Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 27463 

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 6, 2000) do not apply 

to this rule. In addition, This 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). 

IX. 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: May 4, 2007. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention 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 180.1254 is amended by 

designating the existing text as 

paragraph (a) and by adding paragraph 

(b) to read as follows: 

§ 180.1254 Aspergillus flavus NRRL 21882; 

exemption from requirement of a tolerance. 

(a) * * * 

(b) Aspergillus flavus NRRL 21882 is 

temporarily exempt from the 

requirement of a tolerance on corn when 

used in accordance with the 

Experimental Use Permit 75624–EUP–2. 

This temporary exemption from 

tolerance will expire on May 2, 2009. 

[FR Doc. E7–9427 Filed 5–15–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0203; FRL–8126–2] 

Acetochlor; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises and 

separates the tolerances for acetochlor 

in 180.470 into paragraphs (a) through 

(d) and reassigns many of the current 

entries from paragraph (a) to paragraph 

(d), which applies to tolerances for 

indirect and inadvertent residues. This 

regulation also establishes several new 

tolerances and amends several existing 

tolerances under paragraph (a). It further 

establishes several new tolerances under 

paragraph (d); and amends and revises 

two tolerances moved to that paragraph. 

Details of these changes are outlined in 

Unit II. of this document. The 

Acetochlor Registration Partnership 

(ARP) and Monsanto Company 

requested these changes as submitted by 

petitions to EPA pursuant to the Federal 

Food, Drug and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

16, 2007. Objections and requests for 

hearings must be received on or before 

July 16, 2007, 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–2006–0203. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5704; e-mail address: 

walters.vickie@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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 


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27464 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 

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 an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site athttp://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2006–0203 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 July 16, 2007. 

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–2006–0203, 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’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 telephone number is (703) 305–

5805. 

II. Petition for Tolerance 

In the Federal Register of February 7, 

2007 (72 FR 5706) (FRL–8111–8, EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 1F6263, 4F4505, 

6F4791) by the Acetochlor Registration 

Partnership (ARP) and Monsanto 

Company, 1300 ‘‘I’’ St., NW., 

Washington, DC 20005, and PP 5F6918 

by Monsanto Company, 1300 ‘‘I’’ St., 

NW., Suite 450 East, Washington, DC 

20005. The petitions requested that 40 

CFR 180.470(a) be amended by 

establishing tolerances for residues of 

the herbicide, acetochlor [2-chloro-2- 

methyl-6-ethyl-Nethoxymethylacetamide) and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl-aniline (HEMA) 

moiety, and expressed as acetochlor 

equivalents in or on the food 

commodities corn, field, forage at 3.0 

ppm (5F4505) corn, pop, grain at 0.05 

part per million (ppm); corn, pop, stover 

at 1.5 ppm (PP 1F6263); corn, sweet, 

fodder and forage at 1.5 ppm; and corn, 

sweet, kernels plus cob with husks 

removed at 0.05 ppm (6F4791); 

sorghum, forage at 1.0 ppm; sorghum, 

grain at 0.05 ppm; and sorghum, grain, 

stover at 1.5 ppm (5F6918). These 

petitions also requested that 40 CFR 

180.470(d) be amended by establishing 

tolerances for residues of the herbicide, 

acetochlor (2-chloro-2-methyl-6-ethyl-Nethoxymethylacetamide) and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl-aniline (HEMA) 

moiety, and expressed as acetochlor 

equivalents in or on the food 

commodities beet, sugar, root and tops/ 

pea and bean (except soybean) dried 

and shelled (subgroup 6C)/potato/ and 

grain, cereal (except rice) (group 15),at 

0.05 ppm; grain, grain, cereal (except 

rice), forage/fodder/straw (group 16) 

forage at 0.5 ppm; grain, cereal (except 

rice) forage/fodder/straw (group 16) hay 

at 2.0 ppm; grain, cereal (except rice) 

forage/fodder/straw (group 16) stover at 

0.1 ppm; grain, cereal (except rice) 

forage/fodder/straw (group 16), straw at 

0.3 ppm (1F6263); non-grass animal 

feeds (group 18) forage at 1.3 ppm; and 

non-grass animal feeds (group 18) hay at 

3.5ppm (6F4791). That notice 

referenced a summary of the petitions 

prepared by Acetochlor Registration 

Partnership and Monsanto Company, 

the registrants, which have been placed 

in the public docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petitions EPA is 

reassigning the entries for soybean, 

forage at 0.7 ppm; soybean, grain at 0.1 

ppm; soybean, hay at1.0 ppm; wheat, 

forage at 0.5 ppm; wheat, grain at 0.02 

ppm; and wheat, straw at 0.1 ppm; from 

180.470(a) to 180.470(d) and 

establishing a tolerance for wheat, hay 

at 2.0 ppm under 40.CFR 180.470(d). 

The terminology for soybean, grain is 

being updated to read soybean, seed to 

conform to Agency procedures. 

Additionally, EPA is increasing the 

tolerance for corn, field, forage to 3.0 

from 1.0 ppm. This tolerance will be 

listed in 180.470(a). 

Based upon review of the data 

submitted and Agency procedures 

concerning commodity names, the 

Agency is correcting the terminology for 

pending crops under 40 CFR 180.470(a) 

as follows: corn, field, forage at 3.0 ppm; 

corn, pop, grain at 0.05 ppm; corn, pop, 

stover at 1.5 ppm; corn, sweet, kernels 

plus cob with husks removed at 0.05 

ppm; corn, sweet, forage at 1.5 ppm; and 

sorghum, grain, grain at 0.05 ppm. The 

Agency is also correcting the tolerance 

levels and terminology for pending 

crops under 40 CFR 180.470(a) as 

follows: corn, sweet, stover at 1.0 ppm; 

sorghum, grain, forage at 1.6 ppm; 

sorghum, grain, grain at 0.05 ppm; and 

sorghum, grain, stover at 1.7 ppm. The 

above listings for corn, field, forage; 

sorghum, grain, forage; sorghum, grain, 

grain; and sorghum, grain, stover; 

replace the current listings for corn, 

field forage; sorghum, forage; sorghum, 

grain; and sorghum, grain, stover. 

The Agency also determined that the 

tolerance expression and correct 

terminology for the pending crops under 

40 CFR 180.470(d) should be written as 

follows: Tolerances are also established 

for indirect or inadvertent residues of 

acetochlor (2-chloro-2’-methyl-6-ethylN-ethoxymethylacetamide) and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl aniline (HEMA) 

moiety, to be analyzed as acetochlor and 

expressed as acetochlor equivalents, in 

or on the following raw agricultural 

commodities when present therein as a 


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result of application of acetochlor to 

growing crops listed in paragraph (a) of 

this section: Animal feed, nongrass, 

group 18, forage at 1.3 ppm; animal 

feed, nongrass, group 18, hay at 3.5 

ppm; beet, sugar, root at 0.05 ppm; beet, 

sugar, tops at 0.05 ppm; grain, cereal, 

group 15 except for corn, grain sorghum, 

rice and wheat, grain at 0.05 ppm; grain, 

cereal, forage, fodder and straw, group 

16 except for corn, grain sorghum, rice 

and wheat, forage at 0.5 ppm; grain, 

cereal, forage, fodder and straw, group 

16,except corn, grain sorghum, rice and 

wheat, hay at 2.0 ppm; grain, cereal, 

forage, fodder and straw, Group 16, 

except corn, grain sorghum, rice and 

wheat, stover at 0.1 ppm; grain, cereal, 

forage, fodder and straw, group 16, 

except corn, grain sorghum, rice and 

wheat, straw at 0.3 ppm; pea and bean, 

dried shelled, except soybean, subgroup 

6C at 0.05 ppm; potato at 0.05; 

sunflower, seed at 0.05 ppm and wheat, 

hay at 2.0 ppm. 

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. . . .’’ These provisions 

were added to FFDCA by the Food 

Quality Protection Act (FQPA) of 1996. 

Consistent with FFDCA section 

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

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 

the petitioned-for tolerances and 

amendments for tolerances for residues 

of acetochlor (2-chloro-2’-methyl-6- 

ethyl-N-ethoxymethylacetamide) and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl aniline (HEMA) 

moiety, to be analyzed as acetochlor and 

expressed as acetochlor equivalents. 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by acetochlor as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov. The referenced 

document is entitled ‘‘Acetochlor-RED 

Phase 2 Revised HED Chapter of the 

TRED’’ and is available in the docket 

(EPA–HQ–OPP–2005–0227 identified as 

document 0004. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the toxicological level of concern 

(LOC) is derived from the highest dose 

at which no adverse effects are observed 

(the NOAEL) in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, the lowest dose 

at which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment. Uncertainty/ 

safety factors (UF) are used in 

conjunction with the LOC 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 risks by comparing 

aggregate 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 LOC by all 

applicable uncertainty/safety factors. 

Short-, intermediate, and long-term risks 

are evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable 

uncertainty/safety factors is not 

exceeded. 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk and 

estimates risk in terms of the probability 

of occurrence of additional adverse 

cases. Generally, cancer risks are 

considered non-threshold. 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/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

A summary of the toxicological 

endpoints for acetochlor used for 

human risk assessment can be found at 

www.regulations.gov in document 

Acetochlor: Human Health Risk 

Assessment to Support the Proposed 

Uses on Sorghum and Sweet Corn and 

Rotational Crops of Nongrass Animal 

Feeds (Group 18), Sugar Beets, Dried 

Shelled Beans and Peas (Subgroup 6C), 

Sunflowers, Potatoes Cereal Grains 

(Group 15), and Forage, Fodder and 

Straw of Cereal Grains (Group 16) on 

page 11 in Docket ID EPA–HQ–OPP–

2006–0203. 

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. In estimating acute dietary 

exposure, EPA used food consumption 

information from the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII). As to residue levels in food, 

EPA assumed all foods for which there 

are tolerances or for which tolerances 

are proposed, were treated and contain 

tolerance-level residues. Experimentally 

derived processing factors were used for 

cereal grain commodities. Default values 

were used for all other processed 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998; 

Nationwide CSFII. As to residue levels 

in food, EPA chronic dietary analysis 

included anticipated residues from field 

trial data and assumed that all crop 

were treated. Experimentally derived 

processing factors were used for cereal 

grain commodities. Default values were 

used for all other processed 

commodities. 

iii. Cancer. Previously, EPA has 

treated acetochlor as a non-threshold 


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carcinogen and conducted a linear lowdose quantitative cancer risk assessment 

in evaluating its safety. The 

determination that a quantitative linear 

low-dose cancer assessment was 

appropriate was based on findings that 

acetochlor caused mouse lung tumors 

and histiocytic sarcomas in female mice. 

The Agency has reexamined the data 

and concluded they do not support use 

of a quantitative linear low-dose cancer 

assessment. The Agency determined 

that the relationship of the mouse lung 

tumors to treatment was equivocal, due 

to some inconsistencies in doseresponse between the two available 

mouse studies, the relatively frequent 

occurrence of the tumor in older mice 

and the lack of evidence of direct 

genotoxicity of acetochlor. Further the 

Agency found that the increase in the 

histiocytic sarcomas in female mice in 

one study was also equivocal. EPA 

concludes that this equivocal evidence 

of cancer shows no greater than a 

negligible risk of cancer. Nonetheless, 

acetochlor has been associated with 

nasal tumors in the rats and these 

tumors remain as a tumor of concern for 

human exposure to acetochlor. Because, 

however, the nasal tumors have been 

found to be a threshold effect, EPA has 

not used quantitative linear low-dose 

cancer assessment in assessing this 

cancer risk. Rather, EPA has relied on 

the chronic risk assessment because the 

chronic Reference Dose (cRfD), which is 

based on a NOAEL of 2 milligrams/ 

kilograms/day (mg/kg/day), is 

considered to be protective of nasal 

tumors for which a point of departure of 

10 mg/kg/day was identified. EPA has 

used the same exposure assumptions in 

assessing cancer risk as in assessing 

other chronic risks. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

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

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must pursuant to 

section 408(f)(1) of FFDCA require 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 section 408(b)(2)(E) of 

FFDCA and authorized under section 

408(f)(1) of FFDCA. Data will be 

required to be submitted no later than 

5 years from the date of issuance of this 

tolerance. 

2. Dietary exposure from drinking 

water. The drinking water values used 

in the dietary risk assessments were 

based on information provided by the 

Acetochlor Registration Partner ship 

water monitoring program to support 

the current use on field corn. The 

Agency has determined that the new 

uses of acetochlor are not likely to result 

in concentrations exceeding those seen 

in the field corn monitoring data; 

therefore this data can be used to 

estimate drinking water concentrations 

resulting from the new uses on sweet 

corn and sorghum. In the monitoring 

data, exposure to acetochlor parent was 

significantly higher in the surface water 

monitoring sites than the ground water 

monitoring sites; therefore, the 

concentration used in the acute dietary 

assessment was from a surface water 

monitoring site that produced the 

highest concentration of 0.01821 ppm. 

The drinking water value used in the 

chronic dietary risk assessment was 

from a surface water monitoring site that 

produced the highest time-weighted 

annualized mean (TWAM) 

concentration for a single year of 

0.00143 ppm. 

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 use on 

any sites 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.’’

Acetochlor is a member of the 

chloroacetanilide cumulative 

assessment group (CAG) which includes 

alachlor and butachlor. The Agency 

previously conducted a cumulative risk 

assessment for the CAG based on a 

common mode of action for the 

production of tumors of the nasal 

olfactory epithelium in rats. Butachlor 

was determined to be part of the CAG, 

however, there are currently no U.S. 

registrations for the chemical; therefore, 

it was excluded from the cumulative 

risk assessment. This risk assessment is 

fully discussed in the document: 

Cumulative Risks from 

Chloroacetanilide Pesticides dated 

March 6, 2006 identified as document 

EPA–HQ–OPP–2005–0050–0061 which 

is available on the internet at http:// 

www.regulaions.gov in docket number 

EPA–HQ–OPP–2005–0050. Based on 

that cumulative risk assessment (CRA), 

the Agency concluded that the 

cumulative risks from alachlor and 

acetochlor did not exceed the Agency’s 

level of concern since cumulative MOEs 

were above 13,000 for all populations 

compared to a cumulative level of 

concern of 100. 

For this risk assessment the Agency 

believes that the cumulative risk from 

these new uses in addition to the 

current existing uses of acetochlor and 

alachlor will not exceed The Agency’s 

level of concern. Individual risk 

assessments were conducted based on a 

point of departure of 10 mg/kg/day for 

nasal tumors. Anticipated residues 

based on field trial data and 100% crop 

treated was assumed for all existing and 

new uses for acetochlor. The individual 

acetochlor assessment from food 

resulted in MOEs raging from 49,000 for 

children 1-2 years old and children 3- 

5 years old to 179,000 for adults 50+. 

The addition of water to the assessment 

using surrogate data from the corn 

monitoring studies, resulted in MOEs 

ranging from 40,000 for children 1-2 

years old to 116,000 for adults 50+. The 

MOEs for the General U.S. population 

were 111,000 from food and 83,000 from 

both food and water. 

As noted in the March, 2006 

cumulative risk assessment for the 

chloroacetanilide chemicals, alachlor is 

the index chemical and acetochlor is 

included in the assessment with a 

relative potency of 1/20th of alachlor. 

Further, as noted in the cumulative risk 

assessment, acetochlor commodities 

were not considered to be risk drivers in 

the chloroacetanilide CRA; therefore 

given the individual MOEs for 

acetochlor, it is unlikely that the 

addition of the new uses for acetochlor 

will cause an unacceptable cumulative 

risk when considered with the existing 

alachlor and acetochlor uses. 

D. Safety Factor for Infants and 

Children 

1.In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional (‘‘10X’’) tenfold 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 data base 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. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 


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factor, or, if reliable data are available, 

EPA uses a different additional FQPA 

safety factor value based on the use of 

traditional uncertainty/safety factors 

and/or special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

Concern for prenatal and postnatal 

susceptibility is low for acetochlor since 

toxicity to offspring was observed only 

at maternal toxic doses in 

developmental toxicity studies in the rat 

and rabbit and in three multi-generation 

reproductive toxicity studies in the rat. 

In addition, clear NOAELS were 

established in all of these three studies. 

3. Conclusion. A 10X FQPA safety 

factor was applied to the acute dietary 

risk in the form of a database 

uncertainty factor to account for the lack 

of a developmental neurotoxicity study. 

The following findings support this 

determination. 

i. The toxicity database for acetochlor 

is not complete at this time. A 

developmental neurotoxicity study is 

required based on neurological 

observations, primarily in the dog or an 

alternative test which addresses the 

sensitivity of the dog to neurological 

effects. In addition, submission of 

positive control studies for validation of 

the laboratory methodology used in the 

acute and subchronic rat oral 

neurotoxicity screening studies is 

required as confirmatory data and to 

upgrade those studies to acceptable. 

ii. Evidence of neurotoxicity from 

exposure to acetochlor was observed in 

several studies. Salvation and other 

clinical signs (anogential staining, 

diarrhea) were reported in some studies 

in both the rat (two developmental 

studies) and the dog (subchronic and 

chronic oral). The dog appears to be 

more sensitive than the rat or mouse to 

effects on the nervous system, in that 

salivation occurred at lower dose levels 

and frank neuropathology of the brain 

was observed in one study. In the 1–

year oral toxicity study in the dog 

pronounced neurological signs (ataxia, 

abnormal head movements, tremor, 

depressed righting, hoping and flexor 

reflexes, exaggerated tonic neck reflex 

and stiffness and rigidity of the 

hindlimbs) were observed at the high 

dose and were associated with 

degenerative lesions of the cerebellum. 

Other evidence of neurotoxicity is 

discussed on page 46 of the document 

entitled ‘‘Acetochlor-RED Phase 2 

Revised HED Chapter of the TRED’’

which is available on the internet at 

http://www.regulaions.gov in the docket 

identified as EPA–HQ–OPP–2005–0227 

document 0004. 

iii. The acute dietary endpoint of 

concern for the general population 

including females 13-49 years of age, 

was derived from an acute oral 

neurotoxicity screening study in rats 

(NOAEL of 150 mg/kg/day based on 

decreased motor activity in females. 

Given the likely dosing in the 

developmental neurotoxicity study, it is 

possible that this study could lower the 

acute RfD by a factor of 10. 

EPA has determined that reliable data 

show that it would be safe for infants 

and children to reduce the FQPA safety 

factor to 1X for the chronic dietary risk. 

That decision is based on the following 

findings. 

• The toxicity database for acetochlor 

is complete other than the lack of a 

developmental neurotoxicity study. 

• Given likely dosing in the 

developmental neurotoxicity study, it is 

unlikely that this study would lower the 

cRFD. The chronic dietary endpoint of 

concern for all populations was derived 

from the chronic oral toxicity study in 

dogs with a NOAEL of 2 mg/kg/day 

based on the increased salivation and 

histopathology in testes, kidney and 

liver at 10 mg/kg/day. The cRFD of 2.0 

mg/kg/day is less than the NOAELs in 

the reproductive study of 21 mg/kg/day. 

A developmental neurotoxicity study 

will likely be conducted at dose levels 

similar to those of the 2–generation rat 

reproduction study. No evidence of 

neuropathology or overt 

neurobehavioral effects were observed 

in the 2–generation reproductive study 

with rats. 

• 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. 

The FQPA safety factor was reduces to 

1X. 

• There are no residual uncertainties 

identified in the chronic exposure 

database. The chronic dietary food 

exposure assessment was based on the 

assumption of all crops treated and 

anticipated residues from acceptable 

field trial data for all commodities. For 

chronic dietary food exposure 

assessments, experimentally derived 

processing factors were used for cereal 

grain commodities and default 

processing factors were used for all 

other processed commodities. The 

drinking water values used in the 

dietary risk assessments were based on 

information provided by the Acetochlor 

Registration Partnership water 

monitoring program to support the 

current use on field corn. These 

assessments will not underestimate the 

exposure and risks posed by acetochlor. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

exposure to the pesticide to the aPAD 

and cPAD. The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable uncertainty/safety factors. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given aggregate exposure. Short-, 

intermediate, and long-term risks are 

evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

MOE called for by the product of all 

applicable uncertainty/safety factors is 

not exceeded. 

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 at the 95th percentile for the U.S. 

population and 2.6% of the aPAD at the 

95th percentile for all infants, the 

population subgroup receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to acetochlor from food 

and water will utilize <1% of the cPAD 

for the U.S. population and 1.2 % of the 

cPAD for children 1-2 years old, the 

population subgroup receiving the 

greatest exposure. There are no 

residential uses for acetochlor that 

result in chronic residential exposure to 

acetochlor. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Acetochlor is not registered for use on 

any sites that would result in residential 

exposure. Therefore, an aggregate risk 

assessment for this duration is not 

appropriate. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Acetochlor is not registered for use on 

any sites that would result in residential 

exposure. Therefore, an aggregate risk 

assessment for this duration is not 

appropriate. 

5. Aggregate cancer risk for U.S. 

population. As explained above, in Unit 

III.C.iii., the cRfD is considered to be 

protective of any cancer risk posed by 

acetochlor and as discussed in Unit E2, 

EPA has found that chronic acetochlor 

exposure does not exceed the cRfD; 

therefore, aggregate cancer risks are not 

of concern. 


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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. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate high performance liquid 

chromatography with oxidative 

coulometric electrochemical detector 

(HPLC/OCED) method is available for 

enforcing new tolerances for acetochlor 

and its metabolites in sweet corn, 

sorghum, and rotational crops. This 

method is listed as Method I for plants 

in PAM Vol. II. 

B. International Residue Limits 

There are no Codex Maximum 

Residue Levels established for 

acetochlor on agricultural commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acetochlor (2-chloro-2’- 

methyl-6-ethyl-Nethoxymethylacetamide) and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl aniline (HEMA) 

moiety to be analyzed as acetochlor, and 

expressed as acetochlor equivalents as 

discussed in Unit II. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) 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 6, 2000) do not apply 

to this rule. In addition, This 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: May 8, 2007. 

Donald R. Stubbs, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—AMENDED 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.470 is revised to read 

as follows: 

§ 180.470 Acetochlor; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of acetochlor; 2- 

chloro-2’-methyl-6-ethyl-Nethoxymethylacetanilide, and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl aniline (HEMA) 

moiety, to be analyzed as acetochlor and 

expressed as acetochlor equivalents, in 

or on the following raw agricultural 

commodities. 

Commodity Parts per million 

Corn, field, forage ........... 3.0 

Corn, field, grain ............. 0.05 

Corn, field, stover ........... 1.5 

Corn, pop, grain .............. 0.05 

Corn, pop, stover ............ 1.5 

Corn, sweet, forage ........ 1.5 

Corn, sweet, kernels plus 

cob with husks removed ......................... 0.05 

Corn, sweet, stover ........ 1.0 

Sorghum, grain, forage ... 1.6 

Sorghum, grain, grain ..... 0.05 

Sorghum, grain, stover ... 1.7 

(b) Section 18 emergency exemptions. 

[Reserved]. 

(c) Tolerances with regional 

registrations. [Reserved]. 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent residues of acetochlor; 2- 

chloro-2’-methyl-6-ethyl-Nethoxymethylacetanilide, and its 

metabolites containing the ethyl methyl 

aniline (EMA) moiety and the 

hydroxyethyl methyl aniline (HEMA) 

moiety, to be analyzed as acetochlor and 

expressed as acetochlor equivalents, in 

or on the following raw agricultural 

commodities when present therein as a 

result of application of acetochlor to the 

growing crops in paragraph (a) of this 

section: 


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Commodity Parts per million 

Animal feed, nongrass, group 18, forage ........................................................................................................................................ 1.3 

Animal feed, nongrass, group 18, hay ............................................................................................................................................ 3.5 

Beet, sugar, root .............................................................................................................................................................................. 0.05 

Beet, sugar, tops ............................................................................................................................................................................. 0.05 

Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, forage ..................................... 0.5 

Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, hay ......................................... 2.0 

Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, stover ..................................... 0.1 

Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, straw ....................................... 0.3 

Grain, cereal, group 15, except corn, grain sorghum, rice, and wheat, grain ................................................................................ 0.05 

Pea and bean, dried shelled, except soybean, subgroup 6C ......................................................................................................... 0.05 

Potato ............................................................................................................................................................................................... 0.05 

Soybean, forage .............................................................................................................................................................................. 0.7 

Soybean, hay ................................................................................................................................................................................... 1.0 

Soybean, seed ................................................................................................................................................................................. 0.1 

Sunflower, seed ............................................................................................................................................................................... 0.05 

Wheat, forage .................................................................................................................................................................................. 0.5 

Wheat, grain .................................................................................................................................................................................... 0.02 

Wheat, hay ....................................................................................................................................................................................... 2.0 

Wheat, straw .................................................................................................................................................................................... 0.1 

[FR Doc. E7–9430 Filed 5–15–07; 8:45 am] 

BILLING CODE 6560–50–S 


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