[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Notices]
[Pages 21773-21777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8127]


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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.

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

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0093, 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:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American

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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 http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.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  http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0093. 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 [email protected], 
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.
    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

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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 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.

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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