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
46886 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

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 GABA’s natural

occurrence, use as a pharmaceutical

agent, favorable toxicological profile in

chronic toxicology studies, and

inconsequential exposure resulting from

label-directed uses.

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 GABA is

difficult to estimate because of its

prevalence in nature; applications

associated with the EUP would be

comparable to levels found in nature.

GABA in the environment is readily

utilized by microorganisms. The low

toxicity, low application rate, and the

use pattern leads the Agency to

conclude that residues from use of

GABA 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 GABA via lawn care, topical

insect repellents, etc., is not applicable

to this EUP.

B. Cumulative Exposure

GABA is ubiquitous in nature.

Incremental exposure resulting from

this EUP program are miniscule when

compared to the levels found naturallyoccuring in food.

C. Endocrine Disruptors

The Agency has no information to

suggest that GABA 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 after August 3, 1996, for

the Agency to implement a screening

program with respect to endocrine

effects.

D. Safety Considerations

GABA is naturally-occurring in food

and is a pharmaceutical agent.

Incremental exposure to GABA resulting

from this EUP is miniscule. Considering

the negligible contributions to the

environment resulting from the

application of AuxiGro, the abundance

and role of GABA in foods and in the

human body, and its prevalence in

nature, the Agency concludes that

application of GABA 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 the GABA

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 source of

GABA was the plant or the product

treatment.

F. Codex Maximum Residue Level

There are no CODEX tolerances or

international tolerance exemptions for

GABA at this time.

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 GABA. 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 GABA resulting from the EUP labeldirected use is inconsequential, and it is

consumed daily by the human

population from both naturallyoccurring 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 GABA, 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

experimental use permits.

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 experimental use

permit and temporary exemption from

the requirement of a tolerance. This

temporary exemption from the

requirement of a tolerance may be

revoked if the experimental use permit

is revoked or if any experience with or

scientific data on this biochemical

indicate that the tolerance exempton 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 section 408(e) as was

provided in the old 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

publication of this document in the

Federal Register file written objections

to the regulation and may also request

a hearing on those objecitons.

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
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46887

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–300547] (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 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 part 180 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 180.1188 is added to

subpart D to read as follows:

§ 180.1188 Gamma aminobutyric acid;

exemption from the requirement of a

tolerance.

The biochemical gamma aminobutyric

acid (GABA) 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

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 experimental

use permit is revoked or if any

experience with or scientific data on
46888 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

this pesticide indicate that the tolerance

is not safe.

[FR Doc. 97–23628 Filed 9–4–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300535; FRL–5738–8]

RIN 2070–AB78

Triclopyr; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

triclopyr and its 3,5,6-trichloro-2-

pyridinol metabolite in or on fish at 0.2

ppm and shellfish at 5.0 ppm. This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

aquatic sites. This regulation establishes

a maximum permissible level for

residues of triclopyr in these

commodities pursuant to section

408(l)(6) of the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996. These

tolerances will expire and are revoked

on December 31, 1998.

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–300535],

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–

300535], 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 also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300535]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Olga Odiott, Registration Division

7505C, Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Crystal Mall #2, 1921

Jefferson Davis Hwy., Arlington, VA,

(703) 308-308-9363, e-mail:

odiott.olga@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a time-limited tolerances for residues of

the herbicide triclopyr and its

metabolite 3,5,6-trichloro-2-pyridinol,

in or on fish at 0.2 part per million

(ppm) and shellfish at 5.0 ppm. These

tolerances will expire and are revoked

on December 31, 1998. EPA will publish

a document in the Federal Register to

remove the revoked tolerances from the

Code of Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq . The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Triclopyr

on Aquatic Sites and FFDCA

Tolerances

The Applicants stated that the Purple

loosestrife (Lythrum salicaria), an exotic

herbaceous perennial, if not controlled,

will have significant deleterious effects

on the States’ wetlands and wildlife.

The Purple loosestrife rapidly replaces

native vegetation and once established