[Federal Register Volume 63, Number 30 (Friday, February 13, 1998)]
[Rules and Regulations]
[Pages 7291-7299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3751]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300608; FRL-5767-7]
RIN 2070-AB78
Lambda-cyhalothrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the combined
residues of the pyrethroid lambda-cyhalothrin and its epimer in or on
alfalfa forage at 5.0 parts per million (ppm); alfalfa hay at 6.0 ppm;
leaf lettuce at 2.0 ppm; brassica head and stem subgroup (broccoli,
Chinese broccoli, Brussels sprouts, cabbage, Chinese (napa) cabbage,
Chinese mustard, cauliflower, caval broccolo, and kohlrabi) at 0.4 ppm;
replaces the term ``grain dust'' with ``aspirated grain fractions''
with a tolerance of 2.0 ppm; and increases the tolerance for poultry
fat from 0.01 ppm to 0.03 ppm. Zeneca Ag Products requested these
tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective February 13, 1998. Objections and
requests for hearings must be received by EPA on or before April 14,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300608], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300608], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by
[[Page 7292]]
sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies
of objections and hearing requests must be submitted as an ASCII file
avoiding the use of special characters and any form of encryption.
Copies of objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 file format or ASCII file format. All
copies of objections and hearing requests in electronic form must be
identified by the docket control number [OPP-300608]. No Confidential
Business Information (CBI) should be submitted through e-mail.
Electronic copies of objections and hearing requests on this rule may
be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Stephanie Willett,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5419, e-mail:
willett.stephanie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 11, 1997
(62 FR 37234-37246)(FRL-5728-7), EPA issued a notice pursuant to
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e) announcing the filing of pesticide petition (PP) number
5F4588 for lambda-cyhalothrin tolerances on alfalfa, leaf lettuce,
brassica subgroup, aspirated grain fractions, and an increase in the
current poultry fat tolerance by Zeneca Ag Products, 1800 Concord Pike,
P.O. Box 15458, Wilmington, Delaware 19850-5458. This notice included a
summary of the petition prepared by Zeneca Ag Products, as required
under the FFDCA as amended by the Food Quality Protection Act (FQPA) of
1996. There were no comments received in response to the notice of
filing.
The petition requested that 40 CFR 180.438 be amended by
establishing tolerances for the combined residue of the insecticide,
lambda-cyhalothrin and its epimer in or on raw agricultural commodities
(RACs) alfalfa forage at 5.0 ppm; alfalfa hay at 6.0 ppm; leaf lettuce
at 2.0 ppm; head and stem Brassica crop subgroup at 0.4 ppm; aspirated
grain fractions at 2.0 ppm; and increasing the existing tolerance for
poultry fat from 0.01 ppm to 0.03 ppm. The change in terminology from
``grain dust'' to ``aspirated grain fractions'' was recommended by the
EPA, since the term ``grain dust'' is not used. The tolerance for
aspirated grain fractions includes a mixture of all aspirated grains
for which the pesticide has a tolerance, and should be established at
the highest current tolerance set for any grain dust, which is 2.0 ppm.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue*** .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This hundredfold MOE is based on the same rationale as
the hundredfold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic risks.'' These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
[[Page 7293]]
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of lambda-
cyhalothrin and its epimer, and to make a determination on aggregate
exposure, consistent with section 408(b)(2). EPA's assessment of the
dietary exposures and risks associated with establishing the tolerances
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by lambda-cyhalothrin
and its epimer are discussed below. Note that the studies discussed
below were conducted using either cyhalothrin or lambda-cyhalothrin.
Cyhalothrin and lambda-cyhalothrin are basically the same chemical, the
differences are found in their stereo chemistry and the number of
isomers in each mixture. Cyhalothrin consists of four stereo isomers in
each mixture. Cyhalothrin consists of four stereo isomers while lambda-
cyhalothrin is a mixture of the two isomers. The two lambda-cyhalothrin
isomers are contained in cyhalothrin, they represent 40% of the
cyhalothrin mixture. The major studies submitted to the Agency were
conducted with cyhalothrin. However, these studies are used in support
of registration for both mixtures. There is some evidence, based on
subchronic studies in rats, that the two mixtures are not biologically
different with respect to their mammalian toxicity.
1. Acute toxicity. Acute toxicity studies with the technical grade
of the active ingredient lambda-cyahothrin: oral LD50 in the
rat at 79 milligram per kilogram (mg/kg) (males) and 56 mg/kg (females)
- Toxicity Category II; dermal LD50 in the rat at 632 mg/kg
(males) and 696 mg/kg females - Toxicity Category II; primary eye
irritation study showed mild irritation - Toxicity Category II; and
primary dermal irritation study showed no irritation - Toxicity
Category IV.
2. Mutagenicity. The following genotoxicity tests were all
negative: a gene mutation assay (Ames), a mouse micronucleus assay, an
in-vitro cytogenetics assay, and a gene mutation study in mouse
lymphoma cells.
3. Reproductive and developmental toxicity. i. In a three-
generation reproduction study, rats were fed diets containing
cyhalothrin at 0, 10, 30 or 100 ppm (approximately 0, 0.5, 1.5 or 5.0
milligram per kilogram per day (mg/kg/day)). Parental toxicity was
observed as decreased mean body weight and body weight gain during the
premating and gestation periods at 5.0 mg/kg/day. There were no other
treatment-related effects. Offspring toxicity was observed as reduced
mean pup weight and pup weight gains during lactation, again at 5.0 mg/
kg/day. No other treatment-related effects were observed. The
reproductive and parental NOELs are 1.5 mg/kg/day and the reproductive
and parental lowest observed effect level (LOELs) are 5.0 mg/kg/day.
The developmental NOEL is 5.0 mg/kg/day (highest dose tested (HDT)).
ii. In a rabbit developmental toxicity study, rabbits were given
gavage dose levels of cyhalothrin at: 0, 3, 10, 30 mg/kg/day during the
gestation period (days 6 through 18). The maternal NOEL was 10 mg/kg/
day and the maternal LOEL was 30 mg/kg/day based on decreased
[[Page 7294]]
body weight gain (48% of controls) during the dosing period. The
developmental NOEL was 30 mg/kg/day (HDT). No developmental effects
were observed.
iii. In a rat developmental study rats were given gavage dose
levels of cyhalothrin at: 0, 5, 10, 15 mg/kg/day during the gestation
period (days 6 through 15). The maternal NOEL was 10 mg/kg/day and the
maternal LOEL was 15 mg/kg/day based on reduced body weight gain (70%
of control) and food consumption (as low as 76%) during the dosing
period. The developmental NOEL was greater than 15 mg/kg/day (HDT). No
developmental effects were observed.
4. 90-day feeding study. i. In a 90-day feeding study rats were
fed, lambda-cyhalothrin at doses of 0, 10, 50 or 250 ppm (0, 0.5, 2.5,
12.5 mg/kg/day). The animals were examined once daily for clinical
signs of toxicity. Body weights, food consumption, hematological and
clinical chemistry parameters, urinalysis parameters, organ weights,
and macroscopic and microscopic observations were recorded. Body weight
gain and food consumption were significantly reduced for both sexes at
12.5 mg/kg/day. There was also a slight but statistically significant
reduction in food efficiency in females at this dose level. The NOEL is
2.5 mg/kg/day and the lowest effect level (LEL) is 12.5 mg/kg/day based
on reduction in body weight gain and food consumption in both sexes and
food efficiency in females.
ii. In another 90-day feeding study in rats cyhalothrin was fed at
doses of 0, 10, 50 or 250 ppm (0, 0.5, 2.5, 12.5 mg/kg/day). The
animals were examined for clinical signs of toxicity. Body weights,
food consumption, hematological and clinical chemistry parameters,
urinalysis parameters, organ weights, and macroscopic and microscopic
observations were recorded. Body weight gain was significantly reduced
in males at 12.5 mg/kg/day. Body weight gain was also significantly
reduced in females at this level, but only during the first week. Body
weight gain was not significantly affected at lower dose levels. The
NOEL is 2.5 mg/kg/day and the LEL is 12.5 mg/kg/day based on decreased
body weight gain.
5. 28-day study. In a 28-day study in the mouse, cyhalothrin was
fed to mice in the diet as a range-finding study for carcinogenicity at
0, 5, 25, 100, 500, or 2,000 ppm (0, 0.65, 3.30, 13.5, 64.2 or 309 mg/
kg/day for males and 0, 0.80, 4.17, 15.2, 77.9 or 294 mg/kg/day for
females).The NOEL is 500 ppm and the LEL is 2,000 ppm based on
mortality, clinical signs of toxicity, decreases in body weight gain
and food consumption, changes in hematology and organ weights and
minimal centrilobular hepatocyte enlargement.
6. 21-day dermal toxicity study. In a 21-day dermal toxicity study
rats were exposed dermally to doses of 1, 10, or 100 mg/kg of lambda-
cyhalothrin (reduced to 50 mg/kg after two or three applications) 6
hours/day. No significant signs of skin irritation was observed at any
dose level. Two male rats were found dead after three applications of
100 mg/kg. There was no evidence prior to death, at postmortem
examination, or from histopathology, of the possible cause of death,
but it is thought likely to be due to pyrethroid toxicity. Dosage was
reduced to 50 mg/kg/day for the remaining 18 applications. Animals
dosed with 50 mg/kg/day displayed clinical signs of slight general
toxicity (bizarre behavior, paw flicking, splayed gait, sides pinched
in, thin, tip-toe gait, reduced stability, dehydration and reduced
splay reflex). Effects on body weight gain and food consumption were
also seen in males at this dose level. No toxicologically significant
treatment-related effects were observed at any other dose level. The
NOEL is 10 mg/kg/day and the LEL is 100/50 mg/kg/day based on death (at
100 mg/kg/day only), clinical signs of toxicity and decreased body
weight gain and food consumption.
7. 21-day inhalation study. In a 21-day inhalation study rats were
exposed nose-only for 6 hours/day, 5 days/week to lambda-cyhalothrin at
0.3, 3.3, or 16.7 g/L. The NOEL was 0.3 g/L and the
LOEL was 3.3 g/L based on decreased body weight gains (high
dose males) and food consumption (high dose, both sexes), clinical
signs of toxicity (paw flicking, tail erections, tiptoe gait,
lachrymation or salivation), punctate foci on cornea (both sexes, mid-
and high dose), raised prothrombin time, changes in hematology,
clinical chemistry and urinalysis parameters and a slight increase in
the incidence of alveolitis in females.
8. 12-month chronic/carcinogenicity feeding study. In a 12-month
chronic/carcinogenicity feeding study dogs were fed dose (by capsule)
levels of lambda-cyhalothrin at 0, 0.1, 0.5, 3.5 mg/kg/day with a NOEL
of 0.1 mg/kg/day. The LOEL for this study is established at 0.5 mg/kg/
day based upon clinical signs of neurotoxicity.
9. 24-month chronic feeding/carcinogenicity study. In a 24-month
chronic feeding/carcinogenicity study rats were fed diets containing 0,
10, 50, and 250 ppm (0, 0.5, 2.5 or 12.5 mg/kg/day) of cyhalothrin. The
LEL for chronic toxicity in rats is 12.5 mg/kg/day and the NOEL is 2.5
mg/kg/day. There was no indication of carcinogenic effects observed
under the conditions of the study.
10. Carcinogenicity study. In a carcinogenicity study mice were fed
dose levels of 0, 20, 100, or 500 ppm (0, 3, 15, or 75 mg/kg/day) of
cyhalothrin in the diet for 2 years. A systemic NOEL was established at
100 ppm and systemic LOEL at 500 ppm based on decreased body weight
gain in males throughout the study at 500 ppm. The EPA has classified
lambda-cyhalothrin as a Group D carcinogen (not classifiable due to an
equivocal finding in this study). No treatment-related carcinogenic
effects were observed under the conditions of the study.
11. Animal Metabolism. Metabolism studies in rats demonstrated
that distribution patterns and excretion rates in multiple oral dose
studies are similar to single-dose studies. Accumulation of unchanged
compound in fat upon chronic administration with slow elimination was
observed. Otherwise, lambda-cyhalothrin was rapidly metabolized and
excreted. The metabolism of lambda-cyhalothrin in livestock has been
studied in the goat, chicken, and cow. Unchanged lambda-cyhalothrin is
the major residue component of toxicological concern in meat and milk.
12. Neurotoxicity studies. Neurotoxicity studies will be required
under a special data call-in letter pursuant to section 3(c)(2)(B) of
FIFRA. Although these data are lacking, EPA has sufficient toxicity
data to support these tolerances and these additional studies will not
significantly change its risk assessment.
B. Toxicological Endpoints
1. Acute toxicity. For acute dietary risk assessment, EPA used a
systemic NOEL of 0.5 mg/kg/day based on gait abnormalities in dogs on
day 2 in the chronic toxicity study.
2. Short - and intermediate - term toxicity. For short-and
intermediate-term MOE's EPA recommends us of a NOEL of 10.0 mg/kg/day
from the 21-day dermal toxicity based on systemic toxicity at 50 mg/kg/
day (LOEL). A dermal absorption rate of 25% was used based on weight of
evidence available for structurally related pyrethroids. EPA used a
NOEL of 0.3 g/L from the 21-day inhalation study in rats based
on clinical signs indicative of neurotoxicity (paw flicking) tail
erections, and tiptoe gait) at 3.3 g/L.
3. Chronic toxicity. EPA has established the reference dose (RfD)
for lambda-cyhalothrin at 0.001 mg/kg/day
[[Page 7295]]
based on clinical signs of neurotoxicity (ataxia, convulsions) seen at
the LEL of 0.5 mg/kg/day. This RfD is based on a 1-year oral study in
dogs with a NOEL of 0.1 mg/kg/day and an uncertainty factor (UF) of
100. The LEL of 0.5 mg/kg/day was based on clinical signs of
neurotoxicity (convulsions, ataxia, muscle tremors) and a slight
increase in liquid feces.
4. Carcinogenicity. Based on the available carcinogenicity studies
in two rodent species, lambda-cyhalothrin has been classified as a
Group ``D'' chemical, ``not classifiable as to human carcinogenicity''.
Although lambda-cyhalothrin was not shown to be carcinogenic in either
the mouse or rat, the EPA Hazard Evaluation Division (HED) RfD/Peer
review committee based the ``D'' classification on: (i) lambda-
cyhalothrin was not tested at adequate dose levels for carcinogenicity
testing in the mouse, and (ii) the equivocal nature of the findings
with regard to the incidence of mammary adenocarcinomas. No additional
cancer studies are being required at this time.
C. Exposures and Risks
1. From food and feed uses. The primary source of human exposure to
lambda-cyhalothrin will be from ingestion of both raw and processed
food commodities treated with lambda-cyhalothrin. Tolerances have been
established in 40 CFR 180.438, 40 CFR 185.3765 and 40 CFR 186.3765 for
combined residues of lambda-cyhalothrin and its epimer in or on a
variety of food commodities. (The tolerances in 40 CFR 185.1310 and
186.3765 were removed and transferred to 40 CFR 180.438 on November 26,
1997, (62 FR 63010)(FRL-5755-5)). Risk assessments were conducted by
EPA to assess dietary exposures and risks from lambda-cyhalothrin as
follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1 day or single exposure. The acute dietary exposure assessment
for lambda-cyhalothrin used Monte Carlo modeling incorporating
anticipated residue and percent crop treated refinements. The acute
dietary Margin of Exposure (MOE) calculated at the 99.9th percentile
for the most highly exposed population subgroup (nonnursing infants < 1="" year="" old)="" is="" 139.="" the="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" the="" general="" u.s.="" population="" is="" 311.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" for="" moe="" of="" 100="" or="" greater.="" therefore,="" the="" acute="" dietary="" risk="" assessment="" for="" lambda-cyhalothrin="" indicates="" a="" reasonable="" certainty="" of="" no="" harm.="" ii.="" chronic="" exposure="" and="" risk.="" the="" rfd="" used="" for="" the="" chronic="" dietary="" analysis="" is="" 0.001="" mg/kg/day.="" the="" chronic="" dietary="" exposure="" assessment="" used="" anticipated="" residues="" and="" percent="" crop="" treated="" information.="" the="" chronic="" dietary="" exposure="" estimate="" for="" the="" overall="" u.s.="" population="" was="" calculated="" to="" be="" 0.000068="" mg/kg/day,="" which="" utilized="" 6.8%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" for="" the="" most="" highly="" exposed="" population="" subgroup="" (children="" 1-6="" years="" old),="" chronic="" dietary="" exposure="" was="" estimated="" at="" 0.000192="" mg/kg/day,="" which="" utilized="" 19.2%="" of="" the="" rfd.="" epa="" notes="" that="" the="" acute="" dietary="" risk="" assessments="" used="" monte="" carlo="" modeling="" (in="" accordance="" with="" tier="" 3="" of="" epa="" june="" 1996="" ``acute="" dietary="" exposure="" assessment''="" guidance="" document)="" incorporating="" anticipated="" residues="" and="" percent="" crop="" treated="" refinements.="" the="" chronic="" dietary="" risk="" assessment="" used="" percent="" crop="" treated="" information="" and="" anticipated="" residues.="" section="" 408="" (b)(2)(e)="" authorizes="" epa="" to="" consider="" available="" data="" and="" information="" on="" the="" anticipated="" residue="" 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.="" section="" 408(b)(2)(f)="" allows="" the="" agency="" to="" use="" data="" on="" the="" actual="" percent="" of="" crop="" treated="" when="" establishing="" a="" tolerance="" only="" where="" the="" agency="" can="" make="" the="" following="" findings:="" (a)="" that="" the="" data="" used="" are="" reliable="" and="" provide="" a="" valid="" basis="" for="" showing="" the="" percentage="" of="" food="" derived="" from="" a="" crop="" that="" is="" likely="" to="" contain="" residues;="" (b)="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" the="" exposure="" for="" any="" significant="" subpopulation="" and;="" (c)="" where="" data="" on="" regional="" pesticide="" used="" and="" food="" consumption="" are="" available,="" that="" the="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" regional="" population.="" in="" addition,="" the="" agency="" must="" provide="" for="" periodic="" evaluation="" of="" any="" estimates="" used.="" the="" percent="" of="" crop="" treated="" estimates="" for="" lambda-cyhalothrin="" were="" derived="" from="" federal="" and="" market="" survey="" data.="" epa="" considers="" these="" reliable.="" a="" range="" of="" estimates="" are="" supplied="" by="" this="" data="" and="" the="" upper="" end="" of="" this="" range="" was="" used="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" estimate="" of="" percent="" of="" crop="" treated,="" the="" agency="" is="" reasonably="" certain="" that="" exposure="" is="" not="" understated="" for="" any="" significant="" subpopulation="" group.="" further,="" regional="" consumption="" information="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluation="" of="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" review="" of="" this="" regional="" data="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" to="" meet="" the="" requirement="" for="" data="" on="" anticipated="" residues,="" epa="" will="" issue="" a="" data="" call-in="" (dci)="" notice="" pursuant="" to="" ffdca="" section="" 408(f)="" requiring="" submission="" of="" data="" on="" anticipated="" residues="" in="" conjunction="" with="" approval="" of="" the="" registration="" under="" fifra.="" 2.="" from="" drinking="" water.="" laboratory="" and="" field="" data="" have="" demonstrated="" that="" lambda-cyhalothrin="" is="" immobile="" in="" soil="" and="" will="" not="" leach="" into="" groundwater.="" other="" data="" show="" that="" lambda-cyhalothrin="" is="" virtually="" insoluble="" in="" water="" and="" extremely="" lipophilic.="" as="" a="" result,="" epa="" concludes="" that="" residues="" reaching="" surface="" waters="" from="" field="" runoff="" will="" quickly="" adsorb="" to="" sediment="" particles="" and="" be="" partitioned="" from="" the="" water="" column.="" further,="" a="" screening="" evaluation="" of="" leaching="" potential="" of="" a="" typical="" pyrethroid="" was="" conducted="" using="" epa's="" pesticide="" root="" zone="" model="" (przm1).="" based="" on="" this="" screening="" assessment,="" the="" potential="" concentrations="" of="" a="" pyrethroid="" in="" groundwater="" at="" depths="" of="" 1="" and="" 2="" meters="" are="" essentially="" zero="">< 0.001="" parts="" per="" billion="" (ppb)).="" surface="" water="" concentrations="" for="" pyrethroids="" were="" estimated="" using="" przm3="" and="" exposure="" analysis="" modeling="" system="" (exams)="" using="" standard="" epa="" cotton="" runoff="" and="" mississippi="" pond="" scenarios.="" the="" maximum="" concentration="" predicted="" in="" the="" simulated="" pond="" was="" 0.052="" ppb="" concentrations="" in="" actual="" drinking="" water="" would="" be="" much="" lower="" than="" the="" levels="" predicted="" in="" the="" hypothetical,="" small,="" stagnant="" farm="" pond="" model="" since="" drinking="" water="" derived="" from="" surface="" water="" would="" normally="" be="" treated="" before="" consumption.="" i.="" acute="" exposure="" and="" risk.="" the="" acute="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000022="" mg/kg/day="" (moe="" 22,876)="" and="" 0.000042="" mg/kg/="" day="" (moe="" 11,956)="" for="" the="" overall="" population="" and="" non-nursing="" infants=""><1 year,="" respectively.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000000="" mg/kg/day="" (0.0%="" rfd="" utilized)="" and="" 0.000000="" mg/kg/day="" (0.0%="" of="" rfd="" utilized)="" for="" the="" overall="" population="" and="" non-nursing="" infants="">< 1="" year,="" respectively.="" 3.="" from="" non-dietary="" exposure.="" lambda-cyhalothrin="" is="" currently="" [[page="" 7296]]="" registered="" for="" use="" on="" the="" following="" residential="" non-food="" sites:="" general="" indoor/outdoor="" pest="" control="" (crack/crevice/spot),="" termiticide,="" ornamental="" plants="" and="" lawns="" around="" homes,="" parks,="" recreation="" areas="" and="" athletic="" fields,="" and="" golf="" course="" turf.="" application="" of="" this="" pesticide="" in="" and="" around="" these="" sites="" is="" mainly="" limited="" to="" commercial="" applicators.="" analyses="" were="" conducted="" which="" included="" an="" evaluation="" of="" potential="" non-="" dietary="" (residential)="" applicator,="" post-application="" and="" chronic="" dietary="" aggregate="" exposures="" associated="" with="" lambda-cyhalothrin="" products="" used="" for="" residential="" flea="" infestation="" control="" and="" agricultural/commercial="" applications.="" in="" the="" case="" of="" potential="" non-dietary="" health="" risks,="" conservative="" point="" estimates="" of="" nondietary="" exposures,="" expressed="" as="" total="" systemic="" absorbed="" dose="" (summed="" across="" inhalation="" and="" incidental="" ingestion="" routes)="" for="" each="" relevant="" product="" use="" category="" (i.e.="" lawn="" care)="" and="" receptor="" based="" on="" the="" toxicity="" endpoints="" selected="" by="" epa="" for="" lambda-cyhalothrin,="" inhalation="" and="" incidental="" oral="" ingestion="" absorbed="" doses="" were="" combined="" and="" compared="" to="" the="" relevant="" systemic="" noel="" for="" estimating="" moes.="" 4.="" short-="" and="" intermediate="" term="" exposure="" and="" risk.="" epa="" used="" a="" noel="" of="" 0.3="">g/L (0.05 mg/kg/day) from the 21-day inhalation
toxicity study in rats. The LOEL of 3.3 g/L was based on
decreased body weight gains and clinical signs of toxicity including
paw flicking, tail erections and tiptoe gait. For short- and
intermediate-term dermal exposure MOE calculations, EPA used a NOEL of
10.0 mg/kg/day based on systemic toxicity at 50 mg/kg/day (LOEL). The
MOE is 100.
The short and intermediate-term non-dietary aggregate (non-dietary
+ chronic dietary (food and water)) MOEs for lambda-cyhalothrin
indicate a substantial degree of safety. The total non-dietary
(inhalation + incidental + ingestion + dermal) MOEs for post-
application exposure for the lawn care products evaluated was estimated
to be >15,000 for adults, 7,200 for children 1-6 years old, and 7,000
for infants < 1="" year.="" it="" can="" be="" concluded="" that="" the="" potential="" non-="" dietary="" and="" aggregate="" (non-dietary="" +="" chronic="" dietary)="" exposures="" for="" lambda-cyhalothrin="" are="" associated="" with="" substantial="" margins="" of="" safety.="" 5.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" pesticide's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" although="" lambda-cyhalothrin="" is="" structurally="" similar="" to="" other="" members="" of="" the="" synthetic="" pyrethroids="" class="" of="" insecticide,="" 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.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" the="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" food="" and="" water.="" the="" acute="" aggregate="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" the="" u.s.="" population="" is="" 307.="" the="" agency="" generally="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" larger.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" acute="" aggregate="" exposure="" to="" lambda-cyhalothrin="" residues.="" 2.="" chronic="" risk.="" aggregate="" chronic="" exposure="" is="" the="" sum="" of="" chronic="" exposure="" from="" food="" and="" water.="" using="" the="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" lambda-cyhalothrin="" from="" food="" and="" water="" will="" utilize="" 6.8%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" lambda-cyhalothrin="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" for="" lambda-cyhalothrin="" the="" aggregate="" moe="" (inhalation="" +="" incidental="" oral="" +="" chronic="" dietary)="" summed="" across="" all="" product="" use="" categories="" was="" estimated="" to="" be="" 14,000="" for="" the="" u.s.="" population.="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-="" term="" risks="" do="" not="" exceed="" levels="" of="" concern,="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" lambda-cyhalothrin="" residues.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" lambda-cyhalothrin="" has="" been="" classified="" by="" epa="" as="" a="" group="" ``d''="" chemical,="" ``not="" classifiable="" as="" to="" human="" carcinogenicity.''="" therefore,="" this="" risk="" assessment="" was="" not="" conducted.="" f.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" [[page="" 7297]]="" children="" to="" residues="" of="" lambda-cyhalothrin,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" rats="" and="" rabbits="" and="" a="" three-="" generation="" reproductive="" toxicity="" study="" in="" rats.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" prenatal="" development.="" reproduction="" studies="" provide="" information="" relating="" to="" pre-="" and="" post-natal="" effects="" from="" exposure="" to="" the="" pesticide,="" information="" on="" the="" reproductive="" capability="" of="" mating="" animals,="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" 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="" margin="" of="" exposure="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" in="" either="" case,="" epa="" generally="" defines="" the="" level="" of="" appreciable="" risk="" as="" exposure="" that="" is="" greater="" than="" 1/100="" of="" the="" no="" observed="" effect="" level="" (noel)="" in="" the="" animal="" study="" appropriate="" to="" the="" particular="" risk="" assessment.="" this="" hundredfold="" uncertainty="" (safety)="" factor="" is="" designed="" to="" account="" for="" inter-species="" extrapolation="" and="" intra-species="" variability.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" hundredfold="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" factor.="" 1.="" developmental="" toxicity="" studies.="" i.="" from="" the="" developmental="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 10="" mg/kg/day.="" the="" maternal="" lel="" of="" 15="" mg/kg/day="" was="" based="" on="" decreased="" body="" weight="" gain="" and="" decreased="" food="" consumption.="" the="" developmental="" (fetal)="" noel="" was=""> 15 mg/kg/day at the highest dose tested (HDT).
ii. From the developmental toxicity study in rabbits, the maternal
(systemic) NOEL was 10 mg/kg/day. The maternal LEL of 30 mg/kg/day was
based on decreased body weight gain. The developmental (fetal) NOEL was
30 mg/kg/day (HDT).
2. Reproductive toxicity study. From the three-generation
reproductive toxicity study in rats, both the parental (systemic) and
reproductive (pup) NOEL's were 1.5 mg/kg/day. Both the parental
(systemic) and reproductive (pup) LEL's were 5 mg/kg/day. They were
based on a significant decrease in parental body weight (systemic) or a
significant decrease in pup body weight.
3. Pre- and post-natal sensitivity. The toxicology data base for
lambda-cyhalothrin is complete with respect to current toxicological
data requirements. There are no pre- or post-natal toxicity concerns
for infants and children, based on the results of the rat and rabbit
developmental toxicity studies and the three-generation reproductive
toxicity study in rats. Based on the above, EPA concludes that reliable
data support the use of the standard hundredfold margin of uncertainty
factor and that an additional uncertainty factor is not warranted at
this time.
4. Acute risk. The aggregate acute MOE calculated at the 99.9th
percentile for non-nursing infants < 1="" year="" old="" is="" 138.="" in="" a="" conservative="" policy,="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" lambda-cyhalothrin.="" 5.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" lambda-="" cyhalothrin="" from="" food="" will="" utilize="" 19.2="" percent="" of="" the="" rfd="" for="" children="" 1-6="" years.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" lambda-cyhalothrin="" residues.="" 6.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" level)="" plus="" short-term="" and="" intermediate="" term="" residential="" exposure.="" the="" aggregate="" moe="" was="" estimated="" to="" be="" 6,300="" for="" children="" 1-6="" years="" old,="" and="" 6,800="" for="" infants="">< 1="" year="" old.="" epa="" concludes="" that="" the="" aggregate="" short-="" and="" intermediate-term="" risks="" do="" not="" exceed="" levels="" of="" concern,="" and="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" lambda-cyhalothrin="" residues.="" g.="" endocrine="" disruption="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" on="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect***.''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" screening="" and="" testing="" programs="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" enduse="" products="" for="" endocrine="" disrupter="" effects.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" lambda-cyhalothrin="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" tolerances.="" epa="" has="" determined="" that="" plant="" and="" animal="" metabolites="" do="" not="" need="" to="" appear="" in="" the="" tolerance="" expression="" at="" this="" time.="" the="" residues="" to="" be="" regulated="" are="" lambda-cyhalothrin="" and="" its="" epimer="" as="" specified="" in="" 40="" cfr="" 180.438.="" b.="" analytical="" methodology="" there="" is="" a="" practical="" analytical="" method="" available="" for="" determination="" of="" residues="" of="" lambda-cyhalothrin="" and="" its="" epimer.="" adequate="" enforcement="" methodology="" (gas="" chromatography/electron="" capture="" detector)="" for="" plant="" and="" animal="" commodities="" is="" available="" to="" enforce="" the="" tolerances.="" epa="" will="" provide="" information="" on="" this="" method="" to="" fda.="" in="" the="" interim,="" the="" analytical="" method="" is="" available="" to="" anyone="" who="" is="" interested="" in="" pesticide="" residue="" enforcement="" from:="" by="" mail,="" calvin="" furlow,="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m.="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" crystal="" mall="" #2,="" rm.="" 119ff,="" jefferson="" davis="" hwy.,="" arlington,="" va="" 22202,="" 703-305-5805.="" c.="" magnitude="" of="" residues="" field="" residue="" data="" reflecting="" the="" application="" of="" lambda-cyhalothrin="" to="" alfalfa,="" leaf="" lettuce,="" and="" brassica="" subgroup="" crops="" are="" acceptable="" in="" quantity,="" quality="" and="" location="" to="" support="" the="" proposed="" tolerances.="" based="" on="" the="" transfer="" of="" residues="" from="" a="" worst-case="" diet="" consisting="" of="" various="" animal="" feed="" items="" containing="" residues="" of="" lambda-cyhalothrin="" and="" its="" epimer,="" the="" existing="" tolerances="" for="" meat,="" milk,="" poultry="" and="" eggs="" are="" acceptable,="" with="" the="" exception="" of="" poultry="" fat.="" an="" increase="" in="" the="" poultry="" [[page="" 7298]]="" fat="" tolerance="" from="" 0.01="" ppm="" to="" 0.03="" ppm="" is="" needed.="" d.="" international="" residue="" limits="" no="" codex="" maximum="" residue="" levels="" (mrls)="" for="" residues="" of="" lambda-="" cyhalothrin="" have="" been="" established="" for="" alfalfa,="" leaf="" lettuce,="" or="" brassica="" subgroup="" crops.="" mexico="" has="" not="" established="" mrls="" for="" residues="" of="" lambda-cyhalothrin.="" canada="" has="" established="" tolerances="" for="" residues="" of="" lambda-cyhalothrin="" on="" broccoli="" and="" cabbage="" at="" 0.4="" ppm,="" which="" are="" the="" same="" levels="" as="" the="" u.s.="" tolerance.="" iv.="" conclusion="" therefore,="" as="" set="" forth="" in="" this="" document,="" tolerances="" are="" established="" for="" lambda-cyhalothrin="" and="" its="" epimer="" in="" or="" on="" alfalfa="" forage="" at="" 5.0="" ppm;="" alfalfa="" hay="" at="" 6.0="" ppm;="" leaf="" lettuce="" at="" 2.0="" ppm;="" brassica="" head="" and="" stem="" subgroup="" (broccoli,="" chinese="" broccoli,="" brussels="" sprouts,="" cabbage,="" chinese="" (napa)="" cabbage,="" chinese="" mustard,="" cauliflower,="" caval="" broccolo,="" and="" kohlrabi)="" at="" 0.4="" ppm;="" ``aspirated="" grain="" fractions''="" at="" 2.0="" ppm;="" and="" the="" tolerance="" for="" poultry="" fat="" is="" increased="" from="" 0.01="" ppm="" to="" 0.03="" ppm.="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" april="" 14,="" 1998,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" 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="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" confidential="" business="" information="" (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.="" vi.="" public="" docket="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300608]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 119="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances are established on the basis of
a petition under FFDCA section 408(d), 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. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950) and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
VIII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report
[[Page 7299]]
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
General Accounting Office prior to publication of this rule in today's
Federal Register. This 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: January 29, 1998.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I, part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.438, the table to paragraph (a)(1) is amended by
adding entries for alfafa forage; alfalfa hay; aspirated grain
fractions; brassica, head and stem subgroup; lettuce, leaf; by revising
the entries for poultry, fat; and by removing the entries for sorghum,
grain dust; and wheat, grain dust, and broccoli and cabbage, to read as
follows:
Sec. 180.438 Lambda-cyhalothrin; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage,.......................... 5.0
Alfalfa, hay.............................. 6.0
Aspirated grain fractions................. 2.0
Brassica, head and stem subgroup,......... 0.4
* * * * *
Lettuce, leaf............................. 2.0
* * * * *
Poultry Fat............................... 0.03
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-3751 Filed 2-12-98; 8:45 am]
BILLING CODE 6560-50-F
