Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51615 

Commodity Parts per million 

Vegetable, leafy 

except Brassica 

group 4, except 

spinach .............. 4.0 

(2) Tolerances are established for 

combined residues of flonicamid [N- 

(cyanomethyl)-4-(trifluoromethyl)-3- 

pyridinecarboxamide], and its 

metabolites TFNA [4- 

trifluoromethylnicotinic acid], TFNAAM [4-trifluoromethylnicotinamide] in 

or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Cattle, fat .............. 0.02 

Cattle, meat .......... 0.05 

Cattle, meat byproducts ............ 0.08 

Egg ....................... 0.03 

Goat, fat ................ 0.02 

Goat, meat ............ 0.05 

Goat, meat byproducts .................... 0.08 

Horse, fat .............. 0.02 

Horse, meat .......... 0.05 

Horse, meat byproducts ............ 0.08 

Milk ....................... 0.02 

Poultry, fat ............ 0.02 

Poultry, meat ........ 0.02 

Poultry, meat byproducts ............ 0.02 

Sheep, fat ............. 0.02 

Sheep, meat ......... 0.05 

Sheep, meat by 

products ............ 0.08 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 05–17128 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0165; FRL–7719–8] 

Halosulfuron-methyl; Pesticide 

Tolerances for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

halosulfuron-methyl in or on sweet 

potatoes. This action is in response to 

EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on sweet potatoes. 

This regulation establishes a maximum 

permissible level for residues of 

halosulfuron-methyl in this food 

commodity. The tolerance will expire 

and is revoked on December 31, 2008. 

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 VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0165. 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: 

Andrew Ertman, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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 and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a, 

is establishing a tolerance for residues of 

the herbicide halosulfuron-methyl, in or 

on sweet potatoes at 1.0 parts per 

million (ppm). This tolerance will 

expire and is revoked on December 31, 

2008. EPA will publish a document in 

the Federal Register to remove the 

revoked tolerance from the Code of 

Federal Regulations (CFR). 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

tolerances to set binding precedents for 

the application of section 408 of FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

51616 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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. . . .’’

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’

This provision was not amended by the 

Food Quality Protection Act of 1996 

(FQPA). EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Halosulfuron-methyl on Sweet Potatoes 

and FFDCA Tolerances 

Several sweet potato growing States 

requested the use of halosulfuronmethyl due to resistance to pesticides 

registered for the control of the weed 

purple nutsedge in sweet potato fields. 

EPA has authorized under section 18 of 

FIFRA the use of halosulfuron-methyl 

on sweet potatoes for control of purple 

nutsedge in Louisiana, Mississippi, and 

North Carolina. After having reviewed 

the submissions, EPA concurs that 

emergency conditions exist for these 

States. 

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

halosulfuron-methyl in or on sweet 

potatoes. In doing so, EPA considered 

the safety standard in section 408(b)(2) 

of FFDCA, and EPA decided that the 

necessary tolerance under section 

408(l)(6) of FFDCA would be consistent 

with the safety standard and with 

section 18 of FIFRA. Consistent with the 

need to move quickly on the emergency 

exemption in order to address an urgent 

non-routine situation and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this tolerance without 

notice and opportunity for public 

comment as provided in section 

408(l)(6) of FFDCA. Although this 

tolerance will expire and is revoked on 

December 31, 2008, under section 

408(l)(5) of FFDCA, residues of the 

pesticide not in excess of the amounts 

specified in the tolerance remaining in 

or on sweet potatoes after that date will 

not be unlawful, provided the pesticide 

is applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

this tolerance at the time of that 

application. EPA will take action to 

revoke this tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this tolerance is being 

approved under emergency conditions, 

EPA has not made any decisions about 

whether halosulfuron-methyl meets 

EPA’s registration requirements for use 

on sweet potatoes or whether a 

permanent tolerance for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this tolerance serves as a basis for 

registration of halosulfuron-methyl by a 

State for special local needs under 

section 24(c) of FIFRA. Nor does this 

tolerance serve as the basis for any State 

other than Louisiana, Mississippi, and 

North Carolina to use this pesticide on 

this crop under section 18 of FIFRA 

without following all provisions of 

EPA’s regulations implementing section 

18 of FIFRA as identified in 40 CFR part 

166. For additional information 

regarding the emergency exemption for 

halosulfuron-methyl, contact the 

Agency’s Registration Division at the 

address provided under FOR FURTHER

INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7). 

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. EPA has sufficient data to assess 

the hazards of halosulfuron-methyl and 

to make a determination on aggregate 

exposure, consistent with section 

408(b)(2) of FFDCA, for a time-limited 

tolerance for residues of halosulfuronmethyl in or on sweet potatoes at 1.0 

ppm. EPA’s assessment of the dietary 

exposures and risks associated with 

establishing the tolerance follows. 

A. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological 

endpoint. However, the lowest dose at 

which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intra species differences. For 

halosulfuron-methyl, the Agency 

identified the need for a developmental 

neurotoxicity (DNT) study. In the 

absence of a DNT study, EPA concluded 

that an additional database UF of 3X is 

needed for all dietary and residential 

(non-dietary) exposure scenarios until 

the data are received and evaluated. An 

UF of 3X (as opposed to a higher value) 

was viewed to be adequate because the 

NOAEL of 50 mg/kg/day (used for acute 

dietary, short-term incidental oral and 

inhalation risk assessments) and the 

NOAEL of 10 mg/kg/day (used for 

chronic dietary and intermediate-term 

incidental oral, dermal, and inhalation 

risk assessments) are 5X and 25X lower, 

respectively, than the NOAEL of 250 

mg/kg/day in the rat developmental 

study where alterations of the fetal 

nervous system were seen at 750 mg/kg/ 

day (LOAEL). Consequently, based on 

the available data it is unlikely the 

results of the DNT would impact the 

overall risk assessment. 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by the appropriate UF (RfD = NOAEL/ 

UF). Where an additional safety factor is 

retained due to concerns unique to the 

FQPA, this additional factor is applied 

to the RfD by dividing the RfD by such 

additional factor. The acute or chronic 

population adjusted dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of FQPA Safety 

Factor (SF). 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (LOC). 

For example, when 100 is the 

appropriate UF (10X to account for 

interspecies differences and 10X for 

intraspecies differences) the LOC is 100. 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51617 

To estimate risk, a ratio of the NOAEL 

to exposures (margin of exposure (MOE) 

= NOAEL/exposure) is calculated and 

compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk is expressed as 1 x10-6 or one 

in a million). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

derived from the dose response curve. 

To estimate risk, a ratio of the point of 

departure to exposure (MOEcancer = point 

of departure/exposures) is calculated. A 

summary of the toxicological endpoints 

for halosulfuron-methyl used for human 

risk assessment is shown in Table 1 of 

this unit: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HALOSULFURON-METHYL FOR USE IN HUMAN RISK

ASSESSMENT

Exposure scenario 

Dose 

milligram/kilogram/day 

(mg/kg/day) 

UF/MOE 

Hazard based special 

FQPA SF Endpoint for risk assessment 

Dietary risk assessments 

Acute dietary 

Females 13–50 years of age 

NOAEL = 50 UF = 

300a

Acute RfD = 0.17 mg/ 

kg/day 

1x Developmental toxicity—rabbit 

LOAEL = 150 mg/kg/day based on decreased mean litter size, increased number of resorptions (total and per dam) and 

increased post-implantation loss. (developmental toxicity). 

Chronic dietary 

All populations 

NOAEL = 10 UF = 

300a

Chronic RfD = 0.03 

mg/kg/day 

1x Chronic toxicity—dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gains in females. 

Incidental oral 

Short-term (1–30 days) 

Residential only 

NOAEL = 50 

MOE = 300 

1x Developmental toxicity—rabbit 

LOAEL = 150 mg/kg/day based on decreased body weight gain, food consumption, and food efficiency. (maternal toxicity). 

Incidental oral 

Intermediate-term (1–6 months) 

Residential only 

NOAEL = 10 

MOE = 300 

1x 13 Week Subchronic toxicity—dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gain and food efficiency in females. 

Non-dietary risk assessments 

Dermal 

Short-term (1–30 days) 

Dermal NOAEL = 100 21–Day dermal toxicity study—rat 

LOAEL = 1,000 mg/kg/day based on decreased body weight gain in males. 

Residential MOE = 300 

Dermalb

Intermediate-term (1–6 months) 

Oral NOAEL = 10 13 Week subchronic toxicity—dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gain and food efficiency in females. 

Residential MOE = 300 1x 

Dermalb

Long-term (> 6 months) 

Residential 

Oral NOAEL = 10 

MOE = 300 

1x Chronic toxicity—dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gains in females. 

Inhalationc

Intermediate-term (1–6 months) 

Residential 

Oral NOAEL = 10 

MOE = 300 

1x 13 Week subchronic toxicity—dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gain and food efficiency in females. 

Inhalationc

Long-term (> 6 months) 

Residential 

Oral NOAEL = 10 

MOE = 300 

1x Chronic toxicity—dog 

LOAEL = 40 mg/kg/day based on decreased 

body weight gains in females. 

51618 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HALOSULFURON-METHYL FOR USE IN HUMAN RISK

ASSESSMENT—Continued 

Exposure scenario 

Dose 

milligram/kilogram/day 

(mg/kg/day) 

UF/MOE 

Hazard based special 

FQPA SF Endpoint for risk assessment 

Cancer Classification: ‘‘not likely to be carcinogenic to humans’’ by the oral route, based on no evidence from studies in rats and mice. 

a UFDB = 300 (10x for inter-species extrapolation and 10 x for intra-species variability, 3x for lack of DNT). bA 75% dermal absorption factor should be used in route-to-route extrapolation. 

cAbsorption via the inhalation route is presumed to be equivalent to oral absorption. 

B. Exposure Assessment 

1. Dietary exposure from food, feed 

uses, and drinking water. Tolerances 

have been previously established (40 

CFR 180.479) for the residues of 

halosulfuron-methyl, in or on a variety 

of raw agricultural commodities. The 

established tolerances include almond 

hulls; corn (sweet, kernel+cob with 

husks removed, field grain, fodder, 

forage, pop); cotton (gin by-products 

and undelinted seed); pistachio 

nutmeat; sugarcane; rice (grain, straw); 

and tree nuts (crop group 14). 

Additionally, tolerances are established 

(40 CFR 180.479 (a)(1)) for residues of 

halosulfuron-methyl and its metabolites 

determined as 3-chloro-1-methyl-5- 

sulfamoylpyrazole-4-carboxylic acid 

(also referred to as CSA, expressed as 

parent equivalents) at 0.1 ppm in or on 

meat by-products of cattle, goats, hogs, 

horses, and sheep. 

In conducting the acute and chronic 

dietary risk assessments, EPA used the 

Dietary Exposure Evaluation Model 

(DEEMTM) software. Modeled estimates 

of drinking water concentrations were 

directly entered into the exposure 

model to assess the contribution from 

drinking water. Risk assessments were 

conducted by EPA to assess dietary 

exposures from halosulfuron-methyl in 

food as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a one 

day or single exposure. The DEEMTM

analysis evaluated the individual food 

consumption as reported by 

respondents in the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII) and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the acute 

exposure assessments: Tolerance level 

residues and 100 percent crop treated 

(PCT) for all commodities for which 

halosulfuron-methyl tolerances are 

established and for the crop. Aggregate 

acute food and water exposure was 

determined by including modeled 

estimates of drinking water 

concentrations in the dietary model. 

The Agency used the acute water 

concentration (105 parts per billion 

(ppb)) derived from surface water 

modeling results, which was 

significantly higher than the modeled 

ground water concentration, and 

therefore protective of potential 

exposures via ground water sources of 

drinking water. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

DEEMTM analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996 and 1998 nationwide CSFII 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the acute exposure assessments: 

tolerance level residues and 100 PCT for 

all commodities for which halosulfuronmethyl tolerances are established and 

for sweet potatoes. Aggregate chronic 

food and water exposure was 

determined by including modeled 

estimates of drinking water 

concentrations in the dietary model. 

The Agency used the chronic water 

concentration (105 ppb) derived from 

surface water modeling results, which 

was significantly higher than the 

modeled ground water concentration, 

and therefore protective of potential 

exposures via ground water sources of 

drinking water. 

iii. Cancer. Halosulfuron-methyl is 

classified as a ‘‘Not Likely’’ human 

carcinogen. Therefore, risk assessments 

to assess cancer risk were not 

conducted. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

halosulfuron-methyl in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

halosulfuron-methyl. 

The Agency uses the First Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone/Exposure Analysis 

Modeling System (PRZM/EXAMS) to 

produce estimates of pesticide 

concentrations in an index reservoir. 

The Screening Concentration in Ground 

Water Modeling System (SCI-GROW) 

model is used to predict pesticide 

concentrations in shallow ground water. 

For a screening-level assessment for 

surface water EPA will generally use 

FIRST (a tier 1 model) before using 

PRZM/EXAMS (a tier 2 model). The 

FIRST model is a subset of the PRZM/ 

EXAMS model that uses a specific highend runoff scenario for pesticides. 

While both FIRST and PRZM/EXAMS 

incorporate an index reservoir 

environment, the PRZM/EXAMS model 

includes a percent crop area factor as an 

adjustment to account for the maximum 

percent crop coverage within a 

watershed or drainage basin. 

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. 

Based on the FIRST and SCI-GROW 

models the estimated environmental 

concentrations (EECs) of halosulfuronmethyl for acute exposures are 

estimated to be 105 ppb for surface 

water and 0.065 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 105 ppb for surface 

water and 0.065 ppb for ground water. 

3. From non-dietary 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). 

Halosulfuron-methyl is currently 

registered for use on the following 

residential non-dietary sites: Residential 

turfgrass and landscaped areas. 

The short-term aggregate risk 

assessment estimates risks likely to 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51619 

result from 1– to 30–day exposure to 

halosulfuron-methyl residues. A shortterm risk assessment is required for 

adults because there are both residential 

handler and post-application exposure 

scenarios. In addition, a short-term risk 

assessment is required for infants and 

children because there is a residential 

post-application exposure scenario. 

Since the same effect was identified as 

the endpoint across all routes of 

exposure (decreased body-weight gain), 

MOEs are combined to result in an 

aggregate MOE (using the ‘‘1/MOE 

Approach’’). The Agency’s level of 

concern for short-term exposure is an 

MOE of 300 or lower. Results from the 

short-term risk assessment indicate that 

all short-term aggregate MOEs are 3,100 

or higher. Therefore, estimated aggregate 

(food + water + residential) exposure to 

halosulfuron-methyl are not of concern 

for short-term aggregate exposure. 

The intermediate-term aggregate risk 

assessment estimates risks likely to 

result from 1 to 6 months of exposure 

to halosulfuron-methyl residues from 

food, drinking water, and residential 

pesticide uses. An intermediate-term 

risk assessment is not required for 

adults because residential handler 

scenarios are not expected to occur for 

longer than a short-term time frame. 

However, an intermediate-term risk 

assessment is required for infants and 

children because there is a residential 

post-application oral exposure scenario. 

Since the same effect was identified as 

the endpoint across all routes of 

exposure (decreased body weight gain), 

MOEs are combined to result in an 

aggregate MOE (using the ‘‘1/MOE 

Approach’’). High-end estimates of 

residential exposure are used in the 

intermediate-term assessment, while 

average values are used for food and 

drinking water exposure. The Agency’s 

level of concern for intermediate-term 

exposure is an MOE of 300 or lower. 

Results from the intermediate-term risk 

assessment indicate that the 

intermediate-term aggregate MOE is 819 

for the most highly exposed child 

subgroup. Therefore, estimated 

aggregate (food + water + residential) 

exposure to halosulfuron-methyl are not 

of concern for intermediate-term 

aggregate exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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 

halosulfuron-methyl and any other 

substances and halosulfuron-methyl 

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 halosulfuron-methyl 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 OPP 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/. 

C. Safety Factor for Infants and Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for pre-natal 

and post-natal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

that a different margin of safety will be 

safe for infants and children. Margins of 

safety are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using UFs 

in calculating a dose level that poses no 

appreciable risk to humans. 

2. Conclusion. The Agency concludes 

that no special FQPA SF is necessary to 

protect the safety of infants and children 

in assessing halosulfuron-methyl 

exposure and risks because: 

i. There is no evidence of increased 

susceptibility of young rats in the 

reproduction study with halosulfuronmethyl. Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental studies in 

rats and rabbits the Agency is regulating 

at the NOAEL of 50 mg/kg/day for acute 

dietary, short-term incidental oral and 

inhalation risk assessments and the 

NOAEL of 10 mg/kg/day for chronic 

dietary and intermediate-term 

incidental oral, dermal, and inhalation 

risk assessments. These endpoints are 

5X and 25X lower, respectively, than 

the NOAEL of 250 mg/kg/day in the rat 

developmental study where alterations 

of the fetal nervous system were seen at 

750 mg/kg/day (LOAEL). 

ii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

may be refined using anticipated 

residues calculated from field trial data 

with any PCT information. Conservative 

ground and surface water modeling 

estimates have been used. The Agency’s 

residential standard operating 

procedures (SOPs) are used to assess 

post-application exposure to children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by halosulfuron-methyl. 

However, a 3X additional database UF 

will be used to address the data 

deficiency for the developmental 

neurotoxicity study. The 3X safety 

factor should be applied to all dietary 

and residential non-dietary exposure 

scenarios. No FQPA SF is appropriate 

for halosulfuron-methyl. 

D. Aggregate Risks and Determination of 

Safety 

The Agency currently has two ways to 

estimate total aggregate exposure to a 

pesticide from food, drinking water, and 

residential uses. First, a screening 

assessment can be used, in which the 

Agency calculates drinking water levels 

of comparison (DWLOCs) which are 

used as a point of comparison against 

EECs. The DWLOC values are not 

regulatory standards for drinking water, 

but are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure). This 

allowable exposure through drinking 

water is used to calculate a DWLOC. 

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/ 

70 kg (adult male), 2 L/60 kg (adult 

female), and 1 L/10 kg (child). Different 

populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

51620 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. When new uses are added OPP 

reassesses the potential impacts of 

residues of the pesticide in drinking 

water as a part of the aggregate risk 

assessment process. 

More recently the Agency has used 

another approach to estimate aggregate 

exposure through food, residential, and 

drinking water pathways. In this 

approach, modeled surface and ground 

water EECs are directly incorporated 

into the dietary exposure analysis, along 

with food. This provides a more realistic 

estimate of exposure because actual 

body weights and water consumption 

from the CSFII are used. The combined 

food and water exposures are then 

added to estimated exposure from 

residential sources to calculate aggregate 

risks. The resulting exposure and risk 

estimates are still considered to be high 

end, due to the assumptions used in 

developing drinking water modeling 

inputs. This risk assessment for 

halosulfuron-methyl was conducted 

using this approach. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

halosulfuron-methyl will occupy 14% 

for females 13–50 years of age, the 

population subgroup of concern. EPA 

does not expect the aggregate exposure 

to exceed 100% of the aPAD, as shown 

in Table 2 of this unit: 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO HALOSULFURON-METHYL

Population subgroup aPAD 

(mg/kg) 

% aPAD 

(Food and Water) 

Females 13 years and older 0.17 14% 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to halosulfuron-methyl 

from food and water will utilize 2% or 

less of the cPAD for all population 

subgroups in DEEMTM including the 

U.S. population, infants and children. 

There are no residential uses for 

halosulfuron-methyl that result in 

chronic residential exposure to 

halosulfuron-methyl. Based on the use 

pattern, chronic residential exposure to 

residues of halosulfuron-methyl is not 

expected. EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 3 of this 

unit: 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO HALOSULFURON-METHYL

Population subgroup cPAD 

mg/kg/day 

% cPAD 

(Food and Water) 

U.S. population 0.03 1% 

All Infants (< 1 year) 0.03 1% 

Children 1–2 years old 0.03 2% 

Children 3–5 years old 0.03 2% 

Children 6–12 years old 0.03 1% 

All other population subgroups 0.03 <1% 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Halosulfuron-methyl is currently 

registered for use(s) that could result in 

short-term residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic food 

and water and short-term exposures for 

halosulfuron-methyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water and residential exposures 

aggregated result in aggregate MOEs of 

5,800 for the general U.S. population 

and 3,200 for children 3–5 years old for 

dermal, incidental oral, and inhalation 

exposures. These aggregate MOEs do not 

exceed the Agency’s level of concern for 

aggregate exposure to food and 

residential uses. EPA does not expect 

short-term aggregate exposure to exceed 

the Agency’s level of concern, as shown 

in Table 4 of this unit: 

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO HALOSULFURON-METHYL

Population subgroup Aggregate MOE 

(Food + Water + Residential) 

Aggregate Level of Concern 

(LOC) 

U.S. population 5,800 300 

Children 3–5 years 3,200 300 

Adults 20–50 years 5,900 300 

Females 13–49 years 5,800 300 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51621 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account non-dietary, nonoccupational exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Halosulfuron-methyl is currently 

registered for use(s) that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for halosulfuron-methyl. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

food, water and residential exposures 

aggregated result in an aggregate MOE of 

819 for infants and children (the 

population subgroup of concern). This 

aggregate MOE does not exceed the 

Agency’s level of concern for aggregate 

exposure to food, water and residential 

uses. EPA does not expect intermediateterm aggregate exposure to exceed the 

Agency’s level of concern, as shown in 

Table 5 of this unit: 

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO HALOSULFURON-METHYL

Population subgroup Aggregate MOE 

(Food + Water + Residential) 

Aggregate Level of Concern 

(LOC) 

Children 3–5 years 819 300 

5. Aggregate cancer risk for U.S. 

population. Halosulfuron-methyl is 

classified as a ‘‘Not Likely’’ human 

carcinogen. Therefore, risk assessments 

to assess cancer risk were not 

conducted. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

halosulfuron-methyl residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(example—gas chromatography) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There is neither a Codex proposal, nor 

Canadian or Mexican maximum residue 

limits, for residues of halosulfuronmethyl in or on sweet potatoes. 

Therefore, harmonization is not an 

issue. 

VI. Conclusion 

Therefore, the tolerance is established 

for residues of halosulfuron-methyl, 

methyl 5-[(4,6-dimethoxy-2- 

pyrimidinyl)amino]

carbonylaminosulfonyl-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, in or 

on sweet potato at 1.0 ppm. 

VII. Objections and Hearing Requests 

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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of 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 FFDCA, as was 

provided in the old sections 408 and 

409 of 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–2005–0165 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 issues(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 VII.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 the docket ID 

number OPP–2005–0165, 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 e-mail 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. 

51622 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VIII. Statutory and Executive Order 

Reviews 

This final rule establishes a timelimited tolerance under section 408 of 

FFDCA. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

tolerances and exemptions that are 

established on the basis of a FIFRA 

section 18 exemption under section 408 

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. 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. 

IX. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

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

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 19, 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. Section 180.479 is amended by 

revising the introductory text of 

paragraph (a)(1) and by adding text to 

paragraph (b) to read as follows: 

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a) * * * (1) Tolerances are 

established for residues of the herbicide 

halosulfuron-methyl, methyl 5-[(4,6- 

dimethoxy-2-pyrimidinyl) 

amino]carbonylaminosulfonyl-3-chloro1-methyl-1H-pyrazole-4-carboxylate, in 

or on the raw agricultural commodities 

listed in the table in this unit. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of halosulfuron methyl, 

methyl 5-[(4,6-dimethoxy-2- 

pyrimidinyl)amino]

carbonylaminosulfonyl-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, in 

connection with use of the pesticide 

under FIFRA section 18 emergency 

exemptions granted by EPA in or on the 

following commodity: 

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