Terbacil; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 53180-53185 [05-17529]
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53180
Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices
larger nominal dimensions and treated to a
minimum of 0.60 pcf) (C18), Lumber and
Plywood for Permanent Wood Foundations
(C22), Round Poles and Posts Used in
Building Construction(C23), Sawn Timber
Used To Support Residential and
Commercial Structures(C24), Sawn
Crossarms (C25), Structural Glued Laminated
Members and Laminations Before Gluing
(C28), Structural Composite Lumber (C33),
and Shakes and Shingles (C34); and in
accordance with the respective cited
standard (noted parenthetically) of the 2002
edition of the American Wood-Preservers’
Association Standards: Lumber, Timbers and
Plywood for Cooling Towers (C30). Forest
products treated with this product may only
be sold or distributed for uses within the
AWPA Commodity Standards under which
the treatment occurred, except where
otherwise provided above.
Revised Language Manufacturing Use
Product (MUP)
This product may only be used (1) for
formulation of the following end-use wood
preservative products: Ammoniacal copper
zinc arsenate (ACZA) or chromated copper
arsenate (CCA) labeled in accordance with
the Directions for Use shown below, or (2) by
persons other than the registrant, in
combination with one or more other products
to make: ACZA wood preservative; or CCA
wood preservative that is used in accordance
with the Directions for Use shown below.
This product may only be used for
preservative treatment of the following
categories of forest products and in
accordance with the respective cited
standard (noted parenthetically) of the 2001
edition of the American Wood-Preservers’
Association (AWPA) Standards: Lumber and
Timber for Salt Water Use Only (C2), Piles
(C3), Poles (C4), Plywood(C9), Wood for
Highway Construction (C14), Round, Half
Round and Quarter Round Fence Posts (C16),
Poles, Piles and Posts Used as Structural
Members on Farms, and Plywood Used on
Farms (C16), Wood for Marine Construction
(C18), Lumber and Plywood for Permanent
Wood Foundations(C22), Round Poles and
Posts Used in Building Construction (C23),
Sawn Timber Used To Support Residential
and Commercial Structures (C24), Sawn
Crossarms (C25), Structural Glued Laminated
Members and Laminations Before Gluing
(C28), Structural Composite Lumber (C33),
and Shakes and Shingles (C34); and in
accordance with the respective cited
standard (noted parenthetically) of the 2002
edition of the American Wood-Preservers’
Association Standards: Lumber, Timbers and
Plywood for Cooling Towers (C30). Forest
products treated with this product may only
be sold or distributed for uses within the
AWPA Commodity Standards under which
the treatment occurred.
Effective December 31, 2004, this product
may only be used for preservative treatment
of the following categories of forest products
and in accordance with the respective cited
standard (noted parenthetically) of the 2001
edition of the American Wood-Preservers’
Association (AWPA) Standards: Lumber and
Timber for Salt Water Use (also includes
brackish water) Only (C2), Piles (C3), Poles
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(C4), Plywood(C9), Wood for Highway
Construction (C14), Round, Half Round and
Quarter Round Fence Posts (C16), Poles, Piles
and Posts Used as Structural Members on
Farms, and Plywood Used on Farms (C16),
Wood for Marine Construction for Salt Water
Use (also includes brackish water)(immersion
and/or subject to saltwater (or brackish
water) splash [‘‘subject to saltwater (or
brackish water) splash’’ means any member
of a marine structure which is positioned
above mean high tide, but is subject to
frequent wetting from wave action], [Pilings
(sheet, round and square), Timbers, and
Plywood; Walers, Framing, Stringers and
Cross Bracing (2″ x 8″ and/or 3″ x 6″ and
larger nominal dimensions and treated to a
minimum of 0.60 pcf) (C18), Lumber and
Plywood for Permanent Wood Foundations
(C22), Round Poles and Posts Used in
Building Construction(C23), Sawn Timber
Used To Support Residential and
Commercial Structures(C24), Sawn
Crossarms (C25), Structural Glue Laminated
Members and Laminations Before Gluing
(C28), Structural Composite Lumber (C33),
and Shakes and Shingles (C34); and in
accordance with the respective cited
standard (noted parenthetically) of the 2002
edition of the American Wood-Preservers’
Association Standards: Lumber, Timbers and
Plywood for Cooling Towers (C30). Forest
products treated with this product may only
be sold or distributed for uses within the
AWPA Commodity Standards under which
the treatment occurred, except where
otherwise provided above.
Furthermore, any distribution, sale, or
use of existing stocks of the products
identified in Table 2 of Unit II. in a
manner inconsistent with any of the
Provisions for Disposition of Existing
Stocks set forth below in Unit VI. will
be considered a violation of FIFRA.
V. What is the Agency’s Authority for
Taking this Action?
Section 6(f)(1) of FIFRA provides that
a registrant of a pesticide product may
at any time request that any of its
pesticide registrations be canceled or
amended to terminate one or more uses.
FIFRA further provides that, before
acting on the request, EPA must publish
a notice of receipt of any such request
in the Federal Register. Thereafter,
following the public comment period,
the Administrator may approve such a
request.
VI. Provisions for Disposition of
Existing Stocks
Existing stocks are those stocks of
registered pesticide products which are
currently in the United States and
which were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation action.
The cancellation order issued in this
Notice includes the following existing
stocks provisions.
The registrants of affected CCA
products requested that the voluntary
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use terminations become effective
December 31, 2004, with no provisions
for existing stocks. Consequently, the
Agency is not allowing for any existing
stocks provisions for those affected
products in the hands of the registrant
on or after the effective date of the use
terminations. Any sale, distribution, or
use of those affected products on or after
the effective date of this cancellation
order is prohibited. This refers to CCA
product labels that bear the C18 Marine
Use, ‘‘members out of water and not
subject to saltwater [or brackish water]
splash and not in soil use,’’ and which
do not bear labeling consistent with that
set forth in Unit IV. above. Sale,
distribution or use of the stocks in the
channels of trade by persons other than
the registrant may continue until
depleted, provided any sale,
distribution or use is in accordance with
the existing label of that product.
List of Subjects
Environmental protection, Pesticides
and pests, Chromated Copper Arsenate,
CCA, and Treated Wood.
Dated: August 25, 2005.
Frank Sanders,
Acting Director, Antimicrobials Division,
Office of Pesticide Programs.
[FR Doc. 05–17530 Filed 9–6–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0215; FRL–7731–1]
Terbacil; 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–
0215, must be received on or before
October 7, 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:
Sidney Jackson, Registration Division
(7505C), Office of Pesticide Programs,
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Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7610; e-mail address:
jackson.sidney@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 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–
0215. 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
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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
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.1. 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 in 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
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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 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–2005–0215. The
system is an ‘‘anonymous access’’
system, which means EPA will not
know your identity, e-mail address, or
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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–
2005–0215. 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–2005–0215.
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–2005–0215. 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
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docket and EPA’s electronic public
docket. If you submit the copy that does
not contain CBI on disk or CD ROM,
mark the outside of the disk or CD ROM
clearly that it does not contain CBI.
Information not marked as CBI will be
included in the public docket and EPA’s
electronic public docket without prior
notice. If you have any questions about
CBI or the procedures for claiming CBI,
please consult the person listed under
FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare
My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
3. Provide copies of any technical
information and/or data you used that
support your views.
4. If you estimate potential burden or
costs, explain how you arrived at the
estimate that you provide.
5. Provide specific examples to
illustrate your concerns.
6. Make sure to submit your
comments by the deadline in this
notice.
7. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition
as follows proposing the establishment
and/or amendment of regulations for
residues of a certain pesticide chemical
in or on various food commodities
under section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a. EPA has determined that
this petition contains data or
information regarding the elements set
forth in FFDCA section 408(d)(2);
however, EPA has not fully evaluated
the sufficiency of the submitted data at
this time or whether the data support
granting of the petition. Additional data
may be needed before EPA rules on the
petition.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
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Dated: August 19, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Summary of Petition
The petitioner 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 petitioner and
represents the view of the petitioner.
The petition summary announces the
availability of a description of the
analytical methods available to EPA for
the detection and measurement of the
pesticide chemical residues or an
explanation of why no such method is
needed.
Interregional Research Project Number
4 (IR-4)
PP 3E6640
EPA has received a pesticide petition
(PP 3E6640) from Interregional Research
Project Number 4 (IR-4) on behalf of
DuPont Crop Protection, P.O. Box 30,
Newark, Delaware 19714-0030,
proposing, pursuant to section 408(d) of
the FFDCA, 21 U.S.C. 346a(d), to amend
40 CFR part 180 by establishing a
tolerance for residues of the herbicide,
terbacil (3-tert-butyl-5-chloro-6methyluracil) and its metabolites [3-tertbutyl-5-chloro-6-hydroxymethyluracil],
[6-chloro-2,3-dihydro-7-hydroxymethyl
3,3-dimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], and [6-chloro-2,3dihydro-3,3,7-trimethyl-5H-oxazolo(3,2a) pyrimidin-5-one] in or on the raw
agricultural commodity watermelon at
1.0 parts per million (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 supports granting of the
petition. Additional data may be needed
before EPA rules on the petition. This
notice includes a summary of the
petition that was prepared by DuPont
Crop Protection.
A. Residue Chemistry
1. Plant metabolism. The metabolism
and chemical nature of residues of
terbacil in plants and animals are
adequately understood. The fate of
terbacil has been extensively studied
using radioactive tracers in plant and
animal metabolism/nature of the residue
studies.
2. Analytical method. There is a
practical analytical method utilizing
microcoulometric gas chromatography
with thermionic or nitrogen
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phosphorous detection available for
enforcement with a limit of detection
that allows monitoring food with
residues at or above tolerance levels.
The limit of detection for the method
determined by the lowest standard of
0.5 nanogram per microliter (ng/µl) was
0.05 ppm.
3. Magnitude of residues. Crop field
trial residue data from a 69– to 94–day
preharvest interval (PHI) study show
that the proposed tolerance in or on
watermelon at 1.0 ppm will not be
exceeded when DuPont Sinbar (trade
name) herbicide is used as directed.
B. Toxicological Profile
1. Acute toxicity. Terbacil technical
has been placed in EPA Toxicity
Category III for acute oral toxicity (rat
lethal dose (LD50) 934 milligram/
kilogram (mg/kg) in female rats; 1,255
mg/kg in male rats); Category IV for
acute inhalation lethal concentration
(LC50) >4.4 milligrams per liter (mg/L)
in rats); Category IV for acute dermal
(rabbit LD50 >5,000 mg/kg); and
Category III for primary eye irritation
(mild conjunctival effects clearing in 72
hours in rabbits). Although a primary
dermal irritation study is not available
on terbacil technical, the Agency
indicated to the Registrant that if no
dermal irritation was observed in a 21–
day sub-chronic dermal study, then the
requirements for the primary dermal
irritation study would be satisfied. No
dermal irritation was reported in that
study. A dermal sensitization test on
terbacil in guinea pigs showed no
dermal sensitization.
2. Genotoxicity. Terbacil technical
was tested and found negative in a
Chinese hamster ovary (CHO)
Hypoxanthine guanine phophoribosyl
transferase (HGPRT) gene mutation
assay when tested up to cytotoxic levels,
with and without S-9 activation
(cytotoxicity >3.0 micromolar (mM)
without activation; >2.75 mM with
activation). Terbacil technical was also
negative for unscheduled DNA
synthesis when tested up to cytotoxic
levels (5 mM) in the rat. It was also
negative for clastogenicity in a
chromosomal aberration study in rat
bone marrow cells, at doses up to 500
mg/kg.
3. Reproductive and developmental
toxicity. Terbacil was tested in male and
female rats at control and dietary levels
of 50 or 250 ppm (equivalent to 2.5 or
12.5 mg/kg/day, over three generations.
The first litter of each generation was
discarded, and the second litter bred to
produce the next generation. No
reproductive effects were seen at the
highest dose tested. Therefore, the no
observed adverse effect level (NOAEL)
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for reproductive toxicity was equal to or
greater than 250 ppm (12.5 mg/kg/day).
Terbacil has been tested in rats and
rabbits for its potential to produce
developmental toxicity. Rats were fed 0,
250, 1,250 or 5,000 ppm (equivalent to
0, 12.5, 62.5, or 250 mg/kg/day) of
terbacil in the diet from days 6 through
15 of gestation. The developmental
NOAEL was 250 ppm (12.5 mg/kg/day);
the developmental LOAEL of 1,250 ppm
(62.5 mg/kg/day) was based upon
significantly decreased numbers of live
fetuses per litter, apparently due to fetal
loss occurring before or near the time of
implantation. The maternal NOAEL was
250 ppm (12.5 mg/kg/day), based on
decreased body weight at 1,250 ppm
(62.5 mg/kg/day). Teratogenicity in
pregnant rats was not demonstrated.
Rabbits were given doses of terbacil of
0, 30, 200, or 600 mg/kg/day by gavage,
on gestation days 7 through 19. The
maternal NOAEL was 200 mg/kg/day,
based on maternal deaths (5 died and 2
were sacrificed in extremis) at the
LOAEL of 600 mg/kg/day. The
developmental NOAEL was also 200
mg/kg/day based on decreased live fetal
weights in the high dose group.
Teratogenicity in pregnant rabbits was
not demonstrated.
4. Subchronic toxicity. Subchronic
oral toxicity was tested in a 90–day
feeding study in rats. A NOAEL of 100
ppm (equivalent to 5 mg/kg/day) and a
LOAEL of 500 ppm, equivalent to 25
mg/kg/day highest dose tested (HDT)
were established, based on increased
absolute and relative liver weights,
vacuolization and hypertrophy of
hepatocytes. The data requirement for
subchronic oral toxicity in a nonrodent
was satisfied by a 2–year feeding study
in beagle dogs, in which a NOAEL of 50
ppm (equivalent to 1.25 mg/kg/day) and
a LOAEL of 250 ppm (equivalent to 7.2
mg/kg/day) were established, based on
increased thyroid to body weight ratios,
slight increase in liver weights, and
elevated alkaline phosphatase levels.
Subchronic dermal toxicity was tested
in a 21–day study in rabbits. Terbacil
(80% active ingredient (a.i.)) was
applied to prepared skin of male and
female rabbits at 5,000 mg/kg/day, 5
hours/day, 5 days/week. No systemic
toxicity was observed; mild scaling and
staining were reported at the test sites.
5. Chronic toxicity. Terbacil 80% a.i.
was administered to beagle dogs (4/sex/
group) in the diet for 2 years, at doses
of 50, 250, or 2,500/10,000 ppm
(equivalent to 1.25, 6.25, 62.5/250 mg/
kg/day). The NOAEL was 50 ppm (1.25
mg/kg/day) and the LOAEL was 250
ppm (6.25 mg/kg/day) based on
increased thyroid to body weight ratios,
slight increase in liver weights, and
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53183
elevated alkaline phosphatase levels.
Relative liver weights were also
increased at 2,500 and 10,000 ppm in
dogs sacrificed at 1 year and 2 years,
respectively.
A 2–year rat study was conducted
using terbacil 97.4% a.i. administered to
male and female rats at dietary levels of
0, 25, 1,500, or 7,500 ppm (approximate
doses for males of 0,0.9, 58, and 308 mg/
kg/day and for females of 0, 1.4, 83/484
mg/kg/day). The systemic NOAEL is 25
ppm and the LOAEL is 1,500 ppm based
on liver weight and centrilobular
hypertrophy. The study was conducted
at adequate dosages as demonstrated by
the decrement in body weight gain in
both sexes. There was no evidence of
increased tumor incidence in the treated
animals when compared to the controls.
Terbacil has been tested in a chronic
2–year feeding/oncogenicity study in
mice at doses of 0, 50, 1,250, or 5,000/
7,500 ppm (equivalent to 7, 179, 714/
1,071 mg/kg/day). The increase in dose
occurred after week 54. A systemic
NOAEL of 50 ppm is based on the
LOAEL of 1,250 ppm that resulted in
mild hypertrophy of the centrilobular
hepatocytes and decreased pituitary
weights in males. Pituitary weight was
also decreased in high-dose females.
There was an increased incidence of
lung neoplasms (adenomas and
adenocarcinomas) in all treated male
mice, which was not dose-related; in
addition, these tumors were within the
range of similar tumors observed in
historical control mice.
6. Animal metabolism. Radiolabeled
terbacil was tested in rats in single
doses of 6.5 or 500 mg/kg; 97-103% of
radioactivity was recovered within 5
days: 70-86% in urine, and 28% in
feces. The major metabolites were
glucuronide, sulfate, and Nacetylcysteine conjugates. The primary
metabolic pathway is hydroxylation of
the 6-methyl group to form the alcohol,
which is conjugated to form the
glucuronide (35% of the dose) and the
sulfate derivatives (11%). Terbacil is
also metabolized to the 5-hydroxy
intermediate, which is further
conjugated to form a sulfate derivative
(17%).
7. Metabolite toxicology. The parent
molecule is the only moiety of
toxicological significance appropriate
for regulation in plant and animal
commodities.
8. Endocrine disruption. No observed
effects reported.
C. Aggregate Exposure
1. Dietary exposure—i. Food.
Tolerances have been established for the
residues of terbacil in or on a variety of
agricultural commodities. For purposes
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of assessing dietary exposure, chronic
and acute dietary assessments have been
conducted using all existing and
pending tolerances for terbacil. To
estimate acute dietary risk, the endpoint
selected was based on a rat development
toxicity study in which the maternal
and fetal NOAEL were 12.5 mg/kg/day.
The reference dose (RfD) for systemic
toxicity was determined for terbacil as
0.013 mg/kg/day, by the Agency’s RfD
committee in 1986. The RfD was
calculated from a 2–year feeding study
in dogs in which the NOAEL was 1.25
mg/kg/day (based on increased relative
liver weights and increased serum
alkaline phosphatase, seen at 7.25 mg/
kg/day), and an uncertainty factor of
100. The RfD of 0.013 mg/kg/day was
reaffirmed by the Agency’s RfD
Committee on September 1, 1994.
A Tier 1 (screening) assessment was
conducted by DuPont; tolerance values,
indicated below, were used in the
assessment with no adjustments for
processing or usage. (Alfalfa feed
commodities are not included in the
assessment because they are not
consumed by humans.)
Commodity
Tolerance
(ppm)
2 years old with an acute dietary
exposure (at the 95th percentile) of
0.015641 mg/kg bwt/day(12.5% aRfD).
These results of Tier 1 (screening)
assessments support the registrant’s
view that there is reasonable certainty of
no harm from the use of this product as
labeled/proposed.
Terbacil is classified as a Group E
carcinogen—no evidence of
carcinogenicity in either rats or mice.
Therefore, a carcinogenicity risk
analysis for humans is not required.
ii. Drinking water. Other potential
dietary sources of exposure of the
general population to pesticides are
residues in drinking water.
For acute drinking water risk, the
Drinking Water Levels of Concern
(DWLOCs) were calculated using an
aRfD (acute) endpoint of 0.125 mg/kg
and compared to surface water or
ground water EEC (estimated
environmental concentration) values of
0.154 ppm and 0.125 ppm, respectively.
The DWLOC values are as follows:
Population Subgroups
DWLOC
Values
(ppm)
U.S. Population
4.3
Apple
0.3
Non-Nursing Infants
1.1
Asparagus
0.4
Children 1-6 Years
1.1
Blueberry
0.2
Children 7-12 Years
1.2
Caneberry Crop Subgroup
13B
Females 13+ Nursing
3.6
0.2
Males 13-19 Years
4.3
Peach
0.2
Seniors 55+
4.3
Peppermint
2.0
Spearmint
2.0
Strawberry
0.1
Sugarcane
0.4
Watermelon
1.0
(proposed)
The chronic risk values were
calculated with a chronic reference dose
(cRfD) of 0.013 mg/kg body weight
(bwt)/day. The chronic dietary exposure
for the U.S. population was 0.000725
mg/kg bwt/day (5.6% of the cRfD). The
most sensitive subpopulation was
children 1-6 years old with a chronic
dietary exposure of 0.002991 mg/kg
bwt/day (23.0% of the cRfD).
The acute risk values were calculated
with an acute reference dose (aRfD) of
0.125 mg/kg bwt/day. The acute dietary
exposure (at the 95th percentile) for the
U.S. population was 0.003071 mg/kg
bwt/day (2.5% of aRfD). The most
sensitive subpopulation was children 1-
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For chronic drinking water risk, the
DWLOCs were calculated using a cRfD
(chronic) endpoint of 0.013 mg/kg and
compared to surface water or ground
water EEC values of 0.105 ppm and
0.0089 ppm, respectively. The DWLOC
values are as follows:
Population Subgroups
DWLOC
Values
(ppm)
U.S. Population
0.43
Non-Nursing Infants
0.10
Children 1-6 years
0.10
Children 7-12 Years
0.12
Females 13+ Nursing
0.36
Males 13-19 years
0.43
Seniors 55+
0.44
The estimated environmental
concentrations are within acceptable
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Fmt 4703
Sfmt 4703
ranges. Because of the conservative
nature of the screening level dietary
assessments performed, and the fact that
actual ground water monitoring data,
although limited, are not showing large
amounts of terbacil present, DuPont
does not believe that drinking water
sources of terbacil are of concern.
2. Non-dietary exposure. Terbacil is
not registered for any use that could
result in non-occupational, non-dietary
exposure to the general population.
Alfalfa feed commodities were not
included in the assessment because they
are not consumed by humans.
D. Cumulative Effects
Section 408(b)(2)(D)(v) requires that,
when considering whether to establish,
modify, or revoke a tolerance, the
Agency considers ‘‘available
information’’ concerning the cumulative
effects of a particular pesticide’s
residues and ‘‘other substances that
have a common mechanism of toxicity.’’
For most pesticides, although the
Agency has some information in its files
that may turn out to be helpful in
eventually determining whether a
pesticide shares a common mechanism
of toxicity with any other substances,
EPA does not at this time have the
methodologies to resolve the complex
scientific issues concerning common
mechanism of toxicity in a meaningful
way. EPA has begun a pilot process to
study this issue further through the
examination of particular classes of
pesticides. The Agency hopes that the
results of this pilot process will increase
the Agency’s scientific understanding of
this question such that EPA will be able
to develop and apply scientific
principles for better determining which
chemicals have a common mechanism
of toxicity and evaluating the
cumulative effects of such chemicals.
The Agency anticipates, however, that
even as its understanding of the science
of common mechanisms increases,
decisions on specific classes of
chemicals will be heavily dependent on
chemical specific data, much of which
may not be presently available.
In assessing the potential risk from
cumulative effects of terbacil and other
chemical substances, the Agency has
considered structural similarities that
exist between terbacil and other
substituted uracil compounds such as
bromacil and lenacil.
A comparison of the available
toxicological database for terbacil and
bromacil revealed no clear common
mode of toxicity for these chemicals.
The toxicology database for lenacil was
not considered because there are
currently no registered uses of lenacil. A
summary of the most prominent clinical
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Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices
signs from terbacil and bromacil
follows.
The following clinical signs were
observed in the terbacil toxicology
database: Decrease in body weight,
increase in liver weights, vacuolization
and hypertrophy of hepatocytes,
hypertrophy of centrilobular
hepatocytes in males, decreased
pituitary weights in males and females,
increase in thyroid/body weight ratio,
and elevated alkaline phosphatase.
The following clinical signs were
observed in the bromacil toxicology
database: Decreased body weight, focal
atrophy of seminiferous tubules
(testicular abnormalities),
hydronephrosis, suggestive histological
evidence for antithyroid activity (cystic
follicles in the thyroid and enlargement
of centrilobular cells of the liver), and
a positive trend in thyroid tumors for
male rats (basis of C classification for
carcinogenicity).
Based on these data, DuPont
concludes that there is no clear common
mode of toxicity (thyroid or liver)
between terbacil and bromacil. With
both chemicals, there is marginal
evidence of liver effects (principally
enlargement of centrilobular cells).
Enlargement of liver cells is not a
specific enough effect to be considered
a common mode of toxicity. The thyroid
effects observed with bromacil were
cystic follicles. Terbacil induced an
increase in relative thyroid weights but
no increase in absolute thyroid weights.
An increase in relative weight without
a corresponding increase in absolute
weight has very little meaning,
especially without any supporting
histological or hormonal evidence. This
conclusion was based on the marginal
liver effects noted in the databases, and
the absence of thyroid effects in the
terbacil database (with the exception of
increases in relative thyroid weights).
DuPont has no information indicating
that any other chemical has a common
mode of toxicity with terbacil and,
therefore concludes that an aggregate
risk assessment will indicate risks
resulting only from terbacil.
E. Safety Determination
1. U.S. population. EPA has
determined that the established
tolerances for terbacil meet the safety
standards under the FQPA amendments
to section 408(b)(2)(D) for the general
population. In reaching this
determination, EPA has considered
available information on aggregate
exposures (both acute and chronic) from
non-occupational sources, food and
drinking water, as well as the possibility
of cumulative effects from terbacil and
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other chemicals with similar
mechanism of toxicity.
Since there are no residential or lawn
uses of terbacil, no dermal or inhalation
exposure is expected in and around the
home.
In assessing acute dietary risk from
food, the endpoint selected was
developmental toxicity. Because the
endpoint of concern is a developmental
effect, the only sub-population of
concern is females of child-bearing age
(i.e., females, 13+ years old).
The acute risk values were calculated
by DuPont with an aRfD of 0.125 mg/kg
bwt/day. The acute dietary exposure (at
the 95th percentile) for the U.S.
population was 0.003071 mg/kg bwt/
day (2.5% of aRfD). The most sensitive
subpopulation was children 1-2 years
old with an acute dietary exposure (at
the 95th percentile) of 0.015641 mg/kg
bwt/day (12.5% aRfD).
The chronic risk values were
calculated by DuPont with a cRfD of
0.013 mg/kg bwt/day. The chronic
dietary exposure for the U.S. population
was 0.000725 mg/kg bwt/day (5.6% of
the cRfD). The most sensitive
subpopulation was children 1-6 years
old with a chronic dietary exposure of
0.002991 mg/kg bwt/day (23.0% of the
cRfD).
In evaluating the potential for
cumulative effects, EPA compared
terbacil with other structurally similar
substituted uracil compounds, such as
bromacil and lenacil, and then with
other compounds producing similar
effects. A comparison of the available
toxicological database for terbacil and
bromacil revealed no clear common
mode of toxicity for the chemicals. The
toxicology database for lenacil was not
considered because there are currently
no registered uses of lenacil. Based on
the available data, the Agency has
determined that there is no clear
common mode of toxicity between
terbacil and bromacil.
2. Infants and children. EPA has
determined that the established
tolerances for terbacil meet the safety
standard under the FQPA amendment to
section 408(b)(2)(C) for infants and
children. The safety determination for
infants and children considers the
factors noted above for the general
population, but also takes into account
the possibility of increased dietary
exposure due to the specific
consumption patterns of infants and
children, as well as the possibility of
increased susceptibility to the toxic
effects of terbacil residues in this
population subgroup.
In determining whether or not infants
and children are particularly susceptible
to toxic effects from terbacil residues,
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Fmt 4703
Sfmt 4703
53185
EPA considered the completeness of the
database for developmental and
reproductive effects, the nature of the
effects observed, and other information.
Based on current data requirements,
terbacil has a complete database for
developmental and reproductive
toxicity. Because the developmental
NOAELs were the same as those for
maternal toxicity, and the NOAEL for
systemic (parental) toxicity was higher
than the NOAEL for reproductive
toxicity, DuPont believes that these data
do not suggest an increased pre- or postnatal sensitivity of children and infants
to terbacil exposure. Therefore, DuPont
concludes that the available toxicology
data do not support an uncertainty
factor of 1,000 as specified in FQPA and
that the present uncertainty factor of
100 is adequate to ensure the protection
of infants and children from exposure to
terbacil.
It is estimated by DuPont that terbacil
exposure from the chronic diet is as
follows: All infants less than 1 year—
18% of the cRfD; Nursing infants—9.7%
of the cRfD; Non-nursing infants—
21.2% of the cRfD; Children 1-6 years—
23% of the cRfD.
F. International Tolerances
There are no established Codex
maximum residue levels (MRL’s) or
international tolerances for terbacil on
watermelon.
[FR Doc. 05–17529 Filed 9–6–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPPT–2005–0045; FRL–7735–9]
Certain New Chemicals; Receipt and
Status Information
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: Section 5 of the Toxic
Substances Control Act (TSCA) requires
any person who intends to manufacture
(defined by statute to include import) a
new chemical (i.e., a chemical not on
the TSCA Inventory) to notify EPA and
comply with the statutory provisions
pertaining to the manufacture of new
chemicals. Under sections 5(d)(2) and
5(d)(3) of TSCA, EPA is required to
publish a notice of receipt of a
premanufacture notice (PMN) or an
application for a test marketing
exemption (TME), and to publish
periodic status reports on the chemicals
under review and the receipt of notices
of commencement to manufacture those
chemicals. This status report, which
E:\FR\FM\07SEN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Notices]
[Pages 53180-53185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17529]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0215; FRL-7731-1]
Terbacil; 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-
2005-0215, must be received on or before October 7, 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: Sidney Jackson, Registration Division
(7505C), Office of Pesticide Programs,
[[Page 53181]]
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-7610; e-mail
address: jackson.sidney@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 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-2005-0215. 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 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.1. 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 in 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-2005-0215. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or
[[Page 53182]]
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-2005-0215. 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-2005-0215.
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-2005-0215. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you
used that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: August 19, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner 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 petitioner and represents the view of the petitioner.
The petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the pesticide chemical residues or an explanation of why no such
method is needed.
Interregional Research Project Number 4 (IR-4)
PP 3E6640
EPA has received a pesticide petition (PP 3E6640) from
Interregional Research Project Number 4 (IR-4) on behalf of DuPont Crop
Protection, P.O. Box 30, Newark, Delaware 19714-0030, proposing,
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40
CFR part 180 by establishing a tolerance for residues of the herbicide,
terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its metabolites [3-
tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-2,3-dihydro-7-
hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-one], and [6-
chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a) pyrimidin-5-one]
in or on the raw agricultural commodity watermelon at 1.0 parts per
million (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 supports granting of
the petition. Additional data may be needed before EPA rules on the
petition. This notice includes a summary of the petition that was
prepared by DuPont Crop Protection.
A. Residue Chemistry
1. Plant metabolism. The metabolism and chemical nature of residues
of terbacil in plants and animals are adequately understood. The fate
of terbacil has been extensively studied using radioactive tracers in
plant and animal metabolism/nature of the residue studies.
2. Analytical method. There is a practical analytical method
utilizing microcoulometric gas chromatography with thermionic or
nitrogen
[[Page 53183]]
phosphorous detection available for enforcement with a limit of
detection that allows monitoring food with residues at or above
tolerance levels. The limit of detection for the method determined by
the lowest standard of 0.5 nanogram per microliter (ng/[mu]l) was 0.05
ppm.
3. Magnitude of residues. Crop field trial residue data from a 69-
to 94-day preharvest interval (PHI) study show that the proposed
tolerance in or on watermelon at 1.0 ppm will not be exceeded when
DuPont Sinbar (trade name) herbicide is used as directed.
B. Toxicological Profile
1. Acute toxicity. Terbacil technical has been placed in EPA
Toxicity Category III for acute oral toxicity (rat lethal dose
(LD50) 934 milligram/kilogram (mg/kg) in female rats; 1,255
mg/kg in male rats); Category IV for acute inhalation lethal
concentration (LC50) >4.4 milligrams per liter (mg/L) in
rats); Category IV for acute dermal (rabbit LD50 >5,000 mg/
kg); and Category III for primary eye irritation (mild conjunctival
effects clearing in 72 hours in rabbits). Although a primary dermal
irritation study is not available on terbacil technical, the Agency
indicated to the Registrant that if no dermal irritation was observed
in a 21-day sub-chronic dermal study, then the requirements for the
primary dermal irritation study would be satisfied. No dermal
irritation was reported in that study. A dermal sensitization test on
terbacil in guinea pigs showed no dermal sensitization.
2. Genotoxicity. Terbacil technical was tested and found negative
in a Chinese hamster ovary (CHO) Hypoxanthine guanine phophoribosyl
transferase (HGPRT) gene mutation assay when tested up to cytotoxic
levels, with and without S-9 activation (cytotoxicity >3.0 micromolar
(mM) without activation; >2.75 mM with activation). Terbacil technical
was also negative for unscheduled DNA synthesis when tested up to
cytotoxic levels (5 mM) in the rat. It was also negative for
clastogenicity in a chromosomal aberration study in rat bone marrow
cells, at doses up to 500 mg/kg.
3. Reproductive and developmental toxicity. Terbacil was tested in
male and female rats at control and dietary levels of 50 or 250 ppm
(equivalent to 2.5 or 12.5 mg/kg/day, over three generations. The first
litter of each generation was discarded, and the second litter bred to
produce the next generation. No reproductive effects were seen at the
highest dose tested. Therefore, the no observed adverse effect level
(NOAEL) for reproductive toxicity was equal to or greater than 250 ppm
(12.5 mg/kg/day).
Terbacil has been tested in rats and rabbits for its potential to
produce developmental toxicity. Rats were fed 0, 250, 1,250 or 5,000
ppm (equivalent to 0, 12.5, 62.5, or 250 mg/kg/day) of terbacil in the
diet from days 6 through 15 of gestation. The developmental NOAEL was
250 ppm (12.5 mg/kg/day); the developmental LOAEL of 1,250 ppm (62.5
mg/kg/day) was based upon significantly decreased numbers of live
fetuses per litter, apparently due to fetal loss occurring before or
near the time of implantation. The maternal NOAEL was 250 ppm (12.5 mg/
kg/day), based on decreased body weight at 1,250 ppm (62.5 mg/kg/day).
Teratogenicity in pregnant rats was not demonstrated.
Rabbits were given doses of terbacil of 0, 30, 200, or 600 mg/kg/
day by gavage, on gestation days 7 through 19. The maternal NOAEL was
200 mg/kg/day, based on maternal deaths (5 died and 2 were sacrificed
in extremis) at the LOAEL of 600 mg/kg/day. The developmental NOAEL was
also 200 mg/kg/day based on decreased live fetal weights in the high
dose group. Teratogenicity in pregnant rabbits was not demonstrated.
4. Subchronic toxicity. Subchronic oral toxicity was tested in a
90-day feeding study in rats. A NOAEL of 100 ppm (equivalent to 5 mg/
kg/day) and a LOAEL of 500 ppm, equivalent to 25 mg/kg/day highest dose
tested (HDT) were established, based on increased absolute and relative
liver weights, vacuolization and hypertrophy of hepatocytes. The data
requirement for subchronic oral toxicity in a nonrodent was satisfied
by a 2-year feeding study in beagle dogs, in which a NOAEL of 50 ppm
(equivalent to 1.25 mg/kg/day) and a LOAEL of 250 ppm (equivalent to
7.2 mg/kg/day) were established, based on increased thyroid to body
weight ratios, slight increase in liver weights, and elevated alkaline
phosphatase levels.
Subchronic dermal toxicity was tested in a 21-day study in rabbits.
Terbacil (80% active ingredient (a.i.)) was applied to prepared skin of
male and female rabbits at 5,000 mg/kg/day, 5 hours/day, 5 days/week.
No systemic toxicity was observed; mild scaling and staining were
reported at the test sites.
5. Chronic toxicity. Terbacil 80% a.i. was administered to beagle
dogs (4/sex/group) in the diet for 2 years, at doses of 50, 250, or
2,500/10,000 ppm (equivalent to 1.25, 6.25, 62.5/250 mg/kg/day). The
NOAEL was 50 ppm (1.25 mg/kg/day) and the LOAEL was 250 ppm (6.25 mg/
kg/day) based on increased thyroid to body weight ratios, slight
increase in liver weights, and elevated alkaline phosphatase levels.
Relative liver weights were also increased at 2,500 and 10,000 ppm in
dogs sacrificed at 1 year and 2 years, respectively.
A 2-year rat study was conducted using terbacil 97.4% a.i.
administered to male and female rats at dietary levels of 0, 25, 1,500,
or 7,500 ppm (approximate doses for males of 0,0.9, 58, and 308 mg/kg/
day and for females of 0, 1.4, 83/484 mg/kg/day). The systemic NOAEL is
25 ppm and the LOAEL is 1,500 ppm based on liver weight and
centrilobular hypertrophy. The study was conducted at adequate dosages
as demonstrated by the decrement in body weight gain in both sexes.
There was no evidence of increased tumor incidence in the treated
animals when compared to the controls.
Terbacil has been tested in a chronic 2-year feeding/oncogenicity
study in mice at doses of 0, 50, 1,250, or 5,000/7,500 ppm (equivalent
to 7, 179, 714/1,071 mg/kg/day). The increase in dose occurred after
week 54. A systemic NOAEL of 50 ppm is based on the LOAEL of 1,250 ppm
that resulted in mild hypertrophy of the centrilobular hepatocytes and
decreased pituitary weights in males. Pituitary weight was also
decreased in high-dose females. There was an increased incidence of
lung neoplasms (adenomas and adenocarcinomas) in all treated male mice,
which was not dose-related; in addition, these tumors were within the
range of similar tumors observed in historical control mice.
6. Animal metabolism. Radiolabeled terbacil was tested in rats in
single doses of 6.5 or 500 mg/kg; 97-103% of radioactivity was
recovered within 5 days: 70-86% in urine, and 28% in feces. The major
metabolites were glucuronide, sulfate, and N-acetylcysteine conjugates.
The primary metabolic pathway is hydroxylation of the 6-methyl group to
form the alcohol, which is conjugated to form the glucuronide (35% of
the dose) and the sulfate derivatives (11%). Terbacil is also
metabolized to the 5-hydroxy intermediate, which is further conjugated
to form a sulfate derivative (17%).
7. Metabolite toxicology. The parent molecule is the only moiety of
toxicological significance appropriate for regulation in plant and
animal commodities.
8. Endocrine disruption. No observed effects reported.
C. Aggregate Exposure
1. Dietary exposure--i. Food. Tolerances have been established for
the residues of terbacil in or on a variety of agricultural
commodities. For purposes
[[Page 53184]]
of assessing dietary exposure, chronic and acute dietary assessments
have been conducted using all existing and pending tolerances for
terbacil. To estimate acute dietary risk, the endpoint selected was
based on a rat development toxicity study in which the maternal and
fetal NOAEL were 12.5 mg/kg/day. The reference dose (RfD) for systemic
toxicity was determined for terbacil as 0.013 mg/kg/day, by the
Agency's RfD committee in 1986. The RfD was calculated from a 2-year
feeding study in dogs in which the NOAEL was 1.25 mg/kg/day (based on
increased relative liver weights and increased serum alkaline
phosphatase, seen at 7.25 mg/kg/day), and an uncertainty factor of 100.
The RfD of 0.013 mg/kg/day was reaffirmed by the Agency's RfD Committee
on September 1, 1994.
A Tier 1 (screening) assessment was conducted by DuPont; tolerance
values, indicated below, were used in the assessment with no
adjustments for processing or usage. (Alfalfa feed commodities are not
included in the assessment because they are not consumed by humans.)
------------------------------------------------------------------------
Tolerance
Commodity (ppm)
------------------------------------------------------------------------
Apple 0.3
------------------------------------------------------------
Asparagus 0.4
------------------------------------------------------------
Blueberry 0.2
------------------------------------------------------------
Caneberry Crop Subgroup 13B 0.2
------------------------------------------------------------
Peach 0.2
------------------------------------------------------------
Peppermint 2.0
------------------------------------------------------------
Spearmint 2.0
------------------------------------------------------------
Strawberry 0.1
------------------------------------------------------------
Sugarcane 0.4
------------------------------------------------------------
Watermelon 1.0
(proposed)
------------------------------------------------------------------------
The chronic risk values were calculated with a chronic reference
dose (cRfD) of 0.013 mg/kg body weight (bwt)/day. The chronic dietary
exposure for the U.S. population was 0.000725 mg/kg bwt/day (5.6% of
the cRfD). The most sensitive subpopulation was children 1-6 years old
with a chronic dietary exposure of 0.002991 mg/kg bwt/day (23.0% of the
cRfD).
The acute risk values were calculated with an acute reference dose
(aRfD) of 0.125 mg/kg bwt/day. The acute dietary exposure (at the 95th
percentile) for the U.S. population was 0.003071 mg/kg bwt/day (2.5% of
aRfD). The most sensitive subpopulation was children 1-2 years old with
an acute dietary exposure (at the 95th percentile) of 0.015641 mg/kg
bwt/day(12.5% aRfD).
These results of Tier 1 (screening) assessments support the
registrant's view that there is reasonable certainty of no harm from
the use of this product as labeled/proposed.
Terbacil is classified as a Group E carcinogen--no evidence of
carcinogenicity in either rats or mice. Therefore, a carcinogenicity
risk analysis for humans is not required.
ii. Drinking water. Other potential dietary sources of exposure of
the general population to pesticides are residues in drinking water.
For acute drinking water risk, the Drinking Water Levels of Concern
(DWLOCs) were calculated using an aRfD (acute) endpoint of 0.125 mg/kg
and compared to surface water or ground water EEC (estimated
environmental concentration) values of 0.154 ppm and 0.125 ppm,
respectively. The DWLOC values are as follows:
------------------------------------------------------------------------
DWLOC
Population Subgroups Values
(ppm)
------------------------------------------------------------------------
U.S. Population 4.3
------------------------------------------------------------
Non-Nursing Infants 1.1
------------------------------------------------------------
Children 1-6 Years 1.1
------------------------------------------------------------
Children 7-12 Years 1.2
------------------------------------------------------------
Females 13+ Nursing 3.6
------------------------------------------------------------
Males 13-19 Years 4.3
------------------------------------------------------------
Seniors 55+ 4.3
------------------------------------------------------------------------
For chronic drinking water risk, the DWLOCs were calculated using a
cRfD (chronic) endpoint of 0.013 mg/kg and compared to surface water or
ground water EEC values of 0.105 ppm and 0.0089 ppm, respectively. The
DWLOC values are as follows:
------------------------------------------------------------------------
DWLOC
Population Subgroups Values
(ppm)
------------------------------------------------------------------------
U.S. Population 0.43
------------------------------------------------------------
Non-Nursing Infants 0.10
------------------------------------------------------------
Children 1-6 years 0.10
------------------------------------------------------------
Children 7-12 Years 0.12
------------------------------------------------------------
Females 13+ Nursing 0.36
------------------------------------------------------------
Males 13-19 years 0.43
------------------------------------------------------------
Seniors 55+ 0.44
------------------------------------------------------------------------
The estimated environmental concentrations are within acceptable
ranges. Because of the conservative nature of the screening level
dietary assessments performed, and the fact that actual ground water
monitoring data, although limited, are not showing large amounts of
terbacil present, DuPont does not believe that drinking water sources
of terbacil are of concern.
2. Non-dietary exposure. Terbacil is not registered for any use
that could result in non-occupational, non-dietary exposure to the
general population. Alfalfa feed commodities were not included in the
assessment because they are not consumed by humans.
D. Cumulative Effects
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency considers
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' For most pesticides, although the
Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
In assessing the potential risk from cumulative effects of terbacil
and other chemical substances, the Agency has considered structural
similarities that exist between terbacil and other substituted uracil
compounds such as bromacil and lenacil.
A comparison of the available toxicological database for terbacil
and bromacil revealed no clear common mode of toxicity for these
chemicals. The toxicology database for lenacil was not considered
because there are currently no registered uses of lenacil. A summary of
the most prominent clinical
[[Page 53185]]
signs from terbacil and bromacil follows.
The following clinical signs were observed in the terbacil
toxicology database: Decrease in body weight, increase in liver
weights, vacuolization and hypertrophy of hepatocytes, hypertrophy of
centrilobular hepatocytes in males, decreased pituitary weights in
males and females, increase in thyroid/body weight ratio, and elevated
alkaline phosphatase.
The following clinical signs were observed in the bromacil
toxicology database: Decreased body weight, focal atrophy of
seminiferous tubules (testicular abnormalities), hydronephrosis,
suggestive histological evidence for antithyroid activity (cystic
follicles in the thyroid and enlargement of centrilobular cells of the
liver), and a positive trend in thyroid tumors for male rats (basis of
C classification for carcinogenicity).
Based on these data, DuPont concludes that there is no clear common
mode of toxicity (thyroid or liver) between terbacil and bromacil. With
both chemicals, there is marginal evidence of liver effects
(principally enlargement of centrilobular cells). Enlargement of liver
cells is not a specific enough effect to be considered a common mode of
toxicity. The thyroid effects observed with bromacil were cystic
follicles. Terbacil induced an increase in relative thyroid weights but
no increase in absolute thyroid weights. An increase in relative weight
without a corresponding increase in absolute weight has very little
meaning, especially without any supporting histological or hormonal
evidence. This conclusion was based on the marginal liver effects noted
in the databases, and the absence of thyroid effects in the terbacil
database (with the exception of increases in relative thyroid weights).
DuPont has no information indicating that any other chemical has a
common mode of toxicity with terbacil and, therefore concludes that an
aggregate risk assessment will indicate risks resulting only from
terbacil.
E. Safety Determination
1. U.S. population. EPA has determined that the established
tolerances for terbacil meet the safety standards under the FQPA
amendments to section 408(b)(2)(D) for the general population. In
reaching this determination, EPA has considered available information
on aggregate exposures (both acute and chronic) from non-occupational
sources, food and drinking water, as well as the possibility of
cumulative effects from terbacil and other chemicals with similar
mechanism of toxicity.
Since there are no residential or lawn uses of terbacil, no dermal
or inhalation exposure is expected in and around the home.
In assessing acute dietary risk from food, the endpoint selected
was developmental toxicity. Because the endpoint of concern is a
developmental effect, the only sub-population of concern is females of
child-bearing age (i.e., females, 13+ years old).
The acute risk values were calculated by DuPont with an aRfD of
0.125 mg/kg bwt/day. The acute dietary exposure (at the 95th
percentile) for the U.S. population was 0.003071 mg/kg bwt/day (2.5% of
aRfD). The most sensitive subpopulation was children 1-2 years old with
an acute dietary exposure (at the 95th percentile) of 0.015641 mg/kg
bwt/day (12.5% aRfD).
The chronic risk values were calculated by DuPont with a cRfD of
0.013 mg/kg bwt/day. The chronic dietary exposure for the U.S.
population was 0.000725 mg/kg bwt/day (5.6% of the cRfD). The most
sensitive subpopulation was children 1-6 years old with a chronic
dietary exposure of 0.002991 mg/kg bwt/day (23.0% of the cRfD).
In evaluating the potential for cumulative effects, EPA compared
terbacil with other structurally similar substituted uracil compounds,
such as bromacil and lenacil, and then with other compounds producing
similar effects. A comparison of the available toxicological database
for terbacil and bromacil revealed no clear common mode of toxicity for
the chemicals. The toxicology database for lenacil was not considered
because there are currently no registered uses of lenacil. Based on the
available data, the Agency has determined that there is no clear common
mode of toxicity between terbacil and bromacil.
2. Infants and children. EPA has determined that the established
tolerances for terbacil meet the safety standard under the FQPA
amendment to section 408(b)(2)(C) for infants and children. The safety
determination for infants and children considers the factors noted
above for the general population, but also takes into account the
possibility of increased dietary exposure due to the specific
consumption patterns of infants and children, as well as the
possibility of increased susceptibility to the toxic effects of
terbacil residues in this population subgroup.
In determining whether or not infants and children are particularly
susceptible to toxic effects from terbacil residues, EPA considered the
completeness of the database for developmental and reproductive
effects, the nature of the effects observed, and other information.
Based on current data requirements, terbacil has a complete
database for developmental and reproductive toxicity. Because the
developmental NOAELs were the same as those for maternal toxicity, and
the NOAEL for systemic (parental) toxicity was higher than the NOAEL
for reproductive toxicity, DuPont believes that these data do not
suggest an increased pre- or post-natal sensitivity of children and
infants to terbacil exposure. Therefore, DuPont concludes that the
available toxicology data do not support an uncertainty factor of 1,000
as specified in FQPA and that the present uncertainty factor of 100 is
adequate to ensure the protection of infants and children from exposure
to terbacil.
It is estimated by DuPont that terbacil exposure from the chronic
diet is as follows: All infants less than 1 year--18% of the cRfD;
Nursing infants--9.7% of the cRfD; Non-nursing infants--21.2% of the
cRfD; Children 1-6 years--23% of the cRfD.
F. International Tolerances
There are no established Codex maximum residue levels (MRL's) or
international tolerances for terbacil on watermelon.
[FR Doc. 05-17529 Filed 9-6-05; 8:45 am]
BILLING CODE 6560-50-S
