Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12613 

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). 

VII. 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 

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: February 27, 2009. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.434 is amended by 

revising the tolerance for pineapple and 

by alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§180.434 Propiconazole; tolerance for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Beet, garden, roots ................... 0.30 

Beet, garden, tops .................... 5.5 

*****

Cilantro, leaves ......................... 13 

*****

Parsley, fresh leaves ................ 13 

Parsley, dried leaves ................ 35 

*****

Pineapple .................................. 4.5 

Pineapple, process residue ...... 7.0 

* * * * * 

[FR Doc. E9–6273 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

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 http:// 

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 

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 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 


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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 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: 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 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 nonpersistent 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 


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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 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 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, 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 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 nonoccupational, 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 http://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 naturallyoccurring 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 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, 


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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 


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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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 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, paragraph (b) is 

revised to read as follows: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0346; FRL–8404–1] 

Triethanolamine; 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 triethanolamine 

(CAS Reg. No. 102–71–6) when used as 

an inert ingredient in pesticide 

formulations applied to growing crops 

under 40 CFR 180.920. Bayer 

CropScience, LP submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

expansion of the existing § 180.920 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

triethanolamine. 

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–2008–0346. All documents in the 

docket are listed in the docket index 

available at http://www.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 

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 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: Keri 

Grinstead, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8373; e-mail address: 

grinstead.keri@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 electronically 

available documents 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 e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, 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–2008–0346 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–2008–0346, 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 


sroberts on PROD1PC70 with RULES