13264 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Rules and Regulations 

Commodity Parts per 

million 

Goat, meat .................................. 0.03 

Goat, meat byproducts ............... 0.03 

Grape .......................................... 0.01 

Grass, forage, group 17 ............. 1.0 

Grass, hay, group 17 .................. 1.4 

Horse, fat .................................... 0.03 

Horse, meat ................................ 0.03 

Horse, meat byproducts ............. 0.03 

Milk ............................................. 0.03 

Nut, tree, group 14 ..................... 0.01 

Olive ............................................ 0.01 

Peanut ........................................ 0.01 

Peanut, hay ................................ 0.07 

Pistachio ..................................... 0.01 

Pomegranate .............................. 0.01 

Potato ......................................... 0.02 

Sheep, fat ................................... 0.03 

Sheep, meat ............................... 0.03 

Sheep, meat byproducts ............ 0.03 

Soybean, forage ......................... 0.05 

Soybean, hay .............................. 0.10 

Soybean, seed ............................ 0.01 

Wheat, forage ............................. 0.02 

Wheat, grain ............................... 0.01 

Wheat, hay ................................. 0.01 

Wheat, straw ............................... 0.01 

* * * * * 

[FR Doc. 2013–04555 Filed 2–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0302; FRL–9377–6] 

Acetochlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

inadvertent tolerances for residues of 

acetochlor in or on crop groups 15 and 

16 for cereal grains by dropping the 

exclusion for rice grain and straw. 

Monsanto Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 27, 2013. Objections and 

requests for hearings must be received 

on or before April 29, 2013 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0302, is 

available at 

http://www.regulations.gov or at the 

Office of Pesticide Programs Regulatory 

Public Docket (OPP Docket) in the 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Hope Johnson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5410; email address: 

johnson.hope@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2012–0302 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 29, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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 (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0302, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2F7996) by Monsanto 

Company, 1300 I St. NW., Suite 450 

East, Washington, DC 20005. The 

petition requested revisions to the 

current tolerances for residues of the 

herbicide acetochlor, 2-chloro-2′- 

methyl-6′-ethyl-Nethoxymethylacetanilide and its 

metabolites containing either the 2- 

ethyl-6-methylaniline (EMA) or the 2-(1- 

hydroxyethyl)-6-methyl-aniline (HEMA) 

moiety, at 40 CFR 180.470 for grain, 

cereal, group 15, except corn, grain 

sorghum, rice, and wheat, grain and 

grain, cereal, forage, fodder and straw, 

group 16, except corn, grain sorghum, 

rice and wheat, straw. 

Specifically the petition requested 

that crop groups 15 and 16 be amended 


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by dropping the exception for rice grain 

and rice straw, respectively. That 

document referenced a summary of the 

petition prepared by Monsanto 

Company, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Tolerance Level 

Monsanto sought the removal of the 

exception for rice and rice straw for the 

acetochlor tolerances for crop groups 15 

and 16 so that rice crops could be 

rotated to fields previously treated with 

acetochlor. EPA determined that this 

revision to these tolerances was 

appropriate without modifying the 

tolerance value based upon translation 

of residue data reflecting analysis for 

residues of acetochlor and its 

metabolites in/on wheat and sorghum 

commodities planted after treatment 

with acetochlor. Residues in the wheat 

and sorghum grain were nonquantifiable, whereas finite residues 

that were below the existing crop group 

tolerance were reported in the straw. 

IV. 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 acetochlor 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with acetochlor 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. 

Acetochlor has low acute toxicity by 

the oral, dermal, and inhalation routes 

of exposure and is mildly irritating to 

the eyes. The results of two dermal 

irritation studies indicate that it is a 

mild to strong skin irritant. Acetochlor 

is also a strong dermal sensitizer. 

Evidence of neurotoxicity was 

observed in acute and subchronic 

neurotoxicity screening studies in rats, 

developmental toxicity studies in rats, 

and subchronic and chronic studies in 

dogs. In addition to the nervous system, 

the major target organs affected in 

subchronic and chronic studies in rats, 

dogs, and mice exposed to acetochlor 

are the liver, thyroid (secondary to 

liver), kidney, testes, and erythrocytes. 

Species-specific target organs include 

the nasal olfactory epithelium in rats 

and the lungs in mice. 

There is no evidence of increased 

qualitative or quantitative susceptibility 

of fetuses or offspring to acetochlor 

exposure in the developmental and 

reproduction toxicity studies in rats and 

rabbits. In two developmental toxicity 

studies in rats, fetal effects (increased 

early resorptions, post-implantation 

loss, and decreased fetal weight) 

occurred at doses that also resulted in 

maternal toxicity (mortality, clinical 

signs of toxicity, and decreased 

maternal body weight gain). In two 

rabbit developmental toxicity studies 

there were no adverse fetal effects at the 

highest doses tested (HDT) (190 

milligrams/kilograms/day (mg/kg/day) 

and 300 mg/kg/day); whereas maternal 

toxicity (body weight loss) was seen at 

50 mg/kg/day in one study. In three 

reproduction toxicity studies in rats, 

offspring effects (decreased pup weights 

in the first two studies; decreased pup 

weights, decreased F2 litter size at birth, 

and focal hyperplasia and polypoid 

adenomata in nasal epithelium of adult 

F1 offspring at study termination in the 

third study) occurred at the same or 

higher doses than those resulting in 

parental toxicity (decreased body weight 

or weight gain in the first two studies; 

focal hyperplasia and polypoid 

adenomata in nasal epithelium of adult 

F1 offspring at study termination in the 

third study). There was no evidence of 

reproductive toxicity observed at any 

dose tested in two of the three 

reproductive toxicity studies in rats. 

The third reproduction study in rats 

showed a decreased number of 

implantations at the HDT of 1,750 parts 

per million (ppm). 

EPA has determined that 

quantification of carcinogenic risk on a 

linear, non-threshold basis is not 

appropriate for the mouse tumors. There 

are acceptable mode of action data for 

the rat tumors (nasal olfactory epithelial 

tumors and thyroid follicular cell 

tumors) which are adequate to support 

a non-linear, threshold approach for 

assessment of cancer risk. The rat nasal 

tumors are the most sensitive effect for 

cancer risk. However, because rat nasal 

tumors are not the most sensitive 

chronic effect, EPA has not conducted a 

separate cancer-only risk assessment but 

performed a single, chronic risk 

assessment that will be protective of 

both non-cancer and cancer effects, 

including rat nasal tumors, thyroid 

tumors, and mouse tumors. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by acetochlor 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 

entitled ‘‘Acetochlor Human Health 

Risk Assessment for Proposed New Use 

of Acetochlor on Cotton and Soybeans’’ 

at page 41 in docket ID number EPA– 

HQ–OPP–2009–0002. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 


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degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

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 acetochlor used for 

human risk assessment is discussed in 

Unit III.A of the final rule published in 

the Federal Register issue of September 

16, 2009 (74 FR 47445) (FRL–8434–1). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acetochlor, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

acetochlor tolerances in 40 CFR 

180.470. EPA assessed dietary 

exposures from acetochlor 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. 

Such effects were identified for 

acetochlor. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, entitled ‘‘What We 

Eat in America’’ (NHANES/WWEIA). 

This dietary survey was conducted from 

2003 to 2008. As to residue levels in 

food, EPA assumed tolerance level 

residues and 100 percent crop treated 

(PCT) for all commodities. 

Experimentally derived processing 

factors were used for cereal grain 

commodities. Default processing factors 

were used for all other commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA used anticipated residues from 

field trial data and 100 PCT 

assumptions for all commodities. 

Experimentally derived processing 

factors were used for cereal grain 

commodities. Default processing factors 

were used for all other commodities. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier non-cancer key 

event. If carcinogenic mode of action 

data are not available, or if the mode of 

action data determines a mutagenic 

mode of action, a default linear cancer 

slope factor approach is utilized. Based 

on the data summarized in Unit III.A., 

EPA has concluded that a non-linear 

RfD approach is appropriate for 

assessing cancer risk to acetochlor. 

However, cancer-only risk assessment 

was not conducted because the chronic 

RfD of 0.02 mg/kg/day will be protective 

of both non-cancer and cancer effects. 

The chronic exposure assessment 

described in Unit IV.C.1.ii. also 

accurately estimates exposure for the 

purposes of assessing cancer risk. 

iv. Anticipated residue information. 

EPA used anticipated residues derived 

from the results of field trials in the 

chronic dietary exposure assessment. 

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 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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for acetochlor in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of acetochlor. 

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. 

Acetochlor parent residue exposure is 

generally higher and more widespread 

through surface water sources than 

ground water, therefore, the Agency 

generated the surface water 

concentrations using the PRZM 

(Pesticide Root Zone Model) and 

EXAMS (Exposure Analysis Modeling 

System). The estimated drinking water 

concentrations (EDWCs) of acetochlor 

for acute exposures are estimated to be 

75 parts per billion (ppb) for drinking 

water. For chronic exposures for noncancer assessments are estimated to be 

4.8 ppb for drinking water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 75 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 4.8 ppb was used to assess the 

contribution to 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). 

Acetochlor 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 chloroacetanilides have been 

evaluated by the Agency and the 

Federal Insecticides, Fungicides, and 

Rodenticides Act (FIFRA) Scientific 

Advisory Panel (SAP) as a related group 

of chemicals for this purpose. 

Acetochlor is included in a Cumulative 

Assessment Group (CAG) of 

chloroacetanilide pesticides. 

Structurally related chloroacetanilides 

include acetochlor, alachlor, butachlor, 

metolachlor, and propachlor. For 

purposes of a cumulative risk 

assessment, it was determined that the 

common mechanism of toxicity group 

consists of alachlor, acetochlor, and 

butachlor. Butachlor is excluded from 

the group for risk assessment purposes 

at present because there are no 

registered uses or tolerances for this 

chemical in the United States. The 

group was selected based on common 

endpoints of: 

• Nasal turbinate tumors in rats, and 

a known mechanism of toxicity for 

development of these tumors. 

• Induction of hepatic Uridine 

Diphosphate-Glucuronosyl Transferase 

(UDPGT), which results in increased 

incidence of thyroid follicular cell 

tumors secondary to disruption of 

pituitary-thyroid homeostasis. 


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Thyroid effects were not included in 

the final cumulative assessment of the 

chloroacetanilide herbicides because 

they were determined to occur at 

excessively toxic dose levels, and 

therefore were not considered relevant 

to human risk assessment. Nasal tumors 

represent the most sensitive endpoint 

for both compounds. 

An updated cumulative risk 

assessment of the chloroacetanilide 

(CAG) pesticides acetochlor and 

alachlor conducted in April 2007 

provides an assessment of existing and 

new uses of those chemicals to date. 

Based on the most recent 

chloroacetanilide CAG cumulative risk 

assessment, cumulative risk is not of 

concern. A revised quantitative 

cumulative assessment was not 

conducted because the proposed 

amended use would not affect the 

cumulative risk results. Not only is 

acetochlor a very minor contributor to 

chloroacetanilide cumulative risk when 

compared to alachlor, but removing the 

exception for rotation to rice will only 

have a minor impact on acetochlor 

exposure since finite residues on grains, 

including rice, are unlikely. In the 

residue data cited/translated to support 

this petition, non-quantifiable residues 

were reported in wheat and sorghum 

grains. 

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 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF 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 acetochlor includes two rat 

and two rabbit developmental toxicity 

studies and three reproduction toxicity 

studies in rats. As discussed in Unit 

IV.A., there was no evidence of 

qualitative or quantitative susceptibility 

of fetuses or offspring to acetochlor 

exposure in any of these studies. 

3. Conclusion. EPA has determined 

that the FQPA SF of 10X may be 

reduced to 1X for the acetochlor acute 

and chronic dietary risk assessment. 

That decision is based on the following 

findings: 

i. The toxicity database for acetochlor 

is now complete. An immunotoxicity 

study has been reviewed and is 

acceptable/guideline. Immunotoxicity 

was not observed at the highest dose 

tested. The acute neurotoxicity (ACN) 

and subchronic neurotoxicity (SCN) 

studies have also been upgraded to 

acceptable/guideline based on 

acceptable positive control data and 

functional observational battery 

measures. 

ii. Furthermore, EPA has determined 

that a developmental neurotoxicity 

study is not required since: 

a. There is no evidence of increased 

susceptibility in the rat and rabbit in the 

prenatal and 2-generation reproduction 

postnatal studies. 

b. Developmental effects were 

observed in the presence of maternal 

effects. 

c. The effects observed in the 

neurotoxicity studies were only at high 

doses. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues or average 

residue levels derived from reliable field 

trials. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to acetochlor in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by acetochlor. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer 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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

acetochlor will occupy <1% of the 

aPAD for infants <1 year old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to acetochlor from 

food and water will utilize 6.2% of the 

cPAD for infants <1 year old the 

population group receiving the greatest 

exposure. There are no residential uses 

for acetochlor. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Because no short-term adverse effect 

was identified, acetochlor is not 

expected to pose a short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, acetochlor is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. The chronic RfD of 0.02 mg/ 

kg/day will be protective of both noncancer and cancer effects, including rat 

nasal tumors, thyroid tumors, and 

mouse tumors. Chronic dietary risks do 

not exceed the Agency’s level of 

concern. 

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 acetochlor 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography (HPLC) method with 

oxidative coulometric electrochemical 

detection (OCED)) 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 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 


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The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for acetochlor. 

VI. Conclusion 

Therefore, the acetochlor tolerances 

for crop groups 15 and 16 are amended 

to drop the exception for rice and rice 

straw, respectively. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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 15, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.470, revise the entries 

‘‘grain, cereal, forage, fodder and straw, 

group 16, except corn, grain sorghum, 

rice and wheat, straw’’ and ‘‘grain, 

cereal, group 15, except corn, grain 

sorghum, rice, and wheat, grain’’ in the 

table in paragraph (d) to read as follows: 

§ 180.470 Acetochlor; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

*****

Grain, cereal, forage, fodder 

and straw, group 16, except 

corn, grain sorghum, and 

wheat, straw ........................ 0 .3 

Grain, cereal, group 15, except corn, grain sorghum, 

and wheat, grain ................. 0 .05 

*****

[FR Doc. 2013–04532 Filed 2–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL MARITIME COMMISSION 

46 CFR Parts 501 and 540 

[Docket No. 11–16] 

RIN 3072–AC45 

Passenger Vessel Operator Financial 

Responsibility Requirements for 

Nonperformance of Transportation 

AGENCY: Federal Maritime Commission. 

ACTION: Final rule. 

SUMMARY: The Federal Maritime 

Commission amends its rules regarding 

the establishment of passenger vessel 

financial responsibility for 

nonperformance of transportation. The 

amount of coverage required for 

performance is modified to increase the 

cap on required performance coverage 

to $30 million over a two year period 

and thereafter adjust the cap every two 

years using the Consumer Price Index; 

adjust the amount of coverage required 

for smaller passenger vessel operators 

by providing for consideration of 

alternative forms of protection; remove 

the application form for issuance of 

certificates of financial responsibility 

from the Commission’s regulations and 

make it available at its Web site; add an 

expiration date to the Certificate 

(Performance); and make technical 

adjustments to the regulations. 

DATES: The Final Rule is effective: April 

2, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Karen V. Gregory, Secretary, Federal 

Maritime Commission, 800 North 


erowe on DSK2VPTVN1PROD with RULES