Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57207

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.

VIII. 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: September 14, 2004.

Lois Rossi,

Director, Registration Division, Office of 

Pesticide Programs.

■ Therefore, 40 CFR part 180 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 180.464 is amended as 

follows:

a. By revising paragraph (a). 

b. By removing and reserving 

paragraph (b).

§ 180.464 Dimethenamid, 2-chloro-N-[(1-

methyl-2-methoxy)ethyl]-N-(2,4-

dimethylthien-3-yl)-acetamide.

(a) General. Tolerances are 

established for residues of the herbicide 

dimethenamid, 1(R,S)-2-chloro-N-[(1-

methyl-2-methoxy)ethyl]-N-(2,4-

dimethylthien-3-yl)-acetamide, applied 

as either the 90:10 or 50:50 S:R isomers, 

in or on the following food 

commodities:

Commodity Parts per 

million 

Bean, dry, seed ........................ 0.01

Beet, garden, roots ................... 0.01

Beet, garden, tops .................... 0.01

Beet, sugar, dried pulp ............. 0.01

Beet, sugar, molasses .............. 0.01

Beet, sugar, roots ..................... 0.01

Beet, sugar, tops ...................... 0.01

Commodity Parts per 

million 

Corn, field, forage ..................... 0.01

Corn, field, grain ....................... 0.01

Corn, field, stover ..................... 0.01

Corn, pop, forage ..................... 0.01

Corn, pop, grain ........................ 0.01

Corn, pop, stover ...................... 0.01

Corn, sweet, forage .................. 0.01

Corn, sweet, kernal plus cob 

with husks removed .............. 0.01

Corn, sweet, stover .................. 0.01

Garlic ........................................ 0.01

Onion, dry bulb ......................... 0.01

Peanut, hay .............................. 0.01

Peanut, nutmeat ....................... 0.01

Shallot, bulb .............................. 0.01

Sorghum, grain ......................... 0.01

Sorghum, grain, forage ............. 0.01

Sorghum, grain, stover ............. 0.01

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

Tuberous and corm vegetables 0.01

(b) Section 18 emergency exemptions.

[Reserved]

[FR Doc. 04–21501 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0293; FRL–7680–2]

Lactofen; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of lactofen in or 

on cotton undelinted seed, cotton gin 

byproducts, and peanut. Valent U.S.A. 

Corporation requested this tolerance 

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 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0293. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket/. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

57208 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This 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:

Joanne I. Miller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6224; e-mail address: 

miller.joanne@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 and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available on E-CFR 

Beta Site Two 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/.

II. Background and Statutory Findings

In the Federal Register of January 29, 

2003 (68 FR 4475) (FRL–7287–6), 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 8F3591 and 

9F3798) by Valent U.S.A. Corporation, 

1333 North California Blvd., Suite 600, 

Walnut Creek, CA 94596–8025. The 

petitions requested that 40 CFR 180.432 

be amended by establishing tolerances 

for residues of the herbicide lactofen, 1-

(carboethoxy)ethyl 5-[2-chloro-4-

(trifluoromethyl)phenoxy]-2-

nitrobenzoate, in or on cottonseed at 

0.01 part per million (ppm), cotton gin 

byproducts at 0.02 ppm (PP 9F3798), 

and peanut nutmeats at 0.01 ppm (PP 

8F3591). That notice included a 

summary of the petitions prepared by 

Valent U.S.A. Corporation, the 

registrant. There were no comments 

received in response to the notice of 

filing.

The proposed and established 

tolerances are corrected to conform to 

the Food and Feed Commodity 

Vocabulary Database (http://

www.epa.gov/pesticides/foodfeed/) and 

to lower the established tolerances for 

snap bean and soybean to 0.01 ppm as 

required by the Lactofen Tolerance 

Reassessment (http://www.epa.gov/

pesticides/reregistration/lactofen/) to 

read as follows: Tolerances for residues 

of the herbicide lactofen, 1-

(carboethoxy)ethyl 5-[2-chloro-4-

(trifluoromethyl)phenoxy]-2-

nitrobenzoate, in or on beans, snap, 

succulent (excluding limas) at 0.01 

ppm; cotton, undelinted seed at 0.01 

ppm; cotton, gin byproducts at 0.02 

ppm; peanut at 0.01 ppm; and soybean, 

seed at 0.01 ppm. 

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 FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7).

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 residues of 

lactofen on cotton, undelinted seed at 

0.01 ppm; cotton, gin byproducts at 0.02 

ppm; and peanut at 0.01 ppm ppm. 

EPA’s assessment of exposures and risks 

associated with establishing the 

tolerances 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. The nature of the 

toxic effects caused by lactofen are 

discussed in Table 1 of this unit as well 

as the no observed adverse effect level 

(NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies reviewed.

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57209

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 13–Week oral toxicity—rodents (rat)NOAEL = 14.1 milligrams/kilogram/day (mg/kg/day). 

LOAEL = 73.7 mg/kg/day based on decreased body weight, increased incidence of 

anemia, increased levels of serum enzymes and bilirubin, decreased levels of glucose, increased liver weights, and increased incidence of microscopic liver lesions.

870.3100 90–Day oral toxicity—rodents (mouse)NOAEL = not established. 

LOAEL = 28.6 mg/kg/day based on changes clinical chemistry parameters, increases in organ weight, and histopathological findings.

870.3700 Prenatal developmental—

rodents (rat)

Maternal NOAEL = 50 mg/kg/day. 

Maternal LOAEL = 150 mg/kg/day based on signs of toxicity (excessive salivation, 

lethargy, dried red material around the nares and inguinal regions) and statistically 

significant decreases in body weight gain.

Developmental NOAEL = 50 mg/kg/day.

Developmental LOAEL = 150 mg/kg/day based on decreased fetal weight and skeletal abnormalities (increased incidence of bent ribs and/or limb bones) and reduced ossification of vertebral arches.

870.3700 Prenatal developmental—

nonrodents (rabbit)

Maternal NOAEL ≥ 20 mg/kg/day. 

Maternal LOAEL > 20 mg/kg/day Highest Dose Tested (HDT).

Developmental NOAEL ≥ 20 mg/kg/day.

Developmental LOAEL > 20 mg/kg/day HDT.

870.3800 Reproduction and fertility 

effects

Parental/Systemic NOAEL = 2.6 mg/kg/day. 

Parental/Systemic LOAEL = 26.2 mg/kg/day based on mortality and decreased male 

fertility.

Reproductive NOAEL = 2.6 mg/kg/day.

Reproductive LOAEL = 26.2 mg/kg/day based on decreased male fertility.

Offspring NOAEL = 2.6 mg/kg/day.

Offspring LOAEL = 26.2 mg/kg/day based on reduced pup body weigh and decreases in the absolute and relative spleen weight.

870.4100 Chronic toxicity—dogs NOAEL = 0.79 mg/kg/day. 

LOAEL = 3.96 mg/kg/day based on increased incidence of proteinaceous casts in 

the kidneys, and statistically significant increases in the absolute weights of the 

thyroid and adrenal glands in males.

870.4300 Combined Chronic toxicity 

Carcinogenicity—rats

NOAEL = 2 mg/kg/day. 

LOAEL = 19 mg/kg/day based on statistically significant increases in the incidence 

of mottled or discolored livers and changes in clinical chemistry.

No evidence of carcinogenicity.

870.4300 Carcinogenicity—mice NOAEL = not established. 

LOAEL = 1.4 mg/kg/day Lowest Dose Tested (LDT) based on hepatocytomegaly, increased liver weight, and increased sinusoidal cell pigmentation.

Likely to be carcinogenic to humans at high enough doses to cause these biochemical and histopathological effects (peroxisome proliferation) in the livers of rodents but unlikely to be carcinogenic at doses below those causing these 

changes.

870.5100 Gene mutation in S. 

typhimurium/

mammalianmicrosome 

mutagenicity assay.

No cytotoxicity evident at 50 μg (gram)/plate in the absence or presence of metabolic activation. PPG–844 induced a dose-relatedincrease in revertant colonies of 

strain TA1538 in the absence of S9 activation; however, no effect seen in strain 

TA98 (derived from TA1538).

870.5100 Gene mutation in S. 

typhimurium/mammalian 

microsome mutagenicity 

assay

Cytotoxicity was not evident for any strain up to the limit dose (5,000Fg/plate). No 

evidence of PPG–844 induced mutagenic effect.

870.5375 In vitro cytogenetic assay 

with Chinese Hamster 

Ovary (CHO) cells

No evidence of clastogenic effect in the presence or absence of S9 activation.

870.5375 Mammalian cells in culture gene mutation in 

CHO cells

No evidence of cytotoxicity at any dose tested. No clear indication of mutagenic effect in the presence or absence of S9 activation.

870.5550 Unscheduled DNA SynthesisNo unscheduled DNA synthesis.

57210 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results 

In vivo DNA covalent 

binding in mouse liver

A covalent binding index of 1.4 ± 0.6 was determined for lactofen. This suggests a 

low binding to mouse hepatic DNA may occur. This finding could not be attributed 

solely to DNA binding since some protein-binding of the parent compound and/or 

metabolite could be occurring.

Analysis of biochemical 

and microscopic parameters in Chimpanzee 

liver

Aryl CoA oxidase, catalase, and carnitine acetlytransferase activities not affected by 

treatment. No nuclear enlargement, cytoplasmic eosinophilia, or hepertrophy observed in liver biopsies after 0, 1, and 3 months of treatment. Slight + response 

for peroxisomal staining (brown stippling).

Results of the analysis of 

biochemical parameters 

in mouse and rat liver 

Following Exposure to 

PPG–844.

Catalase and CN-insensitive palmiloyl CoA oxidase increased. Rats (2,000 ppm) 

and mice (50 ppm) showed increased nuclear enlargement, cytoplasmic 

eosinophilia, hypertrophy, and peroxisomes in number of peroxisomes. 

The NOAEL for this study was established at 0.3 mg/kg/day, based on increased activities of liver enzymes and increased incidence of liver histopathological findings 

at the LOAEL of 1.5 mg/kg/day.

Measurement of 

peroxisome proliferation 

in primary rat 

hepatocytes induced by 

PPG–844 and five of its 

metabolites

Concentration-dependent increase in CN-insensitive palmitoyl CoA oxidase activities 

with each of the metabolites. 

EM: Lactofen (0.01 millimole (mM)) increased number of peroxisomes and glycogen 

aggregates. Other metabolites showed occasional peroxisomes.

B. Toxicological Endpoints

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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for lactofen used for human 

risk assessment is shown in Table 2 of 

this unit:

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57211

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR LACTOFEN FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary 

(Females 13–50 years of age)

NOAEL = 50 mg/kg/day UF = 

100 Acute RfD = 0.5 mg/

kg/day

Special FQPA SF = 3 

aPAD = acute RfD/Special FQPA SF = 0.17 

mg/kg/day

Rat Developmental Toxicity Study 

LOAEL = 150 mg/kg/day based on decreased 

fetal weight and skeletal abnormalities.

Acute Dietary 

(General population including 

infants and children)

An endpoint attributable to a single dose (exposure) was not identified from the available studies, including 

the developmental toxicity studies in rats and rabbits.

Chronic Dietary 

(All populations)

NOAEL = 0.79 mg/kg/day UF 

= 100 Chronic RfD = 0.008 

mg/kg/day

Special FQPA SF = 1 

cPAD = chronic RfD/

Special FQPA SF = 

0.008 mg/kg/day

Dog chronic toxicity 

LOAEL = 3.96 mg/kg/day based on increased 

incidence of proteinaceous casts in the kidneys, and statistically significant increases in 

the absolute weights of the thyroid and adrenal glands in males.

Cancer 

(Oral, dermal, inhalation)

Lactofen acts via a peroxisome proliferation mechanism of action. Likely to be carcinogenic to humans at 

high enough doses to cause these biochemical and histopathological effects (peroxisome proliferation) 

in the livers of rodents but unlikely to be carcinogenic at doses below those causing these changes. 

Lactofen is considered to be a threshold carcinogen. NOAEL = 0.3 mg/kg/day based on increased activities of liver enzymes and increased incidence of liver histopathological findings at the LOAEL of 1.5 

mg/kg/day.

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.432) for the 

residues of lactofen in or on succulent 

snap bean and soybeans. Risk 

assessments were conducted by EPA to 

assess dietary exposures from lactofen 

in food as follows:

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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 USDA 

1989–1992 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: The 

acute dietary analysis uses average food 

residue values from field trial studies 

and percent crop treated (PCT) 

information.

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment, the 

DEEMTM analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1989–1992 CSFII and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the chronic exposure 

assessments: The chronic dietary 

analysis utilized average residue values 

based on field trial studies, 

concentration factors from processing 

studies, and PCT information.

iii. Cancer. In conducting this cancer 

dietary risk assessment, the DEEMTM

analysis evaluated the individual food 

consumption as reported by 

respondents in the USDA 1989–1992 

CSFII and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: The 

chronic dietary analysis utilized the 

average consumption values for food 

and average residue values for those 

foods over a 70-year lifetime.

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 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. As required by 

section 408(b)(2)(E) of FFDCA, EPA will 

issue a data call-in for information 

relating to anticipated residues 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

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:

TABLE 3.—PCT FOR REGISTERED

LACTOFEN USES

Crop PCT 

Cotton 5

Succulent snap beans 5

Soybeans 5

The Agency believes that the three 

conditions listed in this unit have been 

met. With respect to Condition 1, PCT 

estimates are derived from Federal and 

private market survey data, which are 

57212 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

reliable and have a valid basis. EPA uses 

a weighted average PCT for chronic 

dietary exposure estimates. This 

weighted average PCT figure is derived 

by averaging State-level data for a 

period of up to 10 years, and weighting 

for the more robust and recent data. A 

weighted average of the PCT reasonably 

represents a person’s dietary exposure 

over a lifetime, and is unlikely to 

underestimate exposure to an individual 

because of the fact that pesticide use 

patterns (both regionally and nationally) 

tend to change continuously over time, 

such that an individual is unlikely to be 

exposed to more than the average PCT 

over a lifetime. For acute dietary 

exposure estimates, EPA uses an 

estimated maximum PCT. The exposure 

estimates resulting from this approach 

reasonably represent the highest levels 

to which an individual could be 

exposed, and are unlikely to 

underestimate an individual’s acute 

dietary exposure. 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 

lactofen 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 lactofen 

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 lactofen.

The Agency uses the Generic 

Estimated Environmental Concentration 

(GENEEC) or the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) to estimate 

pesticide concentrations in surface 

water and Screening Concentration in 

Ground Water (SCI-GROW), which 

predicts pesticide concentrations in 

ground water. In general, EPA will use 

GENEEC (a tier 1 model) before using 

PRZM/EXAMS (a tier 2 model) for a 

screening-level assessment for surface 

water. The GENEEC model is a subset of 

the PRZM/EXAMS model that uses a 

specific high-end runoff scenario for 

pesticides. GENEEC incorporates a farm 

pond scenario, while PRZM/EXAMS 

incorporate an index reservoir 

environment in place of the previous 

pond scenario. The PRZM/EXAMS 

model includes a percent crop area 

factor as an adjustment to account for 

the maximum percent crop coverage 

within a watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern.

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs), which are the 

model estimates of a pesticide’s 

concentration in water. EECs derived 

from these models are used to quantify 

drinking water exposure and risk as a 

%RfD or %PAD. Instead drinking water 

levels of comparison (DWLOCs) are 

calculated and used as a point of 

comparison against the model estimates 

of a pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to lactofen they 

are further discussed in the aggregate 

risk sections in Unit III.E.

Based on the PRZM/EXAMS and SCIGROW models, the EECs of lactofen for 

acute exposures are estimated to be 0.39 

parts per billion (ppb) for surface water 

and 0.006 ppb for ground water. The 

EECs for chronic exposures are 

estimated to be 0.008 ppb for surface 

water and 0.006 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).

Lactofen is not registered for use on 

any sites that would result in residential 

exposure.

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Lactofen is a member of the diphenyl 

ether group of herbicides, which 

includes acifluorfen (lactofen’s major 

metabolite), nitrofen, oxyfluorfen, and 

fomefasen. In addition, lactofen 

degrades to acifluorfen in the 

environment. The Agency has evidence 

that these compounds induce similar 

toxic effects but has not yet determined 

whether these compounds exhibit a 

common mechanism of toxicity. The 

Agency defers the cumulative risk 

assessment of lactofen and the other 

diphenyl ethers to a later date. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

lactofen 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 OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

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 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57213

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate.

2. Prenatal and postnatal sensitivity. 

The toxicology database for lactofen is 

complete for FQPA purposes except for 

a developmental toxicity study in 

rabbits. Based on the quality of the 

exposure data, EPA determined that the 

10X SF to protect infants and children 

should be reduced to 3X and still be 

protective for any possible toxicity to 

infants and children which might be 

observed in the missing rabbit 

developmental study. The FQPA factor 

was reduced based on the following:

i. The available data provide no 

indication of quantitative or qualitative 

increased susceptibility from in utero

and/or postnatal exposure to lactofen in 

rats.

ii. The available rabbit developmental 

toxicity study was considered 

unacceptable because dosing was not 

done at a high enough level to observe 

significant toxicity. However, the study 

provides sufficient information to 

indicate that the NOAEL for both 

maternal and developmental effects will 

be 20 mg/kg/day (the HDT that elicited 

no significant toxicity) or higher. The 

acute dietary risk assessment for which 

the missing rabbit developmental study 

could potentially be used currently uses 

a NOAEL = 50 mg/kg/day from the rat 

developmental study. Risk estimates 

using a new developmental rabbit study 

could increase at most by a factor of 

2.5X (50/20 mg/kg/day); therefore, a 3X 

UF is protective for any toxicity which 

might be observed in the outstanding 

rabbit developmental study.

iii. Endpoints for other risk 

assessments (chronic and cancer) utilize 

NOAELs significantly lower than 20mg/

kg/day; therefore the developmental 

rabbit study will not affect these 

assessments. Based on mechanistic 

studies with transgenic mice, lactofen 

has been classified as a non-genotoxic 

hepatocarcinogen in rodents with 

peroxisome proliferation being a 

plausible mode of action. Lactofen is 

currently classified as likely to be 

carcinogenic to humans at high enough 

doses to cause the biochemical and 

histopathological changes in the liver of 

rodents, but unlikely to be carcinogenic 

to humans below those doses causing 

these changes. A non-linear 

methodology (MOE) was applied for the 

estimation of human cancer risk using a 

NOAEL of 0.3 mg/kg/day. Generally, for 

threshold cancer effects where the mode 

of action is well understood, the general 

margin of exposure that indicates a 

reasonable certainty of no harm would 

be 100 (10X for intraspecies 

extrapolation and 10X for interspecies 

variation). Given that the % cPAD 

(Food) is < 0.1 % and the cancer MOE 

is 300,000 for the U.S. population, a 100 

fold safety factor would be protective for 

chronic and cancer toxicity.

iv. Adequate actual data, surrogate 

data, and/or modeling outputs are 

available to satisfactorily assess food 

exposure and to provide a screening 

level drinking water exposure 

assessment (there are currently no 

residential uses). Since there is 

uncertainty associated with the data gap 

for a developmental toxicity study in 

rabbits with lactofen the safety factor is 

reduced to 3X.

3. Conclusion. There is a complete 

toxicity data base for lactofen except for 

a developmental toxicity study in 

rabbits and exposure data are complete 

or are estimated based on data that 

reasonably accounts for potential 

exposures.

E. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EECs. 

DWLOC values are not regulatory 

standards for drinking water. DWLOCs 

are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water [e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure)]. This 

allowable exposure through drinking 

water is used to calculate a DWLOC.

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer.

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to lactofen will 

occupy <0.1% of the aPAD for females 

13 years and older. In addition, there is 

potential for acute dietary exposure to 

lactofen in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the aPAD, as shown in Table 4 of this 

unit:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO LACTOFEN

Population Subgroup aPAD (mg/kg) % aPAD (Food) Surface Water 

EEC (ppb) 

Ground Water EEC 

(ppb) 

Acute DWLOC 

(ppb) 

Females 13 years and older 0.17 <0.1% 0.39 0.006 5,100

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to lactofen from food will 

utilize <0.1% of the cPAD for the U.S. 

population, <0.1 % of the cPAD for 

children 1–6, and <0.1% of the cPAD for 

Females 13 years and older. There are 

no residential uses for lactofen that 

57214 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

result in chronic residential exposure to 

lactofen. In addition, there is potential 

for chronic dietary exposure to lactofen 

in drinking water. After calculating 

DWLOCs and comparing them to the 

EECs for surface and ground water, EPA 

does not expect the aggregate exposure 

to exceed 100% of the cPAD, as shown 

in Table 5 of this unit:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO LACTOFEN

Population Subgroup cPAD mg/kg/day % cPAD (Food) Surface Water 

EEC (ppb) 

Ground Water EEC 

(ppb) 

Chronic DWLOC 

(ppb) 

U.S. Population 0.08 <0.1% 0.008 0.006 80

Females 13–50 0.08 <0.1% 0.008 0.006 80

Children 1–6 0.08 <0.1% 0.008 0.006 80

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).

Lactofen 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. Aggregate cancer risk for U.S. 

population. Lactofen is considered to be 

a threshold carcinogen. Because lactofen 

is considered to be unlikely to be 

carcinogenic at low doses, the chronic 

exposure value is compared with a 

NOAEL to determine the cancer risk 

estimate. DWLOCs were calculated 

based on NOAEL of 0.3 mg/kg/day from 

a special 7-week rodent study which 

evaluated peroxisome proliferation in 

the liver of rats and mice. The aggregate 

cancer risk is presented in Table 6 of 

this unit.

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR CANCER FROM EXPOSURE TO LACTOFEN

Population Subgroup Cancer MOE from food 

alone 

Surface Water EEC 

(ppb) Ground Water EEC (ppb) Cancer DWLOC (ppb) 

U.S. Population 300,000 0.005 0.006 105

5. The Agency also conducted an 

aggregate chronic and cancer risk 

assessment for acifluorfen, derived from 

the use of the herbicides lactofen and 

sodium acifluorfen, by comparing the 

total acifluorfen surface water and 

groundwater EECs with the 

corresponding DWLOCs. As indicated 

in Table 7 of this unit, the EECs for all 

exposures were less than the 

corresponding DWLOCs; therefore, the 

Agency has no concern for the aggregate 

risk of the acifluorfen degradate from 

both lactofen and sodium acifluorfen.

TABLE 7.—AGGREGATE CHRONIC AND CANCER RISK ASSESSMENTS FROM EXPOSURE TO TOTAL ACIFLUROFEN

DEGRADATE FROM ALL SOURCES

Population Subgroup 

Surface Water 

EEC (ppb) (Chronic) 

Surface Water 

EEC (ppb) (Cancer) 

Ground Water 

EEC (ppb) 

Chronic DWLOC 

(ppb) 

Cancer DWLOC 

(ppb) 

U.S. Population 2.43 1.34 3.71 80 105

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 lactofen 

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology 

(example—gas chromotography) 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

No maximum residue limits (MRLs) 

for lactofen have been established or 

proposed by Codex, Canada, or Mexico 

for any agricultural commodity; 

therefore, no compatibility questions 

exist with respect to U.S. tolerances.

C. Conditions

The following data must be 

submitted: Developmental toxicity 

study in rabbits.

V. Conclusion

Therefore, the tolerance is established 

for residues of lactofen, 1-

(carboethoxy)ethyl 5-[2-chloro-4-

(trifluoromethyl)phenoxy]-2-

nitrobenzoate, in or on cotton, 

undelinted seed at 0.01 ppm; cotton, gin 

byproducts at 0.02 ppm, and peanut at 

0.01 ppm.

In addition, this regulatory action is 

part of the tolerance reassessment 

requirements of section 408(q) of 

FFDCA, 21 U.S.C. 346a(q), as amended 

by FQPA. By law, EPA is required to 

reassess all tolerances in existence on 

August 2, 1996 by August 2006. This 

regulatory action will count for two 

reassessments toward the August 2006 

deadline.

VI. Objections and Hearing Requests

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 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 57215

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0293 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 November 23, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–-0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0293, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

VII. 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, entitled 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, 

57216 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Rules and Regulations 

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.

VIII. 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: September 16, 2004.

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 180.432 is revised to read as 

follows:

§ 180.432 Lactofen; tolerances for 

residues.

(a) Tolerances are established for 

residues of the herbicide lactofen, 1-

(carboethoxy)ethyl 5-[2-chloro-4-

(trifluoromethyl)phenoxy]-2- 

nitrobenzoate, in or on the following 

raw agricultural commodities:

Commodity Parts per 

million 

Beans, snap, succulent (excluding limas) ........................ 0.01

Cotton, gin byproducts ............. 0.02

Cotton, undelinted seed ........... 0.01

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

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

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved]

[FR Doc. 04–21500 Filed 9–23–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0209; FRL–7680–9]

Tebufenozide; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes 

tolerances for residues of tebufenozide 

in or on tuberous and corm vegetables 

(except potato) subgroup 1D, grape, 

citrus (crop group 10), and citrus oil and 

indirect or inadvertent combined 

residues of tebufenozide, benzoic acid, 

3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-

ethylbenzoyl)hydrazide and its 

metabolite benzoic acid, 3,5-dimethyl-1-

(1,1dimethylethyl)-2-[4-(1-

hydroxyethyl)benzoyl]hydrazide in or 

on forage, fodder, hay and straw of 

cereal grain; forage, fodder, straw and 

hay of non-grass animal feed; forage, 

fodder and hay of grass and foliage of 

legume vegetables. Dow AgroSciences 

and Interregional Research Project 

Number 4 (IR-4) requested these 

tolerance 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 

September 24, 2004. Objections and 

requests for hearings must be received 

on or before November 23, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0209. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket/. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This 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:

Joseph M. Tavano, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6411; e-mail address: 

tavano.joseph@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