[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