71056 Federal Register / Vol. 65, No. 230 / Wednesday, November 29, 2000 / Rules and Regulations

§ 107.440 Standards governing prior SBA

approval for a proposed transfer of Control.

* * * * *

(c) Require compliance with any other

conditions set by SBA, including

compliance with the requirements for

minimum capital and managementownership diversity as in effect at such

time for new license applicants.

Dated: November 16, 2000.

Aida Alvarez,

Administrator.

[FR Doc. 00–30415 Filed 11–28–00; 8:45 am]

BILLING CODE 8025–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 99F–1912]

Irradiation in the Production,

Processing, and Handling of Food

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 ultraviolet (UV)

irradiation to reduce human pathogens

and other microorganisms in juice

products. This action is in response to

a food additive petition filed by

California Day-Fresh Foods, Inc.

DATES: This rule is effective November

29, 2000. Submit written objections and

requests for a hearing by December 29,

2000.

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:

William J. Trotter, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

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

202–418–3088.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of June 25, 1999 (64 FR 34258),

FDA announced that a food additive

petition (FAP 9M4676) had been filed

by California Day-Fresh Foods, Inc., 533

West Foothill Blvd., Glendora, CA

91741. The petitioner proposed that the

food additive regulations in part 179

Irradiation in the Production, Processing

and Handling of Food (21 CFR part 179)

be amended to provide for the safe use

of UV light to reduce human pathogens

and other microorganisms in juice

products.

II. Safety Evaluation

Under section 201(s) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 321(s)), a source of radiation

used to treat food is defined as a food

additive. The additive is not, literally,

added to food. Instead, a source of

radiation is used to process or treat food

such that, analogous to other food

processes, its use can affect the

characteristics of the food. In the subject

petition, the intended technical effect is

a change in the microbial load of the

food, specifically, a reduction of human

pathogens and other microorganisms in

juice products.

A. Toxicology

FDA has evaluated the safety of the

use of UV irradiation to reduce human

pathogens and other microorganisms in

juices. This safety assessment was based

on the current understanding of the

effects of UV irradiation on the major

chemical components of food. Having

evaluated the data in the petition and

other relevant material in the agency’s

files, the agency finds that any

photochemical changes that may occur

as a result of the UV irradiation are of

no toxicological significance (Ref. 1).

B. Microbiology

The petitioner submitted data

demonstrating the reduction of specific

pathogens (Escherichia coli O157:H7,

Listeria monocytogenes, and

Salmonella) inoculated into four types

of juices (orange, apple, carrot, and

garden vegetable). These four juice

varieties are representative of the types

of juice that are consumed by the U.S.

population and that could be treated

with UV irradiation (Ref. 2). After UV

irradiation, there were significant

reductions in pathogens. FDA concludes

that the proposed use is effective in

reducing human pathogens in juices and

that treated juices will be at least as safe

as untreated juices currently on the

market (Ref. 3). However, the submitted

microbiological data do not constitute

the type of validation studies necessary

to demonstrate the achievement of

specific performance standards, e.g. 5-

log reductions, for human pathogen

control programs (Ref. 3). Therefore,

users of this UV treatment who are

subject to certain performance standards

will need to establish that this treatment

meets their required level of human

pathogen reduction.

C. Specifications for Use

The petitioned UV radiation is

produced by low pressure mercury

lamps, which emit more than 90 percent

of their light at 253.7 nanometers (nm)

(2,537 Angstroms); juice being treated

passes through a transparent tube in

which the juice is subjected to UV

irradiation. Because most juices strongly

absorb UV radiation, most of the UV

radiation would be absorbed by the

juice at the wall of the tube near the

source of the UV irradiation. However,

the amount of UV irradiation that would

reach juice in the middle of the tube

would be insufficient to reduce

significantly human pathogens.

Therefore, the petitioner proposed that

the juices flow under turbulent

conditions that produce eddies and

swirls in the juice to ensure that as

much juice as possible will reach the

wall of the UV transparent tube where

the juice would be exposed to UV

irradiation. This would help to reduce

human pathogens and other

microorganisms throughout the juice.

The conditions for turbulent flow are

described mathematically by the

unitless Reynolds number (Re):

ER29NO00.001

where:

D is the tube diameter,

u is fluid velocity,

p is fluid density, and

μ is fluid viscosity.

To ensure that sufficient turbulent flow

is achieved, the petitioner has requested

that a limit of a Reynolds number of no

less than 2,200 be incorporated into the

regulation. FDA concurs with this

specification (Ref. 4).

The amount of UV irradiation

necessary for human pathogen

reduction will depend on various

factors, such as the type of juice, the

initial microbial load, and the design of

the irradiation system (e.g., flow rate,

number of lamps, and time exposed to

irradiation). Therefore, FDA is not

specifying a minimum or maximum

dose by regulation, but concludes that

this should be achieved for individual

usage situations in a manner consistent

with good manufacturing practice (Ref.

5). FDA expects that the maximum dose

applied to the juice will be

economically self-limiting due to the

costs associated with UV irradiation.

Additionally, the levels of UV

irradiation applied to the juice will be

limited by the possible alterations in

organoleptic characteristics of the juice

(i.e., changes in taste or color) after UV

irradiation, changes that may result in

decreased consumer acceptance. Thus,

Federal Register / Vol. 65, No. 230 / Wednesday, November 29, 2000 / Rules and Regulations 71057

juice processors will also limit the

maximum applied dose of UV

irradiation to avoid production of a

product not acceptable to consumers

(Ref. 5).

Based on the data and studies

submitted in the petition and other

information in the agency’s files, FDA

concludes that the proposed use of UV

irradiation of juice products is safe, that

the irradiation will achieve its intended

technical effect, and therefore, that the

regulations in § 179.39 should be

amended as set forth below.

D. Other Changes to § 179.39

FDA is also making an editorial

change to the existing regulation to

describe more accurately the approved

emission sources and to remove an

unnecessary and confusing description.

This change does not affect the nature

or properties of permitted sources.

Currently, § 179.39(a) stipulates that

‘‘The radiation sources consist of

ultraviolet emission tubes designed to

emit wavelengths within the range of

2200–3000 Angstrom units with 90

percent of the emission being the

wavelength 2537 Angstrom units.’’ The

stipulation that 90 percent of the

emission is at 253.7 nm (2,537

Angstroms) is sufficient to describe the

sources as low pressure mercury lamps.

Furthermore, since a small percentage of

the emission from these tubes is outside

of the 220.0 to 300.0 nm (2,200 to 3,000

Angstroms) range, this restriction is

factually inaccurate. Therefore, FDA is

removing the restriction of the

wavelength range in § 179.39(a) and in

the table in paragraph (b) under the

‘‘Limitations column,’’ and is instead

specifying that the source of the

irradiation to be low pressure mercury

lamps.

III. Public Disclosure

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.

IV. Environmental Impact

The agency has previously considered

the environmental effects of this rule as

announced in the Filing Notice for FAP

9M4676 (June 25, 1999, 64 FR 34258).

No new information or comments have

been received that would affect the

agency’s previous determination that

there is no significant impact on the

human environment and that an

environmental impact statement is not

required.

V. Paperwork Reduction Act of 1995

This 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. Objections

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 December 29, 2000. 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.

VII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. FDA Memorandum, A. Mattia to W.

Trotter, November 2, 1999.

2. FDA Memorandum, E. Jensen to W.

Trotter, September 6, 2000.

3. FDA Memorandum, R. Merker to W.

Trotter, January 26, 2000.

4. FDA Memorandum, E. Jensen to W.

Trotter, October 27, 1999.

5. FDA Memorandum, E. Jensen to W.

Trotter, October 27, 2000.

List of Subjects in 21 CFR Part 179

Food additives, Food labeling, Food

packaging, Radiation protection,

Reporting and recordkeeping

requirements, Signs and symbols.

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 179 is

amended as follows:

PART 179—IRRADIATION IN THE

PRODUCTION, PROCESSING AND

HANDLING OF FOOD

1. The authority citation for 21 CFR

part 179 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 343, 348,

373, 374.

2. Section 179.39 is amended by

revising paragraph (a) and by revising

the table in paragraph (b) to read as

follows:

§ 179.39 Ultraviolet radiation for the

processing and treatment of food.

* * * * *

(a) The radiation sources consist of

low pressure mercury lamps emitting 90

percent of the emission at a wavelength

of 253.7 nanometers (2,537 Angstroms).

(b) * * *

Irradiated food Limitations Use

Food and food products Without ozone production: high fat-content

food irradiated in vacuum or in an inert

atmosphere; intensity of radiation, 1 W (of

2,537 A. radiation) per 5 to 10 ft.2

Surface microorganism control.

71058 Federal Register / Vol. 65, No. 230 / Wednesday, November 29, 2000 / Rules and Regulations

Irradiated food Limitations Use

Potable water Without ozone production; coefficient of

absorption, 0.19 per cm or less; flow rate,

100 gal/h per watt of 2,537 A. radiation;

water depth, 1 cm or less; lamp-operating

temperature, 36 to 46 °C.

Sterilization of water used in food production.

Juice products Turbulent flow through tubes with a minimum

Reynolds number of 2,200.

Reduction of human pathogens and other

microorganisms.

Dated: November 14, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–30453 Filed 11–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD11–00–016]

RIN 2115–AE46

Special Local Regulations: San Diego

Christmas Boat Parade of Lights

AGENCY: Coast Guard, DOT.

ACTION: Notice of implementation.

SUMMARY: This notice implements 33

CFR 100.1101, Southern California

annual marine events, for the San Diego

Christmas Boat Parade of Lights. The

event will consist of private vessels

approximately 10 to 60 feet in length

with Christmas lights formed in a

parade through the San Diego Harbor.

These regulations will be effective on

that portion of San Diego Harbor, from

the northern portion of the main

channel from Seaport Village to the

Shelter Island Yacht Basin. Notice of

Implementation of 33 CFR 100.1101 is

necessary to control vessel traffic in the

regulated areas during the event to

ensure the safety of participants and

spectators.

Pursuant to 33 CFR 100.1101(b)(3),

Commanding Officer, Coast Guard

Activities San Diego, is designated

Patrol Commander for this event; he has

the authority to delegate this

responsibility to any commissioned,

warrant, or petty officer of the Coast

Guard.

EFFECTIVE DATES: This section is

effective on December 10, 2000 from

2:00 p.m. (PST) until 10:00 p.m. (PST)

and on December 17, 2000 from 5:00

p.m. until 10:00 p.m. (PST). If the event

concludes prior to the scheduled

termination date and/or time, the Coast

Guard will cease enforcement of this

section and will announce that fact via

Broadcast Notice to Mariners.

FOR FURTHER INFORMATION CONTACT:

Petty Officer Nicole Lavorgna, U.S.

Coast Guard MSO San Diego, San Diego,

California; Telephone: (619) 683–6495.

Discussion of Implementation. These

Special Local Regulations permit Coast

Guard control of vessel traffic in order

to ensure the safety of spectator and

participant vessels. In accordance with

the regulations in 33 CFR 100.1101, no

persons or vessels shall block, anchor,

or loiter in the regulated area; nor shall

any person or vessel transit through the

regulated area, or otherwise impede the

transit of participant or official patrol

vessels in the regulated area, unless

cleared for such entry by or through an

official patrol vessel acting on behalf of

the Patrol Commander.

Dated: November 21, 2000.

C.D. Wurster,

U.S. Coast Guard, Commander, Eleventh

Coast Guard District, Acting.

[FR Doc. 00–30446 Filed 11–28–00; 8:45 am]

BILLING CODE 4910–15–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD08–00–026]

RIN 2115–AE47

Drawbridge Operating Regulation;

Neches River, TX

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is issuing

this rule as a matter of information to

the public. The Kansas City Southern

Lift Bridge across the Neches River, mile

19.5, in Beaumont, TX is currently

controlled from a remote location. The

owner of the bridge, The Kansas City

Southern Railway Company operates

the bridge from their dispatch office in

Shreveport, LA. This rule provides the

public with a complete description of

the operation of this bridge.

DATES: This rule becomes effective on

November 29, 2000.

ADDRESSES: Documents referred to in

this rule are available for inspection or

copying at the office of the Eighth Coast

Guard District, Bridge Administration

Branch, Hale Boggs Federal Building,

room 1313, 501 Magazine Street, New

Orleans, Louisiana 70130–3396 between

7 a.m. and 3 p.m., Monday through

Friday, except Federal holidays. The

telephone number is (504) 589–2965.

Commander (ob) maintains the public

docket for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Mr.

David Frank, Bridge Administration

Branch, telephone number 504–589–

2965.

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.

An NPRM is not necessary because

this rule makes no substantive changes

to the operation of the Kansas City

Southern Lift Bridge, but it does

describe the full remote operation of the

bridge for the benefit of the public.

Background and Purpose

The Kansas City Southern Lift Bridge

across the Neches River, mile 19.5, in

Beaumont, TX is a remotely operated

railroad bridge that opens to navigation

on demand. The owners of the bridge,

The Kansas City Southern Railway

Company operates the bridge remotely

from Shreveport, LA and has installed a

sound device that transmits the vessel

signals for an opening to the bridge

operator. Then, through this same

device, the bridge operator can respond

whether the bridge can be opened at

that time or not. No changes will be

made to how the bridge currently

operates.

For the benefit of the public, the Coast

Guard is adding a description of the full

operation of this remotely operated

bridge to 33 CFR 117 subpart b.