic in mice and dogs. There 
was a slight increase in thyroid follicular cell ademonas at the high 
dose in both sexes in the rat. A threshold based MOA for these tumors 
based on the EPA publication ``Assessment of thyroid follicular cell 
tumors'' (EPA/630/R 97/002, March, 1998), has been proposed. BASF 
believes the data to support this proposed mode of action are strong, 
and that the thyroid tumors seen in the rat following BAS 510F exposure 
have a threshold. In addition, a battery of genotoxicity studies 
demonstrated that BAS 510F has no genotoxic or clastogenic potential. 
Therefore, BASF believes that the threshold approach to regulating BAS 
510F is appropriate. Also, it should be noted that, while the Agency 
has in the past considered tumors of this type to be potential human 
carcinogens, the European Union has published a policy which considers 
these tumor types, when they occur at low incidence rates in the rat, 
to not be relevant to man. The publication: European Commission, 
European Chemicals Bureau, ECBI/49/99 Add. 1 Rev. 2; ``Draft Summary 
Record, commission group of specialized experts in the fields of 
carcinogenicity, mutagenicity and reprotoxicity,'' meeting at Arona, 
September 1-2 1999), Therefore, BASF believes that these tumors are not 
likely relevant to humans and, if these tumors are to be considered 
relevant to humans, the threshold approach to cancer risk assessment is 
appropriate.
    6. Animal metabolism. In the rat, the predominant route of 
excretion of BAS 510F is fecal with urinary excretion being minor. The 
half-life of BAS 510F is less than 24 hours. Saturation of absorption 
appears to be occurring at the high dose level. BAS 510F is rapidly and 
intensively metabolized to a large number of biotransformation 
products. The hydroxylation of the diphenyl moiety was the 
quantitatively most important pathway. Second most important was the 
substitution of the Cl of the 2-chloropyridine part against SH by 
conjugation with glutathione. No major differences were observed. In 
hens and goats the residues of concern were determined to be parent, 
the hydroxylated metabolite M510 F01 (2-chloro-N-(4'chloro-5-hydroxy-
biphenyl-2-yl)nicotinamide), and the glucuronic acid of the metabolite 
M510 F02.
    7. Metabolite toxicology. No additional studies were required for 
metabolite toxicology.
    8. Endocrine disruption. No specific tests have been conducted with 
BAS 510F to determine whether the chemical may have an effect in humans 
that is similar to an effect produced by a naturally occurring estrogen 
or other endocrine effects. However, there were no significant findings 
in other relevant toxicity studies (i.e., subchronic and chronic 
toxicity, teratology and multi-generation reproductive studies) which 
would suggest that BAS 510F produces endocrine related effects.

[[Page 38916]]

C. Aggregate Exposure

    1. Dietary exposure--i. Food. An assessment was conducted to 
evaluate the potential risk due to chronic dietary exposure of the U.S. 
population and sub-populations to residues of BAS 510F (Boscalid). 
Tolerance values have previously been established and are listed in 
U.S. 40 CFR 180.589. This analysis included all crops with established 
tolerance values, crops pending tolerance assignment (vegetable, leafy 
crop group 4 at 50 ppm, almond hulls at 15 ppm and an import tolerance 
for banana pulp of 0.5 ppm).
    a. Acute dietary exposure assessment. An acute assessment was not 
needed since EPA Toxicological Endpoint Selection (TES) Committees had 
previously evaluated the boscalid toxicity data and determined there 
was no toxic effect attributable to a single dose. Therefore, a 
quantitative acute dietary exposure and risk assessment were not 
required.
    b. Chronic dietary exposure assessment. A Tier 1 chronic dietary 
exposure assessment was conducted assuming tolerance level residues in 
all crops and 100% crop treated for all registered, pending, and 
proposed crops. Default processing factors were also used in the 
assessment. EPA Food Commodity Ingredient Data Base (FCID) was also 
used in Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) 
software. Residues in animal commodities (i.e. meat, meat byproducts, 
milk, eggs) were included at the tolerance levels currently established 
and listed in 40 CFR 180.589.
     Dietary exposure estimates were compared against the established 
boscalid chronic population adjusted dose (cPAD) of 0.218 mg/kg bwt/day 
for all populations. Results of the chronic dietary assessments are 
listed in the Table 1. The estimated chronic dietary exposure from all 
crops and animal commodities was less than 33% of the cPAD for all sub-
populations. Additional refinements such as the use of anticipated 
residues and adjusted crop treated factors would further reduce the 
estimated chronic dietary exposure. The results in the table below 
demonstrate that there are no safety concerns for any sub-population 
based on established and new uses, and that the results clearly meet 
the FQPA standard of reasonable certainty of no harm.

       Table 1.-Summary of Chronic Dietary Exposure Assessment considering crops with established and proposed tolerances for BAS 510F (Boscalid).
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Population Subgroup                      Exposure Estimate (mg/kg bwt/day)                                       %cPAD
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                                       0.028430                                                      13.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants                                                                           0.040972                                                      18.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                                                0.069725                                                      32.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                                                0.053362                                                      24.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 6-12 years old                                                               0.032094                                                      14.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                                                  0.02535                                                      11.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                                               0.021689                                                       9.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                                                0.024906                                                      11.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                                                  0.025333                                                      11.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
%cPAD = percent of chronic population adjusted dose Exposure estimates based on tolerance values, percent crop treated values for established crop
  tolerances, 100% CT for crops with proposed tolerances

    ii. Drinking water. Since the models used are considered to be 
screening tools in the risk assessment process, the Agency does not use 
estimated environmental concentrations (EECs) from these models to 
quantify drinking water exposure and risk as %PAD. Instead, drinking 
water levels of concern (DWLOCs) are calculated and used as points of 
comparison against the model estimates of a pesticide's concentration 
in water. A DWLOC is the theoretical upper allowable limit of a 
pesticide's concentration in drinking water and is calculated with 
consideration of the aggregate exposure to a pesticide from food and 
residential uses. A DWLOC will vary depending on the toxic endpoint, 
drinking water consumption, body weights, and pesticide uses.
     Different populations will have different DWLOCs. If the DWLOC is 
greater than the model water concentrations, the EPA concludes that 
exposure from drinking water is not a risk issue. The modeled water 
concentration is obtained from the FIRST model for surface water and 
the SCIGROW model for ground water. The values used for comparison to 
the DWLOC are the maximum concentrations for any use. When the EEC's 
are less than the calculated DWLOCs, EPA concludes with reasonable 
certainty that exposures to the pesticide in drinking water would not 
result in unacceptable levels of aggregate human health risk.

[[Page 38917]]

    a. Acute aggregate exposure and risk (food and water). Since EPA 
Toxicological Endpoint Selection (TES) Committees has evaluated the 
boscalid toxicity data and determined there was no toxicologic 
endpoints for acute dietary exposure, the determination of an acute 
aggregate exposure and risk evaluation was not required.
    b. Chronic aggregate exposure and risk (food and water). Table 2. 
summarizes the aggregate exposure and risk.

           Table 2.-Aggregate Risk Assessment for Chronic (non-cancer) Exposure to BAS 510F (Boscalid)
----------------------------------------------------------------------------------------------------------------
                                                                Maximum
                                      Chronic                  Allowable                  Sci-Grow      FIRST
                                        Food                     Water        DWLOC        ground      surface
        Population Subgroup           Exposure      cPAD1       Exposure    ([mu]g/L)      water        water
                                    (mg/kg bwt/               (mg/kg/bwt/                ([mu]g/L)    ([mu]g/L)
                                        day                       day)
----------------------------------------------------------------------------------------------------------------
Infants (0-1 year)                     0.040972        0.218     0.177028         1770
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)1                  0.069725        0.218     0.148275        1,483         0.63         26.0
----------------------------------------------------------------------------------------------------------------
Adult females (13-49)                  0.021689        0.218     0.196311        5,889
----------------------------------------------------------------------------------------------------------------
U.S population                         0.028430        0.218     0.189570        6,634
----------------------------------------------------------------------------------------------------------------
 1Inter/intra species safety factor = 100 FQPA safety factor = 1, NOAEL = 21.8 mg/kg bwt/day

     The results in the summary table of chronic DWLOCs demonstrate 
that there are no safety concerns for any subpopulation based on 
established and new uses, and that the results clearly meet the FQPA 
standard of reasonable certainty of no harm.
     In summary, we can conclude with reasonable certainty that no harm 
will occur from chronic aggregate exposure of boscalid.
     Short-term and intermediate term aggregate exposure and Risk 
(food, water and residential exposure)
     Short-term and intermediate-term aggregate exposure takes into 
account residential exposure plus chronic exposure from food and water. 
Residential exposure is used to refer to non-occupational and non-
dietary exposure. No new residential uses are currently being 
registered for boscalid that would increase non-dietary exposure. The 
residential exposure value used in this risk assessment was previously 
determined by the EPA (July 30, 2003, 68 FR 44640) (FRL-7319-6) and 
considers dermal exposure to adults from the golf course use. The MOE 
and DWLOC presented in the table below are considered to be 
representative for youth playing golf because youth and adults possess 
similar body surface area to weight ratios and because the dietary 
exposure for youth (13-19 years old) is less than that of the general 
U.S. population. The aggregate risk for short-term exposure is 
summarized in Table 3.

                                   Table 3.--Aggregate Risk Assessment for Short-Term Exposure to BAS 510F (Boscalid)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Short-Term Scenario
                                                    ----------------------------------------------------------------------------------------------------
                                                                                                                        Max     Ground  Surface   Short-
                        Pop                                                Max      Avg.   Residential    Aggregate    water    water    water     term
                                                     NOAEL(mg/   Target    Exp2     food   Exp3 (mg/kg/  MOE4 (food     Exp5     EEC6     EEC6    DWLOC
                                                      kg/day)     MOE1   (mg/kg/  exp (mg/     day)          and      (mg/kg/  ([mu]g/  ([mu]g/  ([mu]g/
                                                                           day)   kg/day)               residential)    day)      L)       L)      L)7
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S.                                                     21.8       100    0.218    0.028          0           746      0.189     0.63       26    5,663
--------------------------------------------------------------------------------------------------------------------------------------------------------
1Target MOE is 100.
2Maximum Exposure (mg/kg/day) = NOAEL Target MOE.
3Residential Exposure = Exposure to adult while playing golf.
4Aggregate MOE = (NOAEL (Avg. Food + residential Exposure).
5Maximum Water Exposure (mg/kg/day) = Target Max Exposure (Food Exposure + Residential Exposure).
6Crop producing the highest EEC values were used for comparison.
7The DWLOC ([mu]g/L) = maximum water exposure (mg.kg/day) x body weight (kg) water consumption (L) x 0.001 mg/ug. Adult female weight was used to
  calculate, which covers adult male risk. The dietary exposure for the U.S. population is higher than that of groups having residential golf exposure
  (i.e., adults, youth 13-19).

    2. Non-dietary exposure. No new residential uses are currently 
being registered for boscalid that would increase non-dietary exposure. 
A non-occupational dermal post-application exposure/risk assessment for 
individuals golfing and harvesting fruit at ``U-Pick'' farms and 
orchards was previously conducted by EPA, (July 30, 2003, 68 FR 44640) 
(FRL-7319-6). Because U-Pick is a one-time event (duration <1 day) and 
the EPA found that the oral studies indicated there were no endpoints 
appropriate to quantify acute risk.
     Therefore, only the golfing scenario was evaluated with respect to 
non-occupational, non-dietary exposure. The dermal MOE's for adults 
playing golf were 27,000 to 74,000. Although, specific MOE's were not 
calculated for youths playing golf, the adult MOEs are considered 
representative since the body surface area to weight ratios for 
adolescents do not vary significantly from those of adults.

D. Cumulative Effects

     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

[[Page 38918]]

effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' BAS 510F is a foliar 
fungicide chemically belonging to the carboxin class of fungicides. BAS 
510F acts in the fungal cell by inhibiting mitochondrial respiration 
through inhibition of the succinate-ubiquinone oxidase reductase system 
in Complex II of the mitochondrial electron transport chain. BAS 510F 
shares this mode of action with only one other currently registered 
U.S. pesticide - carboxin.
     EPA is currently developing methodology to perform cumulative risk 
assessments. At this time, there is no available data to determine 
whether BAS 510F 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, BAS 
510F does not appear to produce a toxic metabolite produced by other 
substances.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions 
described above and based on the completeness and the reliability of 
the toxicity data, BASF has estimated that dietary exposure to BAS 510F 
will utilize 13.0% of the cPAD for the U.S. population. The aggregate 
exposure including food, water, and residential golf exposure has shown 
that there is no concern from the exposure from drinking water. BASF 
concludes that there is a reasonable certainty that no harm will result 
from the aggregate exposure to residues of BAS 510F, including 
anticipated dietary and drinking water exposures and non-occupational 
exposures.
    2. Infants and children. Using the conservative exposure 
assumptions described above and based on the completeness and the 
reliability of the toxicity data, BASF has estimated that dietary 
exposure to BAS 510F will utilize 32% of the cPAD for most highly 
exposure infant and children subgroup (children 1-2 years of age). The 
aggregate exposure including food, water, and residential golf exposure 
has shown that there is no concern to any subpopulation from the 
exposure from drinking water. BASF concludes that there is a reasonable 
certainty that no harm to infants or children will result from the 
aggregate exposure to residues of BAS 510F, including anticipated 
dietary and drinking water exposures and non-occupational exposures.

F. International Tolerances

     A maximum residue level (MRL) has not been established for 
boscalid BAS 510F in any crop by the codex Alimentarius Commission.
[FR Doc. 05-13175 Filed 7-5-05; 8:45 am]
BILLING CODE 6560-50-S