[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Notices]
[Pages 56168-56171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28664]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-772; FRL-5751-3]


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-772, must 
be received on or before November 28, 1997.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), 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 to: opp-
[email protected]. 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: By mail: Regulatory Action Leader, Edward 
Allen, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., S.W., 
Washington, D.C. 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-772] (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 electronic form must be 
identified by the docket number [PF-772] 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: October 15, 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

[[Page 56169]]

residues or an explanation of why no such method is needed.

1. Auxein Corporation

PP 7F4842

    EPA has received a pesticide petition (7F4842) from Auxein 
Corporation, P. O. Box 27519, 3125 Sovereign Drive, Suite B, Lansing, 
MI, 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 an exemption from the requirement of a tolerance for 
residues of glutamic acid in or on all food commodities.
    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

    Glutamic acid will be incorporated into the end-use product, 
AuxiGro WP Plant Growth Enhancer as an active ingredient. AuxiGro is 
proposed for use in a variety of agricultural, horticultural, and 
floricultural applications to enhance plant growth and crop 
productivity.
    Depending on the crop, the first application of AuxiGro is made at 
first bloom, first bud, at the 4-6 leaf stage, or other prescribed 
growth stage. A subsequent application, for a maximum of two (2) 
applications, may be made 1-3 weeks later. The rate range is 0.10 - 
0.75 pounds of formulated product/acre per treatment, not to exceed a 
maximum of 1.5 lb/A per growing season. This equates to the application 
of 0.55 lb/A glutamic acid at the maximum use rate.

B. Product Identity/Chemistry

    Glutamic acid is an amino acid found in microorganisms, tissues of 
animals, all food, and higher plants as free amino acid or bound in 
protein. The biochemical is a white, practically odorless, free flowing 
crystalline powder. It is slightly soluble in water, forming acidic 
solutions. The pH of a saturated solution is about 3.22. The specific 
gravity for glutamic acid is 1.538 and the decomposition point is 
175 deg. C @ 10 mm Hg.

C. Toxicological Profile

    Glutamic acid is highly regulated in man and other organisms, the 
mechanisms of which are well understood. It is classified as Generally 
Recognized as Safe (GRAS) by the Food and Drug Administration.
    Glutamate has been administered to numerous species in long term 
dietary studies without adverse effects. The end-use product containing 
glutamic acid, AuxiGro WP, has been evaluated for acute toxicity. Acute 
oral toxicity in rats is greater than 5,050 mg/kg (Toxicity Category 
IV). Acute dermal toxicity in rabbits is greater than 5,050 mg/kg 
(Toxicity Category IV). In an eye irritation study, all signs of 
irritation cleared within 24 hours (washed eyes) following 
administration of AuxiGro (Toxicity Category IV); in unwashed eyes, 
irritation cleared in 5/6 rabbits within 24 hours. Irritation cleared 
within 48 hours in the remaining rabbit. A rabbit dermal irritation 
study with AuxiGro resulted in limited signs of irritation that cleared 
within 24 hours (Toxicity Category IV). There was no indication of 
dermal sensitization in a guinea pig dermal sensitization study.
    Waivers have been requested for acute toxicity, genotoxicity, 
reproductive and developmental toxicity, subchronic toxicity, chronic 
toxicity, and acute toxicity to nontarget species based on glutamic 
acid's ubiquity in nature, long history of food uses, favorable 
toxicological profile in chronic toxicology studies, and 
inconsequential exposure resulting from label-directed use rates.

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. Glutamic acid is ubiquitous in nature and is 
found in microorganisms, lower and higher plant species, fish, birds, 
insects, mammals, and natural and processed foods. It is the most 
prevalent amino acid in plant and animal proteins. Worldwide production 
of glutamic acid is over 340,000 tons/yr. Many items in the human daily 
diet contain appreciable quantities of free glutamic acid. For example, 
ripe tomatoes, mushrooms, peas, corn, potatoes, squash, cheese, eggs, 
poultry and meat provide from 20 to 150 mg of glutamic acid per 100 
gram serving. Daily consumption for a 70-kg individual of glutamate has 
been previously reported to be 10.4 g per day, based on an intake of 
100 grams of protein/day. Regarding the sodium salt of glutamic acid, 
monosodium glutamate (MSG), the Joint Expert Committee on Food 
Additives of the United Nations (JEFCA) has assigned an Acceptable 
Daily Intake of ``not specified'' (no numerical limitation), meaning 
that MSG can be used safely according to food manufacturing practices 
in food by people of all ages.
    Dietary exposure due to topical applications of glutamic acid is 
difficult to estimate because of the amino acid's prevalence in nature. 
However, a comparison of naturally-occurring levels of glutamic acid to 
topically applied levels shows that the applied level is a small 
fraction of that found naturally. Naturally-occurring levels of 
glutamic acid in corn and tomatoes are estimated to be 143 lb/A and 195 
lb/A, respectively. Applied levels of glutamic acid resulting from the 
application of AuxiGro at maximum use levels (1.5 lb/A) is 0.55 lb/A, 
several orders of magnitude lower than naturally-occurring levels.
    Considering the low dose of AuxiGro required to achieve the desired 
effect, the levels of glutamic acid found naturally in the diet and the 
quantity consumed from processed foods, it can be concluded that 
incremental dietary exposure to glutamic acid resulting from AuxiGro 
applications is negligible.
    2. Non-dietary, non-occupational exposure. AuxiGro is proposed for 
use on turf and ornamentals. Exposure from turfgrass applications is 
expected to be minimal because golfers will be protected by shoes and 
socks. Further, based on the limited frequency of use on turfgrass, 
this non-food use is not likely to result in potential chronic exposure 
and thus should not be factored into a chronic exposure assessment. 
Exposures resulting from application to ornamentals is also anticipated 
to be negligible because consumers will not be in contact with treated 
plants until after the foliage is dry.

E. Cumulative Exposure

    Glutamic acid is highly regulated in plants and mammals, the 
mechanisms of which are well understood. This amino acid is not 
intended for pesticidal use and does not share a common mechanism of 
toxicity with currently available pesticides, thus Auxein anticipates 
no cumulative effects with other substances.

[[Page 56170]]

F. Endocrine Disruptors

    The Agency has no information to suggest that glutamic acid will 
adversely affect the immune or endocrine systems.

G. Safety Considerations

    Glutamic acid is classified as Generally Recognized as Safe (GRAS) 
for use as a direct food additive by the Food and Drug Administration 
(FDA) and is cleared by the EPA for use as an inert ingredient in 
certain pesticide products. Condensed, extracted fermentation glutamic 
acid is approved by the FDA for use in animal feed.
    Incremental exposure resulting from application of glutamic acid is 
miniscule compared to levels of glutamic acid consumed from natural and 
processed food products. 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, and 
the prevalence of glutamic acid in nature, glutamic acid does not pose 
an undue risk to human health.

H. Analytical Method

    An analytical method using High Performance Liquid Chromatography 
(HPLC) for determining glutamic acid content in AuxiGro, the end-use 
product, is available. However, because this amino acid is found 
naturally in plants, residue analysis would not yield meaningful 
results, i.e., the analysis would not discern whether the glutamic acid 
source was the plant or the product treatment.

I. Codex Maximum Residue Level

    There are no CODEX tolerances or international tolerance exemptions 
for glutamic acid at this time. Glutamic acid is presently listed as 
exempt from tolerances under 40 CFR 180.1001 when used as a plant 
nutrient for seed treatment.

2. Auxein Corporation

PP 7F4843

    EPA has received a pesticide petition (7F4843) from Auxein 
Corporation, P. O. Box 27519, 3125 Sovereign Drive, Suite B, Lansing, 
MI, 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 an exemption from the requirement of a tolerance for 
residues of GABA in or on all food commodities.
    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

    Gamma aminobutyric acid (GABA) will be incorporated into the end-
use product, AuxiGro Plant Growth Enhancer as an active ingredient. 
AuxiGro is proposed for use in a variety of agricultural, 
horticultural, and floricultural applications to enhance plant growth 
and crop productivity.
    Depending on the crop, the first application of AuxiGro is made at 
first bloom, first bud, at the 4-6 leaf stage, or at a prescribed 
growth stage. A subsequent application, for a maximum of two (2) 
applications, may be made 1-3 weeks later. The rate range is 0.10 - 
0.75 pounds of formulated product/acre per treatment, not to exceed a 
maximum of 1.5 lb/A per growing season. This equates to 0.4 lb/A of 
GABA applied at the maximum use rate.

B. Product Identity/Chemistry

    GABA is a non-protein amino acid that is ubiquitous in nature. It 
has been found in microorganisms, lower and higher plants, fish, birds, 
insects, and mammals. GABA is a white, crystalline powder with a pH of 
6.5 to 7.5. It is freely soluble in water, but insoluble or poorly 
soluble in other solvents. The melting point for GABA is 202 deg. C.

C. Toxicological Profile

    GABA is an ubiquitous non-protein amino acid present in all living 
things. It is an inhibitory neurotransmitter in brain regions and 
central nervous systems of mammals. Because of the inability of GABA to 
cross the blood-brain barrier, exogenous sources do not affect the 
levels in the brain.
    The open literature reports studies involving prolonged chronic 
administration of large doses (up to 1 g/kg/day) of GABA to rats and 
dogs. No signs of toxicity or untoward effects were observed in these 
studies. According to the literature, similar doses have been 
administered repeatedly to unanesthetized dogs without untoward 
effects. In clinical studies, daily oral doses of 8 mM/kg have been 
administered to humans for a year or more with no indication of chronic 
or cumulative toxicity.
    AuxiGro, the end-use product containing 29.2% GABA, has been 
studied for acute toxicity. Acute oral toxicity of AuxiGro in rats is 
greater than 5,050 mg/kg (Toxicity Category IV). Acute dermal toxicity 
in rabbits is greater than 5,050 mg/kg (Toxicity Category IV). In an 
eye irritation study, all signs of irritation cleared within 24 hours 
(washed eyes) following administration of AuxiGro (Toxicity Category 
IV); in unwashed eyes, irritation cleared in 5/6 rabbits within 24 
hours. Irritation cleared within 48 hours in the remaining rabbit. A 
rabbit dermal irritation study with AuxiGro resulted in limited signs 
of irritation that cleared within 24 hours (Toxicity Category IV). 
There was no indication of dermal sensitization in a guinea pig dermal 
sensitization study.
    Waivers have been requested for acute toxicity, genotoxicity, 
reproductive and developmental toxicity, subchronic toxicity, chronic 
toxicity, and acute toxicity to nontarget species based on GABA's 
ubiquity in nature, use as a pharmaceutical agent, favorable 
toxicological profile in chronic and other toxicology studies, and 
inconsequential exposure resulting from label-directed uses.

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. GABA is ubiquitous in nature. Therefore, 
applications of AuxiGro would only incrementally add to levels 
occurring naturally in the environment.
    GABA concentrations in plants have been reported to range from 0.03 
to 32.5 uM/g, fresh weight. It is presumed that the higher levels are 
probably due to stress and/or localized high levels within certain 
plant tissues. Based on these figures, the naturally-occurring level of 
GABA is calculated to be 0.1 kg/A 7.15 kg/A. The high-end (maximum 
application rate) estimate of incremental loading of GABA resulting 
from application of AuxiGro is 0.2 kg. Thus, applied GABA is well 
within the range of that found in nature.
    2. Non-dietary, non-occupational exposure. AuxiGro is proposed for 
use on turf and ornamentals. Exposure from turfgrass applications are 
expected to be minimal because golfers will be

[[Page 56171]]

protected by shoes and socks. Further, based on the limited frequency 
of use on turfgrass, this non-food use is not likely to result in 
potential chronic exposure and thus should not be factored into a 
chronic exposure assessment. Exposures resulting from application to 
ornamentals is also anticipated to be negligible because consumers will 
not be in contact with treated plants until after the foliage is dry.

E. Endocrine Disruptors

    Auxein has no information to suggest that GABA will adversely 
affect the immune or endocrine systems.

F. Safety Considerations

    GABA is naturally-occurring in food and is a pharmaceutical agent. 
Incremental exposure to GABA resulting from the application of AuxiGro 
is minimal to negligible. Considering the negligible contributions of 
GABA to the environment resulting from the application of AuxiGro, the 
biochemical's prevalence in nature, and its role and abundance in 
foods, GABA does not pose a human health risk.

G. Analytical Method

    An analytical method using High Performance Liquid Chromatography 
(HPLC) for determining the GABA content in AuxiGro, the end-use 
product, is available. However, because GABA is found naturally in 
plants, residue analysis would not yield meaningful results, i.e., the 
analysis would not discern whether the source of GABA was the plant or 
the product treatment.

H. Codex Maximum Residue Level

    There are no CODEX tolerances or international tolerance exemptions 
for GABA.
[FR Doc. 97-28664 Filed 10-28-97; 8:45 am]
BILLING CODE 6560-50-F