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

■ 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 


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Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’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 June 4, 2008 

(73 FR 31862) (FRL–8365–3), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, as amended 

by FQPA (Public Law 104–170), 

announcing the filing of a pesticide 

petition (PP 8E7332) by Bayer 

CropScience LP, P.O. Box 12014, 2 T.W. 

Alexander Dr., Research Triangle Park, 

NC 27709. The petition requested that 

the exemption in 40 CFR 180.920 for 

triethanolamine be amended by 

removing the restriction that 

triethanolamine could only be used in 

formulations applied before the crop 

emerged from the soil. That notice 

included a summary of the petition 

prepared by the petitioner. There were 

no comments received in response to 

the notice of filing. 

Section 408(b)(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 tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires 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. . . .’’ 

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. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene ploymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. 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. The 

nature of the toxic effects caused by 

triethanolamine are discussed in this 

unit. 

Triethanolamine has an existing 

exemption from tolerance under 40 CFR 

180.920 when used as an inert 

ingredient in pesticide formulations 

applied before the crop emerges from 

the soil. This exemption was reassessed 

by EPA in 2006 and the reassessment 

document can be found at http:// 

www.epa.gov/opprd001/inerts/ 

decisiondoc_a2k.html. For ease of 

reading, triethanolamine is referred to as 

TEA. Summaries of the assessment for 

TEA are presented in this final rule. For 

more detailed information, refer to the 

docket for the more comprehensive 

assessment/decision document. 

In animal studies, TEA has low acute 

toxicity via the oral and dermal routes, 

was nonirritating in eye and skin 

irritation studies, and did not induce 

skin sensitization. In repeat-dose 

testing, the main effect was on the liver 

and kidney with adverse effects seen at 

oral doses > 170 milligrams/kilogram/ 

day (mg/kg/day). TEA is unlikely to be 

carcinogenic and studies indicate it is 

not mutagenic or developmentally toxic. 

Reproductive parameters were not 

affected in rats and mice treated 

dermally with TEA. When ingested, 

TEA appears to be rapidly absorbed in 

the gastrointestinal tract. In rodent 

studies, TEA was eliminated largely 

unchanged in the urine and feces within 

2 days. 

V. 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). 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

The primary route of exposure to TEA 

from its use as an inert ingredient in 

pesticide products applied to growing 

crops would most likely be through 

consumption of food to which pesticide 

products containing TEA have been 

applied, and possibly through drinking 

water (from runoff). Residential (dermal 

and inhalation) exposures are also 

possible from the use of home garden 

pesticide products containing TEA as an 

inert ingredient. 

There are no data provided regarding 

TEA residues in food or any other 

nonoccupational exposures to TEA. In 

the absence of actual residue data for 

TEA, the Agency performed a dietary 

(food and drinking water) exposure 

assessment for TEA when used as an 

inert ingredient in pesticide 

formulations applied to growing crops 

by using a series of very conservative 

assumptions. This exposure assessment 

was calculated based on the following 


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assumptions: (1) TEA would be used as 

an inert ingredient in all food use 

pesticide formulations applied to all 

crops, (2) 100% of all food crops would 

be treated with pesticide products 

containing TEA, (3) TEA residues would 

be present in all crops at levels equal to 

or exceeding the highest established 

tolerance levels for any pesticide active 

ingredient, and (4) TEA would be 

present in all sources of drinking water 

at concentrations equal to the highest 

established standards for drinking water 

contaminants established by EPA. This 

approach is highly conservative as it is 

extremely unlikely that TEA would 

have such use as a pesticide product 

inert ingredient and be present in food 

commodities and drinking water at such 

high levels. In addition, this highly 

conservative exposure assessment is 

protective of any possible nonoccupational exposures to TEA, as it 

results in exposure estimates which are 

orders of magnitude greater than the 

high-end exposure estimates for 

residential uses of pesticides routinely 

used by EPA’s Office of Pesticide 

Programs. 

VI. Cumulative Effects 

Section 408(b)(2)(D)(v) of the 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 TEA 

and any other substances and, TEA 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 

TEA 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/. 

VII. Safety Factor for the Protection of 

Infants and Children 

Section 408(b)(2)(c) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10X) margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. EPA has 

determined that reliable data show the 

safety of infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

1. The database is considered 

adequate for FQPA assessment based on 

available subchronic (rats), chronic/ 

carcinogenicity (rats and mice), 

developmental (rats and mice), and 

reproduction (rats and mice) toxicity 

studies. No acute or subchronic 

neurotoxicity studies are available, but 

there were no clinical signs of 

neurotoxicity observed in the available 

database. Therefore, the Agency 

concluded that these studies are not 

required. In addition, the developmental 

neurotoxicity study is not required 

because there is no evidence of 

increased susceptibility to infants and 

children in the available developmental 

and reproduction studies in rats and 

mice and no clinical signs of 

neurotoxicity in the available studies. 

Based on the overall evidence, the 

Agency concluded that the database for 

triethanolamine is adequate for FQPA. 

2. Based on the developmental 

toxicity studies, EPA concludes that 

there is no evidence of increased 

susceptibility to infants and children. 

Developmental toxicity study in rats via 

the dermal route resulted in no 

biologically significant effects in the 

offspring or in the maternal animals. An 

oral Chernoff-Kavlock screening test 

resulted in a no observed adverse effect 

level (NOAEL) of 1,125 mg/kg/day in 

mice and it was determined that oral 

administration of the test material did 

not affect maternal mortality, the 

number of viable litters, length of 

gestation, litter size, percent survival of 

the pups or birth weight or weight 

gained by the pups. No quantitative or 

qualitative evidence of susceptibility 

was observed from any of the currently 

available toxicological data. 

3. No reproductive parameters were 

affected in rat and mice treated dermally 

at doses up to 2,000 and 4,000 mg/kg/ 

day, respectively. 

4. No evidence of treatment related 

clinical signs of neurotoxicity was 

observed in the available toxicological 

studies. EPA concluded that the 

developmental neurotoxicity study is 

not required. 

5. The highly conservative dietary 

exposure assessment using default 

assumptions would not underestimate 

the risk to infants and children. 

VIII. Determination of Safety for U.S. 

Population 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

Uncertainty/safety factors (UFs) are 

used in conjunction with the POD to 

take into account uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. Safety is assessed for 

acute and chronic dietary risks by 

comparing aggregate food and water 

exposure to the pesticide to the acute 

population adjusted dose (aPAD) and 

chronic population adjusted dose 

(cPAD). The aPAD and cPAD are 

calculated by dividing the POD by all 

applicable UFs. 

Residues of concern are not 

anticipated for dietary exposure (food 

and drinking water) or for residential 

exposure (inhalation and dermal) from 

the use of TEA as an inert ingredient in 

pesticide products. The toxicology data 

indicate that TEA does not pose an 

acute risk. Chronic risk was assessed by 

comparing aggregate exposure to TEA to 

a cPAD of 1.70 mg/kg/day (based on the 

subchronic oral rat study with a NOAEL 

of 170 mg/kg/day and a safety/ 

uncertainty factor of 100X). Utilizing the 

highly conservative aggregate exposure 

assessment described above, the 

resulting chronic exposure estimates do 

not exceed the Agency’s level of 

concern (children 1–2 years were the 

most highly exposed population with 

the chronic exposure estimates 

occupying 26.6% of the cPAD). In 

addition, this highly conservative 

exposure assessment is protective of any 

possible non-occupational exposures to 

TEA, as it results in exposure estimates 

orders of magnitude greater than the 

high-end exposure estimates for 

residential uses of pesticides routinely 

used by EPA’s Office of Pesticide 

Programs. 


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Taking into consideration all available 

information on TEA, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to TEA 

residues. Therefore, the establishment of 

an exemption from the requirement of a 

tolerance under 40 CFR 180.920 for 

residues of TEA when used as an inert 

ingredient in pesticide formulations 

applied to growing crops, is safe under 

section 408(q) of the FFDCA. 

IX. Other Considerations 

A. Analytical Method 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. Existing Exemptions 

Triethanolamine has an existing 

exemption from the requirement of a 

tolerance under 40 CFR 180.920 for use 

as an inert ingredient in pesticide 

formulations applied before the crop 

emerges from the soil. 

C. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for 

triethanoloamine nor have any CODEX 

Maximum Residue Levels (MRLs) been 

established for any food crops at this 

time. 

X. Conclusions 

Therefore, an exemption from the 

requirement for a tolerance is 

established for triethanolamine when 

used as an inert ingredient in pesticide 

formulations applied to growing crops. 

XI. 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, 

entitled 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). 

XII. 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: March 3, 2009. 

Lois Rossi, 

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. In § 180.920, the table is amended 

by revising the entry for 

‘‘Triethanolamine’’ to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Triethanolamine (CAS Reg. No. 102–71–6) Stabilizer, inhibitor 

* * * * * 


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[FR Doc. E9–6263 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0095; FRL–8404–7] 

Tristyrylphenol Ethoxylates (CAS Reg. 

No. 70559-25-0) and (CAS Reg. No. 

99734-09-5); 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 poly(oxy-1,2- 

ethanediyl), a-[2,4,6-tris(1- 

phenylethyl)phenyl]-w-hydroxy- (CAS 

Reg. No. 70559–25–0) and poly(oxy-1,2- 

ethanediyl), a-[tris(1- 

phenylethyl)phenyl]-w-hydroxy-, (CAS 

Reg. No. 99734–09–5), herein referred to 

in this document as tristyrylphenol 

ethoxylates when used as inert 

ingredients in post-harvest applications 

to citrus crops, group 10, under 40 CFR 

180.1288 at a maximum of 10.0% in 

pesticide formulations with 

azoxystrobin and fludioxonil. Syngenta 

Crop Protection, Inc. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of the tristyrylphenol 

ethoxylates. 

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–2008–0095. 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: 

Karen Samek, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8825; e-mail address: 

samek.karen@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–2008–0095 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–2008–0095, 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 

Facility’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 March 12, 

2008 (73 FR 13225) (FRL–8354–6), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, as amended 

by FQPA (Public Law 104–170), 

announcing the filing of a pesticide 

petition (PP 7E7305) by Syngenta Crop 

Protection, Inc., P.O. Box 18300, 

Greensboro, NC 27409. The petition 

requested that 40 CFR 180.910 be 

amended by establishing an exemption 


sroberts on PROD1PC70 with RULES