Thymol; Exemption from the Requirement of a Tolerance, 12613-12617 [E9-6262]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Rules and Regulations]
[Pages 12613-12617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-6262]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0081; FRL-8404-4]


 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 thymol (as present in thyme oil) in or 
on food commodities when applied/used in/on public eating places, dairy 
processing equipment, and/or food processing equipment and utensils. 
Sensible Life Products 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.

DATES: This regulation is effective March 25, 2009. Objections and 
requests for hearings must be received on or before May 26, 2009, 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-2007-0081. To access the 
electronic docket, go to https://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. 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 available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mark Hartman, Antimicrobials Division 
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0734; 
hartman.mark@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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person

[[Page 12614]]


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 https://www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://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 https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by 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-2007-0081 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 May 26, 2009.
    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-2007-0081, by one of the following methods.
     Federal eRulemaking Portal: https://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 
Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 6, 2007 (Vol. 72, No. 129 (FRL-
8136-3), 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 6F7147) by Sensible Life Products (Division of LBD, Ltd.), 
34-7 Innovation Dr, Ontario, Canada L9H7H9. The petition requested that 
40 CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of thymol in or on food 
commodities when used as a hard surface disinfectant. 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 comment is addressed in Unit VIII.C.
    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) of FFDCA, 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) of FFDCA, 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.
    Based on the following, the Agency has concluded that thymol has 
minimal potential toxicity and poses minimal risk:
    1. Thymol is a normal constituent of the human diet and a component 
of many non-pesticidal consumer products currently marketed in the 
United States,
    2. Thymol and the phenols of thymol are listed as food additives by 
the FDA (21 CFR 172.515; synthetic flavoring substances and adjuvants),
    3. Thymol is found naturally occurring in thyme herb, a food 
seasoning ingredient that is generally recognized as safe (GRAS) by the 
FDA (21 CFR 182.10),
    4. Thyme oil (for which thymol is a component) also is recognized 
as a GRAS essential oil by the FDA (21 CFR 182.20),
    5. Thymol can be presumed non-persistent in the environment based 
on knowledge of its composition,
    6. As a conventional pesticide, thymol repels vertebrate pests by a 
non-toxic mode of action,
    7. The available toxicity information does not indicate toxic 
effects at the levels of potential exposure and

[[Page 12615]]

    8. EPA is not aware of any adverse effects to humans or the 
environment in the scientific literature associated with any thymol 
related use.

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 found naturally in food stuffs such as 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 be at concentrations 
significantly higher than those levels expected from the use of thymol 
as a pesticidal product. For example, the U.S. population is 
potentially exposed to roughly 1,000 times more thymol from the 
consumption of foodstuffs such as ice cream, cola beverages and candy, 
to which thymol is intentionally added, than from thymol consumed in as 
a result of use as a pesticide in food handling establishments. 
Aggregate exposure to thymol in food, therefore, is primarily due to 
naturally-occurring thymol and thymol's use as a food additive.
    2. Drinking water exposure. Exposure to thymol residues in drinking 
water is not expected since the use of this product is limited to 
application indoors and release to drinking water sources is unlikely.

B. Other Non-Occupational Exposure

    The term ``residential exposure'' is used in this document to refer 
to non-occupational, non-dietary exposure (e.g., for lawn and garden 
pest control, indoor pest control, termiticides, and flea and tick 
control on pets). Thymol is not registered for any specific use 
patterns that would result in residential exposure.

V. Cumulative Effects

     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.
    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. Thymol has a novel mode of cellular 
action (GABAA receptor, sodium, potassium, and calcium channel 
modulator) compared to other currently registered active ingredients. 
In addition, there is no indication that toxic effects of thymol would 
be cumulative. 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. Safety Factor for the Protection of 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. EPA 
has determined that a quantitative risk assessment using safety factors 
is not needed to assess thymol's safety for the general population due 
to thymol's low toxicity. For similar reasons, an additional safety 
factor is not necessary to protect infants and children.

VII. Determination of Safety for U.S. Population, Infants and Children

    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 presence as a naturally-occurring substance in food, and 
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.

VIII. 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,

[[Page 12616]]

thymol may be subjected to additional screening and/or testing to 
better characterize effects related to endocrine 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 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 milligrams/kilograms (mg/kg) of food grade thymol 
for 19 weeks. (MRID 46282803; Ref. 21).

B. Codex Maximum Residue Level

    There are no CODEX maximum residues levels for thymol .

C. Public Comments

    1. A commenter argued that no greater than zero residues from 
thymol should be allowed because embryonic chickens have multiple 
malformations following thymol injection into the yolk or air sac.
    EPA Response: 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 (including absorption barriers and 
detoxification mechanisms) which are present in mammals. 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.
     Developmental malformations have not been found following thymol 
exposure to 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).
    2. A commenter argued that no greater than zero residues from 
thymol should be allowed because thymol is mutagenic.
    EPA Response: Although the Agency understands thymol did give 
statistically significant positive results in an unscheduled DNA 
synthesis test and a Sister Chromatid Exchange (SCE) test with Syrian 
hamster embryonic cells, these mutagenicity studies do not comply with 
the Agency's current test guideline requirements either because of a 
lack of positive controls, or because a treatment-related dose response 
was not demonstrated even when statistical significance was achieved. 
Based on the available toxicity information, its presence in the human 
diet and several non-pesticidal consumer products, and its long history 
of use with no known adverse effects to human health and the 
environment.The Agency reaffirms that there is no need to establish a 
maximum permissible level for residue of thymol.

IX. 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. 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. Further, because 
thymol residues (as present in thyme oil) in or on food commodities do 
not pose any significant risk under reasonable foreseeable 
circumstances, EPA is establishing an exemption from the tolerance 
requirements pursuant to FFDCA 408(c) and (d) for residues of thymol in 
or on food commodities

 X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 final rule has been 
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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

[[Page 12617]]

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: March 3, 2009.
Joan Harrigan-Farrelly,
Director, Antimicrobials Division, 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, paragraph (b) is revised to read as follows:


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

    * * * * *
    (b) An exemption from the requirement of a tolerance for residues 
of the thymol (as present in thyme oil) in or on food commodities when 
applied/used in/on public eating places, dairy processing equipment, 
and/or food processing equipment and utensils.
[FR Doc. E9-6262 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S