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Cyfluthrin. May 17, 2001, Pesticide Tolerances for Emergency Exemptions. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/May/Day-17/p12440.htm
[Federal Register: May 17, 2001 (Volume 66, Number 96)]
[Rules and Regulations]
[Page 27463-27473]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my01-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301126; FRL-6781-8]
RIN 2070-AB78
Cyfluthrin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of cyfluthrin in or on grapes and raisins; grain of barley,
oats, and wheat; and fat of cattle, goats, hogs, horses and sheep. This
action is in response to EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on grapes and stored grain. This
regulation establishes maximum permissible levels for residues of
cyfluthrin in these food commodities. These tolerances will expire and
are revoked on June 30, 2003.
DATES: This regulation is effective May 17, 2001. Objections and
requests for hearings, identified by docket control number OPP-301126,
must be received by EPA on or before July 16, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301126 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 703-308-9362; and e-mail
address: schaible.stephen@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 categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of Potentially
Categories NAICS Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------
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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that
[[Page 27464]]
might be available electronically,from the EPA Internet Home Page at
http://www.epa.gov. To access this document, on the Home Page select
``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then
look up the entry for this document under the ``Federal Register--
Environmental Documents.'' You can also go directly to theFederal
Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS
Harmonized Guidelines referenced in this document, go directly to the
guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A
frequently updated electronic version of 40 CFR part 180 is available
at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/
40cfr180_00.html, a beta site currently under development.
2.In person. The Agency has established an official record for this
action under docket control number OPP-301126. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is 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 grape
at 1.0 part per million (ppm); grape, raisin at 1.5 ppm; grain of
barley, oats, and wheat at 2.0 ppm; and fat of cattle, goats, hogs,
horses and sheep at 6.0 ppm. These tolerances will expire and are
revoked on June 30, 2003. EPA will publish a document in the Federal
Register to remove the revoked tolerances from the Code of Federal
Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the 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) 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)
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....''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemptions for Cyfluthrin on Grapes and Stored
Grains and FFDCA Tolerances
According to the South Dakota Department of Agriculture, reports of
damage to stored grain from infestations of lesser grain borer have
increased in recent years. Lesser grain borer is a serious pest of
stored grain because it is capable of destroying whole, sound grain.
Storage of grain in larger, less protective structures have caused
grain to be more vulnerable to infestations, primarily because the
grain remains warmer, creating conditions favorable to insect
development. The Applicant claims that there are not currently any
effective registered alternatives for control of lesser grain borer.
Reldan 4E (chlorpyrifos-methyl) is registered for use on wheat and
sorghum but will not control lesser grain borer. Most malathion uses
are no longer available, but even if they were insect resistance has
built up to the point that this chemical is not effective. Phosphine
gas is the primary fumigant of stored grain, but lesser grain borer has
begun to demonstrate resistance. Storcide is a combination product
containing the active ingredients chlorpyrifos-methyl and cyfluthrin;
while the chlorpyrifos-methyl component of this product controls most
insect pests in stored grain, the cyfluthrin component is necessary to
control the lesser grain borer. The Applicant predicts that without the
proposed use of Storcide, between 33% and 50% of bushels could be
affected, resulting in $13.3 million in economic losses.
The California Department of Pesticide Regulation states that
glassy winged sharpshooters are a recently introduced pest of grape
production, and serve as a vector of Pierce's disease, which is caused
by the bacterium Xylella fastidiosa. This disease can destroy a
vineyard within 12 months and can still kill vines 2 to 3 years after
infection. Since 1998, growers have observed a 25-30% reduction in
vines, with 80% of some vineyard blocks being removed due to the
disease. This same infection process and bacterium are the causal
agents for other plant diseases in peaches in the southeastern United
States and citrus in Brazil.
The required feeding time necessary for the pest to successfully
vector bacterium for Pierce's disease is not known as of yet.
Therefore, rapid control of the glassy winged sharpshooter may be
essential to avoid significant economic losses. Given this, the
Applicant claims that the available alternatives, imidacloprid and
dimethoate, are not sufficient to provide control of this pest
throughout the 7-month period of occurrence in California vineyards.
While imidacloprid may provide some control of this pest, the soil
applied formulation is slow acting and the foliar formulation has
little persistence (thus making multiple applications necessary). The
pre-harvest interval for dimethoate makes it impractical for use in
grapes. Because of its rapid population advance
[[Page 27465]]
and ability to vector problem plant diseases, glassy-winged
sharpshooter is now considered to be a significant threat to
California's $2.8 billion/year wine, raisin, table grape and citrus
industries. The California Department of Food and Agriculture (CDFA)
maintains that Pierce's disease is responsible for $12 million in
losses of grapevines in Temecula, California.
EPA has authorized under FIFRA section 18 the uses of cyfluthrin on
grapes for control of glassy winged sharpshooter in California and on
stored grain in South Dakota for control of lesser grain borer and
other insect pests. After having reviewed these submissions, EPA
concurs that emergency conditions exist for these States.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of cyfluthrin in or
on grapes, raisins, and grain, and by secondary residues of cyfluthrin
in animal commodities as a result of treated grain commodities being
used as feed items. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerances
under FFDCA section 408(l)(6) would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemptions in order to address urgent non-
routine situations and to ensure that the resulting food is safe and
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment as provided in section 408(l)(6). Although these
tolerances will expire and are revoked on June 30, 2003, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerances remaining in or on grapes and
raisins; grain of barley, oats, and wheat; and fat of cattle, goats,
hogs, horses and sheep after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed the levels that were authorized by these
tolerances at the time of those applications. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether cyfluthrin
meets EPA's registration requirements for use on grapes or stored grain
or whether permanent tolerances for these uses would be appropriate.
Under these circumstances, EPA does not believe that these tolerances
serve as a basis for registration of cyfluthrin by a State for special
local needs under FIFRA section 24(c). Nor do these tolerances serve as
the basis for any State other than California or South Dakota to use
this pesticide on these crops under section 18 of FIFRA without
following all provisions of EPA's regulations implementing section 18
as identified in 40 CFR part 166. For additional information regarding
the emergency exemptions for cyfluthrin, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
Consistent with section 408(b)(2)(D), 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
cyfluthrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of cyfluthrin in or on grape at 1.0 ppm; grape, raisin at 1.5
ppm; grain of barley, oats and wheat at 2.0 ppm; and fat of cattle,
goat, hogs, horses and sheep at 6.0 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing these
tolerances follows.
A. 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 endpoint. 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.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, 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 FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10?\6\or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for cyfluthrin used for human risk assessment is shown in the
following Table 1:
[[Page 27466]]
Table 1.--Summary of Toxicological Dose and Endpoints for Cyfluthrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Exposure Scenario Dose (mg/kg bwt/day) Endpoint Study
----------------------------------------------------------------------------------------------------------------
Acute Dietary (All population) Developmental NOAEL = Increased numbers of Developmental - rabbit
20.0; LOAEL = 60.0 resorption and percent (oral)
incidence of
postimplantation loss
in rabbits in a
developmental toxicity
study.
--------------------------------------------------
UF=300 (10x inter- and Acute Population
10x intra- and 3x FQPA Adjusted Dose
considerations) (aPAD)aPAD = NOAEL/UF=
20/300 = 0.07 mg/kg
bwt/day
----------------------------------------------------------------------------------------------------------------
Chronic Dietary NOAEL = 2.5; LOAEL = Decreased body weight 2-year rat (oral)
6.2 gain in males, and
inflammatory foci in
kidneys of female rats
in a chronic toxicity/
carcinogenicity study.
--------------------------------------------------
UF = 300: 10X inter- Chronic Population
and 10X intra and 3x Adjusted Dose (cPAD)
FQPA factor for all cPAD = NOAEL/UF = 2.5/
population subgroups 300 = 0.008 mg/kg bwt/
day
----------------------------------------------------------------------------------------------------------------
Short, intermediate-Term (1-7 days) Dermal NOAEL =20.0; Increased numbers of Developmental - rabbit
Occupational/Residential LOAEL =60.0 (Dermal resorption and percent (oral)
absorption rate = 25%) incidence of
postimplantation loss
in rabbits.
-------------------------
MOE = 300
----------------------------------------------------------------------------------------------------------------
Intermediate-Term (one week to Dermal NOAEL = 20.0; Increased numbers of Developmental - rabbit
several months) Occupational/ LOAEL = 60.0 (Dermal resorption and percent (oral)
Residential absorption rate = 25%) incidence of
postimplantation loss
in rabbits. MOE = 300
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal NOAEL = 2.5; Decreased body weight 2-year rat (oral)
NOAEL = 6.2 (Systemic) in male and
Dermal absorption rate inflammatory foci in
= 25% the kidney of female
rats in a chronic
toxicity/
carcinogenicity study.
MOE=300
----------------------------------------------------------------------------------------------------------------
All time periods Inhalation: Short-Term: Decreases in body and 28-day rat inhalation
NOAEL = 0.44 µ thymus weights, study (short-term)
>g/L = 0.12 mg/kg/ hypothermia and
day;LOAEL=6 µg/ clinical pathology in
L rats in a 28-day study
(short-term) and
behavioral effects in
rats in a 90-day study
(intermediate/
chronic). UF = 300
--------------------------------------------------------------------------
Intermediate/Chronic: The extrapolation 90-day rat inhalation
NOAEL = 0.09 µ method was used in study (intermediate/
>g/L = 0.024 mg/kg/ converting the NOAEL chronic)
day;LOAEL=0.7 µ from µg/L to
>g/L mg/kg/day
----------------------------------------------------------------------------------------------------------------
Cancer Oral Cyfluthrin is
classified as a group
E chemical.
Carcinogenicity
studies in rats and
mice were negative.
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
unique to the FQPA.
B. Exposure 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. Existing tolerances for
aspirated grain fractions (300 ppm), sorghum, grain (4 ppm); and meat
and meat byproducts of cattle, goats, hogs, horses, and sheep (0.4 ppm
for both meat and meat byproducts) are sufficient to cover residues
resulting from the application of cyfluthrin under the emergency
[[Page 27467]]
exemption. The existing tolerance of 5.0 ppm for fat of cattle, goats,
hogs, horses, and sheep is insufficient to cover residues resulting
from section 18 use on stored grains; the time-limited tolerance of 6.0
ppm is therefore being established. While time-limited tolerances of
1.0 ppm for grapes and 1.5 ppm for raisins are required, no
concentration of residues occurs in grape juice and a separate
tolerance for that commodity is not required. For purposes of dietary
risk assessment, residue data generated from residue field trials
conducted at maximum application rate and minimum preharvest intervals
were used, as were processing data for grapes. To assess secondary
exposure from edible animal commodities, animal dietary burdens were
calculated using mean field trial residues, adjusted to take into
account percent of crop treated information, and applying appropriate
processing factors for all feed items. 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 one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM) analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: anticipated residues and percent of
crop treated refinements were used for existing tolerances; anticipated
residues and 100% of crop treated were assumed for the proposed
tolerances associated with section 18 uses on stored grains and grapes.
Anticipated residues were also assumed for meat, milk, poultry and egg
tolerances. This Tier 3 Monte Carlo analysis is considered partially to
highly refined. Field trial residue distributions were assumed for
those foods identified by EPA as single-serving commodities. For those
foods considered to be blended or processed, mean field trial residues
were calculated, substituting the full limit of detection (LOD) for
those samples for which residues were reported below the LOD.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
field trial residues and percent of crop treated refinements were used
for the existing tolerances; anticipated residues and 100% of crop
treated were assumed for the section 18 uses on stored grains and
grapes. Anticipated residues were also assumed for meat, milk, poultry
and egg tolerances. This Tier 3 analysis is considered partially to
highly refined.
iii. Cancer. Cyfluthrin has been classified as a not likely human
carcinogen (Group E chemical). A cancer dietary risk assessment is not
required.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) 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 percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used percent crop treated (PCT) information as shown in
the following Table 2:
Table 2.--Percent of Crop Treated Estimates for Acute and Chronic Risk
Assessment
------------------------------------------------------------------------
Percent of Crop Treated
-------------------------------
Site Weighted Estimated
Average Maximum
(Chronic) (Acute)
------------------------------------------------------------------------
Corn 1 3
------------------------------------------------------------------------
Alfalfa 1 1
------------------------------------------------------------------------
Orange 5 13
------------------------------------------------------------------------
Sorghum 1 1
------------------------------------------------------------------------
Sweet Corn 3 6
------------------------------------------------------------------------
Tomato 3 5
------------------------------------------------------------------------
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the
[[Page 27468]]
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. Cyfluthrin is poorly mobile and
moderately persistent, and will remain sorbed to the soil for weeks
following treatment. This suggests little potential to leach and
contaminate groundwater, but high potential for transport to surface
water via particulate run-off during rain events.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever 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) from these models 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 below.
Based on the PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of cyfluthrin for acute exposures
are estimated to be 5.49 parts per billion (ppb) for surface water and
0.006 ppb for ground water. The EECs for chronic exposures are
estimated to be 2.18 ppb for surface water and 0.006 ppb for ground
water. Because the Tier II PRZM/EXAMS exposure estimates exceed the
solubility of cyfluthrin in water, EPA used the value of 1.2 ppb, the
solubility of cyfluthrin in water, as the acute and chronic EEC for the
surface water drinking water assessment. This value represents that
maximum concentration of cyfluthrin that would be found in surface
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).
Cyfluthrin is currently registered for use on the following
residential non-dietary sites: residential lawn and gardens, inside
households, carpets, and as a termiticide. The termite control is
achieved by establishing a continuous chemical barrier between the wood
and the termite colonies in the soil. Like many other termite control
chemicals, cyfluthrin is normally applied to the entire surface of soil
or other substrate to be covered by the slab before the construction,
or applied under the slab after the construction. The potential of
dermal exposure is not expected. However, some termite control
chemicals applied to the soil may penetrate house foundation to become
a source for emission inside of the house. Consequently, short-term and
intermediate-term as well as chronic exposures via inhalation route may
occur. However, the vapor pressure of cyfluthrin is 3.3 x 10 E-8 Torr
which indicates that the amount of emission from this chemical is
extremely limited. For this reason, the potential of inhalation
exposure is also very limited. Based on these considerations,
residential risk assessment was not conducted for the termiticide use.
As mentioned above, cyfluthrin is also registered for use on
residential lawns and carpets (fogger). Under current Office of
Pesticide Programs' (OPP) guidelines, these uses do not present a
chronic exposure scenario; because exposure to cyfluthrin may occur as
a result of inhalation or contact from indoor and outdoor uses, these
uses do constitute a short- and/or intermediate-term exposure scenario.
A residential exposure assessment for those uses of cyfluthrin was
conducted in conjunction with the EPA's risk assessment supporting the
extension of tolerances for synthetic pyrethroids. The exposure data
(in mg/kg/day) from this assessment are summarized in the following
tables 3 and 4:
Table 3.--Exposure Assessment Data from Cyfluthrin Use on Lawns
----------------------------------------------------------------------------------------------------------------
Scenario Individual Inhalation Dermal Oral
----------------------------------------------------------------------------------------------------------------
Lawn Application Adult not conducted not conducted not conducted
----------------------------------------------------------------------------------------------------------------
Post-Application Lawn Adult 1.16E-05 1.39E-03 not conducted
----------------------------------------------------------------------------------------------------------------
Post-Application Lawn Child (1-6) 2.78E-05 2.63E-03 2.85E-04
----------------------------------------------------------------------------------------------------------------
Post-Application Lawn Infant (<1) 3.56E-05 2.72E-03 3.03E-04
----------------------------------------------------------------------------------------------------------------
This product for lawns is a restricted use pesticide, and
therefore, required to be applied by professional lawn care operators
only. Thus, from the applicator perspective, this lawn scenario is
considered out of EPA's
[[Page 27469]]
scope for purposes of residential exposure.
Table 4.--Exposure Assessment Data from Cyfluthrin Use on Carpet
----------------------------------------------------------------------------------------------------------------
Scenario Individual Inhalation Dermal Oral
----------------------------------------------------------------------------------------------------------------
Carpet (fogger) Application Adult not conducted 8.84E-03 not conducted
----------------------------------------------------------------------------------------------------------------
Post-Application Carpet Adult 3.40E-05 1.63E-03 not conducted
----------------------------------------------------------------------------------------------------------------
Post-Application Carpet Child (1-6) 8.56E-06 4.20E-03 3.60E-04
----------------------------------------------------------------------------------------------------------------
Post-Application Carpet Infant (<1) 1.04E-05 4.65E-03 3.84E-04
----------------------------------------------------------------------------------------------------------------
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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.''
EPA does not have, at this time, available data to determine
whether cyfluthrin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
cyfluthrin does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that cyfluthrin has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
C. Safety Factor for Infants and Children
1. Safety factor for infants and children---i. In general. FFDCA
section 408 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 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.
ii. Developmental toxicity studies. In the rat developmental study,
neither a maternal LOAEL nor a developmental LOAEL was observed. The
maternal NOAEL was >10 mg/kg/day (the highest dose tested), as was the
developmental NOAEL. The previously conducted range finding study
supported the dose selection which was used in the developmental study,
and the rat study is classified as an Acceptable guideline. In the
rabbit developmental study, the maternal LOAEL was 60 mg/kg/day, based
on decreased body weight gain and food consumption during the dosing
period. The maternal NOAEL was 20 mg/kg/day. The developmental LOAEL
was 60 mg/kg/day, based on increased numbers of resorptions and percent
incidence of postimplantation loss. The developmental NOAEL is 20 mg/
kg/day.
Two rat developmental toxicity studies via the inhalation route of
exposure were also conducted. In the first study, maternal effects were
observed at 4.7 mg/M3 and above, and effects in the pups
were observed at 1.1 mg/M3 and above. At 1.1 mg/
M3 and above, a dose-related increase in the incidence of
runts and skeletal anomalies in the sternum were observed. At 4.7 mg/
M3 and above, increases in post-implantation losses and
decreases in pup weights were observed. At 23.7 mg/M3,
increased incidences of late embryonic deaths and in skeletal anomalies
in the extremities, pelvis and skull were observed as well as
microphthalmia. The maternal NOAEL is 1.1 mg/M3 and the
maternal LOAEL is 4.7 mg/M3, based on reduced motility,
dyspnea, piloerection, ungroomed coats and eye irritation. The
developmental NOAEL is 0.59 mg/M3 and the developmental
LOAEL is 1.1 mg/M3, based on increases in the incidence of
runts and skeletal anomalies in the sternum (1.1 mg/M3 and
above), increases in post-implantation losses and decreases in pup
weights (4.7 mg/M3 and above), and increased incidences of
late embryonic deaths, in skeletal anomalies in the extremities, pelvis
and skull and in microphthalmia (23.7 mg/M3).
In the second study, the maternal NOAEL and LOAEL were < 0.46 mg/
M3, based on decreased body weight gain and reduced relative
food efficiency. The developmental NOAEL was 0.46 mg/M3 and
the developmental LOAEL was 2.55 mg/M3, based on reduced
fetal and placental weight, and reduced ossification in the phalanx,
metacarpals, and vertebrae.
iii. Reproductive toxicity study. In the 3-generation rat
reproduction study, the LOAEL for parental toxicity was 22.5 mg/kg/day,
based on decreased body weight gains; the NOAEL was 7.5 mg/kg/day. The
LOAEL for reproductive toxicity was 7.5 mg/kg/day based on decreased
viability and lactational indices and decreased pup body weight gains.
The NOAEL was 2.5 mg/kg/day.
iv. Prenatal and postnatal sensitivity. There are no data gaps for
reproductive and developmental toxicity studies. Evidence of increased
sensitivity of young rats following pre- and/or post-natal exposure to
cyfluthrin was observed in the three-generation reproduction study in
rats. There was suggestive sensitivity of rats to in utero exposure
based on bradypnea seen in dams in the developmental inhalation
studies. In addition, the reproductive NOAEL of 2.5 mg/kg/day and the
LOAEL of 7.5 mg/kg/day established in the three-generation reproduction
study in rats are identical to the systemic NOAEL/LOAEL of 2.5/7.5 mg/
kg/day established in the chronic toxicity/carcinogenicity study in
rats. This NOAEL (2.5 mg/kg/day) and a UF of 100 was used in deriving
the RfD (0.025 mg/kg/day) and the RfD does not provide protection for
infants and children.
v. Conclusion. There is a complete toxicity database for cyfluthrin
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Based on the
considerations above, EPA determined that the tenfold FQPA safety
factor should be replaced with an uncertainty factor of three for
acute,
[[Page 27470]]
short- and intermediate-term, and chronic risk assessments. While
evidence of increased sensitivity of young rats following pre- and/or
post-natal exposure to cyfluthrin was observed in the three-generation
reproduction study in rats, an uncertainty factor of 3 was selected
because of the lack of severity of effects (reduced body weight gain in
males in chronic toxicity study and decreased body weight gain in
parental animals in the reproduction study) and the availability of
acceptable reproduction (rat) and developmental (rats and rabbits)
toxicity studies.
D. 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 the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational 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 USEPA Office of Water are used to calculate
DWLOCs: 2L/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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to cyfluthrin in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, OPP will reassess the potential impacts of
cyfluthrin on 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 at the 99.9th percentile will occupy 59% of the aPAD for the
U.S. population, 28% of the aPAD for females age 13-50 years, 89% of
the aPAD for infants and 80% of the aPAD for children aged 1 through 6
years. In addition, despite the potential for acute dietary exposure to
cyfluthrin in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
cyfluthrin in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 5:
Table 5.--Aggregate Risk Assessment for Acute Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/kg/ % aPAD Water EEC Water EEC Acute DWLOC
day) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.07 59 1.2 0.006 1,000
----------------------------------------------------------------------------------------------------------------
All infants < 1 yr. 0.07 89 1.2 0.006 1500
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs. 0.07 80 1.2 0.006 140
----------------------------------------------------------------------------------------------------------------
Female 13-50 yrs. 0.07 28 1.2 0.006 80
----------------------------------------------------------------------------------------------------------------
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 30% of the cPAD for the U.S.
population, 26% of the cPAD for infants < 1 yr. and 73% of the cPAD for
children 1 through 6 years. Based on the use pattern, chronic
residential exposure to residues of cyfluthrin is not expected. In
addition, despite the potential for chronic dietary exposure to
cyfluthrin in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
cyfluthrin in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 6:
Table 6.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.008 30 1.2 0.006 200
----------------------------------------------------------------------------------------------------------------
All infants < 1 yr. 0.008 26 1.2 0.006 79
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs. 0.008 73 1.2 0.006 22
----------------------------------------------------------------------------------------------------------------
[[Page 27471]]
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 uses 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 of 1,500 for adults, 1,400 for
children 1 through 6 years old, and 1,600 for infants < 1 year old.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of cyfluthrin in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
7:
Table 7.--Aggregate Risk Assessment for Short-Term Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adult (male) 1,500 300 1.2 0.006 1,900
----------------------------------------------------------------------------------------------------------------
Adult (female) 1,500 300 1.2 0.006 1,600
----------------------------------------------------------------------------------------------------------------
Child 1-6 yrs. 1,400 300 1.2 0.006 530
----------------------------------------------------------------------------------------------------------------
Infant < 1 yr. 1,600 300 1.2 0.006 540
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Cyfluthrin is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for cyfluthrin.
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 of 460 for
adults, 530 for children 1 through 6, and 470 for infants < 1 year.
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 water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect intermediate-term aggregate exposure
to exceed the Agency's level of concern, as shown in the following
Table 8:
Table 8.-- Aggregate Risk Assessment for Intermediate-Term Exposure to Cyfluthrin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adult (male) 460 300 1.2 0.006 800
----------------------------------------------------------------------------------------------------------------
Adult (female) 460 300 1.2 0.006 690
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs. 530 300 1.2 0.006 290
----------------------------------------------------------------------------------------------------------------
Infants < 1 yr. 470 300 1.2 0.006 240
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. Cyfluthrin has been
classified as a not likely human carcinogen (Group E chemical). A
cancer dietary risk assessment is not required.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to cyfluthrin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas/liquid chromatography with an
electron capture detector) is available to enforce the tolerance
expression. The method may be requested from: Calvin Furlow, PIRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone
number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.
B. International Residue Limits
There are no Codex tolerances established for cyfluthrin on grapes,
raisins, or grains. Nor have any tolerances been established by Canada
or Mexico for cyfluthrin on grapes, raisins, or grains (of barley, oat,
or wheat).
VI. Conclusion
Therefore, the tolerances are established for residues of
cyfluthrin, cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-
dichloroethenyl]-2,2-
[[Page 27472]]
dimethyl-cyclopropanecarboxylate, in or on grape at 1.0 ppm; grape,
raisin at 1.5 ppm; grain of barley, oat, and wheat at 2.0 ppm; and fat
of cattle, goat, hog, horse, and sheep at 6.0 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the 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
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-301126 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 July 16,
2001.
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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3.Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301126, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. 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. Regulatory Assessment Requirements
This final rule establishes time limited tolerances under FFDCA
section 408. 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).
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 FIFRA section 18 exemption under FFDCA
section 408, such as the tolerance in this final rule, do not require
the issuance of a proposed rule, the requirements of the
[[Page 27473]]
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 FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.''
IX. Submission to Congress and the Comptroller General
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: May 3, 2001.
James Jones,
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), 346(a) and 371.
2. Section 180.436 is amended by adding paragraph (b) to read as
follows:
Sec. 180.436 Cyfluthrin; tolerances for residues.
* * * * *
(b)Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide cyfluthrin, cyano[4-fluoro-
3-phenoxyphenyl]-methyl-3-[2,2-dichloroethenyl]-2,2-dimethyl-
cyclopropanecarboxylate in connection with use of the pesticide under
section 18 emergency exemptions granted by EPA. These tolerances will
expire and are revoked on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Barley, grain..................... 2.0 6/30/03
Cattle, fat....................... 6.0 6/30/03
Goat, fat......................... 6.0 6/30/03
Grape............................. 1.0 6/30/03
Grape, raisin..................... 1.5 6/30/03
Hog, fat.......................... 6.0 6/30/03
Horse, fat........................ 6.0 6/30/03
Oat, grain........................ 2.0 6/30/03
Sheep, fat........................ 6.0 6/30/03
Wheat, grain...................... 2.0 6/30/03
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-12440 Filed 5-16-01; 8:45 am]
BILLING CODE 6560-50-S