56168 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices

fees due, and to fulfill any applicable

unsatisfied data requirements.

V. Provisions for Disposition of Existing

Stocks

The effective date of cancellation will

be the date of the cancellation order.

The orders effecting these requested

cancellations will generally permit a

registrant to sell or distribute existing

stocks for 1 year after the date the

cancellation request was received. This

policy is in accordance with the

Agency’s statement of policy as

prescribed in Federal Register (56 FR

29362) June 26, 1991; [FRL 3846-4].

Exceptions to this general rule will be

made if a product poses a risk concern,

or is in noncompliance with

reregistration requirements, or is subject

to a data call-in. In all cases, productspecific disposition dates will be given

in the cancellation orders.

Existing stocks are those stocks of

registered pesticide products which are

currently in the United States and

which have been packaged, labeled, and

released for shipment prior to the

effective date of the cancellation action.

Unless the provisions of an earlier order

apply, existing stocks already in the

hands of dealers or users can be

distributed, sold or used legally until

they are exhausted, provided that such

further sale and use comply with the

EPA-approved label and labeling of the

affected product(s). Exceptions to these

general rules will be made in specific

cases when more stringent restrictions

on sale, distribution, or use of the

products or their ingredients have

already been imposed, as in Special

Review actions, or where the Agency

has identified significant potential risk

concerns associated with a particular

chemical.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: October 16, 1997.

Richard D. Schmitt,

Acting Director, Information Resources and

Services Division, Office of Pesticide

Programs.

[FR Doc. 97–28659 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–772; FRL–5751–3]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

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: oppdocket@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
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices 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° 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 naturallyoccurring 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.
56170 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices

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° 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 bloodbrain 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
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices 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

ENVIRONMENTAL PROTECTION

AGENCY

[PF–775; FRL–5752–2]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

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–775, 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: oppdocket@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 CONTACT: By

mail: Elizabeth Haeberer, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Rm. 250, CM #2, 1921 Jefferson

Davis Highway, Arlington, VA 22202,

(703) 308–2891; e-mail:

haeberer.elizabeth@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–775]

(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–775] 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 16, 1997.

James Jones,

Acting Director, Registration 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.

Gustafson, Inc.

PP 4F4415

EPA has received a pesticide petition

(PP 4F4415) from Gustafson, Inc., 1400

Preston Road, Suite 400, Plano, Texas

75093, proposing pursuant to section

408(d) of the Federal Food, Drug and