[Federal Register Volume 62, Number 232 (Wednesday, December 3, 1997)]
[Notices]
[Pages 63940-63942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31549]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-774; FRL-5751-9]
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-774, must
be received on or before January 2, 1998.
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: docket@epamail.epa.gov. Follow 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: By mail: Treva Alston, Registration
Division (7505W), Office of Pesticide Programs, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number and e-mail
address: Rm. 4W55 4th floor, CS1, 2800 Crystal Drive, Arlington VA,
(703) 308-8373, e-mail: alston.traver@epamail.epa.gov.
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-774] (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-774] 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: November 20, 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.
[[Page 63941]]
1. GlobeTech Industries Corporation
PP 7E4810
EPA has received a pesticide petition (PP 7E4810) from GlobeTech
Industries Corporation, 57 Pratt Street, Suite 504, Hartford, CT 06103
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 to establish
an exemption from the requirement of a tolerance for Crezasin when used
as an inert ingredient in pesticide formulations applied to growing
crops.
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. Toxicological Profile
The toxicity of Crezasin has been studied in Russia and the
territories of the Former USSR for a period of 20 years on insects
(bees, silkworms,) birds (chickens, ducks, turkeys), rabbits, dogs,
sheep, swine and cattle and on an international level with companies
from Japan, Mongolia, France, USA, Bulgaria, Hungary, and Poland. The
results of experiments on the toxic effects of Crezasin on different
animals indicate that the preparation has low toxicity with weakly
defined cumulation and has a high index of safe application,
LD50= 3,600 +/- 320 milligrams/kilogram in laboratory female
mice and LC50= 6,570 +/- 150 milligrams/kilogram in
laboratory female rats. The 50% lethal concentration (LC50)
of Crezasin in water for Daphnia is 221.5 milligrams/liter.
B. Aggregate Exposure
The usage pattern for Crezasin includes an economical effect on a
limited number of agriculture cultures including potatoes, tomatoes,
grapes and cereal grains (wheat, barley and oats). Practical usage of
Crezasin is for the treatment of seeds and foliar spraying of plants.
Rates of seed treatment of agricultural crops is between 2 - 10 grams
per metric tons of seeds. Applications higher than 10 grams/ton can
result in a reduced economic benefit of usage. For spraying of growing
plants, the recommended dosage rates are between 0.32 x 10-4
moles/liter (100 mg/liter) and 0.06 x10-4 moles/liter (20
mg/liter) of Crezasin, with working solution rates up to 166 liters/
acre (400 liters/hectare). Application rates higher than
10-4 moles/liter have resulted in a reduced economic
benefit. The usage of Crezasin in ornamental plants, lawn care and
other decorative public landscaping has not resulted in an economical
or biological benefit, and thus its usage would not be found in these
applications.
Relating to the mobility and persistence in soils. Crezasin is
considered easily soluble in water at 100 grams/liter at pH 7, 25
degrees C. Crezasin is considered moderately stable in water, at pH 7,
25 degrees C, 50% hydrolysis of Crezasin in water is observed in 8.59
days, 95% hydrolysis is observed in 43.5 days. The constant of
hydrolysis in neutral water is: C125 = 0.05
day-1. The persistence of Crezasin in soils, pH 5 - 8,
organic matter content 1% - 4%, at 20 degrees C: 50% Crezasin
degradation is observed in 16 days and 90% degradation is observed in
23.5 days.
C. Safety Determination
Based on the very low level of substance toxicity, relatively short
period of environmental fate and its usage pattern which results in low
concentration usage, Crezasin exhibits very minimal risk exposure both
in dietary and non-occupational exposures to children.
D. International Tolerances
There are no Codex maximum residue levels established for residues
of Crezasin.
2. GlobeTech Industries Corporation
PP 7E4811
EPA has received a pesticide petition (PP 7E4811) from GlobeTech
Industries Corporation, 57 Pratt Street, Suite 504, Hartford, CT 06103.
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 to establish
an exemption from the requirement of a tolerance for Mival when used as
an inert ingredient in pesticide formulations applied to growing crops.
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. Toxicological Profile
The toxicity of Mival has been studied in Russia and the
territories of the Former USSR for a period of 20 years on insects
(bees, silkworms,) birds (chickens, ducks, turkeys), rabbits, dogs,
sheep, swine and cattle and on an international level with companies
from Japan, Mongolia, France, USA, Bulgaria, Hungary, and Poland. The
results of experiments on the toxic effect of Mival on different
animals indicate that the preparation has low toxicity with weakly
defined cumulation and has a high index of safe application,
LD50= 2,300 +/- 240 milligrams/kilogram in laboratory mice
and LD50= 4,150 +/- 520 milligrams/kilogram in laboratory
rats. In reservoir waters, the unaffecting dosage to the chemical
characteristics of water and microbiological plant and animal life is
10 milligrams/liter.
B. Aggregate Exposure
The usage pattern for Mival includes an economical effect on a
limited number of agriculture cultures including cotton, potatoes,
tomatoes, corn, and cereal grains (wheat, barley and oats). Practical
usage of Mival is for the treatment of seeds and foliar spraying of
plants. Rates of seed treatment of agricultural crops is between 2 - 10
grams per metric tons of seeds. Applications higher than 10 grams/ton
can result in a reduced economic benefit of usage for all cultures. For
spraying of growing plants, the recommended dosage rates are between
10-4 moles/liter (225 mg/liter) and 2 x 10-4
moles/liter (450 mg/liter) of Mival, with working solution rates up to
100 liters/acre.). Application rates higher than 2 x10-4
moles/liter have resulted in a reduced economic benefit. The usage of
Mival in ornamental plants, lawn care and other decorative public
landscaping has not resulted in an economical or biological benefit,
and thus its usage would not be found in these applications.
Relating to the mobility and persistence in soils. Mival is
considered easily soluble in water at 1 gram/liter at pH 7, 20 degrees
C. Usage of Mival in concentrations higher the 1 gm/liter must be
accompanied by an acceptable solvent. Based on the usage requirements
of Mival, such concentrations will lead to a negating effect of the
biological benefits of its usage on plants. Mival is considered
unstable in water, at pH 7, 25 degrees C, 50% hydrolysis of Mival in
water is observed in 10-12 hours, 90% hydrolysis is observed in 48
hours. The constant of hydrolysis in neutral water is:
C125 = 9.73 +/- 0.02 liter*mole*sec. The
persistence of Mival in soils, pH 5 - 8, organic matter content 1% -
4%, at 20 degrees C: 50% Mival degradation is observed in 5 days, and
90% degradation is observed in 21 days.
[[Page 63942]]
C. Safety Determination
Based on the very low level of substance toxicity, relatively short
period of environmental fate and its usage pattern, Mival exhibits very
minimal risk exposure both in dietary and non-occupational exposures to
children.
D. International Tolerances
There are no Codex maximum residue levels established for residues
of Mival.
[FR Doc. 97-31549 Filed 12-2-97; 8:45 am]
BILLING CODE 6560-50-F
