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Lambda-cyhalothrin (Syngenta).
September 27, 2002. Pesticide Tolerance. Final Rule.
Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-27/p24486.htm
[Federal Register: September 27, 2002 (Volume 67, Number 188)]
[Rules and Regulations]
[Page 60902-60915]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se02-18]
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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: sproat.william@epa.gov.
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
sexes and 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 in body
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 cleavage of
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:
¥ 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.
¥ 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.
¥ Low application rate is expected for residential handler.
¥ 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit 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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
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 (59 FR 22951, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
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