10490 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 

§ 180.169 [Amended] 

■ 2. Section 180.169 is amended by 

removing paragraphs (a)(3) and (a)(4). 

[FR Doc. E9–5223 Filed 3–10–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0301; FRL–8402–6] 

Chlorimuron-ethyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of chlorimuronethyl in or on berry, low growing, 

except strawberry, subgroup 13-07H. 

Interregional Research Project Number 4 

(IR-4) requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 11, 2009. Objections and requests 

for hearings must be received on or 

before May 11, 2009, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0301. 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 e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. 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–2007–0301 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 May 11, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2007–0301, 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 June 27, 

2007 (72 FR 35237) (FRL–8133–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 6E7153) by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, Suite 201 

W., Princeton, NJ 08540–6635. The 

petition requested that 40 CFR 180.429 

be amended by establishing tolerances 

for residues of the herbicide 

chlorimuron-ethyl, ethyl 2-[[[[(4-chloro6-methoxypyrimidin-2yl) 

amino]carbonyl]sulfonyl]benzoate], in 

or on cranberry; bearberry; bilberry; 

lowbush berry; cloudberry; lingonberry; 

muntries; and partridgeberry, each at 

0.02 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by E.I. du Pont de 

Nemours and Company, 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. 

EPA has determined that a tolerance 

of 0.02 ppm on berry, low growing, 

except strawberry, subgroup 13–07H is 


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appropriate in lieu of the proposed 

individual tolerances on berry 

commodities. The reason for this change 

is explained in Unit IV.C. 

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 chlorimuronethyl on berry, low growing, except 

strawberry, subgroup 13–07H 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. 

Chlorimuron-ethyl has low or 

minimal acute toxicity via the oral, 

dermal and inhalation routes of 

exposure. It is mildly irritating to the 

eye and non-irritating to the skin; it is 

not a skin sensitizer. 

In subchronic toxicity studies with 

chlorimuron-ethyl, no adverse effects 

were observed up to the limit dose 

tested in mice; decreased body weight 

gain and liver pathology (margination of 

hepatocyte cytoplasmic content in the 

centrilobular areas) were observed in 

rats (males only); and mild hemolytic 

anemia, atrophy of the thymus and 

prostate and increased liver weights 

were seen in dogs. Chronic exposure of 

dogs to chlorimuron-ethyl also led to 

mild anemia (decreased erythrocyte 

count, hematocrit, and hemoglobin 

concentration), but atrophy of the 

thymus and prostate were not seen. In 

rats, treatment-related effects observed 

were limited to decreased body weight 

and body weight gain in both sexes after 

long-term exposure. Prostatitis (males) 

and fatty replacement in the pancreas 

(both sexes) were also observed but 

considered incidental occurrences; and 

biliary hyperplasia/fibrosis seen in 

females was attributed to aging. In mice, 

there were no treatment-related effects 

observed up to the highest dose tested 

(216 milligrams/kilograms/day (mg/kg/ 

day)). There were no treatment-related 

increases in tumors in rat and mouse 

carcinogenicity studies after exposure to 

chlorimuron-ethyl. Chlorimuron-ethyl is 

classified as ‘‘Not Likely to be 

Carcinogenic to Humans.’’ 

In the developmental toxicity studies, 

decreases in maternal body weight gain 

and delayed ossification in fetuses were 

observed in rats at the same dose (150 

mg/kg/day). In rabbits, decreases in 

maternal body weight gain were seen at 

300 mg/kg/day, while delayed 

ossification was seen in fetuses at a 

lower dose of 48 mg/kg/day, indicating 

increased quantitative susceptibility. In 

a guideline 2–generation reproduction 

study in rats, decreased body weight 

and histopathology in the cerebellum 

(cellular changes in the internal 

granular and external germinal layers) 

were seen in pups at 177 mg/kg/day. 

These effects were seen in the absence 

of maternal toxicity, indicating potential 

increased quantitative susceptibility of 

the pups to chlorimuron-ethyl. 

However, these effects were not 

associated with any neurotoxicity or 

neurobehavioral changes and not 

observed in other reproduction studies 

in rats. In a non-guideline reproduction 

toxicity study (1–generation) in rats, 

decreased body weight (females) and 

liver histopathology (males) were seen 

in parental animals at 173 mg/kg/day, 

along with decreases in litter weights. In 

another reproduction study (1–year 

interim sacrifice) in rats, decreases in 

maternal and pup body weights were 

observed at 195 mg/kg/day. 

There is no indication of 

neurotoxicity in the toxicity database for 

chlorimuron-ethyl. In a 2–generation 

reproduction study in rats, 

histopathological alterations were seen 

in the cerebellum (cellular changes in 

the internal granular and external 

germinal layers) of F2 pups at 177 mg/ 

kg/day; however, these findings were 

not associated with any neurobehavioral 

changes or any indications of 

neurotoxicity. In addition, these 

histopathological alterations were not 

observed in two other reproduction 

studies, and there was no evidence of 

neurotoxicity observed in other rat 

toxicity studies or toxicity studies in 

other species (rabbits, mice, or dogs). 

Hematological changes (indicative of 

mild anemia) and atrophy of the thymus 

were observed in dogs after subchronic 

exposure. However, atrophy of the 

thymus was not associated with any 

histopathology and not seen after 

chronic exposure. No other potential 

immunotoxic effects were observed in 

the toxicology database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by chlorimuron-ethyl as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Chlorimuron-ethyl: Human Health Risk 

Assessment for Proposed Uses on 

Cranberry and Low-growing Berry 

Subgroup 13–07H, except Strawberry, 

PP# 6E7153, page 36 in docket ID 

number EPA–HQ–OPP–2007–0301. 

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 NOAEL in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, 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 


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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 chlorimuron-ethyl used 

for human risk assessment can be found 

at http://www.regulations.gov in 

document Chlorimuron-ethyl: Human 

Health Risk Assessment for Proposed 

Uses on Cranberry and Low-growing 

Berry Subgroup 13–07H, except 

Strawberry, PP# 6E7153, page 16 in 

docket ID number EPA–HQ–OPP–2007– 

0301. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to chlorimuron-ethyl, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing chlorimuron-ethyl tolerances in 

40 CFR 180.429. EPA assessed dietary 

exposures from chlorimuron-ethyl 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. No such effects were 

identified in the toxicological studies 

for chlorimuron-ethyl; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food 

Intakes by Individuals (CSFII). As to 

residue levels in food, EPA assumed 

tolerance-level residues and 100 percent 

crop treated (PCT) for all existing and 

new uses of chlorimuron-ethyl. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified chlorimuron-ethyl as 

‘‘Not Likely to be Carcinogenic to 

Humans.’’ Therefore, an exposure 

assessment for evaluating cancer risk is 

not needed for this chemical. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for chlorimuron-ethyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

chlorimuron-ethyl. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

chlorimuron-ethyl for chronic exposures 

for non-cancer assessments are 

estimated to be 2.4 parts per billion 

(ppb) for surface water and 1.76 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

only dietary exposure scenario for 

which a toxicological endpoint of 

concern was identified, the water 

concentration value of 2.4 ppb was used 

to assess the contribution to 

chlorimuron-ethyl dietary exposure 

from drinking 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). 

Chlorimuron-ethyl 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.’’ 

EPA has not found chlorimuron-ethyl 

to share a common mechanism of 

toxicity with any other substances, and 

chlorimuron-ethyl does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that chlorimuron-ethyl does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

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 prenatal and postnatal toxicity 

database for chlorimuron-ethyl includes 

guideline rat and rabbit developmental 

toxicity studies and a 2–generation 

reproduction toxicity study in rats, as 

well as two additional non-guideline 

reproduction studies in rats (a 1– 

generation study and 1–year interim 

sacrifice study). No evidence of 

increased prenatal or postnatal 

susceptibility was seen in the 

developmental toxicity study in rats or 

in the non-guideline reproduction 

toxicity studies in rats. In the rabbit 

developmental study, delayed 

ossification was observed in fetuses at 

48 mg/kg/day, while maternal effects 

(decreased body weight gain) were seen 

at 300 mg/kg/day, suggesting increased 

quantitative susceptibility of fetuses. In 

the 2–generation rat reproduction study, 

decreased body weight and 

histopathology findings in the 

cerebellum were observed in pups at 

177/214 mg/kg/day (male/female) in the 

absence of maternal toxicity, also 

suggesting increased quantitative 

susceptibility of the pups. 

Although the data suggest increased 

quantitative susceptibility in the 

developmental rabbit study and the 2– 

generation rat reproduction study, there 

are no residual uncertainties with regard 

to prenatal toxicity following in utero 

exposure of rats or rabbits or prenatal 

and/or postnatal exposures of rats. The 

fetal effect seen in rabbits was limited 

to delayed ossification, and, although 

effects (histopathology in the 

cerebellum) were seen in a rat 

reproduction study, there was no 

evidence of increased susceptibility 

observed in two additional reproduction 

studies in rats. Additionally, there are 

clear NOAELs for the offspring effects 


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seen in rabbits (NOAEL=13 mg/kg/day) 

and rats (17 mg/kg/day). Finally, the 

NOAEL (9 mg/kg/day) used to establish 

the cRfD of 0.09 mg/kg/day is 

considered protective of potential 

developmental effects observed at the 

higher doses. Considering the overall 

toxicity database and doses selected for 

risk assessment, the degree of concern 

for the effects observed in the studies is 

low. 

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 

chlorimuron-ethyl is adequate to 

characterize potential prenatal and 

postnatal risk for infants and children. 

Acceptable/guideline studies for 

developmental toxicity in rats and 

rabbits and reproduction toxicity in rats 

are available for FQPA assessment. 

On December 26, 2007 EPA began 

requiring functional immunotoxicity 

testing and acute and subchronic 

neurotoxicity testing of all food and 

non-food use pesticides. Since these 

requirements went into effect after the 

tolerance petition was submitted, these 

studies are not yet available for 

chlorimuron-ethyl. In the absence of 

specific immunotoxicity and 

neurotoxicity studies, EPA has 

evaluated the available chlorimuronethyl toxicity data and determined that 

an additional uncertainty factor is not 

required to account for potential 

neurotoxicity or immunotoxicity. The 

reasons for this determination are 

explained below: 

a. Hematological changes (indicative 

of mild anemia) and atrophy of the 

thymus were observed in dogs following 

subchronic exposure to chlorimuronethyl at a dose of 45.8/42.7 (M/F) mg/ 

kg/day, indicating potential 

immunotoxicity. However, atrophy of 

the thymus was not associated with any 

histopathology and was not seen after 

chronic exposure; and no other 

potential immunotoxic effects were 

observed in the toxicology database. 

Therefore, EPA does not believe that 

conducting immunotoxicity testing will 

result in a NOAEL less than the NOAEL 

of 9 mg/kg/day already established for 

chlorimuron-ethyl, and an additional 

factor for database uncertainties (UFDB) 

is not needed to account for potential 

immunotoxicity. 

b. There is no indication in the 

toxicity database that chlorimuron-ethyl 

is a neurotoxic chemical, and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

ii. Although there is evidence of 

increased quantitative susceptibility in 

the developmental rabbit study and the 

2–generation rat reproduction study, the 

degree of concern for the effects 

observed in the studies is low, and there 

are no residual uncertainties with regard 

to prenatal toxicity following in utero 

exposure of rats or rabbits or prenatal 

and/or postnatal exposures of rats. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on the 

assumptions of 100 PCT and tolerancelevel residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to chlorimuron-ethyl in 

drinking water. Residential exposure to 

chlorimuron-ethyl is not expected. 

These assessments will not 

underestimate the exposure and risks 

posed by chlorimuron-ethyl. 

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. Shortterm, intermediate-term, and chronicterm 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. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, chlorimuron-ethyl 

is not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to chlorimuronethyl from food and water will utilize 

less than 1% of the cPAD for the general 

population and all population 

subgroups, including infants and 

children. There are no residential uses 

for chlorimuron-ethyl. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure take into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Chlorimuron-ethyl is not registered for 

any use patterns that would result in 

residential exposure. Therefore, the 

short-term/intermediate-term aggregate 

risk is the sum of the risk from exposure 

to chlorimuron-ethyl through food and 

water and will not be greater than the 

chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. EPA has classified 

chlorimuron-ethyl into the category 

‘‘Not Likely to be Carcinogenic to 

Humans’’. Chlorimuron-ethyl is not 

expected to pose a cancer risk. 

5. 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 chlorimuronethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(a high performance liquid 

chromotography (HPLC) 

photoconductivity method) 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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no established or proposed 

Canadian, Mexican or Codex MRLs for 

residues of chlorimuron-ethyl on berry 

commodities. 

C. Revisions to Petitioned-For 

Tolerances 

IR-4 petitioned for individual 

tolerances on bearberry, bilberry, 

lowbush berry, cloudberry, cranberry, 

lingonberry, muntries and 

partridgeberry. In the Federal Register 

of December 7, 2007 (72 FR 69150) 

(FRL–8340–6), EPA issued a final rule 

that revised the crop grouping 

regulations. As part of this action, EPA 

expanded and revised berries group 13. 

Changes to crop group 13 included 

adding new commodities, revising 

existing subgroups and creating new 

subgroups (including a low growing 

berry, except strawberry, subgroup (13– 

07H) consisting of the commodities 

requested in this petition and cultivars, 

varieties, and/or hybrids of these). EPA 

indicated in the December 7, 2007 final 

rule as well as the earlier May 23, 2007 

proposed rule (72 FR 28920) that, for 


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10494 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 

existing petitions for which a Notice of 

Filing had been published, the Agency 

would attempt to conform these 

petitions to the rule. Therefore, 

consistent with this rule, EPA is 

establishing a tolerance on low growing 

berry, except strawberry, subgroup 13– 

07H. EPA concludes it is reasonable to 

establish the tolerance on the newly 

created subgroup, since the individual 

commodities for which tolerances were 

requested are identical to those which 

comprise low growing berry, except 

strawberry, subgroup 13–07H. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of chlorimuron-ethyl, ethyl 

2-[[[[(4-chloro-6-methoxypyrimidin-2yl) 

amino]carbonyl]sulfonyl]benzoate], in 

or on berry, low growing, except 

strawberry, subgroup 13–07H at 0.02 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 24, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.429 is revised to read 

as follows: 

§ 180.429 Chlorimuron ethyl; tolerances 

for residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

chlorimuron ethyl, ethyl 2-[[[[(4-chloro6-methoxypyrimidin-2yl) 

amino]carbonyl]sulfonyl]benzoate], in 

or on the following raw agricultural 

commodities: 

Commodity Parts per million 

Berry, low growing, except strawberry, subgroup 13–07H ............. 0.02 

Peanut ............................ 0.02 

Soybean .......................... 0.05 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E9–5192 Filed 3–10–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0303; FRL–8400–2] 

Bacillus Mycoides Isolate J; 

Temporary Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the Bacillus mycoides isolate J in or 

on pecans, potatoes, sugar beets, 

tomatoes, and peppers when used in 

accordance with good agricultural 

practices. Montana Microbial Products, 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting to amend the 

existing temporary tolerance exemption. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus mycoides isolate 

J in or on pecans, potatoes, sugar beets, 

tomatoes, and peppers on a time-limited 

basis. The temporary tolerance 

exemption expires on March 31, 2011. 


rwilkins on PROD1PC63 with RULES