68908 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations

8859, March 15, 1988) by examining the

takings implications of the rule in

accordance with the ‘‘Attorney

General’s Supplemental Guidelines for

the Evaluation of Risk and Avoidance of

Unanticipated Takings’’ issued under

the executive order. This rule does not

impose an information collection

burden under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

The Congressional Review Act, 5

U.S.C. section 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 the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This action is not a ‘‘major rule’’ as

defined by 5 U.S.C. section 804(2).

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by January 16, 2001.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 62

Environmental protection,

Administrative practice and procedure,

Air pollution control, Hospital/medical/

infectious waste incineration,

Intergovernmental relations, Reporting

and recordkeeping requirements.

Dated: October 25, 2000.

A. Stanley Meiburg,

Acting Regional Administrator, Region 4.

40 CFR part 62 of the Code of Federal

Regulations is amended as follows:

PART 62—[AMENDED]

1. The authority citation for part 62

continues to read as follows:

Authority: 42 U.S.C. 7401–7642.

Subpart K—Florida

2. Section 62.2350 is amended by

adding paragraphs (b)(7) and (c)(5) to

read as follows:

§ 62.2350 Identification of plan.

* * * * *

(b) * * *

(7) State of Florida Department of

Environmental Protection Section

111(d) State Plan for Hospital/Medical/

Infectious Waste Incinerators, submitted

on September 16, 1999, by the Florida

Department of Environmental

Protection.

(c) * * *

(5) Existing hospital/medical/

infectious waste incinerators.

3. Subpart K is amended by adding a

new § 62.2370 and a new undesignated

center heading to read as follows:

Air Emissions From Hospital/Medical/

Infectious Waste Incinerators

§ 62.2370 Identification of sources.

The plan applies to existing hospital/

medical/infectious waste incinerators

for which construction, reconstruction,

or modification was commenced before

June 20, 1996, as described in 40 CFR

part 60, subpart Ce.

[FR Doc. 00–29217 Filed 11–14–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301060; FRL–6747–3]

RIN 2070–AB78

Copper Sulfate Pentahydrate;

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 copper sulfate

pentahydrate when applied as a

fungicide to raw agricultural

commodities after harvest. Magna Bon

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 copper sulfate

pentahydrate. In this final rule, the

Agency is also reordering the structure

of 40 CFR 180.1001(b)(1) and 180.1021

to group most of the copper exemptions

together. The reordering does not

change the regulatory status of these

chemicals.

DATES: This regulation is effective

November 15, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301060

must be received by EPA on or before

January 16, 2001.

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–301060 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Treva Alston, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–8373; and e-mail

address: alston.treva@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.

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations 68909

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–301060. 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 July 14,

1999 (64 FR 37972) (FRL –6085–5), 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

petition (PP 8F4982) by Magna Bon

Corporation, 3213 Ocean Drive, Vero

Beach, Florida 32963. This notice

included a summary of the petition

prepared by the petitioner. There were

no comments received in response to

the notice of filing. Various copper

containing substances have been

exempted from tolerance requirements

for numerous uses. 40 CFR 180.1001 (b)

(1) exempts the listed copper

compounds when applied to growing

crops. However, these substances are

not exempted from the requirement of a

tolerance when applied to a crop at the

time of or after harvest. Other exempted

uses of copper include harvested fish

and shellfish, meat, milk, poultry, eggs,

and irrigated crops as specified in 40

CFR 180.1021. The petition requested

that copper sulfate pentahydrate be

exempted from the requirement of a

tolerance when applied to raw

agricultural commodities at 0.050 ppm.

The Agency does not generally grant an

exemption from the requirement of

tolerance with a numerical limitation.

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

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

copper sulfate pentahydrate are

discussed in this unit.

There is adequate information

available to characterize the toxicity of

the copper ion. Copper is ubiquitous in

nature and is a necessary nutritional

element for both animals (including

humans), and plants. Copper is found

naturally in the food we eat, in the

water we drink, in the air we breathe

and in our bodies themselves. Some of

the environmental copper is due to

direct modification of the environment

by man such as mining and smelting of

the natural ore. It is one of 26 elements

found essential to life. The copper ion

is present in the adult human body at

levels of 80–150 mg.

Oral ingestion of excessive amounts of

the copper ion from pesticidal uses is

unlikely. Copper compounds are

irritating to the gastric mucosa.

Ingestion of large amounts of copper

results in prompt emesis. This

protective reflex reduces the amount of

copper ion available for absorption into

the human body. Additionally, at high

levels humans are also sensitive to the

taste of copper. Because of this

organoleptic property, oral ingestion

would also serve to limit high doses.

Only a small percentage of ingested

copper is absorbed, and most of the

absorbed copper is excreted. The copper

ion occurs naturally in many foods and

the metabolism of copper is well

understood. The Agency published a

registration standard for copper sulfate

in 1985. As indicated in the registration

standard, there are several factors

unique to copper which indicate that

specific studies to fulfill the usual data

requirements are not necessary to

regulate copper sulfate as a pesticide.

One of the foremost of these is the fact

that copper is a required nutritional

element for both plants and animals. It

appears that more evidence is available

to define the adverse effects of a

deficiency in the diet than to show the

toxic effects of an excess intake; in fact,

no account has been found in the

literature reviewed which describes a

toxic effect to normal humans from

ingestion of common foodstuffs

containing copper. Because copper

toxicity to man through the diet has not

been shown in normal persons, little is

known about the minimum levels of

dietary copper necessary to cause

evidence of adverse effects. This

situation is likely due, to an effective

homeostatic mechanism that is involved

in the dietary intake of copper and that

protects man from excess body copper.

This complex mechanism integrates

absorption, retention, and excretion to

stabilize the copper body burden. Given

that copper is ubiquitous and is

routinely consumed as part of the daily

diet, it is unlikely that with current

exposure patterns there would be any

long term adverse effects.

68910 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations

Sulfate has little toxic effect and is

routinely used in medicine as a

cathartic when combined with

magnesium or sodium, the only adverse

manifestation from this use being

dehydration if water intake is

concurrently limited.

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

nonoccupational 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).

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

chemicals, the Agency considers the

toxicity of the chemical in conjunction

with possible exposure to residues of

the chemical 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, an

exemption from the requirement of a

tolerance may be established.

A. Dietary Exposure

Copper is ubiquitous in nature and is

a necessary nutritional element for both

animals (including humans) and plants.

It is one of 26 elements found essential

to life. The human body must have

copper to stay healthy. In fact, for a

variety of biochemical processes in the

body to operate normally, copper must

be part of our diet. Copper is needed for

certain critical enzymes to function in

the body. Too little copper in the body

can actually lead to disease.

1. Food. The main source of copper

for infants, children, and adults,

regardless of age, is the diet. Copper is

typically present in mineral rich foods

like vegetables (potato, legumes (beans

and peas), nuts (peanuts and pecans),

grains (wheat and rye), fruits (peach and

raisins), and chocolate in levels ranging

from 0.3 to 3.9 ppm. A single day’s diet

may contain 10 mg or more of copper.

The daily recommended allowance of

copper for adults nutritional needs is 2

mg. It is not likely that the approval of

this petition would significantly

increase exposure over that of the

existing levels of copper.

2. Drinking water exposure. Copper is

a natural element found in the earth’s

crust. As a result, most of the world’s

surface water and ground water that is

used for drinking purposes contains

copper. The actual amount varies from

region to region, depending on how

much is present in the earth, but in

almost all cases the amount of copper in

water is extremely low. Naturally

occurring copper in drinking water is

safe for human consumption, even in

rare instances where it is at levels high

enough to impart a metallic taste to the

water. The Agency has set a maximum

contaminant level for copper at 1.3 ppm

because the Agency believes that this

level of protection would not cause any

potential health problems, i.e. stomach

and intestinal distress, liver and kidney

damage, and anemia. It is not likely that

the approval of this petition would

significantly increase exposure over that

of the existing levels of copper.

B. Other Non–Occupational Exposure

Copper compounds have many uses

on crops (food as well as non food) and

ornamentals as a fungicide.

1. Dermal exposure. Given the

prevalence of copper in the

environment, no significant increase

above current levels would be expected

from the dermal non–occupational use

of copper sulfate pentahydrate.

2. Inhalation exposure. Air

concentrations of copper are relatively

low. A study based on several thousand

samples assembled by EPA’s

Environmental Monitoring Systems

Laboratory showed copper levels

ranging from 0.003 to 7.32 micrograms

per cubic meter. Other studies indicate

that air levels of copper are much lower.

The Agency does not expect the air

concentration of copper to be

significantly affected by the use of

copper sulfate pentahydrate.

V. Cumulative Effects

The Agency believes that copper has

no significant toxicity to humans and

that no cumulative adverse effects are

expected from long–term exposure to

copper salts including copper sulfate

pentahydrate. EPA does not have, at this

time, available data to determine

whether copper compounds have a

common mechanism of toxicity with

other substances or how to include this

inert ingredient in a cumulative risk

assessment. For the purposes of this

tolerance action, EPA has not assumed

that copper compounds have a common

mechanism of toxicity with other

substances.

VI. Determination of Safety for U.S.

Population, Infants and Children

Copper sulfate pentahydrate is

considered as Generally Recognized as

Safe (GRAS) by the Food and Drug

Administration. EPA has exempted

various copper compounds from the

requirement of a tolerance when used as

aquatic herbicides (40 CFR 180.1021).

Copper compounds are also exempt

from the requirements of a tolerance

when applied to growing crops when

used as a plant fungicide in accordance

with good agricultural practices (40 CFR

180.1001 (b)(1)).

1. U.S. population. Copper is a

component of the human diet and an

essential element. Use of copper sulfate

pentahydrate is not expected to increase

the amount of copper in the diet as a

result of its use on growing crops and

post harvest use.

2. Infants and children. Copper is also

a component of the diet of infants and

children and also an essential element

of their diet. Because of copper’s low

toxicity, EPA has not used a safety

factor approach to analyze the safety of

copper sulfate pentahydrate used in

growing crops as well as post harvest.

For similar reasons, an additional ten–

fold margin of safety is not necessary for

the protection of infants and children.

Based on the information in this

preamble, EPA concludes that there is a

reasonable certainty of no harm to the

general population, including infants

and children, from aggregate exposure

to copper sulfate pentahydrate residues.

VII. Other Considerations

A. Analytical Method(s)

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.

B. Existing Tolerance Exemptions

Copper sulfate pentahydrate has been

exempted from the requirement of a

tolerance under 40 CFR 180.1001(b)(1)

when applied to growing crops.

C. International Tolerances

The Agency is not aware of any

country requiring a tolerance for copper

sulfate pentahydrate nor have any

CODEX Maximum Residue Levels

(MRLs) been established for any food

crops at this time.

VIII. Conclusions

Based on the information in this

preamble, EPA concludes that there is a

reasonable certainty of no harm from

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations 68911

aggregate exposure to residues of copper

sulfate pentahydrate. Accordingly, EPA

finds that exempting post harvest uses

of copper sulfate pentahydrate from the

requirement of a tolerance will be safe.

Although the petitioner requested an

exemption with a maximum residue

limit, the Agency does not generally

grant an exemption from the

requirement of a tolerance with a

numerical limitation. Given the lack of

toxicity of this compound, EPA is

following its general practice of not

establishing a numerical limitation with

this exemption.

In examining the existing tolerance

exemptions for copper compounds, it

was observed that the exemptions from

the requirement of a tolerance are in two

places in the Code of Federal

Regulations, 40 CFR 180.1001 (b)(1) and

40 CFR 180.1021. For ease of use, all of

these exemptions from the requirement

of a tolerance are being placed in

180.1021. While reordering of the

structure of the CFR is occurring, there

have not been any changes with respect

to the exemptions from the requirement

of a tolerance of these copper

compounds. However, copper sulfate

pentahydrate is now exempt from the

requirement of a tolerance when applied

as a fungicide to growing crops or to raw

agricultural commodities after harvest.

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–301060 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 January 16, 2001.

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 email 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–301060, 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).

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

68912 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations

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:October 31, 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), 346(a) and

371.

§ 180.1001 [Amended]

2. Section 180.1001 is amended by

removing and reserving the text of

paragraph (b)(1).

3. Section 180.1021 is revised to read

as follows:

§ 180.1021 Copper; exemption from the

requirement of a tolerance.

(a) Copper is exempted from the

requirement of a tolerance in meat,

milk, poultry, eggs, fish, shellfish, and

irrigated crops when it results from the

use of:

(1) Copper sulfate as an algicide or

herbicide in irrigation conveyance

systems and lakes, ponds, reservoirs, or

bodies of water in which fish or

shellfish are cultivated.

(2) Basic copper carbonate (malachite)

as an algicide or herbicide in

impounded and stagnant bodies of

water

(3) Copper triethanolamine and

copper monoethanolamine as an

algicide or herbicide in fish hatcheries,

lakes, ponds, and reservoirs

(4) Cuprous oxide bearing antifouling

coatings for control of algae or other

coatings for control of algae or other

organisms on submerged concrete or

other (irrigation) structures.

(b) The following copper compounds

are exempt from the requirement of a

tolerance when applied (primarily) as a

fungicide to growing crops using good

agricultural practices: Bordeaux

mixture, basic copper carbonate

(malachite) (CAS Reg. No. 1184–64–1),

copper ethylenediamine complex,

copper hydroxide (CAS Reg. No. 20427–

59–2), copper lime mixtures, copper

linoleate (CAS Reg. No. 7721–15–5),

copper octanoate (CAS Reg. No. 20543–

04–8), copper oleate (CAS Reg. No.

10402–16–1), copper oxychloride (CAS

Reg. No. 1332–40–7), copper sulfate

basic (CAS Reg. No. 1344–73–6), cupric

oxide (CAS Reg. No. 1317–38–0), and

cuprous oxide (CAS Reg. No. 1317–19–

1).

(c) Copper sulfate pentahydrate (CAS

Reg. No. 7758–99–8) is exempt from the

requirement of a tolerance when applied

as a fungicide to growing crops or to raw

agricultural commodities after harvest.

[FR Doc. 00–28715 Filed 11–14–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301077; FRL–6753–3]

RIN 2070–AB78

Pyriproxyfen; Extension of Tolerance

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation re-establishes

a time-limited tolerance for residues of

the insecticide Pyriproxyfen and its

metabolites in or on stone fruits (Crop

Group 12) at 0.1 part per million (ppm)

for approximately an additional 2–year

period. This tolerance will expire and is

revoked on December 31, 2002. This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on stone

fruits. Section 408(l)(6) of the Federal

Food, Drug, and Cosmetic Act requires

EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by