[Federal Register Volume 68, Number 2 (Friday, January 3, 2003)]
[Rules and Regulations]
[Pages 283-291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0335; FRL-7285-2]


Lambda-cyhalothrin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of the pyrethroid lambda-cyhalothrin, 1:1 mixture of 
(S)-[alpha]-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-
[alpha]-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3- 
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and its 
epimer expressed as epimer of lambda-cyhalothrin, a 1:1 mixture of (S)-
[alpha]-cyano-3- phenoxybenzyl-(Z)-(1S,3S) -3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-
[alpha]-cyano-3- phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3- 
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate in or on wild 
rice, grass forage, and grass hay. This action is in response to EPA's 
granting of an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on wild rice and pasture grass. This regulation 
establishes maximum permissible levels for residues of lambda-
cyhalothrin and its epimer in these food commodities. The tolerances 
will expire and are revoked on December 31, 2005.

DATES: This regulation is effective January 3, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0335, 
must be received on or before March 4, 2003.

ADDRESSES: Written objections and hearing requests  may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703)308-9367; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a Federal 
or State government agency involved in administration of environmental 
quality programs (i.e., Departments of Agriculture, Environment, etc). 
Potentially affected entities may include, but are not limited to:
    [sbull] Federal or State Government Entity, (NAICS 9241), i.e., 
Departments of Agriculture, Environment, etc.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0335. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the`` Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml__00/Title__40/40cfr180_(--
00.html, a beta site currently under development.
    An electronic version of the public docket is available through 
EPA's

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electronic public docket and comment system, EPA Dockets. You may use 
EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for combined residues of the 
insecticide lambda-cyhalothrin and its epimer, in or on wild rice at 
1.0 parts per million (ppm), grass forage at 5.0 ppm and grass hay at 
6.0 ppm. These tolerances will expire and are revoked on December 31, 
2005. EPA will publish a document in the Federal Register to remove the 
revoked tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Lambda-Cyhalothrin on Wild Rice and 
Pasture Grass and FFDCA Tolerances

    The State of Minnesota requested the use of lambda-cyhalothrin on 
wild rice to control unusually high populations of riceworms because 
the registered alternatives were ineffective. The State of New York 
requested the use of lambda-cyhalothrin to control alfalfa weevil 
(Hypera postica), Armyworms (Spodoptera spp.) and Potato leafhopper 
(Empoasca fabae) on alfalfa/clover/grass mixed stands. The use of 
insecticides is the only practical means of controlling the three major 
pests that infest alfalfa/clover/grass mixed stands and there are no 
pesticides registered to control insect pests in these stands of mixed 
of alfalfa/clover/grass. Experts estimate a 35% yield loss if these 
mixed stands are not protected. EPA has authorized under section 18 of 
FIFRA the use of lambda-cyhalothrin on wild rice for control of rice 
borers in Minnesota and pasture grass for control of alfalfa weevil, 
armyworms and potato leafhoppers on alfalfa/clover/grass mixed stands 
in New York. After having reviewed the submissions, EPA concurs that 
emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of lambda-cyhalothrin in or 
on wild rice and grass forage and grass hay. In doing so, EPA 
considered the safety standard in section 408(b)(2) of the FFDCA, and 
EPA decided that the necessary tolerances under section 408(l)(6) of 
the FFDCA would be consistent with the safety standard and with section 
18 of FIFRA. Consistent with the need to move quickly on the emergency 
exemption in order to address an urgent non-routine situation and to 
ensure that the resulting food is safe and lawful, EPA is issuing these 
tolerances without notice and opportunity for public comment as 
provided in section 408(l)(6) of the FFDCA. Although these tolerances 
will expire and are revoked on December 31, 2005, under section 
408(l)(5) of the FFDCA, residues of the pesticide not in excess of the 
amounts specified in the tolerances remaining in or on wild rice, grass 
forage and grass hay after that date will not be unlawful, provided the 
pesticide is applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by these tolerances 
at the time of that application. EPA will take action to revoke these 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether lambda-
cyhalothrin meets EPA's registration requirements for use on wild rice 
and pasture grass or whether permanent tolerances for these uses would 
be appropriate. Under these circumstances, EPA does not believe that 
these tolerances serve as a basis for registration of lambda-
cyhalothrin by a State for special local needs under section 24(c) of 
FIFRA. Nor do these tolerances serve as the basis for any States other 
than Minnesota and New York to use this pesticide on these crops under 
section 18 of FIFRA without following all provisions of EPA's 
regulations implementing section 18 of FIFRA as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for lambda-cyhalothrin, contact the Agency's Registration Division at 
the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7) .
    Consistent with section 408(b)(2)(D) of the FFDCA , EPA has 
reviewed the available scientific data and other relevant information 
in support of this action. EPA has sufficient data to assess the 
hazards of lambda-cyhalothrin and to make a determination on aggregate 
exposure, consistent with section

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408(b)(2) of the FFDCA, for time-limited tolerances for the combined 
residues of lambda-cyhalothrin and its epimer in or on wild rice at 1.0 
ppm, grass forage at 5.0 ppm and grass hay at 6.0 ppm. EPA's assessment 
of the dietary exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intra species 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/SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x10-\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 1:

 Table 1.-- Summary of Toxicological Dose and Endpoints for Lambda-Cyhalothrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NOAEL = 0.5 mg/kg/day    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)
                                        day.                                             LOAEL = 3.5 mg/kg/day
                                                                                          based on clinical
                                                                                          signs of neurotoxicity
                                                                                          (ataxia) observed from
                                                                                          day 2, three to seven
                                                                                          hours post-dosing.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 0.1 mg/kg/day    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 Oral Short- and             NOAEL = 0.1              LOC for MOE = 100        Chronic oral study in
 Intermediate-Term (1-30 Days and 1-6                            (Residential)            the dog (lambda-
 Months) Residential Only                                                                 cyhalothrin)
                                                                                         LOAEL = 0.5 based on
                                                                                          gait abnormalities
                                                                                          observed in 2 dogs
----------------------------------------------------------------------------------------------------------------
Dermal (All Durations;- Short-Term (1  dermal (or oral) study   LOC for MOE =            21-Day dermal toxicity
 to 7 days) - Intermediate- Term (1    NOAEL= 10 mg/kg/day....  100 (Residential)......   study in the rat
 week to several months) - Long-Term                                                      (lambda-cyhalothrin)
 (several months to lifetime)                                                            LOAEL = 50 mg/kg/day
 (Residential)                                                                            based on clinical
                                                                                          signs of neurotoxicity
                                                                                          (observed from day 2)
                                                                                          and decreased body
                                                                                          weight and body weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
Inhalation (All Durations; - Short-    inhalation (or oral)     LOC for MOE =            21-Day inhalation study
 Term (1 to 7 days) - Intermediate-     study                   100 (Residential)......   in rats (lambda-
 Term (1 week to several months) -     NOAEL= 0.3 [mu]g/L                                 cyhalothrin)
 Long-Term (several months to           (0.08 mg/kg/day).                                LOAEL = 3.3 [mu]g/L
 lifetime) (Residential)               (inhalation absorption                             (0.90 mg/kg/day) based
                                        rate = 100%).                                     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.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                                                        Classification: Group D
                                                                                          chemical (not
                                                                                          classifiable as to
                                                                                          human carcinogenicity)
 
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.


[[Page 286]]

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. 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 6.0 ppm on alfalfa hay, corn forage, and tomato 
pomace (dry or wet). Tolerances are also established on animal 
commodities ranging from 0.01 ppm in eggs, poultry meat, and poultry 
meat by-products (mbyp) to 5.0 ppm in milk fat (reflecting 0.2 ppm in 
whole milk). The Agency has recently established additional tolerances 
for lambda-cyhalothrin on a number of commodities ranging from 0.05 ppm 
on sugarcane to 3.0 ppm on peanut hay. 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\TM\) 
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. A refined Tier 3 probabilistic acute dietary risk 
assessment was conducted for all currently registered and proposed 
lambda-cyhalothrin food uses. For the acute dietary risk analysis the 
entire distribution of residue field trial data was used for not-
blended or partially-blended commodities; average residue field trial 
data was used for blended commodities; information from cooking and 
processing studies were used when available; and market share data for 
proposed and established tolerances was used.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) 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. For the chronic dietary risk analysis the average of the 
residue field trials, information from cooking and processing studies, 
and market share data were used.
    iii. Cancer. The data base for carcinogenicity is considered 
complete, and no additional studies are required at this time. The 
requirements for oncogenicity studies in the rat and the mouse with 
lambda-cyhalothrin have been satisfied by a combined chronic/
oncogenicity study in rats and an oncogenicity study in mice, both 
conducted with cyhalothrin. Lambda-cyhalothrin has been classified as a 
Group D chemical (not classifiable as to human carcinogenicity) with 
regards to its carcinogenic potential.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must 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) of the FFDCA, 
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) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    A detailed description of how the Agency used PCT information in 
this assessment can be found in the lambda-cyhalothrin pesticide 
tolerance document published on September 27, 2002 (67 FR 60902; FRL-
7200-1) in Unit III.C.1.iv.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the 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. 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

[[Page 287]]

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 generally 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 below. The compounds 
to be regulated in drinking water are lambda-cyhalothrin and degradate 
XV (parent hydroxylated in the 4-position of the phenoxy ring).
    Based on the FIRST, PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of lambda-cyhalothrin and its 
degradate XV for acute exposures are estimated to be 0.62 parts per 
billion (ppb) for surface water (0.51 ppb lambda-cyhalothrin and 0.11 
ppb degradate XV) and 0.012 ppb (0.006 ppb lambda-cyhalothrin and 0.006 
ppb degradate XV) for ground water. The EECs for chronic exposures are 
estimated to be 0.098 ppb for surface water (0.09 ppb lambda-
cyhalothrin and 0.008 ppb degradate XV) and 0.012 ppb for ground water 
(0.006 ppb lambda-cyhalothrin and 0.006 ppb degradate XV).
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The residential 
exposure/risk assessment evaluated both proposed and existing uses for 
lambda-cyhalothrin. Existing uses on turf, in gardens, on golf courses, 
and for structural pest control were qualitatively assessed, but a 
quantitative calculation was only completed for postapplication 
exposure on treated turf because this scenario is expected to have the 
highest associated exposures. This screening level tool is protective 
for all residential exposures, even the handler scenarios, because the 
dose levels for children playing on treated lawns are thought to exceed 
those expected for all other scenarios. For postapplication exposure, 
all residential MOEs 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 aggregated, MOEs were still not of concern (MOEs for children 
= 500 and for adults = 3,000).
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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).

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines 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. Developmental toxicity studies. In a developmental toxicity 
study in rats, the maternal NOAEL was 10 mg/kg/day and the LOAEL was 15 
mg/kg/day based on uncoordiniated limbs, reduced body weight gain and 
food consumption. The developmental NOAEL was 15 mg/kg/day, highest 
dose tested (HDT) and the developmental LOAEL was >15 mg/kg/day.
    In a developmental toxicity study in rabbits, the maternal NOAEL 
was 10 mg/kg/day and the LOAEL was 30 mg/kg/day based on reduced body 
weight gain and food consumption. The developmental NOAEL was 30 mg/kg/
day, HDT and the developmental LOAEL was >30 mg/kg/day.
    3. Reproductive toxicity study. In a 3-generation reproduction 
study in rats, the parental/offspring NOAEL was 1.5 mg/kg/day and the 
LOAEL was 5.0 mg/kg/day based on decreased parental body weight and 
body weight gain during premating and gestation periods and reduced pup 
weight and weight gain during lactation. The reproductive NOAEL was 5.0 
mg/kg/day (HDT)
    4. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the developmental studies with cyhalothrin and there is no 
evidence of increased susceptibility of young rats in the reproduction 
study with cyhalothrin.
    5. Conclusion. Through the use of bridging data, the toxicology 
database for lambda-cyhalothrin is complete. The Agency has determined 
that the special FQPA safety factor should be reduced to 1x because as 
noted above, there is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with cyhalothrin and there is no evidence of increased susceptibility 
of young rats in the reproduction study

[[Page 288]]

with cyhalothrin. The Agency concluded there are no residual 
uncertainties for pre- and/or postnatal exposure. The RfDs and other 
endpoints established for risk assessment are protective of pre-/
postnatal toxicity following exposure to cyhalothrin.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to lambda-cyhalothrin in drinking water (when considered 
along with other sources of exposure for which OPP has reliable data) 
would not result in unacceptable levels of aggregate human health risk 
at this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of lambda-cyhalothrin on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
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 <1 year old and 82% of the aPAD for children 1-6 years old. In 
addition, despite the potential for acute dietary exposure to lambda-
cyhalothrin in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of 
lambda-cyhalothrin in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in Table 2 of 
this unit:

                  Table 2.-- Aggregate Risk Assessment for Acute Exposure to Lambda-Cyhalothrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD  (mg/     % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)                                0.005        40.86         0.62        0.012          103
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year)                                  0.005        71.22         0.62        0.012           14
Children 1-6 years                                     0.005        82.36         0.62        0.012            9
----------------------------------------------------------------------------------------------------------------
Children 7-12 years                                    0.005        46.09         0.62        0.012           27
----------------------------------------------------------------------------------------------------------------
Females 13-50                                          0.005        23.83         0.62        0.012          114
Males 13-19                                            0.005        27.61         0.62        0.012          127
----------------------------------------------------------------------------------------------------------------
Males 20+ years                                        0.005        21.69         0.62        0.012          137
----------------------------------------------------------------------------------------------------------------
Seniors 55+                                            0.005        21.85         0.62        0.012          137
----------------------------------------------------------------------------------------------------------------

    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 8.2% of the cPAD for the U.S. 
population, 11.7% of the cPAD for all infants < 1 year old and 21.8% of 
the cPAD for children 1-6 years old. Based the use pattern, chronic 
residential exposure to residues of lambda-cyhalothrin is not expected. 
In addition, despite the potential for chronic dietary exposure to 
lambda-cyhalothrin in drinking water, after calculating DWLOCs and 
comparing them to conservative model estimated environmental 
concentrations of lambda-cyhalothrin in surface and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in Table 3 of this unit:

          Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Lambda-Cyhalothrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)                                0.001          8.2        0.098        0.012           32
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year)                                 0.001         11.7        0.098        0.012            9
----------------------------------------------------------------------------------------------------------------

[[Page 289]]

 
Children 1-6 years                                     0.001         21.8        0.098       0.0 12            8
----------------------------------------------------------------------------------------------------------------
Children 7-12 years                                    0.001         12.9        0.098        0.012            9
----------------------------------------------------------------------------------------------------------------
Females 13-50                                          0.001          5.7        0.098        0.012           28
----------------------------------------------------------------------------------------------------------------
Males 13-19                                            0.001          7.9        0.098        0.012           32
----------------------------------------------------------------------------------------------------------------
Males 20+ years                                        0.001          6.0        0.098        0.012           33
----------------------------------------------------------------------------------------------------------------
Seniors 55+                                            0.001          5.8        0.098        0.012           33
----------------------------------------------------------------------------------------------------------------

    3. Short and intermediate-term risk. Aggregate risk for short- and 
intermediate-term durations of exposure includes food, drinking water, 
and residential exposure pathways. The residential exposure pathway 
includes dermal, inhalation, and incidental oral (hand-to-mouth-type 
inadvertent exposure) routes of exposure. This aggregate risk 
assessment included lawn post-application exposure, considered the 
scenario with the highest potential for exposure and is a day 0 
screening level assessment.
    Lambda-cyhalothrin is currently registered for use(s) 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-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 of 879 for 
adults, 239 for children 1-6, and 302 for infants <1 year old. These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of lambda-cyhalothrin in ground water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 4 of this unit:

       Table 4.-- Aggregate Risk Assessment for Short and Intermediate-Term Exposure to Lambda-Cyhalothrin
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate                               Short and
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
Adults                                                 879          100        0.098        0.012            31
----------------------------------------------------------------------------------------------------------------
Child (1-6)                                            239         10 0       0.0 98       0 .012             6
----------------------------------------------------------------------------------------------------------------
Infant (<1 yr)                                         302          100        0.098        0.012             7
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Lambda-cyhalothrin 
has been classified as a Group D chemcial (not classifiable as to human 
carcinogenicity) with regards to its carcinogenic potential.
    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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican MRLs established for 
residues of lambda-cyhalothrin in plant or animal commodities. Codex 
MRLs for cyhalothrin are established for several commodities which are 
unrelated to this action. Therefore, a discussion of compatibility with 
U.S. tolerances is not relevant at this time.

VI. Conclusion

    Therefore, the tolerances are established for the combined residues 
of lambda-cyhalothrin and its epimer in or on wild rice at 1.0 ppm, 
grass forage at 5.0 ppm and grass hay at 6.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made.

[[Page 290]]

 The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0335 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 March 4, 
2003.
    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 20460-0001. You may also deliver your 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 20460-0001.
    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 20460-0001.
    3.Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by the docket ID number OPP-2002-0335, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. Regulatory Assessment Requirements

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerances 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,

[[Page 291]]

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

IX. 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: December 20, 2002.
Debra Edwards,
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 alphabetically adding commodities 
to the table in paragraph (b) to read as follows:


Sec.  180.438  Lambda-cyhalothrin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. * * *

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
                              * * * * * * *
Grass, forage                     5.0                 12/31/05
Grass, hay                        6.0                 12/31/05
Rice, wild                        1.0                 12/31/05
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-6 Filed 1-2-03; 8:45am]
BILLING CODE 6560-50-S