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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). 

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 MRLs for dinotefuran in or 

on pome fruit and stone fruit. 

VI. Conclusion 

Therefore, the established timelimited tolerances for residues of 

dinotefuran, (RS)-1-methyl-2-nitro-3- 

((tetrahydro-3-furanyl)methyl)guanidine 

including its metabolites and 

degradates, in or on pome fruit and 

stone fruit are modified by raising them 

to 2.0 ppm. These tolerances expire on 

December 31, 2015. 

VII. Statutory and Executive Order 

Reviews 

This final rule modifies tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the tolerances 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, but 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: January 10, 2014. 

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 § 180.603, revise the table in 

paragraph (b) to read as follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Fruit, pome, Group 

11 ...................... 2.0 12/31/2015 

Fruit, stone, Group 

12 ...................... 2.0 12/31/2015 

* * * * * 

[FR Doc. 2014–01079 Filed 1–21–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0829; FRL–9904–19] 

Acetochlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetochlor in 

or on sugar beets and peanuts. 

Monsanto Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 22, 2014. Objections and 

requests for hearings must be received 

on or before March 24, 2014, 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–2012–0829, 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 


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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: Lois 

Rossi, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–7090; 

email address: RDFRNotices@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–2012–0829 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 March 24, 2014. 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– 

2012–0829, 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 January 16, 

2013 (78 FR 3377) (FRL–9375–4), 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 2F8077) by Monsanto 

Company, 1300 I Street NW., Suite 450 

East, Washington DC 20005. The 

petition requested that 40 CFR 180.470 

be amended by establishing 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, to be expressed as acetochlor 

equivalents, resulting from applications 

to soil or growing crops, in or on the 

following agricultural commodities: 

Beet, sugar, dried pulp at 0.5 parts per 

million (ppm); beet, sugar, molasses at 

1.3 ppm; beet, sugar, roots at 0.3 ppm; 

beet, sugar, tops at 0.8 ppm; peanut at 

0.2 ppm; peanut, hay at 6.0 ppm; and 

peanut, meal at 0.5 ppm. The petition 

also requested that EPA delete from 40 

CFR 180.470(d) tolerances for indirect 

or inadvertent residues in beet, sugar, 

root at 0.05 ppm; and beet, sugar, tops 

at 0.05 ppm. That document referenced 

a summary of the petition prepared by 

Monsanto Company, the registrant, 

which is available in the docket, http:// 

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

increased the proposed tolerances for 

peanut, hay and decreased the proposed 

tolerances for sugar beet, molasses and 

tops, and peanut, meal. The reason for 

these changes are explained in Unit 

IV.D. 

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 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 


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subgroups of consumers, including 

infants and children. 

Acetochlor has low acute toxicity by 

the oral, dermal, and inhalation routes 

of exposure and is minimally irritating 

to the eyes. A dermal irritation study 

indicates that it is a severe 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 (190 milligrams/

kilograms/day (mg/kg/day) and 300 mg/ 

kg/day); whereas maternal toxicity 

(body weight loss) was seen at 190 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 highest dose tested 

of 216 mg/kg/day. 

There was evidence of carcinogenicity 

in studies conducted with acetochlor in 

rats and mice. A 23-month mouse 

carcinogenicity study showed weak 

evidence for increased benign lung 

tumors in females, and a 78-week study 

showed weak evidence for increased 

benign lung tumors in males. The 

increases were considered equivocal, 

based on increases in benign tumors 

only, inconsistent dose-responses 

between the two studies, 

inconsistencies in the responses of 

males and females between the two 

studies, lack of pre-neoplastic lung 

lesions in the 23-month study (while the 

78-week study showed an increase in 

bronchiolar hyperplasia), and the 

variable incidence of lung tumors 

known to occur in older mice. 

Two carcinogenicity studies in rats 

showed an increase in nasal epithelial 

tumors and thyroid follicular cell 

tumors. Thyroid tumor incidence was 

relatively low, and there was evidence 

that the tumors were due to disruption 

of thyroid-pituitary homeostasis. 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, margin of exposure (MOE), 

approach for assessment of cancer risk. 

The data show that, like the related 

compounds, alachlor and butachlor, 

tumor formation is dependent upon 

local cytotoxicity secondary to oxidative 

damage by a reactive quinone imine 

intermediate. The mechanistic data on 

nasal tumorigenesis of acetochlor in the 

rat, when considered together with the 

mutagenicity data on acetochlor and 

consistent findings in mechanistic and 

mutagenicity studies on the closely 

related compound alachlor, are 

considered adequate to demonstrate a 

cytotoxic, non-mutagenic mode of 

tumor induction. 

Because a clear mode of action was 

demonstrated for the rat tumors, EPA 

based the cancer classification on the 

data from the mouse. Given the 

weakness of these data (benign lung 

tumors in male and female mice and 

histiocytic sarcomas in female mice), 

EPA has classified acetochlor as having 

‘‘Suggestive Evidence of Carcinogenic 

Potential’’ and determined that linear 

quantification of carcinogenic potential 

would not be appropriate for the mouse 

tumors. The rat nasal tumors, with a 

point of departure (POD) of 10 mg/kg/ 

day, are the most sensitive effect for 

cancer risk. The chronic population 

adjusted dose (cPAD), based on the no 

observed adverse effect level (NOAEL) 

of 2.0 mg/kg/day from the chronic dog 

study, will be protective of both noncancer 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 NOAEL and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Acetochlor Human Health Risk 

Assessment for Proposed New Uses of 

Acetochlor on Sugar Beet and Peanut at 

pages 41–53 in docket ID number EPA– 

HQ–OPP–2012–0829. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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 

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 shown in 

Table 1. of this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACETOCHLOR FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, for risk 

assessment Study and toxicological effects 

Acute dietary (All populations) .. NOAEL = 150 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.5 mg/ 

kg/day.

aPAD = 1.5 mg/kg/ 

day 

Acute oral neurotoxicity in rats (MRID #45357501) 

LOAEL = 500 mg/kg/day based on decreased motor activity in 

females. 

Chronic dietary (All populations) NOAEL= 2.0 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.02 

mg/kg/day.

cPAD = 0.02 mg/kg/

day 

Chronic oral toxicity in beagle dogs (MRID #41565118) 

LOAEL = 10 mg/kg/day based on increased salivation and 

histopathology in the testes, kidney, and liver. 

Cancer (all routes) .................... ‘‘Suggestive Evidence of Carcinogenic Potential’’. The cRfD of 0.02 mg/kg/day will be protective of both noncancer and cancer effects 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. mg/kg/day = milligram/kilogram/day. 

NOAEL= no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty 

factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). 

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 U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA assumed tolerance level 

residues and 100 percent crop treated 

(PCT) for all commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of 

Agriculture’s NHANES/WWEIA. As to 

residue levels in food, EPA assumed 

anticipated residues from field trial data 

and 100 PCT for all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A.; based on the 

results of carcinogenicity studies in rats 

and mice, EPA classified acetochlor as 

having ‘‘Suggestive Evidence of 

Carcinogenic Potential’’ but determined 

that the chronic risk assessment will be 

protective of both non-cancer and 

cancer effects. Therefore, a separate 

exposure assessment to evaluate cancer 

risk is unnecessary. 

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. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of acetochlor 

for acute exposures are estimated to be 

74.9 parts per billion (ppb) for surface 

water and 129.0 ppb for ground water. 

EDWCs of acetochlor for chronic 

exposures for non-cancer assessments 

are estimated to be 4.84 ppb for surface 

water and 82.6 ppb for ground 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 129.0 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 82.6 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 Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) Scientific 

Advisory Panel (SAP) as a related group 

of chemicals for this purpose. 

Acetochlor is included in a Cumulative 

Assessment Group of chloroacetanilide 

pesticides. 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 U.S. The group was 

selected based on common endpoints of: 

i. Nasal turbinate tumors in rats, and 

a known mechanism of toxicity for 

development of these tumors. 

ii. 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. Thyroid 

effects were not included in the final 


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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 

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 

cumulative assessment group (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 adding the 

use on sugar beets and peanuts will only 

have a minor impact on acetochlor 

exposure since only low residues 

occurred on sugar beet and peanut food 

commodities. 

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. 

No increase in susceptibility was seen 

in developmental toxicity studies in rats 

and rabbits or in three multi-generation 

reproductive toxicity studies in rats. 

Toxicity to offspring was observed at 

dose levels which were the same or 

greater than those causing maternal or 

parental toxicity. Based on the results of 

developmental and reproductive 

toxicity studies, there is no concern for 

increased qualitative and/or quantitative 

susceptibility of the young following 

exposure to acetochlor. 

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 for acute dietary, 

chronic dietary, and dermal. That 

decision is based on the following 

findings: 

i. The toxicity database for acetochlor 

is complete for the purpose of 

evaluating this tolerance petition. 

ii. Evidence of neurotoxicity from 

exposure to acetochlor was observed in 

several oral studies. However, these 

effects were typically observed at high 

doses. The points of departure selected 

for risk assessment are protective of the 

potential neurotoxicity observed in the 

database. 

iii. There is no evidence that 

acetochlor results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. No increase in 

susceptibility was seen in 

developmental toxicity studies in rats 

and rabbits or in three multi-generation 

reproductive toxicity studies in rats. 

Toxicity to offspring was observed at 

dose levels which were the same or 

greater than those causing maternal or 

parental toxicity. Based on the results of 

developmental and reproductive 

toxicity studies, there is no concern for 

increased qualitative and/or quantitative 

susceptibility following exposure to 

acetochlor. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to acetochlor in drinking water. The 

acute dietary exposure analysis used 

tolerance level residues and 100 PCT. 

The chronic dietary exposure analysis 

used field trial residues and 100 PCT. 

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 aPAD and cPAD. 

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. In examining acute 

aggregate risk, the only pathway of 

exposure relevant to the acute time 

frame is dietary exposure. Therefore, the 

acute aggregate risk is comprised of 

exposures to acetochlor residues in food 

and drinking water and is equivalent to 

the acute dietary risk estimates. Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure from food and water to 

acetochlor will occupy 1.6% of the 

aPAD for all infants (< 1 year old), the 

population group receiving the greatest 

exposure. 

2. Chronic risk. In examining chronic 

aggregate risk, the only pathway of 

exposure relevant to the chronic time 

frame is dietary exposure. Therefore, the 

chronic aggregate risk is comprised of 

exposures to acetochlor residues in food 

and drinking water and is equivalent to 

the chronic dietary 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 26% of the cPAD for all infants 

(< 1 year old), the population group 

receiving the greatest exposure. There 

are no residential uses for acetochlor. 

3. Short- and intermediate-term 

aggregate risk. Short-term and 

intermediate-term aggregate exposure 

take into account short-term or 

intermediate-term residential exposure 

plus chronic exposure from food and 

water (considered to be a background 

exposure level). Acetochlor 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 

acetochlor through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. The Agency has concluded 

that assessments using a non-linear 

approach (e.g. a chronic RfD-based 

approach) will adequately protect for all 

chronic toxicity, including 

carcinogenicity that could result from 

exposure to acetochlor. Chronic 

aggregate risk estimates are below the 

Agency’s level of concern, therefore, 

cancer risk is also below the Agency’s 

level of concern. 

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 acetochlor 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An Enforcement Analytical Method is 

available to enforce the proposed 

tolerances. The method is a high 

performance liquid chromatography/

oxidative coulometric electrochemical 

detector (HPLC/OCED) method and is 

listed as Method I in the Pesticide 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 3517 

Analytical Manual (PAM) Vol. II 

(§ 180.470). 

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). 

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 an 

MRL for acetochlor. 

C. Response to Comments 

EPA received one comment from an 

anonymous citizen objecting to the 

presence of any pesticide residues on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by section 

408 of the FFDCA states that tolerances 

may be set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-for 

Tolerances 

The requested tolerance levels for 

residues of acetochlor on the raw 

agricultural commodities beet, sugar, 

tops, and peanut, hay were changed as 

a result of the Organisation for 

Economic Cooperation and 

Development (OECD) Tolerance 

Calculation Procedures. Tolerance 

proposals for the processed 

commodities beet, sugar, molasses and 

peanut, meal, were changed as a result 

of the calculation based on the highest 

average field trial residue multiplied by 

the average processing factor. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acetochlor, (2-chloro-2′- 

methyl-6′-ethyl-Nethoxymethylacetanilide), including its 

metabolites and degradates, on beet, 

sugar, dried pulp at 0.50 ppm, beet, 

sugar, molasses at 0.80 ppm, beet, sugar, 

roots at 0.30 ppm, beet, sugar, tops at 

0.70 ppm, peanut at 0.20 ppm, peanut, 

hay at 7.0 ppm, and peanut, meal at 0.25 

ppm; and to delete from 40 CFR 

180.470(d) tolerances for indirect or 

inadvertent residues in beet, sugar, root 

at 0.05 ppm, and beet, sugar, tops at 

0.05 ppm because they will now be 

covered under the sugar beet tolerances 

from direct application to the crop. 

VI. 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). 

VII. 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: January 10, 2014. 

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: 

■ a. Add alphabetically the 

commodities to the table in paragraph 

(a). 

■ b. Remove the following commodities 

in the table in paragraph (d) ‘‘Beet, 

sugar, root’’ and ‘‘Beet, sugar, tops.’’ 

The additions read as follows: 


pmangrum on DSK3VPTVN1PROD with RULES
3518 Federal Register / Vol. 79, No. 14 / Wednesday, January 22, 2014 / Rules and Regulations 

§ 180.470 Acetochlor; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per million 

Beet, sugar, dried pulp ........................................................................................................................................................ 0.50 

Beet, sugar, molasses ......................................................................................................................................................... 0.80 

Beet, sugar, roots ................................................................................................................................................................ 0.30 

Beet, sugar, tops ................................................................................................................................................................. 0.70 

*****

Peanut .................................................................................................................................................................................. 0.20 

Peanut, hay .......................................................................................................................................................................... 7.0 

Peanut, meal ........................................................................................................................................................................ 0.25 

*****

* * * * * 

[FR Doc. 2014–01183 Filed 1–21–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2013–0002] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Associate 

Administrator for Mitigation has 

resolved any appeals resulting from this 

notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

Interested lessees and owners of real 

property are encouraged to review the 

proof Flood Insurance Study and FIRM 

available at the address cited below for 

each community. The BFEs and 

modified BFEs are made final in the 

communities listed below. Elevations at 

selected locations in each community 

are shown. 

National Environmental Policy Act. 

This final rule is categorically excluded 

from the requirements of 44 CFR part 

10, Environmental Consideration. An 

environmental impact assessment has 

not been prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 

1993, Regulatory Planning and Review, 

58 FR 51735. 

Executive Order 13132, Federalism. 

This final rule involves no policies that 

have federalism implications under 

Executive Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This final rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 67 

Administrative practice and 

procedure, Flood insurance, Reporting 

and recordkeeping requirements. 

Accordingly, 44 CFR part 67 is 

amended as follows: 

PART 67—[AMENDED] 

■ 1. The authority citation for part 67 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp., p. 376. 

§ 67.11 [Amended] 

■ 2. The tables published under the 

authority of § 67.11 are amended as 

follows: 


pmangrum on DSK3VPTVN1PROD with RULES