26304 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

B. Analytical Method(s) 

A method for extraction and ELISA 

analysis of the Vip3Aa19 protein in 

cotton has been submitted and is under 

review by the Agency. For the 

temporary tolerance exemption, the 

ELISA method described with the 

expression data is sufficient. 

C. Codex Maximum Residue Level 

No Codex maximum residue levels 

exist for the PIP Bacillus thuringiensis 

Vip3Aa19 protein and the genetic 

material necessary for its production in 

cotton. 

VIII. 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). 

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 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 26, 2007. 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

[PART 174—AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

Authority: 7 U.S.C. 136-136y; 21 U.S.C. 

346a and 371. 

■ 2. Section 174.452 is revised to read 

as follows: 

§ 174.452 Bacillus thuringiensis Vip3Aa19 

protein in cotton; temporary exemption 

from the requirement of a tolerance. 

Residues of Bacillus thuringiensis 

Vip3Aa19 protein in cotton are 

temporarily exempt from the 

requirement of a tolerance when used as 

a plant-incorporated protectant (PIP) in 

the food and feed commodities of 

cotton; vegetative-insecticidal protein in 

cotton seed, cotton oil, cotton meal, 

cotton hay, cotton hulls, cotton forage, 

and cotton gin byproducts. This 

temporary exemption from the 

requirement of tolerance will permit the 

use of the food commodities in this 

section when treated in accordance with 

the provisions of the experimental use 

permit (EUP) 67979–EUP–7, which is 

being issued in accordance with the 

provisions of the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), as amended (7 U.S.C. 136). 

This temporary exemption from the 

requirement of a tolerance expires and 

is revoked May 1, 2008. However, if the 

EUP is revoked, or if any experience 

with or scientific data on this pesticide 

indicate that the temporary tolerance 

exemption is not safe, this temporary 

exemption from the requirement of a 

tolerance may be revoked at any time. 

[FR Doc. E7–8951 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0965; FRL–8124–2] 

Flufenacet; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

pesticide tolerances under the Federal 

Food, Drug, and Cosmetic Act (FFDCA) 

for combined residues of flufenacet and 

its metabolites containing the 4-fluoroN-methylethyl benzenamine moiety in 

or on grass (forage, hay), sweet corn 

(forage, kernel plus cob with husk 

removed, stover), wheat (bran, forage, 

grain, hay, straw), cattle kidney, goat 

kidney, hog kidney, horse kidney, and 

sheep kidney. Bayer Cropscience 

petitioned EPA to establish these 

tolerances. 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 2007, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 


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Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0965. 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 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: Jim 

Tompkins, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail address: 

tompkins.jim@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 

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 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 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–2006–0965 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 July 9, 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–2006–0965, 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 Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of December 

20, 2006 (71 FR 76321) (FRL–8104–4), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP 0F6095) by Bayer 

CropScience, 2 T.W. Alexander Dr., 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.527 

be amended by establishing a tolerance 

for combined residues of the herbicide 

flufenacet (N-(4-fluorophenyl)-N-(1- 

methylethyl)-2-[[5-(trifluoromethyl)- 

1,3,4-thiadiazol-2-yl] oxy] acetamide 

and its metabolites containing the 4- 

fluoro-N-methylethyl benzenamine 

moiety in or on the food commodities: 

corn, sweet, forage at 0.4 parts per 

million (ppm); corn, sweet, kernel plus 

cob with husks removed at 0.05 ppm; 

corn, sweet, stover at 0.4 ppm; wheat, 

forage at 10.0 ppm; wheat, grain at 1.0 

ppm; wheat, hay at 2.0 ppm; wheat, 

straw at 0.5 ppm; seed-grass, forage at 

7.0 ppm; seed-grass, forage, regrowth at 

0.1 ppm; seed-grass, hay, regrowth at 0.5 

ppm. That notice included a summary 

of the petition prepared by Bayer 

CropScience, the registrant. There were 

no comments received in response to 

the notice of filing. 

After completing a review of the 

submitted data, the Agency determined 

that additional tolerances are needed in 

connection with the petitioned-for 

tolerances for wheat bran 0.80 ppm, 

grass forage at 7.0 ppm, and grass hay 

at 0.4 ppm, cattle kidney at 0.05 ppm, 

goat kidney at 0.05 ppm, hog kidney at 

0.05 ppm, horse kidney at 0.05 ppm, 

and sheep kidney at 0.05 ppm. EPA 

determined that tolerance levels are 

needed that differ from those proposed 

by the registrant for sweet corn forage at 

0.45 ppm (0.4 ppm proposed) sweet 

corn stover at 0.30 ppm, (0.4 ppm 

proposed) wheat forage at 6.0 ppm (10.0 

ppm proposed), wheat grain at 0.60 ppm 

(1.0 ppm proposed), wheat hay at 1.2 

ppm (2.0 ppm proposed), and wheat 

straw at 0.35 ppm (0.5 ppm proposed). 

EPA determined that tolerances are not 

necessary for fat, meat, and meat 

byproducts of cattle, goat, hog, horse, 


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and sheep. Since permanent tolerances 

are being established for wheat and 

kidney of cattle, goat, hog, horse, and 

sheep, emergency exemption tolerances 

for these commodities are being deleted. 

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. . . .’’

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. 

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 a tolerance for combined 

residues of flufenacet. 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 

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

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

in the document, entitled Flufenacet: 

HED Human Health Risk Assessment for 

Uses on Wheat, Perennial Grasses 

Grown for Seed and Sweet Corn which 

is in the docket for this rule. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (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 lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) 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 http://www.epa.gov/ 

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for flufenacet used for human 

risk assessment can be found in Table 

4 (p.14) of the document, entitled 

Flufenacet: HED Human Health Risk 

Assessment for Uses on Wheat, 

Perennial Grasses Grown for Seed and 

Sweet Corn which is in the docket for 

this rule. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.527) for the 

combined residues of flufenacet and its 

metabolites, in or on a variety of raw 

agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from flufenacet 

in food from existing and proposed 

tolerances 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. 

The Dietary Exposure Evaluation 

Model (DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1988 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: Anticipated residues for 

many crops (field corn, soybean, sweet 

corn, and wheat) were developed using 

field trial data. Anticipated residues for 

livestock commodities were derived 

using available feeding and metabolism 

studies in conjunction with the 

anticipated dietary burden to ruminants, 

swine and poultry. Tolerance level 

residues were used to assess flufenacet 

exposure from the remaining 

commodities (i.e., cereal grains other 

than wheat). Exposure estimates for all 

commodities were further refined using 

percent crop treated (PCT) data. 

Projected PCT data were used to refine 

anticipated residues for the new food 

uses (sweet corn and wheat). Available 

processing data were used to refine 

anticipated residues for cereal grains 

and corn. For all other processed 

commodities, DEEM (ver. 7.81) default 

processing factors were assumed. 

ii. Chronic exposure. In conducting 

the chronic 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 CSFII, and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the chronic exposure 

assessments: Anticipated residues for 

many crops (field corn, soybean, sweet 

corn, and wheat) were developed using 

field trial data. Anticipated residues for 

livestock commodities were derived 

using available feeding and metabolism 

studies in conjunction with the 

anticipated dietary burden to ruminants, 

swine and poultry. Tolerance level 

residues were used to assess flufenacet 

exposure from the remaining 

commodities (i.e., cereal grains). 

Exposure estimates for all commodities 

were further refined using PCT data. 

Projected PCT data were used to refine 

anticipated residues for the new food 

uses (sweet corn and wheat). Available 

processing data were used to refine 

anticipated residues for cereal grains 

and corn. For all other processed 


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commodities, DEEM (ver. 7.81) default 

processing factors were assumed. 

iii. Cancer. A cancer aggregate 

exposure assessment was not performed 

because flufenacet is not carcinogenic. 

iv. Anticipated residue and 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 

chemicals that have been measured in 

food. If EPA relies on such information, 

EPA must pursuant 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. 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 

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

authorized under section 408(f)(1) of 

FFDCA. 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 as 

follows: 

Chronic and acute dietary exposure 

analyses for sweet corn were based on 

projected PCT when treated with 

flufenacet of an average of 3% (used for 

chronic exposure assessment) and a 

maximum of 10% (used for acute 

exposure assessment). These projected 

PCT estimates were based on the 

following. Flufenacet has been 

registered and used on field corn since 

1998. Field corn and sweet corn are the 

same species and there are many weeds 

and herbicides used to control those 

weeds which are common to the two 

crops. Therefore the use of flufenacet on 

field corn was used as the basis for 

predicting flufenacet use on sweet corn. 

EPA also analyzed other factors based 

on available information that included 

more recent usage of other acetamide 

herbicides on both field corn and sweet 

corn, information on new products 

desired for sweet corn, including 

flufenacet, to combat newly invasive 

weeds and resistant weeds, and 

differences in importance of individual 

herbicides between field corn and sweet 

corn. 

Chronic and acute dietary exposure 

analyses for wheat were based on 

projected PCT when treated with 

flufenacet of an average of 1% and a 

maximum of 3%. These projected PCT 

estimates were based on the following: 

Emergency exemption uses have been 

issued for flufenacet on wheat for 

several years. EPA initially estimated 

the PCT for wheat based on recent PCTs 

for winter wheat due to emergency 

exemption usage. EPA later examined 

acres treated in individual states and 

compared that information to the 

treatment acres permitted under the 

emergency exemptions. EPA also 

analyzed other factors based on 

available information that included 

usage of metribuzin on winter wheat 

(since a new use is the combination 

metribuzin and flufenacet), current and 

past Emergency Exemption requests for 

flufenacet in the Northwest and on the 

East Coast to control resistant Italian 

ryegrass, and more recent usage data. 

For all other commodities, PCT 

estimates were based on a screening 

level usage analysis of pesticide usage 

data from the following sources: 

• USDA-NASS (United States 

Department of Agriculture’s National 

Agricultural Statistics Service)—

pesticide usage data from 1998 to 2003. 

• NCFAP (National Center for Food 

and Agricultural Policy—pesticide 

usage data from 1997 and is only used 

if data is not available from the other 

sources. 

• Private pesticide market research—

pesticide usage data from 1998 to 2004. 

The Agency believes that the three 

conditions previously discussed have 

been met. With respect to Condition 1, 

EPA finds that the PCT information 

described above for flufenacet on sweet 

corn, wheat, and grass forage and other 

commodities with existing registrations 

for flufenacet is reliable and has 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 

flufenacet 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 

flufenacet 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 

flufenacet. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppfeed1/models/water/index. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentrations in Groundwater (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

flufenacet (plus its degradate thiadione 

in surface water) for acute exposures are 

estimated to be 8.64 parts per billion 

(ppb) for surface water and 0.10 ppb for 

ground water. The EECs for chronic 

exposures are estimated to be 2.23 ppb 

for surface water and 0.10 ppb for 

ground 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). 

Flufenacet 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 


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‘‘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 

flufenacet and any other substances and 

flufenacet 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 flufenacet 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. 

There is no indication of additional 

susceptibility of young rats or rabbits 

following prenatal exposure to 

flufenacet in the developmental toxicity 

studies. There was an indication of 

qualitative susceptibility in the 2–

generation reproduction study. Effects 

seen in the offspring in the reproductive 

toxicity studies (including increased 

pup death in early lactation and 

cannibalism) were more severe than 

those seen in the parental animals 

(increased liver weight and cytomegaly), 

although there was no difference in the 

NOAELs/LOAELS between parental 

animals and offspring in that study. 

Increased susceptibility (qualitative and 

quantitative) was seen in the 

developmental neurotoxicity study in 

rats. Decreased body weight was seen in 

pups at all dose levels, and additional 

effects, including decreased motor 

activity, delayed developmental 

landmarks, and decreases in 

morphometric measurements were seen 

at mid and high doses. Morphometric 

measurements were not made at the low 

dose. A slight decrease in body weight 

in mid and high dose dams during early 

lactation may have been due to 

palatability of test substance and was 

not considered adverse. 

The selection of 1.7 milligrams/ 

kilograms/day (mg/kg/day) as a LOAEL 

for the developmental neurotoxicity 

study is considered to be a conservative 

recommendation as to the decreased 

body weight effect, because the decrease 

in pup body weight at that dose is 

transient, and a similar decrease was not 

seen in the 2–generation reproduction 

study (decreased pup body weight seen 

in the 1–generation range-finding 

reproduction study occurred at higher 

doses than those evaluated in the 

developmental neurotoxicity study). 

3. Conclusion. Several factors 

weighed in favor of the conclusion that 

no additional safety factor is needed to 

protect the safety of infants and 

children. First, there was no evidence of 

increased susceptibility in the 

developmental toxicity studies (rats and 

rabbits), and qualitative susceptibility 

seen in the rat reproduction study did 

not raise concerns because the pup 

death may be attributable to maternal 

cannibalism, and there was a clear 

NOAEL for the effect. Second, there are 

also no additional residual uncertainties 

with respect to exposure data: 

•The dietary drinking water 

assessment utilizes water concentration 

values generated by models and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations which will not 

likely be exceeded. 

• Although the exposure assessment 

from pesticide residues in food was 

somewhat refined, the assessment is 

based on reliable data and will not 

underestimate exposure/risk. 

•There are no residential uses for 

flufenacet. 

Nonetheless, for several reasons EPA 

determined that the 10X FQPA Safety 

Factor should be retained. The primary 

reason for retaining the additional safety 

factor is that there is uncertainty 

regarding the protectiveness of selected 

RfDs because of a lack of comparative 

susceptibility data for thyroid hormone 

levels. Secondarily there is also some 

uncertainty due to the lack of a NOAEL 

in the DNT for the decrease in 

morphometric measurements and body 

weight effects in pups and the lack of 

data on comparative sensitivity to 

neuropathologic lesions. Concerns with 

regard to these latter issues are more 

limited given dose response data on the 

morphometric changes indicating that 

these effects would not be expected at 

the low dose, the transient nature of the 

body weight effects seen at the low 

dose, and the fact that neuropathologic 

lesions were only seen at relatively high 

doses. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food plus drinking water 

to flufenacet will occupy 30% of the 

aPAD for the U.S. population, 25% of 

the aPAD for females 13 years and older, 

89% of the aPAD for all infants (< 1 year 

old), and 42% of the aPAD for children 

1–2 years old. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to flufenacet from food 

plus drinking water will utilize 2.9% of 

the cPAD for the U.S. population, 9.2% 

of the cPAD for all infants (< 1 year old), 

and 4.4% of the cPAD for children 1–

2 years old. There are no residential 

uses for flufenacet that result in chronic 

residential exposure to flufenacet. EPA 

does not expect the aggregate exposure 

to exceed 100% of the cPAD. 

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). 

Flufenacet is not registered for use on 

any sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 

water, which do not exceed the 

Agency’s level of concern. 

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). 

Flufenacet is not registered for use on 

any sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 


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water, which do not exceed the 

Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Because flufenacet is 

classified as a ‘‘not likely’’ carcinogen, 

the Agency does not expect exposure to 

flufenacet to result in any 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 flufenacet 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatographic/single ion mode 

(GC/SIM) common moiety method) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

Flufenacet is not in the Codex system, 

i.e., there are no established or pending 

Codex MRLs for flufenacet. Therefore, 

there are no harmonization issues. 

V. Conclusion 

Therefore, the tolerances are 

established for combined residues of 

flufenacet, (N-(4-fluorophenyl)-N-(1- 

methylethyl)-2-[[5-(trifluoromethyl)- 

1,3,4-thiadiazol-2-yl] oxy] acetamide 

and its metabolites containing the 4- 

fluoro-N-methylethyl benzenamine 

moiety, in or on grass forage at 7.0 ppm, 

grass hay at 0.4 ppm, sweet corn forage 

at 0.45, sweet corn kernel plus cob with 

husk removed at 0.05 ppm, sweet corn 

stover at 0.30 ppm, wheat bran at 0.80 

ppm, wheat forage at 6.0 ppm, wheat 

grain at 0.60 ppm, wheat hay at 1.2 

ppm, wheat straw at 0.35 ppm, cattle 

kidney at 0.05 ppm, goat kidney at 0.05 

ppm, hog kidney at 0.05 ppm, horse 

kidney at 0.05 ppm, and sheep kidney 

at 0.05 ppm. Section 18 emergency 

exemption tolerances are deleted for 

flufenacet in or on wheat (forage, grain, 

hay, straw) and fat, kidney, meat, and 

meat byproducts of cattle, goat, hog, 

horse, and sheep. 

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., 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 final 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. 


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26310 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

Dated: May 1, 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 180.527 is amended as 

follows: 

■ i. By revising the section heading; 

■ ii. By revising paragraph (a); 

■ iii. By removing the text of paragraph 

(b) and reserving with heading; 

■ iv. By revising the introductory text of 

paragraph (c) and adding commodities 

to the table; and 

■ v. By revising the introductory text of 

paragraph (d). 

The amendments read as follows: 

§ 180.527 Flufenacet, N-(4-fluorophenyl)-N- 

(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, 

4-thiadiazol-2-yl] oxy]acetamide and its 

metabolites containing the 4-fluoro-Nmethylethyl benzenamine tolerances for 

residues. 

(a) General. Tolerances are 

established for the combined residues of 

the herbicide flufenacet, N-(4- 

fluorophenyl)-N-(1-methylethyl)-2-[[5- 

(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] 

oxy]acetamide and its metabolites 

containing the 4-fluoro-N-methylethyl 

benzenamine moiety in or on the 

following commodities. 

Commodity Parts per million 

Cattle, kidney ........ 0.05 

Corn, field, forage 0.4 

Corn, field, grain ... 0.05 

Corn, field, stover 0.4 

Corn, sweet, forage .................... 0.45 

Corn, sweet, kernel 

plus cob with 

husks removed .. 0.05 

Corn, sweet, stover 0.30 

Goat, kidney ......... 0.05 

Hog, kidney ........... 0.05 

Horse, kidney ........ 0.05 

Sheep, kidney ....... 0.05 

Soybean, seed ...... 0.1 

Wheat, bran .......... 0.80 

Wheat, forage ....... 6.0 

Wheat, grain ......... 0.60 

Wheat, hay ........... 1.2 

Wheat, straw ......... 0.35 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. Tolerances are established 

for combined residues of flufenacet, N- 

(4-fluorophenyl)-N-(1-methylethyl)-2- 

[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2- 

yl] oxy]acetamide, and its metabolites 

containing the 4-fluoro-N-methylethyl 

benzenamine moiety, with regional 

registration. 

Commodity Parts per million 

Grass, forage ........ 7.0 

Grass, hay ............ 0.4 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent residues of the herbicide 

flufenacet, N-(4-fluorophenyl)-N-(1- 

methylethyl)-2-[[5-(trifluoromethyl)- 

1,3,4-thiadiazol-2-yl]oxy]acetamide and 

its metabolites containing the 4-fluoroN-methylethyl benzenamine moiety in 

or on the following raw agricultural 

commodities when present therein as a 

result of application of flufenacet to the 

growing crops in paragraph (a) of this 

section. 

* * * * * 

[FR Doc. E7–8936 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0535; FRL–8127–2] 

Clethodim; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

clethodim and certain of its metabolites 

in or on asparagus; flax, seed; herb, 

subgroup 19A; hop, dried cones; leafy 

greens subgroup 4A; safflower, meal; 

safflower, seed; sesame, seed; and 

vegetable, legume, group 6, except 

soybean. The Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 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–2005–0535. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 305-7610; e-mail address: 

jackson.sidney@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 

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 


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