Document ID: EPA-HQ-OPP-2006-0695-0001
Agency: epa
Document Type: Rule
Title: Eucalyptus Oil; Exemption from the Requirement of a Tolerance
Posted Date: 2006-09-13T13:11:14Z

[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Rules and Regulations]               
[Page 53974-53979]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se06-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0695; FRL-8089-7]

 
Eucalyptus Oil; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of eucalyptus oil on honey and honeycomb 
when applied at 2 g or less eucalyptus oil per hive to suppress varroa 
mites. Brushy Mountain Bee farm, c/o IR-4 Project 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 eucalyptus oil in honey and honeycomb.

DATES: This regulation is effective September 13, 2006. Objections and 
requests for hearings must be received on or before November 13, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0695. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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

[[Page 53975]]

available only in hard copy form. Publicly available docket materials 
are available in the electronic docket at http://www.regulations.gov
,or, if only available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. The 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: Driss Benmhend, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9525; e-mail address: benmhend.driss@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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0695 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 November 13, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0695, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460–0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 19, 2006 (71 FR 41018) (FRL-8077-
8), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition PP 6E7082 by Brushy Mountain Bee farm, c/o IR-4 Project 
Rutgers University, 681 U.S. Highway 1 South, North Brunswick, New 
Jersey 08902. The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of eucalyptus oil. This notice included a summary of the 
petition prepared by the petitioner Brushy Mountain Bee farm, c/o IR-4 
Project Rutgers. There were no comments received in response to the 
notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption 6efrom 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 the 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 into account 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 the 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 the 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.

[[Page 53976]]

    Eucalyptus oil (EO) is an essential oil that is obtained from steam 
distillation of the leaves of Eucalyptus globulus. Eucalyptus oil has a 
long history of safe medicinal uses and has been classified by FDA as a 
GRAS substance and permitted as a direct additive to foods for human 
consumption (21 CFR 172.510). It is used as a component of decongestant 
products, as an expectorant component of cough and cold products, in 
various oral dosages from (e.g., lozenges and syrups), and as an 
inhalant in vapor baths, etc. In 2002, 100,000 tons of Halls cough 
drops were consumed. There are no incident reports of adverse effects 
associated with exposures to EO.
    There is limited information in the public literature and 
information reported by the FDA that provides a limit to the levels of 
EO that can be present in foods and or medicines. One exception 
however, is that EO is currently allowed at 1.2 to 1.3% (12,000 to 
13,000 mg/kg) as a topical antitussive drug in mixtures with camphor 
and menthol (21 CFR 341.14(b); 341.40(u); 341.74(b),(c),(d)). A topical 
antitussive is defined as a drug that relieves cough when inhaled after 
being applied topically to the throat or chest in the form of an 
ointment or from a steam vaporizer or when dissolved in the mouth in 
the form of a lozenge for a local effect (21 CFR 341.3(c). Eucalyptus 
oil can be used orally in cough drops at 162 to 2,000 mg/kg (Ref. 1). 
There is information in the public literature that EO is known to be 
toxic at high levels. However, based on the most likely use pattern for 
EO as a pesticide, the Agency has determined that EO, when used as a 
pesticide, will be safe because it is likely to be used at very low 
levels. The lack of information in the public literature on the levels 
of EO that is present in certain foods and medicines is due to a lack 
of an available method to detect residues of eucalyptus oil in foods 
and medicines. This is primarily due to the fact that most essential 
oils from plants such a Eucalyptus spp. contain many components and 
therefore, may be difficult to characterize the actual oil component. 
Eucalyptus oil from Eucalyptus globulus is composed eucalyptol, 
triterpenes, monoterpenes, sesquiterpenes, aldehydes and ketones of 
which eucalyptol (1,8-cineole) makes up to 80% or more of EO. Since 
there is no method of detection for EO in foods, the Agency has 
conducted a dietary risk assessment in order to estimate the exposure 
to eucalyptus oil when used as a pesticide in or on honey and honey 
comb.
    Toxicity data requirements were satisfied by the registrant with 
data and/or information from the public literature and requests to 
waive toxicity testing for the studies below. Data waiver rationales 
were provided and were acceptable and therefore data waivers were 
granted by the Agency.

A. Acute and Short-term Toxicity

    Information submitted by the applicant demonstrated that acute oral 
LD50 values for EO is 4,400 mg/kg body weight in rats, 3,320 
mg/kg body weight in mice, and a dermal LD50 of > 5,000 mg/
kg body weight in rabbits. These classify EO as Toxicity Category IV 
for acutely toxic oral and dermal effects. EO is also a mild dermal 
irritant (Ref. 2). Embryotoxicity and fetotoxicity were not observed in 
a teratogenicity study in which mice were dosed with EO (from 
Eucalyptus globulus) subcutaneously during days 6-15 of gestation (Ref. 
1).
    Acute inhalation toxicity and primary eye irritation studies on EO 
were waived because the product requires personal protective equipment 
equivalent to Toxicity Category I. Inhalation and eye irritation only 
apply to workers using the product and not to people consuming the 
honey because the EO residue levels in honey are so low (0.125 ppm) 
when applied at 2g or less EO per hive. In addition, EO has a long 
history of safe use as a common ingredient in ointments applied to the 
skin and steam vaporizer solution for the relief of cold and flu 
symptoms. Hypersensitivity incidents must be reported to the Agency. No 
incidents have been reported during the last few years when EO in 
combination with other compounds has been used under the FIFRA section 
18 program to control Varroa mites in bees.

B. Genotoxicity / Mutagenicity

    Data submitted supported the waiver request for genotoxicity. No 
genotoxicity was observed following exposure of eucalyptus oil to 
Salmonella strains TA100, TA1535, TA1537, TA98 in tests with or without 
activation by rat and hamster liver S9 fractions (Ref. 3). An 
additional study (Ref. 4) also reported that eucalyptol, the main 
component of eucalyptus oil, was negative for mutation in S. 
typhimurium strains TA100, TA97A, TA98, TA102 both with and without 
metabolic activation (via rat liver S-9). Other in vitro studies show a 
weak positive to positive increases in sister chromatid exchanges were 
reported in Chinese hamster ovary (CHO) cells without metabolic 
activation (Ref. 5). Equivocal or weakly positive increases in 
chromosome aberrations were observed in CHO cells with S9 metabolic 
activation (Ref. 5). Overall, the weight of evidence suggests that EO 
is not genotoxic or mutagenic.

C. Subchronic Toxicity

    Oral subchronic studies are typically required when the pesticidal 
use requires a tolerance or an exemption from the requirement of a 
tolerance, a food additive regulation, or its use results in repeated 
human oral exposure. Dietary subchronic exposure to EO in honey is 
probable. EO residues are found in other food items at significantly 
higher concentrations than those resulting from pesticidal treatments. 
Because the dietary contribution of EO from honey is expected to be 
negligible compared to that already in the diet, subchronic studies are 
not required.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the 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).
    The Agency believes that establishing a tolerance exemption for 
residues of eucalyptus oil in or on honey or honey comb will not cause 
any new exposure that would not be safe. As mentioned in Unit III., the 
U.S. population in general is already exposed to EO from the 
consumption of cough lozenges and other food products at levels which 
are equivalent to the limit levels for this tolerance exemption without 
any reports of adverse effects. Further, the daily exposure to EO from 
honey consumption is negligible when compared to the level ingested for 
therapeutic use. In order to validate the determination that any new 
exposure from the use of eucalyptus oil is safe, the Agency conducted a 
dietary risk assessment using magnitude of residue data measuring 
eucalyptol and adjusted by 20 percent because eucalyptol is 80 percent 
of EO. As a result of this risk assessment, the Agency concludes that 
the use of EO when used as a pesticide on honey or honey comb to 
suppress varroa mites when applied at 2g or less EO will not add any 
new exposures or risks and is considered safe.

A. Dietary Exposure

    A dietary risk was estimated by comparing theoretical exposures 
using the EO residues approved for use by FDA in cough drops as stated 
above.

[[Page 53977]]

These theoretical exposures were compared to the current consumption of 
eucalyptol, the therapeutic dose of eucalyptol. Comparisons were not 
calculated for the infant population because honey is generally not 
recommended for infant consumption due to the dangers it can pose to 
infants. Before comparisons could be made, exposures had to be put into 
terms of EO, not the marker analyte eucalyptol as described above. The 
amount of eucalyptus oil allowed in cough drops is 2,000 ppm which is 
16,000 times that found in the honey submitted residue trial (Ref. 6).
    Based on the dietary risk assessment conducted by the Agency, it 
has been determined that daily exposures to EO from honey consumption 
would be orders of magnitude less than the level ingested for 
therapeutic use. Therefore, the Agency concludes that residues of EO in 
honey when applied at 2g or less per hive are of no dietary concern to 
the U.S. population including children.
    1. Food. Eucalyptus oil is commonly found in numerous food items 
such as yellow cake, vanilla ice cream, cola beverages, and caramel 
candy. In 2002, people consumed 100,000 tons of Halls drops (http://www.cadburyschweppes.com/EN
 /Brands/About/Confectionery/factsheet--

halls.htm); while in the Northern Hemisphere these are sold as cough 
drops, other parts of the world consume them as candy. The daily 
exposure to EO from honey consumption when used at 2g or less is orders 
of magnitude less than the level ingested for therapeutic use (Ref. 1). 
Therefore, residues of EO in honey are not considered a dietary 
concern. Conservative exposure estimates and the use of lowest toxicity 
concentrations ensure that residues of EO present a reasonable 
certainty of no harm. Therefore, no adverse effects associated with 
exposures to EO by oral route are expected from the use of EO as a 
pesticide when used at 2g or less EO per hive.
    2. Drinking water exposure. No exposure to EO residues in drinking 
water is expected because 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.
    3. Magnitude of the Residue in/on Honey and Honeycomb. The end-use 
product, ApiLife VAR, has acceptable magnitude of the residue data on 
eucalyptol in honey and honeycomb when used as a treatment for Varroa 
mites in bee hives (Ref. 6; Ref. 7). Eucalyptol is the marker analyte 
for EO and comprises 80% (v/v) of the original mixture. Residue 
estimates and dietary exposures estimated with eucalyptol (0.1 mg/kg) 
were modified to account for the percentage of eucalyptol in EO (80%). 
Essentially, this meant increasing these estimates by 20% (equivalent 
to 0.125 mg/kg EO residues). The dietary exposure of eucalyptol in 
honey is below EPA's levels of concern for all population subgroups 
(Ref. 1).

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to EO residues for the 
general population, including infants and children, is unlikely because 
the proposed use-site is limited to beehives.

V. Cumulative Effects

    There is no indication that the toxic effects of EO are cumulative. 
Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, EPA 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 EO 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 EO and any other substances 
and EO 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 EO 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

    There is a reasonable certainty that no harm will result to the 
U.S. population including children from aggregate exposure to residues 
of EO as a result of its use as a pesticide in or on honey and honey 
comb when used at 2g or less EO per hive since no toxicity is expected 
and the U.S. population in general is already exposed to EO from the 
consumption of cough lozenges at much higher levels without any reports 
of adverse effects. This includes all anticipated dietary exposures and 
all other exposures for which there is reliable information. The 
anticipated residues in honey are at 0.125 ppm, which is more than 
16,000 times lower than the established acceptable level in cough 
lozenges. Moreover, at high levels, EO gives off an undesirable or ill 
taste to the palate when consumed at levels which far exceed those 
levels reported for medicinal uses such as teas. For these reasons, it 
is unlikely that EO will be consumed at levels exceeding those reported 
here based on the undesirable taste alone. In addition, there is very 
little potential for exposure to EO from drinking water since the 
product will volatize or exposure and is limited to beehives or from 
non dietary, non occupational exposure since its use is limited to 
beehives. Therefore, based on its long history of safe use therapeutic 
and medicinal agents without any reports of any toxic or adverse 
effects and the fact that EO is classified by FDA as a substance that 
is generally recognized as safe (GRAS) when used as a direct additive 
to foods for human consumption, the Agency believes that the health 
risk to humans is negligible and concludes that there is a reasonable 
certainty that no harm will result from aggregate exposures to EO.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the 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 was scientific basis 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 FIFRA and, 
to the extent that effects in wildlife may help determine whether a 
substance may have an effect in humans, FFDCA authority to require the 
wildlife evaluations. As the science develops and resources allow, 
screening

[[Page 53978]]

of additional hormone systems may be added to the Endocrine Disruptor 
Screening Program (EDSP).
    At this time, the Agency is not requiring information on the 
endocrine effects of this active ingredient, EO. Based on the weight of 
the evidence of available data and the absence of any reports to the 
Agency of sensitivity or other adverse effects, no endocrine system 
related effects are identified for EO and none is expected because of 
its use. To date there is no evidence that EO affects the immune 
system, functions in a manner similar to any known hormone, or that it 
acts as an endocrine disruptor. Thus, there is no impact via endocrine-
related effects on the Agency's safety finding set forth in this 
proposed rule to establish an exemption from the requirement of a 
tolerance for residues of EO used at 2g or less EO per hive.

B. Analytical Method

    Through this action the Agency proposes to establish an exemption 
from the requirement of a tolerance for EO on honey and honeycomb when 
used at 2g or less EO per hive to suppress varroa mites. This decision 
was reached based on the reasons stated above which include low 
toxicity to mammals and negligible exposure from the pesticidal use of 
products containing EO. For the same reasons, the Agency concludes that 
an analytical method is not required for enforcement purposes for EO.

C. Codex Maximum Residue Level

    There are no CODEX maximum residues levels for EO.

VIII. Conclusions

    Based on the data submitted and other information available to the 
Agency, there is a reasonable certainty that no harm will result from 
the aggregate exposure to residues of EO to the U.S. population, 
including infants and children, under reasonable foreseeable 
circumstances, when the biochemical pesticide EO is used in accordance 
with the product label directions and at 2 g or less eucalyptus oil per 
hive. 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 publicly available) demonstrating relatively low 
toxicity of EO. As a result, EPA is establishing an exemption from the 
tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of 
EO in or on honey, honeycomb and honeycomb with honey when used at 2g 
or less EO per hive.

IX. References

    1. August 8, 2006. EPA Memo: Api Life VAR: Toxicology Review and a 
Dietary Exposure Assessment for Eucalyptus Oil (CAS No. 6000-48-4) in 
Support of an Exemption for the Requirement of a Tolerance. Kent 
Carlson to Driss Benmhend.
    2. Inchem. 2004. Aliphatic and Aromatic Ethers. Chapter 2.2.2 
Toxicological Studies. JEFCA. 52
    3. National Toxicology Program. 1982. Salmonella assay for genetic 
toxicity from exposure to 1,8 cineole. Study 246429.
    4. Gomes-Carneiro. R. 1998. Mutagenicity testing ()-camphor, 1,8 
cineole, citral, citronellol, (-)-menthol, and terpineol with the 
Salmonella microsome assay. Mutation Research. 416(1-2). 129-136.
    5. National Toxicology Program. 1982. CHO cell cytogenetics; 
chromosome aberrations and sister chromatid exchanges from exposure to 
1,8 cineole. Study 590755.
    6. July 25, 2005. MRID 466828-01. Thymol, Eucalyptol, Campho: 
Magnitude of the Residue on honey and beeswax. IR-$ PR No. 08661. 
251pp.
    7. June 29, 2006. EPA Memo: Apilife VAR: Dietary Exposure 
Assessment Involving Review of Toxicology and Exposure Data to Address 
Application to Bee Hives. Kent Carlson to Driss Benmhend.

X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of the 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 the FFDCA, such as the exemption from 
the requirement of a tolerance in this final rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure

[[Page 53979]]

``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

XI. 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: August 31, 2006.
James Jones,
Director, Office of Pesticides 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 180.1271 is added to subpart D to read as follows:

Sec.  180.1271  Eucalyptus oil; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of tolerance is established for 
residues of eucalyptus oil in or on honey, honeycomb, and honeycomb 
with honey when used at 2g or less eucalyptus oil per hive, where the 
eucalyptus oil contains 80% or more eucalyptol.
[FR Doc. E6-14995 Filed 9-12-06; 8:45 am]

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