Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58399

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 tolerance 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).

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: September 21, 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 180.499 is amended by

adding text to paragraph (a) to read as

follows:

§ 180.499 Propamocarb hydrochloride;

tolerances for residues.

(a) General. Tolerances are

established for the residues of propyl[3-

(dimethylamino)propyl]carbamate

monohydrochloride also known as

propamocarb hydrochloride in or on the

following raw agricultural commodity:

Commodity Parts per million

Potato 0.06

* * * * *

[FR Doc. 00–25049 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301055; FRL–6745–1]

RIN 2070–AB78

Dimethyl silicone polymer with silica;

silane, dichloromethyl-, reaction

product with silica;

hexamethyldisilizane, reaction product

with silica; Tolerance Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

amendment to the exemptions from the

requirement of a tolerance for residues

of dimethyl silicone polymer with

silica; silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica; when used as inert

ingredients on growing crops, when

applied to raw agricultural commodities

after harvest, or to animals. Cabot

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 dimethyl silicone

polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica.

DATES: This regulation is effective

September 29, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301055,

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–301055 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 and e-mail address:

soltero.vera@epa.gov.

SUPPLEMENTARY INFORMATION:

58400 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

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–301055. 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 June 30,

2000 (65 FR 40632) (FRL–6592–6), 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 pesticide

petitions (PP 9E6017, PP 9E6018 and PP

9E6018) by Cabot Corporation, 75 State

Street, Boston, MA, 02109. This notice

included a summary of the petitions

prepared by the petitioner. There were

no comments received in response to

the notice of filing.

The petition requested that 40 CFR

180.1001 (c) and (e) be amended by

revising the existing exemptions from

the requirement of a tolerance for

residues of dimethyl silicone polymer

with silica; silane, dichloromethyl-,

reaction product with silica; and

hexamethyldisilizane, reaction product

with silica; CAS No. 67762–90–7, CAS

No. 68611–44–8, and CAS No. 68909–

20–6, respectively.

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 an exemption

from the requirement of 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...’’ and specifies factors EPA is

to consider in establishing an

exemption.

III. Inert Ingredient Definition

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125 and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

Solvents such as alcohols and

hydrocarbons; surfactants such as

polyoxyethylene ploymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active. Generally, EPA has

exempted inert ingredients from the

requirement of a tolerance based on the

low toxicity of the individual inert

ingredients.

IV. Risk Assessment and Statutory

Findings

EPA establishes exemptions from the

requirement of a tolerance only in those

cases where it can be clearly

demonstrated that the risks from

aggregate exposure to pesticide

chemical residues under reasonably

foreseeable circumstances will pose no

appreciable risks to human health. In

order to determine the risks from

aggregate exposure to pesticide inert

ingredients, the Agency considers the

toxicity of the inert in conjunction with

possible exposure to residues of the

inert ingredient through food, drinking

water, and through other exposures that

occur as a result of pesticide use in

residential settings. If EPA is able to

determine that a finite tolerance is not

necessary to ensure that there is a

reasonable certainty that no harm will

result from aggregate exposure to the

inert ingredient, an exemption from the

requirement of a tolerance may be

established.

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. In the

case of certain chemical substances that

are defined as polymers, the Agency has

established a set of criteria to identify

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58401

categories of polymers that should

present minimal or no risk. The

definition of a polymer is given in 40

CFR 723.250(b). The following

exclusion criteria for identifying these

low risk polymers are described in 40

CFR 723.250(d).

1. The polymers, dimethyl silicone

polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica, are not

cationic polymers nor are they

reasonably anticipated to become

cationic polymers in a natural aquatic

environment.

2. The polymers do contain as an

integral part of their compostion the

atomic elements carbon, hydrogen, and

oxygen.

3. The polymers do not contain as an

integral part of their composition,

except as impurities, any element other

than those listed in 40 CFR

723.250(d)(2)(ii).

4. The polymers are neither designed

nor can they be reasonably anticipated

to substantially degrade, decompose, or

depolymerize.

5. The polymers are manufactured or

imported from monomers and/or

reactants that are already included on

the TSCA Chemical Substance

Inventory or manufactured under an

applicable TSCA section 5 exemption.

6. The polymers are not water

absorbing polymers with a number

average molecular weight (MW) greater

than or equal to 10,000 daltons.

Additionally, the polymers, dimethyl

silicone polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica, also meet

as required the following exemption

criteria specified in 40 CFR 723.250(e).

7. The polymers’ number average MW

of 1,100,000 daltons; 3,340,000 daltons;

and 645,000 daltons, respectively is

greater than or equal to 10,000 daltons.

The polymer contains less than 2%

oligomeric material below MW 500 and

less than 5% oligomeric material below

MW 1,000.

Thus, dimethyl silicone polymer with

silica; silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica meet all the criteria for a

polymer to be considered low risk under

40 CFR 723.250. Based on their

conformance to the above criteria, no

mammalian toxicity is anticipated from

dietary, inhalation, or dermal exposure

to dimethyl silicone polymer with

silica; silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica.

V. Aggregate Exposures

For the purposes of assessing

potential exposure under this

exemption, EPA considered that

dimethyl silicone polymer with silica;

silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica could be present in all raw

and processed agricultural commodities

and drinking water, and that nonoccupational non-dietary exposure was

possible. The number average MW of

dimethyl silicone polymer with silica;

silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica are 1,100,000 daltons;

3,340,000 daltons; and 645,000 daltons,

respectively. Generally, a polymer of

this size would be poorly absorbed

through the intact gastrointestinal tract

or through intact human skin.

Additionally, since the polymer are not

water-absorbing, it is expected that

respirable fractions would be cleared

from the lungs. Since dimethyl silicone

polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica conform to

the criteria that identify a low risk

polymer, there are no concerns for risks

associated with any potential exposure

scenarios that are reasonably

foreseeable. The Agency has determined

that a tolerance is not necessary to

protect the public health.

VI. 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 dimethyl silicone polymer with

silica; silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica share a common mechanism

of toxicity with any other chemicals.

However, dimethyl silicone polymer

with silica; silane, dichloromethyl-,

reaction product with silica; and

hexamethyldisilizane, reaction product

with silica conform to the criteria that

identify a low risk polymer. Due to the

expected lack of toxicity based on the

above conformance, the Agency has

determined that a cumulative risk

assessment is not necessary.

VII. Determination of Safety for U.S.

Population

Based on the conformance to the

criteria used to identify a low risk

polymer, EPA concludes that there is a

reasonable certainty of no harm to the

U.S. population from aggregate exposure

to residues of dimethyl silicone polymer

with silica; silane, dichloromethyl-,

reaction product with silica; and

hexamethyldisilizane, reaction product

with silica.

VIII. Determination of Safety for Infants

and Children

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the data base unless

EPA concludes that a different margin

safety will be safe for infants and

children. Due to the expected low

toxicity of dimethyl silicone polymer

with silica; silane, dichloromethyl-,

reaction product with silica; and

hexamethyldisilizane, reaction product

with silica, EPA has not used a safety

factor analysis to assess the risk. For the

same reasons the additional tenfold

safety factor is unnecessary.

IX. Other Considerations

A. Endocrine Disruptors

There is no available evidence that

dimethyl silicone polymer with silica;

silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica are endocrine disruptors.

B. Existing Exemptions from a

Tolerance

An exemption from tolerance under

40 CFR 180.1001(c) and (e) was

established for dimethyl silicone

polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica published

in the Federal Register of March 1,

2000, (65 FR 10946) (FRL–6490–9). The

following uses were exempted for both

dimethyl silicone polymer with silica

and hexamethyldisilizane, reaction

product with silica: moisture barrier,

anti-caking agent, anti-settling agent.

This amendment to the existing

exemption adds thickening agent to the

uses for dimethyl silicone polymer with

silica and hexamethyldisilizane,

reaction product with silica under 40

CFR 180.1001(c) and (e).

The uses exempted for silane,

dichloromethyl-, reaction product with

silica were: moisture barrier, anti-caking

agent, anti-settling agent, antiVerDate 11<MAY>2000 19:39 Sep 28, 2000 Jkt 190000 PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM pfrm01 PsN: 29SER1
58402 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

thickening agent. This final rule

establishes that anti-thickening be

revised by deleting anti, so that the uses

for silane, dichloromethyl-, reaction

product with silica under 40 CFR

180.1001(c) and (e) will read as follows:

moisture barrier, anti-caking agent, antisettling agent, thickening agent.

C. Analytical Enforcement Methodology

An analytical method is not required

for enforcement purposes since the

Agency is establishing an exemption

from the requirement of a tolerance

without any numerical limitation.

D. International Tolerances

The Agency is not aware of any

country requiring a tolerance for

dimethyl silicone polymer with silica;

silane, dichloromethyl-, reaction

product with silica; and

hexamethyldisilizane, reaction product

with silica nor have any CODEX

Maximum Residue Levels (MRLs) been

established for any food crops at this

time.

X. Conclusion

Accordingly, EPA finds that

exempting residues of dimethyl silicone

polymer with silica; silane,

dichloromethyl-, reaction product with

silica; and hexamethyldisilizane,

reaction product with silica from the

requirement of a tolerance will be safe.

XI. 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–301055 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.

M3708, Waterside Mall, 1200

Pennsylvania Ave., NW., 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–301055, 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: 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).

XII. 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

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58403

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).

XIII. 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 rule in

the Federal Register. This 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 19, 2000.

James Jones,

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 tables in

paragraphs (c) and (e) are amended by

revising the following entries to read as

follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(c) * * *

Inert ingredients Limits Uses

*******

Dimethyl silicone polymer with silica, Minimum number average

molecular weight (in amu) 1,100,000 daltons, CAS Reg. No.

67762–90–7

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

Hexamethyldisilizane, reaction product with silica, minimum number average molecular weight (in amu) 645,000 daltons, CAS

Reg. No. 68909–20–6

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

Silane, dichloromethyl-, reaction product with silica minimum number average molecular weight (in amu) 3,340,000 daltons, CAS

Reg. No. 68611–44–9

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

(e) * * *

58404 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

Inert ingredients Limits Uses

*******

Dimethyl silicone polymer with silica, Minimum number average

molecular weight (in amu) 1,100,000 daltons, CAS Reg. No.

67762–90–7

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

Hexamethyldisilizane, reaction product with silica, Minimum number average molecular weight (in amu) 645,000 daltons, CAS

Reg. No. 68909–20–6

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

Silane, dichloromethyl-, reaction product with silica, Minimum

number average molecular weight (in amu) 3,340,000 daltons,

CAS Reg. No. 68611–44–9

.................... Moisture barrier, anti-caking agent,

anti-settling agent, thickening agent

*******

[FR Doc. 00–25050 Filed 9–28–00]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301069; FRL–6749–1]

RIN 2070–AB78

Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for the combined residues of

azoxystrobin (methyl (E)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) and

its Z isomer (methyl (Z)-2-(2-(6-(2-

cyanophenoxy)pyrimidin-4-

yloxy)phenyl)-3-methoxyacrylate) in or

on barley, bran at 0.2 parts per million

(ppm); barley, grain at 0.1 ppm; barley,

hay at 15.0 ppm; barley, straw at 4.0

ppm; citrus, dried pulp at 2.0 ppm;

citrus, oil at 4.0 ppm; coriander, leaves

at 30.0 ppm; corn, field, forage at 12.0

ppm; corn, field, grain at 0.05 ppm;

corn, field, refined oil at 0.3 ppm; corn,

field, stover at 25.0 ppm; corn, pop,

grain at 0.05 ppm; corn, pop, stover at

25.0 ppm; corn, sweet, forage at 12.0

ppm; corn, sweet (kernels plus cob with

husks removed) at 0.05 ppm; corn,

sweet, stover at 25.0 ppm; cotton, gin

byproducts at 0.02 ppm; cotton,

undelinted seed at 0.02 ppm; fruit,

citrus, group at 1.0 ppm; grain, aspirated

grain fractions at 30.0 ppm; onion, dry

bulb at 1.0 ppm; onion, green at 7.5

ppm; peanut at 0.2 ppm; peanut, refined

oil at 0.6 ppm; peanut, hay at 15.0 ppm;

soybean, forage at 25.0 ppm; soybean,

hay at 55.0 ppm; soybean, hulls at 1.0

ppm; soybean, seed at 0.5 ppm;

vegetable, leafy, except Brassica, group

at 30.0 ppm; vegetable, leaves of root

and tuber, group at 50.0 ppm; vegetable,

root, subgroup at 0.5 ppm; and

vegetable, tuberous and corm, subgroup

at 0.03 ppm; and increases the tolerance

for azoxystrobin (only) in or on cattle,

fat to 0.03 ppm; cattle, meat byproducts

to 0.07 ppm; goat, fat to 0.03 ppm; goat,

meat byproducts to 0.07 ppm; horse, fat

to 0.03 ppm; horse, meat byproducts to

0.07 ppm; sheep, fat to 0.03 ppm; and

sheep, meat byproducts to 0.07 ppm.

Zeneca Ag Products requested these

tolerances in pesticide petition number

(PP#) 9F6058 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–301069,

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–301069 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT By

mail: Dan Kenny, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW.,Washington,

DC 20460; telephone number: (703)305–

7546; and e-mail address:

kenny.dan@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

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/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly