Boscalid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 38911-38918 [05-13175]
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Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices
procedural policies. As such, all public
meetings will be announced in the
Federal Register at least 15 days prior
to their scheduled times.
Background: The U.S. Navy and the
State of Florida are planning to deploy
the ex-Oriskany, a World War II era
aircraft carrier, as an artificial reef in the
Gulf of Mexico. In accordance with the
Toxic Substances Control Act (TSCA)
and its Federal PCB regulations (40 CFR
part 761), the U.S. Navy has applied for
and must obtain a risk-based PCB
disposal approval prior to sinking the
vessel with non-liquid PCBs onboard.
The EPA may approve such an
application if it finds the disposal action
will not pose an unreasonable risk of
injury to human health or the
environment. To evaluate the potential
transfer of non-liquid PCBs to the
marine environment and the subsequent
risk that they might pose to human and
ecological receptors using the artificial
reef, the Navy performed leaching
studies of different on-board PCB
containing materials followed by fate
and transport modeling of the leaching
results to evaluate how released
chemicals might behave in the near-reef
marine environment. The U.S. Navy has
also developed a fate and transport
model known as the Prospective Risk
Assessment Model (PRAM). EPA Region
4 has requested that the SAB conduct a
consultation followed by an advisory on
the U.S. Navy’s assessment of potential
human health and environmental risks
from PCBs released from the exOriskany following deployment as an
artificial reef. The focus of the SAB
consultation and advisory includes the
leaching studies, the PRAM, and
characterization of potential risks.
Procedures for Providing Public
Comment: The EPA SAB Staff Office
will accept written public comments of
any length for the SAB Panel’s
consideration, and accommodate oral
public comments whenever possible.
The EPA SAB Staff Office expects that
public statements presented at this
meeting will not repeat previously
submitted oral or written statements to
this Panel. Oral Comments: Requests to
provide oral comments must be in
writing (e-mail, fax or mail) and
received by Dr. Shallal no later than five
business days prior to the
teleconference or meeting to reserve
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organization and no more than fifteen
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Written comments should be received in
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business days prior to the meeting date
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so that the comments may be made
available to the committee for their
consideration. Comments should be
supplied to the DFO at the address/
contact information noted above in the
following formats: one hard copy with
original signature and one electronic
copy via e-mail (acceptable file format:
Adobe Acrobat, WordPerfect, Word, or
Rich Text files (in IBM–PC/Windows
98/2000/XP format).
Dated: June 28, 2005.
Anthony F. Maciorowski,
Acting Director, EPA Science Advisory Board
Staff Office.
[FR Doc. 05–13278 Filed 7–5–05; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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:mcneilly.dennis@epa.gov.
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)
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• 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
https://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 https://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.
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Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices
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
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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 email 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 https://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 opp-docket@epa.gov,
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
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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.
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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
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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, 2chloro-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
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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 preharvest 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
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(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
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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 10fold 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 2generation 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 2generation 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 2generation 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
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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-inhand 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
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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
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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
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38915
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 (2chloro-N-(4’chloro-5-hydroxy-biphenyl2-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 multigeneration reproductive studies) which
would suggest that BAS 510F produces
endocrine related effects.
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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 (DEEMFCID) 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
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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
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Sfmt 4703
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.
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Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices
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)
Chronic
Food Exposure (mg/kg
bwt/day
Population Subgroup
Maximum
Allowable
Water Exposure (mg/kg/
bwt/day)
cPAD1
DWLOC
(µg/L)
Infants (0–1 year)
0.040972
0.218
0.177028
0.069725
0.218
0.148275
0.021689
0.218
0.196311
0.028430
0.218
0.189570
26.0
5,889
U.S population
0.63
1,483
Adult females (13–49)
FIRST surface water
(µg/L)
1770
Children (1–2 years)1
Sci-Grow
ground
water (µg/L)
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 shortterm exposure is summarized in Table
3.
TABLE 3.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO BAS 510F (BOSCALID)
Short-Term Scenario
NOAEL(mg/
kg/day)
Target
MOE1
21.8
Pop
Max
Exp2
(mg/kg/
day)
100
0.218
U.S.
Avg.
food
exp
(mg/kg/
day)
Residential
Exp3
(mg/kg/
day)
Aggregate
MOE4
(food
and
residential)
Max
water
Exp5
(mg/kg/
day)
Ground
water
EEC6
(µg/L)
0.028
0
746
0.189
0.63
Surface
water
EEC6
(µg/L)
26
Shortterm
DWLOC
(µg/L)7
5,663
1Target
MOE is 100.
Exposure (mg/kg/day) = NOAEL Target MOE.
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 (µg/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).
2Maximum
3Residential
2. Non-dietary exposure. No new
residential uses are currently being
registered for boscalid that would
increase non-dietary exposure. A nonoccupational 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
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(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 nonoccupational, 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
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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
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06JYN1
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Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices
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 nonoccupational 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.
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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
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0058; FRL–7719–3]
Ethaboxam; Notice of Filing a
Pesticide Petition to Establish a
Tolerance for a Certain Pesticide
Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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–
0058, 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:
Bryant Crowe, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–0025; e-mail address:
crowe.bryant@epa.gov.
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 code 111)
• Animal production (NAICS code
112)
• Food manufacturing (NAICS code
311)
• Pesticide manufacturing (NAICS
code 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
PO 00000
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Fmt 4703
Sfmt 4703
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–
0058. 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
https://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 https://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
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38911-38918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13175]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:mcneilly.dennis@epa.gov.
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 https://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 https://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 https://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 opp-docket@epa.gov,
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
