58434 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

* * * * *

[FR Doc. 00–25048 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–-50–-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301067; FRL–6748–3]

RIN 2070–AB78

Yucca Extract; 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 yucca

extract on raw agricultural commodities

when applied/used in accordance with

good agricultural practices as an inert

ingredient in pesticide formulations

applied to growing crops. EDM

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 yucca extract.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301067,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VIII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301067 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Vera Soltero, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9359; e-mail address:

soltero.vera@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:

Categories NAICS

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

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,’’ ‘‘Regulations

and Proposed Rules,’’ 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–301067. 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 November

20, 1998 (63 FR 64494) (FRL–6027–7),

EPA issued a notice pursuant to section

408 of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C. 346a,

as amended by the Food Quality

Protection Act (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

tolerance petition by, EDM Corporation,

2278 S. Indiana St., Porterville, CA

93257. This notice included a summary

of the petition prepared by the

petitioner EDM Corporation. There were

no comments received in response to

the notice of filing.

The petition requested that 40 CFR

180.1001(d) be amended by establishing

an exemption from the requirement of a

tolerance for residues of yucca extract.

Section 408(b)(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(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....’’

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.

III. 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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58435

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. The

nature of the toxic effects caused by are

discussed in this unit.

An acute oral gavage toxicity study

performed on Sprague–Dawley derived

rats was performed on a 70% yucca

extract syrup. The LD50 for males was

found to be greater than 5,000

milligram/kilogram (mg/kg), and for

females it was calculated to be greater

than 500 mg/kg. Even though the use of

a 70% extract is a minor deviation from

accepted guidelines, the Agency

concluded that yucca extract belonged

in Toxicity Category III. Thus, there are

no concerns for acute oral exposure.

Yucca extract has been historically

used among the Native American

population in Mexico and the United

States for medicinal purposes. It was

approved by the U.S. Food and Drug

Administration (FDA) as a natural food

additive under 21 CFR 172.510.

Furthermore, it has been used as a

dietary supplement without evidence of

toxicity. For these reasons, the Agency

has concluded there are no concerns for

chronic oral exposure, and that chronic

toxicity data were not necessary.

IV. Aggregate Exposures

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other non–

occupational exposures, including

drinking water from ground water or

surface water and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

A. Dietary Exposure

Yucca extract is derived from the

species Yucca schidigera which is part

of the lily family of plants and is native

to the deserts of Southwestern United

States and Northern Baja California,

Mexico. The plant and its extracts have

a long history of safe use as food

material for both humans and livestock.

It is used for human consumption in the

soft drink industry, natural food

supplement, cosmetics, etc. Other uses

include: natural feed additive for

livestock, poultry, swine, pets, and

shrimp to reduce ammonia, hydrogen

sulfide and offensive odors. The extract

is approved by the FDA as a natural

food additive under 21 CFR 172.510.

1. Food. Information supplied to the

Agency indicates that approximately

350 tons of raw yucca material are used

annually in the United States. It is

expected that 150 tons of these materials

would be used in making yucca extract

for agricultural uses. A 70% yucca

extract solution would be used in

pesticide products in a concentration no

greater than 6%. If yucca extract is

approved as an inert ingredient in

pesticide products to be applied to food

crops, it can be assumed that exposure

to yucca extract will increase. However,

the amount of increase is necessarily

limited by the availability of raw yucca.

In addition, the main ingredient in

yucca extract is sarsaponin which is

naturally found in several types of food,

such as legumes and asparagus at

significant levels. The Agency

concludes that the use of yucca extract

as an inert ingredient would result in a

negligible increase in exposure over

those levels which would occur as the

result of the use of yucca extract as an

unrestricted food additive or naturally

as the result of ingestion of various food

items.

2. Drinking water exposure. Yucca

extract has general history of safe use as

a natural food additive approved by the

FDA under 21 CFR 172.510 present in

dietary supplements, herbal teas, soft

drinks, among others. The main

ingredient in yucca extract, sarsaponin,

has been shown to degrade in 60°C

water within 8 days. Because of this

rapid degradation, the lack of toxicity

and its history of safe use, the Agency

is confident that the use of yucca extract

as a food–use inert ingredient in

pesticide products will not affect the

water supply.

B. Other Non–Occupational Exposure

On October 6, 1998, the Agency

approved the use of yucca extract as a

non–food use inert ingredient in

pesticide formulations applied to

grasses grown for seeds and for sod. No

data was required for this approval. The

Agency has determined that due to the

long history of safe use as a dietary

supplement and food additive, there is

no need for the petitioners to submit

dermal and inhalation exposure data.

V. Cumulative Effects

Section 408 (b)(2)(D)(v) of FFDCA

requires that, when considering whether

to establish, modify or revoke a

tolerance or tolerance exemption, the

Agency consider available information

concerning the cumulative effects of a

particular chemical’s residues and other

substances that have a common

mechanism of toxicity. The Agency has

not made any conclusions as to whether

or not yucca extract shares a common

mechanism of toxicity with other

chemicals. However, yucca extract is

expected to be practically non-toxic to

mammals. Due to the expected lack of

toxicity, a cumulative risk assessment is

not necessary.

VI. Determination of Safety for U.S.

Population, Infants and Children

Yucca extract has been approved for

use in food and beverages by the FDA

under 21 CFR 172.510 with no limits.

As previously stated in sections A1 and

A2, approval of yucca extract as an inert

ingredient for use on food crops will not

significantly increase dietary exposure

to this chemical. Accordingly, there is

reasonable certainty that no harm will

result from aggregate exposure of the

U.S. population, including infants and

children, to yucca extract.

The Agency did not use the safety

factor analysis in evaluating the risk

posed by the compound. The lack of

toxicity of yucca extract supported not

applying an additional tenfold safety

factor to protect infants and children. In

conclusion, the Agency is reasonably

certain that no harm will result to

infants and children, or to the general

population from aggregate exposure to

residues of yucca extract. Accordingly,

EPA finds that exempting yucca extract

from the requirement of a tolerance will

be safe.

VII. Other Considerations

A. Endocrine Disruptors

FQPA requires EPA to develop a

screening program to determine whether

certain substances, including pesticides

and inert ingredients, may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect.... The Agency has been working

with interested stakeholders to develop

a screening and testing program as well

as a priority–setting scheme. As the

Agency proceeds with implementation

of this program, further testing of

products containing the inert ingredient

yucca extract for endocrine effects may

be required. At this moment, there is no

evidence that yucca extract is an

endocrine disruptor.

B. Analytical Method(s)

Since an exemption from the

requirement of a tolerance is being

established without restriction on

residue level, the Agency has concluded

that an analytical method is not

required for enforcement purposes for

yucca extract from Yucca schidigera.

58436 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

C. Existing Tolerance Exemptions

There are no existing tolerance

exemptions for yucca extract from

Yucca schidigera.

D. International Tolerances

There are no international tolerances

or tolerance exemptions for yucca

extract from Yucca schidigera.

E. Conclusion

Therefore, based on the information

and the data considered, EPA is

establishing an exemption from the

requirement of a tolerance for residues

of yucca extract from Yucca schidigera.

VIII. 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–301067 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 November 28, 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, 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, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

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, 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 VIII.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 control

number OPP–301067, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 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: opp–

docket@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).

IX. 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 October 4, 1993 (58 FR 51735).

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 May 19,

1998 (63 FR 27655); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low–Income

Populations February 16, 1994 (59 FR

7629); or require OMB review or any

Agency action under Executive Order

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58437

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks April 23, 1997 (62 FR

19885). 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 August 10, 1999 (64 FR

43255). 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).

X. 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: September 21, 2000.

Peter Caulkins,

Acting Director, Registration Division, 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. In § 180.1001, the table in

paragraph (d) is amended by adding

alphabetically the following inert

ingredient to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(d)* * *

Inert ingredients Limits Uses

*****

Yucca extract from

Yucca schidigera.

............. Wetting

agent

*****

* * * * *

[FR Doc. 00–24946 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301061; FRL–6746–5]

RIN 2070–AB78

Hexythiazox; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of the ovicide/

miticide hexythiazox (trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as

parent) in or on wet apple pomace,

almonds, strawberries, stone fruit

(excluding plums), milk, fat and meat

byproducts in cattle, goats, horses,

swine, and sheep. It also increases the

tolerance in apples and establishes a

tolerance with regional registration in

cotton. Gowan Company requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act, as amended by the

Food Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301061,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301061 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: William G. Sproat, Jr., Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: (703) 308–8587; and e-mail

address: sproat.william@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:

Categories NAICS 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