Thymol; Exemption from the Requirement of a Tolerance, 2889-2895 [06-436]
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Port Valdez at 61°05′03.6″ N, 146°25′42″
W; thence northerly to yellow buoy at
61°06′00″ N, 146°25′42″ W; thence east
to the yellow buoy at 61°06′00″ N,
146°21′30″ W; thence south to 61°05′06’’
N, 146°21′30″ W; thence west along the
shoreline and including the area 2000
yards inland along the shoreline to the
beginning point.
(2) Tank Vessel Moving Security
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(b) Regulations. (1) The general
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(2) Tank vessels transiting directly to
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(3) All persons and vessels must
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Dated: January 5, 2006.
M.S. Gardiner,
Commander, United States Coast Guard,
Coast Guard, Captain of the Port, Prince
William Sound, Alaska.
[FR Doc. 06–449 Filed 1–17–06; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0483; FRL–7754–9]
Thymol; Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of the thymol (5methyl-2-isopropyl-1-phenol) on honey,
honeycomb, and honeycomb with
honey when applied/used as treatment
to decrease the incidence of Varroa mite
infestation in the honey bee. Vita
(Europe) Limited, c/o Landis
International Limited, submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA), requesting an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of thymol
(5-methyl-2-isopropyl-1-phenol).
DATES: This regulation is effective
January 18, 2006. Objections and
requests for hearings must be received
on or before March 20, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit X. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
OPP–2005–0483. All documents in the
docket are listed on the
www.regulations.gov web site.
(EDOCKET, EPA’s electronic public
docket and comment system was
replaced on November 25, 2005, by an
enhanced Federal-wide electronic
docket management and comment
system located at https://
www.regulations.gov/. Follow the online instructions.) Although listed in the
index, some information is not publicly
available, i.e., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
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the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in
EDOCKET or in hard copy 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.
FOR FURTHER INFORMATION CONTACT:
Andrew Bryceland, Biopesticides and
Pollution Prevention Division (7511C),
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 are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (https://
www.epa.gov/edocket/), you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document go directly
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to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of April 27,
2005 (70 FR 21773) (FRL–7707–8), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 3F6752)
by Vita (Europe) Limited c/o Landis
International, Inc., P.O. Box 5126,
Valdosta, GA 31603–5126. The petition
requested that 40 CFR part 180 be
amended by establishing a temporary
exemption from the requirement of a
tolerance for residues of thymol (5methyl-2-isopropyl-1-phenol). This
notice included a summary of the
petition prepared by the petitioner. A
public comment has been received
objecting to ‘‘any tolerance, exemption,
or waiver allowing more than zero
residue of thymol on food.’’ This
objection was supported by the
arguments that:
1. Embryonic chickens have multiple
malformations following thymol
injection into the yolk or air sac, and;
2. Switzerland has established an
Maximum Residue Limit (MRL) of 0.8
milligram/kilogram (mg/kg). The
commenter did not provide a specific
data citation for either of these
arguments.
The results from the chicken study are
of questionable relevance to mammals.
Currently, EPA does not use chickens
(or intrayolk or intra-airsac exposure
routes) as an animal model for
developmental toxicity because of the
differences in developmental
physiology and anatomy between the
two species. Developmental timing,
duration, and potential environmental
effects on developing young are also
different in mammals and birds, again
precluding this model for use in setting
developmental toxicity endpoints for
the regulation of pesticides (Reference
13).
Developmental malformations have
not been found following thymol
exposure to other mammalian species
such as mice, rats, hamsters, and rabbits
(Environmental Risk Management
Agency of New Zealand, 2005). In
addition, Mortazavi et al. (2003)
reported no external tissue
abnormalities in fetuses following
dosing of female rats with an infusion
of the plant Satureja khuzestanica
(which has the components thymol and
carvacrol).
Regulatory limits have been set for
thymol in other countries. The Swiss
Federal Department of the Interior has
set a tolerance (MRL) concentration for
thymol in honey as an antiparasitic
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agent (0.8 mg/kg; pharmacological
substance active in nutrition or
therapeutic application; 817.021.23).
This tolerance was derived to prevent
exceedance of the taste threshold for
thymol in honey (1.1 - 1.3 mg/kg;
Bogdanov et al., 1999), not safety.
Tolerances set by EPA are based on ‘‘the
reasonable certainty of no harm,’’
FFDCA section 408(c)(2)(A)(ii), and
therefore, are not constrained by criteria
such as taste.
Section 408(c)(2)(A)(i) of 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 exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide 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. Pursuant to
section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from
the requirement of a tolerance, EPA
must take intoaccount the factors set
forth in section 408(b)(2)(C), which
require 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. . . .’’ Additionally, section
408(b)(2)(D) of FFDCA requires that 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 performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. 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
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variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
Thymol is an essential oil that is
extracted from thyme and mandarine
and tangerine oils and is FDA approved
when used as a synthetic flavoring (21
CFR 172.515), a preservative and
indirect food additive of adhesives (21
CFR 175.105). Additionally, the source
plant (thyme), from which thymol is
extracted is acknowledged by FDA as
generally recognized as safe (GRAS) (21
CFR 182.10, 21 CFR 182.20). Residues of
thymol can be found in other food stuffs
either naturally such as that found in
lime honey or intentionally added to
foods such as ice cream, non-alcoholic
beverages, candy, baked goods, and
chewing gum. Information from the
public literature documents that levels
of thymol residues in such foods are
present at significantly higher
concentrations than those resulting from
pesticidal treatments (Refs. 1, 3, 14, 15,
16, 17, and 18). End use products
containing thymol as the active
ingredient will be used as a slow release
treatment within the beehive itself to
decrease the incidence of Varroa mite
infestation in the honey bee.
Toxicity data requirements were
addressed by requests for data waivers.
The Agency granted data waivers based
on publically available information/data
submitted by the registrant and
reviewed by the Agency.
1. Acute oral toxicity waiver (OPPTS
870.1100, 152–10). The waiver rationale
submitted in support of the acute oral
toxicity (870.1100) data requirement is
based on oral LD50s from the open
literature and reviewed by the Agency.
The oral LD50 of thymol has been
reported to be 980, 640–1800, and 880
mg/kg in rats, mice, and guinea pigs,
respectively (Refs. 3 and 5). Thymol
occurs in various food stuffs and spices
from 0.02 mg/kg to 100 mg/kg (Refs. 3,
14, 15, 16, 17, and 18). The lowest level
in which there was an effect from
thymol was 640 mg/kg (Refs. 3 and 5).
The amount in which thymol causes an
acute effect is approximately 6 times
higher than the 100 mg/kg found in the
food stuff with the highest amount of
thymol present. The information/data
described above support the waiver
form the data requirement for the acute
oral toxicity study.
2. Acute dermal toxicity data waiver
(OPPTS 870.1200, 152.11). The waiver
rationale submitted in support of the
acute dermal toxicity data requirement
is based upon information collected
from a report by the Environmental Risk
Management Agency (ERMA, 2005) of
New Zealand and Anonymous (2000)
which found dermal LD50’s for thymol
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greater than 2,000 mg/kg. Thymol
occurs in various food stuffs and spices
from 0.02 mg/kg to 100 mg/kg (Refs. 3,
14, 15, 16, 17, and 18). Dermal exposure
to thymol already occurs from contact
with foodstuffs and seasonings
containing thymol as it is FDA approved
when used as a direct food additive and
is generally recognized as safe by FDA
as a spice, natural oil, oleoresin, or
natural extract and therefore, any
additional exposure resulting from
dermal contact with thymol will not
result in any significant exposure.
Thymol, when used as a pesticide, is to
be applied to the inside of beehives.
Data from U.S. and European field trials
demonstrate maximum residue
concentrations of 2.59 mg/kg thymol in
honey (at 30 days following treatment in
U.S. trials) and 4.61 mg/kg thymol in
honey (at 2 days following treatment in
European trials) demonstrate that,
following good agricultural practices (as
specified in the tolerance exemption),
the amount of thymol residues
remaining in the beehive after
application will be well below the
dermal LD50 and within the range of
those thymol residues already present in
food stuffs (MRID No.’s: 460435–10, 11,
12, and 13). Based on this information,
the Agency therefore concludes that the
information/data described above
support the waiver from the data
requirement for the acute dermal
toxicity study.
Classification: Acceptable.
3. Acute inhalation toxicity waiver
(OPPTS 870.1300, 152–12). The waiver
rationale submitted in support of the
acute inhalation toxicity data
requirment is based upon information
from the U.S. Food and Drug
Administration Center for Drug
Evaluation and Research (Ref. 19).
Thymol is added to the anesthetic
halothane as a preservative (0.01%) and
is considered inactive at this
concentration (Ref. 19). Halothane is
used to anesthetize dogs, cats, and other
non-food animals for periods sometimes
exceeding 4 hours (Ref. 19). Anesthetic
induction concentrations can typically
reach approximately 5% (Ref. 19).
Calculation of the exposure from these
factors yields a thymol atmospheric
concentration of 5 milligram/liter (mg/
L). Thymol is for application to the
inside of beehives. Thymol occurs in
various food stuffs and spices from 0.02
mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16,
17, and 18). Inhalation exposure to
thymol already occurs from contact with
foodstuffs and seasonings containing
thymol as it is FDA approved when
used as a direct food additive and is
generally recognized as safe by FDA as
a spice, natural oil, oleoresin, or natural
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extract and therefore, any additional
exposure resulting from inhalation
contact with thymol will not result in
any significant exposure The
information/data described above
support the waiver from the data
requirement for the acute inhalation
toxicity study.
Classification: Acceptable.
4. Skin hypersensitivity study waiver
(OPPTS 870.2600, 152.15). The waiver
rationale for skin hypersensitivity is
based on publically available
information (Ref. 20). Using quantitative
structure activity relationships, from the
public literature, it was predicted that
thymol is a dermal sensitizer (Ref. 20).
Thymol is for application to the inside
of beehives. Thymol occurs in various
food stuffs and spices from 0.02 mg/kg
to 100 mg/kg (Refs. 3, 14, 15, 16, 17, and
18). Dermal exposure to thymol already
occurs from contact with foodstuffs and
seasonings containing thymol as it is
FDA approved when used as a direct
food additive and is generally
recognized as safe by FDA as a spice,
natural oil, oleoresin, or natural extract
and therefore, any additional exposure
resulting from dermal contact with
thymol will not result in any significant
exposure. The information/data
described above support the waiver
from the data requirement for the skin
hypersensitivity study.
Classification: Acceptable.
The information/data described above
support the waiver from the data
requirement for the skin
hypersensitivity study. However, the
registrant is obliged under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) section 6(a)(2) to notify the
Agency in the events of such incidents.
Classification: Acceptable.
5. Genotoxicity and mutagenicity
study waivers, Master Record
Identification Numbers (MRIDs)
46282801 and 46282802 (OPPTS
870.2300, 870.5195; 152–17, and
152.19). Genotoxicity and mutagenicity
studies submitted on September 18th of
2003 (MRIDs 462828-01 and -02),
presumably as waiver rationales for
genotoxicity (870.5000) and other peerreviewed publications retrieved by EPA
(Refs. 3, 6, 7, 8, 9, 10, and 11), were
used to support the waivers from the
data requirements. These data
demonstrate that thymol is not
genotoxic and/or mutagenic. The
information/data described above
support the waivers from the data
requirements for the genotoxicity and
mutagenicity studies.
Classification: Acceptable.
6. Immune response study waiver
(OPPTS 870.3550, 152.18). The waiver
rationale for immune response
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(870.3550) is based upon information
presented in a peer-reviewed
publication (Ref. 21). No effects were
shown in this data (Ref. 21). The
information/data described above
support the waiver form the data
requirement for the acute inhalation
toxicity study.
Classification: Acceptable.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of FFDCA directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational 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).
A. Dietary Exposure
1. Food. Thymol is already found
naturally in food stuffs such lime honey
and cooking herbs and/or food stuffs
derived from cranberry and mandarin
and tangerine oils. Thymol is also added
to food stuffs commonly consumed by
humans such as ice cream, nonalcoholic beverages, candy, baked
goods, and chewing gum. It is FDA
approved when used as a synthetic
flavoring, (21 CFR 172.515), a
preservative and indirect food additive
of adhesives (21 CFR 175.105) and the
source plant (thyme), from which
thymol is extracted is acknowledged by
FDA as generally recognized as safe
(GRAS) (21 CFR 182.10, 21 CFR 182.20).
The information and/or data reviewed
in support of this tolerance exemption
demonstrate that the levels of thymol
already present in foods or intentionally
added to food stuffs will at
concentrations significantly higher that
those levels expected from the use of
thymol as a pesticidal product. Because
thymol is already present, either
naturally or intentionally added to
various food stuffs, there is a great
likelihood of exposure to thymol for
most, if not all individuals, including
infants and children. Even if there is a
significant increase in exposure to
thymol due to it’s use as a pesticide, the
acute toxicity information from the
public literature demonstrating
relatively low mammalian toxicity
indicate that any possible risk
associated with acute exposures by the
oral route would below to non-existent.
2. Drinking water exposure. No
exposure to thymol residues in drinking
water is expected since the use of this
product is limited to application within
the hive box in which the product is
contained in a dispenser tray, where the
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product is rapidly volatilized or
redistributed. Because thymol has
relatively low toxicity, has been
approved for food use by FDA as a
direct food additive and is generally
recognized as safe by FDA, even if
exposure through drinking water were
to occur, the exposure would be far less
than the exposure that humans already
get from consumption of thymol thru
the diet and therefore, no risk is
anticipated.
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B. Other Non-Occupational Exposure
The potential for non dietary
exposure to residues of thymol for the
general population, including infants
and children, is unlikely because the
uses are limited to application to certain
agricultural crops within the hive box
containing the bees and there is no
honey present in the bee hive. Thymol
is consumed by humans thru the diet
and for this reason, from a dietary
exposure standpoint, has been
determined to have relatively low
toxicity. Therefore, while the likelihood
of exposure exists for most if not all
individuals, any increased exposure due
to the proposed product would not add
any significant risks.
1. Dermal exposure. Dermal exposure
to thymol already occurs from contact
with foodstuffs and seasonings
containing thymol as it is FDA approved
when used as a direct food additive and
is generally recognized as safe by FDA
as a spice, natural oil, oleoresin, or
natural extract and therefore, any
additional exposure resulting from
dermal contact with thymol will not
result in any significant risk.
2. Inhalation exposure. Inhalation
exposure to thymol already occurs from
contact with foodstuffs and seasonings
containing thymol as it is FDA approved
when used as a direct food additive and
is generally recognized as safe by FDA
as a spice, natural oil, oleoresin, or
natural extract and therefore, any
additional exposure resulting from
dermal contact with thymol will not
result in any significant risk.
V. Cumulative Effects
Thymol has a novel mode of cellular
action (GABAA receptor, sodium,
potassium, and calcium channel
modulator) compared to other currently
registered active ingredients (Ref. 1). In
addition, there is no indication that
toxic effects of thymol would be
cumulative (Ref. 1). Section
408(b)(2)(D)(v) of 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
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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. Unlike
other pesticides for which EPA has
followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
thymol and any other substances and
thymol does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has not
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 policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative/.
VI. Determination of Safety for U.S.
Population, Infants and Children
1. U.S. population. The Agency has
determined that there is a reasonable
certainty that no harm will result from
aggregate exposure to residues of thymol
to the U.S. population. This includes all
anticipated dietary exposures and other
non-occupational exposures for which
there is reliable information. The
Agency arrived at this conclusion based
on the relatively low levels of
mammalian dietary toxicity associated
with thymol, its FDA approval as a
direct food additive, a preservative and
indirect food additive of adhesives and
GRAS listing as a spice, natural oil,
oleoresin, or natural extract and
information and/or data which
demonstrate that the U.S. population is
potentially exposed to 938 times more
thymol from the consumption of
foodstuff such as ice cream, cola
beverages and candy, to which thymol
is intentionally added, than from
thymol consumed in honey (Refs. 22,
23, and MRID 46043510). These data
indicate that thymol residues found in
food and foodstuffs exist at significantly
higher concentrations that those
residues levels resulting from the use of
thymol as a pesticide. For these reasons,
the Agency has determined that thymol
residues in honey will not pose any
significant dietary risk under reasonable
foreseeable circumstances residue.
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2. Infants and children. FFDCA
section 408 provides that EPA shall
apply an additional tenfold margin of
exposure (safety) for infants and
children in the case of threshold effects
to account for prenatal and postnatal
toxicity and the completeness of the
data base unless the EPA determines
that a different margin of exposure
(safety) will be safe for infants and
children. Based on all the reliable
available information the Agency
reviewed on thymol, the Agency
concludes that there are no residual
uncertainties for prenatal/postnatal
toxicity resulting from thymol and that
thymol has relatively low toxicity to
mammals from a dietary standpoint,
including infants and children thus,
there are no threshold effects of concern
and an additional margin of safety is not
necessary to protect infants and
children.
VII. Other Considerations
A. Endocrine Disruptors
No studies illustrating thymolinduced immune and endocrine toxicity
were submitted by the registrant.
EPA is required under FFDCA, as
amended by FQPA, to develop a
screening program to determine whether
certain substances (including all
pesticide active and other ingredients)
‘‘may have an effect in humans that is
similar to an effect produced by a
naturally occurring estrogen, or other
such endocrine effects as the
Administrator may designate.’’
Following the recommendations of its
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
EPA determined that there were
scientific bases for including, as part of
the program, the androgen and thyroid
hormone systems, in addition to the
estrogen hormone system. EPA also
adopted EDSTAC’s recommendation
that the Program include evaluations of
potential effects in wildlife. For
pesticide chemicals, EPA will use
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and, to the
extent that effects in wildlife may help
determine whether a substance may
have an effect in humans, FFDCA has
authority to require the wildlife
evaluations. As the science develops
and resources allow, screening of
additional hormone systems may be
added to the Endocrine Disruptor
Screening Program (EDSP). When the
appropriate screening and/or testing
protocols being considered under the
Agency’s EDSP have been developed,
thymol may be subjected to additional
screening and/or testing to better
characterize effects related to endocrine
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disruption. Based on available data, no
endocrine system-related effects have
been identified with consumption of
thymol. Information submitted from the
public literature and reviewed by the
Agency however, describe
immunological endpoints in relation to
short-term and chronic dosing. No
effects were seen in the thymus, spleen,
lymph nodes, white cell counts, red cell
counts, hemoglobin counts, or
hematocrits following the dosing of rats
with 1,000 or 10,000 mg/kg of food
grade thymol for 19 weeks. (MRID
46282803; Ref. 21). This information
does not however, provide evidence to
suggest that thymol affects the immune
system, functions in a manner similar to
any known hormone, or that it acts as
an endocrine disruptor.
B. Analytical Method(s)
An analytical method for measuring
thymol in honey and beeswax was
submitted and reviewed by the Agency
and found to be acceptable.
C. Codex Maximum Residue Level
The are no CODEX maximum
residues levels for thymol.
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VIII. Conclusions
Based on the information/data
submitted and other information
available to the Agency, there is a
reasonable certainty that no harm will
result from aggregate exposure to
residues of thymol to the U.S.
population, including infants and
children, under reasonable foreseeable
circumstances, when the biochemical
pesticide is used in accordance with the
product label directions. This includes
all anticipated dietary exposures and all
other non-occupational exposures for
which there is reliable information. The
Agency has arrived at this conclusion
based on the information/data
submitted (and publically available)
demonstrating relatively low toxicity of
thymol. As a result, EPA is establishing
an exemption from the tolerance
requirements pursuant to FFDCA 408(c)
and (d) for residues of thymol in or on
honey, honeycomb and honeycomb
with honey.
IX. References
1. 12/7/05 Agency review
memorandum; From Dr. Kent Carlson,
Biologist; Through Dr. Russell Jones,
Senior Biologist; To Andrew Bryceland,
Regulatory Action Leader; Subject:
Addendum to the 7/19/05 Agency
review memorandum and Review of
Response to Deficiency Letter, Waiver
Rationales, and Product Chemistry.
2. 7/19/05 Agency review
memorandum; From Dr. Kent Carlson,
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15:03 Jan 17, 2006
Jkt 208001
Biologist; Through Dr. Russell Jones,
Senior Biologist; To Andrew Bryceland,
Regulatory Action Leader; Review of
Response to Deficiency Letter, Waiver
Rationales, and Product Chemistry.
3. Environmental Risk Management
Authority (ERMA). 2005. Form HS1,
Application for approval to import or
manufacture any hazardous substance
for release (for APILIFE VAR).
www.ermanz.govt.nz.
4. Mortazavi, S.H.R., Ebrahimi, M.,
Salehnia, A., and M. Abdollahi. 2003.
Effects of satureja khuzestanica on
reproduction potency of female rats.
Neurotoxicology and Teratology. 25.
381–397.
5. Sax, N.I., 1984. Dangerous
properties of industrial materials. 6th
edition. New York, NY. Van Nostrand
Reinhold. p2580.
6. Anonymous. 2000. Thymol.
Toxikologische Bewertung. Heidleberg,
Berufsgenossenschaft der chemischen
Industrie Vol:259 (2000) 38p.
7. Azizan, A. and R.D. Blevins. 1995.
Mutagenicity and antimutagenicity
testing of six chemicals associated with
the pungent properties of specific spices
as revealed by the Ames Salmonella/
microsomal assay. Arch. Environ.
Contam. Toxicol. 28: 248–258.
8. Stammati, A., Bonsi, P., Zucco, F.,
Moezelaar, R., Alakomi, H.-L., and A.
von Wright. 1999. Toxicity of selected
plant volatiles in microbial and
mammalian short-term assays. Food and
Chemical Toxicology. 37: 813–823.
9. Zani, F., Massimo, G., Benvenuti,
S., Bianchi, A., Albasini, A., Melegari,
M., Vampa, G., Bellotti, A., and P.
Mazza. 1990. Studies on the genotoxic
properties of essential oils with Bacillus
subtilis rec-assay and Salmonella/
microsome reversion assay. Planta Med.
57:237–241.
10. Tsutsui, T., Suzuki, N., Kobayashi,
Y., Suzuki, H., Fukuda, S., and H.
Maizumi. 1987. Assessment of the
carcinogenic hazard of 27 substances
used in dental practices. Japanese
Journal of Pharmacology. 43 (suppl).
132P.
11. Grant, W.F. 1982. Chromosome
aberration assays in Allium. A report of
the U.S. Environmental Protection
Agency Gene-Tox program. Mutat. Res.
99(3). 273–291.
12. Environmental Protection Agency.
2001. Risk assessment guidance for
superfund volume I: Human health
evaluation manual (Part E,
Supplemental Guidance for Dermal Risk
Assessment) Interim. EPA/540/R/99/
005, OSWER 9285.7–02EP, PB99–
963312.
13. EPA Health Effects Guidelines
(OPPTS.7300, Prenatal development
toxicity study, pg.1 (e)(1)).
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2893
14. FR Notice 7308–1, Vol.68, No.
109, Friday June 6, 2003.
15. Fenaroli’s Handbook of Flavoring
ingredients. Vol 2. Edited, translated
and revised by T.E. Furia and Bellanca.
2nd edition. Cleeland: The Chemical
Rubber Co., 1975., p536.
16. De Vincenzi, M., Maialetti, F., and
M. Di Pasquale. 1991. Monographs on
botanical flavoring substances used in
food; Part 1. Fitoterapia. 62(1). 47–63.
17. Piasenzotto, L., Gracco, L., Conte,
L.S., and S. Bodenov. 2002. Application
of solid phase microextraction to
evaluate traces of thymol in honey.
Apidologie. 33. 545–552.
18. Council of Europe. 2000. Council
of Europe Publishing, F-67075
Strousburg Cedex, Koelblin-FortunaDick, p. 85.
19. Food and Drug Administration,
April 10, 1997, NADA, Freedom of
Information Summary, p3.
20. Hostynek, J.J. and P.S. Magee.
1997. Fragrance allergens: Classification
and ranking by QSAR. Toxicology In
Vitro. 11. 377–384.
21. Hagan, E.C., Hansen, W.H.,
Fitzhugh, O.G., Jenner, P.M., Jones, W.I.,
Taylor, J.M., Long, E.L., Nelson, A.A.,
and J.B. Brouwer. 1967. Food
flavourings and compounds of related
structure. II. Subacute and Chronic
Toxocity. Fd. Cosmet. Toxicol. 5. 141–
157.
22. USEPA NCEA–ORD. 1997.
Exposure Factors Handbook, Chapter 7
Body Weight Studies, at https://
cfpub.epa.gov/ncea/cfm/
recordisplay.cfm?deid=
12464CFID=17826586
&CFTOKEN=20588395.
23. Food and Drug Administration.
FDA Total Diet Study. 1990. FDA Total
Diet Study. 2003. TDS Diets, Version 1
(1990 food list + 1987–88 NFCS data),
at https://www.cfsan.fda.gov/∼comm/tdshist.html#fca.
X. Objections and Hearing Requests
Under section 408(g) of 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 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 FFDCA provides
essentially the same process for persons
to ‘‘object ’’ to a regulation setting an
exemption from the requirement of a
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tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of 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
EPA–HQ–OPP–2005–0483 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 March 20, 2006.
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 (1900L),
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 Suite 350, 1099 14th St., NW.,
Washington, DC 20005. 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 (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit IX.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
EPA–HQ–OPP–2005–0483, to: Public
Information and Records Integrity
Branch, Information Technology and
Resource Management Division (7502C),
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15:03 Jan 17, 2006
Jkt 208001
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 ADDRESSES. You may also
send an electronic copy of your request
via e-mail to: opp-docket@epa.gov.
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).
XI. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the tolerance
requirement under section 408(d) of
FFDCA in response to a petition
submitted to the Agency. 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
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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 petition
under section 408(d) of 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
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
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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.
XII. 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.
Dated: December 30, 2005.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1240 is amended by
redesignating the existing text as
paragraph (a) and adding a new
paragraph (b) to read as follows:
I
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§ 180.1240 Thymol; exemption from the
requirement of a tolerance.
*
*
*
*
*
(b) An exemption from the
requirement of tolerance is established
for residues of Thymol (5-methyl-2isopropyl-1-phenol in or on honey,
honeycomb, and honeycomb with
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15:03 Jan 17, 2006
Jkt 208001
honey when used in accordance with
good agricultural practices.
[FR Doc. 06–436 Filed 1–17–06; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CC Docket No. 94–129; DA 05–1618]
Policies and Rules Concerning
Unauthorized Changes of Consumers’
Long Distance Carriers
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: A Petition for Declaratory
Ruling regarding the Commission’s
carrier change verification rules was
filed by a coalition of rural local
exchange carriers (LEC Petitioners).
Specifically, the LEC Petitioners asked
the Commission to declare that certain
carrier change verification actions do
not violate the Commission’s rules,
which prohibits executing carriers from
verifying the submission of a change
request by a submitting carrier or
causing an unreasonable delay in the
execution of a change. In this document,
the Commission denies the LEC
Petitioners’ request.
DATES: Effective January 18, 2006.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
David Marks, Consumer &
Governmental Affairs Bureau, (202)
418–2512 (voice), David.Marks@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s
Declaratory Ruling (Order) DA 05–1618,
CC Docket No. 94–129, adopted June 8,
2005 and released June 9, 2005. The
Order denies a Petition for Declaratory
Ruling regarding the Commission’s
carrier change verification rules filed by
a coalition of rural local exchange
carriers (LEC Petitioners) on February 1,
2005.
This document does not contain new
or modified information collection
requirements subject to the Paperwork
Reduction Act of 1995 (PRA), Public
Law 104–13. In addition, it does not
contain new or modified ‘‘information
collection burdens for small business
concerns with fewer than 25
employees,’’ pursuant to the Small
Business Paperwork Relief Act of 2002,
Public Law 107–198, see 44 U.S.C.
3506(c)(4). Copies of any subsequently
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2895
filed documents in this matter will be
available for public inspection and
copying during regular business hours
at the FCC Reference Information
Center, Portals II, Room CY–A257, 445
12th Street, SW., Washington, DC
20054. The complete text of this
decision may be purchased from the
Commission’s duplicating contractor at
Portals II, 445 12th Street, SW., Room
CY–B402, Washington, DC 20554.
Customers may contact the
Commission’s contractor at their Web
site: https://www.bcpiweb.com or call 1–
800–378–3160. To request materials in
accessible formats for people with
disabilities (Braille, large print,
electronic files, audio format), send an
e-mail to fcc504@fcc.gov or call the
Consumer & Governmental Affairs
Bureau at (202) 418–0530 (voice) or
(202) 418–0432 (TTY). The Order can
also be downloaded in Word and
Portable Document Format (PDF) at
https://www.fcc.gov/cgb/policy.
Synopsis
On February 1, 2005, a coalition of
rural local exchange carriers (LEC
Petitioners) filed a Petition for
Declaratory Ruling regarding the
Commission’s carrier change
verification rules. In their Petition, LEC
Petitioners set forth three main
arguments that their practices do not
violate the Commission’s rules. First,
they argue that there is no basis in law,
including agency law, for the
proposition that a third party (such as
an executing LEC) should rely on a
claim of authority of a person who the
executing carrier believes to be without
authorization. See Petition for
Declaratory Ruling, CC Docket No. 94–
129, filed February 1, 2005 (Petition), by
3 Rivers Telephone Cooperative, Inc.,
Armstrong Telephone Company
Maryland, Armstrong Telephone
Company New York, Armstrong,
Telephone Company North, Armstrong
Telephone Company Northern Division,
Armstrong Telephone Company
Pennsylvania, Armstrong Telephone
Company West Virginia, Calaveras
Telephone Company, Inc., Chester
Telephone Company, Chibardun
Telephone Cooperative, Inc., Chickasaw
Telephone Company, Citizens
Telephone Company of Higginsville,
Concord Telephone Company, CTC
Telcom, Inc., Darien Telephone
Company, DTC Communications,
Egyptian Telephone Cooperative, Five
Area Telephone, Hardy Telephone
Company, Horry Telephone
Cooperative, Inc., HTC
Communications, Lackawaxen
Telecommunications Services, Inc.,
Lockhart Telephone Co., Margaratville
E:\FR\FM\18JAR1.SGM
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Agencies
[Federal Register Volume 71, Number 11 (Wednesday, January 18, 2006)]
[Rules and Regulations]
[Pages 2889-2895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-436]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0483; FRL-7754-9]
Thymol; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the thymol (5-methyl-2-isopropyl-1-
phenol) on honey, honeycomb, and honeycomb with honey when applied/used
as treatment to decrease the incidence of Varroa mite infestation in
the honey bee. Vita (Europe) Limited, c/o Landis International Limited,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of thymol (5-methyl-2-isopropyl-1-phenol).
DATES: This regulation is effective January 18, 2006. Objections and
requests for hearings must be received on or before March 20, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit X. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0483. All documents in the
docket are listed on the www.regulations.gov web site. (EDOCKET, EPA's
electronic public docket and comment system was replaced on November
25, 2005, by an enhanced Federal-wide electronic docket management and
comment system located at https://www.regulations.gov/. Follow the on-
line instructions.) Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy 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.
FOR FURTHER INFORMATION CONTACT: Andrew Bryceland, Biopesticides and
Pollution Prevention Division (7511C), 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 are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document
go directly
[[Page 2890]]
to the guidelines at https://www.epa.gpo/opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of April 27, 2005 (70 FR 21773) (FRL-7707-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3F6752) by Vita (Europe) Limited c/o Landis International,
Inc., P.O. Box 5126, Valdosta, GA 31603-5126. The petition requested
that 40 CFR part 180 be amended by establishing a temporary exemption
from the requirement of a tolerance for residues of thymol (5-methyl-2-
isopropyl-1-phenol). This notice included a summary of the petition
prepared by the petitioner. A public comment has been received
objecting to ``any tolerance, exemption, or waiver allowing more than
zero residue of thymol on food.'' This objection was supported by the
arguments that:
1. Embryonic chickens have multiple malformations following thymol
injection into the yolk or air sac, and;
2. Switzerland has established an Maximum Residue Limit (MRL) of
0.8 milligram/kilogram (mg/kg). The commenter did not provide a
specific data citation for either of these arguments.
The results from the chicken study are of questionable relevance to
mammals. Currently, EPA does not use chickens (or intrayolk or intra-
airsac exposure routes) as an animal model for developmental toxicity
because of the differences in developmental physiology and anatomy
between the two species. Developmental timing, duration, and potential
environmental effects on developing young are also different in mammals
and birds, again precluding this model for use in setting developmental
toxicity endpoints for the regulation of pesticides (Reference 13).
Developmental malformations have not been found following thymol
exposure to other mammalian species such as mice, rats, hamsters, and
rabbits (Environmental Risk Management Agency of New Zealand, 2005). In
addition, Mortazavi et al. (2003) reported no external tissue
abnormalities in fetuses following dosing of female rats with an
infusion of the plant Satureja khuzestanica (which has the components
thymol and carvacrol).
Regulatory limits have been set for thymol in other countries. The
Swiss Federal Department of the Interior has set a tolerance (MRL)
concentration for thymol in honey as an antiparasitic agent (0.8 mg/kg;
pharmacological substance active in nutrition or therapeutic
application; 817.021.23). This tolerance was derived to prevent
exceedance of the taste threshold for thymol in honey (1.1 - 1.3 mg/kg;
Bogdanov et al., 1999), not safety. Tolerances set by EPA are based on
``the reasonable certainty of no harm,'' FFDCA section
408(c)(2)(A)(ii), and therefore, are not constrained by criteria such
as taste.
Section 408(c)(2)(A)(i) of 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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide 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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take intoaccount the factors set forth in
section 408(b)(2)(C), which require 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. . . .''
Additionally, section 408(b)(2)(D) of FFDCA requires that 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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. 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.
Thymol is an essential oil that is extracted from thyme and
mandarine and tangerine oils and is FDA approved when used as a
synthetic flavoring (21 CFR 172.515), a preservative and indirect food
additive of adhesives (21 CFR 175.105). Additionally, the source plant
(thyme), from which thymol is extracted is acknowledged by FDA as
generally recognized as safe (GRAS) (21 CFR 182.10, 21 CFR 182.20).
Residues of thymol can be found in other food stuffs either naturally
such as that found in lime honey or intentionally added to foods such
as ice cream, non-alcoholic beverages, candy, baked goods, and chewing
gum. Information from the public literature documents that levels of
thymol residues in such foods are present at significantly higher
concentrations than those resulting from pesticidal treatments (Refs.
1, 3, 14, 15, 16, 17, and 18). End use products containing thymol as
the active ingredient will be used as a slow release treatment within
the beehive itself to decrease the incidence of Varroa mite infestation
in the honey bee.
Toxicity data requirements were addressed by requests for data
waivers. The Agency granted data waivers based on publically available
information/data submitted by the registrant and reviewed by the
Agency.
1. Acute oral toxicity waiver (OPPTS 870.1100, 152-10). The waiver
rationale submitted in support of the acute oral toxicity (870.1100)
data requirement is based on oral LD50s from the open
literature and reviewed by the Agency. The oral LD50 of
thymol has been reported to be 980, 640-1800, and 880 mg/kg in rats,
mice, and guinea pigs, respectively (Refs. 3 and 5). Thymol occurs in
various food stuffs and spices from 0.02 mg/kg to 100 mg/kg (Refs. 3,
14, 15, 16, 17, and 18). The lowest level in which there was an effect
from thymol was 640 mg/kg (Refs. 3 and 5). The amount in which thymol
causes an acute effect is approximately 6 times higher than the 100 mg/
kg found in the food stuff with the highest amount of thymol present.
The information/data described above support the waiver form the data
requirement for the acute oral toxicity study.
2. Acute dermal toxicity data waiver (OPPTS 870.1200, 152.11). The
waiver rationale submitted in support of the acute dermal toxicity data
requirement is based upon information collected from a report by the
Environmental Risk Management Agency (ERMA, 2005) of New Zealand and
Anonymous (2000) which found dermal LD50's for thymol
[[Page 2891]]
greater than 2,000 mg/kg. Thymol occurs in various food stuffs and
spices from 0.02 mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16, 17, and 18).
Dermal exposure to thymol already occurs from contact with foodstuffs
and seasonings containing thymol as it is FDA approved when used as a
direct food additive and is generally recognized as safe by FDA as a
spice, natural oil, oleoresin, or natural extract and therefore, any
additional exposure resulting from dermal contact with thymol will not
result in any significant exposure. Thymol, when used as a pesticide,
is to be applied to the inside of beehives. Data from U.S. and European
field trials demonstrate maximum residue concentrations of 2.59 mg/kg
thymol in honey (at 30 days following treatment in U.S. trials) and
4.61 mg/kg thymol in honey (at 2 days following treatment in European
trials) demonstrate that, following good agricultural practices (as
specified in the tolerance exemption), the amount of thymol residues
remaining in the beehive after application will be well below the
dermal LD50 and within the range of those thymol residues
already present in food stuffs (MRID No.'s: 460435-10, 11, 12, and 13).
Based on this information, the Agency therefore concludes that the
information/data described above support the waiver from the data
requirement for the acute dermal toxicity study.
Classification: Acceptable.
3. Acute inhalation toxicity waiver (OPPTS 870.1300, 152-12). The
waiver rationale submitted in support of the acute inhalation toxicity
data requirment is based upon information from the U.S. Food and Drug
Administration Center for Drug Evaluation and Research (Ref. 19).
Thymol is added to the anesthetic halothane as a preservative (0.01%)
and is considered inactive at this concentration (Ref. 19). Halothane
is used to anesthetize dogs, cats, and other non-food animals for
periods sometimes exceeding 4 hours (Ref. 19). Anesthetic induction
concentrations can typically reach approximately 5% (Ref. 19).
Calculation of the exposure from these factors yields a thymol
atmospheric concentration of 5 milligram/liter (mg/L). Thymol is for
application to the inside of beehives. Thymol occurs in various food
stuffs and spices from 0.02 mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16,
17, and 18). Inhalation exposure to thymol already occurs from contact
with foodstuffs and seasonings containing thymol as it is FDA approved
when used as a direct food additive and is generally recognized as safe
by FDA as a spice, natural oil, oleoresin, or natural extract and
therefore, any additional exposure resulting from inhalation contact
with thymol will not result in any significant exposure The
information/data described above support the waiver from the data
requirement for the acute inhalation toxicity study.
Classification: Acceptable.
4. Skin hypersensitivity study waiver (OPPTS 870.2600, 152.15). The
waiver rationale for skin hypersensitivity is based on publically
available information (Ref. 20). Using quantitative structure activity
relationships, from the public literature, it was predicted that thymol
is a dermal sensitizer (Ref. 20). Thymol is for application to the
inside of beehives. Thymol occurs in various food stuffs and spices
from 0.02 mg/kg to 100 mg/kg (Refs. 3, 14, 15, 16, 17, and 18). Dermal
exposure to thymol already occurs from contact with foodstuffs and
seasonings containing thymol as it is FDA approved when used as a
direct food additive and is generally recognized as safe by FDA as a
spice, natural oil, oleoresin, or natural extract and therefore, any
additional exposure resulting from dermal contact with thymol will not
result in any significant exposure. The information/data described
above support the waiver from the data requirement for the skin
hypersensitivity study.
Classification: Acceptable.
The information/data described above support the waiver from the
data requirement for the skin hypersensitivity study. However, the
registrant is obliged under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) section 6(a)(2) to notify the Agency in the
events of such incidents.
Classification: Acceptable.
5. Genotoxicity and mutagenicity study waivers, Master Record
Identification Numbers (MRIDs) 46282801 and 46282802 (OPPTS 870.2300,
870.5195; 152-17, and 152.19). Genotoxicity and mutagenicity studies
submitted on September 18th of 2003 (MRIDs 462828-01 and -02),
presumably as waiver rationales for genotoxicity (870.5000) and other
peer-reviewed publications retrieved by EPA (Refs. 3, 6, 7, 8, 9, 10,
and 11), were used to support the waivers from the data requirements.
These data demonstrate that thymol is not genotoxic and/or mutagenic.
The information/data described above support the waivers from the data
requirements for the genotoxicity and mutagenicity studies.
Classification: Acceptable.
6. Immune response study waiver (OPPTS 870.3550, 152.18). The
waiver rationale for immune response (870.3550) is based upon
information presented in a peer-reviewed publication (Ref. 21). No
effects were shown in this data (Ref. 21). The information/data
described above support the waiver form the data requirement for the
acute inhalation toxicity study.
Classification: Acceptable.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA 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).
A. Dietary Exposure
1. Food. Thymol is already found naturally in food stuffs such lime
honey and cooking herbs and/or food stuffs derived from cranberry and
mandarin and tangerine oils. Thymol is also added to food stuffs
commonly consumed by humans such as ice cream, non-alcoholic beverages,
candy, baked goods, and chewing gum. It is FDA approved when used as a
synthetic flavoring, (21 CFR 172.515), a preservative and indirect food
additive of adhesives (21 CFR 175.105) and the source plant (thyme),
from which thymol is extracted is acknowledged by FDA as generally
recognized as safe (GRAS) (21 CFR 182.10, 21 CFR 182.20). The
information and/or data reviewed in support of this tolerance exemption
demonstrate that the levels of thymol already present in foods or
intentionally added to food stuffs will at concentrations significantly
higher that those levels expected from the use of thymol as a
pesticidal product. Because thymol is already present, either naturally
or intentionally added to various food stuffs, there is a great
likelihood of exposure to thymol for most, if not all individuals,
including infants and children. Even if there is a significant increase
in exposure to thymol due to it's use as a pesticide, the acute
toxicity information from the public literature demonstrating
relatively low mammalian toxicity indicate that any possible risk
associated with acute exposures by the oral route would below to non-
existent.
2. Drinking water exposure. No exposure to thymol residues in
drinking water is expected since the use of this product is limited to
application within the hive box in which the product is contained in a
dispenser tray, where the
[[Page 2892]]
product is rapidly volatilized or redistributed. Because thymol has
relatively low toxicity, has been approved for food use by FDA as a
direct food additive and is generally recognized as safe by FDA, even
if exposure through drinking water were to occur, the exposure would be
far less than the exposure that humans already get from consumption of
thymol thru the diet and therefore, no risk is anticipated.
B. Other Non-Occupational Exposure
The potential for non dietary exposure to residues of thymol for
the general population, including infants and children, is unlikely
because the uses are limited to application to certain agricultural
crops within the hive box containing the bees and there is no honey
present in the bee hive. Thymol is consumed by humans thru the diet and
for this reason, from a dietary exposure standpoint, has been
determined to have relatively low toxicity. Therefore, while the
likelihood of exposure exists for most if not all individuals, any
increased exposure due to the proposed product would not add any
significant risks.
1. Dermal exposure. Dermal exposure to thymol already occurs from
contact with foodstuffs and seasonings containing thymol as it is FDA
approved when used as a direct food additive and is generally
recognized as safe by FDA as a spice, natural oil, oleoresin, or
natural extract and therefore, any additional exposure resulting from
dermal contact with thymol will not result in any significant risk.
2. Inhalation exposure. Inhalation exposure to thymol already
occurs from contact with foodstuffs and seasonings containing thymol as
it is FDA approved when used as a direct food additive and is generally
recognized as safe by FDA as a spice, natural oil, oleoresin, or
natural extract and therefore, any additional exposure resulting from
dermal contact with thymol will not result in any significant risk.
V. Cumulative Effects
Thymol has a novel mode of cellular action (GABAA receptor, sodium,
potassium, and calcium channel modulator) compared to other currently
registered active ingredients (Ref. 1). In addition, there is no
indication that toxic effects of thymol would be cumulative (Ref. 1).
Section 408(b)(2)(D)(v) of 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. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to thymol and
any other substances and thymol does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not 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 policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative/.
VI. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. The Agency has determined that there is a
reasonable certainty that no harm will result from aggregate exposure
to residues of thymol to the U.S. population. This includes all
anticipated dietary exposures and other non-occupational exposures for
which there is reliable information. The Agency arrived at this
conclusion based on the relatively low levels of mammalian dietary
toxicity associated with thymol, its FDA approval as a direct food
additive, a preservative and indirect food additive of adhesives and
GRAS listing as a spice, natural oil, oleoresin, or natural extract and
information and/or data which demonstrate that the U.S. population is
potentially exposed to 938 times more thymol from the consumption of
foodstuff such as ice cream, cola beverages and candy, to which thymol
is intentionally added, than from thymol consumed in honey (Refs. 22,
23, and MRID 46043510). These data indicate that thymol residues found
in food and foodstuffs exist at significantly higher concentrations
that those residues levels resulting from the use of thymol as a
pesticide. For these reasons, the Agency has determined that thymol
residues in honey will not pose any significant dietary risk under
reasonable foreseeable circumstances residue.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of exposure (safety) for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base unless the EPA
determines that a different margin of exposure (safety) will be safe
for infants and children. Based on all the reliable available
information the Agency reviewed on thymol, the Agency concludes that
there are no residual uncertainties for prenatal/postnatal toxicity
resulting from thymol and that thymol has relatively low toxicity to
mammals from a dietary standpoint, including infants and children thus,
there are no threshold effects of concern and an additional margin of
safety is not necessary to protect infants and children.
VII. Other Considerations
A. Endocrine Disruptors
No studies illustrating thymol-induced immune and endocrine
toxicity were submitted by the registrant.
EPA is required under FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases for including, as part of the program, the
androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may
help determine whether a substance may have an effect in humans, FFDCA
has authority to require the wildlife evaluations. As the science
develops and resources allow, screening of additional hormone systems
may be added to the Endocrine Disruptor Screening Program (EDSP). When
the appropriate screening and/or testing protocols being considered
under the Agency's EDSP have been developed, thymol may be subjected to
additional screening and/or testing to better characterize effects
related to endocrine
[[Page 2893]]
disruption. Based on available data, no endocrine system-related
effects have been identified with consumption of thymol. Information
submitted from the public literature and reviewed by the Agency
however, describe immunological endpoints in relation to short-term and
chronic dosing. No effects were seen in the thymus, spleen, lymph
nodes, white cell counts, red cell counts, hemoglobin counts, or
hematocrits following the dosing of rats with 1,000 or 10,000 mg/kg of
food grade thymol for 19 weeks. (MRID 46282803; Ref. 21). This
information does not however, provide evidence to suggest that thymol
affects the immune system, functions in a manner similar to any known
hormone, or that it acts as an endocrine disruptor.
B. Analytical Method(s)
An analytical method for measuring thymol in honey and beeswax was
submitted and reviewed by the Agency and found to be acceptable.
C. Codex Maximum Residue Level
The are no CODEX maximum residues levels for thymol.
VIII. Conclusions
Based on the information/data submitted and other information
available to the Agency, there is a reasonable certainty that no harm
will result from aggregate exposure to residues of thymol to the U.S.
population, including infants and children, under reasonable
foreseeable circumstances, when the biochemical pesticide is used in
accordance with the product label directions. This includes all
anticipated dietary exposures and all other non-occupational exposures
for which there is reliable information. The Agency has arrived at this
conclusion based on the information/data submitted (and publically
available) demonstrating relatively low toxicity of thymol. As a
result, EPA is establishing an exemption from the tolerance
requirements pursuant to FFDCA 408(c) and (d) for residues of thymol in
or on honey, honeycomb and honeycomb with honey.
IX. References
1. 12/7/05 Agency review memorandum; From Dr. Kent Carlson,
Biologist; Through Dr. Russell Jones, Senior Biologist; To Andrew
Bryceland, Regulatory Action Leader; Subject: Addendum to the 7/19/05
Agency review memorandum and Review of Response to Deficiency Letter,
Waiver Rationales, and Product Chemistry.
2. 7/19/05 Agency review memorandum; From Dr. Kent Carlson,
Biologist; Through Dr. Russell Jones, Senior Biologist; To Andrew
Bryceland, Regulatory Action Leader; Review of Response to Deficiency
Letter, Waiver Rationales, and Product Chemistry.
3. Environmental Risk Management Authority (ERMA). 2005. Form HS1,
Application for approval to import or manufacture any hazardous
substance for release (for APILIFE VAR). www.ermanz.govt.nz.
4. Mortazavi, S.H.R., Ebrahimi, M., Salehnia, A., and M. Abdollahi.
2003. Effects of satureja khuzestanica on reproduction potency of
female rats. Neurotoxicology and Teratology. 25. 381-397.
5. Sax, N.I., 1984. Dangerous properties of industrial materials.
6th edition. New York, NY. Van Nostrand Reinhold. p2580.
6. Anonymous. 2000. Thymol. Toxikologische Bewertung. Heidleberg,
Berufsgenossenschaft der chemischen Industrie Vol:259 (2000) 38p.
7. Azizan, A. and R.D. Blevins. 1995. Mutagenicity and
antimutagenicity testing of six chemicals associated with the pungent
properties of specific spices as revealed by the Ames Salmonella/
microsomal assay. Arch. Environ. Contam. Toxicol. 28: 248-258.
8. Stammati, A., Bonsi, P., Zucco, F., Moezelaar, R., Alakomi, H.-
L., and A. von Wright. 1999. Toxicity of selected plant volatiles in
microbial and mammalian short-term assays. Food and Chemical
Toxicology. 37: 813-823.
9. Zani, F., Massimo, G., Benvenuti, S., Bianchi, A., Albasini, A.,
Melegari, M., Vampa, G., Bellotti, A., and P. Mazza. 1990. Studies on
the genotoxic properties of essential oils with Bacillus subtilis rec-
assay and Salmonella/microsome reversion assay. Planta Med. 57:237-241.
10. Tsutsui, T., Suzuki, N., Kobayashi, Y., Suzuki, H., Fukuda, S.,
and H. Maizumi. 1987. Assessment of the carcinogenic hazard of 27
substances used in dental practices. Japanese Journal of Pharmacology.
43 (suppl). 132P.
11. Grant, W.F. 1982. Chromosome aberration assays in Allium. A
report of the U.S. Environmental Protection Agency Gene-Tox program.
Mutat. Res. 99(3). 273-291.
12. Environmental Protection Agency. 2001. Risk assessment guidance
for superfund volume I: Human health evaluation manual (Part E,
Supplemental Guidance for Dermal Risk Assessment) Interim. EPA/540/R/
99/005, OSWER 9285.7-02EP, PB99-963312.
13. EPA Health Effects Guidelines (OPPTS.7300, Prenatal development
toxicity study, pg.1 (e)(1)).
14. FR Notice 7308-1, Vol.68, No. 109, Friday June 6, 2003.
15. Fenaroli's Handbook of Flavoring ingredients. Vol 2. Edited,
translated and revised by T.E. Furia and Bellanca. 2\nd\ edition.
Cleeland: The Chemical Rubber Co., 1975., p536.
16. De Vincenzi, M., Maialetti, F., and M. Di Pasquale. 1991.
Monographs on botanical flavoring substances used in food; Part 1.
Fitoterapia. 62(1). 47-63.
17. Piasenzotto, L., Gracco, L., Conte, L.S., and S. Bodenov. 2002.
Application of solid phase microextraction to evaluate traces of thymol
in honey. Apidologie. 33. 545-552.
18. Council of Europe. 2000. Council of Europe Publishing, F-67075
Strousburg Cedex, Koelblin-Fortuna-Dick, p. 85.
19. Food and Drug Administration, April 10, 1997, NADA, Freedom of
Information Summary, p3.
20. Hostynek, J.J. and P.S. Magee. 1997. Fragrance allergens:
Classification and ranking by QSAR. Toxicology In Vitro. 11. 377-384.
21. Hagan, E.C., Hansen, W.H., Fitzhugh, O.G., Jenner, P.M., Jones,
W.I., Taylor, J.M., Long, E.L., Nelson, A.A., and J.B. Brouwer. 1967.
Food flavourings and compounds of related structure. II. Subacute and
Chronic Toxocity. Fd. Cosmet. Toxicol. 5. 141-157.
22. USEPA NCEA-ORD. 1997. Exposure Factors Handbook, Chapter 7 Body
Weight Studies, at https://cfpub.epa.gov/ncea/cfm/
recordisplay.cfm?deid= 12464CFID=17826586 &CFTOKEN=20588395.
23. Food and Drug Administration. FDA Total Diet Study. 1990. FDA
Total Diet Study. 2003. TDS Diets, Version 1 (1990 food list + 1987-88
NFCS data), at https://www.cfsan.fda.gov/~comm/tds-hist.html#fca.
X. Objections and Hearing Requests
Under section 408(g) of 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 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 FFDCA provides essentially the same process for
persons to ``object '' to a regulation setting an exemption from the
requirement of a
[[Page 2894]]
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of 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 EPA-HQ-OPP-2005-0483 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 March 20,
2006.
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 (1900L),
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 Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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 (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number EPA-HQ-OPP-2005-0483, to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management 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 ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
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).
XI. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of FFDCA in response to a petition
submitted to the Agency. 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
petition under section 408(d) of 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 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
[[Page 2895]]
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.
XII. 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.
Dated: December 30, 2005.
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), 346a and 371.
0
2. Section 180.1240 is amended by redesignating the existing text as
paragraph (a) and adding a new paragraph (b) to read as follows:
Sec. 180.1240 Thymol; exemption from the requirement of a tolerance.
* * * * *
(b) An exemption from the requirement of tolerance is established
for residues of Thymol (5-methyl-2-isopropyl-1-phenol in or on honey,
honeycomb, and honeycomb with honey when used in accordance with good
agricultural practices.
[FR Doc. 06-436 Filed 1-17-06; 8:45 am]
BILLING CODE 6560-50-S