Cyfluthrin; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 13, 2005 (Volume 70, Number 176)]
[Rules and Regulations]
[Page 53944-53953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se05-19]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0205; FRL-7725-7]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
cyfluthrin in or on almond hulls, cucurbit vegetable crop group 9,
fruiting vegetable group 8; grass forage; grass hay; grape; grape,
raisin; leafy Brassica greens, subgroup 5B; leafy vegetable group,
except Brassica, group 4; pistachio; pome fruit group 11; stone fruit
group 12; tuberous and corm vegetable subgroup 1C; peanut; peanut, hay;
pea and bean, dried shelled, except soybean, subgroup 6C; tree nuts,
Crop Group 14; turnip greens; wheat forage; wheat hay; and wheat straw.
Bayer CropScience and the Interregional Research Project Number 4 (IR-
4) requested the 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 13, 2005. Objections and
requests for hearings must be received on or before November 14, 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-2005-0205.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: Olga Odiott, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9369; e-mail address: odiott.olga@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
? Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
? Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
? Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
? Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

In addition to using EDOCKET (http://www.regulations.gov/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. 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 at
http://www.epa.gov/opptsfrs/home/guidelin.htm.

II. Background and Statutory Findings

In the Federal Register of January 28, 2004 (69 FR 4143) (FRL-7339-
6), 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
1F6290, 2F6445, and 2F6479) by Bayer CropScience, 2 T.W. Alexander
Drive, Research Triangle Park, NC 27709; and (PP 1E6318, 3E6776, and
3E6583) by the Interregional Research Project Number 4 (IR-4),
Technology Centre and Rutgers State University of New Jersey, 681 U.S.
Highway #1 South, North Brunswick, NJ 08902-390. The petitions
requested that 40 CFR 180.436 be amended by establishing tolerances for
residues of the insecticide cyfluthrin, cyano (4-fluoro-3-
phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-
cyclopropanecarboxylate, in or on almond hulls at 1.0 parts per million
(ppm); pistachio at 0.01 ppm; and tree nuts, crop group 14 at 0.01 ppm
(PP 1F6290); cucurbit vegetable crop group at 0.10 ppm; fruiting
vegetable group at 0.5 ppm; leafy Brassica greens subgroup at 7.0 ppm;
leafy vegetable group at 6.0 ppm; pome fruit group at 0.10 ppm; pome
fruit wet pomace at 0.30 ppm; stone fruit group at 0.30 ppm; wheat
forage, wheat hay and wheat straw at 5.0 ppm; and wheat shorts at 3.5
ppm (PP 2F6445); grape at 0.8 ppm; grape, raisin at 3.5 ppm; peanut at
0.01 ppm; and peanut, hay at 6.0 ppm (PP 2F6479); tuberous and corm
vegetable subgroup at 0.01 ppm (PP 1E6318); turnip greens at 7 ppm (PP
3E6583); and grass forage at 6 ppm; grass hay at 8 ppm; and pea and
bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm (PP
3E6776). That notice included a summary of the petition prepared by
Bayer Crop Science, the registrant. The registrant has submitted a
request to voluntarily

[[Page 53945]]

cancel uses of cyfluthrin on stored grains effective December 31, 2004.
Based on EPA's review, the petitions were revised by the
petitioners as follows: i. by increasing proposed tolerances for grapes
to 1.0 ppm and the proposed tolerances for wheat hay and straw to 6.0
ppm; ii. by increasing the proposed pome fruit crop group tolerance to
0.5 ppm to harmonize with the Codex apple MRL and deleting the proposed
tolerance on pome fruit wet pomace since expected residues are below
the pome fruit tolerance of 0.5 ppm; iii. by decreasing proposed
tolerances for almond hulls to 0.5 ppm; iv. by removing tolerances for
peanut oil since residues will be lower than residues in peanuts; v. by
removing tolerances in prume since maximum expected residues are below
the proposed tolerance for the stone fruit crop group; and vi. by
withdrawing the proposed tolerance for wheat shorts since it is already
covered under wheat milled by products.
Although EPA requested a number of changes to the initial
petitions, the nature of the changes (changes in tolerance levels) are
not considered significant. Therefore, EPA is issuing this as a final
action. EPA is also removing the existing tolerance for potato, since a
tolerance is being established on the entire tuberous and corm
vegetable subgroup; removing time-limited tolerances established for
grape and grape, raisin at 1.0 and 1.5 ppm, respectively, in connection
with Section 18 emergency exemptions since they are no longer needed;
and establishing tolerances with regional registrations for grass
forage and hay.
One comment was received in response to the notice of filing. The
comment is described and discussed in Unit V. Comments.
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 in the Federal Register November 26,
1997 (62 FR 62961) (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 the cyfluthrin tolerances described in Unit II.
EPA's assessment of exposures and risks associated with establishing
the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by cyfluthrin and its
enriched isomer, beta-cyfluthrin]
as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed are discussed in the Federal
Register of September 27, 2002 (67 FR 60976) (FRL-7199-8).
Cyfluthrin is a type II pyrethroid (i.e., it has a cyano group at
the carbon position of the alcohol moiety and it is more effective when
the ambient temperature is raised). Beta-cyfluthrin is an enriched
isomer of cyfluthrin. Bridging data on beta-cyfluthrin were submitted
so that the toxicity of beta-cyfluthrin could be compared with that of
cyfluthrin and the databases could be combined to form one complete
database for both chemicals. The scientific quality of the data is
relatively high, and the toxicity profiles of both cyfluthrin and beta-
cyfluthrin can be characterized for all effects, including potential
developmental, reproductive and neurotoxic effects. A beta-cyfluthrin
developmental neurotoxicity study has been submitted and a preliminary
review indicates that effects are seen only at doses higher than those
chosen for risk assessment purposes.

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional UFs'' the ``special FQPA safety factor;'' and the
``default FQPA safety factor.'' By the term ``traditional UF,'' EPA is
referring to those additional UFs used prior to FQPA passage to account
for database deficiencies. These traditional UFs 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
UF 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 (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by an UF of 100 to account for
interspecies and intraspecies differences and any traditional UFs
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

[[Page 53946]]

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 cyfluthrin used for
human risk assessment is shown in following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for cyfluthrin 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 = 2.0 mg/kg/day Special FQPA SF = 1 Acute mammalian
including infants and children) UF = 100............... aPAD = acute RfD = 0.02 neurotoxicity (beta-
Acute RfD = 0.02 mg/kg/ mg/kg/day. cyfluthrin)
day. LOAEL = 10 mg/kg/day
based on clinical
signs, changes in FOB
parameters and
decreases in motor
activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL = 2.4 mg/kg/day Special FQPA SF = 1 53-week chronic
UF = 100............... cPAD = chronic RfD = toxicity feeding - dog
Chronic RfD = 0.024 mg/ 0.024 mg/kg/day. (cyfluthrin)
kg/day. LOAEL = 10.64 mg/kg/day
based on clinical
signs, gait
abnormalities, and
abnormal postural
reactions.
----------------------------------------------------------------------------------------------------------------
Incidental oral short term, and NOAEL = 2.36/2.5 mg/kg/ Special FQPA SF = 1 90-day dog feeding
intermediate-term (1 to 30 days and day LOC for MOE = 100...... study (beta-
1 to 6 months)(residential) cyfluthrin) LOAEL =
13.9/15.4 mg/kg/day
for males/females,
respectively based on
gait abnormalities,
increased incidence of
vomiting, and
suggestive decreased
body weight gain.
----------------------------------------------------------------------------------------------------------------
Short-term and intermediate-term oral study NOAEL = 2.36/ LOC for MOE = 100 90-day dog feeding
dermal (1 to 30 days and 1 to 6 2.5 mg/kg/day (dermal study (beta-
months) (residential) absortion rate = 5% cyfluthrin)
LOAEL = 13.9/15.4 mg/kg/
day for males/females,
respectively, based on
gait abnormalities,
increased incidence of
vomiting, and
suggestive decreased
body weight gain.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to Oral study NOAEL = 2.4 LOC for MOE = 100 53-week chronic
lifetime) (residential) mg/kg/day (dermal toxicity feeding - dog
absorption rate = 5% (cyfluthrin)
when appropriate) LOAEL = 10.64 mg/kg/day
based on clinical
signs, gait
abnormalities, and
abnormal postural
reactions.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 30 days) inhalation study NOAEL LOC for MOE= 100 28-day inhalation study
(residential) = 0.00026 mg/L (0.07 - rat (beta-
mg/kg/day) (inhalation cyfluthrin)
absorption rate = LOAEL = 0.0027 mg/L
100%) (0.73 mg/kg/day) based
on decreases in body
weight in both sexes
and decreased urinary
pH in males.
----------------------------------------------------------------------------------------------------------------
Intermediate and long-term inhalation inhalation study NOAEL LOC for MOE = 100 13-week inhalation
(1 to 6 months and < 6 months) = 0.00009 mg/L (0.02 study - rat
(residential) mg/kg/day) (inhalation (cyfluthrin)
absorption rate = LOAEL = 0.00071 mg/L
100%) (0.16 mg/kg/day) based
on decreases in body
weight and body weight
gain in males and
clinical signs in
females.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

The residue included in the risk assessment and tolerance
expression for plants and animals is cyfluthrin per se. Parent
cyfluthrin is also the residue of concern in the drinking water assessment.
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.436) for the residues of cyfluthrin, in or on a
variety of raw agricultural commodities. Tolerances have been
established on plant commodities ranging from 0.01 ppm for corn grain
and potatoes to 300 ppm for aspirated grain fractions and on animal
commodities ranging from 0.01 ppm for poultry commodities to 15 ppm for
milk fat. In addition, a tolerance of 0.05 ppm is established for
cyfluthrin in animal feeds and processed foods as a

[[Page 53947]]

result of its use in food, and feed-handling establishments.
Although the uses on stored grain have been voluntarily cancelled
by the registrant established tolerances reflecting these uses are to
remain in 40 CFR Sec. 180.436(a)(1) to allow for clearance of the
remaining product and treated stored grain from the channels of trade.
Although the Agency did not specifically include potential cyfluthrin
residues in stored grains in the dietary exposure assessments, the
Agency concludes that these assessments do not underestimate dietary
exposure and risk because:
? About 90% of the stored grain usage was for treatment of
stored wheat grain, so potential exposure from cyfluthrin use on stored
grains would come from wheat;
? Residue monitoring data in wheat flour indicate very low
or non-detectable residues from cyfluthrin use on stored grain;
? The current dietary exposure estimates from the remaining
existing and the newly proposed uses includes a new foliar use on
wheat. The wheat field trial data used to estimate dietary exposure
reflect maximum rates and minimum pre-harvest intervals (PHI's), and
these residues were significantly higher than monitoring data residues
for wheat. Monitoring data residues in wheat flour from cyfluthrin use
on stored grain were so low that they would not increase dietary
exposure estimates if they had been included in the assessment;
? Exposure from residues in wheat (based on the high end
foliar use residues) was not significant for any of the population
subgroups, including infants and children; and
? Residues in stored grains were not a major component of
secondary residue estimates in livestock commodities, and concomitant
dietary exposure from consumption of animal commodities such as meat
and milk.
Risk assessments were conducted by EPA to assess dietary exposures
from cyfluthrin 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 (DEEMTM/FCID), which incorporates food
consumption data as reported by respondents in the United States
Department of Agriculture (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: Percent crop
treated (PCT) values for crops with established tolerances, for crops
with proposed tolerances, anticipated residues in animal commodities,
and processing factors (including washing and peeling factors). Crop
field trial data were used for proposed commodities and Pesticide Data
Program (PDP) monitoring data were used for registered commodities.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEMTM software with the FCID, 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: Average PCT values for crops with
established tolerances, projected PCT estimates for crops with proposed
tolerances, anticipated residues in animal commodities, and processing
factors (including washing and peeling factors). Crop field trial data
were used for proposed commodities, and PDP monitoring data were used
for registered commodities.
iii. Anticipated residue and 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 PCT information as follows. Average and maximum
values for PCT data were used in the chronic and acute analyses,
respectively, for the following commodities with established
tolerances: Alfalfa (1 chronic, 2.5 acute), broccoli (3 chronic, 5
acute) cabbage (8 chronic, 12 acute), cantaloupes (2 chronic, 5 acute),
carrots (1 chronic, 5 acute), cauliflower (1 chronic, 2.5 acute), corn
(5 chronic, 10 acute), cotton (10 chronic, 15 acute), garlic (1
chronic, 2.5 acute), grapefruit (1 chronic, 2.5 acute), green beans (1
chronic, 2.5 acute), lemons (5 chronic, 10 acute), lettuce (5 chronic,
10 acute), mustard greens (1 chronic, 2.5 acute), onions (1 chronic,
2.5 acute), oranges (15 chronic, 20 acute), peas (1 chronic, 2.5
acute), peppers (10 chronic, 15 acute), potatoes (25 chronic, 35
acute), pumpkins (1 chronic, 5 acute), sorghum (1 chronic, 2.5 acute),
soybeans (1 chronic, 2.5 acute), squash (1 chronic, 2.5 acute),
sugarcane (5 chronic, 8 acute), sunflowers (3 chronic, 5 acute), sweet
corn (5 chronic, 8 acute), tangerines (5 chronic, 8 acute), tomatoes (5
chronic, 8 acute), and watermelons (5 chronic, 8 acute).
Projected PCT estimates were used for commodities with proposed
tolerances as follows: Apples 73%, grapes 23%, peaches 39%, pears 59%,
plums 28%, spinach 15%, winter wheat 4%, and collards greens 15%.
The Agency believes that the three conditions listed in Unit
III.C.1.iii have been met. With respect to Condition 1, PCT estimates
are derived from available federal, state, and private market survey
data. For existing crop sites on pesticide registrations (``existing
use''), EPA uses an average PCT for chronic dietary exposure estimates.
The average PCT figure is derived by combining available federal,
state, and private market survey data on the existing use, averaging by
year, averaging across all years, and rounding

[[Page 53948]]

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. EPA uses a maximum PCT for
acute dietary exposure estimates. 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. However, in cases where the
rounded average PCT and the maximum PCT were initially identical at 5%,
the maximum was further adjusted upward to 8%. 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. The Agency is reasonably certain
that the percentage of the food treated is not likely to be an
underestimation
The Agency projects PCT for a new pesticide use by assuming that
the PCT for the pesticide's initial five years will not exceed the
average PCT of the dominant pesticide (the one with the largest PCT)
within its chemical type over three latest available years. For apples,
grapes, peaches, pears, plums, and winter wheat the chemical type
within which cyfluthrin was compared consisted of all other
insecticides. For spinach and collards the corresponding chemical type
consisted of all other synthetic pyrethroids with which cyfluthrin was
price competitive (which excluded permethrin for spinach). The PCTs
included in the average may be each for the same pesticide or for
different pesticides since the same or different pesticides 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. The assumption was made that cyfluthrin
would entirely replace the current market leader among all insecticides
for each crop. This assumption is a conservative one because it is not
likely that cyfluthrin will entirely replace the market leader for each
commodity. For spinach and collard greens, the Agency looked at all the
competing pyrethroids only (as opposed to all insecticides) and assumed
that cyfluthrin would compete with pyrethroids that are priced
competitively with cyfluthrin. The assumption was made that cyfluthrin
would entirely replace the current market leader among all competitive
pyrethroids for spinach and collards. The value of 15% used for spinach
and collard greens is very consistent with the PCT values determined
for the registered commodities. These are considered to be conservative
estimates of the percent crop treated that cyfluthrin will obtain.
This method of projecting PCT for a new pesticide, 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 pesticide is well-established and accepted by farmers. Factors
that bear on whether a projection based on the dominant pesticide could
be exceeded are whether the new pesticide is more efficacious or
controls a broader spectrum of pests than the dominant pesticide within
its similar type, whether it is more cost-effective than the dominant
pesticide, and whether it is likely to be readily accepted by growers
and experts. These factors have been considered for cyfluthrin, and
they indicate that it is unlikely that actual PCT for cyfluthrin will
exceed the PCT for the dominant pesticide in the next five years.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which cyfluthrin may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for cyfluthrin 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 cyfluthrin.
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 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 (PC) area factor as
an adjustment to account for the maximum PC coverage within a watershed
or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to cyfluthrin they are
further discussed in the aggregate risk sections in Unit III.E.
Based on the FIRST and SCI-GROW models, the EECs of cyfluthrin for
acute exposures are estimated to be 3.4 ppb for surface water and
0.0016 ppb for ground water. The EECs for chronic exposures are
estimated to be 0.082 ppb for surface water and 0.0016 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).

[[Page 53949]]

Cyfluthrin is currently registered for use on a variety of indoor
(e.g. total release fogger and crack and crevice spray) and outdoor
(e.g. spray fogger) applications. Residential exposure for adults was
assessed via the inhalation and dermal routes, while exposure for
infants and children was assessed via inhalation, dermal, and oral
(hand-to-mouth) routes. Outdoor handler inhalation and dermal exposure
were assessed. Residential applicator for indoor total release fogger
was not assessed quantitatively, because indoor inhalation exposure to
a homeowner would likely be less than inhalation exposure to a
homeowner that would result from outdoor lawn treatments.
Residential post-application inhalation exposure following
treatments to lawns was estimated using time weight averages from an
imidacloprid study (Eberhart and Ellisor, 1994). In the study, air
concentration measurements were taken in the vicinity of the volunteer
subjects performing the Jazzercize routines. These data served as
appropriate surrogate data for cyfluthrin since the vapor pressure of
cyfluthrin (3.3 x 10-8 torr) is similar to that of
imidacloprid (6.9 x 10-9 torr).
Residential MOEs were assessed for indoor and outdoor uses for
application and post-application exposure. This is considered a
conservative assessment assuming the lawn and carpet uses happen on the
same day. All residential cyfluthrin MOEs calculated were well above
the target MOEs (100 for inhalation, oral, and dermal exposures) and
therefore, do not exceed the Agency's level of concern.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
Cyfluthrin is a member of the pyrethroid class of pesticides. EPA
is not currently following a cumulative risk approach based on a common
mechanism of toxicity for the pyrethroids. Although all pyrethroids
alter nerve function by modifying the normal biochemistry and
physiology of nerve membrane sodium channels, available data show that
there are multiple types of sodium channels and it is currently unknown
whether the pyrethroids as a class have similar effects on all channels
or whether modifications of different types of sodium channels would
have a cumulative effect. Nor do we have a clear understanding of
effects on key downstream neuronal function, e.g., nerve excitability,
or how these key events interact to produce their compound specific
patterns of neurotoxicity. Without such understanding, there is no
basis to make a common mechanism of toxicity finding. There is ongoing
research by the EPA's Office of Research and Development and pyrethroid
registrants to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When available, the Agency will consider this
research and make a determination of common mechanism as a basis for
assessing cumulative risk. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure (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 FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility of rats or rabbits to in utero exposure in
developmental oral studies; however, there was some indication of
increased susceptibility in developmental inhalation studies. A clear
NOAEL was established for the fetal effects in every case. No residual
uncertainties were identified.
The data also demonstrated increased susceptibility of rats and
mice to postnatal exposure to cyfluthrin. A clear NOAEL was established
for the offspring effects in every case. No residual uncertainties were
identified.
3. Conclusion. EPA determined that the FQPA SF to protect infants
and children should be removed. The recommendation is based on the
following:

? The toxicology databases for cyfluthrin and beta-
cyfluthrin together are considered adequate for selecting toxicity
endpoints for risk assessment. The toxicity profiles of both cyfluthrin
and beta-cyfluthrin can be characterized for all effects, including
potential developmental, reproductive and neurotoxic effects. Exposure
data are complete or are estimated based on data that reasonably
accounts for potential exposures.
? There is no evidence of increased susceptibility of rats
or rabbits to in utero exposure in developmental oral studies, and the
degree of concern for the effects observed in the inhalation
developmental studies is considered low since a clear NOAEL was
established for the fetal effects in every case.
? The NOAEL used for short-term inhalation exposure
scenarios is protective of the effects seen in the developmental
studies via the inhalation route.
? The degree of concern for the effects observed in the
reproductive studies was considered low since a clear NOAEL was
established for the offspring effects in every case.
? The NOAEL used to establish the cRfD for all populations
is protective of the effects seen in the young in the reproduction studies.
? A beta-cyfluthrin developmental neurotoxicity study has
been submitted and a preliminary review indicates that effects are seen
only at doses higher than those chosen for risk assessment purposes.

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

[[Page 53950]]

food + residential exposure). This allowable exposure through drinking
water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure 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. If new
uses are added in the future, EPA 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
cyfluthrin will occupy 42% of the aPAD for the U.S. population, 34% of
the aPAD for females 13-years and older, 85% of the aPAD for all
infants < 1 year old, and 81% of the aPAD for children 3-5 years old,
the children population at greatest exposure. In addition, there is
potential for acute dietary exposure to cyfluthrin in drinking water.
After calculating DWLOCs and comparing them to the EECs for surface
water and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD, as shown in the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Cyfluthrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup aPAD (mg/kg/ day) % aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.02 42 3.4 0.0 016 400
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 0.02 85 3.4 0.0016 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.02 81 3.4 0.0 016 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.02 34 3.4 0.0 016 400
--------------------------------------------------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
cyfluthrin from food will utilize 1.5% of the cPAD for the U.S.
population, 2.4% of the cPAD for all infants < 1 year old, the infant
subpopulations at greatest exposure, and 5.7% of the cPAD for children
1-2 years old, the children subpopulation at greatest exposure. The
registered residential termiticide uses do constitute a chronic
inhalation exposure scenario, however, the vapor pressure of cyfluthrin
is so low (3.3 x 10-8 torr) that such exposures are
anticipated to be negligible. In addition, there is potential for
chronic dietary exposure to cyfluthrin in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Cyfluthrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC Chronic DWLOC
Population Subgroup cPAD mg/kg/day %cPAD (Food) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.024 1.5 0.082 0.0016 840
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 0.024 2.4 0.082 0.0016 230
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.024 5.7 0.082 0.0016 230
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.024 1.0 0.082 0.0016 720
--------------------------------------------------------------------------------------------------------------------------------------------------------

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).
Cyfluthrin is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for cyfluthrin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs =/>500. 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 cyfluthrin in ground water
and surface water. After calculating DWLOCs and comparing them to-the
EECs for surface water and ground water, EPA does not expect short-term
aggregate exposure to exceed the Agency's level of concern, as shown in
the following Table 4:

[[Page 53951]]

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Cyfluthrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC Short-Term DWLOC
Residential) of Concern (LOC) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult male 500 100 0.082 0.0016 630
------------------------------------------------------------------------------
Adult female 500 100 0.082 0.0016 540
------------------------------------------------------------------------------
Child 500 100 0.082 0.0016 180
------------------------------------------------------------------------------
Infant 550 100 0.082 0.0016 200
--------------------------------------------------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs =/> 250.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition,
intermediate-term DWLOCs were calculated and compared to the EECs for
chronic exposure of cyfluthrin in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect intermediate-term aggregate exposure
to exceed the Agency's level of concern, as shown in following Table 5:

Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Cyfluthrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC Intermediate-Term
Residential) of Concern (LOC) (ppb) (ppb) DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult male 250 100 0.082 0.0016 490
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult female 250 100 0.082 0.0016 420
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child 300 100 0.082 0.0016 160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant 290 100 0.082 0.0016 160
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 cyfluthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (GC/electron capture detection
(ECD) methods) is available in PAM Vol. II to enforce the tolerances.
GC/ECD enforcement method 85823, and Bayer's GC/MS method 108139-1,
with modifications, were used to analyze samples in the current crop
field trials and processing studies. Each method was adequately
validated using fortified control samples analyzed in conjunction with
the field trial or processing study samples.

B. International Residue Limits

A tolerance of 0.5 ppm is recommended for the pome fruit crop group
to harmonize with the Codex apple MRL.

V. Comments

In response to the notice of filing one communication was received
from a private citizen objecting to the establishment of the proposed
tolerances. The comment contained general and unsubstantiated
objections to the use of pesticides on food , the use of animal testing
to determine the safety of pesticides, and EPA's risk assessment and
safety finding methodologies. The Agency understands the commentor's
concerns and recognizes that some individuals believe that pesticides
should be banned completely. However, under the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute.
The Agency disagrees with the commenter's objections to animal
testing. Since humans and animals have complex organ systems and
mechanisms for the distribution of chemicals in the body, as well as
processes for eliminating toxic substances from their systems, EPA
relies on laboratory animals such as rats and mice to mimic the
complexity of human and higher-order animal physiological responses
when exposed to a pesticide. EPA is committed, however, to reducing the
use of animals whenever possible. EPA-required studies include animals
only when the requirements of sound toxicological science make the use
of an animal absolutely necessary. The Agency's goal is to be able to
predict the potential of pesticides to cause harmful effects to humans
and wildlife by using fewer laboratory animals as models and have been
accepting data from alternative (to animals) test methods for several
years. As progress is made on finding or developing non-animal test
models that reliably predict the potential for harm to humans or the
environment, EPA expects that it will need fewer animal studies to make
safety determinations.

VI. Conclusion

Therefore, tolerances are established for residues of cyfluthrin as
requested in the revised petitions.

[[Page 53952]]

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-2005-0205 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
14, 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 issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0205, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VIII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 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, entitledFederal 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. 601et
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

[[Page 53953]]

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 (59 FR 22951, 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. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: August 22, 2005.
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 180.436 is amended by removing the commodity potato from the
table in paragraph (a); by alphabetically adding new commodities to the
table in paragraph (a); and by adding paragraph (c) to read as follows:

Sec. 180.436 Cyfluthrin; tolerances for residues.

(a) * * *

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Almond, hulls............................. 0.5
Brassica, leafy greens, subgroup 5B....... 7.0
Fruit, pome, group 11..................... 0.5
Fruit, stone, group 12.................... 0.3
Grape..................................... 1.0
Grape, raisin............................. 3.5
Nut, tree, group 14....................... 0.01
Pea and bean, dried shelled, except 0.15
soybean, subgroup 6C.....................
Peanut.................................... 0.01
Peanut, hay............................... 6.0
Pistachio................................. 0.01
Turnips, greens........................... 7.0
Vegetable, cucurbit, group 9.............. 0.1
Vegetable, fruiting, group 8.............. 0.5
Vegetable, leafy greens, except Brassica, 6.0
group 4..................................
Vegetable, tuberous and corm, subgroup 1C. 0.01
Wheat, forage............................. 5.0
Wheat, hay................................ 6.0
Wheat, straw.............................. 6.0
----------------------------------------------------------------------------------------------------------------

* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec. 180.1(n), are established
for residues of cyfluthrin in or on the following raw agricultural
commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Grass, forage........................................ 6.0
Grass, hay........................................... 8.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 05-17823 Filed 9-12-05; 8:45 am]
BILLING CODE 6560-50-S

Notices For
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Cyfluthrin; Pesticide Tolerance

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