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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.

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

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      		thymus weights,          study (short-term)
                                        >g/L = 0.12 mg/kg/      hypothermia and
                                        day;LOAEL=6 g/  		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      		method was used in       study (intermediate/
                                        >g/L = 0.024 mg/kg/     converting the NOAEL     chronic)
                                        day;LOAEL=0.7     		from g/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