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Lambda-cyhalothrin. September
3, 2003. Pesticide Tolerances for Emergency Exemptions in New York State. Final
Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-03/p22315.htm
[Federal Register: September 3, 2003 (Volume 68, Number 170)]
[Rules and Regulations]
[Page 52354-52363]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03se03-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0267; FRL-7321-3]
Lambda Cyhalothrin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance 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
[[Page 52355]]
(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
clover, forage and clover, 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 alfalfa/clover/grass mixed stands. This regulation
establishes a maximum permissible level 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 September 3, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0267,
must be received on or before November 3, 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: sec-18-mailbox@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are 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:
¥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-2003-0267. 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 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 clover, forage
at 5.0 parts per million (ppm) and clover, 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 Alfalfa/Clover/Grass
Mixed Stands and FFDCA Tolerances
The state of New York requested the use of lambda-cyhalothrin to
control alfalfa weevil (Hypera postica),
[[Page 52356]]
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 FIFRA section 18 the use of
lambda-cyhalothrin on alfalfa/clover/grass mixed stands for control of
alfalfa weevil, armyworms and potato leafhoppers in New York. After
having reviewed the submissions, EPA concurs that an emergency
condition exists for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of lambda-cyhalothrin in or
on clover, forage and clover, 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 FIFRA section 18.
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 clover, forage and clover, 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 alfalfa/
clover/grass mixed stands 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 FIFRA
section 24(c). Nor do these tolerances serve as the basis for any State
other than New York to use this pesticide on these crops under section
18 of FIFRA without following all provisions of EPA's regulations
implementing FIFRA section 18 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 408(b)(2) of the FFDCA, for time-limited
tolerances for the combined residues of lambda-cyhalothrin and its
epimer in or on clover, forage at 5.0 ppm and clover, 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 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 1:
[[Page 52357]]
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 = 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 mg/kg/day FQPA SF = 1 Chronic oral study in
UF = 100............... cPAD = chronic RfD / the dog (lambda-
Chronic RfD = 0.001 mg/ FQPA SF = 0.001 mg/kg/ cyhalothrin)
kg/day. 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 (Residential) the dog (lambda-
- 6 Months) Residential Only cyhalothrin)
LOAEL = 0.5 based on
gait abnormalities
observed in 2 dogs
----------------------------------------------------------------------------------------------------------------
Dermal (All Durations; - Short-Term dermal (or oral) study LOC for MOE = 100 21-Day dermal toxicity
(1 to 7 days) - Intermediate-Term (1 NOAEL= 10 mg/kg/day (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 = 100 21-Day Inhalation Study
Term (1 to 7 days) - Intermediate- study NOAEL= 0.3 (Residential) in Rats (lambda-
Term (1 week to several months) - Environmental cyhalothrin)
Long-Term (several months to protection, Cut and LOAEL = 3.3 [mu]g/L
lifetime) (Residential) past remainder of (0.90 mg/kg/day) based
subjects. [mu]g/L on clinical signs of
(0.08 mg/kg/day) neurotoxicity,
(inhalation absorption decreased body weight
rate = 100%) 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.
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 egg; poultry, meat; and poultry,
meat by-products 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[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. 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 DEEM[reg]
analysis evaluated the individual
food consumption as reported by respondents in the USDA 1989-1992
nationwide CSFII and accumulated exposure to the chemical for each
commodity. 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
[[Page 52358]]
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 produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Ground Water (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
[[Page 52359]]
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 (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
data base 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 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 USEPA 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, EPA concludes with reasonable certainty that
exposures to lambda-cyhalothrin 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 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
[[Page 52360]]
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the aPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Acute Exposure to 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
----------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------============
----------------------------------------------------------------------------------------------------------------
Males 13-19 0.005 27.61 0.62 0.012 127
----------------------------------------------------------------------------------------------------------------
Males 20+ years 0.005 21.69 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 on 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 water and ground water,
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to 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
----------------------------------------------------------------------------------------------------------------
Children 1-6 years 0.001 21.8 0.098 0.012 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 the following Table 4:
[[Page 52361]]
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) 239 100 0.098 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: residuemethods@epa.gov.
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 clover, forage at 5.0 ppm
and clover, 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.
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-2003-0267 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
3, 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 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-
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
[[Page 52362]]
inclusion in the official record that is described in Unit I.B.1. Mail
your copies, identified by the docket ID number OPP-2003-0267, 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: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes time-limited tolerances under 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, 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 (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.
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: August 22, 2003.
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 alphabetically adding commodities to
the table in paragraph (b) to read as follows:
[[Page 52363]]
Sec. 180.438 Lambda-cyhalothrin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Clover, forage 5.0 12/31/05
Clover, hay 6.0 12/31/05
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 03-22315 Filed 9-2-03; 8:45 am]
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