[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: 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: 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: allen.edward@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-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:
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-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
