[Federal Register Volume 62, Number 128 (Thursday, July 3, 1997)]
[Notices]
[Pages 36063-36065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17590]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-749; FRL-5728-9]
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-749, must
be received on or before August 4, 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 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: By mail: Regulatory Action Leader
Edward Allen, Biopesticides and Pollution Prevention Division, Office
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: 5th floor
CS #1, 2800 Crystal Drive, Arlington, VA 22202. Telephone No. (703)
308-8699. e-mail: [email protected].
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-749] (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:
[email protected]
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
[[Page 36064]]
electronic form must be identified by the docket number [PF-749] 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: June 26, 1997.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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.
1. Auxein Corporation
PP 7G4838
EPA has received a pesticide petition (7G4838) from Auxein
Corporation, 3900 Collins Road, P. O. Box 27519, Lansing, MI, proposing
pursuant to section 408 (d) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. section 346a (d), to amend 40 CFR part 180 by establishing an
exemption from the requirement of a tolerance for residues of GABA in
or on snap beans, peanuts, cotton, potatoes, tomatoes, lettuce, green
peppers, spinach, broccoli, cauliflower, and cabbage. Pursuant to the
section 408(d)(2)(A)(I) of the FFDCA, as amended, Auxein Corporation
has submitted the following summary of information, data and arguments
in support of their pesticide petition. This summary was prepared by
Auxein Corporation and EPA has not fully evaluated the merits of the
petition. The summary may have been edited by EPA if the terminology
used was unclear, the summary contained extraneous material, or the
summary was not clear that it reflected the conclusion of the
petitioner and not necessarily EPA.
A. Proposed Use Practices
The proposed experimental program will be conducted in the states
of Alabama, Arizona, California, Florida, Georgia, Idaho, Maine,
Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New
Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas,
Washington, and Wisconsin. Crops to be treated are snap beans, peanuts,
cotton, potatoes, tomatoes, lettuce, green peppers, spinach, broccoli,
cauliflower, and cabbage. Depending on the crop, application is made at
first bloom, first bud or at the 5-6 leaf stage. Subsequent
applications, for a maximum of three (3) applications, are at 1- to 3-
week intervals. The rate range is 0.125 - 0.75 pounds of formulated
product /acre per treatment not to exceed a maximum of 1.5 lbs/A per
growing season. The proposed EUP program would utilize 462 pounds of
active ingredients (231 pounds of gamma aminobutyric acid and 231
pounds of L-glutamic acid) in 793 pounds of formulated product. A total
of 822 pounds of formulated product will be shipped. A maximum of 790
acres will be treated under this EUP. The formulated product,
AuxiGroTM Plant Growth Enhancer, increases plant growth,
yield and fruit quality.
B. Product Identity/Chemistry
AuxiGro WP is an off-white colored, wettable powder. AuxiGro
contains two active ingredients: 36.5% L-glutamic acid, a key amino
acid, and 29.2% gamma aminobutyric acid (GABA), a non-protein amino
acid. GABA is a white, crystalline powder with a pH of 6.5 to 7.5. The
pH of a 1% solution of AuxiGro is 4.4. The bulk density of the end-use
formula is 0.52 g/ml. GABA is ubiquitous in nature and has been found
in microorganisms, lower and higher plants, fish, birds, insects and
mammals.
C. Toxicological Profile
GABA is a ubiquitous non-protein amino acid present in all living
things. It is an inhibitory neurotransmitter in many brain regions and
central nervous systems of mammals. Due to GABA's role in the nervous
system, it has been administered to humans with the aim of improving
central GABA-mediated transmission and to control Huntington's disease,
Parkinson's disease, schizophrenia and other seizure states. AuxiGro,
the end-use formula containing 29.2% GABA, has been studied for acute
toxicity. Acute oral toxicity in rats is greater than 5,050 mg/kg.
Acute dermal toxicity in rabbits is greater than 5,050 mg/kg. An eye
irritation study using rabbits resulted in redness in one rabbit's
unwashed eye, but cleared within 48 hours. Limited signs of dermal
irritation cleared within 24 hours. There was no indication of dermal
sensitization in a guinea pig dermal sensitization study.
D. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency considers include drinking water or
groundwater, and exposure through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses.
1. Dietary exposure. Dietary exposure due to topical applications
of GABA and glutamic acid is difficult to estimate because both
chemicals are ubiquitous in nature; applications associated with the
EUP would be minuscule compared to levels found in nature, and both are
readily utilized by microorganisms. Furthermore, GABA and glutamic acid
are presently available for direct human consumption.
2. Non-dietary, non-occupational exposure. Increased non-dietary
exposure of GABA and glutamic acid via lawn care, topical insect
repellents, etc., is not applicable to this EUP application.
E. Cumulative Exposure
GABA is ubiquitous in nature. Incremental levels of exposure
resulting from this EUP program are minuscule when compared to the high
levels of GABA found naturally-occurring in food.
F. Endocrine Disruptors
Auxein has no information to suggest that GABA will adversely
affect the immune or endocrine systems.
G. Safety Considerations
GABA is available for human consumption as a food additive and
pharmaceutical agent. It also occurs naturally in food. Incremental
exposure to GABA resulting from this EUP program is minuscule.
Considering the negligible contributions to the environment resulting
from the application of AuxiGro, the abundance and role of GABA in
foods and in the human body, it can be concluded that GABA is safe for
the intended use, i.e., without measurable hazard.
[[Page 36065]]
H. Analytical Method
An analytical method for residues is not applicable as this
proposes an exemption from the requirement for a tolerance.
I. Existing Tolerances
Auxein is not aware of any tolerances or MRLs issued for GABA
outside of the United States.
2. Auxein Corporation
PP 7G4839
EPA has received a pesticide petition (7G4839) from Auxein
Corporation, 3900 Collins Road, P. O. Box 27519, Lansing, MI, proposing
pursuant to section 408 (d) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. section 346a (d), to amend 40 CFR part 180 by establishing an
exemption from the requirement of a tolerance for residues of glutamic
acid in or on snap beans, peanuts, cotton, potatoes, tomatoes, lettuce,
green peppers, spinach, broccoli, cauliflower, and cabbage. Pursuant to
the section 408 (d) (2) (A) (i) of the FFDCA, as amended, Auxein
Corporation has submitted the following summary of information, data
and arguments in support of their pesticide petition. This summary was
prepared by Auxein Corporation and EPA has not fully evaluated the
merits of the petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous
material, or the summary was not clear that it reflected the conclusion
of the petitioner and not necessarily EPA.
A. Proposed Use Practices
The proposed experimental program will be conducted in the states
of Alabama, Arizona, California, Florida, Georgia, Idaho, Maine,
Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New
Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas,
Washington, and Wisconsin. Crops to be treated are snap beans, peanuts,
cotton, potatoes, tomatoes, lettuce, green peppers, spinach, broccoli,
cauliflower, and cabbage. Depending on the crop, application is made at
first bloom, first bud or at the 5-6 leaf stage. Subsequent
applications, for a maximum of three (3) applications, are at 1- to 3-
week intervals. The rate range is 0.125 - 0.75 pounds of formulated
product /acre per treatment not to exceed a maximum of 1.5 lbs/A per
growing season. The proposed EUP program would utilize 462 pounds of
active ingredients (231 pounds of gamma aminobutyric acid and 231
pounds of L-glutamic acid) in 793 pounds of formulated product. A total
of 822 pounds of formulated product will be shipped. A maximum of 790
acres will be treated under this EUP. The formulated product,
AuxiGrogG5TM Plant Growth Enhancer, increases plant growth, yield and
fruit quality.
B. Product Identity/Chemistry
AuxiGro WP is an off-white colored, wettable powder. AuxiGro
contains two active ingredients: 36.5% L-glutamic acid, a key amino
acid, and 29.2% gamma aminobutyric acid (GABA), a non-protein amino
acid. Glutamic acid is a white, practically odorless, free flowing
crystalline powder. It is slightly soluble in water, forming acidic
solutions. The pH of a 1% solution of AuxiGro is 4.4. The bulk density
of the end-use formula is 0.52 g/ml. Glutamic acid is ubiquitous in
nature and has been found in microorganisms, lower and higher plants,
fish, birds, insects and mammals. Glutamate is widely available as a
direct food additive and as a pharmaceutical agent. Glutamic acid is
presently cleared by EPA for use as an inert ingredient in certain
pesticide products.
C. Toxicological Profile
Glutamic acid is an ubiquitous and very abundant amino acid. It is
found in virtually all proteins. Glutamic acid is listed as Generally
Recognized as Safe the Food and Drug Administration (FDA) and is
approved by the EPA as (GRAS) by an inert for seed treatment as a plant
nutrient. Condensed, extracted fermentation glutamic acid is approved
by the FDA for use in animal feed. Glutamic acid is highly regulated in
man and other organisms, the mechanisms of which are well understood.
Glutamate has been administered to numerous species in long term
dietary studies without adverse effects. AuxiGro, the end-use formula,
has been studied for acute toxicity. Acute oral toxicity in rats is
greater than 5,050 mg/kg. Acute dermal toxicity in rabbits is greater
than 5,050 mg/kg. An eye irritation study using rabbits resulted in
redness in one rabbit's unwashed eye, but cleared within 48 hours.
Limited signs of dermal irritation cleared within 24 hours. There was
no indication of dermal sensitization in a guinea pig dermal
sensitization study.
D. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency considers include drinking water or
groundwater, and exposure through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses).
1. Dietary exposure. Dietary exposure due to topical applications
of GABA and glutamic acid is difficult to estimate because both
chemicals are ubiquitous in nature; applications associated with the
EUP would be minuscule compared to levels found in nature, and both are
readily utilized by microorganisms. Furthermore, GABA and glutamic acid
are presently available for direct human consumption.
2. Non-dietary, non-occupational exposure. Increased non-dietary
exposure of GABA and glutamic acid via lawn care, topical insect
repellents, etc., is not applicable to this EUP application.
E. Cumulative Exposure
Glutamic acid is ubiquitous in nature. Incremental levels of
exposure resulting from this EUP program are miniscule when compared to
the high levels of glutamic acid found naturally-occurring in food.
F. Endocrine Disruptors
Auxein has no information to suggest that glutamic acid will
adversely affect the immune or endocrine systems.
G. Safety Considerations
Glutamic acid is available for human consumption as a food additive
and pharmaceutical agent. All food contains relatively high levels of
glutamic acid. Incremental exposure resulting from this EUP program is
minuscule. Considering the negligible contributions to the environment
resulting from the application of AuxiGro, the abundance and role of
glutamic acid in foods and in the human body, it can be concluded that
glutamic is safe for the intended use, i.e., without measurable hazard.
H. Analytical Method
An analytical method for residues is not applicable as this
proposes an exemption from the requirement for a tolerance.
I. Existing Tolerances
L-Glutamic acid is presently listed as exempt from tolerances under
40 CFR 180.1001 when used as a plant nutrient for seed treatment.
Auxein is not aware of any tolerances or MRLs issued for glutamic
acid outside of the United States.
[FR Doc. 97-17590 Filed 7-2-97; 8:45 am]
BILLING CODE 6560-50-F