30352 Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations

(65 FR 5860), and by the Commission on

April 17, 2000, 65 FR 20352.

Regulatory Flexibility Act

The provisions of the Regulatory

Flexibility Act relating to a Regulatory

Flexibility Act analysis (5 U.S.C. 603–

604) are not applicable to this

proceeding because the amendments do

no impose any new obligations on

entities regulated by the Appliance

Labeling Rule. Thus, the amendments

will not have a ‘‘significant economic

impact on a substantial number of small

entities’’ (5 U.S.C. 605). The

Commission has concluded, therefore,

that a regulatory flexibility analysis is

not necessary, and certifies, under

Section 605 of the Regulatory Flexibility

Act (5 U.S.C. 605(b)), that the

amendments announced today will not

have a significant economic impact on

a substantial number of small entities.

Paperwork Reduction Act

The Paperwork Reduction Act

(‘‘PRA’’), 44 U.S.C. 3501 et seq., requires

government agencies, before

promulgating rules or other regulations

that require ‘‘collections of information’’

(i.e., recordkeeping, reporting, or thirdparty disclosure requirements), to obtain

approval from the Office of Management

and Budget (‘‘OMB’’), 44 U.S.C. 3502.

The Commission currently has OMB

clearance for the Rule’s information

collection requirements (OMB No.

3084–0069). The amendment will not

impose any new information collection

requirements. Instead, it will provide

manufacturers with revised ranges of

comparability to use on the

EnergyGuide labels already required by

the Rule.

List of Subjects in 16 CFR Part 305

Advertising, Energy conservation,

Household appliances, Labeling,

Reporting and recordkeeping

requirements.

Accordingly, 16 CFR Part 305 is

amended as follows:

PART 305—[AMENDED]

1. The authority citation for Part 305

continues to read as follows:

Authority: 42 U.S.C. 6294.

2. Appendix F to Part 305 is revised

to read as follows:

Appendix F to Part 305—Clothes

Washers

Range Information

‘‘Compact’’ includes all household

clothes washers with a tub capacity of

less than 1.6 cu. ft. or 13 gallons of

water.

‘‘Standard’’ includes all household

clothes washers with a tub capacity of

1.6 cu. ft or 13 gallons of water or more.

Capacity

Range of estimated annual

energy consumption

(kWh/yr.)

Low High

Compact .. 576 607

Standard .. 177 1298

Cost Information

When the above ranges of

comparability are used on EnergyGuide

labels for clothes washers, the estimated

annual operating cost disclosures

appearing in the box at the bottom of the

labels must be derived using the 2000

Representative Average Unit Costs for

electricity (8.03¢ per kilo Watt-hour)

and natural gas (68.8¢ per therm), and

the text below the box must identify the

costs as such.

Donald S. Clark,

Secretary.

[FR Doc. 00–11605 Filed 5–10–00; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 25

[Docket No. 00N–0085]

National Environmental Policy Act;

Food Contact Substance Notification

System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations on environmental impact

considerations as part of the agency’s

implementation of the FDA

Modernization Act (FDAMA) of 1997.

FDAMA amended the Federal Food,

Drug, and Cosmetic Act (the act) to

establish a notification process for food

contact substances (FCS); this process

will be the primary method for

authorizing new uses of food additives

that are FCS, and it will largely replace

the existing food additive petition

process for such substances. The

regulations will expand the existing

categorical exclusions to include

allowing a notification submitted under

the act to become effective and will

amend the list of those actions that

require an environmental assessment

(EA) to add allowing a notification

under the act to become effective in

cases where a categorical exclusion

doesn’t apply. This will allow notifiers

of FCS to claim the categorical

exclusions now available to sponsors of

other requests for authorization of FCS.

Elsewhere in this issue of the Federal

Register, FDA is publishing a

companion proposed rule, under FDA’s

usual procedures for notice and

comment to provide a procedural

framework to finalize the rule in the

event the agency receives any

significant adverse comment and

withdraws the direct final rule.

DATES: This rule is effective August 24,

2000. Submit written comments by July

25, 2000. If FDA receives no significant

adverse comments within the specified

comment period, the agency intends to

publish a document confirming the

effective date of the final rule in the

Federal Register within 30 days after

the comment period on this direct final

rule ends. If timely significant adverse

comments are received, the agency will

publish a document in the Federal

Register withdrawing this direct final

rule before its effective date.

ADDRESSES: Submit written comments

on the direct final rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mitchell A. Cheeseman, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3083.

SUPPLEMENTARY INFORMATION:

I. Introduction

In 1958, Congress amended the act to

require premarket approval of food

additives (sections 201(s), 402(a)(2)(C),

and 409 (21 U.S.C. 321(s), 342(a)(2)(C),

and 348)). ‘‘Food additive’’ is defined in

section 201(s) of the act as ‘‘any

substance the intended use of which

results or may reasonably be expected to

result, directly or indirectly, in its

becoming a component or otherwise

affecting the characteristics of any

food,’’ unless, among other reasons,

such substance is generally recognized

as safe (GRAS) by qualified experts or is

prior sanctioned for its intended use.

Under section 409 of the act as

originally established, food additives

require premarket approval by FDA and

publication of a regulation authorizing

their intended use. Subsequently, in

1995, FDA codified a process, the

‘‘threshold of regulation’’ process (21

CFR 170.39), by which certain food

additives may be exempted from the

requirement of a listing regulation if the

Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations 30353

substance is expected to migrate to food

at only negligible levels (60 FR 36582,

July 17, 1995).

More recently, FDAMA amended

section 409 of the act to establish a

premarket notification (PMN) process as

the primary method for authorizing new

uses of food additives that are FCS. FDA

expects most new uses of FCS that

previously would have been regulated

by issuance of a listing regulation in

response to a food additive petition or

would have been exempted from the

requirement of a regulation under the

threshold of regulation process will be

the subject of PMN’s.

As part of the agency’s process of

implementing FDAMA’s amendments to

section 409 of the act, FDA convened a

public meeting on March 12, 1999, to

provide interested parties with an

opportunity to comment on FDA’s

current thinking on administration of

the PMN process. As a result of the

March 12, 1999, public meeting, FDA

received comments on the applicability

of the National Environmental Policy

Act (NEPA) (42 U.S.C. 4321 et seq.

(1998)) to the notification process for

food contact substances. FDA has

considered those comments in

developing this direct final rule and the

companion proposed rule. FDA has

filed copies of the transcript of the

meeting and the comments received

from interested parties with the Dockets

Management Branch (address above)

(Docket No. 99N–0235). The transcript

and comments are available for public

review at the Dockets Management

Branch.

II. Analysis of the Applicability of

NEPA to the Notification Process

As part of implementing the FDAMA

amendments on food contact

substances, FDA has considered the

applicability of NEPA to the PMN

process. As discussed in more detail in

this section, FDA has concluded that

agency activities under section 409(h) of

the act are subject to NEPA’s procedural

requirements. Furthermore, as also

discussed in this section, FDA currently

expects that most PMN’s will be subject

to a categorical exclusion. (See 40 CFR

1508.4; 21 CFR 25.30 and 25.32.)

Congress enacted NEPA in 1969 to

ensure that Federal Government

agencies consider the environmental

effects of proposed Federal actions.

NEPA’s purpose is to ensure that ‘‘the

Agency, in reaching its decision, will

have available, and will carefully

consider, detailed information

concerning significant environmental

impacts.’’ (Robertson v. Methow Valley

Citizens Council, 490 U.S. 332, 349

(1989).) NEPA requires agencies to

‘‘include in every recommendation or

report on proposals for legislation and

other major federal actions significantly

affecting the quality of the human

environment, a detailed statement by

the responsible official on * * * the

environmental impact of the proposed

action * * *. ’’ (See 42 U.S.C.

4332(2)(C).) Regulations implementing

NEPA define ‘‘major federal action’’ as:

* * * actions with effects that may be

major and which are potentially subject to

Federal control and responsibility. Major

reinforces but does not have a meaning

independent of significantly (40 CFR

1508.27). Actions include the circumstance

where the responsible officials fail to act and

that failure to act is reviewable by courts or

administrative tribunals under the

Administrative Procedure Act or other

applicable law as Agency action (40 CFR

1508.18).

FDA has concluded that under the

NEPA implementing regulations, NEPA

applies to FDA’s decision not to object

to a PMN. Under section 409(h) of the

act, if FDA does not object to an FCS

notification within 120 days of filing,

the notification becomes effective and

the substance may legally be marketed

for the notified use. As discussed in

more detail, under the relevant case law,

FDA has concluded that this inaction

constitutes final agency action under the

Administrative Procedure Act (APA). As

a final agency action, FDA’s decision

not to object is subject to NEPA’s

procedural requirements.

Under the APA, unless otherwise

provided by statute, only ‘‘final Agency

action’’ is subject to judicial review (5

U.S.C. 704). The Supreme Court

recently held that to meet the finality

requirement, agency action ‘‘must mark

the consummation of the Agency’s

decision making process—it must not be

of a merely tentative or interlocutory

nature,’’ and ‘‘must be one by which

rights or obligations have been

determined, or from which legal

consequences will flow.’’ (Bennett v.

Spear, 520 U.S. 154, 177 (1997).) Both

conditions must be satisfied for agency

action to be considered ‘‘final.’’ Id.

Inaction under section 409(h) of the act

meets both parts of this test. First, the

consummation requirement is met

because, by operation of law, if FDA

does not object, the agency can be

considered to have reached its

conclusion about the safety of the

substance. Second, the determination of

rights and obligations requirement is

met because, under section 409(h)(2)(A)

of the act, the notifier may now market

the FCS for the notified use in the

United States. This authorization for

marketing is a ‘‘direct and appreciable’’

legal consequence of the agency’s

decision not to object. Id. at 178.

FDA currently believes that a

notification for a food contact substance

must contain either an EA or a claim of

categorical exclusion. If the

environmental component of a

notification is missing or deficient

under 21 CFR 25.40, the agency will not

accept the notification for review. In

cases where the agency does not accept

a notification based on deficiencies in

environmental information, FDA

expects to inform the notifier in writing

within 30 days of receipt of the

submission.

In adopting procedures to implement

NEPA, Federal agencies are directed to

reduce paperwork (40 CFR 1500.4 and

1500.2(b)) and to reduce delay (40 CFR

1500.5) by using several means,

including the use of categorical

exclusions. A categorical exclusion is a

category of actions which do not

individually or cumulatively have a

significant effect on the human

environment and for which neither an

EA nor an Environmental Impact

Statement (EIS) is required (40 CFR

1508.4).

FDA has identified a number of

categorical exclusions in its

environmental regulations in part 25 (21

CFR part 25), including some specified

uses of certain food packaging materials

when approval is sought through the

food additive petition process or

exemption through the threshold of

regulation process. For example, when

the substance is a component of a

coating of a finished food-packaging

material or is present in such material

at not greater than 5 percent-by-weight,

and it is expected to remain with the

finished food contact material through

use by the consumer, neither an EA nor

EIS is required to be submitted

(§ 25.32(i)).

This direct final rule amends

§ 25.20(i) to add allowing a notification

submitted under section 409(h) of the

act to become effective to the list of

those actions that require an EA. In

addition this document will expand the

existing categorical exclusions in

§ 25.32(i), (j), (k), (q), and (r) to include

allowing a notification submitted under

section 409(h) of the act to become

effective. Any existing categorical

exclusions for food additive petitions or

threshold of regulation exemption

requests for such food contact materials

could logically be extended to cover

PMN’s for such materials because the

effects on the environment of allowing

marketing of the substances—regardless

of the process of authorization—are

comparable in either case. Based on

FDA’s experience, the agency

30354 Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations

anticipates that a majority of PMN’s will

be subject to a categorical exclusion.

III. Rulemaking Action

In the Federal Register of November

21, 1997 (62 FR 62466), FDA described

when and how it will employ direct

final rulemaking. FDA believes that this

rule is appropriate for direct final

rulemaking because FDA views this rule

as making noncontroversial

amendments to an existing regulation,

and FDA anticipates no significant

adverse comment. Consistent with

FDA’s procedures on direct final

rulemaking, elsewhere in this issue of

the Federal Register, FDA is publishing

a companion proposed rule to amend

the existing relevant regulations in part

25. The companion proposed rule is

identical to the direct final rule. The

companion proposed rule provides a

procedural framework within which the

rule may be finalized in the event that

the direct final rule is withdrawn

because of any significant adverse

comment. The comment period for the

direct final rule runs concurrently with

the comment period of the companion

proposed rule. Any comments received

under the companion proposed rule will

be considered as comments regarding

the direct final rule.

FDA is providing a comment period

on the direct final rule of 75 days after

May 11, 2000. If the agency receives any

significant adverse comments, FDA

intends to withdraw this final rule by

publication of a document in the

Federal Register within 30 days after

the comment period ends. A significant

adverse comment is a comment that

explains why the rule would be

inappropriate, including challenges to

the rule’s underlying premise or

approach, or would be ineffective or

unacceptable without change. In

determining whether a significant

adverse comment is sufficient to

terminate a direct final rulemaking, FDA

will consider whether the comment

raises an issue serious enough to

warrant a substantive response in a

notice-and-comment process. Comments

that are frivolous, insubstantial, or

outside the scope of the rule will not be

considered significant or adverse under

this procedure. For example, a comment

requesting an amendment of part 25

requirements for food additive petitions

will not be considered a significant

adverse comment because it is outside

the scope of the direct final rule. On the

other hand, a comment recommending

an additional change to the rule may be

considered a significant adverse

comment if the comment explains why

the rule would be ineffective without

the additional change. In addition, if a

significant adverse comment applies to

an amendment, paragraph, or section of

this rule and that provision can be

severed from the remainder of the rule,

FDA may adopt as final those provisions

of the rule that are not the subject of a

significant adverse comment.

If FDA withdraws the direct final rule,

all comments received will be

considered under the companion

proposed rule in developing a final rule

under the usual notice-and-comment

procedures of the APA (5 U.S.C. 552 et

seq.). If FDA receives no significant

adverse comment during the specified

comment period, FDA intends to

publish a confirmation document in the

Federal Register within 30 days after

the comment period ends. Because the

direct final rule grants an exemption

from the requirement to file an EA,

under 5 U.S.C. 553(d), the rule may be

made immediately effective. Therefore,

FDA intends to make the direct final

rule effective on the date the

confirmation document is published in

the Federal Register.

IV. Analysis of Economic Impacts

A. Benefit-Cost Analysis

FDA has examined the economic

implications of this final rule under

Executive Order 12866. Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select the regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). Executive Order

12866 classifies a rule as significant if

it meets any one of a number of

specified conditions, including: Having

an annual effect on the economy of $100

million, adversely affecting a sector of

the economy in a material way,

adversely affecting competition, or

adversely affecting jobs. A regulation is

also considered significant if it raises

novel legal or policy issues. FDA has

determined that this final rule is not a

significant regulatory action as defined

by Executive Order 12866.

The Unfunded Mandates Reform Act

of 1995 (Public Law 104–4), requiring

cost-benefit and other analyses, in

section 1531(a) defines a significant rule

as ‘‘a Federal mandate that may result

in the expenditure by State, local, and

tribal governments in the aggregate, or

by the private sector, of $100,000,000

(adjusted annually for inflation) in any

1 year.’’ FDA has determined that this

final rule does not constitute a

significant rule under the Unfunded

Mandates Reform Act.

The Small Business Regulatory

Enforcement Fairness Act of 1996

(Public Law 104–121) defines a major

rule for the purpose of congressional

review as having caused or being likely

to cause one or more of the following:

An annual effect on the economy of

$100 million; a major increase in costs

or prices; significant effects on

competition, employment, productivity,

or innovation; or significant effects on

the ability of U.S.-based enterprises to

compete with foreign-based enterprises

in domestic or export markets. In

accordance with the Small Business

Regulatory Enforcement Fairness Act,

FDA has determined that this final rule

is not a major rule for the purpose of

congressional review.

The final rule allows firms using the

new notification process for food

contact substances to claim the same

categorical exclusions from the

requirement of an EA that are currently

applicable for food additive petitions

and threshold of regulation exemption

requests for the same uses. The rule

therefore imposes no additional costs on

producers or consumers.

B. Small Entity Analysis

FDA has examined the economic

implications of this final rule as

required by the Regulatory Flexibility

Act (5 U.S.C. 601–612). If a rule has a

significant economic impact on a

substantial number of small entities, the

Regulatory Flexibility Act requires

agencies to analyze regulatory options

that would lessen the economic effect

on the rule on small entities. The agency

certifies that this final rule will not have

a significant impact on a substantial

number of small entities.

This final rule will permit notifiers

under the new notification process for

FCS to claim the same categorical

exclusions from the requirement of an

EA that are currently applicable for food

additive petitions and threshold of

regulation exemption requests for the

same uses. The final rule will not result

in any additional costs to any firm.

Therefore, this final rule will not have

a significant impact on a substantial

number of small entities.

V. Paperwork Reduction Act of 1995

This direct final rule contains no

collections of information. Therefore,

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995 is not required.

VI. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Rules and Regulations 30355

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VII. Comments

Interested persons may, on or before

July 25, 2000, submit to the Dockets

Management Branch (address above)

written comments regarding this direct

final rule. This comment period runs

concurrently with the comment period

for the companion proposed rule. Two

copies of any comment are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday. All comments received

will be considered comments regarding

the proposed rule and this direct final

rule. In the event the direct final rule is

withdrawn, all comments received

regarding the companion proposed rule

and the direct final rule will be

considered comments on the proposed

rule.

VIII. Report to Congress

For purposes of congressional review

requirements under 5 U.S.C. 801–808,

the report to Congress for this direct

final rule will be issued when FDA

confirms the effective date of this rule.

Thus, no report is due at this time. If,

however, a significant adverse comment

is received, the agency will withdraw

this direct final rule and no report will

be issued to Congress.

List of Subjects in 21 CFR Part 25

Environmental impact statements,

Foreign relations, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 25 is

amended as follows:

PART 25—ENVIRONMENTAL IMPACT

CONSIDERATIONS

1. The authority citation for 21 CFR

part 25 continues to read as follows:

Authority: 21 U.S.C. 321–393; 42 U.S.C.

262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR

parts 1500–1508; E.O. 11514, 35 FR 4247, 3

CFR, 1971 Comp., p. 531–533 as amended by

E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp.,

p. 123–124 and E.O. 12114, 44 FR 1957, 3

CFR, 1980 Comp., p. 356–360.

2. Section 25.20 is amended by

revising paragraph (i) to read as follows:

§ 25.20 Actions requiring preparation of an

environmental assessment.

* * * * *

(i) Approval of food additive petitions

and color additive petitions, approval of

requests for exemptions for

investigational use of food additives, the

granting of requests for exemption from

regulation as a food additive under

§ 170.39 of this chapter, and allowing

notifications submitted under 21 U.S.C.

348(h) to become effective, unless

categorically excluded in § 25.32(b), (c),

(i), (j), (k), (l), (o), (q), or (r).

* * * * *

3. Section 25.32 is amended by

revising paragraphs (i), (j), (k), (q), and

(r) to read as follows:

§ 25.32 Foods, food additives, and color

additives.

* * * * *

(i) Approval of a food additive

petition or GRAS affirmation petition,

the granting of a request for exemption

from regulation as a food additive under

§ 170.39 of this chapter, or allowing a

notification submitted under 21 U.S.C.

348(h) to become effective, when the

substance is present in finished foodpackaging material at not greater than 5

percent-by-weight and is expected to

remain with finished food-packaging

material through use by consumers or

when the substance is a component of

a coating of a finished food-packaging

material.

(j) Approval of a food additive

petition or GRAS affirmation petition,

the granting of a request for exemption

from regulation as a food additive under

§ 170.39 of this chapter, or allowing a

notification submitted under 21 U.S.C.

348(h) to become effective, when the

substance is to be used as a component

of a food-contact surface of permanent

or semipermanent equipment or of

another food-contact article intended for

repeated use.

(k) Approval of a food additive

petition, color additive petition, or

GRAS affirmation petition, or allowing

a notification submitted under 21 U.S.C.

348(h) to become effective, for

substances added directly to food that

are intended to remain in food through

ingestion by consumers and that are not

intended to replace macronutrients in

food.

* * * * *

(q) Approval of a food additive

petition, the granting of a request for

exemption from regulation as a food

additive under § 170.39 of this chapter,

or allowing a notification submitted

under 21 U.S.C. 348(h) to become

effective for a substance registered by

the Environmental Protection Agency

under FIFRA for the same use requested

in the petition, request for exemption, or

notification.

(r) Approval of a food additive

petition, color additive, GRAS

affirmation petition, or allowing a

notification submitted under 21 U.S.C.

348(h) to become effective for a

substance that occurs naturally in the

environment, when the action does not

alter significantly the concentration or

distribution of the substance, its

metabolites, or degradation products in

the environment.

Dated: January 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–11749 Filed 5–10–00; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA 154–0236; FRL–6587–1]

Revisions to the California State

Implementation Plan, Mojave Desert

Air Quality Management District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is finalizing a limited

approval and limited disapproval of

revisions to the Mojave Desert Air

Quality Management District portion of

the California State Implementation

Plan (SIP). This action was proposed in

the Federal Register on March 2, 2000

and concerns oxide of nitrogen (NOx)

emissions from cement kilns. Under

authority of the Clean Air Act as

amended in 1990 (CAA or the Act), this

action simultaneously approves local

rules that regulate these emission

sources and directs California to correct

rule deficiencies.

EFFECTIVE DATE: This rule is effective on

June 12, 2000.

ADDRESSES: You can inspect copies of

the administrative record for this action

at EPA’s Region IX office during normal

business hours. You can inspect copies

of the submitted rule revisions at the

following locations:

Environmental Protection Agency,

Region IX, 75 Hawthorne Street, San

Francisco, CA 94105–3901.

Environmental Protection Agency, Air

Docket (6102), Ariel Rios Building,

1200 Pennsylvania Avenue, N.W.,

Washington D.C. 20460.

California Air Resources Board,

Stationary Source Division, Rule