[Federal Register Volume 68, Number 109 (Friday, June 6, 2003)]
[Rules and Regulations]
[Pages 33876-33882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14198]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0002; FRL-7308-1]


Thymol and Eucalyptus Oil; Exemptions from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited exemptions from the 
requirement of a tolerance for residues of thymol and eucalyptus oil on 
honey and honeycomb. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of these 
pesticides in beehives. This regulation eliminates the need to 
establish a maximum permissible level for residues of thymol and 
eucalyptus oil in or on honey and honeycomb. These time-limited 
exemptions from the requirement of a tolerance for residues of the 
thymol and eucalyptus oil will expire and are revoked on June 30, 2005.

DATES: This regulation is effective June 6, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0002, 
must be received on or before August 5, 2003.

ADDRESSES: Written objections and hearing requests  may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 are a Federal 
or State government agency involved in administration of environmental 
quality programs. Potentially affected entities may include, but are 
not limited to:
    [sbull]Federal or State Government Entity, (NAICS 9241), i.e., 
Departments of Agriculture, Environment, etc.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0002. 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, 
1921 Jefferson Davis Hwy., 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/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml__00/Title__40/40cfr180__00.html, a beta site currently under development.
    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.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing time-limited exemptions from the 
requirement of a tolerance for residues of thymol and eucalyptus oil in 
or on honey and honeycomb. These time-limited exemptions from the 
requirement of a tolerance for residues of the thymol and eucalyptus 
oil will expire and are revoked on June 30, 2005. EPA will publish a 
document in the Federal Register to remove the revoked exemptions from 
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide

[[Page 33877]]

chemical residue, including all anticipated dietary exposures and all 
other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Thymol and Eucalyptus Oil on Honey and 
Honeycomb and FFDCA Tolerances

    The varroa mite is an ectoparasite of honey bees. It was first 
detected in the continental United States in Maryland in 1979, and 
found in Florida and Wisconsin by 1987. Currently, it is the most 
important pest of honey bee colonies. The mites feed on the hemolymph 
of the developing bee larva, pupa, and adult bees. Dead or dying newly 
emerged bees have malformed wings, legs, abdomens, and thoraces. Recent 
anecdotal evidence suggests that bee viruses and varroa mites are 
closely linked. The mites have been shown to activate some of these 
viruses; causing virus outbreaks that ultimately lead to colony 
mortality.
    Fluvalinate is currently registered for the control of varroa 
mites; however, populations of varroa mites have developed resistance 
to fluvalinate. Varroa mite resistance to fluvalinate has been well 
documented by the United States Department of Agriculture (USDA), 
Agricultural Research Service (ARS). According to USDA, ARS many hives 
treated with fluvalinate have resulted in wholesale colony losses. Due 
to the destructive nature of this pest coupled with the importance of 
honey bees (for honey production and pollination of numerous 
agricultural crops) to the U.S. economy, it is imperative that 
alternative means of controlling the varroa mite be developed.
    The Agency has authorized the use of coumaphos in beehives to 
control varroa mites under section 18 of FIFRA since 1999 in up to 46 
states. During the 2001 use season there were limited reports of mites 
resistant to coumaphos in Maine and Florida. Resistance to coumaphos in 
Florida was confirmed by the USDA's Texas Bee Lab in December of 2001. 
In Maine, bees are primarily imported during the growing season from 
Florida. South Carolina has indicated that the beekeeping industry is 
migratory in nature, especially in the coastal region of the state and 
subject to the introduction of coumaphos resistant mites from Florida. 
Therefore, the states have requested use of the unregistered product 
ApiLife VAR, containing thymol and eucalyptus oil to control mites 
resistant to coumaphos. EPA has authorized under FIFRA section 18 the 
use of thymol and eucalyptus oil in beehives for control of varroa 
mites in Maine, Minnesota, Mississippi, Utah, Indiana, and South 
Carolina. After having reviewed the submission, EPA concurs that 
emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of thymol and eucalyptus oil 
in or on honey and honeycomb. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary exemptions from the requirement of a tolerance under section 
408(l)(6) of the FFDCA would be consistent with the safety standard and 
with FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing these exemptions without notice and opportunity for public 
comment as provided in section 408(l)(6) of the FFDCA. Although these 
exemptions from the requirement of a tolerance will expire and are 
revoked on June 30, 2005, under section 408(l)(5) of the FFDCA, 
residues of the pesticide in the tolerance remaining in or on honey and 
honeycomb after that date will not be unlawful, provided the pesticide 
is applied in a manner that was lawful under FIFRA. EPA will take 
action to revoke these exemptions earlier if any experience with, 
scientific data on, or other relevant information on these pesticides 
indicate that the residues are not safe.
    Because these exemptions from the requirement of a tolerance are 
being approved under emergency conditions, EPA has not made any 
decisions about whether thymol and eucalyptus oil meets EPA's 
registration requirements for use on honey and honeycomb or whether 
permanent exemptions for this use would be appropriate. Under these 
circumstances, EPA does not believe that these exemptions from the 
requirement of a tolerance serve as a basis for registrations of thymol 
and eucalyptus oil by a State for special local needs under FIFRA 
section 24(c). Nor do these exemptions serve as the basis for any State 
other than Maine and South Carolina to use these pesticides in beehives 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemptions for 
thymol and eucalyptus oil, contact the Agency's Registration Division 
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety for Thymol

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of thymol 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2) of the FFDCA, for exemptions from the requirement of 
a tolerance for residues of thymol in or on honey and honeycomb. EPA's 
assessment of the dietary exposures and risks associated with 
establishing these exemptions from the requirement of a tolerance 
follows.

A. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by thymol 
is discussed in this unit.
    The EPA has not received nor does it have available any guideline 
studies on the mammalian toxicity of thymol. Thymol is found naturally 
occurring in

[[Page 33878]]

thyme herb (e.g., Thymus vulgaris, T. zygis). Thyme herb is used as a 
food seasoning ingredient, and is generally recognized as a safe (GRAS) 
natural seasoning by the Food and Drug Administration (FDA) (21 CFR 
182.10). Thyme oil also is recognized as a GRAS essential oil by FDA 
(21 CFR 182.20).
    In September of 1993, the EPA issued a Reregistration Eligibility 
Decision (RED) for thymol. At that time the Agency concluded that 
thymol is an active ingredient that should be considered for a broad 
waiver of generic data requirements. This conclusion was based on the 
following information:
    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 rapidly degraded in the 
environment to elemental constituents by normal biological, physical, 
and/or chemical processes that can be reasonably expected to exist 
where the pesticide is applied.... The phenols of thymol are considered 
GRAS as set forth in 21 CFR 172.515 (synthetic flavoring substances and 
adjuvants)....
    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 grams 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. (Refer to pages 6 and 7 of the RED)
    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. 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. 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.

B. Exposure Assessment

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    1. Dietary exposure--i. Food. Thymol is found naturally occurring 
in thyme herb (e.g., Thymus vulgaris, T. zygis). Thyme herb is used as 
a food seasoning ingredient, and is generally recognized as a safe 
(GRAS) natural seasoning by FDA (21 CFR 182.10). Thyme oil also is 
recognized as a GRAS essential oil by FDA (21 CFR 182.20). The volatile 
oil component of thyme herb is about 2% to 5% content, and thyme oil is 
reported to contain from 30% to 75% thymol, and even up to 90%. Thymol 
may be safely used in foods as a synthetic flavoring substance when 
used in the minimum quantity to produce the intended effect (21 CFR 
172.515). Levels of thymol reported in foods where it is permitted as a 
direct food additive have been stated as 44 ppm in ice cream, ices, 
etc.; 2.5 ppm to 11 ppm in non-alcoholic beverages; 9.4 ppm in candy, 5 
ppm to 6.5 ppm in baked goods, and 100 ppm in chewing gum. Thymol is a 
natural component of lime blossom honey, where the maximum thymol 
content has been determined to be 0.16 mg/kg.
    Studies in Europe showed that when ApiLife Var was used for 8 weeks 
in the autumn over 1 to 5 years the maximum thymol residue observed was 
0.48 mg/kg. The average (median) residue value for thymol was 0.16 mg/
kg in honey. When export and import tonnage values of honey are taken 
into consideration with U.S. honey production, the average yearly per 
capita intake of honey is about 2 pounds, roughly equivalent to 1 kg. 
If all the honey contained 0.5 mg/kg thymol then the per capita intake 
of thymol would be about 1.4 [mu]g/day. For a 60 kg adult the chronic 
exposure value is about 0.022 [mu]g/kg body weight/day. If a 60 kg 
adult consumed 1 kg of honey containing 0.5 mg thymol in 90 days the 
subchronic dietary exposure to thymol would be about 2 [mu]g/kg body 
weight/day. Even if all 2 kg of the thymol-containing honey were 
consumed in one sitting, the acute exposure to thymol still would be as 
low as 83 [mu]g.
    2. Drinking water exposure. 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. In the RED, 
the Agency concluded that the registered uses of thymol will result in 
negligible exposure of the environment and nontarget organisms (refer 
to page 7 of the RED). Therefore, thymol is not expected to be found in 
drinking water.
    3. Other non-occupational 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(g)].
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether thymol has a common mechanism of toxicity with other substances 
or how to include this pesticide in a cumulative risk assessment. 
Unlike other pesticides for which EPA has followed a cumulative risk 
approach based on a common mechanism of toxicity, thymol does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this exemption from the requirement of a tolerance, 
therefore, EPA has not

[[Page 33879]]

assumed that thymol has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Aggregate Risks and Determination of Safety for U.S. Population, 
Infants and Children

    The dietary exposure to residues of thymol to the U. S. population 
from use of ApiLife Var is not likely to add significantly to current 
dietary exposure to thymol. For instance, thymol has been measured in 
chewing gum at 100 mg/kg, in candy at 9.4 mg/kg, and in ice cream at 44 
mg/kg. These values respectively are 200-, 20-, and 100-fold greater 
than the highest level of thymol (i.e., 0.48 mg/kg) measured in honey 
treated with ApiLife Var. In addition, thymol as measured in ice cream 
is about 300-fold higher than the average residue level of thymol 
(i.e., 0.16 mg/kg) in hives treated with ApiLife Var. Additionally, 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. Older 
children likely have been exposed to thymol residues from consumption 
of candy, ice cream, and baked goods. Consumption of honey from hives 
treated with ApiLife Var 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 ApiLife Var. Accordingly, EPA finds 
that exempting thymol from the requirement of a tolerance will be safe.

V. Aggregate Risk Assessment and Determination of Safety for Eucalyptus 
Oil

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
eucalyptus oil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for exemptions from the 
requirement of a tolerance for residues of eucalyptus oil in or on 
honey and honeycomb. EPA's assessment of the dietary exposures and 
risks associated with establishing these exemptions from the 
requirement of a tolerance follows.

A. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
eucalyptus oil is discussed in this unit.
    The EPA has not received nor does it have available any guideline 
studies on the mammalian toxicity of eucalyptus oil. Eucalyptus oil is 
obtained from steam distillation of the leaves of Eucalyptus globulus 
and, in addition to cineole, contains triterpenes, monoterpenes, 
sesquiterpenes, aldehydes and ketones. Information submitted by the 
applicant allows for the statements that acute oral LD50 
value for eucalyptus oil in rats is 2,480 mg/kg. Eucalyptol (1,8-
cineole) which makes up 70% or more of eucalyptus oil may be safely 
used in foods as a synthetic flavoring substance when used in the 
minimum quantity to produce the intended effect (21 CFR 172.515). 
Eucalyptus globulus leaves also may safely be used in foods (21 CFR 
172.510).

B. Exposure Assessment

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    1. Dietary exposure.--i. Food. Eucalyptus oil is obtained from 
steam distillation of the leaves of Eucalyptus globulus and, in 
addition to cineole, contains triterpenes, monoterpenes, 
sesquiterpenes, aldehydes and ketones. Levels of eucalyptus oil 
reported in foods where it is permitted as a direct food additive have 
been stated as 0.5 to 50 ppm in ice cream, ices etc.; 1.7 ppm in non-
alcoholic beverages; 1.0 ppm in alcoholic beverages; 130 ppm in candy; 
and 76 ppm in baked goods. Cineole in foods has been reported at 0.13 
ppm in non-alcoholic beverages; 0.50 ppm in ice cream, ices, etc.; 15 
ppm in candy; 0.5 to 4.0 ppm in baked goods, and 190 ppm in chewing 
gum.
    Studies in Europe showed that when ApiLife Var was used for 8 weeks 
in the autumn over 1 to 5 years, residues of eucalyptus oil (measured 
as 1,8-cineole) were less than the limit of detection, i.e., <0.01 ppm.
    ii. Drinking water exposure. No drinking water exposure is expected 
from the pesticidal use of eucalyptus oil which is confined to 
placement in beehives. Further, there are no products registered that 
will result in exposure to drinking water. Therefore, eucalyptus oil is 
not expected to found in drinking water.
    2. Other non-occupational exposure. The potential for non-dietary 
exposure to eucalyptus oil residues for the general population, 
including infants and children, is unlikely because the proposed use-
site is limited to beehives. Eucalyptus oil is a constituent of the 
human diet as a direct food additive. Eucalyptus oil is used as a 
component of decongestant products, as an expectorant component of 
cough and cold products, in various oral dosage forms (e.g., lozenges 
and syrups), and as an inhalant in vapor baths. It is used in dermally 
applied products for burns, blisters, and for muscle and joint aches. 
It may be a component of toothpaste, soaps, detergents and toiletries. 
It is reported to be used internally at 0.3 to 0.6 grams/day, and 
externally at 5% to 20% in paraffin, jelly, or vegetable oil bases. Oil 
of eucalyptus has antimicrobial properties, and has been registered as 
an active pesticide ingredient in an herbal flea collar pet product 
(active ingredient is in the product at 1.00%).
    3. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether eucalyptus oil has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
eucalyptus oil does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this exemption from the 
requirement of a

[[Page 33880]]

tolerance, therefore, EPA has not assumed that eucalyptus oil has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

C. Aggregate Risks and Determination of Safety for U.S. Population, 
Infants and Children

    The dietary exposure to residues of eucalyptus oil to the U.S. 
population from use of ApiLife Var is not likely to add significantly 
to current dietary exposure to eucalyptus oil. This is because no 
residues of eucalyptus oil were detectable (i.e., <0.01 ppm; measured 
as 1,8-cineole) when ApiLife was used in hives in the autumn in Europe 
for up to 5 years. Even if oil of eucalyptus residues were found in 
honey from hives treated with Apilife Var, they would have to be 
present at 5,000 times greater than the limit of detection to reach the 
level reported in ice cream (i.e., 50 mg/kg) and 170 times greater than 
the limit of detection to reach the level reported in non-alcoholic 
beverages (i.e., 1.7 mg/kg). Therefore, based on the long history of 
use of eucalyptus oil in the diet with no known adverse effect, coupled 
with the expectation of no to minimal residues from use of ApiLife Var 
in hives, it is reasonable to conclude that no harm will result from 
this pesticidal use. Accordingly, EPA finds that exempting eucalyptus 
oil from the requirement of a tolerance will be safe.

VI. Other Considerations

A. Analytical Enforcement Methodology

    The Agency has not reviewed the method, nor its accuracy or 
reliability, used to previously analyze thymol and eucalyptus oil 
residues in honey; nor has it confirmed that prior use of ApiLife Var 
in European hives will give equivalent residues in hives in the United 
States. However, review of information submitted on a gas 
chromatographic method of analysis to measure thymol and eucalyptus oil 
in European hives, and the similarity of the European hives to U.S. 
hives allow for the conclusion that thymol and eucalyptus oil residues 
in honey from these hives will not be significantly greater, provided 
ApiLife Var is applied at the same rates to overwintering hives in the 
United States as was done previously in Europe.
    The method may be requested from: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:(703) 305-6463; e-mail address: 
[email protected].

B. International Residue Limits

    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. No Codex Maximum Residue Levels (MRL) are established 
for eucalyptus oil.

VII. Conclusion

    Therefore, time-limited exemptions from the requirement of a 
tolerance are established for residues of thymol and eucalyptus oil in 
or on honey and honeycomb.

VIII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0002 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before August 5, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.

[[Page 33881]]

    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by the docket ID number OPP-2003-0002, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established, resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IX. Statutory and Executive Order Reviews

    This final rule establishes a time-limited exemption from the 
tolerance requirement under section 408 of the FFDCA. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 33882]]


    Dated: May 23, 2003.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.1240 is added to subpart D to read as follows:


Sec.  180.1240  Thymol; exemption from the requirement of a tolerance.

    Time-limited exemptions from the requirement of a tolerance are 
established for residues of thymol in or on honey and honeycomb in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by the EPA. These time-limited exemptions from the 
requirement of a tolerance for residues of the thymol will expire and 
are revoked on June 30, 2005.

0
3. Section 180.1241 is added to subpart D to read as follows:


Sec.  180.1241  Eucalyptus oil; exemption from the requirement of a 
tolerance.

    Time-limited exemptions from the requirement of a tolerance are 
established for residues of eucalyptus oil in or on honey and honeycomb 
in connection with use of the pesticide under section 18 emergency 
exemptions granted by the EPA. These time-limited exemptions from the 
requirement of a tolerance for residues of the eucalyptus oil will 
expire and are revoked on June 30, 2005.
[FR Doc. 03-14198 Filed 6-5-03; 8:45 am]
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DATE][RULES]