31840 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Rules and Regulations

PART 200—ORGANIZATION;

CONDUCT AND ETHICS; AND

INFORMATION AND REQUESTS

Subpart A—Organization and Program

Management

1. The authority citation for Part 200,

Subpart A, continues to read, in part, as

follows:

Authority: 15 U.S.C. 77s, 78d–1, 78d–2,

78w, 78ll(d), 78mm, 79t, 77sss, 80a–37, 80b–

11, unless otherwise noted.

* * * * *

2. Section 200.30–3 is amended by

adding paragraph (a)(73) to read as

follows:

§ 200.30–3 Delegation of authority to

Director of Division of Market Regulation.

* * * * *

(a) * * *

(73) Pursuant to section 6(a) of the

Act, 15 U.S.C. 78f(a), and Rule 6a–1

thereunder, 17 CFR 240.6a–1:

(i) To publish a notice of filing of an

application for registration as a national

securities exchange, or for exemption

from registration based on limited

volume; and

(ii) To publish amendments to an

application for registration as a national

securities exchange, or for exemption

from registration based on limited

volume.

* * * * *

Dated: June 7, 2001.

By the Commission.

Jonathan G. Katz,

Secretary.

[FR Doc. 01–14830 Filed 6–12–01; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 00F–1488]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of acidified sodium chlorite

solutions as an antimicrobial agent on

processed, comminuted or formed meat

food products (unless precluded by

United States Department of

Agriculture’s standards of identity) prior

to packaging of the food for commercial

purposes in accordance with current

industry standards of good

manufacturing practice. This action is in

response to a petition filed by Alcide

Corp.

DATES: This rule is effective June 13,

2001. Submit written objections and

requests for a hearing by July 13, 2001.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, Washington,

DC 20204–0001, 202–418–3074.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 11, 2000 (65 FR 54855), FDA

announced that a food additive petition

(FAP 0A4724 ) had been filed by Alcide

Corp., 8561 154th Ave. NE., Redmond,

WA 98052. The petition proposed to

amend the food additive regulations in

§ 173.325 Acidified sodium chlorite

solutions (21 CFR 173.325) to provide

for the safe use of acidified sodium

chlorite solutions as an antimicrobial

agent on processed, comminuted, or

formed meat food products prior to

packaging of the food.

FDA has evaluated data in the

petition and other relevant material.

FDA is approving the use of acidified

sodium chlorite solutions on processed,

comminuted or formed meat food

products, unless such use is precluded

by standards of identity in 9 CFR part

319, prior to packaging of the food for

commercial purposes. For example, this

acidified sodium chlorite solution is not

permitted to be added to ground beef

under 9 CFR 319.15. Based on this

information, the agency concludes that

the proposed use of the additive is safe,

that the additive will achieve its

intended technical effect, and therefore,

that the regulation in § 173.325 should

be amended as set forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

In the notice of filing, FDA gave

interested parties an opportunity to

submit comments on the petitioner’s

environmental assessment. FDA

received no comments in response to

that notice.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This final 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.

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by July 13, 2001. Each

objection shall be separately numbered,

and each numbered objection shall

specify with particularity the provisions

of the regulation to which objection is

made and the grounds for the objection.

Each numbered objection on which a

hearing is requested shall specifically so

state. Failure to request a hearing for

any particular objection shall constitute

a waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

are to be submitted and are to be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

List of Subjects in 21 CFR Part 173

Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 173 is

amended as follows:

Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Rules and Regulations 31841

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.325 is amended by

redesignating paragraph (f) as paragraph

(g) and by adding new paragraph (f) to

read as follows:

§ 173.325 Acidified sodium chlorite

solutions.

* * * * *

(f) The additive is used as an

antimicrobial agent on processed,

comminuted or formed meat food

products (unless precluded by standards

of identity in 9 CFR part 319) prior to

packaging of the food for commercial

purposes, in accordance with current

industry standards of good

manufacturing practice. Applied as a

dip or spray, the additive is used at

levels that result in sodium chlorite

concentrations of 500 to 1200 ppm, in

combination with any GRAS acid at

levels sufficient to achieve a pH of 2.5

to 2.9.

* * * * *

Dated: June 5, 2001.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 01–14811 Filed 6–12–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD09–01–036]

RIN 2115–AA97

Safety Zone—Ottawa River, Toledo,

Ohio

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone on

the Ottawa River, Toledo, Ohio. This

zone restricts the entry of vessels into

the area designated for the June 23,

2001, Summerfest fireworks display.

This temporary safety zone is necessary

to protect spectators and vessels from

the hazards associated with fireworks

displays.

DATES: This rule is effective from 6:30

p.m. until 11 p.m. on June 23, 2001.

ADDRESSES: Comments and material

received from the public, as well as

documents indicated in this preamble as

being available in the docket, are part of

docket [CGD09–01–036] and are

available for inspection or copying at

U.S. Coast Guard Marine Safety Office

Toledo, 420 Madison Ave, Suite 700,

Toledo, Ohio, 43604 between 9:30 a.m.

and 2 p.m., Monday through Friday,

except Federal holidays.

FOR FURTHER INFORMATION CONTACT: LT

Herb Oertli, Chief of Port Operations,

Marine Safety Office, 420 Madison Ave,

Suite 700, Toledo, Ohio 43604; (419)

418–6050.

SUPPLEMENTARY INFORMATION:

Regulatory Information

We did not publish a notice of

proposed rulemaking (NPRM) for this

regulation. Under 5 U.S.C. 553(b)(B), the

Coast Guard finds that good cause exists

for not publishing an NPRM, and, under

5 U.S.C. 553(d)(3), good cause exists for

making this rule it effective less than 30

days after publication in the Federal

Register. The Coast Guard had

insufficient advance notice to publish

an NPRM followed by a temporary final

rule. Publication of a notice of proposed

rulemaking and delay of effective date

would be contrary to the public interest

because immediate action is necessary

to prevent possible loss of life, injury, or

damage to property.

Background and Purpose

This temporary rule is necessary to

ensure the safety of spectators and

vessels during the setup, loading and

launching of a fireworks display in

conjunction with the City of Toledo’s

Summerfest Fireworks. The fireworks

display will occur between 6:30 p.m.

and 11 p.m. on June 23rd.

This safety zone will encompass all

waters and the adjacent shoreline of the

Ottawa River, Toledo, Ohio, bounded by

the arc of a circle with a 560-foot radius

with its center in approximate position

41° 43.21 N, 083° 28.46 W. The

fireworks will be launched off the

southeast end of the Summit Street

Bridge. The Captain of the Port Toledo

or his designated on scene

representative have the authority to

terminate the event.

All persons and vessels shall comply

with the instructions of the Coast Guard

Captain of the Port or the designated on

scene patrol personnel. Entry into,

transiting, or anchoring within the

safety zone is prohibited unless

authorized by the Captain of the Port

Chicago or his designated on scene

representative. The Captain of the Port

or his designated on scene

representative may be contacted via

VHF Channel 16.

Regulatory Evaluation

This rule is not a ‘‘significant

regulatory action’’ under section 3(f) of

Executive Order 12866, Regulatory

Planning and Review, and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

Order. The Office of Management and

Budget has not reviewed it under that

order. It is not ‘‘significant’’ under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040, February 26, 1979). We

expect the economic impact of this rule

to be so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary. This finding is

based on the historical lack of vessel

traffic during this time of year.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612), we have considered

whether this rule would have a

significant economic impact on a

substantial number of small entities.

The term ‘‘small entities’’ comprises

small businesses, not-for-profit

organizations that are independently

owned and operated and are not

dominant in their fields, and

governmental jurisdictions with

populations of less than 50,000.

The Coast Guard certifies under 5

U.S.C. 605(b) that this rule will not have

a significant economic impact on a

substantial number of small entities.

This safety zone will not have a

significant economic impact on a

substantial number of small entities for

the following reasons: this rule will be

in effect for only a few hours for one

event and vessel traffic can pass safely

around the safety zone.

Assistance for Small Entities

Under section 213(a) of the Small

Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104–121),

we offered to assist small entities in

understanding the rule so that they

could better evaluate its effects on them

and participate in the rulemaking

process. If the rule would affect your

small business, organization, or

governmental jurisdiction and you have

questions concerning its provisions or

options for compliance, please contact

Marine Safety Office Toledo (see

ADDRESSES).

Small businesses may send comments

on the actions of Federal employees

who enforce, or otherwise determine

compliance with, Federal regulations to

the Small Business and Agriculture

Regulatory Enforcement Ombudsman

and the Regional Small Business