[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Rules and Regulations]
[Pages 55740-55748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19062]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0133; FRL-7738-7]
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fenpropathrin in or on bushberry subgroup 13B; lingonberry; juneberry;
salal; pea, succulent; and vegetable, fruiting, group 8. 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 23, 2005. Objections and
requests for hearings must be received on or before November 22, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0133. 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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; 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 code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also
[[Page 55741]]
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/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of March 24, 2004 (69 FR 13833) (FRL-7347-
2-), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP
1E6261, PP 1E6331, PP 1E6336, and PP 3E6588 by IR-4, 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390. The petitions
requested that 40 CFR 180.466 be amended by establishing tolerances for
residues of the insecticide fenpropathrin, [alpha]-cyano-3-phenoxy-
benzyl 2,2,3,3-tetra-methylcyclopropanecarboxylate, in or on currant at
3.0 parts per million (ppm) requested by PP 1E6261; vegetable,
fruiting, group 8, except tomato at 1.0 ppm requested by PP 1E6331;
pea, succulent at 0.02 ppm requested by PP 1E6336, and bushberry
subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm requested by
PP 3E6588. Currant is a member of the bushberry subgroup, and will
receive a tolerance at 3.0 ppm as requested for the bushberry subgroup.
Therefore, a separate tolerance will not be established for currant
under PP 1E6261. The proposed petition (1E6331) for vegetable,
fruiting, group 8, except tomato at 1.0 ppm was subsequently amended to
establish a tolerance for vegetable, fruiting, group 8 at 1.0 ppm. The
Agency will delete the existing tolerance for tomato at 0.6 ppm since
tomato is covered by the vegetable, fruiting group 8 tolerance
promulgated under this ruling. That notice included a summary of the
petition prepared by Valent U.S.A. Corporation, the registrant. One
comment was received. EPA's response to this comment is discussed in
Unit IV.C. below.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
these actions. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) ofFFDCA, for tolerances for residues of fenpropathrin on
vegetable, fruiting, group 8 at 1.0 ppm; pea, succulent at 0.02 ppm;
and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0
ppm. EPA's assessment of exposures and risks associated with
establishing these tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by fenpropathrin is
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 15 milligrams/
toxicity-- kilogram/day (mg/kg/
rodents (Rat) day)
LOAEL = 30 mg/kg/day
based on clinical
signs of tremors,
body weight
reductions,
decreased blood
clotting time in
females, and
possibly increased
alkaline phosphatase
levels (both sexes)
-------------------------------
870.3150 90-Day oral NOAEL = < 6.2 mg/kg/
toxicity-- day
nonrodents LOAEL = 6.2 mg/kg/day
(Beagle dog) based on effects on
the gastrointestinal
system, tremors, and
body weight changes
-------------------------------
870.3200 21-Day dermal NOAEL = >3,000 mg/kg/
toxicity (NZW day
rabbit) Only local irritation
was seen. There were
no systemic effects,
thus the LOAEL was
not determined
-------------------------------
[[Page 55742]]
870.3700 Prenatal Maternal NOAEL = 3 mg/
developmental-- kg/day
rodents(Fischer The maternal NOAEL
Rats) for the
developmental rat
study was 3.0 mg/kg/
day based on
decreased food
consumption and body
weight gains.
However, these
effects are not
characteristic of an
acute exposure and
are not a suitable
option for this
exposure scenario.
One of the factors
to consider in
selecting an acute
dietary endpoint is
when the toxic
effects occur. For
an acute effect, a
relevant endpoint
would occur as the
result of a single
dose. Since the
neurotoxic signs
observed in the dams
of the developmental
rat study were most
severe within two
hours after dosing,
the clinical effects
are resultant from a
single dose, and are
therefore
appropriate
endpoints for acute
exposure scenarios.
Maternal LOAEL = 6
mg/kg/day based on
decreased food
consumption and body
weight gains. At 10
mg/kg/day, 6 dams
died between days 7
and 13, and one dam
was sacrificed
moribund on day 8.
The remaining 23
dams survived
through the end of
gestation. Also in
the high dose group,
many clinical signs
were observed in the
dams including
ataxia, sensitivity
to external stimuli,
spastic jumping, and
tremors. These signs
were most severe 2
hours post-dosing
and during the first
days of dosing.
Developmental NOAEL
= 6 mg/kg/day
Developmental LOAEL
= 10 mg/kg/day based
on increased
incidence of
asymmetrical
ossification of
sternabrae and
incomplete
ossification of the
5th and 6th
sternabrae.
-------------------------------
870.3700 Prenatal Maternal NOAEL = 4 mg/
developmental-- kg/day
nonrodents (NZW Maternal LOAEL = 12
rabbit) mg/kg/day based on
flicking of the
forepaws
Developmental NOAEL =
>36 mg/kg/day
No dose related
effects were seen,
thus the LOAEL was
not determined
-------------------------------
870.3800 Reproduction and Parental/Systemic
fertility NOAEL = M:3.0; F:
effects (Sprague- 3.0 mg/kg/day
Dawley rats) LOAEL = M: 8.9; F:
10.1 mg/kg/day based
on death and
clinical signs of
neurotoxicity in
females.
Offspring NOAEL =
M:3.0; F:3.4 mg/kg/
day
LOAEL = M: 8.9; F:
10.1 mg/kg/day based
on increased
mortality and body
tremors.
-------------------------------
870.4100 Chronic toxicity NOAEL = 2.5 mg/kg/day
(Beagle Dog) LOAEL = 6.25 mg/kg/
day based on tremors
and ataxia in both
sexes
-------------------------------
870.4200 Carcinogenicity- NOAEL = Not
CD-1 mice established
LOAEL = M: >56.0; F:
>65.2 mg/kg/day
There was an overall
lack of toxic
response. However an
aborted mouse
carcinogenicity
study demonstrated
that at a slightly
higher maximum
tolerated dose (MTD)
of 1,000 ppm, the
test article was
lethal to 15% of the
mice after only 13
weeks. Thus the
maximum dose used in
this completed study
(600 ppm) was very
close to the MTD. A
repeat study is not
justified.
no evidence of
carcinogenicity
-------------------------------
870.4300 Carcinogenicity- NOAEL = M:17.06; F:
rat 7.23 mg/kg/day
LOAEL = 19.45 mg/kg/
day based on
increase mortality
and body tremors in
the females
no evidence of
carcinogenicity
-------------------------------
870.5100 Gene mutation Negative in
Bacterial Reverse Salmonella
Mutation Test. typhimurium TA 1535,
TA1537, TA1538,
TA98, and TA100 and
Escerichia coli Wp2
uvrA up to the limit
concentration with
evidence of compound
insolubility
-------------------------------
870.5300 Gene Mutation There was no clear
In vitro evidence (or a
mammalian cell concentration
gene mutation related positive
test. response) of induced
mutant colonies over
background
-------------------------------
870.5375 Cytogenetics Negative in Chinese
In vitro hamster ovary (CHO)
mammalian cell cells (cytotoxicity
chromosomal observed at >=30
aberration assay. [mu]g/mL -S9 and
compound
precipitation at
1,000 [mu]g/mL +S9)
-------------------------------
870.5500 Other effects Negative in Bacillus
Bacterial DNA subtilis H17 (DNA
damage or repair repair proficient)
test. and M45 (DNA repair
deficient)
-------------------------------
870.5900 Other effects Negative in CHO cells
In vitro sister up to the solubility
chromatid limit.
exchange assay.
-------------------------------
[[Page 55743]]
870.7485 Metabolism and Greater than 99% of
pharmacokinetics the administered
(Sprague-Dawley dose was excreted
rat) within 168 hours
with 28% to 56%
excreted in the
urine and the
remainder in the
feces. Major
biotransformations
of the absorbed
compound included
the oxidation of the
methyl group of the
acid moiety,
hydroxylation at the
4'-position of the
alcohol moiety,
cleavage of the
ester linkage, and
conjugation with
sulfuric acid or
glucuronic acid.
Mean dermal
absorption for the
10-hour interval was
33.3%, 20.1%, and
17.6% in the low,
mid, and high dose
groups, respectively
-------------------------------
870.7600 Dermal Dermal absorption
penetration-rats increased with dose
but not
proportionally. The
percentage of the
dose absorbed
decreased with the
increasing
administered dose.
The total body
burden could be
expected to rapidly
decrease due to
excretion via urine
and feces. Mean
dermal absorption
for the 10-hour
interval was 33.3%,
20.1%, and 17.6% in
the low, mid, and
high dose groups,
respectively
------------------------------------------------------------------------
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for fenpropathrin used for
human risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for Fenpropathrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population NOAEL = 6 mg/kg/day Special FQPA SF = 1X Developmental Toxicity
including infants and children) UF = 1,000............. aPAD = acute RfD / in Rats
Acute RfD = 0.006 mg/kg/ Special FQPA SF = LOAEL = 10 mg/kg/day
day. 0.006 mg/kg/day. based on death and
neurological signs
At 10 mg/kg high dose
death in 6 out of 30
--------------------------------------
Chronic Dietary (All populations) NOAEL= 2.5 mg/kg/day Special FQPA SF = 1X 52-Week Chronic Oral
UF = 1,000............ cPAD = chronic RfD / Toxicity in Dogs
Chronic RfD = 0.0025 mg/ Special FQPA SF = LOAEL = 6.25 mg/kg/day
kg/day. 0.0025 mg/kg/day. based on tremors and
ataxia in both sexes
--------------------------------------
Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogen to humans
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.466) for the residues of fenpropathrin, in or
on the following raw agricultural commodities: Cotton; grapes;
strawberries; peanuts; tomatoes; Brassica, head and stem, Crop Subgroup
5A; fruit, citrus, group 10; fruit, pome, group 11; eggs; milk fat; and
the meat; meat byproducts, and fat of cattle, goats, hogs, horses,
sheep, and poultry. Risk assessments were conducted by EPA to assess
dietary exposures from fenpropathrin 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, Version 2.03), 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 acute dietary exposure analysis was a refined one. It was refined
through the use of crop field trial data, Pesticide Data Program (PDP)
monitoring data, anticipated residues (ARs) in animal commodities,
processing factors, and percent crop treated and projected percent crop
treated estimates.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation
[[Page 55744]]
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 chronic exposure assessments: The chronic
dietary exposure analysis was also a refined one. It was refined
through the use of crop field trial data, PDP monitoring data, ARs in
animal commodities, processing factors, and average percent crop
treated and projected market share estimates.
iii. Cancer. A cancer dietary exposure analysis was not performed
because fenpropathrin was classified as ``not likely to be carcinogenic
to humans.''
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used maximum PCT information as follows: Apples 15%;
broccoli <2.5%; brussels sprouts <2.5%; cabbage <1%; cantaloupes 10%;
cotton <2.5%; grapefruit 5%; grapes 10%; oranges 5%; peanuts
<2.5%;pears 10%; pumpkins <2.5%; squash 10%; strawberries 20%;
tangerines <2.5%; tomatoes <2.5%; and watermelons <2.5%; blueberries
18%.
The Agency used average PCT information as follows: Apples 10%;
broccoli <1%; brussels sprouts <2.5%; cabbage <1%; cantaloupes 5%;
cotton <1%; grapefruit 2%; grapes 5%; oranges 2%; peanuts <1%; pears
5%; pumpkins <1%; squash 5%; strawberries 15%; tangerines <1%; tomatoes
<1%; and watermelons <1%; peas 27%; peppers 49%.
The Agency used projected acreage PCT information as follows:
Blueberries 18%; peas 27%; peppers 49%.
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five except for those situations in which the
average PCT is less than one. In those cases <1% is used as the average
and <2.5% is used as the maximum. The percent of crop treated for
grapefruit and oranges is 2%. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the single maximum value
reported overall from available Federal, state, and private market
survey data on the existing use, across all years, and rounded up to
the nearest multiple of five. In most cases, EPA uses available data
from United States Department of Agriculture/National Agricultural
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the
National Center for Food and Agriculture Policy (NCFAP) for the most
recent 6 years.
EPA projects PCT for a new insecticide use by assuming that the PCT
for the insecticide's initial 5 years will not exceed the average PCT
of the dominant insecticide (the one with the largest PCT) within all
insecticides over the three latest available years. The PCTs included
in the average may be for the same insecticide or for different
insecticides since the same or different insecticides may dominate for
each year selected. Typically, EPA uses USDA/NASS as the source for raw
PCT data because it is non-proprietary and directly available without
computation.
This method of projecting PCT for a new insecticide use, with or
without regard to specific pest(s), produces an upper-end projection
that is unlikely, in most cases, to be exceeded in actuality because
the dominant insecticide is well-established and accepted by farmers.
Factors that bear on whether a projection based on the dominant
insecticide could be exceeded are whether the new insecticide is more
efficacious or controls a broader spectrum of pests than the dominant
insecticide, whether it is more cost-effective than the dominant
insecticide, and whether it is likely to be readily accepted by growers
and experts. EPA has considered these factors for the new uses of this
insecticide, and indicates that it is unlikely that actual PCT for this
new use will exceed the PCT for the dominant insecticide in the next 5
years.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenpropathrin 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 fenpropathrin. Further information regarding EPA
drinking water models used in pesticide exposure assessments can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservior Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWC's) of fenpropathrin for
acute exposures are estimated to be 10.3 parts per billion (ppb) for
surface water and 0.005 ppb for ground water. The EDWC's for chronic
exposures are estimated to be 1.8 ppb for surface water and 0.005 ppb
for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM- FCID). For acute dietary
risk assessment, the peak water concentration value of 10.3 ppb was
used to access the contribution to drinking water. For chronic dietary
risk assessment, the annual average concentration of 1.8 ppb was used
to access the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure
[[Page 55745]]
(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Fenpropathrin is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Fenpropathrin is a member of the pyrethroid class of
pesticides. Although all pyrethroids alter nerve function by modifying
the normal biochemistry and physiology of nerve membrane sodium
channels, EPA is not currently following a cumulative risk approach
based on a common mechanism of toxicity for the pyrethroids. Although
all pyrethroids interact with sodium channels, there are multiple types
of sodium channels, and it is currently unknown whether they have
similar effects on all channels. In addition, EPA does not have a clear
understanding of effects on key downstream neuronal function, e.g.,
nerve excitability, nor does EPA understand how these key events
interact to produce their compound-specific patterns of neurotoxicity.
There is ongoing research by both the EPA's Office of Research and
Development and the pyrethroid registrants to evaluate the differential
biochemical and physiological actions of pyrethroids in mammals. This
research is expected to be completed by 2007. When the results of this
research are available, the Agency will make a determination of common
mechanism of toxicity as a basis for assessing cumulative risk. For
information regarding EPA's procedures for cumulating effects from
substances found to have a common mechanism of toxicity, see EPA's
website at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database 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. The Agency has determined
that there is no concern for pre- and/or post-natal toxicity resulting
from exposure to fenpropathrin based on the submitted guidelines
studies. There is no evidence (qualitative or quantitative) of
increased susceptibility following in utero and/or pre- or post-natal
exposure in adequate developmental toxicity studies in rats or rabbits
and in a two-generation reproduction study in rats. In the rat
developmental toxicity study, developmental effects occurred at a dose
that was higher than the dose that caused maternal toxicity. In the
study in rabbits, no developmental effects were seen at the highest
dose tested. In the two-generation reproduction study in rats, the
deaths in two pups of the F2 generation were not considered to be
evidence of qualitative increased susceptibility as (i) the deaths
occurred at the same dose that caused severe maternal toxicity (i.e.,
maternal deaths and neurotoxic clinical signs) and, (ii) the deaths
occurred during lactation (days 19 and 21) when these pups were exposed
to the compound via the milk and the diet. The Agency has concluded
that there are no concerns or residual uncertainties for pre- and post-
natal toxicity, based on the submitted guideline study results.
However, EPA is lacking acute and subchronic neurotoxicity studies, and
a developmental neurotoxicity study. The developmental neurotoxicity
study has been required based on neurotoxicity being seen in all four
tested animal species, and the fact that no detailed neuropathology
data were available.
3. Conclusion. Because analysis of the existing database does not
provide a reliable basis for concluding that these missing studies will
not affect the regulatory endpoints for fenpropathrin, EPA is retaining
the additional 10X FQPA factor for fenpropathrin, in the form of a
database uncertainty factor, for the protection of infants and
children.
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EDWCs. The DWLOC values are not
regulatory standards for drinking water, but are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter(L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/
10 kg (child). 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 EDWCs for surface water and ground water are less than the
calculated DWLOCs, EPA can conclude with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposures for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. When new
uses are added EPA reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure and drinking water, the acute dietary exposure
from food and water to fenpropathrin will occupy 50% of the aPAD for
the U.S. population, 43% of the aPAD for females 13 years
[[Page 55746]]
and older, 86% of the aPAD for all infants <1 year old, and 91% of the
aPAD for children 3 to 5 years old, the subpopulation at greatest
exposure. Therefore, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure and drinking water, EPA has concluded that
exposure to fenpropathrin from food and water will utilize 3.7% of the
cPAD for the U.S. population, 6.7% of the cPAD for all infants < 1 year
old, the subpopulation at greatest exposure, and 6.4% of the cPAD for
children 1 to 2 years old. There are no residential uses for
fenpropathrin. Therefore, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Fenpropathrin is not registered for use on
any sites that would result in residential exposure. Therefore, the
aggregate risks are the sums of the risks from food and water, which do
not exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Fenpropathrin has
been classified as not likely to be carcinogenic to humans. Therefore,
fenpropathrin is expected to pose at most a negligible cancer risk.
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 fenpropathrin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An enforcement method is available for the analysis of
fenpropathrin in plants. This method, Residue Method Number RM-22-4
(11/1/89, revised 5/3/93) is entitled ``Determination of Fenpropathrin
in Crops.'' Residues in crops are extracted with acetone/hexane,
partitioned into hexane, cleaned up by silica gel and C18
Sep Pak chromatography, and measured by gas chromatography equipped
with an electron capture detector. The limit of detection of this
method is 0.01 ppm. An EPA trial of this method for the determination
of fenpropathrin residues in apples has been successfully conducted. No
additional animal commodity tolerances are being established with these
petitions. As a result, enforcement methods for animal commodities are
not being addressed. Recovery of fenpropathrin was tested through FDA
multiresidue methods, and fenpropathrin was found to be completely
recovered by the PAM I Section 302 Method (Luke Method).
Adequate enforcement methodology 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 are no Codex, Canadian, or Mexican MRLs for fenpropathrin in
or on the proposed commodities. Therefore, harmonization of tolerances
is not an issue.
C. Response to Comments
One comment was received from a private citizen who opposed the
authorization to sell any pesticide that leaves a residue on food. The
Agency has received this same comment from this commenter on numerous
previous occasions and rejects it for the reasons previously stated (70
FR 1349, 1354, January 7, 2005).
V. Conclusion
Therefore, the tolerances are established for residues of
fenpropathrin, [alpha]-cyano-3-phenoxy-benzyl 2,2,3,3-tetra-
methylcyclopropanecarboxylate, in or on bushberry subgroup 13B;
lingonberry; juneberry, and salal at 3.0 ppm; pea, succulent at 0.02
ppm, and vegetable, fruiting, group 8 at 1.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the 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-2005-0133 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
22, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0133, to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a
[[Page 55747]]
copy to the location of the PIRIB described in ADDRESSES. You may also
send an electronic copy of your request via e-mail to: [email protected]. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in
your electronic copy. You may also submit an electronic copy of your
request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to petitions submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. 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 19, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.466 is amended in the table to paragraph (a) by by
removing the commodity ``tomato'' and by adding alphabetically
commodities to the table to read as follows:
Sec. 180.466 Fenpropathrin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Bushberry subgroup 13B..................................... 3.0
* * * * *
Juneberry.................................................. 3.0
* * * * *
Lingonberry................................................ 3.0
[[Page 55748]]
* * * * *
Pea, succulent............................................. 0.02
* * * * *
Salal...................................................... 3.0
* * * * *
Vegetable, fruiting, group 8............................... 1.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-19062 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S