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Lambda-cyhalothrin (Zeneca). October 8, 1997. Pesticide Tolerance Petition. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/October/Day-08/p26536.htm
[Federal Register: October 8, 1997 (Volume 62, Number 195)]
[Notices]
[Page 52558-52563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc97-62]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-769; FRL 5748-6]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-769, must
be received on or before November 7, 1997.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticides Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under ``SUPPLEMENTARY
INFORMATION'' of this document. No Confidential Business Information
(CBI) should be submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the comment 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. All written comments will be available for
public inspection in Rm. 1132 at the address given above, from 8:30
a.m. to 4 p.m.,
[[Page 52559]]
Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: The product manager listed in the
table below:
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Office location/
Product Manager telephone number Address
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Adam Heyward (PM 13).......... Rm. 227, CM #2, 703- 1921 Jefferson
305-5418, e-mail: Davis Hwy,
heyward.adam@epamail. Arlington, VA
epa.gov.
Beth Edwards (PM 13).......... Rm. 206, CM #2, 703- Do.
305-5400, e-mail:
edwards.beth@epamail.
epa.gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various food
commodities under section 408 of the Federal Food, Drug, and Comestic
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions
contain data or information regarding the elements set forth in section
408(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-769] (including comments and data submitted
electronically as described below). 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 official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can 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. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number PF-769 and appropriate petition number.
Electronic comments on notice may be filed online at many Federal
Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: September 25, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summary announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
2. Zeneca Ag Products
PP 7F4875
EPA has received a pesticide petition (PP 7F4875) from Zeneca Ag
Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE 19850-5458.
The petition proposes pursuant to section 408(d) of the Federal Food,
Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish tolerances for residues of the insecticide lambda-cyhalothrin
and its epimer in or on the raw agricultural commodities avocados
(imported) at 0.2 parts per million (ppm); cereal grain crop group
(except rice and wild rice): grain, 0.2 ppm, forage (except sorghum)
6.0 ppm, hay 2.0 ppm, straw 2.0 ppm, aspirated grain dust 2.0 ppm, bran
0.8 ppm and flour 0.6 ppm; fruiting vegetable crop group (except
cucurbits) 0.2 ppm; peas and beans - edible podded crop subgroup 0.2
ppm; peas and beans - succulent shelled crop subgroup 0.01 ppm; peas
and beans - dried shelled subgroup (except soybean) 0.1 ppm; peanut hay
3.0 ppm; sorghum forage 0.3 ppm; sorghum fodder 0.5 ppm; and sugarcane
0.05 ppm. The names for lambda-cyhalothrin and its epimer are as
follows: lambda-cyhalothrin, a 1:1 mixture of (S)-alpha-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro- 3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-alpha-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3- trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate. Epimer of lambda-cyhalothrin, a 1:1
mixture of (S)-alpha-cyano-3-phenoxybenzyl- (Z)(1S,3S)-3-(2-chloro-
3,3,3-trifluoroprop-1-enyl)-2,2- dimethylcyclopropanecarboxylate and
(R)-alpha-cyano-3-phenoxybenzyl- (Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2- dimethylcyclopropanecarboxylate. EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition. Additional data
may be needed before EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of lambda-cyhalothrin has been
studied in cotton, soybean, cabbage, and wheat plants. The studies show
that the metabolism generally follows that of other pyrethroid
insecticides. The ester linkage is cleaved to form
cyclopropanecarboxylic acids and the corresponding phenoxybenzyl
alcohol. Overall the studies show that unchanged lambda-cyhalothrin is
the principal constituent of the residue on edible portions of these
crops.
2. Analytical method. An adequate analytical method (gas liquid
chromatography with an electron capture detector) is available for
enforcement purposes.
3. Magnitude of residues. Avocados - six trials were conducted at 3
sites within Mexico. In these trials the maximum observed residue was
0.11 ppm. Peppers (nonbell) - three trials were conducted with a
maximum observed residue of 0.13 ppm. Peppers (bell) - eight trials
were conducted with a maximum observed residue of 0.16 ppm. Edible
podded peas - three trials were conducted with a maximum observed
residue of 0.14 ppm. Edible podded beans - six trials were conducted
with a maximum observed residue of 0.035 ppm. Succulent shelled peas -
six trials were conducted with a maximum observed residue of 0.01 ppm.
Succulent shelled beans - six trials were conducted with a maximum
observed residue of 0.01 ppm. Dried shelled peas - five trials were
conducted with a maximum observed residue of 0.06 ppm. Dried shelled
peas - eight trials were conducted with a maximum observed residue of
0.015 ppm. Peanut hay - eleven trials were conducted with a maximum
observed residue of 2.61 ppm. Sorghum forage and fodder - thirteen
trials were conducted with a maximum observed residue of 0.3 and 0.42
ppm, respectively, in forage and fodder. Sugarcane - nine trials were
conducted with a maximum observed residue of 0.035 ppm. A sugarcane
processing study was conducted to determine if residues concentrated in
molasses or refined sugar. No concentration of residues was observed in
either processed commodity.
B. Toxicological Profile
The following toxicity studies have been conducted to support the
request for a regulation for residues of lambda-cyhalothrin in or on
rice.
1. Acute toxicity. Acute toxicity studies with the technical grade
of the active ingredient lambda-cyhalothrin: oral LD50 in
the rat of 79 milligram/
[[Page 52562]]
kilogram (mg/kg) (males) and 56 mg/kg (females), dermal
LD50 in the rat of 632 mg/kg (males) and 696 mg/kg females,
primary eye irritation study showed mild irritation, and primary dermal
irritation study showed no irritation.
2. Genotoxicity. 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. A three-generation
reproduction study in rats fed diets containing 0, 10, 30, and 100 ppm
with no developmental toxicity observed at 100 ppm, the highest dose
tested. The maternal no-observed-effect-level (NOEL) and lowest-
observed-effect-level (LOEL) for the study are established at 30 (1.5
mg/kg/day) and 100 ppm (5 mg/kg/day), respectively, based upon
decreased parental body weight gain. The reproductive NOEL and LOEL are
established at 30 (1.5 mg/kg/day) and 100 ppm (5 mg/kg/day),
respectively, based on decreased pup weight gain during weaning.
ii. A developmental toxicity study in rats given gavage doses of 0,
5, 10, and 15 mg/kg/day with no developmental toxicity observed under
the conditions of the study. The developmental NOEL is greater than 15
mg/kg/day, the highest dose tested. The maternal NOEL and LOEL are
established at 10 and 15 mg/kg/day, respectively, based on reduced body
weight gain.
iii. A developmental toxicity study in rabbits given gavage doses
of 0, 3, 10, and 30 mg/kg/day with no developmental toxicity observed
under the conditions of the study. The maternal NOEL and LOEL are
established at 10 and 30 mg/kg/day, respectively, based on decreased
body weight gain. The developmental NOEL is greater than 30 mg/kg/day,
the highest dose tested.
4. Subchronic toxicity--i. A 90-day feeding study in rats fed doses
of 0, 10, 50, and 250 ppm with a NOEL of 50 ppm and a LOEL of 250 ppm
based on body weight gain reduction.
ii. A 21-day study in rabbits exposed dermally to doses of 0, 10,
100, and 1,000 mg/kg/day, 6 hours/day, 5 days/week with a systemic NOEL
> 1,000 mg/kg/kg. There were no clinical signs of systemic toxicity at
any dose level tested.
5. Chronic toxicity--i. A 12-month feeding study in dogs fed dose
(by capsule) levels of 0, 0.1, 0.5, and 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.
ii. A 24-month chronic feeding/carcinogenicity study with rats fed
diets containing 0, 10, 50, and 250 ppm. The NOEL was established at 50
ppm and LOEL at 250 ppm based on reduced body weight gain. There were
no carcinogenic effects observed under the conditions of the study.
iii. A carcinogenicity study in mice fed dose levels of 0, 20, 100,
or 500 ppm (0, 3, 15, or 75 mg/kg/day) 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 Agency has classified lambda-cyhalothrin as a Group D
carcinogen (not classifiable due to an equivocal finding in this
study). Zeneca concludes that no treatment-related carcinogenic effects
were observed under the conditions of the study.
6. Animal metabolism. Metabolism studies in rats demonstrated that
distribution patterns and excretion rates in multiple oral dose studies
are similar to single-dose studies. There is an 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. Unchanged lambda-cyhalothrin is
the major residue component of toxicological concern in meat and milk.
7. Metabolite toxicology. The Agency has previously determined that
the metabolites of lambda-cyhalothrin are not of toxicological concern
and need not be included in the tolerance expression. Given this
determination, Zeneca concludes that there is no need to discuss
metabolite toxicity.
8. Endocrine effects. No evidence of such effects were reported in
the toxicology studies described above. There is no evidence at this
time that lambda-cyhalothrin causes endocrine effects.
C. Aggregate Exposure
1. Dietary exposure--i. Food. For the purposes of assessing the
potential dietary exposure for all existing and pending tolerances for
lambda-cyhalothrin, Zeneca has utilized available information on
anticipated residues and percent crop treated. For all existing and
pending tolerances the anticipated residue contribution (ARC) is
estimated at 0.000212 mg/kg/body weight (bwt)/day.
ii. Drinking water. Laboratory and field data have demonstrated
that lambda-cyhalothrin and its degradates are 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, Zeneca concludes that residues reaching surface waters
from field runoff will quickly adsorb to sediment particles and be
partitioned from the water column. Zeneca concludes that together these
data indicate that residues are not expected in drinking water.
2. Non-dietary exposure. Other potential sources of exposure are
from non-occupational sources such as structural pest control and
ornamental plant and lawn use of lambda-cyhalothrin. Zeneca has no data
upon which to estimate exposure from these uses. However, given the
extremely low vapor pressure of lambda-cyhalothrin (1.5 x
10-9 millimeters (mm) of mercury (Hg)) and the low use
rates, Zeneca concludes that inhalation and dermal exposure from these
uses will be insignificant.
D. Cumulative Effects
At this time, Zeneca cannot make a determination based on available
and reliable information that lambda-cyhalothrin and other substances
that may have a common mechanism of toxicity would have cumulative
effects. Thus, Zeneca concludes that for purposes of this tolerance it
is appropriate only to consider the potential risks of lambda-
cyhalothrin in an aggregate exposure assessment.
E. Safety Determination
The acceptable Reference Dose (RfD) based on a NOEL of 0.1 mg/kg/
bwt/day from the chronic dog study and a safety factor of 100 is 0.001
mg/kg/bwt/day. A chronic dietary exposure/risk assessment has been
performed for lambda-cyhalothrin using the above RfD. Available
information on anticipated residues and percent crop treated was
incorporated into the analysis to estimate the ARC. The ARC is
generally considered a more realistic estimate than an estimate based
on tolerance level residues.
1. U.S. population. The ARC from established tolerances and the
current and pending actions are estimated to be 0.000212 mg/kg/bwt/day
and utilize 24.9% of the RfD for the U.S. population.
2. Infants and children. The ARC for children, aged 1 to 6 years
old, and non-nursing infants (subgroups most highly exposed) utilizes
77% and 48% of the RfD, respectively. Generally speaking, the Agency
has no cause for concern if ARC for all published and proposed
tolerances is less than the RfD.
[[Page 52563]]
F. International Tolerances
There are no Codex maximum residue levels (MRL) established for
residues of lambda-cyhalothrin in or on avocados; cereal grain crop
group: grain, forage, hay, straw, aspirated grain dust, bran, flour;
fruiting vegetable crop group; peas and beans - edible podded crop
subgroup; peas and beans - succulent shelled crop subgroup; peas and or
beans - dried shelled subgroup. (Beth Edwards)
[FR Doc. 97-26536 Filed 10-7-97; 8:45 am]
BILLING CODE 6560-50-F