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thymol (API LIFE) Pesticide Tolerance Petition Filing 3/01




ENVIRONMENTAL PROTECTION AGENCY


[PF-1001; FRL-6770-7]



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


AGENCY:  Environmental Protection Agency (EPA).


ACTION:  Notice.


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


DATES:  Comments, identified by docket control number PF-1001, must be
received on or before May 4, 2001.


ADDRESSES:  Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-1001 in the subject line on the first page of your
response.


FOR FURTHER INFORMATION CONTACT: By mail: Andrew Bryceland, Biochemical
Pesticides Branch, Biopesticides and Pollution Prevention Division
(7511C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; 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 affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:


------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?


    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number PF-1001. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.


C. How and to Whom Do I Submit Comments?


    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-1001 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-1001. Electronic comments may
also be filed online at many Federal Depository Libraries.


D. How Should I Handle CBI That I Want to Submit to the Agency?


    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
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 version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified 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.


[[Page 17893]]


    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
control 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 Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in 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: March 22, 2001.
Kathleen Knox,
Acting 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 section 408(d)(3) of the FFDCA. This summary was
prepared by Chemicals Laif 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. 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)


1E6251


    EPA has received a pesticide petition 1E6251 from Interregional
Research Project Number 4 (IR-4), Technology Centre of New Jersey,
Rutgers University, 681 U.S. Highway #1 South, North Brunswick, NJ
08902-3390, 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 of a tolerance for
the biochemical pesticide Thymol in or on the raw agricultural
comodities honey and beeswax.


A. Product Name and Proposed Use Practices


    Thymol, the main component of the herb thyme and API LIFE VAR, has
been shown to control varroa mites in bee hives. One tablet of API LIFE
VAR (containing thymol) and weighing approximately 20 grams, is broken
into two to three pieces and placed on the top bars of the frames over
the brood chamber in the autumn after the honey harvest is complete.
After 7 to 8 days the tablet is replaced with a fresh tablet. Then 7 to
8 days later the second tablet is replaced with a third tablet. The
third tablet is left in the hive for 12 days, after which it is removed
form the hive. The product label requires the thymol treatment to be
discontinued at least 5 months (150 days) prior to harvesting honey.


B. Product Identity/Chemistry


    1. Identity of the pesticide and corresponding residues. Thymol is
mixed with other ingredients and then injected into a vermiculite
tablet. The tablets containing 74.08% thymol are then sealed in a vapor
proof pouch (bag). This is the end product.
    2. Magnitude of residue at the time of harvest and method used to
determine the residue. Residues in honey varied between 2 ppm and 48
ppm with average being 15 ppm. Residues were determined via gas
chromatography using a flame ionization detector.
    3. Analytical method. An analytical method for residues is not
applicable, as this proposes an exemption from the requirement of a
tolerance.


C. Mammalian Toxicological Profile


    Thymol is not very toxic via the oral route. Thymol has an acute
oral LD50 of 980 mg/kg in rats; 1,800 mg/kg in mice; and 880
mg/kg in guinea pigs. Thymol can cause eye irritation and with
prolonged contact can cause skin irritation. Thymol is currently used
as a flavoring agent in several foods and is a major constituent of
thyme which is a commercially grown herb used for seasoning foods.
Thymol is considered generally recognized as safe (GRAS) by the Food
and Drug Administration. Thyme and thyme oil are exempted from
pesticidal regulation under FIFRA section 25(b). Thyme oil contains at
least 36% thymol.


D. Aggregate Exposure


    1. Dietary exposure--i. Food. The potential dietary exposure of the
general public to thymol residues resulting from its use in bee hives
for the control of varroa mites is not expected to be significant. The
public is exposed to thymol through its use as a direct food additive.
Thymol is also a naturally occuring substance in lime honey and thyme
(which is used to season many foods).
    ii. Drinking water. It is not anticipated that residues of thymol
will occur in drinking water due to its low application rate and
because the use is considered an indoor use since it is placed inside
bee hives.
    2. Non-dietary exposure. There may be minor amounts of non-dietary
esposure to thymol from use in mouth washes and medicines. Thyme oil
(which contains at least 36% thymol) is classified as a GRAS substance
for use as a flavoring agent in food (21 CFR 182.20) and was recently
exempted from pesticide regulation under FIFRA section 25(b) because
EPA views it as having minimal risk. Based on the small amount of
thymol and thyme oil used in these instances, very minimal dietary
exposure is expected.


E. Cumulative Exposure


    Because of the low oral toxicity of thymol and because of the fact
that its presence in the diet is, for the most part, as a naturally-
occurring food ingredient, no cumulative mode of exposure is expected
for thymol and other substance having a common mechanism of action.


F. Safety Determination


    1. U.S. population. The use of products containing thymol, which is
of low toxicity and is used in such low concentrations, is compatible
with EPA's objectives to register reduced risk pesticides. Based on the
low toxicity, there is reasonable certainty that no harm will result
from aggregate exposure of the U.S. population, including infants and
children, to residues from thymol. This includes all anticipated
dietary exposures and all other exposures for which there is
reliable information. There is an inconsequential increase in dietary
exposure resulting from application to bee hives. Thymol is applied at
low rates and with its proven low toxicity and its history of safe use,
it does not pose a safety concern.
    2. Infants and children. Based on the low toxicity of thymol, there
is a reasonable certainty that no harm to children or adults will
result from aggregate exposure to thymol. Exempting thymol from the
requirement of a tolerance should pose no significant risk to humans.


G. Effects on the Immune and Endocrine Systems


    Thymol is a naturally occurring biochemical. To date there is no
evidence to suggest that thymol functions in a manner similar to any
known hormone, or that it acts as an endocrine disruptor.


H. Existing Tolerances


    There are no existing tolerances for thymol in the United States.


I. International Tolerances


    There are no known approved CODEX maximum residue levels (MRLs)
established for residues of thymol.


[FR Doc. 01-8280 Filed 4-3-01; 8:45 am]