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Lambda-Cyhalothrin (Zeneca). November 26, 1997. Pesticide Tolerances. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30959.htm
[Federal Register: November 26, 1997 (Volume 62, Number 228)]
[Rules and Regulations]
[Page 63002-63010]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no97-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300581; FRL-5755-5]
RIN 2070-AB78
Lambda-Cyhalothrin; Pesticide Tolerance
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
broccoli, cabbage, corn (grain, fodder and forage), corn (sweet),
cottonseed, dry bulb onion, garlic, lettuce, head, peanuts, rice,
soybeans, sorghum, sunflower, tomatoes, wheat, sunflower, and livestock
commodities. It also removes time limitations for tolerances for
residues of lambda-cyhalothrin on the same commodities that expire on
November 15, 1997. The Zeneca Ag Products requested these tolerances
under the Federal Food, Drug and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective November 26, 1997. Objections and
requests for hearings must be received by EPA on or before January 28,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300581], 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-300581], must also be submitted to: 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. In person,
bring a copy of objections and hearing requests to Rm. 1132, 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 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
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300581]. 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: Adam Heyward, 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) 308-6100, e-mail:
heyward.adam@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On May 24, 1988, EPA established a time
limited tolerance under section 408 of the FFDCA, 21 U.S.C. 346 a(d)
and 348 for residues of lambda-cyhalothrin and its epimer on cottonseed
(53 FR 18558). As additional crops tolerances were established, they
were also made time-limited. These tolerance expire on November 15,
1997. Zeneca Ag Products, on September 15, 1997, requested that the
time limitation for tolerances for residues of the insecticide lambda-
cyhalothrin and its epimer in or on the commodities mentioned above be
removed based on environmental effects data that they had submitted as
a condition of registration. Zeneca Ag Products also submitted a
summary of its petition as required under the FFDCA as amended by the
Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-170).
In the Federal Register of Friday, September 25, 1997 (62 FR 50337)
(FRL-5748-2), 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 petitions (PP 6F3318, 7F3560,
7H5543, 7F3488, 1F3952, 1H5607, 1F3992, 2F4109, 2F4100, 2F4114, 1F3985,
9F3770 and 6F4769) for tolerances 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, the
registrant. There were no comments received in response to the notice
of filing.
The petitions requested that 40 CFR 180.438 be amended by removing
time limitatioins for tolerances for the combined residue of the
insecticide, lambda-cyhalothrin and its epimer in or on the following
crops and commodities: broccoli at 0.4 parts per millions (ppm);
cabbage at 0.4 ppm; cattle, fat at 3.0 ppm; cattle, meat at 0.2 ppm;
cattle, meat and meat by-products (mbyp) at 0.2 ppm; corn, grain (field
and pop) at 0.05 ppm; corn, fodder at 1.0 ppm; corn, forage at 6.0 ppm;
corn, sweet (k+kwhr) at 0.05 ppm; cottonseed at 0.05 ppm; dry bulb
onion at 0.1 ppm; eggs at 0.01 ppm; garlic at 0.1 ppm; goats, fat at
3.0 ppm; goats, meat at 0.2 ppm; goats, mbyp at 0.2 ppm, hogs, fat at
3.0 ppm; hogs, meat at 0.2 ppm; hogs, mbyp at 0.2 ppm; horses, fat at
3.0 ppm; horses, meat at 0.2 ppm; horses, mbyp at 0.2 ppm; lettuce,
head at 2.0 ppm; milk, fat (reflecting 0.2 ppm in whole milk) at 5.0
ppm; peanuts at 0.05 ppm; peanuts, hulls at 0.05 ppm; poultry, fat at
0.01 ppm; poultry, meat at 0.01 ppm; poultry, mbyp at 0.01 ppm; rice,
grain at 1.0 ppm; rice, hulls at 5.0 ppm; rice, straw at 1.8 ppm;
sheep, fat at 3.0 ppm; sheep, meat at 0.2 ppm; sheep, mbyp at 0.2 ppm;
soybeans at 0.01 ppm; sorghum, grain at 0.02 ppm; sorghum, grain dust
at 1.5 ppm; sunflower, seeds at 0.2 ppm; sunflower, forage at 0.2 ppm;
tomatoes at 0.1 ppm; wheat, grain at 0.05 ppm; wheat, forage at 2.0
ppm; wheat, hay at 2.0 ppm; wheat, straw at 2.0 ppm; wheat, grain dust
at 2.0 ppm; corn, grain flour at 0.15 ppm; sunflower, oil at 0.30 ppm;
sunflower, hulls at 0.50 ppm; tomato pomace (dry or wet) at 6.0 ppm;
and wheat, bran at 0.2 ppm.
In the Notice of Filing the established tolerance level for sorghum
grain was inadvertently listed as 0.02 ppm. The correct tolerance level
for this commodity if 0.2 ppm. The correct tolerance was considered by
EPA for risk assessment purposes. In the latest CFR, 40 CFR 180.438
(revised as of July 1, 1997), the tolerance for garlic was incorrectly
listed as 0.02 ppm. The correct level if 0.1 ppm. This error occurred
when the CFR was updated. The 0.1 ppm level was considered by EPA for
risk assessment.
The basis for time limited tolerances that expire November 15, 1997
was given in the October 20, 1993 Federal Register (58 FR 54094). These
time-limited tolerances were predicated on the expiration of pesticide
product registrations that were made conditional
[[Page 63003]]
due to lack of certain environmental effects data. The rational for
using time-limited tolerances was to encourage pesticide manufacturers
to comply with the conditions of registration in a timely manner. There
is no regulatory requirement to make tolerances time-limited due to the
conditional status of a product registration under the Federal
Insecticide, Fungicide, Rodenticide Act (FIFRA) as amended. It is
current EPA policy to no longer establish time limitations on
tolerance(s) if none of the conditions of registration had any bearing
on human dietary risk. The current petition action meets that condition
and thus the expiration dates associated with specific crop tolerances
are being deleted.
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.
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
[[Page 63004]]
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) in or on the crops and
commodities listed above under SUPPLEMENTARY INFORMATION. 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 steno isomers while lambda-
cyhalothrin is a mixture of the two iomers. 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 evidence, based on
subchronic studies in rats, that the two mixtures are not biologically
different with respect to their mammalian toxicity.
1. Acute toxicity studies with the technical grade of the active
ingredient lambda-cyahothrin: oral LD<INF>50</INF> in the rat of 79
milligrams/kilogram (mg/kg) (males) and 56 mg/kg (females)(Tox Category
II), dermal LD<INF>50</INF> in the rat of 632 mg/kg (males) and 696 mg/
kg females (Tox Category II), primary eye irritation study showed mild
irritation (Tox Category II) and primary dermal irritation study showed
no irritation (Tox Category IV).
2. 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. 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 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 LOELs are 5.0
mg/kg/day. The developmental NOEL is 5.0 mg/kg/day (highest dose
tested).
4. In a 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 body
weight gain (48% of controls) during the dosing period. The
developmental NOEL was 30 mg/kg/day highest dose tested (HDT). No
developmental effects were observed.
5. In a 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.
6. In a 90-day feeding study in rats, lambda-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 once daily for clinical signs of toxicity.
Bodyweights, 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 LEL is 12.5 mg/kg/day based on reduction in bodyweight gain
and food consumption in both sexes and food efficiency in females.
7. 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. Bodyweights, 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
[[Page 63005]]
levels. The NOEL is 2.5 mg/kg/day and the LEL is 12.5 mg/kg/day based
on decreased bodyweight gain.
8. A In 28-day study in the mouse cyhalothrin was fed to mice in
the diet as a range-finding study for the carcinogenicity study 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.
9. 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 for 21 consecutive days.
No significant signs of skin irritation was observed at any dose level.
Two male rats were found dead after 3 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. 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, clinical signs of
toxicity and decreased bodyweight gain and food consumption.
10. In a 21-day inhalation study rats were exposed nose-only 6
hours/day, 5 days/week for 21 days to lambda-cyhalothrin at 0.3, 3.3,
or 16.7 <greek-m>g/L. The NOEL was 0.3 <greek-m>g/L and the LOEL was
3.3 <greek-m>g/L based on decreased bodyweight 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.
11. 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.
12. 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.
13. 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.
14. 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. Otherwise, lambda-
cyhalothrin was rapidly metabolized and excreted. The metabolism of
lambda-cyhalothrin in livestock has been studied in the goat, chicken,
and cow.
15. No neurotoxicity studies are available. These 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
are not expected to 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 adnormalities in dogs on
day 2 in the chronic toxicity study.
2. Short - and intermediate - term toxicity. For short-and
intermediate-term dermal risk assessment, EPA recommends use of a NOEL
of 10.0 mg/kg/day from the 21-day dermal toxicity study based on
systemic toxicity at 50 mg/kg/day (LOEL). A dermal absorption rate of
25% was used based on weight of the evidence available for all
structurally related pyrethroids. EPA used a NOEL of 0.3 <greek-m>g/L
from the 21-day inhalation study in rats based on clinical signs
indicative of neurotoxicity (paw slicking) tail erections, and tiptoe
gait) at 3.3 <greek-m>g/L.
3. Chronic toxicity. EPA has established the reference dose (RfD)
for lambda-cyhalothrin at 0.001 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 Health Effects Division (HED) RfD/PEER review
committee based the ``D'' classification on: (1) Lambda-cyhalothrin was
not tested at adequate dose levels for carcinogenicity testing in the
mouse, and (2) 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 and 40 CFR 186.3765 for combined residues
of lambda-cyhalothrin and its epimer in or on a variety of food
commodities. Risk assessments were conducted by EPA to assess dietary
exposures and risks from lambda-cyhalothrin as follows:
i. Acute exposure and risk. An 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 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 (non-nursing 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
[[Page 63006]]
0.001 mg/kg/day from the lambda-cyhalothrin chronic dog study and an
uncertainty factor of 100. 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 (6.8% of the RfD utilized) and for
children 1-6 years was calculated to be 0.000192 mg/kg/day (19.2% of
the RfD utilized).
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 antipicated residue levels of pesticide
chemicals that have been measure 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, demonstration
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 timeframe 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: (1) 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; (2) that the exposure estimate does not
underestimate the exposure for any significant subpopulation and; (3)
where data on regional pesticide use 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 end 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 evaluating 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 Date 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 the 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 U.S. population and non-nursing
infants < 1 year old, respectively.
ii. Chronic exposure and risk. The chronic drinking water exposure
and risk estimates are 0.000000 mg/kg/day (0.0% of RfD utilized) and
0.000000 mg/kg/day (0.0% of RfD. Utilized) for the overall U.S.
population and non-nursing infants < 1 year old, respectively.
3. From non-dietary exposure. Lambda-cyhalothrin is currently
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 non-dietary 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 <greek-m>g/L (0.05 mg/kg/day) from the 21-day inhalation
toxicity study in rats. The LOEL of 3.3 <greek-m>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). MOE =
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 product 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 margin 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,
[[Page 63007]]
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.th percentile for the U.S. population is 307. 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
large. 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 chronic 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 aggegrate MOE
(inhalation + incidental oral + chronic dietary summed across all
product use category 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 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
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 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
<gr-thn-eq> 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
[[Page 63008]]
parental body weight (systemic) or a significant decrease in pup body.
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.
The toxicological database relative to pre- and post- natal
sensitivity is complete. 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. 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 through
food and drinking water.
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% of the RfD for children 1-6
years old. 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 in 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 a screening and testing program 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 end use 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 purpose of this tolerance. 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 Enforcement 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. 1128, 1921
Jefferson Davis Hwy., Arlington, VA 22202, 703-305-5805.
C. Magnitude of Residues
A report entitled ``Reanalysis of Chronic and Acute Exposure and
Risk for Lambda-Cyhalothrin Residues'' contains revisions to the
originally submitted report: ``Chronic and Acute Dietary Exposure
Analyses and Risk Assessment for Lambda-Cyhalothrin Residues in Food.''
The report dated October 10, 1997 contains a list of all residue values
used in the chronic and acute dietary exposure analyses (including
drinking water). The residue values have been verified by EPA and are
appropriate.
D. International Residue Limits
No Codex MRLs for residues of lambda-cyhalothrin have been
established. Canadian MRLs have been established for residues of
lambda-cyhalothrin. Mexico has established tolerances for residues of
lambda-cyhalothrin on cottonseed (0.05 ppm) which is in harmony with
the U.S. tolerance. Mexico has established tolerances which are below
their U.S. counterparts for corn grain (0.01 vs. 0.05 ppm) and sorghum
grain (0.1 vs. 0.2 ppm).
As indicated above there are differences between the section 408
tolerances and the Codex MRL values for specific commodities. These
differences could be caused by differences in methods used to establish
tolerances, calculate animal feed dietary exposure, and as a result of
different agricultural practices. EPA will specifically address these
differences when the pesticides are reregistered and the tolerances
made permanent.
IV. Conclusion
Therefore, tolerances are established for lambda-cyhalothrin and
its epimer in or on broccoli at 0.4 ppm; cabbage at 0.4 ppm; cattle,
fat at 3.0 ppm; cattle, meat at 0.2 ppm; cattle, meat and meat by-
products (mbyp) at 0.2 ppm; corn, grain (field and pop) at 0.05 ppm;
corn, fodder at 1.0 ppm; corn, forage at 6.0 ppm; corn, sweet (k+kwhr)
at 0.05 ppm; cottonseed at 0.05 ppm; dry bulb onion at 0.1 ppm; eggs at
0.01 ppm; garlic at 0.1 ppm; goats, fat at 3.0 ppm; goats, meat at 0.2
ppm; goats, mbyp at 0.2 ppm, hogs, fat at 3.0 ppm; hogs, meat at 0.2
ppm; hogs, mbyp at 0.2 ppm; horses, fat at 3.0 ppm; horses, meat at 0.2
ppm; horses, mbyp at 0.2 ppm; lettuce, head at 2.0 ppm; milk, fat
(reflecting 0.2 ppm in whole milk) at 5.0 ppm; peanuts at 0.05 ppm;
peanuts, hulls at 0.05 ppm; poultry, fat at 0.01 ppm; poultry, meat at
0.01 ppm; poultry, mbyp at 0.01 ppm; rice, grain at 1.0 ppm; rice,
hulls at 5.0 ppm; rice, straw at 1.8 ppm; sheep, fat at 3.0 ppm; sheep,
meat at 0.2 ppm; sheep, mbyp at 0.2 ppm; soybeans at 0.01 ppm; sorghum,
grain at 0.02 ppm; sorghum, grain dust at 1.5 ppm; sunflower, seeds at
0.2 ppm; sunflower, forage at 0.2 ppm; tomatoes at 0.1 ppm; wheat,
grain at 0.05 ppm; wheat, forage at 2.0 ppm; wheat, hay at 2.0 ppm;
wheat, straw at 2.0 ppm; wheat, grain dust at 2.0 ppm; corn, grain
flour at 0.15 ppm; sunflower, oil at 0.30 ppm; sunflower, hulls at 0.50
ppm; tomato pomace (dry or wet) at 6.0 ppm; and wheat, bran at 0.2 ppm.
[[Page 63009]]
In addition to the tolerance being amended, since for purposes of
establishing tolerances FQPA has eliminated all distinctions between
raw and processed food, EPA is combining the tolerances that now appear
in Secs. 185.3765 and 186.3765 with the tolerances in Sec. 180.438 and
is removing Secs. 185.3765 and 186.3765.
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 January 26, 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 Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300581] (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 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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 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
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 63010]]
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Feed additives, Pesticides and pests.
Dated: November 14, 1997.
James Jones,
Acting Director, Registration Division Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.438 is amended by revising paragraph (a) to read as
follows:
Sec. 180.438 Lambda-cyhalothrin; tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of the pyrethroid lambda-cyhalothrin, 1:1 mixture of (S)-
<greek-a>-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2- dimethylcyclopropanecarboxylate and (R)-
<greek-a>-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2- dimethylcyclopropanecarboxylate and its
epimer expressed as epimer of lambda-cyhalothrin, a 1:1 mixture of (S)-
<greek-a>-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2- dimethylcyclopropanecarboxylate and (R)-
<greek-a>-cyano-3- phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2- dimethylcyclopropanecarboxylate, on plants
and livestocks, as indicated in the following table.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Broccoli.................................. 0.4
Cabbage................................... 0.4
Cattle, fat............................... 3.0
Cattle, meat.............................. 0.2
Cattle, mbyp.............................. 0.2
Corn, grain (field and pop)............... 0.05
Corn, fodder.............................. 1.0
Corn, forage.............................. 6.0
Corn, grain flour......................... 0.15
Corn, sweet (K+kwhr)...................... 0.05
Cottonseed................................ 0.05
Dry bulb onion............................ 0.1
Eggs...................................... 0.01
Garlic.................................... 0.1
Goats, fat................................ 3.0
Goats, meat............................... 0.2
Goats, mbyp............................... 0.2
Hogs, fat................................. 3.0
Hogs, meat................................ 0.2
Hogs, mbyp................................ 0.2
Horses, fat............................... 3.0
Horses, meat.............................. 0.2
Horses, mbyp.............................. 0.2
Lettuce, head............................. 2.0
Milk, fat (reflecting 0.2 ppm in whole 5.0
milk).
Peanuts................................... 0.05
Peanuts, hulls............................ 0.05
Poultry, fat.............................. 0.01
Poultry, meat............................. 0.01
Poultry, mbyp............................. 0.01
Rice, grain............................... 1.0
Rice, hulls............................... 5.0
Rice, straw............................... 1.8
Sheep, fat................................ 3.0
Sheep, meat............................... 0.2
Sheep, mbyp............................... 0.2
Soybeans.................................. 0.01
Sorghum, grain............................ 0.2
Sorghum, grain dust....................... 1.5
Sunflower, forage......................... 0.2
Sunflower, hulls.......................... 0.50
Sunflower, oil............................ 0.30
Sunflowers, seeds......................... 0.2
Tomatoes.................................. 0.1
Tomato pomace (dry or wet)................ 6.0
Wheat, grain.............................. 0.05
Wheat, forage............................. 2.0
Wheat, hay................................ 2.0
Wheat, straw.............................. 2.0
Wheat, grain dust......................... 2.0
Wheat, bran............................... 0.2
------------------------------------------------------------------------
(2) A food additive tolerance of 0.01 part per million is
established for residues of the insecticide
[1<greek-a>(S*),3<greek-a>(Z)]-(<plus-minus>)-cyano(3-
phenoxyphenyl)methyl 3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate (lambdacyhalothrin) as follows:
(i) In or on all food items (other than those already covered by a
higher tolerance as a result of use on growing crops) in food-handling
establishments where food products are held, processed, or prepared.
(ii) Application shall be limited solely to spot and/or crack and
crevice treatment with a spray solution maximum of a 0.06-percent
active ingredient by weight. Food must be removed or covered during
treatment. Spray should not be applied directly to surfaces or utensils
that may come into contact with food. Food-contact surfaces and
equipment should be thoroughly cleaned with an effective cleaning
compound and rinsed with potable water before using.
(iii) For spot treatment, a coarse low-pressure spray shall be
used. Limit individual spot treatments to an area no larger than 20
percent of the surface area. Any individual spot treatment shall not
exceed 2 square feet.
(iv) For crack and crevice treatment, equipment capable of
delivering a pin-stream of spray directly into the cracks and crevices
shall be used.
(v) To assure safe use of the additive, its label and labeling
shall conform to that registered with the U.S. Environmental Protection
Agency, and it shall be used in accordance with such label and
labeling.
(3) A food additive tolerance is established for residues of the
insecticide [1<greek-a> (S*),3<greek-a>(Z)]-(<plus-minus>)-cyano-(3-
phenoxylphenyl)methyl 3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Hops, dried................................................ 10.0
------------------------------------------------------------------------
* * * * *
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 348.
Sec. 185.3765 [Removed]
b. Section 185.3765 is removed.
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
Sec. 186.3765 [Removed]
b. Section 186.3765 is removed.
[FR Doc. 97-30959 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F