Federal Register: January 18, 2006 (Volume 71, Number 11)
DOCID: FR Doc 06-436
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
EPA ID: [EPA-HQ-OPP-2005-0483; FRL-7754-9]
ACTION: Pesticides; tolerances in food, animal fees, and raw agricultural commodities:
DOCUMENT ACTION: Final rule.
Thymol; Exemption from the Requirement of a Tolerance
DATES: This regulation is effective January 18, 2006. Objections and requests for hearings must be received on or before March 20, 2006.
This regulation establishes an exemption from the requirement of a tolerance for residues of the thymol (5methyl2isopropyl1 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 (5methyl2isopropyl1phenol).
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:
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 (http://www.epa.gov/edocket/), 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 on ECFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document go directly
to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/. II. Background and Statutory Findings
In the Federal Register of April 27, 2005 (70 FR 21773) (FRL7707 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 316035126. 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 (5methyl2 isopropyl1phenol). 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, nonalcoholic 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, 15210). The waiver
rationale submitted in support of the acute oral toxicity (870.1100)
data requirement is based on oral LD
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 LD
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 LD
3. Acute inhalation toxicity waiver (OPPTS 870.1300, 15212). 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 nonfood 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.
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.
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.
5. Genotoxicity and mutagenicity study waivers, Master Record Identification Numbers (MRIDs) 46282801 and 46282802 (OPPTS 870.2300, 870.5195; 15217, and 152.19). Genotoxicity and mutagenicity studies submitted on September 18th of 2003 (MRIDs 46282801 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.
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 peerreviewed 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.
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
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 NonOccupational 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 http://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 nonoccupational 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 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
disruption. Based on available data, no endocrine systemrelated 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 shortterm 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 nonoccupational 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.
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). http://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. 381397.
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: 248258.
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 shortterm assays. Food and Chemical Toxicology. 37: 813823.
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. 57:237241.
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 GeneTox program. Mutat. Res. 99(3). 273291.
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 9285.702EP, PB99963312.
13. EPA Health Effects Guidelines (OPPTS.7300, Prenatal development toxicity study, pg.1 (e)(1)).
14. FR Notice 73081, 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). 4763.
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. 545552.
18. Council of Europe. 2000. Council of Europe Publishing, F67075 Strousburg Cedex, KoelblinFortunaDick, 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. 377384.
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. 141157.
22. USEPA NCEAORD. 1997. Exposure Factors Handbook, Chapter 7 Body Weight Studies, at http://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 + 198788 NFCS data), at http://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
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 EPAHQOPP20050483 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 204600001. 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) 5646255.
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 EPAHQOPP20050483, 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 204600001. 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 email to: firstname.lastname@example.org. 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 1044). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and LowIncome 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 104113, 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
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.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
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: 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 (5methyl2isopropyl1phenol in or on honey, honeycomb, and honeycomb with honey when used in accordance with good agricultural practices.
[FR Doc. 06436 Filed 11706; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT
Andrew Bryceland, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3056928; email address:email@example.com.