Thymol; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemicalin or on Food, 21773-21777 [05-8127]
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Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices
period on the request for voluntary
cancellation or use termination. In
addition, section 6(f)(1)(C) of FIFRA
requires that EPA provide a 180–day
comment period on a request for
voluntary cancellation or termination of
any minor agricultural use before
granting the request, unless:
1. The registrants request a waiver of
the comment period, or
2. The Administrator determines that
continued use of the pesticide would
pose an unreasonable adverse effect on
the environment.
In a letter dated September 22, 2004,
the thiram registrant requested that EPA
waive the 180–day comment period.
Therefore, EPA will provide a 30–day
comment period on the proposed
requests.
Unless a request is withdrawn by the
registrant within 30 days of publication
of this notice, or if the Agency
determines that there are substantive
comments that warrant further review of
this request, an order will be issued
amending the affected registrations.
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.
V. Procedures for Withdrawal of
Request and Considerations for
Reregistration of Thiram
Registrants who choose to withdraw a
request for cancellation must submit
such withdrawal in writing to the
person listed underFOR FURTHER
INFORMATION CONTACT, postmarked
before May 27, 2005. This written
withdrawal of the request for
cancellation will apply only to the
applicable FIFRA section 6(f)(1) request
listed in this notice. If the products have
been subject to a previous cancellation
action, the effective date of cancellation
and all other provisions of any earlier
cancellation action are controlling.
VI. Provisions for Disposition of
Existing Stocks
TABLE 1.—THIRAM PRODUCT REGExisting stocks are those stocks of
ISTRATIONS WITH PENDING REregistered pesticide products which are
QUESTS FOR AMENDMENT
Registration
No.
Product
name
Company
45728-1
Thiram
Technical
Taminco,
Inc.
45728-21
Thiram 75
WP Fruit,
Vegetable
and Turf
Fungicide
Taminco,
Inc.
Thiram 65
Taminco,
Inc.
45728-24
Table 2 of this unit includes the name
and address of record for the registrant
of the products listed in Table 1 of this
unit.
TABLE 2.—REGISTRANT REQUESTING
VOLUNTARY AMENDMENTS
EPA
Company No.
45728
Company name and address
Taminco, Inc.
1950 Lake Park Drive
Smyrna, GA 30080
IV. 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
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currently in the United States and
which were packaged, labeled, and
released for shipment prior to the
effective date of the cancellation action.
If the request for voluntary use
termination is granted as discussed
above, the Agency intends to issue a
cancellation order that will allow
persons other than the registrant to
continue to sell and/or use existing
stocks of cancelled products until such
stocks are exhausted, provided that such
use is consistent with the terms of the
previously approved labeling on, or that
accompanied, the cancelled product.
The order will specifically prohibit any
use of existing stocks that is not
consistent with such previously
approved labeling. If, as the Agency
currently intends, the final cancellation
order contains the existing stocks
provision just described, the order will
be sent only to the affected registrants
of the cancelled products. If the Agency
determines that the final cancellation
order should contain existing stocks
provisions different than the ones just
described, the Agency will publish the
cancellation order in the Federal
Register.
List of Subjects
Environmental protection, Pesticides
and pests.
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21773
Dated: April 19, 2005.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. 05–8380 Filed 4–26–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0093; FRL–7707–8]
Thymol; Notice of Filing a Pesticide
Petition to Establish a Tolerance for a
Certain Pesticide Chemicalin 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–
0093, must be received on or before May
27, 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:
Andrew C. Bryceland, Biopesticides and
Pollution Prevention Division (7511C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6928; e-mail
address:bryceland.andrew@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
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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 identification (ID) number
OPP–2005–0093. 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
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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
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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–2005–0093. 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–
2005–0093. 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
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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–2005–0093.
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–2005–0093. 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.
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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: April 5, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention 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.
Vita (Europe) Limited
PP 3F6752
EPA has received a pesticide petition
(PP 3F6752) from Vita (Europe) Limited,
c/o Landis International, P.O. Box 5126,
Valdosta, GA 31603–5126, proposing
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21775
pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the
requirement for a tolerance for the
biochemical pesticide thymol.
Pursuant to section 408(d)(2)(A)(i) of
FFDCA, as amended, Vita (Europe)
Limited has submitted the following
summary of information, data, and
arguments in support of their pesticide
petition. This summary was prepared by
Vita (Europe) Limited and EPA has not
fully evaluated the merits of the
pesticide petition. The summary may
have been edited by EPA if the
terminology used was unclear, the
summary contained extraneous
material, or the summary
unintentionally made the reader
conclude that the findings reflected
EPA’s position and not the position of
the petitioner.
A. Product Name and Proposed Use
Practices
Thymol (5-methyl-2-isopropyl-1phenol) (CAS No. 89–83–8), when used
as an acaricide, controls varroa mites in
honeybees. Efficacy is maximized if the
product is used in late summer after the
honey harvest (when the amount of
brood present is diminishing). However,
in the case of severe infestations, thymol
can also be used during springtime,
when temperatures are above 60°F, but
not when the maximum daily
temperature is above 105°F. If further
significant mite fall is observed during
the following winter or spring, it is
recommended to use an additional
secondary winter or spring treatment for
varroa.
B. Product Identity/Chemistry
1. Identity of the pesticide and
corresponding residues. Thymol is a
constituent of oil of thyme, a naturally
occurring mixture of compounds in the
plant Thymus vulgaris L., or thyme.
Thymol is an active ingredient in
pesticide products registered for use as
animal repellents, fungicides/fungistats,
medical disinfectants, tuberculocides,
and virucides. Thymol also has many
non-pesticidal uses, including use in
perfumes, food flavorings,
mouthwashes, pharmaceutical
preparations, and cosmetics.
Thymol is a constituent of a mixture
of organic compounds known to be
rapidly degraded in the environment to
elemental compounds by normal
biological, physical and/or chemical
processes that can be reasonably
expected to exist where the pesticide is
applied.
2. Magnitude of residue at the time of
harvest and method used to determine
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the residue. In samples collected from
supers 30 days and 103 days after
thymol was removed from the frames,
thymol residues ranged from <0.03 parts
per million (ppm) limit of quantitation
(LOQ) to 1.5 ppm in honey and 0.75
ppm to 20.59 ppm in wax. These are the
residues that are expected as the label
requires that the supers be removed
from the frames prior to treatment with
thymol and re-installed after thymol
removal (i.e., no treatment during honey
flow). Samples collected from the brood
frames, in which honey was being
formed while thymol was present,
resulted in thymol residues between
<0.03 ppm and 4.61 ppm in honey and
between 1.18 ppm to 682.83 ppm in
wax. These samples were collected 0 to
14 days after thymol removal.
Thymol was applied to brood frames
in trays in two applications at 15 day
intervals (total thymol = 25 gram (g)) in
all three trials. In one of the trials (3B–
217) three applications at 10 day
intervals (total thymol = 37.5 g) was
tested as well as the 25 g rate. These
studies were conducted in Europe in
two different years (1997 and 1998).
Samples were collected in the brood
nest for analysis on the last day of
treatment (0 day preharvest interval
(phi)) and in the super 30 days after
treatment (30 day phi) in trial 3B–214.
The supers were placed on the brood
nest at the end of treatment. Thymol
was added in trays at the top and/or
bottom of the brood frames in all three
trials. In trial 3B–215, samples were
collected in the brood nest on the last
day of treatment (0 day phi) as well as
in the super 103 days after treatment. In
trial 3B–217, samples were collected in
the brood nest 2 days after treatment
and 14 days after treatment. In all honey
samples, thymol concentration ranged
from 4.61 ppm to <LOQ with a mean
concentration of 1.22 ppm. Concurrent
recoveries ranged from 73.9% to
116.9%. In wax samples, which were
collected at the time of honey
collection, residues ranged from 0.75
ppm to 683 ppm with overall
concurrent recoveries ranging from 72.0
to 95.9%. All concurrent recoveries
were between the acceptable range of
70% and 120%. The data were variable
but there does not appear to be a
significant difference between residues
found in the different treatments for
honey or wax samples. Thymol was
extracted in hexane dichloromethane
and analyzed using gas chromatography
with either a (MS)-detection or (FI)detection. The LOQ using these
techniques was 0.03 mg/kg.
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C. Mammalian Toxicological Profile
Thymol toxicity data reported
available literature cite acute oral LD50
values as 980 milligrams/kilogram (mg/
kg) and 880 mg/kg for the rat and guinea
pig, respectively (Sax, 1984). The acute
oral toxicity reported for the rat and
guinea pig, respectively, corresponds to
Toxicity Category III. The Material
Safety Data Sheet (MSDS) for the
manufacture of technical grade thymol
cites human health effects as irritating
when exposed by inhalation, dermal, or
eye contact. The MSDS also estimates a
human ingestion LD50 at 2 g of the
synthetic thymol. Based upon an
estimated thymol dermal toxicity LD50
of greater than 2,000 mg/kg, the dermal
toxicity would be Toxicity Category III.
A summary of the submitted
information on thymol toxicity allows
for the statements that the acute oral
LD50 in the rat is 980 mg/kg and in the
mouse is 640 to 1,800 mg/kg. Thymol is
corrosive to the rabbit eye and skin, and
is not reported as a dermal sensitizer in
the guinea pig. Thymol is readily
absorbed from the gastrointestinal tract
and is essentially excreted in the urine
as a glucuronate and sulfate conjugate of
the parent compound.
Thymol is not mutagenic in
Salmonella, but gives statistically
significant positive results in an
Unscheduled DNA synthesis and Sister
Chromatid Exchange tests, and in a cell
transformation test with Syrian hamster
embryonic cells. Multiple
malformations are noted when thymol is
injected into the air bubble or yolk sac
of embryonic chickens.
Dosing of rats with thymol in the feed
at 667 mg/kg body weight/day (highest
dose tested) for 19 weeks did not
produce any harmful effects.
D. Aggregate Exposure
1. Dietary exposure—i. Food. Thymol
is a component of many non-pesticidal
consumer products currently marketed
in the United States. Thymol is listed as
a food additive by the Food and Drug
Administration (21 CFR 172.515;
synthetic flavoring substances and
adjuvants). Thymol is considered
Generally Recognized As Safe or GRAS
(21 CFR 172.515, 182.10, and 182.20).
ii. Drinking water. No drinking water
exposure is expected from the pesticidal
use of thymol which is confined to
placement in beehives. Thymol is
currently registered for use on
ornamental plants, shrubs and grasses
so there is some potential for exposure
to water. However, thymol is a
constituent of a mixture of organic
compounds known to be rapidly
degraded in the environment to
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elemental compounds by normal
biological, physical and/or chemical
processes.
2. Non-dietary exposure. The
potential for non-dietary exposure to
thymol residues for the general
population, including infants and
children, is unlikely because the
proposed use site is limited to beehives.
Thymol is a normal constituent of the
human diet, as a component of thyme
and thyme oil, and as a direct food
additive. Therefore, while there exists a
great likelihood of prior exposure for
most, if not all, individuals to thymol,
any increased exposure due to the
proposed use would be negligible.
Thyme, which contains thymol, is a
pesticide active ingredient for the
control of aphids on ornamental plants.
Thyme and thyme oil are considered
minimum risk pesticides, and are
exempted as active ingredients under
FIFRA 40 CFR 152.25(f).
E. Cumulative Exposure
Thymol does not appear to produce a
toxic metabolite produced by other
substances.
F. Safety Determination
1. U.S. population. The dietary
exposure to residues of thymol to the
U.S. population from use of Apiguard is
not likely to add significantly to current
dietary exposure to thymol.
2. Infants and children. It is typical
for language to appear on labels of
honey that states ‘‘Do not feed to infants
under 1 year,’’ so there likely would be
no exposure of this population to
residues of thymol in the honey. It is
likely that older children have been
exposed to thymol residues from
consumption of candy, ice cream, and
baked goods. Consumption of honey
from hives treated with Apiguard is
unlikely to significantly increase
exposure to thymol. Therefore, based on
the long history of use of thyme, thyme
oil, and thymol in the diet with no
known adverse effects, it is reasonable
to conclude that no harm will result
from exposure to thymol in honey from
beehives treated with Apiguard.
G. Effects on the Immune and Endocrine
Systems
Thymol does not belong to a class of
chemicals known or suspected of having
adverse effects on the endocrine system.
There is no evidence that thymol has
any effect on endocrine function.
H. Existing Tolerances
There are no existing tolerances for
thymol in the United States.
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I. International Tolerances
No Codex Maximum Residue Levels
(MRL) are established for thymol.
However, Switzerland has established
an MRL of 0.8 mg/kg, apparently not
from a safety finding, but rather arising
from legislation that prohibits foreign
odors or tastes in honey. According to
the World Health Organization, thymol
residues in food are safe to consumers
at up to 50 mg/kg. According to
European Union regulation Nr. 2377/90,
thymol is in group II of the non-toxic
veterinary drugs which do not require a
MRL.
[FR Doc. 05–8127 Filed 4–26–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–7904–7]
Draft of the Causal Analysis/Diagnosis
Decision Information System (CADDIS)
E-Docket No. ORD–2005–0001
AGENCY:
Environmental Protection
Agency.
ACTION: Notice of external review draft
for public review and comment.
SUMMARY: The U.S. Environmental
Protection Agency (EPA) is announcing
that Versar Inc., an EPA contractor for
external scientific peer review, will
convene a panel of experts and organize
and conduct an external peer-review
workshop to review the external review
draft Web site titled ‘‘Causal Analysis/
Diagnosis Decision Information
System.’’ The EPA is also announcing a
30-day public review and comment
period for the draft Web site. The
CADDIS Web site was developed and
prepared by EPA’s National Center for
Environmental Assessment (NCEA), in
the Office of Research and Development
(ORD). NCEA will consider public
comment submissions in revising the
Web site.
DATES: The peer-review panel workshop
will begin on June 6, 2005, at 8:30 a.m.
and end at 5, eastern daylight time. The
30-day public comment period begins
April 27, 2005, and ends May 27, 2005.
Technical comments should be in
writing and must be submitted
electronically or postmarked by May 27,
2005.
ADDRESSES: The peer-review workshop
will be held in the 7th floor conference
room, at 633 3rd St., NW., Washington
DC. To attend the workshop, register by
June 1, 2005, by calling Crystal Edwards
of NCEA, at 202–564–1140, or send a
facsimile to 202–564–2018. You may
also register via e-mail at
VerDate jul<14>2003
16:41 Apr 26, 2005
Jkt 205001
edwards.crystal@epa.gov. The draft
CADDIS Web site can be accessed via
the Internet at https://www.epa.gov/
caddis. Comments may be submitted
electronically, by mail, by facsimile, or
by hand delivery/courier. Please follow
the detailed instructions as provided in
the section of this notice entitled
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For
workshop information, registration, and
logistics, contact Crystal Edwards,
USEPA (8623–N), 1200 Pennsylvania
Ave., NW., Washington DC 20460;
telephone: 202–564–1140; facsimile:
202–564–2018. For information on the
public comment period, contact the
Office of Environmental Information
Docket; telephone: 202–566–1752;
facsimile: 202–566–1753; or e-mail:
ORD.Docket@epa.gov. For technical
information, contact Susan Norton,
Ph.D., NCEA, via facsimile: 202–564–
2018, or e-mail: norton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
Summary of CADDIS Project
Over a thousand water bodies in the
United States are listed by states as
biologically impaired. For many of these
sites, the cause of impairment is
reported as ‘‘unknown.’’ Before
appropriate management actions can be
formulated for impaired water bodies,
the causes of biological impairment
(e.g., excess fine sediments, nutrients, or
toxics) need to be identified. Effective
causal analyses call for knowledge of
the mechanisms, symptoms, and
stressor-response relationships for
various stressors, as well as the ability
to use that knowledge to draw
appropriate, defensible conclusions. To
aid in these causal analyses, NCEA has
developed the first version of CADDIS.
CADDIS is a Web-based decision
support system that will help regional,
state, and tribal scientists find, access,
organize, and share information useful
for causal evaluations in aquatic
systems. It is based on EPA’s Stressor
Identification process, which is an EPArecommended method for identifying
causes of impairments in aquatic
environments. Current features of
CADDIS include a step-by-step guide to
conducting causal analysis,
downloadable worksheets and
examples, a library of conceptual
models, and links to useful information
sources.
How To Submit Comments to EPA’s EDocket
EPA has established an official public
docket for information pertaining to the
revision of the CADDIS website, Docket
ID No. ORD–2005–0001. The official
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
21777
public docket is the collection of
materials, excluding Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute, that is available for
public viewing at the Office of
Environmental Information (OEI) Docket
in the Headquarters EPA Docket Center,
EPA West Building, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
202–566–1744, and the telephone
number for the OEI Docket is 202–566–
1752; facsimile: 202–566–1753; or email: ORD.Docket@epa.gov.
An electronic version of the official
public docket is available through EPA’s
electronic public docket and comment
system, E-Docket. You may use EDocket at https://www.epa.gov/edocket/
to submit or view public comments, to
access the index listing of the contents
of the official public docket, and to view
those documents in the public docket
that are available electronically. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket identification
number.
Certain types of information will not
be placed in E-Docket. Information
claimed as CBI and other information
with disclosure restricted by statute,
which is not included in the official
public docket, also will not be available
for public viewing in E-Docket.
Copyrighted material will not be placed
in E-Docket, but will be referenced there
and available as printed material in the
official public docket.
For people submitting public
comments, please note that EPA’s policy
makes that information available for
public viewing as received and at no
charge at the EPA Docket Center or in
E-Docket. This policy applies to
information submitted electronically or
in paper form, except where restricted
by copyright, CBI, or statute. When EPA
identifies a comment containing
copyrighted material, EPA will provide
a reference to that material in the
version of the comment 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 E-Docket. Physical objects
will be photographed, where practical,
and the photograph will be placed in EDocket along with a brief description
written by the docket staff.
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Notices]
[Pages 21773-21777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8127]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0093; FRL-7707-8]
Thymol; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemicalin 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-
2005-0093, must be received on or before May 27, 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: Andrew C. Bryceland, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-6928; e-mail
address:bryceland.andrew@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
[[Page 21774]]
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 identification (ID) number OPP-2005-0093. 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-2005-0093. 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-2005-0093. 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
[[Page 21775]]
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-2005-0093.
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-2005-0093. 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: April 5, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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.
Vita (Europe) Limited
PP 3F6752
EPA has received a pesticide petition (PP 3F6752) from Vita
(Europe) Limited, c/o Landis International, P.O. Box 5126, Valdosta, GA
31603-5126, proposing pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the requirement for a tolerance for
the biochemical pesticide thymol.
Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Vita
(Europe) Limited has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This
summary was prepared by Vita (Europe) Limited and EPA has not fully
evaluated the merits of the pesticide petition. The summary may have
been edited by EPA if the terminology used was unclear, the summary
contained extraneous material, or the summary unintentionally made the
reader conclude that the findings reflected EPA's position and not the
position of the petitioner.
A. Product Name and Proposed Use Practices
Thymol (5-methyl-2-isopropyl-1-phenol) (CAS No. 89-83-8), when used
as an acaricide, controls varroa mites in honeybees. Efficacy is
maximized if the product is used in late summer after the honey harvest
(when the amount of brood present is diminishing). However, in the case
of severe infestations, thymol can also be used during springtime, when
temperatures are above 60[deg]F, but not when the maximum daily
temperature is above 105[deg]F. If further significant mite fall is
observed during the following winter or spring, it is recommended to
use an additional secondary winter or spring treatment for varroa.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Thymol is
a constituent of oil of thyme, a naturally occurring mixture of
compounds in the plant Thymus vulgaris L., or thyme. Thymol is an
active ingredient in pesticide products registered for use as animal
repellents, fungicides/fungistats, medical disinfectants,
tuberculocides, and virucides. Thymol also has many non-pesticidal
uses, including use in perfumes, food flavorings, mouthwashes,
pharmaceutical preparations, and cosmetics.
Thymol is a constituent of a mixture of organic compounds known to
be rapidly degraded in the environment to elemental compounds by normal
biological, physical and/or chemical processes that can be reasonably
expected to exist where the pesticide is applied.
2. Magnitude of residue at the time of harvest and method used to
determine
[[Page 21776]]
the residue. In samples collected from supers 30 days and 103 days
after thymol was removed from the frames, thymol residues ranged from
<0.03 parts per million (ppm) limit of quantitation (LOQ) to 1.5 ppm in
honey and 0.75 ppm to 20.59 ppm in wax. These are the residues that are
expected as the label requires that the supers be removed from the
frames prior to treatment with thymol and re-installed after thymol
removal (i.e., no treatment during honey flow). Samples collected from
the brood frames, in which honey was being formed while thymol was
present, resulted in thymol residues between <0.03 ppm and 4.61 ppm in
honey and between 1.18 ppm to 682.83 ppm in wax. These samples were
collected 0 to 14 days after thymol removal.
Thymol was applied to brood frames in trays in two applications at
15 day intervals (total thymol = 25 gram (g)) in all three trials. In
one of the trials (3B-217) three applications at 10 day intervals
(total thymol = 37.5 g) was tested as well as the 25 g rate. These
studies were conducted in Europe in two different years (1997 and
1998). Samples were collected in the brood nest for analysis on the
last day of treatment (0 day preharvest interval (phi)) and in the
super 30 days after treatment (30 day phi) in trial 3B-214. The supers
were placed on the brood nest at the end of treatment. Thymol was added
in trays at the top and/or bottom of the brood frames in all three
trials. In trial 3B-215, samples were collected in the brood nest on
the last day of treatment (0 day phi) as well as in the super 103 days
after treatment. In trial 3B-217, samples were collected in the brood
nest 2 days after treatment and 14 days after treatment. In all honey
samples, thymol concentration ranged from 4.61 ppm to 50 values as 980 milligrams/kilogram (mg/kg) and 880 mg/kg
for the rat and guinea pig, respectively (Sax, 1984). The acute oral
toxicity reported for the rat and guinea pig, respectively, corresponds
to Toxicity Category III. The Material Safety Data Sheet (MSDS) for the
manufacture of technical grade thymol cites human health effects as
irritating when exposed by inhalation, dermal, or eye contact. The MSDS
also estimates a human ingestion LD50 at 2 g of the
synthetic thymol. Based upon an estimated thymol dermal toxicity
LD50 of greater than 2,000 mg/kg, the dermal toxicity would
be Toxicity Category III.
A summary of the submitted information on thymol toxicity allows
for the statements that the acute oral LD50 in the rat is
980 mg/kg and in the mouse is 640 to 1,800 mg/kg. Thymol is corrosive
to the rabbit eye and skin, and is not reported as a dermal sensitizer
in the guinea pig. Thymol is readily absorbed from the gastrointestinal
tract and is essentially excreted in the urine as a glucuronate and
sulfate conjugate of the parent compound.
Thymol is not mutagenic in Salmonella, but gives statistically
significant positive results in an Unscheduled DNA synthesis and Sister
Chromatid Exchange tests, and in a cell transformation test with Syrian
hamster embryonic cells. Multiple malformations are noted when thymol
is injected into the air bubble or yolk sac of embryonic chickens.
Dosing of rats with thymol in the feed at 667 mg/kg body weight/day
(highest dose tested) for 19 weeks did not produce any harmful effects.
D. Aggregate Exposure
1. Dietary exposure--i. Food. Thymol is a component of many non-
pesticidal consumer products currently marketed in the United States.
Thymol is listed as a food additive by the Food and Drug Administration
(21 CFR 172.515; synthetic flavoring substances and adjuvants). Thymol
is considered Generally Recognized As Safe or GRAS (21 CFR 172.515,
182.10, and 182.20).
ii. Drinking water. No drinking water exposure is expected from the
pesticidal use of thymol which is confined to placement in beehives.
Thymol is currently registered for use on ornamental plants, shrubs and
grasses so there is some potential for exposure to water. However,
thymol is a constituent of a mixture of organic compounds known to be
rapidly degraded in the environment to elemental compounds by normal
biological, physical and/or chemical processes.
2. Non-dietary exposure. The potential for non-dietary exposure to
thymol residues for the general population, including infants and
children, is unlikely because the proposed use site is limited to
beehives. Thymol is a normal constituent of the human diet, as a
component of thyme and thyme oil, and as a direct food additive.
Therefore, while there exists a great likelihood of prior exposure for
most, if not all, individuals to thymol, any increased exposure due to
the proposed use would be negligible. Thyme, which contains thymol, is
a pesticide active ingredient for the control of aphids on ornamental
plants. Thyme and thyme oil are considered minimum risk pesticides, and
are exempted as active ingredients under FIFRA 40 CFR 152.25(f).
E. Cumulative Exposure
Thymol does not appear to produce a toxic metabolite produced by
other substances.
F. Safety Determination
1. U.S. population. The dietary exposure to residues of thymol to
the U.S. population from use of Apiguard is not likely to add
significantly to current dietary exposure to thymol.
2. Infants and children. It is typical for language to appear on
labels of honey that states ``Do not feed to infants under 1 year,'' so
there likely would be no exposure of this population to residues of
thymol in the honey. It is likely that older children have been exposed
to thymol residues from consumption of candy, ice cream, and baked
goods. Consumption of honey from hives treated with Apiguard is
unlikely to significantly increase exposure to thymol. Therefore, based
on the long history of use of thyme, thyme oil, and thymol in the diet
with no known adverse effects, it is reasonable to conclude that no
harm will result from exposure to thymol in honey from beehives treated
with Apiguard.
G. Effects on the Immune and Endocrine Systems
Thymol does not belong to a class of chemicals known or suspected
of having adverse effects on the endocrine system. There is no evidence
that thymol has any effect on endocrine function.
H. Existing Tolerances
There are no existing tolerances for thymol in the United States.
[[Page 21777]]
I. International Tolerances
No Codex Maximum Residue Levels (MRL) are established for thymol.
However, Switzerland has established an MRL of 0.8 mg/kg, apparently
not from a safety finding, but rather arising from legislation that
prohibits foreign odors or tastes in honey. According to the World
Health Organization, thymol residues in food are safe to consumers at
up to 50 mg/kg. According to European Union regulation Nr. 2377/90,
thymol is in group II of the non-toxic veterinary drugs which do not
require a MRL.
[FR Doc. 05-8127 Filed 4-26-05; 8:45 am]
BILLING CODE 6560-50-S
