64604 Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations

Note 2: For the purposes of this AD, a

general visual inspection is defined as: ‘‘A

visual examination of an interior or exterior

area, installation, or assembly to detect

obvious damage, failure, or irregularity. This

level of inspection is made under normally

available lighting conditions such as

daylight, hangar lighting, flashlight, or

droplight, and may require removal or

opening of access panels or doors. Stands,

ladders, or platforms may be required to gain

proximity to the area being checked.’’

(d) If no corrosion of the drain valves is

detected, prior to further flight, perform the

actions specified in either paragraph (d)(1) or

(d)(2) of this AD at the time specified.

(1) Perform the leak test specified in

paragraph (a) of this AD, and thereafter,

repeat the leak test requirements at intervals

not to exceed 300 hours time-in-service.

(2) Prior to further flight, modify any

inoperative valve in accordance with

Raytheon Aircraft Service Bulletin SB 34–

3282, dated August 1999. Thereafter, repeat

the leak test requirements of paragraph (a) of

this AD at intervals not to exceed 300 hours

time-in-service. Modification of ALL the

drain valves constitutes terminating action

for the requirement to perform repetitive leak

tests.

(e) If any drain valve is corroded, prior to

further flight: Inspect the connecting tubing

for corrosion and replace any corroded valve

or tubing with a new or serviceable valve or

tubing in accordance with Raytheon Aircraft

Service Bulletin SB 34–3207, dated August

1999. Accomplish the actions of paragraph

(e)(1) or (e)(2) of the AD at the time specified.

(1) Prior to further flight, perform the leak

test specified in paragraph (a) of this AD, and

thereafter, repeat the leak test requirements

of paragraph (a) of this AD at intervals not

to exceed 300 hours time-in-service.

(2) Prior to further flight, modify any

replaced drain valve in accordance with

Raytheon Aircraft Service Bulletin SB 34–

3282, dated August 1999. Thereafter, repeat

the leak test requirements of paragraph (a) of

this AD at intervals not to exceed 300 hours

time-in-service. Modification of ALL the

drain valves constitutes terminating action

for the requirement to perform repetitive leak

tests.

Alternative Methods of Compliance

(f) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Wichita

Aircraft Certification Office (ACO), ACE–

116W, FAA. Operators shall submit their

requests through an appropriate FAA

Principal Maintenance Inspector, who may

add comments and then send it to the

Manager, Wichita ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Wichita ACO.

Special Flight Permit

(g) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

Incorporation by Reference

(h) The actions shall be done in accordance

with Raytheon Aircraft Service Bulletin SB

34–3207, dated August 1999; Raytheon

Aircraft Service Bulletin SB 34–3223, dated

August 1999; or Raytheon Aircraft Service

Bulletin SB 34–3282, dated August 1999; as

applicable. This incorporation by reference

was approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Raytheon Aircraft Company, ManagerService Engineering, Hawker Customer

Support Department, P. O. Box 85, Wichita,

Kansas 67201–0085. Copies may be inspected

at the FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the FAA, Wichita Aircraft

Certification Office, 1801 Airport Road,

Room 100, Mid-Continent Airport, Wichita,

Kansas; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Effective Date

(i) This amendment becomes effective on

December 4, 2000.

Issued in Renton, Washington, on October

23, 2000.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 00–27631 Filed 10–27–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 92F–0305]

Food Additives Permitted for Direct

Addition to Food for Human

Consumption; Polydextrose

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 polydextrose as a bulking

agent, texturizer, or both in

tablespreads. This action is in response

to a petition filed by Pfizer, Inc.

DATES: This rule is effective October 30,

2000. Submit written objections and

requests for a hearing by November 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:

Rosalie M. Angeles, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

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

202–418–3107.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal

Register of August 24, 1992 (57 FR

38311), FDA announced that a food

additive petition (FAP 2A4332) had

been filed by Pfizer, Inc., 235 East 42d

St., New York, NY 10017–5755. Pfizer,

Inc., subsequently announced the sale of

the Pfizer Food Science Group and the

transfer of the petition to Cultor Food

Science, Inc., 430 Saw Mill River Rd.,

Ardsley, NY 10502. Recently, the

petitioner announced a name change

from Cultor Food Science, Inc., to

Danisco Cultor America, Inc. (Danisco),

to reflect the acquisition of the company

by Danisco. The petition proposed to

amend the food additive regulations in

§ 172.841 Polydextrose (21 CFR 172.841)

to provide for the safe use of

polydextrose as a bulking agent,

texturizer, or both in tablespreads.

Polydextrose is intended to replace

fully caloric ingredients and to produce

reduced- or lower calorie and/or lowerfat tablespreads. The proposed use level

of polydextrose in tablespreads is 5 to

12 percent with the weighted mean use

level estimated to be 8.5 percent. The

petitioner contends that this use level

makes possible the formulation of

lower-calorie tablespreads that compare

favorably with prototypes that contain

no polydextrose. The petitioner

submitted data to substantiate this claim

and to demonstrate that the use of

polydextrose in tablespreads is

technologically self-limiting (Ref. 1).

II. Conclusions

FDA estimated that the mean

consumption of polydextrose from the

proposed use in tablespread is 0.7 gram

per person per day (g/p/d). The agency

considers this consumption

insignificant compared to the estimated

cumulative intake of polydextrose of

17.5 g/p/d from all currently regulated

uses of the additive. Therefore, FDA

concludes that there will be a negligible

increase in dietary exposure to

polydextrose from the issuance of this

amendment to the regulation (Ref. 2).

FDA has evaluated data in the

petition and other relevant material in

its files. Based on this information, the

agency concludes that: (1) The proposed

food additive use is safe, (2) the additive

will achieve its intended technical

effect, and therefore, (3) the regulation

Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Rules and Regulations 64605

in § 172.841 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.

On June 1, 1998, the President

directed all Federal agencies to use

‘‘plain language’’ in all new documents.

In compliance with this directive, FDA

has drafted its amendment to § 172.841

using the principles of ‘‘plain language’’

set forth by the President. In amending

the regulation, the agency is also making

an editorial change by alphabetizing the

list of regulated uses of polydextrose.

III. Environmental Impact

In the notice of filing, FDA gave

interested parties an opportunity to

submit comments on the petitioner’s

environmental assessment. The agency

received no comments in response to

that notice.

The agency has carefully considered

the potential environmental effects of

this rule. 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.

IV. Paperwork Reduction Act of 1995

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.

V. 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 November 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.

VI. Reference

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. Memorandum dated December 2, 1992,

from the Division of Product Manufacture

and Use to the Division of Petition Control,

‘‘FAP 2A4332: Pfizer, Inc., Polydextrose in

Tablespreads, Technologically Self-limiting

Level, Submission of 11–12–92.’’

2. Memorandum dated September 30,

1992, from the Division of Product

Manufacture and Use to the Division of

Petition Control, ‘‘FAP 2A4332 (MATS #658):

Pfizer, Inc., Polydextrose as a Bulking Agent/

Texturizer in Tablespreads, Submission of 6–

22–92.’’

List of Subjects in 21 CFR Part 172

Food additives, Reporting and

recordkeeping requirements.

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 172 is

amended as follows:

PART 172—FOOD ADDITIVES

PERMITTED FOR DIRECT ADDITION

TO FOOD FOR HUMAN

CONSUMPTION

1. The authority citation for 21 CFR

part 172 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 348,

371, 379e.

2. Section 172.841 is amended by

revising paragraph (c) to read as follows:

§ 172.841 Polydextrose.

* * * * *

(c) Polydextrose is used in accordance

with current good manufacturing

practice as a bulking agent, formulation

aid, humectant, and texturizer in the

following foods when standards of

identity established under section 401

of the act do not preclude such use:

(1) Baked goods and baking mixes

(restricted to fruit, custard, and

pudding-filled pies; cakes; cookies; and

similar baked products);

(2) Chewing gum;

(3) Confections and frostings;

dressings for salads;

(4) Film coatings on single and

multiple vitamin and mineral

supplement tablets;

(5) Frozen dairy desserts and mixes;

(6) Fruit spreads;

(7) Gelatins, puddings and fillings;

(8) Hard and soft candy;

(9) Peanut spread;

(10) Sweet sauces, toppings, and

syrups; and

(11) Tablespreads.

* * * * *

Dated: October 20, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–27734 Filed 10–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 99F–673]

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 ionizing radiation to

control microbial pathogens in seeds for

sprouting. This action is in response to

a petition filed by Caudill Seed Co., Inc.

DATES: This regulation is effective

October 30, 2000. Submit written

objections and requests for a hearing by

November 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:

Lane A. Highbarger, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

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

202–418–3032.