46882 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300546; FRL–5741–3]

RIN 2070–AB78

Glutamic Acid; Pesticide Tolerance

Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

temporary exemption from the

requirement of a tolerance for residues

of the biochemical glutamic acid, when

used to enhance the growth, vegetable

quality, and yield of the following

crops: broccoli, cabbage, cauliflower,

cotton, green peppers, lettuce, peanuts,

potatoes, snap beans, spinach, and

tomatoes.

DATES: This regulation is effective

September 5, 1997. Objections and

requests for hearings must be received

by EPA on or before November 4, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300546],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300546], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [OPP–300546]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Edward Allen, Regulatory Action

Leader, Biopesticides and Pollution

Prevention Division (7501W), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460, Office location,

telephone number, and e-mail: 5th floor,

Crystal Station #1, 2800 Crystal Drive,

Arlington, VA, telephone: (703) 308–

8699; e-mail:

allen.edward@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Auxein

Corporation, 3125 Sovereign Drive,

Suite B, Lansing, MI 48911 has

requested in pesticide petition (PP)

7G4839 the establishment of a

temporary exemption from the

requirement of a tolerance for residues

of the biochemical glutamic acid. A

notice of filing (FRL–5728–9) was

published in the Federal Register (62

FR 36063, July 3, 1997), and the notice

announced that the comment period

would end on August 4, 1997; no

comments were received. This

temporary exemption from the

requirement of a tolerance will permit

the marketing of the above food

commodities when treated in

accordance with the provisions of

experimental use permit (EUP) 70810–

EUP–1, which is being issued under the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended

(Pub. L. 95–396, 92 Stat. 819; 7 U.S.C.

136). The data submitted in the petition

and all other relevant material have

been evaluated. Following is a summary

of EPA’s findings regarding this petition

as required by section 408(d) of the

Federal Food, Drug and Cosmetic Act

(FFDCA), 21 U.S.C. 346a, as recently

amended by the Food Quality Protection

Act (FQPA), Pub. L. 104–170.

I. Summary

A. Proposed Use Practices

The 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 broccoli,

cabbage, cauliflower, cotton, green

peppers, lettuce, peanuts, potatoes, snap

beans, spinach, and tomatoes.

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 applications, are

at 1– to 3–week intervals. The rate range

is 0.125–0.75 pounds (lbs) of formulated

product/acre(A) per treatment, not to

exceed a maximum of 1.5 lbs/A per

growing season. The proposed EUP

program would utilize 462 lbs of active

ingredients (231 lbs of gamma

aminobutyric acid and 231 lbs of

glutamic acid) in 793 lbs of formulated

product. A total of 822 lbs of formulated

product will be shipped. A maximum of

790 acres will be treated under this

EUP. The experimental program is

intended for evaluation of plant growth,

yield and vegetable quality.

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. Glutamic acid

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 @ 20/

4 C and the decomposition point is 175°

C @ 10 millimeters (mm) mercury (Hg).

II. Toxicological Profile

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. 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 milligram (mg)/kilogram (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 were requested for

genotoxicity, reproductive and

developmental toxicity, subchronic

toxicity, chronic toxicity, and acute

toxicity to nontarget species. Waivers

were accepted based on glutamic acid’s

natural occurrence, long history of food
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46883

uses, favorable toxicological profile in

chronic toxicology studies, and

inconsequential exposure resulting from

label-directed use rates.

A. 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 glutamic

is difficult to estimate because of its

prevalence in nature; applications

associated with the EUP would be

minuscule compared to levels found in

nature. Glutamic acid in the

environment is readily utilized by

microorganisms. Furthermore, glutamic

acid is presently consumed by humans

in the form of glutamate in relatively

high quantities. The low toxicity, low

application rate, and the use pattern

leads the Agency to conclude that

residues from use of the biochemical

glutamic acid will not pose a dietary

risk of concern under reasonable

foreseeable circumstances. Therefore,

EPA concludes that there is a reasonable

certainty of no harm from aggregate

exposure under this temporary

exemption.

2. Non-dietary, non-occupational

exposure. Increased non-dietary

exposure to glutamic acid via lawn care,

topical insect repellents, etc., is not

applicable to this EUP.

B. Cumulative Exposure

Glutamic acid is ubiquitous in nature.

Incremental exposure resulting from

this EUP program are miniscule when

compared to the high levels of glutamic

found naturally occuring in food.

C. Endocrine Disruptors

The Agency has no information to

suggest that glutamic acid will adversely

affect the immune or endocrine systems.

The Agency is not requiring information

on the endocrine effects of this

biochemical pesticide at this time;

Congress has allowed 3 years (yrs) after

August 3, 1996, for the Agency to

implement a screening program with

respect to endocrine effects.

D. Safety Considerations

Glutamic acid is ubiquitous in nature

and is found in microorganisms, lowerand 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 (g) 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 g of protein/

day.

Glutamic acid is listed 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

this EUP 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, the Agency

concludes that application of glutamic

acid to the aforementioned vegetable

crops does not pose a dietary risk.

E. 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, the Agency has determined that

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.

F. 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.

G. Conclusion

Based on its abundance in nature and

long history of use by humans without

deleterious effects, there is reasonable

certainty that no harm will result from

aggregate exposure to the U. S.

population, including infants and

children, to residues of glutamic acid.

This includes all anticipated dietary

exposures and all other exposures for

which there is reliable information. The

Agency has arrived at this conclusion

because, as discussed above, exposure

to glutamic acid resulting from the EUP

label-directed use is inconsequential,

and it is consumed daily by the human

population from both naturally

occurring sources and from processed

foods. As a result, EPA establishes a

temporary exemption from the

requirement of a tolerance pursuant to

FFDCA section 408(j)(3) for glutamic

acid, on the condition that it be used in

accordance with the experimental use

permit 70810–EUP–1, with the

following provisions:

The total amount of the active

ingredients to be used must not exceed

the quantity authorized by the EUP.

Auxein Corporation must

immediately notify the EPA of any

findings from the experimental use that

have a bearing on safety. The company

must also keep records of product,

distribution, and performance and on

request make the records available to

any authorized officer or employee of

the EPA or the Food and Drug

Administration (FDA).

This temporary exemption from the

requirement of a tolerance expires and

is revoked August 27, 1998. Residues

remaining in or on the raw agricultural

commodity after this expiration date

will not be considered actionable if the

biochemical is legally applied during

the term of, and in accordance with, the

provisions of the EUP and temporary

exemption from the requirement of a

tolerance. This temporary exemption

from the requirement of a tolerance may

be revoked if the EUP is revoked or if

any experience with or scientific data

on this biochemical indicate that the

tolerance exemption is not safe.

III. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

exemption regulation issued by EPA

under new FFDCA section 408(e) as was

provided in the old FFDCA section 408.

However, the period for filing objections

is 60 days, rather than 30 days. EPA

currently has procedural regulations

which govern the submission of

objections and hearing requests. These

regulations will require some

modification to reflect the new law.

However, until those modifications can

be made, EPA will continue to use those

procedural regulations with appropriate

adjustments to reflect the new law.

Any person adversely affected by this

regulation may within 60 days after
46884 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

publication of this document in the

Federal Register file written objections

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given under ‘‘ADDRESSES’’ at

the beginning of this rule (40 CFR

178.20). A copy of the objections and/

or hearing requests filed with the

Hearing Clerk should be submitted to

the OPP Docket for this rulemaking. The

objections submitted must specify the

provisions of the regulation deemed

objectionable and the grounds for the

objections (40 CFR 178.25). Each

objection must be accompanied by the

fee prescribed by 40 CFR 180.33(i). If a

hearing is requested, the objections

must include a statement of the factual

issue(s) on which a hearing is requested,

the requestor’s contentions on such

issues, and a summary of any evidence

relied upon by the objector (40 CFR

178.27). A request for a hearing will be

granted if the Administrator determines

that the material submitted shows the

following: There is genuine and

substantial issue of fact; there is

reasonable possibility that available

evidence identified by the requestor

would, if established, resolve one or

more of such issues in favor of the

requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issue(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

‘‘Confidential Business Information’’

(CBI). Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information 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.

IV. Public Record

A record has been established for this

rulemaking under the docket control

number [OPP–300546] (including any

comments and data submitted

electronically). 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 public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

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.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

rule.

V. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the exemption in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VI. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated:August 27, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. Section 180.1187 is added to

subpart D to read as follows:

§ 180.1187 Glutamic acid; exemption from

the requirement of a tolerance.

The biochemical glutamic acid is

temporarily exempted from the

requirement of a tolerance for residues

when used on crops including: snap

beans, peanuts, cotton, potatoes,

tomatoes, lettuce, green peppers,

spinach, broccoli, cauliflower, and

cabbage to enhance crop yields. This

temporary exemption from the

requirement of a tolerance will permit

the marketing of the food commodities

in this paragraph when treated in

accordance with the provisions of
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46885

experimental use permit 70810–EUP–1,

which is being issued under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA), as amended (7 U.S.C. 136).

This temporary exemption from the

requirement of a tolerance expires and

is revoked August 27, 1998. This

temporary exemption from the

requirement of a tolerance may be

revoked at any time if the EUP is

revoked or if any experience with or

scientific data on this pesticide indicate

that the tolerance is not safe.

[FR Doc. 97–23629 Filed 9–4–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300547; FRL–5741–4]

RIN 2070–AB78

Gamma Aminobutyric Acid; Pesticide

Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a

temporary exemption from the

requirement of a tolerance for residues

of the biochemical gamma aminobutyric

acid when used to increase yields of the

following crops: snap beans, peanuts,

cotton, potatoes, tomatoes, lettuce, green

peppers, spinach, broccoli, cauliflower,

and cabbage.

DATES: This regulation is effective

September 5, 1997. Objections and

requests for hearings must be received

by EPA on or before November 4, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300547],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300547], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [OPP–300547]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Edward Allen, Regulatory Action

Leader, Biopesticides and Pollution

Prevention Division (7501W), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460, Office location,

telephone number, and e-mail: 5th floor

CS 1, 2800 Crystal Drive, Arlington, VA,

telephone: (703) 308–8699; e-mail:

allen.edward@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Auxein

Corporation, 3125 Sovereign Drive,

Suite B, Lansing, MI 48911 has

requested in pesticide petition # 7G4838

the establishment of a temporary

exemption from the requirement of a

tolerance for residues of the biochemical

gamma aminobutyric acid (GABA). A

notice of filing was published in the

Federal Register on July 3, 1997 (62 FR

36063)(FRL–5728–9), and the notice

announced that the comment period

would end on August 4, 1997; no

comments were received. This

temporary exemption from the

requirement of a tolerance will permit

the marketing of the above food

commodities when treated in

accordance with the provisions of

experimental use permit 70810–EUP–1,

which is being issued under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA), as amended (Pub. L. 95–

396, 92 Stat. 819; 7 U.S.C. 136). The

data submitted in the petition and all

other relevant material have been

evaluated. Following is a summary of

EPA’s findings regarding this petition as

required by section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

21 U.S.C. 346a, as recently amended by

the Food Quality Protection Act (FQPA),

Pub. L. 104–170.

I. Summary

A. Proposed Use Practices

The 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 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 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

experimental program is intended for

evaluation of plant growth, yield and

vegetable quality.

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° C on

rapid heating.

II. 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 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