Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58071

the following inert ingredients to read as 

follows

§ 180.950 Tolerance exemptions for 

minimal risk active and inert ingredients.

* * * * *

(e) * * *

Chemical Name CAS No. 

*****

Citric acid, 2-(acetyloxy)-, 

tributyl ester ................ 77–90–7

*****

Citric acid, triethyl ester .. 77–93–0

*****

[FR Doc. 04–21587 Filed 9–28–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0256; FRL–7678–9]

Carfentrazone-ethyl; Pesticide 

Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

carfentrazone-ethyl and its metabolite in 

or on certain raw agricultural 

commodities. FMC Corporation and 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective 

September 29, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0256. 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:

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 at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

In the Federal Register of March 31, 

2004 (69 FR 16921) (FRL–7348–4), 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 petitions (PP 2F6468 and 

3E6746) by FMC Corporation, 1735 

Market Street, Philadelphia, PA 19103 

and IR-4, Technology Center, of New 

Jersey, 681 U.S. Highway #1 South, 

North Brunswick, NJ 08902–3390. That 

notice included a summary of the 

petition prepared by FMC Corporation, 

the registrant. Comments on the petition 

were filed by B. Sachau, 15 Elm St., 

Florham Park, NJ 07932. A response to 

these comments is provided in Unit V.

In the Federal Register of July 28, 

2004 (69 FR 45042) (FRL–7365–2), 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 petitions (PP 2F6468, 3E6746, 

4E6814, and 3F6584) by FMC 

Corporation, 1735 Market Street, 

Philadelphia, PA 19103 and IR-4, 

Technology Center, of New Jersey, 681 

U.S. Highway #1 South, North 

Brunswick, NJ 08902–3390. That notice 

included a summary of the petition 

prepared by FMC Corporation, the 

registrant. Comments on the petition 

were filed by B. Sachau, 15 Elm St., 

Florham Park, NJ 07932, and Bonita 

Poulin, R. R. #3, Brockville, Ont. A 

response to these comments is provided 

in Section V. 

The petitions requested that 40 CFR 

180.515(a) be amended by establishing 

proposed tolerances for combined 

residues of the herbicide carfentrazoneethyl (ethyl-alpha,2-dichloro-5-[4-

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl)-4-

fluorobenzenepropanoate and the 

metabolite carfentrazone-ethyl 

chloropropionic acid (alpha,2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3-

methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoic acid), in or on: 

Acerola at 0.1 parts per million (ppm); 

almond hulls at 0.20 ppm and grass, 

forage, fodder and hay, group 17 at 12 

ppm; hops at 0.05 ppm; avocado at 0.1 

ppm; atemoya at 0.1 ppm; banana at 0.1 

ppm; berry group 13 at 0.1 ppm; birida 

at 0.1 ppm; borage, seed at 0.1 ppm; 

cacao at 0.1 ppm; cactus at 0.1 ppm; 

canistel at 0.1 ppm; cherimoya at 0.1 

ppm; citrus, crop group 10 at 0.1 ppm; 

citrus cultivars and/or hybrids of 

grapefruit and pummelo, including uniq 

fruit at 0.1 ppm; coconut at 0.1 ppm; 

coffee at 0.1 ppm; crambe, seed at 0.1 

ppm; custard apple at 0.1 ppm; date at 

58072 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

0.1 ppm; feijoa at 0.1 ppm; fig at 0.1 

ppm; fish at 0.2 ppm; flax, seed at 0.1 

ppm; grape at 0.1 ppm; grapefruit at 0.1 

ppm; guava at 0.1 ppm; guayule at 0.1 

ppm; herbs and spice group 19 at 0.1 

ppm; horseradish at 0.1 ppm; ilama at 

0.1 ppm; Indian mulberry at 0.1 ppm; 

jabotica at 0.1 ppm; Juneberry at 0.1 

ppm; kava at 0.1 ppm; kiwi fruit at 0.1 

ppm; lingonberry at 0.1 ppm; lychee at 

0.1 ppm; longan at 0.1 ppm; mango at 

0.1 ppm; mustard seed, Indian at 0.1 

ppm; mustard seed, field at 0.1 ppm; 

mustard seed, black at 0.1 ppm; okra at 

0.1 ppm; olive at 0.1 ppm; palm heart, 

leaves at 0.1 ppm; passionfruit at 0.1 

ppm; papaya at 0.1 ppm; pawpaw at 0.1 

ppm; peanut at 0.1 ppm; persimmon at 

0.1 ppm; pistachio at 0.1 ppm; pome 

fruit, crop group 11 at 0.1 ppm; 

pomegranate at 0.1 ppm; pulasan at 0.1 

ppm; pummelo at 0.1 ppm; rambutan at 

0.1 ppm; rapeseed, Indian at 0.1 ppm; 

rapeseed, seed at 0.1 ppm; safflower, 

seed at 0.1 ppm; salal at 0.1 ppm; 

sapodilla at 0.1 ppm; sapote, black at 0.1 

ppm; sapote, mamey at 0.1 ppm; 

shellfish at 0.2 ppm; sorghum, sweet, 

stalks at 0.1 ppm; sorghum, sweet, syrup 

at 0.1 ppm; soursop at 0.1 ppm; Spanish 

lime at 0.1 ppm; star apple at 0.1 ppm; 

starfruit at 0.1 ppm; stone fruit, crop 

group 12 at 0.1 ppm; strawberry at 0.1 

ppm; strawberrypear at 0.1 ppm; stevia 

at 0.1 ppm; sugar apple at 0.1 ppm; 

sugarcane at 0.1 ppm; sunflower, seed at 

0.1 ppm; ti, leaves at 0.1 ppm; tea at 0.1 

ppm; tree nut, crop group 14 at 0.1 ppm; 

tuberous and corm vegetables, crop 

subgroup 1C at 0.1 ppm; vanilla at 0.1 

ppm; vegetable, brassica, leafy, group 5 

at 0.1 ppm; vegetable, bulb, group 3 at 

0.1 ppm; vegetable, cucurbit group 9 at 

0.1 ppm; vegetable, foliage of legume, 

group 7 at 0.1 ppm; vegetables, fruiting, 

group, crop group 8 at 0.1 ppm; 

vegetable, leaves of root and tuber, 

group 2 at 0.1 ppm; vegetable, leafy, 

except brassica, group 4 at 0.1 ppm; 

vegetable, legume, group 6 at 0.1 ppm; 

vegetable, root and tuber, group 1 at 0.1 

ppm; wasabi, roots at 0.1 ppm; and wax 

jambu at 0.1 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 a tolerance for combined 

residues of carfentrazone-ethyl and its 

metabolite, carfentrazone-ethyl 

chloropropionic acid, on Vegetable, root 

and tuber, group 01 at 0.10 ppm; 

vegetable, leaves of root and tuber, 

group 2 at 0.10 ppm; vegetable, bulb, 

group 3 at 0.10 ppm; vegetable, leafy, 

except brassica, group 4 at 0.10 ppm; 

vegetable, brassica, leafy, group 5 at 0.10 

ppm; vegetable, legume, group 6 at 0.10 

ppm; vegetable, foliage of legume 

(except soybean), group 7 at 0.10 ppm; 

vegetable, fruiting, group 8 at 0.10 ppm; 

vegetable, cucurbit, group 9 at 0.10 

ppm; fruit, citrus, group 10 at 0.10 ppm; 

fruit, pome, group 14 at 0.10 ppm; fruit, 

stone, group 12 at 0.10 ppm; berry, 

group 13 at 0.10 ppm; nut, tree, group 

14 at 0.10 ppm; herbs and spices, group 

19 at 2.0 ppm; almond, hull at 0.20 

ppm; grape at 0.10 ppm; grass, forage at 

5.0 ppm; grass, hay at 8.0 ppm; canola 

at 0.10 ppm; hop, dried cones at 0.10 

ppm; peanut at 0.10 ppm; peanut, hay 

at 0.10 ppm; strawberry at 0.10 ppm; 

sugarcane at 0.10 ppm; sunflower, seed 

at 0.10 ppm; okra at 0.10 ppm; stevia at 

0.10 ppm; pistachio at 0.10 ppm; 

coconut at 0.10 ppm; strawberrypear at 

0.10 ppm; date at 0.10 ppm; fig at 0.10 

ppm; papaya at 0.10 ppm; avocado at 

0.10 ppm; sapote, black at 0.10 ppm; 

canistel at 0.10 ppm; sapote, mamey at 

0.10 ppm; mango at 0.10 ppm; sapodilla 

at 0.10 ppm; star apple at 0.10 ppm; 

pummelo at 0.10 ppm; guava at 0.10 

ppm; feijoa at 0.10 ppm; jaboticaba at 

0.10 ppm; wax jambu at 0.10 ppm; 

starfruit at 0.10 ppm; passionfruit at 

0.10 ppm; acerola at 0.10 ppm; lychee 

at 0.10 ppm; longan at 0.10 ppm; 

Spanish lime at 0.10 ppm; rambutan at 

0.10 ppm; pulasan at 0.10 ppm; sugar 

apple at 0.10 ppm; atemoya at 0.10 ppm; 

custard apple at 0.10 ppm; cherimoya at 

0.10 ppm; ilama at 0.10 ppm; soursop at 

0.10 ppm; biriba at 0.10 ppm; 

lingonberry at 0.10 ppm; Juneberry at 

0.10 ppm, salal at 0.10 ppm; kiwifruit at 

0.10 ppm; pomegranate at 0.10 at ppm; 

persimmon at 0.10 ppm; pawpaw at 

0.10 ppm; palm heart at 0.10 ppm; palm 

heart, leaves at 0.10 ppm; kava, kava at 

0.10 ppm; ti, leaves at 0.10 ppm; ti, 

roots at 0.10 ppm; wasabit, roots at 0.10 

ppm; cactus at 0.10 ppm; sorghum, 

sweet at 0.10 ppm; rapeseed, seed at 

0.10 ppm; rapeseed, forage at 0.10 ppm; 

mustard, seed at 0.10 ppm; flax, seed at 

0.10 ppm; safflower, seed at 0.10 ppm; 

crambe, seed at 0.10 ppm; borage at 0.10 

ppm; olive at 0.10 ppm; banana at 0.10 

ppm; cacao at 0.10 ppm; tea at 0.10 

ppm; mulberry, Indian at 0.10 ppm; 

vanilla at 0.10 ppm; coffee at 0.10 ppm; 

horseradish at 0.10 ppm; fish at 0.30 

ppm; shellfish at 0.30 ppm; meat, 

byproducts (cattle, goat, horse, and 

sheep) at 0.10 ppm; meat (cattle, goat, 

horse, and sheep) at 0.10 ppm; fat 

(cattle, goat, horse, and sheep) at 0.10 

ppm and milk at 0.05 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance follows:

A. Toxicological Profile

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. The nature of the 

toxic effects caused by carfentrazoneethyl are discussed in the Unit III.A. of 

the final rule on carfentrazone-ethyl 

published in the Federal Register of 

August 9, 2000 (65 FR 48620) (FRL–

6597–7). 

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 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58073

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 

(MOE cancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for carfentrazone-ethyl used 

for human risk assessment is discussed 

in Unit III.B. of the final rule published 

in the Federal Register of August 9, 

2000 (65 FR 48620).

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.515(a) for the 

combined residues of carfentrazoneethyl and its metabolite, in or on a 

variety of raw agricultural commodities. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

carfentrazone-ethyl 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. 

In conducting the acute dietary risk 

assessment EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM-FCIDTM), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessments: For the acute analyses, 

conservative estimates of expected 

residues were assumed for all food 

commodities with current or proposed 

carfentrazone-ethyl tolerances, and it 

was assumed that all of the crops 

included in the analysis were treated. 

Percent Crop Treated (PCT) and/or 

anticipated residues were not used in 

the acute risk assessment.

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the DEEM-FCIDTM , which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: For 

the chronic analyses, conservative 

estimates of expected residues were 

assumed for all food commodities with 

current or proposed carfentrazone-ethyl 

tolerances, and it was assumed that all 

of the crops included in the analysis 

were treated. PCT and/or anticipated 

residues were not used in the chronic 

risk assessment. 

iii. Cancer. Carfentrazone-ethyl is 

classified as ‘‘not likely’’ a human 

carcinogen. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

carfentrazone-ethyl 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 

carfentrazone-ethyl.

The Agency uses the FQPA Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/

EXAMS), to produce estimates of 

pesticide concentrations in an index 

reservoir. The Screening Concentrations 

in Groundwater (SCI-GROW) model is 

used to predict pesticide concentrations 

in shallow ground water. For a 

screening-level assessment for surface 

water EPA will use FIRST (a tier 1 

model) before using PRZM/EXAMS (a 

tier 2 model). The FIRST model is a 

subset of the PRZM/EXAMS model that 

uses a specific high-end runoff scenario 

for pesticides. Both FIRST and PRZM/

EXAMS incorporate an index reservoir 

environment, and both models include 

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 driinking 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 

58074 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

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 

carfentrazone-ethyl they are further 

discussed in the aggregate risk sections 

in Unit III.E.

Based on the FIRST and SCI-GROW 

models, the EECs of carfentrazone-ethyl 

for acute exposures are estimated to be 

34.3 parts per billion (ppb) for surface 

water and 13.4 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 19.0 ppb for surface 

water and 13.4 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).

Carfentrazone-ethyl is currently 

registered for use on the following 

residential non-dietary sites: 

Ornamental lawns and turf (application 

by commercial operators only. There is 

a proposed aquatic use under review. 

The risk assessment was conducted 

using the following residential exposure 

assumptions: Exposures to toddlers in 

the residential lawn setting would be 

higher than that encountered by 

toddlers in an institutional setting, such 

as in schools and parks. It was 

anticipated that herbicide application to 

homeowner lawns is a seasonal event, 

thus, only short-term post-application 

residential exposures were conducted. 

A swimmer exposure assessment was 

conducted based on the proposed 

aquatic application. The swimmer 

assessment estimates exposures from 

oral (ingestion) and inhalation routes. 

No systemic toxicity was seen at the 

limit-dose (1,000 milligrams/kilogram/

day (mg/kg/day)) in a 21–day dermal 

toxicity study in rats, therefore, these 

risk assessments are not required. Based 

on the use pattern, long-term exposure 

is not anticipated.

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.’’

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 

carfentrazone-ethyl and any other 

substances and carfentrazone-ethyl 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 

carfentrazone-ethyl 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 

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 evidence of increased 

susceptibility of rat or rabbit fetuses 

following in utero exposure in the 

developmental studies with 

carfentrazone-ethyl. There is no 

evidence of increased susceptibility of 

rats in the reproduction study with 

carfentrazone-ethyl. EPA concluded 

there are no residual uncertainties for 

prenatal and/or postnatal exposure.

3. Conclusion. EPA concluded that, 

based on the absence of residual 

uncertainties for prenatal and/or 

postnatal exposure and complete 

toxicology, environmental fate, residue 

chemistry data bases, and the 

conservative assumptions used when 

generating the dietary and residential 

exposure estimates, there are reliable 

data showing that it is safe for infants 

and children to remove the additional 

10X safety factor.

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 youth 13-19, 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 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58075

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 carfentrazoneethyl will occupy less than 1% of the 

aPAD for the U.S. population and all 

population subgroups.

In addition, there is potential for 

acute dietary exposure to carfentrazoneethyl 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 1 of this 

unit.

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CARFENTRAZONE-ETHYL

Population Subgroup aPAD %aPAD 

(Food) 

Surface Water 

EDWC1 ppb 

Ground Water 

EDWC1 ppb DWLOC2 ppb 

U.S. pop - all seasons 5 < 1 34.3 13.4 1.7e + 05

All Infants (< 1 year old) 5 < 1 34.3 13.4 5.0e + 04

Children (1-2 years old) 5 < 1 34.3 13.4 5.0e + 04

Children (3-5 years old) 5 < 1 34.3 13.4 5.0e + 04

Children (6-12 years old) 5 < 1 34.3 13.4 5.0e + 04

Youth (13-19 years old) 5 < 1 34.3 13.4 1.5e + 05

Adults (20-49 years old) 5 < 1 34.3 13.4 1.7e + 05

Adults (50+ years old) 5 < 1 34.3 13.4 1.7e + 05

Females (13-49 years old) 5 < 1 34.3 13.4 1.5e + 05

1EDWCs resulting from maximum registered and proposed application rate (0.4 lbs ai/acre/season - caneberry) 

2 DWLOC = ((aPAD -food exposure) x (body weigth) x (1,000 μg/mg)) ÷ (water consumption) 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to carfentrazone-ethyl 

from food will utilize ≤75% of the of the 

cPAD with children 1–2 years old the 

population subgroup with the highest 

exposures. Based the use pattern, 

chronic residential exposure to residues 

of carfentrazone-ethyl is not expected. 

In addition, there is potential for 

chronic dietary exposure to 

carfentrazone-ethyl 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 2 of this 

unit:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CARFENTRAZONE-ETHYL

Population Subgroup cPAD mg/

kg/day 

% cPAD 

(Food) 

Surface 

Water 

EDWC1 ppb 

Ground 

Water 

EDWC1 ppb 

DWLOC2 ppb 

U.S. population - all seasons 0.03 24 19.0 13.4 8.1e + 02

All Infants (<1 year old) 0.03 43 19.0 13.4 1.8e + 02

Children (1-2 years old) 0.03 75 19.0 13.4 8.6e + 01

Children (3-5 years old) 0.03 58 19.0 13.4 1.3e + 02

Children (6-12 years old) 0.0 35 19.0 13.4 2.1e + 02

Youth (13-19 years old) 0.03 21 19.0 13.4 7.3e + 02

Adults (20-49 years old) 0.03 18 19.0 13.4 8.5e + 02

Adults (50+ years old) 0.03 18 19.0 13.4 8.5e + 02

Females (13-49 years old) 0.03 18 19.0 13.4 7.1e + 02

1EDWCs resulting from registered and proposed application rate (0.4 lbs ai/acre/season - caneberry); 56–day surface water average ÷ 3 2 DWLOC = ((cPAD -food exposure) x (body weigth) x (1,000 μg/mg)) ÷ (water consumption) 

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).

Carfentrazone-ethyl is currently 

registered for use that could result in 

short-term residential exposure and the 

58076 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

Agency has determined that it is 

appropriate to aggregate chronic food 

and water and short-term exposures for 

carfentrazone-ethyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that food 

and residential exposures (including 

potential aquatic exposure) aggregated 

result in aggregate MOEs of 72,875 for 

the general population and 22,339 for 

children 1–2 years old. These aggregate 

MOEs do not exceed the Agency’s level 

of concern for aggregate exposure to 

food and residential uses. In addition, 

short-term DWLOCs were calculated 

and compared to the EECs for chronic 

exposure of carfentrazone-ethyl in 

ground and surface water. After 

calculating DWLOCs and comparing 

them to the EECs for surface and ground 

water, EPA does not expect short-term 

aggregate exposure to exceed the 

Agency’s level of concern, as shown in 

Table 3 of this unit:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO CARFENTRAZONE-ETHYL

Population Subgroup 

Agg. MOE 

(food and 

res.)1

Aggregate 

Level of 

Concern 

(LOC) 

Ground 

Water 

EDWC 

(ppb) 

Surface 

Water 

EDWC 

(ppb) 

DWLOC2 (ppb) 

General U.S. population 72875 100 19.0 13.4 1.7e + 05

All Infants (<1 year old) 37843 100 19.0 13.4 5.0e + 04

Children (1-2 years old) 22339 100 19.0 13.4 5.0e + 04

Children (3-5 years old) 29228 100 19.0 13.4 5.0e + 04

Children (6-12 years old) 51965 100 19.0 13.4 5.0e + 04

Youth (13-19 years old) 85253 100 19.0 13.4 1.5e + 05

Adults (20-49 years old) 87396 100 19.0 13.4 1.7e + 05

Adults (50+ years old) 87457 100 19.0 13.4 1.7e + 05

Females (13-19 years old) 78541 100 19.0 13.4 1.5e + 05

1Aggregate MOE = (NOAEL ÷ (Avg Food Exposure + Residential Exposure)) 2 DWLOC = ((maximum water exposure) x (body weight) x (1,000 μg/mg)) ÷ (water consumption) 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

carfentrazone-ethyl 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 

There is neither a Codex proposal, nor 

Canadian or Mexican maximum residue 

limits, for residues of carfentrazoneethyl and F8426-Cl-PAC in/on the 

proposed crops, livestock, fish, or 

shellfish. Therefore, harmonization is 

not an issue.

C. Conditions 

Residue chemistry: Successful Agency 

Validation of Proposed Livestock/Fish/

Shellfish Enforcement Method. 

V. Comments 

Three comments were received in 

response to the notices of filing. Two 

comments from B. Sachau objected to 

the proposed tolerances because of the 

amounts of pesticides already consumed 

and carried by the American 

population. She further indicated that 

testing conducted on animals have 

absolutely no validity and are cruel to 

the test animals. Bonita Poulin 

commented that she doesn’t approve of 

more chemical contamination of our 

food when we should be decreasing the 

residual poisons building up within us, 

which are already causing health 

problems. She also indicated that there 

are safe alternatives available.

Ms. Sachau’s and Ms. Poulin’s 

comments contained no scientific data 

or evidence to rebut the Agency’s 

conclusion that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to carfentrazone 

ethyl, including all anticipated dietary 

exposures and all other exposures for 

which there is reliable information.

VI. Conclusion

Therefore, the tolerance is established 

for combined residues of carfentrazoneethyl (ethyl-alpha,2-dichloro-5-[4-

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl)-4-

fluorobenzenepropanoate and the 

metabolite carfentrazone-ethyl 

chloropropionic acid (alpha,2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3-

methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoic acid), all 

expressed as carfentrazone-ethyl, in or 

on vegetable, root and tuber, group 01 

at 0.10 ppm; vegetable, leaves of root 

and tuber, group 2 at 0.10 ppm; 

vegetable, bulb, group 3 at 0.10 ppm; 

vegetable, leafy, except brassica, group 4 

at 0.10 ppm; vegetable, brassica, leafy, 

group 5 at 0.10 ppm; vegetable, legume, 

group 6 at 0.10 ppm; vegetable, foliage 

of legume (except soybean), group 7 at 

0.10 ppm; vegetable, fruiting, group 8 at 

0.10 ppm; vegetable, cucurbit, group 9 

at 0.10 ppm; fruit, citrus, group 10 at 

0.10 ppm, fruit; pome, group 14 at 0.10 

ppm; fruit, stone, group 12 at 0.10 ppm; 

berry, group 13 at 0.10 ppm; nut, tree, 

group 14 at 0.10 ppm; herbs and spices, 

group 19 at 2.0 ppm; almond, hull at 

0.20 ppm; grape at 0.10 ppm; grass, 

forage at 5.0 ppm; grass, hay at 8.0 ppm; 

canola at 0.10 ppm, hop, dried cones at 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58077

0.10 ppm; peanut at 0.10 ppm; peanut, 

hay at 0.10 ppm; strawberry at 0.10 

ppm; sugarcane at 0.10 ppm; sunflower, 

seed at 0.10 ppm; okra at 0.10 ppm; 

stevia at 0.10 ppm; pistachio at 0.10 

ppm; coconut at 0.10 ppm; 

strawberrypear at 0.10 ppm; date at 0.10 

ppm; fig at 0.10 ppm; papaya at 0.10 

ppm; avocado at 0.10 ppm; sapote, black 

at 0.10 ppm; canistel at 0.10 ppm; 

sapote, mamey at 0.10 ppm; mango at 

0.10 ppm; sapodilla at 0.10 ppm; star 

apple at 0.10 ppm; pummelo at 0.10 

ppm; guava at 0.10 ppm; feijoa at 0.10 

ppm; jaboticaba at 0.10 ppm; wax jambu 

at 0.10 ppm; starfruit at 0.10 ppm; 

passionfruit at 0.10 ppm; acerola at 0.10 

ppm; lychee at 0.10 ppm; longan at 0.10 

ppm; Spanish lime at 0.10 ppm; 

rambutan at 0.10 ppm; pulasan at 0.10 

ppm; sugar apple at 0.10 ppm; atemoya 

at 0.10 ppm; custard apple at 0.10 ppm; 

cherimoya at 0.10 ppm; ilama at 0.10 

ppm; soursop at 0.10 ppm; biriba at 0.10 

ppm; lingonberry at 0.10 ppm; 

Juneberry at 0.10 ppm, salal at 0.10 

ppm; kiwifruit at 0.10 ppm; 

pomegranate at 0.10 at ppm; persimmon 

at 0.10 ppm; pawpaw at 0.10 ppm; palm 

heart at 0.10 ppm; palm heart, leaves at 

0.10 ppm; kava, kava at 0.10 ppm; ti, 

leaves at 0.10 ppm; ti, roots at 0.10 ppm; 

wasabit, roots at 0.10 ppm; cactus at 

0.10 ppm; sorghum, sweet at 0.10 ppm; 

rapeseed, seed at 0.10 ppm; rapeseed, 

forage at 0.10 ppm; mustard, seed at 

0.10 ppm; flax, seed at 0.10 ppm; 

safflower, seed at 0.10 ppm; crambe, 

seed at 0.10 ppm; borage at 0.10 ppm; 

olive at 0.10 ppm; banana at 0.10 ppm; 

cacao at 0.10 ppm; tea at 0.10 ppm; 

mulberry, Indian at 0.10 ppm; vanilla at 

0.10 ppm; coffee at 0.10 ppm; 

horseradish at 0.10 ppm; fish at 0.30 

ppm; shellfish at 0.30 ppm; meat, 

byproducts (cattle, goat, horse, and 

sheep) at 0.10 ppm; meat (cattle, goat, 

horse, and sheep) at 0.10 ppm; fat 

(cattle, goat, horse, and sheep) at 0.10 

ppm and milk at 0.05 ppm.

VII. 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 

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–2004–0256 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 29, 2004. 

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 

d(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.

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). 

VIII. Statutory and Executive Order 

Reviews

This final rule establishes a tolerance 

under section 408(d) of the 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 the 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 

58078 Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

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

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

IX. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801et 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 180.515(a) is amended by 

alphabetically adding the following 

commodities to the table in paragraph (a) 

to read as follows:

§ 180.515 Carfentrazone-ethyl; tolerances 

for residues.

(a) * * *

Commodity Parts per million 

Acerola ............................ 0.10

Almond, hull .................... 0.20 

Atemoya .......................... 0.10 

Avocado .......................... 0.10 

Banana ........................... 0.20 

Berry, group 13 ............... 0.10 

Birida ............................... 0.10 

Borage ............................ 0.10 

Cacao ............................. 0.10 

Cactus ............................. 0.10

* * * * * 

Canistel ........................... 0.10 

Canola ............................ 0.10 

Cherimoya ...................... 0.10 

Coffee ............................. 0.10 

Coconut .......................... 0.10

* * * * * 

Crambe, seed ................. 0.10 

Custard apple ................. 0.10 

Date ................................ 0.10 

Fat (cattle, goat, horse, 

and sheep) .................. 0.10 

Feijoa .............................. 0.10 

Fig ................................... 0.10 

Fish ................................. 0.30 

Flax, seed ....................... 0.10 

Fruit, citrus, group 10 ..... 0.10 

Fruit, pome, group 11 ..... 0.10 

Fruit, stone, group 12 ..... 0.10

* * * * * 

Grape .............................. 0.10 

Grass, forage .................. 5.0 

Grass, hay ...................... 8.0 

Guava ............................. 0.10 

Commodity Parts per million 

Herb and Spices, group 

19 ................................ 2.0 

Hops, dried cones .......... 0.10 

Horseradish .................... 0.10 

Ilama ............................... 0.10 

Jaboticaba ...................... 0.10 

Juneberry ........................ 0.10 

Kava, Kava ..................... 0.10 

Kiwi fruit .......................... 0.10 

Lingonberry ..................... 0.10 

Longan ............................ 0.10 

Lychee ............................ 0.10 

Mango ............................. 0.10 

Meat, (cattle, goat, horse, 

and sheep) .................. 0.10 

Meat, byproducts, cattle, 

goat, horse, and 

sheep) ......................... 0.10 

Milk ................................. 0.05 

Mulberry, Indian .............. 0.10 

Mustard, seed ................. 0.10 

Nut, tree, group 14 ......... 0.10 

Okra ................................ 0.10 

Olive ................................ 0.10 

Palm heart ...................... 0.10 

Palm heart, leaves .......... 0.10 

Papaya ............................ 0.10 

Passionfruit ..................... 0.10 

Pawpaw .......................... 0.10 

Peanut ............................ 0.10 

Peanut, hay .................... 0.10 

Persimmon ...................... 0.10 

Pistachio ......................... 0.10 

Pomegranate .................. 0.10 

Pummelo ......................... 0.10 

Pusalan ........................... 0.10 

Rambutan ....................... 0.10 

Rapeseed, forage ........... 0.10 

Rapeseed, seed ............. 0.10

* * * * * 

Safflower, seed ............... 0.10 

Salal ................................ 0.10 

Sapodilla ......................... 0.10 

Sapote, black .................. 0.10 

Sapote, mamey .............. 0.10 

Shellfish .......................... 0.30 

Sorghum, sweet .............. 0.10 

Soursop, group ............... 0.10

* * * * * 

Spanish lime ................... 0.10 

Star apple ....................... 0.10 

Starfruit ........................... 0.10 

Stevia .............................. 0.10 

Strawberry ...................... 0.10 

Strawberrypear ............... 0.10 

Sugar, apple ................... 0.10 

Sugarcane ...................... 0.10 

Sunflower, seed .............. 0.10 

Tea .................................. 0.10 

Ti, leaves ........................ 0.10 

Ti, roots ........................... 0.10 

Vanilla ............................. 0.10 

Vegetable, bulb, group 

03 ................................ 0.10 

Vegetable, brassica, 

leafy, group 05 ............ 0.10 

Vegetable, cucurbit, 

group 09 ...................... 0.10 

Vegetable, foliage of legume (except soybean), 

group 07 ...................... 0.10 

Vegetable, fruiting, group 

8 .................................. 0.10 

Federal Register / Vol. 69, No. 188 / Wednesday, September 29, 2004 / Rules and Regulations 58079

Commodity Parts per million 

Vegetable, legume, 

group 06 ...................... 0.10 

Vegetable, leafy, except 

brassica, group 04 ...... 0.10 

Vegetable, leaves of root 

and tuber, group 02 .... 0.10 

Vegetable, root and 

tuber, group 01 ........... 0.10 

Wasabia, roots ................ 0.10 

Wax, Jambu .................... 0.10

* * * * *

[FR Doc. 04–21586 Filed 9–28–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0260; FRL–7679–7]

Allethrin, Bendiocarb, Burkholderia 

cepacia, Fenridazon potassium, and 

Molinate; Tolerance Actions

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is revoking all tolerances 

for residues of the insecticides allethrin 

and bendiocarb, plant growth regulator 

fenridazon potassium, herbicide 

molinate, and biological pesticide 

Burkholderia cepacia because EPA 

canceled food registrations or deleted 

food uses from registrations following 

requests for voluntary cancellation or 

use deletion by the registrants. The 

regulatory actions in this document 

contribute toward the Agency’s 

tolerance reassessment requirements of 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) section 408(q), as amended 

by the Food Quality Protection Act 

(FQPA) of 1996. By law, EPA is required 

by August 2006, to reassess the 

tolerances in existence on August 2, 

1996. The regulatory actions in this 

document pertain to the revocation of 

110 tolerances and tolerance 

exemptions of which 106 count as 

tolerance reassessments toward the 

August 2006 review deadline.

DATES: This regulation is effective 

September 29, 2004. However, certain 

regulatory actions will not occur until 

the date specified in the regulatory text. 

Objections and requests for hearings 

must be received on or before November 

29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit IV. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2004–

0260. 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., 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 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 Nevola, Special Review and 

Reregistration Division (7508C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (703) 308–

8037; e-mail address: 

nevola.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 

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 at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background 

A. What Action is the Agency Taking? 

In the Federal Register of July 7, 2004 

(69 FR 40831) (FRL–7362–2), EPA 

issued a proposed rule to revoke certain 

tolerances and tolerance exemptions for 

residues of the insecticides allethrin and 

bendiocarb, plant growth regulator 

fenridazon potassium, herbicide 

molinate, and biological pesticide 

Burkholderia cepacia. Also, the July 7, 

2004 proposal provided a 60–day 

comment period which invited public 

comment for consideration and for 

support of tolerance retention under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) standards. 

In this final rule, EPA is revoking 

certain tolerances and tolerance 

exemptions for residues of the 

insecticides allethrin and bendiocarb, 

plant growth regulator fenridazon 

potassium, herbicide molinate, and the 

biological pesticide Burkholderia 

cepacia because these specific 

tolerances and exemptions correspond 

to uses no longer current or registered 

under FIFRA in the United States. The 

tolerances revoked by this final rule are 

no longer necessary to cover residues of 

the relevant pesticides in or on 

domestically treated commodities or 

commodities treated outside but 

imported into the United States. It is 

EPA’s general practice to revoke those 

tolerances and tolerance exemptions for 

residues of pesticide active ingredients 

on crop uses for which there are no 

active registrations under FIFRA, unless 

any person in comments on the 

proposal indicates a need for the 

tolerance or tolerance exemption to 

cover residues in or on imported 

commodities or domestic commodities 

legally treated. 

EPA has historically expressed a 

concern that retention of tolerances that