[Federal Register Volume 70, Number 176 (Tuesday, September 13, 2005)]
[Rules and Regulations]
[Pages 53944-53953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17823]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0205; FRL-7725-7]


Cyfluthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
cyfluthrin in or on almond hulls, cucurbit vegetable crop group 9, 
fruiting vegetable group 8; grass forage; grass hay; grape; grape, 
raisin; leafy Brassica greens, subgroup 5B; leafy vegetable group, 
except Brassica, group 4; pistachio; pome fruit group 11; stone fruit 
group 12; tuberous and corm vegetable subgroup 1C; peanut; peanut, hay; 
pea and bean, dried shelled, except soybean, subgroup 6C; tree nuts, 
Crop Group 14; turnip greens; wheat forage; wheat hay; and wheat straw. 
Bayer CropScience and the Interregional Research Project Number 4 (IR-
4) requested the tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective September 13, 2005. Objections and 
requests for hearings must be received on or before November 14, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0205.All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Olga Odiott, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9369; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of January 28, 2004 (69 FR 4143) (FRL-7339-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petitions (PP 
1F6290, 2F6445, and 2F6479) by Bayer CropScience, 2 T.W. Alexander 
Drive, Research Triangle Park, NC 27709; and (PP 1E6318, 3E6776, and 
3E6583) by the Interregional Research Project Number 4 (IR-4), 
Technology Centre and Rutgers State University of New Jersey, 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-390. The petitions 
requested that 40 CFR 180.436 be amended by establishing tolerances for 
residues of the insecticide cyfluthrin, cyano (4-fluoro-3-
phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-
cyclopropanecarboxylate, in or on almond hulls at 1.0 parts per million 
(ppm); pistachio at 0.01 ppm; and tree nuts, crop group 14 at 0.01 ppm 
(PP 1F6290); cucurbit vegetable crop group at 0.10 ppm; fruiting 
vegetable group at 0.5 ppm; leafy Brassica greens subgroup at 7.0 ppm; 
leafy vegetable group at 6.0 ppm; pome fruit group at 0.10 ppm; pome 
fruit wet pomace at 0.30 ppm; stone fruit group at 0.30 ppm; wheat 
forage, wheat hay and wheat straw at 5.0 ppm; and wheat shorts at 3.5 
ppm (PP 2F6445); grape at 0.8 ppm; grape, raisin at 3.5 ppm; peanut at 
0.01 ppm; and peanut, hay at 6.0 ppm (PP 2F6479); tuberous and corm 
vegetable subgroup at 0.01 ppm (PP 1E6318); turnip greens at 7 ppm (PP 
3E6583); and grass forage at 6 ppm; grass hay at 8 ppm; and pea and 
bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm (PP 
3E6776). That notice included a summary of the petition prepared by 
Bayer Crop Science, the registrant. The registrant has submitted a 
request to voluntarily

[[Page 53945]]

cancel uses of cyfluthrin on stored grains effective December 31, 2004.
    Based on EPA's review, the petitions were revised by the 
petitioners as follows: i. by increasing proposed tolerances for grapes 
to 1.0 ppm and the proposed tolerances for wheat hay and straw to 6.0 
ppm; ii. by increasing the proposed pome fruit crop group tolerance to 
0.5 ppm to harmonize with the Codex apple MRL and deleting the proposed 
tolerance on pome fruit wet pomace since expected residues are below 
the pome fruit tolerance of 0.5 ppm; iii. by decreasing proposed 
tolerances for almond hulls to 0.5 ppm; iv. by removing tolerances for 
peanut oil since residues will be lower than residues in peanuts; v. by 
removing tolerances in prume since maximum expected residues are below 
the proposed tolerance for the stone fruit crop group; and vi. by 
withdrawing the proposed tolerance for wheat shorts since it is already 
covered under wheat milled by products.
    Although EPA requested a number of changes to the initial 
petitions, the nature of the changes (changes in tolerance levels) are 
not considered significant. Therefore, EPA is issuing this as a final 
action. EPA is also removing the existing tolerance for potato, since a 
tolerance is being established on the entire tuberous and corm 
vegetable subgroup; removing time-limited tolerances established for 
grape and grape, raisin at 1.0 and 1.5 ppm, respectively, in connection 
with Section 18 emergency exemptions since they are no longer needed; 
and establishing tolerances with regional registrations for grass 
forage and hay.
    One comment was received in response to the notice of filing. The 
comment is described and discussed in Unit V. Comments.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances in the Federal Register November 26, 
1997 (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for the cyfluthrin tolerances described in Unit II. 
EPA's assessment of exposures and risks associated with establishing 
the tolerances follows.

A. Toxicological Profile

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

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional UFs'' the ``special FQPA safety factor;'' and the 
``default FQPA safety factor.'' By the term ``traditional UF,'' EPA is 
referring to those additional UFs used prior to FQPA passage to account 
for database deficiencies. These traditional UFs have been incorporated 
by the FQPA into the additional safety factor for the protection of 
infants and children. The term ``special FQPA safety factor'' refers to 
those safety factors that are deemed necessary for the protection of 
infants and children primarily as a result of the FQPA. The ``default 
FQPA safety factor'' is the additional 10X safety factor that is 
mandated by the statute unless it is decided that there are reliable 
data to choose a different additional factor (potentially a traditional 
UF or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by an UF of 100 to account for 
interspecies and intraspecies differences and any traditional UFs 
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor 
or the default FQPA safety factor is used, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and

[[Page 53946]]

10X for intraspecies differences) the LOC is 100. To estimate risk, a 
ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/
exposure) is calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-5), one in a million (1 x 10- 6), or one in 
ten million (1 x 10-7). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for cyfluthrin used for 
human risk assessment is shown in following Table 1:

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

C. Exposure Assessment

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

[[Page 53947]]

result of its use in food, and feed-handling establishments.
    Although the uses on stored grain have been voluntarily cancelled 
by the registrant established tolerances reflecting these uses are to 
remain in 40 CFR Sec.  180.436(a)(1) to allow for clearance of the 
remaining product and treated stored grain from the channels of trade. 
Although the Agency did not specifically include potential cyfluthrin 
residues in stored grains in the dietary exposure assessments, the 
Agency concludes that these assessments do not underestimate dietary 
exposure and risk because:
     About 90% of the stored grain usage was for treatment of 
stored wheat grain, so potential exposure from cyfluthrin use on stored 
grains would come from wheat;
     Residue monitoring data in wheat flour indicate very low 
or non-detectable residues from cyfluthrin use on stored grain;
     The current dietary exposure estimates from the remaining 
existing and the newly proposed uses includes a new foliar use on 
wheat. The wheat field trial data used to estimate dietary exposure 
reflect maximum rates and minimum pre-harvest intervals (PHI's), and 
these residues were significantly higher than monitoring data residues 
for wheat. Monitoring data residues in wheat flour from cyfluthrin use 
on stored grain were so low that they would not increase dietary 
exposure estimates if they had been included in the assessment;
     Exposure from residues in wheat (based on the high end 
foliar use residues) was not significant for any of the population 
subgroups, including infants and children; and
     Residues in stored grains were not a major component of 
secondary residue estimates in livestock commodities, and concomitant 
dietary exposure from consumption of animal commodities such as meat 
and milk.
    Risk assessments were conducted by EPA to assess dietary exposures 
from cyfluthrin in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEMTM/FCID), which incorporates food 
consumption data as reported by respondents in the United States 
Department of Agriculture (USDA) 1994-1996, and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII), and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments: Percent crop 
treated (PCT) values for crops with established tolerances, for crops 
with proposed tolerances, anticipated residues in animal commodities, 
and processing factors (including washing and peeling factors). Crop 
field trial data were used for proposed commodities and Pesticide Data 
Program (PDP) monitoring data were used for registered commodities.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEMTM software with the FCID, which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996, and 1998 Nationwide CSFII, and accumulated exposure to 
the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: Average PCT values for crops with 
established tolerances, projected PCT estimates for crops with proposed 
tolerances, anticipated residues in animal commodities, and processing 
factors (including washing and peeling factors). Crop field trial data 
were used for proposed commodities, and PDP monitoring data were used 
for registered commodities.
    iii. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the FFDCA authorizes EPA to use available data and information on 
the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must pursuant to section 
408(f)(1) require that data be provided 5-years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. For the present action, EPA will issue such 
Data Call-Ins for information relating to anticipated residues as are 
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA 
section 408(f)(1). Such Data Call-Ins will be required to be submitted 
no later than 5-years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows. Average and maximum 
values for PCT data were used in the chronic and acute analyses, 
respectively, for the following commodities with established 
tolerances: Alfalfa (1 chronic, 2.5 acute), broccoli (3 chronic, 5 
acute) cabbage (8 chronic, 12 acute), cantaloupes (2 chronic, 5 acute), 
carrots (1 chronic, 5 acute), cauliflower (1 chronic, 2.5 acute), corn 
(5 chronic, 10 acute), cotton (10 chronic, 15 acute), garlic (1 
chronic, 2.5 acute), grapefruit (1 chronic, 2.5 acute), green beans (1 
chronic, 2.5 acute), lemons (5 chronic, 10 acute), lettuce (5 chronic, 
10 acute), mustard greens (1 chronic, 2.5 acute), onions (1 chronic, 
2.5 acute), oranges (15 chronic, 20 acute), peas (1 chronic, 2.5 
acute), peppers (10 chronic, 15 acute), potatoes (25 chronic, 35 
acute), pumpkins (1 chronic, 5 acute), sorghum (1 chronic, 2.5 acute), 
soybeans (1 chronic, 2.5 acute), squash (1 chronic, 2.5 acute), 
sugarcane (5 chronic, 8 acute), sunflowers (3 chronic, 5 acute), sweet 
corn (5 chronic, 8 acute), tangerines (5 chronic, 8 acute), tomatoes (5 
chronic, 8 acute), and watermelons (5 chronic, 8 acute).
    Projected PCT estimates were used for commodities with proposed 
tolerances as follows: Apples 73%, grapes 23%, peaches 39%, pears 59%, 
plums 28%, spinach 15%, winter wheat 4%, and collards greens 15%.
    The Agency believes that the three conditions listed in Unit 
III.C.1.iii have been met. With respect to Condition 1, PCT estimates 
are derived from available federal, state, and private market survey 
data. For existing crop sites on pesticide registrations (``existing 
use''), EPA uses an average PCT for chronic dietary exposure estimates. 
The average PCT figure is derived by combining available federal, 
state, and private market survey data on the existing use, averaging by 
year, averaging across all years, and rounding

[[Page 53948]]

up to the nearest multiple of five except for those situations in which 
the average PCT is less than one. In those cases < 1% is used as the 
average and < 2.5% is used as the maximum. EPA uses a maximum PCT for 
acute dietary exposure estimates. The maximum PCT figure is the single 
maximum value reported overall from available federal, state, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of five. However, in cases where the 
rounded average PCT and the maximum PCT were initially identical at 5%, 
the maximum was further adjusted upward to 8%. In most cases, EPA uses 
available data from United States Department of Agriculture /National 
Agricultural Statistics Service (USDA/NASS), Proprietary Market 
Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent 6 years. The Agency is reasonably certain 
that the percentage of the food treated is not likely to be an 
underestimation
    The Agency projects PCT for a new pesticide use by assuming that 
the PCT for the pesticide's initial five years will not exceed the 
average PCT of the dominant pesticide (the one with the largest PCT) 
within its chemical type over three latest available years. For apples, 
grapes, peaches, pears, plums, and winter wheat the chemical type 
within which cyfluthrin was compared consisted of all other 
insecticides. For spinach and collards the corresponding chemical type 
consisted of all other synthetic pyrethroids with which cyfluthrin was 
price competitive (which excluded permethrin for spinach). The PCTs 
included in the average may be each for the same pesticide or for 
different pesticides since the same or different pesticides may 
dominate for each year selected. Typically, EPA uses USDA/NASS as the 
source for raw PCT data because it is non-proprietary and directly 
available without computation. The assumption was made that cyfluthrin 
would entirely replace the current market leader among all insecticides 
for each crop. This assumption is a conservative one because it is not 
likely that cyfluthrin will entirely replace the market leader for each 
commodity. For spinach and collard greens, the Agency looked at all the 
competing pyrethroids only (as opposed to all insecticides) and assumed 
that cyfluthrin would compete with pyrethroids that are priced 
competitively with cyfluthrin. The assumption was made that cyfluthrin 
would entirely replace the current market leader among all competitive 
pyrethroids for spinach and collards. The value of 15% used for spinach 
and collard greens is very consistent with the PCT values determined 
for the registered commodities. These are considered to be conservative 
estimates of the percent crop treated that cyfluthrin will obtain.
    This method of projecting PCT for a new pesticide, with or without 
regard to specific pest(s), produces an upper-end projection that is 
unlikely, in most cases, to be exceeded in actuality because the 
dominant pesticide is well-established and accepted by farmers. Factors 
that bear on whether a projection based on the dominant pesticide could 
be exceeded are whether the new pesticide is more efficacious or 
controls a broader spectrum of pests than the dominant pesticide within 
its similar type, whether it is more cost-effective than the dominant 
pesticide, and whether it is likely to be readily accepted by growers 
and experts. These factors have been considered for cyfluthrin, and 
they indicate that it is unlikely that actual PCT for cyfluthrin will 
exceed the PCT for the dominant pesticide in the next five years.
    As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which cyfluthrin may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for cyfluthrin in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of cyfluthrin.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will use FIRST (a Tier 1 model) before 
using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and both models include a percent crop (PC) area factor as 
an adjustment to account for the maximum PC coverage within a watershed 
or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to cyfluthrin they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of cyfluthrin for 
acute exposures are estimated to be 3.4 ppb for surface water and 
0.0016 ppb for ground water. The EECs for chronic exposures are 
estimated to be 0.082 ppb for surface water and 0.0016 ppb for ground 
water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 53949]]

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

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rats or rabbits to in utero exposure in 
developmental oral studies; however, there was some indication of 
increased susceptibility in developmental inhalation studies. A clear 
NOAEL was established for the fetal effects in every case. No residual 
uncertainties were identified.
    The data also demonstrated increased susceptibility of rats and 
mice to postnatal exposure to cyfluthrin. A clear NOAEL was established 
for the offspring effects in every case. No residual uncertainties were 
identified.
    3. Conclusion. EPA determined that the FQPA SF to protect infants 
and children should be removed. The recommendation is based on the 
following:

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

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average

[[Page 53950]]

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

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

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

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

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Cyfluthrin is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for cyfluthrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs =/>500. These aggregate MOEs do not 
exceed the Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, short-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of cyfluthrin in ground water 
and surface water. After calculating DWLOCs and comparing them to-the 
EECs for surface water and ground water, EPA does not expect short-term 
aggregate exposure to exceed the Agency's level of concern, as shown in 
the following Table 4:

[[Page 53951]]



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

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

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

    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to cyfluthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

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

V. Comments

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

VI. Conclusion

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

[[Page 53952]]

VII. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0205 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
14, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0205, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitledFederal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.''``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not

[[Page 53953]]

alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. For these same reasons, the Agency has determined 
that this rule does not have any ``tribal implications'' as described 
in Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive 
Order 13175, requires EPA to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.''``Policies that 
have tribal implications'' is defined in the Executive Order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 22, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.436 is amended by removing the commodity potato from the 
table in paragraph (a); by alphabetically adding new commodities to the 
table in paragraph (a); and by adding paragraph (c) to read as follows:


Sec.  180.436  Cyfluthrin; tolerances for residues.

    (a) * * *

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

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

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

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