8916 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

such as the exemption 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. In 

addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

XII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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 rule in 

the Federal Register. This rule is not a 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 14, 2007. 

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

■ 2. In § 180.960 the table is amended 

by alphabetically adding a polymer to 

read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

Polymer CAS No. 

* * * * * 

2-Propenoic acid, 

methyl ester, polymer with ethenyl 

acetate, 

hydrolyzed, sodium 

salts..

886993–11–9 

Polymer CAS No. 

* * * * * 

[FR Doc. E7–3118 Filed 2–27–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0321; FRL–8115–8] 

Sethoxydim; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

sethoxydim {2-[1-(ethoxyimino)butyl]- 

5-[2-(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one }and its metabolites 

containing the 2-cyclohexen-1-one 

moiety (calculated as sethoxydim) in or 

on buckwheat grain, buckwheat flour, 

okra, borage seed, borage meal, fresh 

dillweed leaves, radish tops, turnip 

greens, and vegetable, root and tuber, 

group 1. Interregional Research Project 

No. 4 (IR-4) requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). 

DATES: This regulation is effective 

February 28, 2007. Objections and 

requests for hearings must be received 

on or before April 30, 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–2006–0321. All documents in the 

docket are listed in the index for the 

docket. 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 Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 


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Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 8917 

excluding legal holidays. The Docket 

telephone number is (703) 305-5805. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Madden, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 305-6463; e-mail address: 

Madden.Barbara@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

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 provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0321 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before April 30, 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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0321, 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 Building), 2777 S. 

Crystal Drive, 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. Background and Statutory Findings 

In the Federal Register of July 5, 2006 

(71 FR 38154) (FRL–8074–7), 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 0E6204 and 

4E6885) by IR-4, 500 College Road East, 

Suite 201 W, Princeton, NJ 08540. The 

petitions requested that 40 CFR 180.412 

be amended by establishing tolerances 

for combined residues of the herbicide 

sethoxydim {2-[1-(ethoxyimino)butyl]- 

5-[2-(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one} and its metabolites 

containing the 2-cyclohexen-1-one 

moiety in or on turnip tops at 5.0 parts 

per million (ppm) (PP 0E6204) and 

buckwheat, grain at 20 ppm; buckwheat, 

flour at 20 ppm; borage; seed at 5.0 

ppm; borage, meal at 40 ppm; borage, oil 

at 40 ppm; dill, fresh leaves at 10 ppm; 

dill, dried leaves at 10 ppm; okra at 4.0 

ppm; vegetable root, except sugar beet, 

group 1B at 4.0 ppm; and radish tops at 

5.0 ppm (4E6885). That notice 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, that is available in EPA’s 

electronic docket. There were no 

comments received in response to the 

notice of filing. 

Upon completing review of the 

current sethoxydim database, the 

Agency concluded that the appropriate 

tolerance levels and preferred 

commodity terms for sethoxydim 

residues in or on pending crops should 

be established as follows: Buckwheat, 

grain at 19 ppm; buckwheat, flour at 25 

ppm; okra at 2.5 ppm; borage, seed at 

6.0 ppm; borage, meal at 10 ppm; 

dillweed, fresh leaves at 10 ppm; radish, 

tops at 4.5 ppm; turnip, greens at 5.0 

ppm and Vegetable, root and tuber, 

group 1 at 4.0 ppm. Vegetable, root and 

tuber, group 1 incorporates both the 

request for vegetable root, except sugar 

beet, group 1B at 4.0 ppm and existing 

tolerances for carrot, roots at 1.0 ppm; 

horseradish at 4.0 ppm; beet, garden at 

1.0 ppm; beet, sugar, root at 1.0 ppm; 

and tuberous and corm vegetable 

subgroup 1D at 4.0 ppm. Turnip, greens 

replaces the term turnip tops. In 

addition, the proposed tolerance for 

borage oil was withdrawn because no 

separate tolerance is required since oil 

is covered by the borage seed tolerance 

and the proposed tolerance for dill, 

dried leaves was withdrawn because no 

separate tolerance is required since 

dried dillweed is covered by the fresh 

dillweed tolerance. 

EPA is also deleting several 

established tolerances in section 

180.412(a) that are no longer needed as 

a result of this action. The revisions to 

section 180.412(a) are as follows: Delete 

beet, garden at 1.0 ppm; beet, sugar, 

roots at 1.0 ppm; carrot, roots at 1.0 

ppm; horseradish at 4.0 ppm; and 

tuberous and corm vegetable crop 

subgroup at 4.0 ppm. All of these 

tolerances are replaced with vegetable, 

root and tuber, group 1 at 4.0 ppm. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 


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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. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm and 

http://www.epa.gov/fedrgstr/EPA-PEST/ 

2003/July/Day-30/p19357.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for combined 

residues of sethoxydim and its 

metabolites containing the 2- 

cyclohexen-1-one moiety on buckwheat, 

grain at 19 ppm; buckwheat, flour at 25 

ppm; okra at 2.5 ppm; borage, seed at 

6.0 ppm; borage, meal at 10 ppm; 

dillweed, fresh leaves at 10 ppm; radish, 

tops at 4.5 ppm; turnip, greens at 5.0 

ppm and vegetable, root and tuber, 

group 1 at 4.0 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

sethoxydim as well as the no-observedadverse-effect-level (the NOAEL) and 

the lowest-observed-adverse-effect-level 

(the LOAEL) from the toxicity studies 

can be found in the final rule published 

in the Federal Register of September 29, 

2003 (68 FR 55858) (http:// 

www.epa.gov/EPA-PEST/2003/ 

September/Day-29/p24562.htm). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which the (NOAEL) 

from the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the 

(LOAEL) of concern are identified is 

sometimes used for risk assessment if no 

NOAEL was achieved in the toxicology 

study selected. An uncertainty factor 

(UF) is applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at be found on the 

general principles EPA uses in risk 

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

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for sethoxydim used for 

human risk assessment can be found at 

www.regulations.gov in document 0003 

(page 9) in Docket ID EPA–HQ–OPP–

2006–0321. To locate this information 

on the Regulations.gov website follow 

these steps: 

Select ‘‘Advanced Search’’, then 

‘‘Docket Search.’’

In the ‘‘Keyword’’ field type the 

chemical name or insert the applicable 

‘‘Docket ID number.’’ (example: EPA–

HQ–OPP–2005–9999). 

Click the ‘‘Submit’’button. 

Follow the instructions on the 

regulations.gov web site to view the 

index for the docket and access 

available documents. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.412) for the 

combined residues of sethoxydim and 

its 2-cyclohexen-1-one moiety 

containing metabolites, in or on a 

variety of raw agricultural commodities. 

Tolerances have also been established 

for combined residues of sethoxydim in 

or on milk, egg, and fat, meat, and meat 

byproducts of cattle, goat, hog, horse, 

poultry and sheep. Risk assessments 

were conducted by EPA to assess 

dietary exposures from sethoxydim 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 one-day or 

single exposure. 

In conducting the acute dietary 

exposure assessment EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: For all proposed new uses 

and for all commodities in Vegetable, 

root and tuber, group 1, tolerance level 

residues and 100 percent crop treated 

(PCT) were assumed. For the remaining 

crops with existing tolerances available 

maximum PCT values were used. 

Tolerance level residues were assumed 

for most crops except for grapes, 

oranges, potatoes, tomatoes, 

strawberries, apples, pears and other 

pome fruits where anticipated residues 

were calculated through the 

incorporation of field trial data. 

Empirical processing data for apples, 

grapes, tomatoes, potatoes and oranges 

were used, and were sometimes 

translated to other members of the crop 

group. For livestock commodities, the 

available PCT information was 

incorporated into the dietary burden 

calculation and the feeding studies were 

used to determine the appropriate 

residue level, however at least one food 

item in each diet was assumed to be 100 

PCT. PCT information was incorporated 

into the acute exposure and risk 

assessments through use of probabilistic 

risk assessment model. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEMTM software with 

the Food Commodity Intake Database, 

which incorporates food consumption 

data as reported by respondents in the 

United States Department of Agriculture 


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(USDA) 1994-1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII), and 

accumulated exposure to the chemical 

for each commodity. The following 

assumptions were made for the chronic 

exposure assessments: For the proposed 

new uses and all commodities in 

Vegetable, root and tuber, group 1 

tolerance level residues and 100% CT 

were assumed. For most of the crops 

with existing tolerances, tolerance level 

residues and average PCT values were 

assumed. PCT data for some livestock 

feeds were incorporated into the 

calculations of the theoretical dietary 

burdens for livestock, which were then 

used in conjunction with the available 

feeding studies to determine the 

anticipated residues in livestock 

commodities. 

iii. Cancer. The Agency has classified 

sethoxydim as not likely to be a human 

carcinogen based on lack of evidence of 

carcinogenicity in rats and mice. 

Therefore, a cancer dietary exposure 

assessment was not performed 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of the 

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 

chemicals that have been measured in 

food. If EPA relies on such information, 

EPA must pursuant to section 408(f)(1) 

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. Following the initial 

data submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 

action, EPA will issue such Data CallIns for information relating to 

anticipated residues as are required by 

FFDCA section 408(b)(2)(E) and 

authorized under FFDCA section 

408(f)(1). Such Data Call-Ins will be 

required to be submitted no later than 

5 years from the date of issuance of this 

tolerance. 

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

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if the 

Agency can make the following 

findings: Condition 1, that the data used 

are reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain such pesticide residue; 

Condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

Condition 3, if data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

section 408(b)(2)(F) of FFDCA, EPA may 

require registrants to submit data on 

PCT. 

The Agency used PCT information for 

the chronic dietary risk assessment as 

follows: 1% apples, 1% apricots, 6% 

globe artichokes, 5% asparagus, 14% 

dry beans, 9% lima beans, 8% snap 

beans, 5% garden beet tops, 1% 

broccoli, 5% cabbage, 8% cantaloupes, 

2% cauliflower, 1% cherries, 2% 

collards, 1% corn, 1% cotton, 8% 

cranberries, 6% cucumbers, 5% 

eggplants, 38% flax, 1% grapes, 1% 

grapefruits, 5% lemons, 1% lettuce, 1% 

nectarines, 3% oranges, 2% succulent 

peas, 14% dry peas, 1% peaches, 5% 

peanuts, 1% pears, 3% bell peppers, 6% 

nonbell peppers, 4% potatoes, 8% 

pumpkins, 4% rapeseed, 6% rhubarb, 

2% soybeans, 1% spinach, 8% summer 

squash, 5% strawberry, 14% sunflower, 

4% tomatoes, 5% turnip greens, and 

12% watermelons. 

EPA uses an average PCT for chronic 

dietary risk analysis. The average PCT 

figure for each existing use is derived by 

combining available Federal, State, and 

private market survey data for that use, 

averaging by year, averaging across all 

years, and rounding up to the nearest 

multiple of five percent except for those 

situations in which the average PCT is 

less than one. In those cases <1% is 

used as the average and <2.5% is used 

as the maximum. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the single 

maximum value reported overall from 

available federal, state, and private 

market survey data on the existing use, 

across all years, and rounded up to the 

nearest multiple of five percent. In most 

cases, EPA uses available data from 

United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

Proprietary Market Surveys, and the 

National Center for Food and 

Agriculture Policy (NCFAP) for the most 

recent six years. 

The Agency believes that the three 

conditions listed III.C.1.iv. have been 

met. With respect to Condition 1, PCT 

estimates are derived from Federal and 

private market survey data, which are 

reliable and have a valid basis. The 

Agency is reasonably certain that the 

percentage of the food treated is not 

likely to be an underestimation. As to 

Conditions 2 and 3, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available information on the 

regional consumption of food to which 

sethoxydim may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

sethoxydim in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

sethoxydim. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the First Index Screening 

Tool Reservoir (FIRST) and Screening 

Concentration in Groundwater (SCIGROW) models, the estimated 

environmental concentrations (EECs) of 

sethoxydim for acute exposures are 

estimated to be 130 parts per billion 

(ppb) for surface water and 1.5 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 16 ppb for 

surface water and 1.5 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 130 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration 

value of 16 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). 

Sethoxydim is currently registered for 

use on the following residential nondietary sites: Ornamentals and flowering 


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8920 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 

plants, recreational areas, rights-of-way, 

along fences and hedgerows, and public 

and commercial buildings/structures 

(non-agricultural-outdoors). The risk 

assessment was conducted using the 

following residential exposure 

assumptions: Homeowners who apply 

sethoxydim to ornamental gardens and 

turf may be exposed for short-term (up 

to 30 days) durations via the dermal and 

inhalation routes. Short-term post 

application exposures to children may 

result from incidental oral contact via 

hand-to-mouth, turf-to-mouth, and soilto-mouth activities with treated turf. No 

dermal toxicity endpoints were 

identified, therefore, only exposure from 

inhalation (adult handlers) and 

incidental ingestion (children) were 

assessed. For short-term and 

intermediate-term aggregate exposure, 

the inhalation exposures estimated for 

adult handlers cannot be combined with 

dietary exposure due to lack of common 

toxicity via the oral [transitory clinical 

signs: Irregular gait at doses of 650 

milligrams/kilogram (mg/kg) and 1,000 

mg/kg and inhalation (hepatotoxicity)] 

routes of exposure. Therefore, only 

short-term aggregate exposures from 

incidental ingestion for children via 

hand-to-mouth, turf-to-mouth, and soilto-mouth activities with treated turf 

were assessed. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

sethoxydim and any other substances 

and sethoxydim does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that sethoxydim has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional 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. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

Since there is evidence of increased 

susceptibility of the young following 

exposure to sethoxydim in the rat 

developmental study and the rat 

reproduction study, the EPA performed 

a Degree of Concern Analysis to: 1. 

Determine the level of concern for the 

effects observed when considered in the 

context of all available toxicity data; and 

2. Identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment of this chemical. 

If residual uncertainties are identified, 

EPA examines whether these residual 

uncertainties can be addressed by a 

special FQPA safety factor and, if so, the 

size of the factor needed. The results of 

Degree of Concern analysis for 

sethoxydim are presented as follows: 

The degree of concern is low for the 

fetal effects in the developmental rat 

study since the fetal anomalies were 

seen only at the high dose (650 mg/kg/ 

day) which is close to the Limit Dose 

(1,000 mg/kg/day), they were seen in the 

presence of maternal toxicity (irregular 

gait) and clear NOAELs/LOAELs were 

established for maternal and 

developmental toxicities. 

EPA has determined that the degree of 

concern was low for prenatal and/or 

postnatal toxicity resulting from 

exposure to sethoxydim toxicity. 

3. Conclusion. In the final rule 

published in the Federal Register of 

September 29, 2003 (68 FR 55858) 

(FRL–7328–6) (http://www.epa.gov/ 

EPA-PEST/2003/September/Day-29/ 

p24562.htm). EPA retained the 

additional 10X FQPA safety factor in the 

form of a Data base Uncertainty Factor 

because EPA had required submission 

of subchronic and developmental 

neurotoxicity studies due to various 

clinical signs in the rat developmental 

study and evidence of developmental 

abnormalities in the rat developmental 

and reproductive studies. In December 

of 2004, the EPA revisited the 

requirement for the subchronic and 

developmental neurotoxicity studies 

and determined that the evidence does 

not support the need for neurotoxicity 

studies for the reasons discussed below. 

First, EPA concluded that the clinical 

signs seen in the rat developmental 

study were not neurotoxicity. The 

clinical signs following sethoxydim 

exposure in that study were irregular 

gait, decreased activity, excessive 

salivation, and anogenital staining. 

These effects were only observed in 

animals receiving very high doses of 

sethoxydim (650 mg/kg/day and 1,000 

mg/kg/day). Irregular gait was observed 

in 12/24 dams at 650 mg/kg/day and 10/ 

10 dams at 1,000 mg/kg/day on the first 

day of dosing, after 3 doses the signs 

began to dissipate. Decreased activity 

was noted in 1/34 dams at 650 mg/kg/ 

day and in 4/10 dams at 1,000 mg/kg/ 

day and reversed after several days. 

Excessive salivation was noted in 23/34 

dams at 650 mg/kg/day and 10/10 dams 

at 1,000 mg/kg/day. Anogenital staining 

was documented in 13/34 dams at 650 

mg/kg/day and 7/10 dams at 1,000 mg/ 

kg/day. All clinical signs reported were 

transient, with the exception of the 

anogenital staining which did not 

reverse. Because the clinical signs 

occurred shortly after dosing, only 

occurred at very high treatment doses 

(over one half the limit dose) and were 

transitory, it is unlikely that the signs 

observed are the result of a primary 

systemic effect on the nervous system 

but, rather, are reflective of the general 

toxicity at the high dose. It should be 

noted that clinical signs indicative of 

nervous system effects were not 

observed in any other standard toxicity 

study for sethoxydim. Although none of 

these other studies dosed up to 650 and 

1,000 mg/kg/day, a maximum tested 

dose was reached because of evidence of 

other toxicities (e.g., liver effects or 

body weight reductions). 

Second, EPA found that there were no 

developmental effects seen in the rat 

and rabbit prenatal studies indicative of 

an effect on the nervous system. The 

main effect seen in the rat and rabbit 

prenatal studies was an increased 

incidence of fetal skeletal variations due 


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Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 8921 

to delayed ossification. In the rat 

prenatal study, tail abnormalities 

(filamentous tail or lack of a tail) were 

noted. These abnormalities were 

observed at a very low incidence (10 

fetuses in 7 litters, 650 milligrams/ 

kilogram/body weight/day (mg/kg/bwt/ 

day and at high treatment doses (650 

and 1,000 mg/kg/day). In the 2- 

generation reproduction study in rat, a 

tail anomaly (short, thread-like tail, no 

anal opening, hindlimbs curved toward 

central midline) was found in one pup 

in the F2b generation (1/344 total pups; 

in 1/4 litters). Tail abnormalities are 

sometimes thought to relate to central 

nervous system (CNS) malformations; 

however, in this case, these tail 

abnormalities are not likely to be the 

result of a primary neurotube effect. In 

the rat prenatal study, there is no 

description of any effect on neural tube 

derived structures. Furthermore, the 

class of compounds, cyclohexones 

(which sethoxydim is a member), do not 

demonstrate neurotoxicity or 

developmental malformations of the 

nervous system. 

Therefore, after a weight-of-evidence 

examination of all the toxicological 

studies available in the data base, the 

previous requirement for a neurotoxicity 

studies have been waived. 

In light of its finding that 

neurotoxicity studies are not needed, 

EPA has now determined that reliable 

data show that it would be safe for 

infants and children to reduce the FQPA 

safety factor to 1X. That decision is 

based on the following findings: 

1. The toxicity database for 

sethoxydim is complete. 

2. There is no indication that 

sethoxydim is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors to account 

for neurotoxicity. 

3. Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental studies in 

rats and rabbits, the risk assessment 

team did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional uncertainty 

factors to be used in the risk assessment 

for sethoxydim. The degree of concern 

for pre-and/or postnatal toxicity is low. 

4. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on tolerance level 

residues and 100 PCT for all proposed 

new uses and for all commodities in 

Vegetable, root and tuber, group 1. For 

most of the remaining crops available 

maximum PCT treated values were used 

for acute dietary assessment and average 

PCT values were assumed for chronic 

dietary assessment. Tolerance level 

residues were assumed for crops with 

existing tolerances or anticipated 

residues were calculated through the 

incorporation of field trial data. 

Conservative ground and surface water 

modeling estimates were used. Similarly 

conservative Residential SOPs were 

used to assess post-application exposure 

to children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by sethoxydim. 

E. Aggregate Risks and Determination of 

Safety 

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. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given aggregate exposure. Shortterm, 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. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

sethoxydim will occupy 11% of the 

aPAD for the U.S. population, 7.2% of 

the aPAD for females 13 years and older, 

14% of the aPAD for all infants (<1 year 

old), and 20% of the aPAD for children 

1-2 years old, the subpopulation at 

greatest exposure 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to sethoxydim from food 

and water will utilize 6.9% of the cPAD 

for the U.S. population, 15% of the 

cPAD for all infants (<1 year old), and 

16% of the cPAD for children 1-2 years 

old, the subpopulation at greatest 

exposure. Based on the use pattern, 

chronic residential exposure to residues 

of sethoxydim is not expected. 

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). 

Sethoxydim is currently registered for 

use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for sethoxydim. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water and residential exposures 

aggregated result in aggregate MOEs of 

5,700 for children/toddlers 1-2 years of 

age. Since this is the subpopulation 

with the highest estimated food and 

water exposures and the calculated 

MOE of 5,700 is substantially greater 

than the target MOE of 100 EPA has no 

concern for short-term aggregate risk for 

other subpopulations as well. 

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). 

Though residential exposure could 

occur with the use of sethoxydim 

intermediate-term exposures are not 

expected. Only risks associated with 

short-term exposures of up to 30 days 

were assessed. 

5. Aggregate cancer risk for U.S. 

population. The Agency has classified 

sethoxydim as not likely to be a human 

carcinogen based on lack of evidence of 

carcinogenicity in rats and mice. 

Sethoxydim is not expected to pose a 

cancer risk. 

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, and to infants and children 

from aggregate exposure to sethoxydim 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas-liquid chromatography with flame 

photometric detection in the sulfur 

mode) is available BASF Wyandotte 

Corporations’ (BWCs) Method No. 30, 3/ 

15/82; MRID 44864501; Method I, PAM 

II to enforce the tolerance expression for 

the purpose of this request. 

B. International Residue Limits 

There are currently no Codex 

maximum residue levels for 

sethoxydim. 

V. Conclusion 

Therefore, the tolerance is established 

for combined residues of sethoxydim 

{2-[1-(ethoxyimino)butyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one}and its metabolites 

containing the 2-cyclohexen-1-one 

moiety (calculated as sethoxydim), in or 

on buckwheat, grain at 19 ppm; 

buckwheat, flour at 25 ppm; okra at 2.5 

ppm; borage, seed at 6.0 ppm; borage, 

meal at 10 ppm; dillweed, fresh leaves 


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8922 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 

at 10 ppm; radish, tops at 4.5 ppm; 

turnip, greens at 5.0 ppm and vegetable, 

root and tuber, group 1 at 4.0 ppm. 

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 due to its lack of 

significance, 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). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 13, 2007. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.412 is amended in 

paragraph (a), in the table, by removing 

the commodities ‘‘Beet, garden’’, ‘‘Beet, 

sugar, roots’’, ‘‘Carrot, roots’’

‘‘Horseradish’’, and ‘‘Tuberous and 

corm vegetable crop subgroup’’; and 

alphabetically adding commodities to 

read as follows: 

§180.412 Sethoxydim: Tolerances for 

residues. 

(a) *** 

Commodity Parts per million 

*****

Borage, meal ................................................................................................................................................... 10 

Borage, seed ................................................................................................................................................... 6.0 

Buckwheat, flour .............................................................................................................................................. 25 

Buckwheat, grain ............................................................................................................................................. 19 

*****

Dillweed, fresh leaves ...................................................................................................................................... 10 

*****

Okra ................................................................................................................................................................. 2.5 


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Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 8923 

Commodity Parts per million 

*****

Radish, tops ..................................................................................................................................................... 4.5 

*****

Turnip, greens .................................................................................................................................................. 5.0 

*****

Vegetable, root and tuber, group 1 ................................................................................................................. 4.0 

[FR Doc. E7–3010 Filed 2–27–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0205; FRL–8113–8] 

Halosulfuron-methyl; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of halosulfuronmethyl in or on the commodities alfalfa, 

forage at 1.0 parts per million (ppm) and 

alfalfa, hay at 2.0 ppm. Gowan Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

The Agency is also correcting the 

tolerance expression for 40 CFR 

180.479(a)(1) with this regulation. The 

tolerance expression is being corrected 

because the metabolites were 

inadvertently deleted from the most 

recent edition of 40 CFR 180.479. 

DATES: This regulation is effective 

February 28, 2007. Objections and 

requests for hearings must be received 

on or before April 30, 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–2006–0205. 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 

website 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 

Facility 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: 

• 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 

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 provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0205 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before April 30, 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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0205, by one of 

the following methods: 


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