Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53725 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 4, 2008. 

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 180.940 is amended by 

alphabetically adding entries to the 

table in paragraph (a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

(a) * * * 

Pesticide Chemical CAS Reg. No. Limits 

* * * * * * * 

Amylopectin, acid-hydrolyzed, 1-oxtenylbutanedioate ............................................................ 113894–85–2 none

Amylopectin, hydrogen 1-octadecenylbutanedioate ................................................................ 125109–81–1 none

* * * * * * * 

* * * * * 

■ 3. Section 180.950 is amended by 

alphabetically adding entries to the 

table in paragraph (e) to read as follows: 

§ 180.950 Tolerance exemptions for 

minimal risk active and inert ingredients. 

* * * * * 

(e) * * * 

Chemical CAS No. 

* * * * * 

Amylopectin, acidhydrolyzed, 1- 

octenylbutanedioate .... 113894–85–2 

Amylopectin, hydrogen 1- 

octadecenylbutanedioate ............................... 125109–81–1 

* * * * * 

[FR Doc. E8–21737 Filed 9–16–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0894; FRL–8382–6] 

Ethoprop; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of ethoprop in or 

on hop, dried cones; peppermint, tops; 

and spearmint, tops. Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 17, 2008. Objections and 

requests for hearings must be received 

on or before November 17, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0894. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 those engaged in the 

following activities: 

• 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 to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

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53726 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

identify docket ID number EPA–HQ– 

OPP–2007–0894 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 

as required by 40 CFR part 178 on or 

before November 17, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2007–0894, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of September 

28, 2007 (72 FR 55204) (FRL–8147–1), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 5E4491 and PP 

7E7247) by Interregional Research 

Project Number 4 (IR-4), 500 College 

Road East, Suite 201, Princeton, NJ 

08540. The petitions requested that 40 

CFR 180.262 be amended by 

establishing tolerances for residues of 

the insecticide and nematicide, 

ethoprop, O-ethyl S,S-dipropyl 

phosphorodithioate, in or on hop, dried 

cone (PP7E7247) and mint, hay (PP 

5E4491) at 0.02 parts per million (ppm). 

That notice referenced a summary of the 

petitions prepared by Bayer 

CropScience, the registrant, on behalf of 

IR-4, which is available to the public in 

the docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

IR-4 proposed a tolerance on the 

commodity ‘‘mint, hay’’ at 0.02 ppm. 

EPA has determined that separate 

tolerances at 0.02 ppm should be 

established on the commodities 

‘‘spearmint, tops’’ and ‘‘peppermint, 

tops’’ instead of the single tolerance on 

‘‘mint, hay’’ to agree with the preferred 

commodity terms in the Agency’s Food 

and Feed Commodity Vocabulary. EPA 

has also modified the commodity term 

‘‘hop, dried cone’’ slightly to read ‘‘hop, 

dried cones’’ to agree with the Food and 

Feed Commodity Vocabulary. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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.’’ 

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....’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of ethoprop on 

hop, dried cones; peppermint, tops; and 

spearmint, tops at 0.02 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies 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 toxic mode of action of ethoprop 

in insects and humans is by 

phosphorylation of the 

acetylcholinesterase (referred to as 

cholinesterase or ChE in this document) 

enzyme in the brain and peripheral 

nervous systems. The resulting enzyme 

inhibition causes accumulation of the 

neurotransmitter, acetylcholine, and 

resulting signs of neurotoxicity. 

Ethoprop is acutely toxic by both oral 

and dermal routes. In the longer term 

studies, the most sensitive indication of 

toxicity was inhibition of brain and red 

blood cell (RBC) ChE. Signs of 

neurotoxicity related to inhibition of 

ChE by ethoprop include tremors, 

ataxia, muscle fasiculations, 

lacrimation, salivation, rapid/shallow 

respiration, repetitive chewing 

movements, nasal and perianal stains, 

vocalization, aggressive behavior, 

decreased grip strength, and decreased 

motor activity. A slight anemia and liver 

toxicity (elevated liver enzymes and 

microscopic liver lesions) were also 

noted in dog studies. 

Ethoprop is classified ‘‘likely to be 

carcinogenic to humans’’ based on 

malignant adrenal pheochromocytomas 

in male rats and is regulated by EPA 

using the linear low dose extrapolation 

approach with a potency factor (Q1*) of 

2.81 x 10-2 milligrams/kilogram/day 

(mg/kg/day)-1. 

No developmental toxicity was noted 

in rat and rabbit developmental studies. 

In the rat developmental toxicity study, 

maternal toxicity included decreased 

body weight gain and increased 

incidence of soft stool, the latter effect 

attributed to ChE inhibition. No 

maternal toxicity occurred in the rabbit 

developmental study. Despite the 

absence of toxicity in this study, dosing 

was considered adequate, since the 

highest dose was close to the lethal dose 

determined in the range-finding 

developmental rabbit study. Ethoprop 

did not affect reproductive parameters 

in the 2-generation reproduction 

toxicity study in rats. Pup mortality in 

this study occurred at a high dietary 

concentration and was accompanied by 

significant maternal toxicity (clinical 

signs of tremors and loose stool and 

brain ChE inhibition). 

In the developmental neurotoxicity 

(DNT) study, an effect on learning in the 

water maze test was noted in high-dose 

males. Motor activity in all male 

treatment groups was increased on 

postnatal day 17 due to a lack of 

habituation (i.e., there was little or no 

decrease in activity over the course of 

the test session). There was no 

indication of increased fetal or offspring 

sensitivity to ChE inhibition in this 

study. 

The relative sensitivities of adult rats 

and 11–day old rat pups to ChE 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53727 

inhibition were compared in acute and 

11–day comparative cholinesterase 

studies. Pups were 8 times as sensitive 

as adults for brain ChE inhibition in the 

acute study and were 12 times as 

sensitive as adults in the 11–day study. 

Pup sensitivity is believed to be due to 

their immature metabolic capacity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ethoprop, as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies, can be found at http:// 

www.regulations.gov in the document 

Ethoprop Human Health Risk 

Assessment of New Uses on Hops and 

Mint at page 47 in docket ID number 

EPA–HQ–OPP–2007–0894. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for ethoprop used for human 

risk assessment can be found at http:// 

www.regulations.gov in the document 

Ethoprop Human Health Risk 

Assessment of New Uses on Hops and 

Mint at page 20 in docket ID number 

EPA–HQ–OPP–2007–0894. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to ethoprop, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

ethoprop tolerances in 40 CFR 180.262, 

except peanuts. Although tolerances for 

peanuts and peanut hay have been 

established, there have been no active 

registrations for use of ethoprop on 

peanuts since April, 2002, and the 

Agency proposed to revoke the peanut 

tolerances in the Federal Register of 

June 4, 2008 (73 FR 31788) (FRL–8363– 

9). For these reasons, peanuts were not 

considered in the dietary assessment. 

The residues of concern for acute and 

chronic dietary risk assessment include 

parent ethoprop and the metabolites SME, O-ethyl-S-methyl-Spropylphosphorodithioate, and O-ME, 

O-ethyl-O-methyl-Spropylphosphorothioate. For cancer 

dietary risk, the residues of concern are 

parent and the metabolites S-ME-, O-ME 

and M-1, O-ethyl-S-propyl 

phosphorodithioate. Since the available 

field trial and monitoring data do not 

include information on the metabolites, 

metabolite ratios derived from 

metabolism and rotational crop studies 

were used to estimate metabolite levels 

in ethoprop-treated commodities. 

Further information on the development 

of the metabolite ratios can be found at 

http://www.regulations.gov in the 

document Ethoprop. Anticipated 

Residues to Support New Uses on Hops 

and Mint in docket ID number EPA– 

HQ–OPP–2007–0894. EPA assessed 

dietary exposures from the combined 

residues of ethoprop and its metabolites 

of concern in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA relied on anticipated 

residues derived from field trials or 

monitoring data from USDA’s Pesticide 

Data Program (PDP) for most 

commodities. PDP data were used to 

develop anticipated residues for 

bananas, snap beans (fresh and canned), 

corn syrup, cucumber, pineapple, potato 

and sweet potato. Field trial data were 

used for field corn, sweet corn, 

sugarcane and cabbage. EPA assumed 

tolerance-level residues for lima beans 

and the new commodities, hops and 

mint. Acute dietary exposure estimates 

were further refined using maximum 

percent crop treated (PCT) estimates for 

snap beans, cabbage, sweet corn, field 

corn, cucumber, potatoes, sugarcane and 

sweet potato. EPA assumed 100 PCT for 

bananas, lima beans, pineapple, hops 

and mint. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

relied on anticipated residues derived 

from field trials or PDP monitoring data 

for the same commodities specified 

above under ‘‘Acute exposure.’’ Again, 

EPA assumed tolerance-level residues 

for lima beans, hops and mint. Chronic 

dietary exposure estimates were further 

refined using average percent crop 

treated (PCT) estimates for snap beans, 

cabbage, sweet corn, field corn, 

cucumber, potatoes, sugarcane and 

sweet potato. EPA assumed 100 PCT for 

bananas, lima beans, pineapple, hops 

and mint. 

iii. Cancer. Cancer risk was assessed 

using the linear low dose extrapolation 

approach with a potency factor (Q1*) of 

2.81 x 10-2 (mg/kg/day)-1 . In conducting 

the cancer dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII and the same field trial/PDP 

monitoring data and PCT data used in 

the chronic assessment. Different 

metabolite ratios were used, since the 

metabolites of concern for cancer risk 

differ from the metabolites of concern 

for chronic risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

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53728 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency used PCT information as 

follows: 

Acute dietary exposure assessment: 

Snap beans 5%; cabbage 5%; sweet corn 

5%; field corn 2.5%; cucumber 5%; 

potatoes 5%; sugarcane 5%; and sweet 

potato 15%. 

Chronic and cancer dietary exposure 

assessments: Snap beans 5%; cabbage 

5%; sweet corn 1%; field corn 1%; 

cucumber 1%; potatoes 5%; sugarcane 

5%; and sweet potato 15%. 

In most cases, EPA uses available data 

from the United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which ethoprop may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. Concerns about the potential for 

ethoprop or its metabolites to reach 

water used for drinking water at levels 

of concern were identified in the 

‘‘Interim Reregistration Eligibility 

Decision for Ethoprop’’, published in 

September, 2001 and available on the 

Office of Pesticide Programs’ web site at 

http://www.epa.gov/pesticides/ 

reregistration/status.htm. EPA’s 

concerns were based on screening 

drinking water assessments conducted 

using the Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, which indicated 

potential drinking water concentrations 

above EPA’s levels of concern for acute 

and cancer exposures. As a result of 

these concerns, the registrant was 

required by the Agency to conduct 

targeted monitoring surveys of 

presumed high vulnerability community 

water supplies to determine 

concentrations of ethoprop that may 

occur in ground water and surface 

water. The monitoring data required by 

EPA have been submitted and reviewed 

and demonstrate considerably lower 

water concentrations of ethoprop than 

the modeled values (by more than 2 

orders of magnitude). Although the 

monitoring surveys do not reflect the 

new uses on hops and mint, EPA does 

not expect the new uses to contribute 

substantially to high-end ethoprop 

drinking water exposure, since both of 

the proposed use sites are of minor 

acreage, and the production regions do 

not correspond to the areas that were 

found to be at greatest risk for drinking 

water exposure. Therefore, EPA believes 

the monitoring survey results represent 

reasonable estimates of ethoprop 

residues likely to occur in drinking 

water from all existing and new uses. 

Although the highest measured values 

from the monitoring surveys do not 

represent the peak concentrations that 

could occur in drinking water, the 

theoretical peak is highly likely to be 

much closer to the monitoring values 

than the modeled values, in part 

because the usage intensity (i.e., pounds 

active ingredient per acre) assumed by 

the model is 250 to 500 times the 

highest actual watershed-wide usage 

intensity estimated in the monitoring 

study; and sales data recently submitted 

by the registrant show that ethoprop 

usage has gradually declined 

nationwide since the drinking water 

study was completed. Therefore, the 

Agency relied on the monitoring survey 

data in assessing drinking water 

exposures to ethoprop and its 

degradates of concern as described 

below. 

The sum of the highest concentrations 

of ethoprop and its drinking water 

degradates of concern (S-ME; O-ME; OHE, O-ethyl-S-propylphosphorothioate; 

and SSDP, S,Sdipropylphosphorodithioate) measured 

in the targeted monitoring surveys was 

0.231 parts per billion (ppb). This water 

concentration value was directly 

entered into the dietary exposure model 

and used to assess acute, chronic and 

cancer drinking water exposures to 

ethoprop. Recognizing that this value 

does not represent the theoretical peak 

ethoprop drinking water concentration, 

EPA conducted additional acute, 

chronic and cancer dietary analyses 

using a drinking water concentration of 

0.52 ppb, equivalent to more than 2x the 

highest measured monitoring value. For 

the drinking water exposure scenarios of 

greatest concern (acute and cancer), EPA 

also conducted analyses using the 

highest drinking water concentration 

that would result in aggregate risks 

below the level of concern: 15 ppb (65x 

the highest monitoring value) for the 

acute assessment and 5 ppb (22x the 

highest monitoring value) for the cancer 

assessment. 

EPA notes that the highest measured 

concentrations of ethoprop used in the 

dietary assessment occurred in raw 

water and, therefore, do not account for 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53729 

any mitigation of exposure that might 

occur as a result of water treatment. The 

registrant did analyze finished water on 

dates for which raw water bore 

detectable residues, and the 

concentrations in finished water were 

generally lower than those in raw water 

samples taken on the same day. 

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). 

Ethoprop is not registered for any 

specific use patterns that would result 

in residential 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.’’ The reason for 

consideration of other substances is due 

to the possibility that low-level 

exposures to multiple chemical 

substances that cause a common toxic 

effect by a common mechanism could 

lead to the same adverse health effect as 

would a higher level of exposure to any 

of the substances individually. A person 

exposed to a pesticide at a level that is 

considered safe may, in fact, experience 

harm if that person is also exposed to 

other substances that cause a common 

toxic effect by a mechanism common 

with that of the subject pesticide, even 

if the individual exposure levels to the 

other substances are also considered 

safe. 

The organophosphate pesticides (OPs) 

were established as the first common 

mechanism group by EPA in 1999, 

based on their shared ability to bind to 

and phosphorylate the enzyme 

acetylcholinesterase in both the central 

(brain) and peripheral nervous systems. 

Ethoprop is an OP pesticide. In 

December 2001, the Agency issued the 

‘‘Preliminary OP Cumulative Risk 

Assessment’’, available at http:// 

www.epa.gov/pesticides/cumulative/ 

pra_op_methods.htm. In June 2002, the 

Agency released its Revised OP CRA, 

available at http://www.epa.gov/ 

pesticides/cumulative/rra-op/, which 

included the cumulative risk due to the 

OPs from exposures in food, drinking 

water and residential uses. In August 

2006, the Agency issued an update to 

the 2002 Revised OP CRA document, 

which emphasized changes, 

modifications and amendments. With 

the 2006 update, available at http:// 

www.epa.gov/pesticides/cumulative/ 

2006-op/index.htm, the Agency has 

developed a highly refined and complex 

cumulative risk assessment for the OPs 

that represents the state of the science 

regarding existing hazard and exposure 

data and the models and approaches 

used. Based upon the results from the 

2006 update, the Agency concluded that 

the results of the OP cumulative risk 

assessment support a reasonable 

certainty of no harm finding. 

In both the 2002 revised OP CRA, as 

well as the 2006 update, the cumulative 

dietary risk associated with the use of 

OP pesticides on food crops was 

assessed using residue monitoring data 

collected by the USDA Pesticide Data 

Program (PDP) and dietary consumption 

data collected by USDA’s CSFII. Both 

assessments relied primarily on the PDP 

for residue data; the 2006 update added 

PDP data collected in 2002–2004 to the 

1994–2001 data used in the 2002 

Revised Assessment. The PDP has been 

collecting pesticide residue data since 

1991, primarily for purposes of 

estimating dietary exposure. The 

program focuses on high-consumption 

foods for children and reflects foods 

typically available throughout the year. 

A complete description of the PDP and 

all data through 2004 are available 

online at http://www.ams.usda.gov/ 

science/pdp. No PDP data on mint or 

hops currently exist that could have 

been used in a cumulative assessment. 

OP residues in hops and mint were not 

included in the PDP database, in part 

because hops and mint are lowconsumption foods. A quantitative 

estimate of mint consumption over a 

single day was obtained for the general 

U.S. population and subpopulations 

using the Dietary Exposure Evaluation 

Model (DEEM-FCID(TM)

, Version 2.03), 

which uses food consumption data from 

the USDA’s CSFII from 1994–1996 and 

1998. The maximum consumption 

estimate at the 99.9th percentile of 

exposure for all populations is less than 

0.1 grams mint/day. Hops are used 

when brewing beer, and there can be 

relatively high consumption of beer in 

some population groups. However, the 

relative amount of hops used in brewing 

beer, on a weight basis, is low, so hops 

consumption is low as well. 

EPA does not believe that inclusion of 

ethoprop residues in hops and mint in 

the OP CRA will significantly modify 

the calculated risk. First, hops and mint 

are low consumption foods, and, thus, 

even if hops and mint contained 

quantifiable levels of OPs, it would be 

unlikely to significantly alter the OP 

CRA. Secondly, residues of ethoprop in 

hops and mint are non-detectable at the 

label application rate, based on 

controlled crop field trials. Also, there 

is virtually no difference in ethoprop 

exposure when hops and mint are 

excluded from the dietary exposure 

assessment. If ethoprop exposure from 

hops and mint is insignificant in 

comparison to exposure to ethoprop 

from other uses of the chemical, it 

necessarily is insignificant in 

comparison to exposure to the more 

than 30 other OPs. For these reasons, 

EPA concludes that the establishment of 

ethoprop hops and mint tolerances will 

not raise a concern regarding 

cumulative OP exposure. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The following acceptable studies are 

available for assessing potential 

sensitivity of infants and children to 

ethoprop: Rat and rabbit developmental 

toxicity studies, a DNT study in rats, a 

2-generation reproduction toxicity study 

in rats, acute and subchronic 

neurotoxicity studies, an acute 

comparative cholinesterase study in 

adult and rat pups, and an 11–day 

comparative cholinesterase study in 

adult and rat pups. There was no 

evidence of increased quantitative or 

qualitative susceptibility to ethoprop of 

in utero rats or rabbits in the 

developmental toxicity studies and no 

evidence of increased susceptibility of 

fetuses or offspring in the DNT study. In 

the DNT study the NOAEL for brain ChE 

activity in pups was the same as for 

adults and the NOAEL for RBC ChE 

activity was greater in pups than for 

adults. Fetuses were less sensitive to 

ChE inibition by ethoprop than were the 

adults. 

Pup mortality in the 2-generation 

reproduction study occurred at a high 

dietary concentration and was 

accompanied by significant maternal 

toxicity (clinical signs of tremors and 

loose stool and brain ChE inhibition). 

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The NOAEL for pup mortality was 13 

mg/kg/day. Because the POD for chronic 

dietary exposure (0.14 mg/kg/day) is 

much lower than the NOAEL for pup 

mortality and is protective of this 

endpoint, there are no residual concerns 

for sensitivity to infants and children 

from this study. 

In the acute comparative 

cholinesterase study, pups were eight 

times as sensitive as adults for brain 

ChE inhibition. This study was used to 

select a POD for acute dietary 

assessment. Because the POD is 

protective of the population of concern, 

there are no residual concerns from this 

study. 

In the 11–day comparative 

cholinesterase study, pups were 12 

times as sensitive as adults for brain 

ChE inhibition. This study was used to 

select a POD for chronic dietary 

assessment. Because the POD is 

protective of the population of concern, 

there are no residual concerns from this 

study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for ethoprop 

is complete, except for immunotoxicity 

studies. EPA began requiring functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Since this requirement went 

into effect well after the tolerance 

petitions were submitted, these studies 

are not yet available for ethoprop. In the 

absence of specific immunotoxicity 

studies, EPA has evaluated the available 

ethoprop toxicity data to determine 

whether an additional database 

uncertainty factor is needed to account 

for potential immunotoxicity. Ethoprop 

does not belong to a class of chemicals 

that would be expected to be 

immunotoxic; however, there was some 

indication of possible immunotoxicity 

in the form of decreased white blood 

cell counts in high-dose males (4 mg/kg/ 

day) in the mouse carcinogenicity study. 

Since the dose at which this effect was 

seen is nearly 30 times higher than the 

BMDL10 of 0.14 mg/kg/day already 

established for ethoprop, and since 

there was no other evidence of 

immunotoxicity in the ethoprop toxicity 

studies, EPA does not believe that 

conducting immunotoxicity testing will 

result in a lower POD for ethoprop, and 

an additional database uncertainty 

factor for ethoprop is not needed to 

account for potential immunotoxicity. 

ii. Ethoprop is a neurotoxic chemical. 

Although there is evidence in the acute 

and 11–day comparative cholinesterase 

studies of increased offspring senstivity 

to ChE inhibition by ethoprop, there are 

no residual uncertainties with regard to 

these effects in infants and children. 

The points of departure for acute and 

chronic dietary assessment are based on 

brain ChE inhibition in pups in the 

comparative cholinesterase studies. 

Benchmark dose (BMD) modeling was 

used to select points of departure for 

dietary exposure. In comparison to other 

toxicity studies, the comparative 

cholinesterase studies had much closer 

dose spacing around the NOAEL and 

LOAEL doses and thus provided an 

accurate determination of BMDL10 

values (the lower 95% confidence limit 

on the estimated mean brain ChE 

inhibition 10% effect level) used to 

evaluate risk. Furthermore, since the 

comparative cholinesterase studies 

provided an assessment of comparative 

sensitivity of adults and offspring; and 

provided the lowest, most sensitive 

points of departure for the most 

vulnerable population, the points of 

departure based on these studies are 

protective of other toxic effects. 

iii. There is no evidence that ethoprop 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies. Although there 

is some evidence of increased 

qualitative susceptibility of offspring in 

the 2-generation reproduction study 

(pup mortality vs. clinical signs of 

tremors, loose stool and brain ChE 

inhibition in maternal animals), the 

Agency did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

utilized anticipated residues that are 

based on reliable field trial or 

monitoring data. For most currently 

registered commodities, the dietary 

assessments also utilized PCT data that 

have a valid basis and are considered to 

be reliable. The drinking water exposure 

assessments utilized targeted 

monitoring data from vulnerable 

community raw water supplies intended 

to provide reasonably conservative (i.e., 

high-end) estimates of drinking water 

concentrations. To account for the 

possibility of higher drinking water 

concentrations than those measured in 

the monitoring surveys, EPA utilized 

concentrations from 2x to 65x the 

highest measured value in the dietary 

exposure assessments. Residential 

exposure to ethoprop is not expected to 

occur. These assessments will not 

underestimate the exposure and risks 

posed by ethoprop. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the food exposure 

assumptions discussed in this unit for 

acute exposure and the highest 

measured concentrations of ethoprop 

and its degradates from the targeted 

drinking water monitoring surveys 

(0.231 ppb), the acute dietary exposure 

from food and water to ethoprop will 

occupy 18% of the aPAD for infants less 

than 1 year old, the population group 

receiving the greatest exposure. Using a 

drinking water estimate for ethoprop 

and its degradates of 0.52 ppb, 

equivalent to more than 2x the 

maximum measured value from 

monitoring data, acute dietary exposure 

to ethoprop from food and water will 

occupy 19% of the aPAD for infants less 

than 1 year old. These acute dietary risk 

estimates are based on high-end 

exposures at the 99.9th percentile. 

2. Chronic risk. Using the food 

exposure assumptions described in this 

unit for chronic exposure and the 

highest measured concentrations of 

ethoprop and its degradates from the 

targeted drinking water monitoring 

surveys (0.231 ppb), EPA has concluded 

that chronic exposure to ethoprop from 

food and water will utilize 2.7% of the 

cPAD for infants less than 1 year old 

and children 1 to 2 years old, the 

population groups receiving the greatest 

exposure. Using a drinking water 

estimate for ethoprop and its degradates 

of 0.52 ppb, equivalent to more than 2x 

the maximum measured value, chronic 

dietary exposure to ethoprop from food 

and water will occupy 4.2% of the 

cPAD for infants less than 1 year old 

and 3.4% for children 1 to 2 years old. 

There are no residential uses for 

ethoprop. 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53731 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposures take into account 

short-term or intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Ethoprop is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term or 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

ethoprop through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Using the food exposure 

assumptions described in this unit for 

the cancer risk assessment and the 

highest measured concentrations of 

ethoprop and its degradates from the 

targeted drinking water monitoring 

surveys (0.231 ppb), EPA has concluded 

that exposure to ethoprop from food and 

water will result in a lifetime cancer risk 

of 4 x 10-7 for the U.S. population. EPA 

generally considers cancer risks in the 

range of 10-6 or less to be negligible. 

Residues of ethoprop and its degradates 

of concern in drinking water could be as 

high as 5 ppb (22x the highest measured 

monitoring value) before lifetime cancer 

risk exceeded this level. 

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, or to infants and children 

from aggregate exposure to ethoprop 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. Two gas chromatography 

(GC)/sulfur microcoulometric detection 

methods are available in the Pesticide 

Analytical Methods, Volume II 

(Methods I and A). Both involve solvent 

extraction and clean-up by sweep codistillation and have a reported limit of 

quantitation (LOQ) of 0.01 ppm for most 

commodities. 

B. International Residue Limits 

There are no Canadian, CODEX or 

Mexican Maximum Residue Limits 

established for residues of ethoprop on 

mint or hops. 

V. Conclusion 

Therefore, tolerances are established 

for residues of ethoprop, O-ethyl S,Sdipropyl phosphorodithioate, in or on 

hop, dried cones; peppermint, tops; and 

spearmint, tops at 0.02 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to petitions submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 8, 2008. 

Donald R. Stubbs, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.262 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.262 Ethoprop; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Hop, dried cones .................. 0.02 

* * * * * 

Peppermint, tops .................. 0.02 

* * * * * 

Spearmint, tops .................... 0.02 

* * * * * 

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53732 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

* * * * * 

[FR Doc. E8–21589 Filed 9–16–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0674; FRL–8375–2] 

2,4-D, Bensulide, Chlorpyrifos, DCPA, 

Desmedipham, Dimethoate, 

Fenamiphos, Metolachlor, Phorate, 

Sethoxydim, Terbufos, 

Tetrachlorvinphos, and Triallate; 

Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances for the herbicides 

metolachlor and sethoxydim and the 

insecticides chlorpyrifos, dimethoate, 

fenamiphos, terbufos, and 

tetrachlorvinphos. Also, EPA is 

modifying certain tolerances for the 

herbicides 2,4-D, DCPA, desmedipham, 

metolachlor, sethoxydim, and triallate 

and the insecticides chlorpyrifos, 

dimethoate, fenamiphos, phorate, and 

tetrachlorvinphos. In addition, EPA is 

establishing new tolerances for the 

herbicides bensulide, metolachlor, and 

sethoxydim and the insecticide 

chlorpyrifos. The regulatory actions 

finalized in this document are in followup to the Agency’s reregistration 

program under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), and tolerance reassessment 

program under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), section 

408(q). 

DATES: This regulation is effective 

September 17, 2008. Objections and 

requests for hearings must be received 

on or before November 17, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0674. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Jane 

Smith, Special Review and 

Reregistration Division (7508P), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 308– 

0048; e-mail address: smith.janescott@epa.gov@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 436a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2007–0674 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 November 17, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2007–0674, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background 

A. What Action is the Agency Taking? 

In the Federal Register of February 6, 

2008 (73 FR 6867) (FRL–8345–2), 

August 8, 2007 (72 FR 44439) (FRL– 

8138–8), and May 23, 2007 (72 FR 

28912) (FRL–8130–8), EPA issued 

proposals to revoke, modify, and 

establish specific tolerances for residues 

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