[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60902-60915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24486]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0204; FRL-7200-1]


Lambda-cyhalothrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
lambda-cyhalothrin in or on almond, hulls and various other food 
commodities in 40 CFR 180.438. Syngenta Crop Protection, Inc. requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective September 27, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0204, 
must be received on or before November 26, 2002.

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 VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0204 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: William G. Sproat, Jr., 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: 703-308-8587; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be 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 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 the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0204. 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

    In the Federal Register of October 8, 1997 (62 FR 52588-52563) 
(FRL-5748-6) and May 12, 2000 (65 FR 30591-30596) (FRL-6497-1), EPA 
issued notices pursuant to section 408 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the 
filing of pesticide petitions (PP 7F4875 and 0F6092) by Syngenta Crop 
Protection, P.O. Box 18300, Greensboro, NC 27419-8300.

[[Page 60903]]

 These notices included a summary of the petition prepared by Syngenta, 
the registrant. There were no comments received in response to the 
notice of filing.
    The petition(s) requested that 40 CFR 180.438 be amended by 
establishing a tolerance for residues of the insecticide lambda-
cyhalothrin, in or on almond, hulls at 1.5 parts per million (ppm); 
apple pomace, wet at 2.50 ppm; avocados (imported) at 0.20 ppm; canola, 
seed at 0.15 ppm; cereal grain crop group (except rice and wild rice), 
grain, at 0.2 ppm; forage (except sorghum) at 6.0 ppm; hay at 2.0 ppm; 
straw at 2.0 ppm; aspirated grain dust at 2.0 ppm; bran at 0.8 ppm; 
flour at 0.6 ppm; fruit, pome, group at 0.3 ppm; fruit, stone, group at 
0.50 ppm; nut, tree, group at 0.05 ppm; peanut, hay at 3.0 ppm; peas 
and beans - dried shelled, (except soybean), subgroup at 0.1 ppm; peas 
and beans - succulent shelled, subgroup at 0.01 ppm; sorghum, grain, 
forage at 0.3 ppm; sorghum, grain, stover at 0.5 ppm; sugarcane at 0.05 
ppm; vegetables, fruiting, group (except cucurbits) at 0.2 ppm; and 
vegetables, legumes, edible podded subgroup at 0.2 ppm.
    EPA has concluded that the tolerance requests for the cereal grain 
crop group are unacceptable at this time since additional residue field 
trial data are necessary in support of these tolerances. PP 0F06092 
proposed a tolerance for canola seed of 0.15 ppm, subsequently revised 
in this final rule to 1.0 ppm on canola and 2.0 ppm in canola oil.
    In addition, existing tolerances under Sec.  180.438(a) for 
tomatoes at 0.1 ppm is no longer needed. It is being replaced with the 
new tolerance for the vegetables, fruiting, group (except cucurbits) at 
0.2 ppm. In addition, existing tolerances for the section 18 emergency 
exemption under Sec.  180.438(b) for sugarcane at 0.03 ppm is not 
needed since a tolerance is established by this regulation rule under 
Sec.  180.438(a) for sugarcane at 0.05 ppm.
    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....''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of lambda-cyhalothrin on 
almond, hulls at 1.5 ppm; apple pomace, wet at 2.50 ppm; avocados 
(imported) at 0.20 ppm; canola, seed at 0.15 ppm; fruit, pome, group at 
0.3 ppm; fruit, stone, group at 0.50 ppm; nut, tree, group at 0.05 ppm; 
peanut, hay at 3.0 ppm; peas and beans - dried shelled, (except 
soybean), subgroup at 0.1 ppm ; peas and beans - succulent shelled, 
subgroup at 0.01 ppm; sorghum, grain, forage at 0.3 ppm; sorghum, 
grain, stover at 0.5 ppm; sugarcane at 0.05 ppm; vegetables, fruiting, 
group (except cucurbits) at 0.2 ppm; and vegetables, legumes, edible 
podded subgroup at 0.2 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance 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 lambda-cyhalothrin 
are discussed in the Table 1 below as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed. Note that studies discussed 
below were conducted using either cyhalothrin or lambda-cyhalothrin. 
Cyhalothrin and lambda-cyhalothrin are basically the same chemical, the 
differences are found in their stereo chemistry and the number of 
isomers in each mixture. Cyhalothrin consists of four stereo isomers in 
each mixture. Cyhalothrin consists of four steno isomers while lambda-
cyhalothrin is a mixture of the two isomers. The two lambda-cyhalothrin 
isomers are contained in cyhalothrin and they represent 40% of the 
cyhalothrin mixture. The major studies submitted to the Agency were 
conducted with cyhalothrin. However, these studies are used in support 
of registration for both mixtures. There is evidence, based on 
subchronic studies in rats, that the two mixtures are not biologically 
different with respect to their mammalian toxicity.

                                Table 1.--Toxicity Profile of Lambda-Cyhalothrin
----------------------------------------------------------------------------------------------------------------
                                                                    MRID No. (year)/
            Guideline No.                     Study Type          Classification/Doses           Results
----------------------------------------------------------------------------------------------------------------
870.3100                               13-Week feeding - rat    00154805                 NOAEL: 2.5 mg/kg/day
                                        (cyhalothrin)           1981/Acceptable........  LOAEL: 12.5 mg/kg/day
                                                                0, 0.5, 2.5, 12.5 mg/kg/  (decreased body weight
                                                                 day.                     gain in males).
----------------------------------------------------------------------------------------------------------------
870.3100                               13-Week feeding - rat    00153028                 NOAEL: 2.5 mg/kg/day
                                        (lambda-cyhalothrin)    1985/Acceptable........  LOAEL: 12.5 mg/kg/day
                                                                0, 0.5, 2.5, 12.5 mg/kg/  (reduced body weight
                                                                 day.                     gain and food
                                                                                          consumption in both
                                                                                          sexesand food
                                                                                          efficiency in
                                                                                          females).
----------------------------------------------------------------------------------------------------------------

[[Page 60904]]

 
N/A                                    28-Day feeding - rat     00153029                 NOAEL: 2 mg/kg/day
                                        (cyhalothrin)           1984/Acceptable          LOAEL: 10 mg/kg/day
                                                                 nonguideline.            (clinical signs of
                                                                0, 2, 10, 25, 50, 75 mg/  neurotoxicity). At
                                                                 kg/day.                  higher doses,
                                                                                          decreases inbody
                                                                                          weight gain and food
                                                                                          consumption and
                                                                                          changes in organ
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
N/A                                    28-Day feeding - rat     00154806                 NOAEL: 1.0 mg/kg/day
                                        (cyhalothrin)           1984/Acceptable          LOAEL: 2.0 mg/kg/day
                                                                 nonguideline.            (decreases in mean
                                                                0, 0.1, 0.5, 1.0, 2.0,    body weight gain in
                                                                 25.0 mg/kg/day.          females).
----------------------------------------------------------------------------------------------------------------
N/A                                    4-Week feeding - mouse   43241901                 NOAEL: 64.2/77.9 mg/kg/
                                        (cyhalothrin)           1981/Acceptable           day
                                                                 nonguideline.           LOAEL: 309/294 mg/kg/
                                                                0, 0.65, 3.30, 13.5,      day (mortality,
                                                                 64.2, 309 mg/kg/day      clinical signs of
                                                                 (males).                 toxicity, decreases in
                                                                0, 0.80, 4.17, 15.2,      bodyweight gain and
                                                                 77.9, 294 mg/kg/day      food consumption.
                                                                 (females).               changes in hematology
                                                                                          and organ weights,
                                                                                          minimal
                                                                                          centrilobularhepatocyt
                                                                                          e enlargement).
----------------------------------------------------------------------------------------------------------------
870.3150                               26-Week feeding - dog    00154795                 NOAEL: 1.0 mg/kg/day
                                        (cyhalothrin)           1981/Acceptable........  LOAEL: 2.5 mg/kg/day
                                                                0, 1.0, 2.5, 10.0 mg/kg/  (increase in liquid
                                                                 day.                     feces. At 10.0 mg/kg/
                                                                                          day, clinical signs
                                                                                          ofneurotoxicity).
----------------------------------------------------------------------------------------------------------------
870.3200                               21-Day dermal toxicity - 00154869                 NOAEL: 100 mg/kg/day
                                         rabbit (cyhalothrin)   1982/Acceptable........  LOAEL: 1,000 mg/kg/day
                                                                0, 10, 100, 1,000 mg/kg/  (significant weight
                                                                 day for 6 hours/day, 5   loss)
                                                                 days/week for total of
                                                                 15 applications.
----------------------------------------------------------------------------------------------------------------
870.3200                               21-Day dermal toxicity - 44333802                 NOAEL: 10 mg/kg/day
                                         rat (lambda-           1989/Acceptable........  LOAEL: 50 mg/kg/day
                                        cyhalothrin)            0, 1, 10 mg/kg/day for    (clinical signs of
                                                                 6 hours/day for 21       toxicity, decreased
                                                                 consecutive days;.       body weight and body
                                                                2-3 applications at 100   weight gain)
                                                                 mg/kg/day, reduced to
                                                                 50 mg/kg/day for 21
                                                                 consecutive days.
----------------------------------------------------------------------------------------------------------------
N/A                                    21-Day inhalation        41387702                 NOAEL: 0.08 mg/kg/day
                                        toxicity - rat (lambda- 1990/Acceptable          LOAEL: 0.90 mg/kg/day
                                        cyhalothrin)             nonguideline.            (clinical signs of
                                                                0, 0.3, 3.3, 16.7 [mu]g/  neurotoxicity,
                                                                 L; approx. 0, 0.08,      decreased body weight
                                                                 0.90, 4.5 mg/kg/day.     gains, increased
                                                                                          incidence of punctuate
                                                                                          foci in cornea, slight
                                                                                          reductions in
                                                                                          cholesterol in
                                                                                          females, slight
                                                                                          changes in selected
                                                                                          urinalysis
                                                                                          parameters).
----------------------------------------------------------------------------------------------------------------
870.3700                               Developmental toxicity - 00154800                 Maternal NOAEL: 10 mg/
                                         rat (cyhalothrin)      1981/Acceptable........   kg/day
                                                                0, 5, 10, 15 mg/kg/day.  Maternal LOAEL: 15 mg/
                                                                                          kg/day (uncoordinated
                                                                                          limbs, reduced body
                                                                                          weight gain and food
                                                                                          consumption).
                                                                                         Developmental NOAEL: 15
                                                                                          mg/kg/day, the highest
                                                                                          dose tested (HDT)
                                                                                         Developmental LOAEL:
                                                                                          >15 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3700                               Developmental toxicity - 00154801                 Maternal NOAEL: 10 mg/
                                         rabbit (cyhalothrin)   1981/Acceptable........   kg/day
                                                                0, 3, 10, 30 mg/kg/day.  Maternal LOAEL: 30 mg/
                                                                                          kg/day (reduced body
                                                                                          weight gain and food
                                                                                          consumption).
                                                                                         Developmental NOAEL: 30
                                                                                          mg/kg/day (HDT)
                                                                                         Developmental LOAEL:
                                                                                          >30 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3800                               3-Generation             00154802                 Parental/Offspring
                                        Reproduction - rat      1984/Acceptable........   NOAEL: 1.5 mg/kg/day
                                        (cyhalothrin)           0, 0.5, 1.5, 5.0 mg/kg/  Parental/Offspring
                                                                 day.                     LOAEL: 5.0 mg/kg/day
                                                                                          (decreased parental
                                                                                          body weight and body
                                                                                          weight gain during
                                                                                          premating and
                                                                                          gestation periods and
                                                                                          reduced pup weight and
                                                                                          weight gain during
                                                                                          lactation).
                                                                                         Reproductive NOAEL: 5.0
                                                                                          mg/kg/day (HDT)
----------------------------------------------------------------------------------------------------------------
870.4100                               1- Year oral - dog       40027902                 NOAEL: 0.1 mg/kg/day
                                        (capsule: lambda-       1986/Acceptable........  LOAEL: 0.5 mg/kg/day
                                        cyhalothrin)            0, 0.1, 0.5, 3.5 mg/kg/   (clinical signs of
                                                                 day.                     neurotoxicity).
----------------------------------------------------------------------------------------------------------------

[[Page 60905]]

 
870.4200                               Carcinoge nicity -       00150842                 NOAEL: 15 mg/kg/day
                                        mouse (cyhalothrin)     1984/Acceptable........  LOAEL: 75 mg/kg/day
                                                                0, 3, 15, 75 mg/kg/day.   (increased incidence
                                                                                          of piloerection,
                                                                                          hunched posture;
                                                                                          decreased body weight
                                                                                          gain in males). Not
                                                                                          oncogenic under
                                                                                          conditions of study.
                                                                                          HDT inadequate. New
                                                                                          study not required at
                                                                                          this time.
----------------------------------------------------------------------------------------------------------------
870.4300                               Chronic/Carcinogenicity  00154803                 NOAEL: 2.5 mg/kg/day
                                        - rat (cyhalothrin)     1984/Acceptable........  LOAEL: 12.5 mg/kg/day
                                                                0, 0.5, 2.5, 12.5 mg/kg/  (decreases in mean
                                                                 day.                     body weight). Not
                                                                                          oncogenic under
                                                                                          conditions of study.
----------------------------------------------------------------------------------------------------------------
870.6200                               Acute neurotoxicity -    44861510                 NOAEL: 10 mg/kg
                                        rat (lambda-            1999/Acceptable........  LOAEL: 35 mg/kg
                                        cyhalothrin)            0, 2.5, 10, 35 mg/kg...   (clinical observations
                                                                                          indicative of
                                                                                          neurotoxicity and
                                                                                          changes in functional
                                                                                          observational battery
                                                                                          (FOB) parameters).
----------------------------------------------------------------------------------------------------------------
870.7485                               Metabolism and           00151116, 00150852,      In the rat,
                                        Pharmacokinetics         00150852, 00150852,      approximately 55% of
                                                                 00153036, 00153037       the oral dose is
                                                                1981, 1984, 1985/         absorbed. It is
                                                                 Acceptable when          extensively
                                                                 combined together.       metabolized when
                                                                                          absorbed. After
                                                                                          subcutaneous
                                                                                          administration, the
                                                                                          urinary/fecal
                                                                                          excretion ratio is
                                                                                          2.5:1.0. Over 50% of
                                                                                          the dose remained in
                                                                                          the carcass 7 days
                                                                                          after a subcutaneous
                                                                                          dose. Metabolism
                                                                                          includes cleavage of
                                                                                          the ester to
                                                                                          cyclopropylcarboxylic
                                                                                          acid and a
                                                                                          phenoxybenzyl
                                                                                          derivative. The
                                                                                          distribution patterns
                                                                                          and excretion rates in
                                                                                          the multiple oral dose
                                                                                          studies are similar to
                                                                                          the single oral dose
                                                                                          studies. There is
                                                                                          accumulation of
                                                                                          unchanged compound in
                                                                                          the fat upon chronic
                                                                                          administration.
                                                                                          Otherwise, cyhalothrin
                                                                                          is rapidly metabolized
                                                                                          and excreted.
                                                                                          Cyclopropyl carboxylic
                                                                                          acid, 3-phenoxybenzoic
                                                                                          acid, glucuronide
                                                                                          conjugated 3-4'-
                                                                                          hydroxyphenoxy benzoic
                                                                                          acid and a sulfate
                                                                                          conjugate were
                                                                                          identified in the
                                                                                          urine. Cyhalothrin is
                                                                                          taken up slowly by the
                                                                                          fat and released
                                                                                          slowly. It is rapidly
                                                                                          released by blood,
                                                                                          kidneys, liver. The
                                                                                          rate of metabolism of
                                                                                          both enantiomer pairs
                                                                                          are likely identical
                                                                                          (i.e. PP321 and
                                                                                          PP563). The
                                                                                          absorption,
                                                                                          distribution,
                                                                                          metabolism and
                                                                                          excretion patterns of
                                                                                          PP321 and cyhalothrin
                                                                                          following a single
                                                                                          dose of 1 mg/kg in the
                                                                                          male rat appear to be
                                                                                          identical.
----------------------------------------------------------------------------------------------------------------
870.7485                               Metabolis m and          00150843, 00150852       In the dog, absorption
                                        Pharmacokinetics        1984/Acceptable when      of the C14 benzyl
                                                                 combined together.       label was 80% and
                                                                                          absorption of the C14
                                                                                          cyclopropyl label was
                                                                                          48%. The metabolite
                                                                                          patterns were
                                                                                          different, indicating
                                                                                          extensive cleavageof
                                                                                          the ester bond. Seven
                                                                                          metabolites in urine
                                                                                          were identified for
                                                                                          the benzyl label and
                                                                                          12 metabolites for the
                                                                                          isopropyl label. In
                                                                                          the feces, a large
                                                                                          proportion of the
                                                                                          radioactivity was due
                                                                                          to unchanged compound.
                                                                                          Excretion in urine and
                                                                                          feces was rapid
                                                                                          (nearly all in 48
                                                                                          hrs.).
----------------------------------------------------------------------------------------------------------------
870.7600                               Dermal penetration       44990402                 Absorption ranged from
                                                                1991/Acceptable........   3.46 to 15.89%
                                                                0.979, 0.099,0.001 and
                                                                 0.0008 mg/cm2 for 0.5,
                                                                 1, 2, 4, 10 and 24
                                                                 hours.
----------------------------------------------------------------------------------------------------------------

[[Page 60906]]

 
870.7600                               Dermal penetration       44333801                 Mild paraesthesia of
                                                                1984/Acceptable           varying degrees was
                                                                 nonguideline.            observed following
                                                                Dermal studies: 1.25 mg/  dermal dosing. The
                                                                 50 cm2 dermal and 20     minimal oral
                                                                 mg/800 cm2.              absorption was
                                                                Dermal dose washed        estimated to be from
                                                                 quantitatively after 8   50.35 to 56.71%. The
                                                                 hours..                  minimal dermal
                                                                Oral study: 5 mg.......   absorption was
                                                                                          estimated to be from
                                                                                          0.115 to 0.122%. The
                                                                                          estimated dermal
                                                                                          absorption value of 1%
                                                                                          was determined by
                                                                                          rounding these values
                                                                                          up to the nearest
                                                                                          whole number. No
                                                                                          metabolites were found
                                                                                          near the limit of
                                                                                          detection in plasma
                                                                                          from the oral dose
                                                                                          study. Blood was not
                                                                                          analyzed from the
                                                                                          dermal study.
----------------------------------------------------------------------------------------------------------------

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.
    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 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 as1 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 lambda-cyhalothrin used for human risk assessment is 
shown in the following Table 2:

  Table 2.--Summary of Toxicological Dose and Endpoints for Lambda-Cyhalothrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA Safety    Study and Toxicological
          Exposure Scenario            Dose (mg/kg/day) UF/MOE          Factor*                  Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NOAEL = 0.5              FQPA SF = 1              Chronic oral study in
 including infants and children        UF = 100...............  aPAD = acute RfD/FQPA     the dog (lambda-
                                       Acute RfD = 0.005 mg/kg   SF = 0.005 mg/kg/day.    cyhalothrin)
                                                                                         LOAEL = 3.5 mg/kg/day
                                                                                          based on clinical
                                                                                          signs of neurotoxicity
                                                                                          (ataxia) observed from
                                                                                          day 2, 3 to 7 hours
                                                                                          post-dosing.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 0.1               FQPA SF = 1              Chronic oral study in
                                       UF = 100...............  cPAD = chronic RfD/FQPA   the dog (lambda-
                                       Chronic RfD = 0.001 mg/   SF = 0.001 mg/kg/day.    cyhalothrin)
                                        kg/day.                                          LOAEL = 0.5 based on
                                                                                          gait abnormalities
                                                                                          observed in 2 dogs
----------------------------------------------------------------------------------------------------------------
Incidental OralShort- and              NOAEL= 0.1               1                        Chronic oral study in
 Intermediate-Term (1-30 days and 1-6  MOE= 100...............                            the dog (lambda-
 months) Residential Only                                                                 cyhalothrin)
                                                                                         LOAEL = 0.5 based on
                                                                                          gait abnormalities
                                                                                          observed in 2 dogs
----------------------------------------------------------------------------------------------------------------
Dermal (All Durations)                 Dermal NOAEL= 10 mg/kg/                           21-Day dermal toxicity
                                        day                                               study in the rat
                                                                                          (lambda-cyhalothrin)
----------------------------------------------------------------------------------------------------------------

[[Page 60907]]

 
    Residential                        MOE = 100                1                        LOAEL = 50 mg/kg/day
                                                                                          based on clinical
                                                                                          signs of neurotoxicity
                                                                                          (observed from day 2)
                                                                                          and decreased body
                                                                                          weight and body weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
    Occupational                       MOE = 100                1                        .......................
----------------------------------------------------------------------------------------------------------------
Inhalation (All Durations)             Inhalation NOAEL= 0.3    .......................  21-Day Inhalation Study
                                        [mu]g/L (0.08 mg/kg/                              in Rats (lambda-
                                        day)                                              cyhalothrin)
                                                                                         LOAEL = 3.3 [mu]g/L
                                                                                          (0.90 mg/kg/day) based
                                                                                          on clinical signs of
                                                                                          neurotoxicity,
                                                                                          decreased body weight
                                                                                          gains, increased
                                                                                          incidence of punctuate
                                                                                          foci in the cornea,
                                                                                          slight reductions in
                                                                                          cholesterol in females
                                                                                          and slight changes in
                                                                                          selected urinalysis
                                                                                          parameters.
----------------------------------------------------------------------------------------------------------------
    Residential                        MOE = 100                1                        .......................
----------------------------------------------------------------------------------------------------------------
    Occupational                       MOE = 100                1                        .......................
----------------------------------------------------------------------------------------------------------------
Cancer                                       Classification: Group D chemical (not classifiable as to human
                                                                    carcinogenicity).
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.438) for the residues of lambda-cyhalothrin, in 
or on a variety of raw agricultural commodities. Currently established 
tolerances for residues of lambda-cyhalothrin are listed under 40 CFR 
180.438 and include permanent tolerances on plants ranging from 0.01 
ppm on soybeans to 10.0 ppm on hops. Tolerances are also established 
for aspirated grain fractions, the head and stem Brassica subgroup, 
corn, cotton seed, dry bulb onions, lettuce, peanuts, soybeans, 
sorghum, sunflowers, tomatoes, and wheat; and on animal commodities 
ranging from 0.01 ppm in eggs, poultry meat, and poultry meat by-
products to 5.0 ppm in milk fat (reflecting 0.2 ppm in whole milk). A 
tolerance of 0.01 ppm has been established for residues in foods 
potentially exposed to the insecticide during treatment of food 
handling establishments. A temporary tolerance for canola (0.1 ppm) is 
listed as expired as of 12/31/00.
    Lambda-cyhalothrin is used to control a wide range of pests 
(including aphids, adult Japanese beetles, grasshoppers, and butterfly 
larvae) in a variety of agricultural applications and crops. For some 
crop uses, it is applied to soil before crops emerge. Current non-
agricultural uses include ornamental gardens, lawns, landscapes, turf, 
golf courses, and general insect control (spot treatments and crack and 
crevice treatments) in around and on buildings, structures, and 
immediate surroundings. It may also be used for structural pest 
management and in public health applications to control insects such as 
mosquitoes, cockroaches, ticks, and flies, which may act as disease 
vectors. Other uses include ear tags and pour-ons for beef cattle.
    Risk assessments were conducted by EPA to assess dietary exposures 
from lambda-cyhalothrin 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[reg]) 
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: A refined Tier 3 probabilistic acute dietary risk 
assessment was conducted for all currently registered and proposed 
lambda-cyhalothrin food uses. The acute dietary assessment includes 
dietary exposures calculated in a previous dietary assessment (Risk 
Assessment for Extension of Tolerances for Synthetic Pyrethroids, (62 
FR 63002, Nov. 26, 1997; FRL-5755-5) as well as dietary exposures 
calculated for proposed uses.
    The following data for the commodities with proposed new uses and 
tolerances were added to the original analysis: The entire distribution 
of residue field trial data was used for not-blended or partially-
blended commodities; average residue field trial data were used for 
blended commodities; information from cooking and processing studies 
were used when available; and market share data for proposed and 
established tolerances were used.
    For this updated analysis, with the exception of peas and beans 
(Crop Group 6), commodities as part of a crop group for which 
tolerances were proposed but data on each individual crop were not 
submitted, were analyzed using tolerance levels and 100%CT. For 
example, apples and pears, the representative crops for pome fruits, 
included residue field trial data and market share data which were 
included in the analysis. The remainder of the crop group was analyzed 
using tolerance level residues and 100%CT. The exception, peas and 
beans (Crop Group 6), used the submitted residue field trial data and 
market share data as appropriate for the entirety of each subgroup. In 
accordance with present EPA policy, potential residues from uses in 
food handling establishments were not included in the acute assessment.
    The original 1997 analysis included probabilistic methods for acute 
dietary analyses for cattle (beef and dairy) to select the feed items 
comprising the potential cattle diets and associated residues. The same 
livestock information was used for the present analysis since the 
additional uses are not expected to increase dietary burden.

[[Page 60908]]

    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 CSFII and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: This chronic dietary assessment includes dietary 
exposures calculated in a previous dietary assessment (Risk Assessment 
for Extension of Tolerances for Synthetic Pyrethroids, (62 FR 63002, 
Nov. 26, 1997, FRL-5755-5) as well as dietary exposures calculated for 
proposed uses.
    The following data for the commodities with proposed new uses and 
tolerances were added to the original analysis: average of the residue 
field trials, information from cooking and processing studies, and 
market share data.
    The original chronic dietary analysis (1997) included dietary 
burdens calculated using mean field trial residues, adjusted for 
percent of crop treated and applying appropriate processing factors, 
for all animal feed items and associated residues. For the updated 
analysis, with the exception of peas and beans (Crop Group 6), 
commodities as part of a crop group for which tolerances were proposed 
but data on each individual crop were not submitted were analyzed using 
tolerance levels and 100%CT. For example, apples and pears, the 
representative crops for pome fruits, included residue field trial data 
and market share data which were included in the analysis. The 
remainder of the crop group were analyzed using tolerance level 
residues and 100%CT. The exception, peas and beans (Crop Group 6), used 
the submitted residue field trial data and market share data as 
appropriate for the entirety of each subgroup.
    In addition, the food handling establishment tolerance was included 
in the chronic analysis for all foods which did not have individual 
proposed or established tolerances. Since the tolerance was based on 
the LOQ, half of the LOQ was used in the chronic dietary analysis.
    iii. Cancer. The database for carcinogenicity is considered 
complete, no additional studies are required at this time. The 
requirements for carcinogenicity studies in the rat and the mouse with 
lambda-cyhalothrin have been satisfied by a combined chronic/
carcinogenicity study in rats and a carcinogenicity study in mice, both 
conducted with cyhalothrin. Although mice should have been tested at a 
higher dose, it was determined that there was not enough toxicological 
concern to warrant a requirement for a new carcinogenicity study in 
mice. Therefore, a dietary exposure assessment was not conducted. See 
Unit III.E.5 of this preamble for further discussion.
    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.
    For existing uses, the Agency used estimates of PCT for the acute 
and chronic exposure assessments which were determined using Doanes 
market survey data (1998-2000). The following PCT estimates were used 
for existing registrations: alfalfa 1.8%; broccoli 13.11%; bulb onions/
garlic 45.53%; cabbage 31.33%; sweet corn 43.61%; cotton 12.97%; 
lettuce (head and leaf) 20.47%; rice 10.33%; soybean 0.2%; squash 
0.24%; tomatoes 21.03%; wheat 1.13%; and food handling establishments 
(13.7 %).
    The Agency believes that the three conditions listed in Unit 
III.C.1.iv. of this preamble have been met. With respect to Condition 
1, PCT estimates are derived from market survey data, which are 
reliable and have a valid basis. EPA uses an average PCT for chronic 
dietary exposure estimates. An 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 
assessments, the Agency incorporates PCT information by creating a 
residue distribution file which includes the measured residue values 
from field trials, and zero residue values added to account for the 
percent of crop not treated. This approach is used only for nonblended 
or partially blended commodities as defined under EPA SOP99.6. For 
blended commodities, a single point estimate is created from the 
residue value multiplied by the upper bound PCT. The Agency is 
reasonably certain that the percentage of the food treated is not 
likely to be an underestimation.
    For the new uses, the Agency used PCT estimates for acute and 
chronic exposure based on market share projections as follows: almonds 
11.72%; apples 2.69%; avocados 2.0%; canola seed 1.87%; cherries 17.3%; 
dried shelled beans and peas 13.41%; edible podded beans and peas 
0.40%; hazelnuts 17.91%; peanuts 4.53%; peaches 20.73%; pears 4.84%; 
pecans 12.5%; peppers 6.24%; sorghum 1.43%; succulent shelled beans and 
peas 0.84%; sugarcane 3.97%; and walnuts 11.82%.
    The Agency believes that the three conditions previously discussed 
have been met regarding %CT estimates for the new lambda-cyhalothrin 
uses. With respect to Condition 1, EPA finds that the %CT information 
described in Unit II.C.1(iv) for lambda-cyhalothrin is reliable and has 
a valid basis. To support the use of these PCT estimates, the Agency 
has compared these estimates to existing usage data for currently 
registered insecticides used on the proposed lambda-cyhalothrin crop 
sites. Based on this comparison these estimates should not 
underestimate actual usage of lambda-cyhalothrin on the new crops/
sites. The Agency also conducted a DEEM[reg] analysis using the highest 
percent crop treated for a

[[Page 60909]]

competing alternative chemical for apples and peaches, high dietary 
contributors, and determined no significant increase in the acute RFD. 
To further support the reliability of these %CT estimates, as a 
condition of registration, the registrant will be required to agree to 
report annually on the market share attained for the new uses for which 
lambda-cyhalothrin is registered. As a condition of registration, they 
will also be required to agree to mitigate dietary risk as deemed 
appropriate by the Agency should the market share data raise a concern 
for increased dietary risk. The Agency will then compare that market 
share information with the percent crop treated estimates used to 
evaluate potential dietary risk. In those instances where percent 
market share is approaching or exceeding the predicted percent crop 
treated estimate used in the Agency's risk assessment, EPA will conduct 
a new dietary risk assessment to evaluate the new dietary risk. If the 
market share data raise a concern for increased pesticide risk, the 
Agency will act to mitigate that dietary risk and could employ several 
approaches not limited to production caps, geographical limitations, 
removal of uses, or other means deemed appropriate by the Agency. 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 lambda-
cyhalothrin may be applied in a particular area.
    2. Dietary exposure from drinking water. Environmental fate studies 
suggest that lambda-cyhalothrin is moderately persistent in the 
environment, with laboratory half-lives ranging from 13-73 days and the 
field half-lives ranging from 12 to 63 days. This chemical has a strong 
tendency to bind to soil and sediments (Kd=1,970-7,610). The low 
mobility (due to high Kd) indicates that ground water contamination 
with the insecticide is highly unlikely. However, under runoff 
conditions, lambda-cyhalothrin is likely to reach surface water 
resources bound to soil particles. Once in the water system, lambda-
cyhalothrin tends to partition to sediments.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for lambda-
cyhalothrin 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 lambda-cyhalothrin.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/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 groundwater. 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. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, 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 lambda-cyhalothrin they are 
further discussed in the aggregate risk sections.
    Based on the FIRST and SCI-GROW models the EECs of lambda-
cyhalothrin for acute exposures are estimated to be 0.62 parts per 
billion (ppb) for surface water and 0.012 ppb for ground water. The 
EECs for chronic exposures are estimated to be 0.098 ppb for surface 
water and 0.012 ppb for ground water. The EECs for lambda-cyhalothrin 
are based on an application of the insecticide to sweet corn at a 
maximum of 16 applications per year at a rate of 0.48 lb active 
ingredient per acre per application.
    3. 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).
    Lambda-cyhalothrin is currently registered for use on the following 
residential non-dietary sites: ornamental gardens, lawns, landscapes, 
turf, golf courses, and general insect control (spot treatments and 
crack and crevice treatments) in, around, and on buildings, structures, 
and immediate surroundings. The risk assessment was conducted using the 
following residential exposure assumptions: A review of current labels 
indicates that all products, except for one aerosol can product, are 
limited to use only by certified applicators. As such, this assessment 
addresses the single residential handler scenario and postapplication 
scenarios associated with any use in a residential environment. It 
should be noted that the residential exposure/risk assessment is based 
on both proposed and existing uses for lambda-cyhalothrin because all 
potential residential exposures must be considered in the calculation 
of aggregate risks.
    A non-occupational (residential) exposure assessment for lambda-
cyhalothrin was completed in 1997 in conjunction with the Risk 
Assessment for Extension of Tolerances for Synthetic Pyrethroids (62 FR 
63002, Nov. 26, 1997, FRL-5755-5). In the 1997 pyrethroid assessment, 
due to the wide variety of residential uses, it was agreed that flea 
control (simultaneous use on pets, lawns and indoor surfaces) would 
serve as a screening level scenario for all residential uses because it 
was anticipated to represent the highest potential for residential 
exposure. However, at that time, lambda-cyhalothrin uses did not 
include indoor surfaces or pets, so only

[[Page 60910]]

exposure estimates pertaining to the lawn uses were used as appropriate 
in the 1997 assessment for lambda-cyhalothrin.
    The 1997 lambda-cyhalothrin assessment served as the basis for the 
current risk calculations. The only modifications have been adjusting 
the values from the 1997 assessment for appropriate absorption factors. 
This represents a definitive screening level approach because since 
that time the Agency has engaged in a series of revisions to its 
Standard Operating Procedures (SOPs) for Residential Exposure 
Assessments (i.e., latest on February 22, 2001). Incorporating the 
revisions to the SOPs would only refine the exposure estimates (i.e., 
in all cases MOEs would be higher).
    For the residential assessment, existing uses on turf, in gardens, 
on golf courses, and for structural pest control were considered, but a 
quantitative calculation was only completed for postapplication 
exposure on treated turf because this scenario is expected to have the 
highest associated exposures (i.e., this scenario was used as a 
screening level tool for all residential exposures).
    The Agency used a screening level approach to address the risks 
associated with the use of the aerosol can product of lambda-
cyhalothrin that can be purchased and used by homeowners. In this case, 
a screening level quantitative calculation was only completed for 
postapplication exposure on treated turf because this scenario is 
expected to have the highest associated exposures of all residential 
exposures. In other words, this is a lower tier approach and EPA 
believes that the selected postapplication assessment on lawns for 
children is protective for all residential exposures (even the aerosol 
can handler scenario) because the dose levels for children playing on 
treated lawns are thought to exceed those expected for all other 
scenarios (i.e., lawn exposures for children represents the worst case 
scenario). This approach is based on the following considerations:
    [sbull] For children on lawns, there was no dissipation of residues 
from the treated lawn since it was assumed that exposure was determined 
immediately after application of the lawn product.
    [sbull] For children on lawns, dermal exposure was high because it 
was based on a jazzercise scenario which involves a high duration of 
exposure on the lawn and an intensity of activity that results in a 
high degree of contact with the treated lawn.
    [sbull] Low application rate is expected for residential handler.
    [sbull] Postapplication oral exposure to children on lawns was also 
calculated which resulted in acceptable MOEs (aggregate MOE = 500), 
this approach is thought to provide conservative estimates of exposure 
and it is not a route of consideration for adult handlers.
    All residential (non-occupational) MOEs calculated using this 
screening level approach were well above the Agency target MOE of 100.
    The Agency uses the term postapplication to describe exposures to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. Lambda-cyhalothrin can be 
used in many areas that can be frequented by the general population 
including residential areas such as lawns. As a result, individuals can 
be exposed by entering these areas if they have been previously 
treated.
    The postapplication assessment for treatment on lawns is based on a 
screening level approach in which children's and adult's exposure from 
treated turf were selected to represent the highest anticipated 
exposure scenarios. In this case, the Agency believes that exposures 
associated with contact to treated turf represent the high exposure 
scenario. Adults and children of varying ages can potentially be 
exposed by dermal and inhalation routes of exposure when they contact 
previously treated turf. Children may also be exposed by incidental 
non-dietary ingestion of turf. Each of these elements was considered in 
the calculation of postapplication exposure for lambda-cyhalothrin on 
turf. The residential MOEs were aggregated together because, regardless 
of the exposure route (dermal, inhalation or oral), lambda-cyhalothrin 
has similar adverse effects (i.e. neurotoxicity).
    All residential (non-occupational) MOEs calculated using this 
screening level approach were well above the Agency target MOE of 100 
for the inhalation, dermal, and oral routes and therefore do not exceed 
EPA's level of concern (range 700 to 14,700). Additionally, when total 
MOEs were calculated (i.e., each routes added together), MOEs still 
were not of concern (MOEs for children = 500 and for adults = 3,000).
    A quantitative postapplication risk assessment for termiticide use 
was not performed for this use. Since the IMPASSE TM Barrier is placed 
under the foundation (poured concrete) of houses the potential for 
dermal exposure is negligible. The potential for postapplication 
inhalation exposure is also expected to be extremely minimal. 
Furthermore, the vapor pressure for lambda-cyhalothrin is very low (1.5 
x 10-9 mmHg) and therefore EPA does not anticipate any 
significant air concentrations accumulating of lambda-cyhalothrin.
    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 lambda-cyhalothrin 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, 
lambda-cyhalothrin 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 lambda-cyhalothrin 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).

D. Safety Factor for Infants and Children

    1. 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 MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. Through the use of bridging 
data, the toxicology database for lambda-cyhalothrin has been completed 
using developmental, reproduction, chronic (rodent) and oncogenicity 
studies conducted with cyhalothrin. With the exception of the 
developmental neurotoxicity study, the toxicology database for lambda-
cyhalothrin, when

[[Page 60911]]

bridged with cyhalothrin, is complete and there are no data gaps. The 
scientific quality is relatively high and the toxicity profile of 
lambda-cyhalothrin can be characterized for all effects, including 
potential developmental, reproductive and neurotoxic effects. The data 
provided no indication of increased susceptibility of rats or rabbits 
to in utero and/or postnatal exposure to cyhalothrin. The requirement 
for developmental studies conducted with lambda-cyhalothrin have been 
satisfied with developmental studies conducted with cyhalothrin. The 
data demonstrate no indication of increased quantitative or qualitative 
sensitivity of rats or rabbits to in utero exposure to cyhalothrin. No 
developmental toxicity was observed in either of the developmental 
toxicity studies in rats and rabbits. Maternal toxicity was observed in 
the form of clinical signs of neurotoxicity and reduced body weight 
gain and food consumption in the rat study and reduced body weight gain 
and food consumption in the rabbit study. In the 3-generation 
reproduction study in rats, the parental/offspring NOAELs are the same 
based on decreased parental and pup body weight and body weight gain.
    3. Conclusion. The cyhalothrins induce clinical signs of 
neurotoxicity in at least three species (rats, mice and dogs), and a 
developmental neurotoxicity (DNT) study has been required. A subchronic 
neurotoxicity study has recently been submitted but has not yet been 
reviewed; a preliminary review found that the NOAELs are higher than 
endpoints selected by EPA and this study is not expected to change 
conclusions of this risk assessment.
    EPA has required that a DNT be conducted for lambda-cyhalothrin 
based upon structure activity relationship (SAR), mode of action, and 
toxicity information that identifies cyhalothrin and lambda-cyhalothrin 
as neurotoxic pesticides. Developmental neurotoxicity testing with 
cyhalothrin is required, to further characterize the potential hazard 
to the developing animal, in accordance with standard OPP guidance. 
This determination was based upon a weight-of-evidence evaluation of 
the database, conducted in accordance with principles first developed 
at a 1989 Agency workshop on quantitative and qualitative comparability 
of human and animal developmental neurotoxicity (Levine, T.E and R.E. 
Butcher (1990) Triggers for developmental neurotoxicity testing. 
Neurotoxicology and Teratology 12:281-284.), and which have been 
subsequently reviewed by the FIFRA Scientific Advisory Panel in 
connection with DNT guideline development (1989), the retrospective 
analysis of DNT studies submitted to OPPTS (December, 1998), and FQPA 
10X guidance (May, 1999).
    Although a DNT has been required, EPA evaluated whether the 
existing reliable toxicity data for lambda-cyhalothrin provided EPA 
with the confidence to make a safety finding for infants and children 
using a different safety factor than the default additional safety 
factor of 10X. For the reasons set forth, EPA has concluded that 
existing, reliable toxicity data provide reasonable certainty that a 
risk assessment conducted using no additional factor (1X) will protect 
the safety of infants and children. First, it is noted that there was 
no indication, in the developmental or reproductive toxicity studies or 
in any published literature studies, of increased sensitivity in the 
offspring of rats or rabbits to in utero and/or postnatal exposure to 
cyhalothrin. Since there is no evidence that immature animals respond 
more severely than adults to cyhalothrin exposure in these studies, 
there is less concern regarding the potential for increased sensitivity 
in a developmental neurotoxicity study.
    Second, an extensive evaluation of the data base for the 
cyhalothrins revealed that no damage to the neurological system (i.e., 
microscopic lesions, commonly referred to as ``neuropathology'') was 
observed in the brain of rats or dogs following subchronic or chronic 
exposure and with formalin fixation of tissues. Even more importantly, 
in the acute neurotoxicity study with lambda-cyhalothrin, both central 
and peripheral nervous system tissues were examined following in situ 
perfusion fixation of tissues (which reduces microscopic artifacts that 
can result during processing). As per guideline recommendations, this 
included more extensive sampling and microscopic evaluation of these 
tissues than is required in standard subchronic or chronic studies. 
Even with this expanded examination, no treatment-related lesions were 
observed in the central and peripheral nervous system. (The subchronic 
neurotoxicity study with lambda-cyhalothrin is currently under review 
by EPA and was not available at the time of the prior EPA review; 
however, preliminary evaluation of the neuropathology data by EPA 
scientists did not reveal the presence of treatment-related lesions.) 
These findings demonstrate that lambda-cyhalothrin does not alter 
nervous system structure in adult rats, even at the microscopic level. 
Additionally, there was no evidence from the prenatal developmental 
toxicity studies (in rats and rabbits) and the two-generation 
reproduction study in rats, of malformations or variations of the 
central nervous system in offspring following in utero and/or postnatal 
exposures. Further, the generally accepted mechanism of action for 
pyrethroids, sodium channel disruption, has not been traditionally 
associated with developmental neuropathology. Together with the 
apparent lack of structural alterations in the nervous system of either 
adult or developing animals, this line of evidence leads to reduced 
concern regarding the potential that such effects would be observed in 
guideline developmental neurotoxicity testing.
    Another critical factor in the database that supports EPA's 
determination that a safety finding can be made without use of an 
additional safety factor are the data bearing on the level at which 
neurotoxic effects and non-neurotoxic effects are observed in the rat 
(the animal used in performing DNTs) and the data pertaining to the 
level at which neurotoxic effects occur in dogs. While the precise 
outcome of a DNT study with lambda-cyhalothrin cannot be known prior to 
completion of the study, the existing toxicity data provide important 
information on whether any information is likely to emerge from the 
lambda-cyhalothrin DNT that would change the dose level used in 
estimating safe exposure levels to lambda-cyhalothrin in the lambda-
cyhalothrin risk assessment. Based upon common principles of dose-
setting, which utilize data from less complicated studies to inform the 
design of more complicated studies, it is highly probable that dietary 
dose levels for the DNT study will be based upon toxicity observed in 
the reproduction study in rats, considered in context of the complete 
toxicology database. In the reproduction study, parental and offspring 
effects consisted solely of body weight and body weight gain reductions 
at a dietary level of 100 ppm (approximately 5.0 mg/kg/day), and a 
NOAEL was established at 30 ppm (approximately 1.5 mg/kg/day) which was 
the mid-dose level on that study. Neurotoxicity effects have only been 
seen in the rat at significantly higher doses (acute oral neurotoxicity 
study having a NOAEL of 10 mg/kg/day and a LOAEL of 35 mg/kg/day). In 
the dog, neurotoxic effects have been found at lower levels (NOAEL of 
0.5 mg/kg/day) than the non-neurotoxic effects seen in the rat 
reproductive study. What this indicates is that the DNT will likely be 
conducted at dose levels significantly lower than at which any 
neurotoxic

[[Page 60912]]

effects have previously been seen in the rat but still significantly 
greater than the levels used for assessing acute and chronic risk. 
Thus, the results from the DNT, even if they show sensitivity in the 
rat young (which would not be expected), are unlikely to change the 
levels used for assessing chronic and acute risk.
    No quantitative or qualitative evidence of increased susceptibility 
of rat or rabbit fetuses to in utero exposure in the developmental 
studies was observed. No developmental toxicity was observed in either 
of these studies. No quantitative or qualitative evidence of increased 
susceptibility was observed in the 3-generation reproduction study in 
rats. Offspring toxicity (decreased pup weight and pup weight gain) was 
observed in the reproduction study at the same dose level as parental 
toxicity (decreased body weight and body weight gain). These effects 
are not considered to be more severe than the effects in the parents. 
There are no residual uncertainties for pre- and/or post-natal toxicity 
in any of the available studies with Cyhalothrin.
    This information supports the dose analysis conducted by EPA as 
well as the removal of the special Food Quality Protection Act (FQPA) 
Safety Factor required for the protection of infants and children. 
Therefore, the FQPA Safety Factor (as discussed in the February 2002 
OPP 10X guidance document) was reduced to 1X.

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 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 + 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 USEPA 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, 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 
lambda-cyhalothrin will occupy 41% of the aPAD for the U.S. population, 
24% of the aPAD for females 13 years and older, 71% of the aPAD for all 
infants (< year old) and 82% of the aPAD for children 1-6 years old. In 
addition, there is potential for acute dietary exposure to lambda-
cyhalothrin in drinking water. After calculating DWLOCs and comparing 
them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 3:

                  Table 3.--Aggregate Risk Assessment for Acute Exposure to Lambda-Cyhalothrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)                      (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Infant (<1 year old)                                   0.005           71         0.62        0.012           14
----------------------------------------------------------------------------------------------------------------
Child (1-6 years old)                                  0.005           82         0.62        0.012            9
----------------------------------------------------------------------------------------------------------------
Adult                                                  0.005           41         0.62        0.012          168
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to lambda-
cyhalothrin from food will utilize 8% of the cPAD for the U.S. 
population, 12% of the cPAD for all infants (<1 year old) and 22% of 
the cPAD for children 1-6 years old. Based on current use patterns, 
chronic residential exposure to residues of lambda-cyhalothrin is not 
expected. In addition, there is potential for chronic dietary exposure 
to lambda-cyhalothrin in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 4:

                               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Lambda-Cyhalothrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     Ground Water EEC    Chronic DWLOC
        Population Subgroup            cPAD mg/kg/day     % cPAD (Food)            Surface Water EEC (ppb)                (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant (<1 year old)                             0.001                 12                                    0.098              0.012                  9
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 60913]]

 
Child (1-6 years old)                            0.001                 22                                    0.098              0.012                  8
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                  0.001                  8                                    0.098              0.012                 32
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Lambda-cyhalothrin is currently registered for use that could 
result in short- and intermediate-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic food 
and water and short- and intermediate-term exposures for lambda-
cyhalothrin.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs listed in 
Table 5 below. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food and residential uses. In 
addition, short- and intermeidate-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of lambda-cyhalothrin in 
ground and surface water. After calculating DWLOCs and comparing them 
to the EECs for surface and ground water, EPA does not expect short- 
and itermediate-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 5:

     Table 5.--Aggregate Risk Assessment for Short-Term and Intermediate Term Exposure to Lambda-Cyhalothrin
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Infant                                                   315          149        0.098        0.012            7
----------------------------------------------------------------------------------------------------------------
Child                                                    239          172        0.098        0.012            6
----------------------------------------------------------------------------------------------------------------
General Population                                       867          113        0.098        0.012           31
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. The database for 
carcinogenicity is considered complete, no additional studies are 
required at this time. The requirements for carcinogenicity studies in 
the rat and the mouse with lambda-cyhalothrin have been satisfied by a 
combined chronic/carcinogenicity study in rats and a carcinogenicity 
study in mice, both conducted with cyhalothrin. Although mice should 
have been tested at a higher dose, it was determined that there was not 
enough toxicological concern to warrant a requirement for a new 
carcinogenicity study in mice. Lambda-cyhalothrin is classified as a 
Group D chemical (not classifiable as to human carcinogenicity).
    Under the conditions of the studies, lambda-cyhalothrin is not 
considered to be carcinogenic in either rats or mice. However, there 
has been a question concerning a slight but not statistically 
significant increase in mammary tumors in the mouse study. In that 
study, the dose levels were not sufficiently high to totally rule these 
out. Nevertheless, it is determined that there is not a sufficient 
toxicological concern to ask for a new study for the following reasons: 
an examination of the evidence of carcinogenicity with other 
pyrethroids showed no increases in mammary tumors with any other 
pyrethroid. In addition, from a mode of action standpoint, the primary 
effect of the pyrethroids is on the neuromuscular system. Pyrethroids 
generally stimulate nerve cells to produce repetitive discharges which 
are caused by their action on the sodium channel. Mammary gland 
carcinogenesis in the rodent can be caused by either mutagenesis or by 
a hormonal imbalance leading to elevated or prolonged exposure to 
estrogen. There is no evidence that the pyrethroid mode of action leads 
to a hormonal imbalance and lambda-cyhalothrin has not been shown to be 
a DNA reactive mutagen. For these reasons, it is unlikely that a repeat 
mouse study on lambda-cyhalothrin would provide any additional 
evidence. Therefore, a risk assessment for potential carcinogenicity to 
humans 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 lambda-cyhalothrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of 
lambda-cyhalothrin residues in plant and animal commodities. ICI Method 
81 (PRAM 81) is used to determine the residues of lambda-cyhalothrin 
and its epimer in plant matrices and ICI Method 86 is used to determine 
residues of lambda-cyhalothrin and its epimer in animal matrices. Both 
methods have been validated by EPA as adequate enforcement methods for 
determination of parent lambda-cyhalothrin and its epimer in the 
respective matrices. ICI Method 96 is used to determine lambda-
cyhalothrin metabolites in meat, milk, poultry and eggs. The LOQ for 
all three methods is 0.01 ppm.

B. International Residue Limits

    There are currently no Mexican, Canadian or Codex maximum residue 
limits (MRLs) for lambda-cyhalothrin.

[[Page 60914]]

 There are MRLs for cyhalothrin from which lambda-cyhalothrin is 
derived as an enriched isomer.

C. Magnitude of Residue

    Residue field trial data are adequate to support the established 
and proposed lambda-cyhalothrin tolerances. The Monte Carlo methods for 
acute dietary analyses for cattle (beef and dairy) to select the feed 
items comprising the potential cattle diets and associated residues 
have been previously reviewed and found acceptable. The nature of the 
residues of lambda-cyhalothrin in plants and animals is understood. 
Quantifiable residues are expected on most treated commodities.

V. Conclusion

    Therefore, the tolerance is established for residues of lambda-
cyhalothrin, in or on almond, hulls at 1.5 ppm; apple pomace, wet at 
2.50 ppm; avocados (imported) at 0.20 ppm; canola, seed at 0.15 ppm; 
fruit, pome, group at 0.3 ppm; fruit, stone, group at 0.50 ppm; nut, 
tree, group at 0.05 ppm; peanut, hay at 3.0 ppm; peas and beans - dried 
shelled, (except soybean), subgroup at 0.1 ppm ; peas and beans - 
succulent shelled, subgroup at 0.01 ppm; sorghum, grain, forage at 0.3 
ppm; sorghum, grain, stover at 0.5 ppm; sugarcane at 0.05 ppm; 
vegetables, fruiting, group (except cucurbits) at 0.2 ppm; and 
vegetables, legumes, edible podded subgroup at 0.2 ppm.

VI. 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 ID number OPP-2002-0204 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 
26, 2002.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your written request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 [email protected], 
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 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 Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0204 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: [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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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,

[[Page 60915]]

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

VIII. 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: September 20, 2002.
Peter Caulkins,
Acting 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 180.438 is amended by adding new commodities to the 
table in paragraph (a)(1) to read as follows, and by removing the entry 
for ``sugarcane'' from the table in paragraph (b).


Sec.  180.438  Lambda-Cyhalothrin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Almond, hulls..............................................          1.5
Apple pomace, wet..........................................         2.50
                                * * * * *
Avocados (imported)........................................         0.20
                                * * * * *
Canola.....................................................          1.0
Canola, oil................................................          2.0
                                * * * * *
Fruit, pome, group.........................................         0.30
Fruit, stone, group........................................         0.50
                                * * * * *
Nut, tree, group...........................................         0.05
                                * * * * *
Pea and bean, dried shelled,(except soybean), subgroup.....         0.10
Pea and bean, succulent shelled, subgroup..................         0.01
Peanut, hay................................................          3.0
                                * * * * *
Sorghum, grain, forage.....................................         0.30
Sorghum, grain, stover.....................................         0.50
                                * * * * *
Sugarcane..................................................         0.05
                                * * * * *
Vegetables, fruiting, group (except cucurbits).............         0.20
Vegetables, legume, edible podded, subgroup................         0.20
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-24486 Filed 9-26-02; 8:45 a.m.]
BILLING CODE 6560-50-S