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Lambda-cyhalothrin (Zeneca). July 11, 1997. Pesticide Petition Filing. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/July/Day-11/p18256.htm
[Federal Register: July 11, 1997 (Volume 62, Number 133)]
[Notices]
[Page 37234-37246]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy97-94]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-748; FRL-5728-7]
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-748, must
be received on or before August 11, 1997.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7506C), Information Resources and Services
Division, 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 by following
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential
business information 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
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI 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., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: The product manager listed in the
table below:
[[Page 37235]]
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Office location/
Product Manager telephone number Address
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Joanne Miller (PM 23)......... Rm. 237, CM #2, 703- 1921 Jefferson
305-6224, e- Davis Hwy,
mail:miller.joanne@ep Arlington, VA
amail.epa.gov.
George LaRocca (PM 13)........ Rm. 204, CM #2, 703- Do.
305-6100, e-mail:
larocca.george@epamai
l.epa.gov.
James Tompkins (PM 25)........ Rm. 229, CM #2, 703- Do.
305-7830, e-mail:
tompkins.james@epamai
l.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-748] (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-748] and appropriate petition
number. Electronic comments on this 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: July 1, 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.
[NOTE FROM FAN: We deleted the first three petitions.]
4. Zeneca AG
PP 5F4588
EPA has received a pesticide petition (PP 5F4588) from Zeneca Ag
Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, Delaware
19850-5458, proposing 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 by
establishing a tolerance for combined residues of the insecticide
lambda-cyhalothrin and its epimer in or on the raw agricultural
commodities (RACs) alfalfa forage at 5.0 parts per million (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 time-limited tolerance for poultry fat to 0.03
ppm. The proposed analytical method is gas liquid chromatography with
an electron capture detector.
Pursuant to section 408 (d) (2) (A) (i) of the FFDCA, as amended,
Zeneca Ag Products has submitted the following summary of information,
data and arguments in support of their pesticide petition. This summary
was prepared by Zeneca and EPA has not fully evaluated the merits of
the petition. EPA edited the summary to clarify that the conclusions
and arguments were the petitioner's and not necessarily EPA's.
A. Residue Chemistry
1. Plant Metabolism. The metabolism of lambda-cyhalothrin in plants
is adequately understood for this use. Any secondary residues occurring
in meat and meat by-products will be covered by the existing tolerances
with the exception of the fat of poultry, which is discussed under
Magnitude of Residues.
2. Analytical method. An adequate analytical method (gas liquid
chromatography with an electron capture detector) is available for
enforcement purposes.
3. Magnitude of residues--i. Alfalfa. Sixteen field trials were
carried out on alfalfa forage and hay in twelve states during 1990 in
the USA. The trials were conducted in the states of Arizona,
California, Iowa, Idaho, Kansas, Michigan, Minnesota, Montana,
Nebraska, New York, South Dakota, and Wisconsin. The number and
geographical distribution of the trials agrees with the recommendation
given in the ``EPA Residue Chemistry Guidance'' (1994).
In these trials, the maximum combined residues of lambda-
cyhalothrin and epimer in or on alfalfa
[[Page 37245]]
forage is 5.0 ppm and alfalfa hay is 6.0 ppm.
ii. Leaf lettuce. Eight field trials were carried out on leaf
lettuce in eight states during 1990 in the USA. The trials were
conducted in Arizona, California, Colorado, Florida, Michigan, New
York, Texas, and Washington. The number and geographical distribution
of the trials agrees with the recommendation given in the ``EPA Residue
Chemistry Guidance'' (1994).
In these trials, the maximum combined residues of lambda-
cyhalothrin and epimer in or on leaf lettuce is 1.8 ppm.
iii. Head and stem Brassica crop subgroup. No additional residue
crop field data were conducted for the head and stem Brassica crop
subgroup. The tolerance request is based on existing data and the
existing time-limited tolerances for combined residues of lambda-
cyhalothrin and epimer in or the Brassica crops, cabbage, and broccoli
at 0.4 ppm.
iv. Aspirated grain fractions. The existing tolerance for wheat
grain dust at 2.0 ppm is being revised to read ``aspirated grain
fractions'' at the same tolerance level. This change reflects Agency
policy to establish grain dust tolerances in terms of aspirated grain
fractions which include a mixture of all aspirated grains for which the
pesticide has a tolerance and is established at the highest current
tolerance for any grain dust.
v. Poultry fat. Alfalfa forage, hay, meal and silage are animal
feed items for beef and dairy cattle. Alfalfa meal is a feed item for
poutry and swine. No feed items are involved with the proposed uses on
leaf lettuce and the head and stem Brassica crop subgroup. Based on
calculated realistic worst case secondary dietary burdens for animal
commodities, the maximum calculated residues expected for the fat of
poultry is 0.0225 ppm compared to the existing tolerance of 0.01 ppm.
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-cyahothrin: oral LD50 in the
rat of 79 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. A 3-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 NOEL (no-observed effect level) and LOEL (lowest
observed effect level) 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.
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.
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. 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.
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. A 12-month feeding study in dogs fed dose (by
capsule) levels of 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.
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.
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). It is
Zeneca's position 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. 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 is also adequately understood for
the proposed use on alfalfa.
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, it is concluded that there is no need to discuss
metabolite toxicity.
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 0.000310 mg/kg/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, residues reaching surface waters from field runoff will
quickly adsorb to sediment particles and be partitioned from the water
column. 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
[[Page 37246]]
uses. However, given the extremely low vapor pressure of lambda-
cyhalothrin (1.5 x 10-9 millimeters of Hg) and the low use
rates, it is anticipated 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. Therefore for purposes of these tolerances 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/
body weight/day from the chronic dog study and a safety factor of 100
is 0.001 mg/kg/body weight/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 Anticipated
Residue Contribution (ARC) for all existing and the proposed
tolerances. The ARC is generally considered a more realistic estimate
than an estimate based on tolerance level residues.
1. US population. The ARC from established tolerances and the
current and pending actions are estimated to be 0.000310 mg/kg/bwt/day
and utilize 31.04 per cent of the RfD for the U.S. population.
2. Infants and children. The ARC for children, aged 1 to 6 years
old, and nonnursing infants (subgroups most highly exposed) utilizes 60
and 67% of the RfD, respectively. Generally speaking, the Agency has no
cause for concern if anticipated residues contribution for all
published and proposed tolerances is less than the RfD.
F. International Tolerances
There are no Codex maximum residue levels [MRL] established for
residues of lambda-cyhalothrin in or on alfalfa hay, forage, leaf
lettuce, or Brassica crop subgroup. (George LaRocca)
[FR Doc. 97-18256 Filed 7-10-97; 8:45 am]
BILLING CODE 6560-50-F