Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51623 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Sweet potato ..... 1.0 12/31/08 

* * * * * 

[FR Doc. 05–17204 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2003–0230; FRL–7729–5] 

Lactic Acid, 2-Ethylhexyl Ester; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

four exemptions from the requirement 

of a tolerance for residues of lactic acid, 

2-ethylhexyl ester or ethylhexyl lactate 

when used as an inert ingredient 

(solvent) in or on growing crops, when 

applied to raw agricultural commodities 

after harvest, or to animals. Purac 

America, Inc. 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 lactic acid, 2-ethylhexyl 

ester. 

DATES: This regulation is effective 

August 31, 2005. Objections and 

requests for hearings must be received 

on or before October 31, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit XI. of theSUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2003–

0230. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn Boyle, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6304; e-mail address: 

boyle.kathryn@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 Get Electronic Documents 

and Other Related Information? 

In addition to using EDOCKET at 

(http://www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings 

athttp://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two athttp:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

In the Federal Register of July 11, 

2003 (68 FR 41349) (FRL–7316–1), EPA 

issued a notice pursuant to section 408 

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

amended by the FQPA (Public Law 104–

170), announcing the filing of a 

pesticide petition (PP 0F6179) by Purac 

America, Inc., 111 Barclay Boulevard, 

Lincolnshire, IL 60069. The petition 

requested that 40 CFR 180.950 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of the (S) isomer of lactic acid, 

2-ethylhexyl ester, also known as lactic 

acid, 2-ethylhexyl ester, (2S)- or 2- 

ethylhexyl lactate (CAS Reg. No. 

186817–80–1) when used as a solvent, 

an inert ingredient, in pesticide 

products. That notice included a 

summary of the petition prepared by the 

petitioner. There were no comments 

received in response to the notice of 

filing. 

PURAC’s petition requested only the 

establishment of a tolerance exemption 

for the (S) isomer of lactic acid, 2- 

ethylhexyl ester. However, according to 

information on the PURAC website, 

there is also a general CAS Reg. No. for 

lactic acid, 2-ethylhexyl ester (CAS Reg. 

No. 6283–86–9). In the simplest terms 

an isomer can be defined as a substance 

which has the same molecular formula 

as another, but the individual elements 

of the molecule—the links from one 

element to another within the 

molecule—are arranged differently. A 

stereochemical isomer differs in the 3- 

D spatial arrangement of the elements. 

In certain cases, this is sometimes 

referred to as ‘‘mirror images.’’ An 

example of such a mirror image 

arrangement is a person’s right and left 

hand. A person holding his hands out, 

both palms up, cannot make the 

presentation of four fingers and the 

thumb of the right hand match the 

orientation of the left hand. They can be 

viewed as if there is a mirror between 

the two. The chemical and physical 

properties of two isomeric chemicals are 

essentially the same. There can be some 

differences in the biological properties 

of the two isomers. The Agency has 

determined that both of the names are 

appropriate for this chemical and is 

therefore establishing tolerance 

exemptions using the (S) isomer and the 

general nomenclature of lactic acid, 2- 

ethylhexyl ester. 

Section 408(b)(2)(A)(i) of the 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 the FFDCA 

defines‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

51624 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of the 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 polymers 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 the FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. The 

nature of the toxic effects caused by 

lactic acid, 2-ethylhexyl ester are 

discussed in this unit. 

A. Acute Toxicity 

The Agency’s review of the following 

two acute toxicity studies and the 

toxicity category classification, are 

shown in the following Table. The 

Agency uses a scale of I to IV to rate the 

toxicity of acute studies. Toxicity 

Category I is indicative of very high 

acute toxicity. Toxicity Category IV is 

the Agency’s lowest rating of acute 

toxicity. 

ACUTE TOXICITY STUDIES

Study/Species Results Toxicity Category 

Acute oral toxicity/rat LD50 is equal to or greater than 2,000 mg/kg III 

Primary eye irritation/rabbit Irritating to the eye II 

B. Repeated Dose Inhalation Toxicity 

Study 

In a 28–day inhalation toxicity study, 

rats received 6-hour/day nose only 

exposure, for 5 days/week over a 4-week 

period. The target concentrations of 

lactic acid, 2-ethylhexyl ester were 0 

(control), 75, 200, 600, or 1,800 mg/ 

cubic meter ( mg/m3). A NOEL (noobserved effect level) was not defined as 

microscopic effects in the respiratory 

tract were noted even at 75 mg/m3. The 

Agency’s reviewer noted that effects 

seen at 600 mg/m3 (decreased absolute 

spleen weight in males), and 1,800 mg/ 

m3 (gross pathology changes of the 

lungs, significantly decreased body 

weight in males, increases in relative 

liver weight in both sexes, increases in 

lung weight in males, decreases in 

absolute spleen weights in both sexes, 

and in relative spleen weight in females) 

would be more consistent with 

consideration of an adverse effect. 

C. Developmental Inhalation Toxicity 

Study 

Pregnant rats were exposed to lactic 

acid, 2-ethylhexyl ester at target 

concentrations of 0 (control), 200 or 600 

mg/m3 for 6 hours/day nose only 

exposure from gestation days 6 to 15. 

Both the 200 and 600 mg/m3

concentration groups experienced an 

increased breathing rate. Body weight 

gains were slightly depressed in both 

groups. There was also a reduced food 

consumption relative to controls. A 

maternal NOAEL (no observed adverse 

effect level) was not determined. The 

maternal LOAEL (lowest observed 

adverse effect level) is 200 mg/m3. 

Mean fetal body weight values for the 

600 mg/m3 group were below those of 

controls. The only effect at 200 mg/m3, 

a slight retardation in fetal ossification, 

was considered to be equivocal and 

probably secondary to maternal toxicity. 

The developmental NOAEL is 200 mg/ 

m3 and the developmental LOAEL is 

600 mg/m3 based on reduced mean fetal 

body weights. 

D. Metabolism 

Lactic acid, 2-ethylhexyl ester is 

formed by combining lactic acid and 2- 

ethylhexanol. In mammalian 

metabolism, this process is reversed. 

Simple esters such as the lactic acid 

esters undergo hydrolysis yielding lactic 

acid and the corresponding alcohol. The 

human body has well-understood 

pathways for metabolizing ingested 

lactic acid. Humans also produce lactic 

acid as an intermediate product of 

carbohydrate or glucose metabolism. 

The Food and Drug Administration 

(FDA) has estimated the lactate turnover 

rate in man to be of the order of 2 

grams/kg/day. The Agency’s evaluation 

of lactic acid has been placed as a 

support document in the EDOCKET for 

this final rule. 

In the hydrolysis of lactic acid, 2- 

ethylhexyl ester, the corresponding 

alcohol would be 2-ethylhexanol. The 

mammalian body would metabolize 2- 

ethylhexanol to the corresponding 

aldehyde, which would then be 

metabolized to the corresponding 

carboxylic acid. The mammalian body 

has well-understood pathways for 

metabolism of carboxylic acids to 

carbon dioxide and water. 

E. Toxicity of 2-Ethylhexanol 

Since 2-ethylhexanol (CAS Reg. No. 

104–76–7) is the alcohol formed via 

hydrolysis, toxicity studies performed 

using 2-ethylhexanol as the test 

substance can be used to further 

understand the toxicity of lactic acid, 2- 

ethylhexyl ester. Three sources of data 

are available: Data submitted to the 

Agency under a Toxic Substances 

Control Act (TSCA) test rule, the 

conclusions and recommendations of 

the Organization for Economic 

Cooperation and Development (OECD), 

and the International Uniform Chemical 

Information Database (IUCLID) 

submitted by industry to the European 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51625 

Chemicals Bureau. Taken together these 

three data sources supply more than 

adequate information to evaluate the 

toxicity of 2-ethylhexanol. 

Under a TSCA test rule, toxicity 

studies performed using 2-ethylhexanol 

were submitted to the Agency’s Office of 

Pollution Prevention and Toxics 

(OPPT). Reviews of two carcinogenicity 

studies (mouse and rat) and a dermal 

developmental toxicity study are posted 

on the Agency’s website (see http:// 

www.epa.gov/opptintr/chemtest/ 

ethylhex.htm). The conclusions of the 

Agency’s reviewers were that 2- 

ethylhexanol is not carcinogenic in the 

mouse under the conditions of the 

study, and that there is no evidence of 

carcinogenicity in the rat at any dose 

level tested. In the developmental 

toxicity study there was no evidence of 

developmental toxicity at any dose 

level. The dermal developmental 

NOAEL is therefore equal to or greater 

than the highest dose tested (HDT), 3.0 

milliliter (mL)/kg/day or 2,520 

milligram/kilogram/day (mg/kg/day). 

Maternal effects (reduced weight gain) 

were noted at the 3.0 mL/kg/day dose 

level. Exfoliation occurred at the 

application site at the 1.0 mL/kg/day 

dose level. The maternal NOAEL is 0.3 

mL/kg/day or 252 mg/kg/day. 

The agreed upon conclusions and 

recommendations of the OECD 

Screening Information Dataset Initial 

Assessment Profile (SIAP) are available 

via the internet (see http://cs3- 

hq.oecd.org/scripts/hpv/Home.asp). The 

SIAP contains summarized results of 

OECD’s review of several 90–day 

toxicity studies, two carcinogenicity 

studies, and several developmental 

toxicity studies. The IUCLID for 2- 

ethylhexanol was obtained from the 

European Chemicals Bureau website 

(see http://ecb.jrc.it.esis/). The IUCLID 

dataset is a compilation of data 

submitted by the manufacturers of 2- 

ethylhexanol and is posted as received. 

By combining these two sources, the 

Agency was able to obtain more details 

on certain of the toxicity studies than 

available in the SIAP. 

Results of three 90–day oral toxicity 

studies are available: 

• In a rat feed study, the NOAEL is 

57 mg/kg/day and the LOAEL is 282 

mg/kg/day based on swelling of the liver 

and kidney. 

• In a rat gavage study the NOAEL is 

125 mg/kg/day and the LOAEL is 250 

mg/kg/day based on clinical effects: 

Cyanide insensitive palmitoyl CoAoxidation in the liver. 

• In a mouse gavage study the 

NOAEL is 125 (male) and 250 (female) 

mg/kg/day. The LOAEL is 250(M) and 

500(F) based on stomach effects. 

These results are consistent (the 57 

mg/kg/day is an artifact of dose spacing) 

and indicate that the target organs were 

the liver, stomach, and kidney. 

2-Ethylhexanol was negative in 

numerous mutagenicity studies. Both 

the SIAP and the IUCLID indicated that 

2-ethylhexanol is not carcinogenic in 

the rat or mouse. 

Results of developmental toxicity 

studies via the oral and inhalation 

routes of exposure performed using 2- 

ethylhexanol were reported in the SIAP 

and IUCLID. 

• For the rat oral (gavage) study the 

maternal NOAEL is 130 mg/kg/day and 

the maternal LOAEL is 650 mg/kg/day. 

The developmental NOAEL is 130 mg/ 

kg/day, and the developmental LOAEL 

is 650 mg/kg/day based on slightly 

reduced mean fetal body weights and 

increased frequency of fetuses with 

skeletal variations and retardations. 

• In a mouse oral (gavage) 

developmental toxicity study both the 

maternal and the developmental 

NOAEL are equal to or greater than 191 

mg/kg/day, the HDT. 

• In a single dose rat developmental 

inhalation toxicity study, maternal feed 

consumption was reduced, but no fetal 

malformations were noted. The 

maternal NOAEL would be less than or 

equal to 0.850 mg/m3. The 

developmental LOAEL would be equal 

to or greater than 0.850 mg/m3. 

Metabolism studies performed using 

2-ethylhexanol indicate that after oral 

administration, 2-ethylhexanol is 

rapidly excreted in respiratory carbon 

dioxide, feces, and urine. Elimination is 

essentially complete by 28 hours after 

administration. Only 3% of the 

administered 2-ethylhexanol is excreted 

unchanged. 

The SIAP conclusions called for 

additional testing with the metabolite of 

2-ethylhexanol, which is 2- 

ethylhexanoic acid. The rationale for 

this conclusion was based on the results 

of several oral studies conducted at 

time-frames of less than two weeks 

duration. The IUCLID indicated that 

these studies were conducted at high 

dose levels ranging from over 300 to 

1,500 mg/kg/day. Alterations in 

testicular weights were consistently 

noted at 1,000 and 1,500 mg/kg/day. 

Alterations in testicular weights were 

not consistent at dose levels in the 300’s 

mg/kg/day. However, the testicular 

effects were not noted in the 90–day 

oral toxicity studies even at dose levels 

up to 500 mg/kg/day. 

F. Conclusions 

Acute toxicity studies indicate that 

lactic acid, 2-ethylhexyl ester is of low 

to moderate acute oral toxicity, and is 

irritating to the eye. The database 

supplied by the petitioner, most 

specifically the 28–day study, indicate 

that lactic acid, 2-ethylhexyl ester is 

irritating to the lung and respiratory 

tract. Irritation effects such as these are 

handled through the use of personal 

protective equipment as determined by 

the end-product acute toxicity testing 

not through the establishment of 

tolerance exemptions. 

Of significant note for dietary 

exposure, chemical substances such as 

lactic acid esters hydrolyze in the 

mammalian body to lactic acid and the 

corresponding alcohol (2-ethylhexanol). 

The human body has well-understood 

pathways for metabolizing such 

chemicals. Given the relationship of 2- 

ethylhexanol as a metabolite of the 

mammalian body’s metabolism of lactic 

acid, 2-ethylhexyl ester, data on 2- 

ethylhexanol is useful for understanding 

the toxicity of lactic acid, 2-ethylhexyl 

ester. Data on 2-ethylhexanol can be 

used to judge that lactic acid, 2- 

ethylhexyl ester is not a carcinogen. 

The Office of Pesticide Programs has 

reviewed and evaluated a 

developmental inhalation toxicity study 

conducted with lactic acid, 2-ethylhexyl 

ester. OPPT has reviewed and evaluated 

a dermal developmental toxicity study 

conducted with 2-ethylhexanol. The 

SIAP and IUCLID provided information 

on another developmental inhalation 

toxicity study conducted with 2- 

ethylhexanol. None of these studies are 

the route of exposure most appropriate 

for evaluating dietary exposure; 

however, there are in these studies no 

indications of any increased 

susceptibility. 

For evaluating dietary exposure the 

oral developmental and 90–day studies 

conducted using 2-ethylhexanol provide 

the most appropriate information for 

assessing the toxicity of lactic acid, 2- 

ethylhexyl ester. These studies 

consistently demonstrate NOAELs 

greater than 100 mg/kg/day. 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the FFDCA directs EPA 

to consider available information 

concerning exposures from the pesticide 

residue in food and all other 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 

51626 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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. 

A. Dietary Exposure 

1. Food. The Agency has developed a 

screening-level model for predicting 

dietary exposure to inert ingredients. 

The results of this model are considered 

to over-estimate exposure to an inert 

ingredient in a pesticide product. The 

modeled chronic dietary exposure for 

the U.S. population for an inert 

ingredient is 0.12 mg/kg/day. This is 

well-below the dose levels (discussed 

above) at which an adverse effect is 

expected from exposure to lactic acid, 2- 

ethylhexyl ester. 

The Agency must also consider the 

potential for exposure to lactic acid as 

a result of application of a pesticide 

product containing a lactate ester. Lactic 

acid occurs naturally in meats, fruits, 

tomato juice, beer, wine, molasses, sour 

milk, yogurt and cottage cheese. Lactic 

acid has been added to commercially 

prepared foods since the 1940-1950s. 

The FDA has estimated a per capita 

daily intake for lactic acid of 15 mg. 

Given the existing and wide-spread 

presence of lactic acid in the food 

supply, the amount of lactic acid that 

could be present as a result of an 

application of a pesticide product 

containing lactic acid or a lactate ester 

is expected to be a very small 

proportion. 

2. Drinking water exposure. When 

released to the environment, lactic acid, 

2-ethylhexyl ester will be present 

predominantly in the dissolved phase 

surface and ground water. The chemical 

is soluble in water (0.3 g/liter). Once 

lactic acid, 2-ethylhexyl is in the water, 

it is expected that at neutral pH 

degradation would begin immediately 

via hydrolysis. Lactic acid, 2-ethylhexyl 

ester would also degrade rapidly via 

biodegradation. The estimated half-life 

of lactic acid, 2-ethylhexyl ester in soil 

is 17 days. Based on information 

submitted by the petitioner and 

estimates from the Agency’s PBT 

profiler (http://www.pbt.profiler.net) 

lactic acid, 2-ethylhexyl ester should 

completely degrade to water and carbon 

dioxide in days. Given the rapid 

biodegradation (i.e. lack of persistance) 

significant concentrations of lactic acid, 

2-ethylhexyl ester are very unlikely in 

either ground or surface water used as 

sources of drinking water. 

B. Other Non-Occupational Exposure 

Given their physical/chemical 

properties, lactate esters could have a 

variety of uses in and around the home. 

According to information on the 

internet they are being considered as 

‘‘green’’ replacements for many of the 

organic solvents traditionally used in 

the manufacturing industry. 

VI. Cumulative Effects 

Section 408 (b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance or tolerance exemption, the 

Agency consider ‘‘available 

information’’ concerning the cumulative 

effects of a particular chemical’s 

residues and ‘‘other substances that 

have a common mechanism of toxicity.’’

Unlike other pesticide chemicals 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 lactic acid, 2-ethylhexyl 

ester. The lactate esters are a 

structurally-related group of chemicals 

that all hydrolyze to lactic acid, which 

is not a toxic metabolite. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

these chemical substances have 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 Infants and 

Children 

FFDCA section 408 provides that EPA 

shall apply an additional tenfold 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 unless 

EPA concluded that a different margin 

of safety will be safe for infants and 

children. Lactic acid, 2-ethylhexyl ester 

has been tested in an inhalation 

developmental toxicity study in which 

there were no indications of increased 

susceptibility. The hydrolysis product 

of lactic acid, 2-ethylhexyl ester is 2- 

ethylhexanol. Developmental toxicity 

studies conducted using 2-ethylhexanol 

as the test substance have been 

performed via the oral, dermal, and 

inhalation routes of exposure. The 

results of these studies also do not 

indicate any increased susceptibility. A 

safety factor analysis has not been used 

to assess the risk of lactic acid, 2- 

ethylhexyl ester. For the same reasons, 

the additional tenfold safety factor for 

the protection of infants and children is 

unnecessary. 

VIII. Determination of Safety for U.S. 

Population, and Infants and Children 

Based on the available toxicity data 

on lactic acid, 2-ethylhexyl ester and on 

its metabolites lactic acid and 2- 

ethylhexanol, EPA concludes that there 

is a reasonable certainty of no harm 

from aggregate exposure to residues of 

lactic acid, 2-ethylhexyl ester (CAS Reg. 

No. 6283–86–9) and lactic acid, 2- 

ethylhexyl ester, (2S)- (CAS Reg. No. 

186817–80–1). EPA finds that 

establishing exemptions from the 

requirement of a tolerance for lactic 

acid, 2-ethylhexyl ester (CAS Reg. No. 

6283–86–9) and lactic acid, 2-ethylhexyl 

ester, (2S)- (CAS Reg. No. 186817–80–1) 

will be safe for the general population 

including infants and children. 

IX. Other Considerations 

A. Endocrine Disruptors 

FQPA requires EPA to develop a 

screening program to determine whether 

certain substances, including all 

pesticide chemicals (both inert and 

active ingredients), ‘‘may have an effect 

in humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other endocrine 

effect...’’ EPA has been working with 

interested stakeholders to develop a 

screening and testing program as well as 

a priority setting scheme. As the Agency 

proceeds with implementation of this 

program, further testing of products 

containing lactic acid, 2-ethylhexyl ester 

(CAS Reg. No. 6283–86–9) and lactic 

acid, 2-ethylhexyl ester, (2S)- (CAS Reg. 

No. 186817–80–1) for endocrine effects 

may be required. 

B. 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. 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51627 

C. Existing Exemptions 

There are no existing tolerances or 

tolerance exemptions forlactic acid, 2- 

ethylhexyl ester (CAS Reg. No. 6283–

86–9) and lactic acid, 2-ethylhexyl ester, 

(2S)- (CAS Reg. No. 186817–80–1). 

D. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for lactic 

acid, 2-ethylhexyl ester (CAS Reg. No. 

6283–86–9) and lactic acid, 2-ethylhexyl 

ester, (2S)- (CAS Reg. No. 186817–80–1) 

nor have any CODEX Maximum Residue 

Levels been established for any food 

crops at this time. 

E. List 4B Classification 

It has been determined that lactic 

acid, 2-ethylhexyl ester (CAS Reg. No. 

6283–86–9) and lactic acid, 2-ethylhexyl 

ester, (2S)- (CAS Reg. No. 186817–80–1) 

are to be classified as List 4B inert 

ingredients. This classification is due to 

the Toxicity Category II determination 

for the acute eye irritation study and the 

lung irritation effects in the 28–day 

study. Tolerance exemptions for lactic 

acid, 2-ethylhexyl ester (CAS Reg. No. 

6283–86–9) and lactic acid, 2-ethylhexyl 

ester, (2S)- (CAS Reg. No. 186817–80–1) 

are established in 40 CFR 180.910 and 

180.930 instead of 40 CFR 180.950 as 

requested by the petitioner PURAC. 

X. Conclusions 

Accordingly, exemptions from the 

requirement of a tolerance are 

established for lactic acid, 2-ethylhexyl 

ester (CAS Reg. No. 6283–86–9) and 

lactic acid, 2-ethylhexyl ester, (2S)- 

(CAS Reg. No. 186817–80–1). 

XI. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old FFDCA sections 408 

and 409 of the FFDCA. However, the 

period for filing objections is now 60 

days, rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2003–0230 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 October 31, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit XI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2003–0230, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

XII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the tolerance 

requirement under section 408(d) of the 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). This final rule 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA), 44 U.S.C. 3501 et seq., or impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

51628 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

such as the exemption in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. In 

addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications ’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

XIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in theFederal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 23, 2005. 

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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

Lactic acid, 2- 

ethylhexyl 

ester (CAS 

Reg. No. 

6283–86–9).

................ Solvent 

Inert Ingredients Limits Uses 

Lactic acid, 2- 

ethylhexyl 

ester, (2S)- 

(CAS Reg. 

No. 186817–

80–1).

................ Solvent 

* * * * * 

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

Lactic acid, 2- 

ethylhexyl 

ester (CAS 

Reg. No. 

6283–86–9).

................ Solvent 

Lactic acid, 2- 

ethylhexyl 

ester, (2S)- 

(CAS Reg. 

No. 186817–

80–1).

................ Solvent 

* * * * * 

[FR Doc. 05–17360 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2004–0326; FRL–7716–1] 

S-metolachlor; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues (free 

and bound) of S-metolachlor in or on 

certain commodities as set forth in Unit 

II. of the SUPPLEMENTARY INFORMATION. 

The Interregional Research Project 

Number 4 (IR–4), 681 U.S. Highway #1 

South, North Brunswick, NJ 08902–

3390, requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

on behalf of the registrant, Syngenta 

Crop Protection, Swing Road, 

Greensboro, NC 276419. 

DATES: This regulation is effective 

August 31, 2005. Objections and