[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Rules and Regulations]
[Pages 58071-58079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21586]


-----------------------------------------------------------------------

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: 
[email protected].

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 
carfentrazone-ethyl (ethyl-alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-fluorobenzenepropanoate 
and the metabolite carfentrazone-ethyl chloropropionic acid (alpha,2-
dichloro-5-[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

[[Page 58072]]

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 carfentrazone-ethyl 
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

[[Page 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 
carfentrazone-ethyl 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 food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), 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-FCID\TM\ , 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

[[Page 58074]]

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 non-occupational, 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

[[Page 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 
carfentrazone-ethyl 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 
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 aPAD, as shown in 
Table 1 of this unit.

                                      Table 1.--Aggregate Risk Assessment for Acute Exposure to Carfentrazone-ethyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Surface Water   Ground Water
                      Population Subgroup                             aPAD        %aPAD (Food)     EDWC\1\ ppb     EDWC\1\ ppb         DWLOC\2\ 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ EDWCs 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 [mu]g/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
----------------------------------------------------------------------------------------------------------------
                                                                       Surface       Ground
           Population Subgroup             cPAD mg/kg/     % cPAD       Water        Water        DWLOC\2\ ppb
                                               day         (Food)    EDWC\1\ ppb  EDWC\1\ 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
----------------------------------------------------------------------------------------------------------------
\1\ EDWCs 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 [mu]g/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

[[Page 58076]]

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
----------------------------------------------------------------------------------------------------------------
                                                         Aggregate
                                             Agg. MOE     Level of      Ground      Surface
           Population Subgroup              (food and     Concern     Water EDWC   Water EDWC    DWLOC\2\ (ppb)
                                             res.)\1\      (LOC)        (ppb)        (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
----------------------------------------------------------------------------------------------------------------
\1\ Aggregate MOE = (NOAEL / (Avg Food Exposure + Residential Exposure))
\2\ DWLOC = ((maximum water exposure) x (body weight) x (1,000 [mu]g/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: [email protected].

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican maximum 
residue limits, for residues of carfentrazone-ethyl 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 
carfentrazone-ethyl (ethyl-alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-fluorobenzenepropanoate 
and the metabolite carfentrazone-ethyl chloropropionic acid (alpha,2-
dichloro-5-[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

[[Page 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

[[Page 58078]]

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:


Sec.  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
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                0.10
 07..................................................
Vegetable, fruiting, group 8.........................               0.10

[[Page 58079]]

 
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