25660 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of this final

rule in the Federal Register. This final

rule 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: April 26, 2000.

Susan B. Hazen,

Acting 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. 321(q), (346a) and

371.

2. Section 180.547 is added to read as

follows:

§ 180.547 Prohexadione calcium;

tolerances for residues.

(a) General. Tolerances are

established for residues of the plant

growth regulator, prohexadione calcium

(calcium 3-oxido-5-oxo-4-

propionylcyclohex-3-enecarboxylate) in

or on the following raw agricultural

commodities:

Commodity Parts per

million

Cattle, kidney .......................... 0.10

Cattle, mbyp (except kidney) .. 0.05

Goats, kidney .......................... 0.10

Goats, mbyp (except kidney) .. 0.05

Hogs, kidney ........................... 0.10

Hogs, mbyp (except kidney) ... 0.05

Horses, kidney ........................ 0.10

Horses, mbyp (except kidney) 0.05

Peanuts ................................... 1.0

Peanut hay .............................. 0.60

Fruit, pome, group .................. 3.0

Sheep, kidney ......................... 0.10

Sheep, mbyp (except kidney) 0.05

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 00–11030 Filed 5–2–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300984; FRL–6497–4]

RIN 2070–AB78

Harpin Protein; Exemption From the

Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of the biochemical

pesticide harpin protein on all food

commodities when applied/used in

agricultural fields and greenhouses for

the management of plant diseases, the

significant improvement in growth and

yields, and the suppression of certain

insects and other pests. EDEN

Bioscience Corporation submitted a

petition to EPA under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996,

requesting an exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of harpin protein.

DATES: This regulation is effective May

3, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300984, must be received

by EPA, on or before July 3, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit IX. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–300984 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Diana M. Horne, Biopesticides and

Pollution Prevention Division (7511C),

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460; telephone

number: (703) 308–8367; and e-mail

address: horne.diana@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25661

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–300984. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of September

9, 1999 (64 FR 49010) (FRL–6095–9),

EPA issued a notice pursuant to section

408 of the Federal Food, Drug, and

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

346a(d), as amended by the Food

Quality Protection Act (FQPA) (Public

Law 104–170) announcing the filing of

a pesticide tolerance petition (PP

9F6027) by EDEN Biosciences, 11816

North Creek Parkway N., Bothell, WA

98011–8205. This notice included a

summary of the petition prepared by the

petitioner EDEN Bioscience

Corporation. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

part 180 be amended by establishing an

exemption from the requirement of a

tolerance for residues of harpin protein.

III. Risk Assessment

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

FFDCA allows EPA to establish an

exemption from the requirement for 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(c)(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. . . .’’ Additionally, section

408(b)(2)(D) requires that the Agency

consider ‘‘available information’’

concerning the cumulative effects of a

particular pesticide’s residues and

‘‘other substances that have a common

mechanism of toxicity.’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

IV. Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the

available scientific data and other

relevant information in support of this

action and considered its validity,

completeness, and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

Harpin exhibits no adverse effects in

Tier I mammalian toxicity studies;

therefore, Tier II and III studies are not

required. Acute toxicity studies indicate

that Messenger is a Toxicity Category IV

substance. No toxicity was observed in

acute oral toxicity studies conducted

with Messenger. Acute oral and dermal

toxicity LD50 values for Messenger were

greater than 5,000 grams/kilograms (g/

kg) in the rat (Toxicity Category IV). The

LC50 for Messenger was greater than 2

milligrams/liter (mg/L) in an acute

inhalation study in the rat. Messenger

also showed no effect in eye and dermal

irritation studies. For example, the

dermal irritation index for Messenger

was zero at 500 mg and no eye irritation

was shown in the rabbit at 100 mg.

There have been no reported incidents

of Messenger-induced hypersensitivity

in individuals exposed to Messenger

during research, production, and/or

field testing and there are no published

reports indicating that harpin proteins

are toxic. Further, the harpin protein

has a non-toxic mode of action by

eliciting a systemic acquired resistance

response in plants, and it has been

demonstrated that the product has no

direct antimicrobial effect on bacteria

and fungi, for species examined to date.

For a more complete discussion, see the

Harpin Registration Eligibility

Document.

V. Aggregate Exposures

In examining aggregate exposure,

FQPA directs EPA to take into account

available information concerning

dietary exposures from pesticide

residues in food and drinking water and

all other exposures for which there is

reliable information. These other

sources of exposure include such nonoccupational exposures as those

resulting from the use of pesticides

around the home or in public areas such

as parks and schools. The Agency

defines acute and chronic aggregate

risks to include only dietary (food and

water) exposures. Short-, intermediate-,

and long-term aggregate exposures are

defined to include non-occupational

exposures in addition to dietary

exposures. Any or all of these aggregate

risk assessments may be required for a

pesticide depending on its registered

uses.

A. Dietary Exposure

Harpin and related harpin proteins

are common constituents of plant

pathogenic bacteria which are often

found on fruits and vegetables.

Additional dietary exposure to harpin

protein resulting from labeled uses is

unlikely to occur because of extremely

low use rates and rapid degradation in

the field. Furthermore, the lack of

demonstrable toxicity in acute studies,

and the natural occurrence of harpins in

the environment support the

establishment of an exemption from the

requirement of a tolerance for harpin

protein.

1. Food. Messenger is applied at very

low rates of application (generally 2 to

11.5 grams of active ingredient per acre).

Harpin also degrades rapidly in

sunlight, high temperatures, and in the

presence of chlorine. Because of the low

use rates and rapid degradation in the

field, no harpin residues are detectable,

using available methods, on treated

crops even immediately after

application. Therefore, the Agency

believes that dietary exposure to harpin

via consumption of treated food or feed

will be negligible.

25662 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

2. Drinking water exposure. Because

harpin protein is applied at extremely

low use rates and rapidly degrades in

the environment, residues are unlikely

to occur in ground or surface water. In

addition, harpin is highly sensitive to

small amounts of chlorine, as contained

in many municipal water systems.

Therefore, residues of harpin protein are

unlikely to occur in drinking water.

B. Other Non-Occupational Exposure

The Agency believes that the potential

for non-dietary exposure and attendant

risks to the general population

including infants and children is

minimal to non-existent, due to low use

rates, the instability of harpin protein in

the environment, and lack of

demonstrated toxicity. In addition, the

label use sites are commercial,

agricultural, and horticultural, as

opposed to domestic settings; thus, nonoccupational exposure to the general

population is expected to be minimal.

1. Dermal exposure. Harpin is a

Toxicity Category IV product, and is not

expected to pose any risk via the dermal

route of exposure.

2. Inhalation exposure. Acute

inhalation tests place harpin in Toxicity

Category IV, thus risk via the inhalation

route is expected to be minimal to nonexistent.

VI. Cumulative Effects

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and other substances that have

a common mechanism of toxicity.

Consideration of a common mode of

toxicity is not appropriate, given that

there is no indication of mammalian

toxicity of harpin protein and no

information that indicates that toxic

effects would be cumulative with any

other compounds. Moreover, harpin

does not exhibit a toxic mode of action

in its target pests or diseases.

VII. Determination of Safety for U.S.

Population, Infants and Children

Harpin’s lack of toxicity has been

demonstrated by the results of acute

toxicity testing in mammals in which

harpin caused no adverse effects when

dosed orally and via inhalation at the

limit dose for each study. Thus, based

on this and other information in this

preamble, EPA concludes that there is a

reasonable certainty that no harm to the

United States population in general, or

to infants or children will result from

aggregate exposure to harpin residues.

This includes all anticipated dietary

exposures and all other exposures for

which there is reliable information.

VIII. Other Considerations

A. Endocrine Disruptors

The Agency has no information

regarding endocrine effects of this

biochemical pesticide at this time;

however, since there was no

demonstrable toxicity in acute tests,

there is no evidence to suggest that

harpin will adversely affect the

endocrine system.

B. Analytical Method

Because this notice establishes an

exemption from the requirement of a

tolerance, no anlytical method is

necessary. The Agency is establishing

an exemption from the requirement of a

tolerance without any numerical

limitation for the reasons enumerated in

this preamble, including harpin’s lack of

toxicity. Accordingly, the Agency has

concluded that an analytical method is

not needed for enforcement purposes for

harpin residues.

C. Codex Maximum Residue Level

There are no Codex Maximum

Residue Levels nor any tolerances or

exemptions issued for harpin protein

outside the United States.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–300984 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before July 3, 2000.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(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). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460. You may also

deliver your request to the Office of the

Hearing Clerk in Rm. C400, Waterside

Mall, 401 M St., SW., Washington, DC

20460. The Office of the Hearing Clerk

is open from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays. The telephone number for the

Office of the Hearing Clerk is (202) 260–

4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25663

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

3. Copies for the docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit IX.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket number

OPP–300984, to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460. In person

or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid 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 6.1/8.0 file

format or ASCII file format. Do not

include any CBI in your electronic copy.

You may also submit an electronic copy

of your request at many Federal

Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a 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

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

X. 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)

(Public Law 104–4). Nor does it require

any prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); 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 or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). 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. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

XI. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of this final

rule in the Federal Register. This final

rule 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: April 19, 2000.

Susan B. Hazen,

Acting 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. 321(q), 346(a) and

371.

2. Section 180.1204 is revised to read

as follows:

§ 180.1204 Harpin protein; exemption from

the requirement of a tolerance.

An exemption from the requirement

of a tolerance is established for residues

of the biochemical pesticide harpin

protein on all food commodities when

applied/used in agricultural fields and

greenhouses for the management of

plant diseases, the significant

improvement in growth and yields, and

the suppression of certain insects and

other pests.

[FR Doc. 00–11029 Filed 5–2–00; 8:45 am]

BILLING CODE 6560–50–F