30366 Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Proposed Rules

that we will consider information such

as the pest risk assessment and risk

management analysis prepared for the

rulemaking that established the current

program; fruit fly trapping data and pest

survey data from the growing area; fruit

cutting data from both the

packinghouses in Mexico and the U.S.

port-of-entry inspections; temperature

data for the production areas in Mexico,

the currently approved States, and any

States that might be added; and the

results of APHIS’ most recent

comprehensive review of the Mexican

Hass avocado program. Copies of this

information may be obtained by calling

or writing to the person listed under FOR

FURTHER INFORMATION CONTACT.

We are asking the public for its

comments and recommendations

regarding the scope of our review and

are soliciting any additional data or

information that may have a bearing on

our review of the Mexican

Government’s request. We wish to

emphasize the preliminary nature of our

review; we are not, at this time,

proposing to make any changes to the

provisions of the current Mexican

avocado import program found in

§ 319.56–2ff. We would, therefore, ask

that any comments focus on the

scientific, technical, or other issues that

commenters believe should be

considered during our review of the

Mexican Government’s request.

If, after completing our review of the

available data and any pertinent

information submitted by the public, we

conclude that there are sufficient data

available to support Mexico’s request,

APHIS will prepare a proposed rule for

public comment before making any final

decision to approve additional States to

receive Mexican Hass avocados or to

expand the shipping season to include

the months of October and March.

Authority: 7 U.S.C. 150dd, 150ee, 150ff,

151–167, 450, 2803, and 2809; 21 U.S.C. 136

and 136a.

Done in Washington, DC, this 8th day of

May 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–11835 Filed 5–10–00; 8:45 am]

BILLING CODE 3410–34–P

RAILROAD RETIREMENT BOARD

20 CFR Part 217

RIN 3220–AB45

Application for Annuity or Lump Sum

AGENCY: Railroad Retirement Board.

ACTION: Proposed rule.

SUMMARY: The Railroad Retirement

Board hereby proposes to amend its

regulations to enable a divorced spouse

who remarries the employee within six

months of the divorce to use the spouse

application to qualify for a divorced

spouse annuity for the period prior to

the remarriage. This amendment will

eliminate the necessity for the spouse to

file a separate application for a short

period of benefits.

DATES: Comments must be received on

or before July 10, 2000.

ADDRESSES: Comments may be

addressed to the Secretary to the Board,

Railroad Retirement Board, 844 North

Rush Street, Chicago, Illinois 60611.

FOR FURTHER INFORMATION CONTACT:

Michael C. Litt, General Attorney,

Railroad Retirement Board, telephone

(312) 751–4929, TTD (312) 751–4701.

SUPPLEMENTARY INFORMATION: Section

217.8 of the Board’s regulations

describes situations where the Board

will accept an application filed for one

type of annuity as an application for

another type of annuity. An application

may be effective for the period six

months prior to the date of filing. This

amendment will add a provision to

enable a divorced spouse who remarries

the employee within six months of the

divorce to use the spouse application to

qualify for a divorced spouse annuity

for the period after the divorce and prior

to the remarriage. In such cases the

requirement that a claimant be married

to the employee for a period of one year

prior to application for a spouse

annuity, as required by § 216.54 of this

part, is waived.

The Board, with the concurrence of

the Office of Management and Budget,

has determined that this is not a

significant regulatory action under

Executive Order 12866; therefore, no

regulatory impact analysis is required.

There are no information collections

associated with this rule.

List of Subjects in 20 CFR Part 217

Railroad employees, Railroad

retirement.

For the reasons set out in the

preamble, the Railroad Retirement

Board proposes to amend chapter II of

title 20 of the Code of Federal

Regulations as follows:

PART 217—APPLICATION FOR

ANNUITY OR LUMP SUM

1. The authority citation for part 217

continues to read as follows:

Authority: 45 U.S.C. 231d and 45 U.S.C.

231f.

2. In subpart B, § 217.8, redesignate

paragraphs (m) through (u) as (n)

through (v), and add a new paragraph

(m) to read as follows:

§ 217.8 When one application satisfies the

filing requirement for other benefits.

* * * * *

(m) A divorced spouse annuity if the

spouse claimant has remarried the

employee during the six-month

retroactive period of the spouse annuity

application.

* * * * *

Dated: May 4, 2000.

By authority of the Board.

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 00–11855 Filed 5–10–00; 8:45 am]

BILLING CODE 7905–01–P

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; Companion to Direct Final

Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend 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.

This proposed rule is a companion

document to the direct final rule

Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Proposed Rules 30367

published elsewhere in this issue of the

Federal Register.

DATES: Submit written comments on

this proposed rule by July 25, 2000. If

FDA receives no significant adverse

comment on the provisions of these

regulations 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 in the direct final

rule ends. The direct final rule will be

effective August 24, 2000.

ADDRESSES: Submit written comments

on this companion proposed 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

A. Rulemaking

This proposed rule is a companion to

the direct final rule published in the

final rules section of this issue of the

Federal Register. The direct final rule

and this companion proposed rule are

substantively identical. FDA is

publishing the direct final rule because

the rule contains noncontroversial

changes, and FDA anticipates that it

will receive no significant adverse

comments. If no significant adverse

comment is received in response to the

direct final rule, no further action will

be taken related to this proposed rule.

Instead, FDA will publish a

confirmation document within 30 days

after the comment period ends

confirming that the direct final rule will

go into effect on August 24, 2000.

Additional information about FDA’s

direct final rulemaking procedures is set

forth in a guidance published in the

Federal Register of November 21, 1997

(62 FR 62466).

The comment period for this

companion proposed rule runs

concurrently with the direct final rule’s

comment period. Any comments

received under this companion

proposed rule will also be considered as

comments regarding the direct final

rule. If FDA receives any significant

adverse comment regarding either this

proposed rule or the direct final rule,

FDA will publish a document

withdrawing the direct final rule within

30 days after the comment period ends

and will proceed to respond to all of the

comments under this companion

proposed rule using customary noticeand-comment procedures. 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 a 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 adverse under this

procedure. For example, a comment

recommending a rule change in addition

to the rule will not be considered a

significant adverse comment, unless the

comment states 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.

B. Background

In 1958, Congress amended the act to

require premarket approval of food

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

and 409 of the act (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 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

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 the direct final rule and this

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

below, FDA has concluded that agency

activities under section 409(h) of the act

are subject to NEPA’s procedural

requirements. Furthermore, as also

discussed below, FDA currently expects

that most PMN’s will be subject to a

categorical exclusion (see 40 CFR

1508.4; §§ 25.30 and 25.32 (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

30368 Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Proposed Rules

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 below, 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 that 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 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 companion proposed rule

proposes to amend § 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

anticipates that a majority of PMN’s will

be subject to a categorical exclusion.

III. Analysis of Economic impacts

A. Benefit-Cost Analysis

FDA has examined the economic

implications of this companion

proposed 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 companion

proposed 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 million

(adjusted annually for inflation) in any

1 year.’’ FDA has determined that this

companion proposed 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

companion proposed rule is not a major

rule for the purpose of congressional

review.

The companion proposed 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

Federal Register / Vol. 65, No. 92 / Thursday, May 11, 2000 / Proposed Rules 30369

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 companion

proposed 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 companion proposed rule will

not have a significant impact on a

substantial number of small entities.

This companion proposed 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

proposed rule will not result in any

additional costs to any firm. Therefore,

this proposed rule will not have a

significant impact on a substantial

number of small entities.

IV. Paperwork Reduction Act of 1995

FDA tentatively concludes that this

companion proposed rule contains no

collection of information. Therefore,

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995 is not required.

V. 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

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Comments

Interested persons may, by July 24,

2000, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. This comment period runs

concurrently with the comment period

for the direct final 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 received comments

will be considered as comments

regarding the direct final rule and this

proposed rule. In the event the direct

final rule is withdrawn, all comments

received will be considered comments

on this proposed rule.

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, it is proposed that

21 CFR part 25 be 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 an

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. 00–11750 Filed 5–10–00; 8:45 am]

BILLING CODE 4160–01–F

OVERSEAS PRIVATE INVESTMENT

CORPORATION

22 CFR Part 706

RIN 3420–ZA00

Information Disclosure

AGENCY: Overseas Private Investment

Corporation.

ACTION: Proposed rule.

SUMMARY: This proposed rule revises the

Overseas Private Investment

Corporation’s (‘‘OPIC’’) Freedom of

Information Act (‘‘FOIA’’) regulations by