This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

385

Vol. 61, No. 4

Friday, January 5, 1996

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 90F–0344]

Secondary Direct Food Additives

Permitted in Food for Human

Consumption; Polymaleic Acid and its

Sodium Salt

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to increase the

permitted use level of polymaleic acid

and its sodium salt to control mineral

scale during the production of beet and

cane sugar juice and liquor, and to

amend the specifications for the

additives. This action is in response to

a petition filed by Ciba-Geigy, Inc.

DATES: Effective January 5, 1996; written

objections and requests for a hearing by

February 5, 1996. The Director of the

Office of the Federal Register approves

the incorporation by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51 of a publication listed in 21

CFR 173.45(a), effective January 5, 1996.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Vincent Zenger, Center for Food Safety

and Applied Nutrition (HFS–206), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3105.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 28, 1990 (55 FR 49426), FDA

announced that a food additive petition

(FAP 0A4226) had been filed by CibaGeigy, Inc., proposing that § 173.45 (21

CFR 173.45) be amended to provide for

the safe use of polymaleic acid and its

sodium salt to control mineral scale

during the production of beet and cane

sugar juice and liquor at higher levels

than the maximum currently permitted

under the regulation.

The petition contained information on

a new manufacturing process for

polymaleic acid and its sodium salt,

which results in a lower weight-average

molecular weight and number-average

molecular weight for the additives than

those currently permitted. The

molecular weight determinations were

based on an improved analytical

method. In the original filing notice for

the petition, the agency gave notice of

the proposal to increase the permitted

use levels of polymaleic acid and its

sodium salt, but it did not give notice

of the part of the proposal that

concerned amending the allowed

molecular weight range for the additives

or the method for determining the

molecular weight. Therefore, FDA

published a tentative final rule in the

Federal Register of May 2, 1995 (60 FR

21474), to allow interested persons to

comment on these changes. FDA did not

receive any comments or responses to

the tentative final rule. Therefore, the

agency concludes that the tentative final

rule should be issued as a final rule.

As noted in the tentative final rule,

the molecular weight determinations of

the additives are to be based on the

improved analytical method entitled

‘‘Determinations of Molecular Weight

Distribution of Poly(Maleic)Acid’’

submitted by Ciba-Geigy, Inc., and dated

March 17, 1992, which is incorporated

by reference in amended § 173.45(a).

This improved analytical method,

which replaces the previous method,

has the same title and a different date.

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 21 CFR

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.

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.

Any person who will be adversely

affected by this regulation may at any

time on or before February 5, 1996, file

with the Dockets Management Branch

(address above) written objections

thereto. 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

shall be submitted and shall 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, Incorporation by

reference.

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 of the Center for Food

Safety and Applied Nutrition, 21 CFR

part 173 is amended as follows:
386 Federal Register / Vol. 61, No. 4 / Friday, January 5, 1996 / Rules and Regulations

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: Secs. 201, 402, 409 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348).

2. Section 173.45 is amended by

revising paragraphs (a) and (c) to read as

follows:

§ 173.45 Polymaleic acid and its sodium

salt.

* * * * *

(a) The additives have a weightaverage molecular weight in the range of

540 to 850 and a number-average

molecular weight in the range of 520 to

650, calculated as the acid. Molecular

weights shall be determined by a

method entitled ‘‘Determination of

Molecular Weight Distribution of

Poly(Maleic) Acid,’’ March 17, 1992,

produced by Ciba-Geigy, Inc., Seven

Skyline Dr., Hawthorne, NY 10532–

2188, which is incorporated by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies are

available from the Division of Product

Policy, Center for Food Safety and

Applied Nutrition (HFS–205), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, or are available

for inspection at the Center for Food

Safety and Applied Nutrition’s Library,

200 C St. SW., rm. 3321, Washington,

DC, or at the Office of the Federal

Register, 800 North Capitol St. NW.,

suite 700, Washington, DC.

* * * * *

(c) The additives are to be used so that

the amount of either or both additives

does not exceed 4 parts per million

(calculated as the acid) by weight of the

beet or cane sugar juice or liquor

process stream.

Dated: December 27, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–120 Filed 1–4–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Office of Labor-Management Programs

29 CFR Part 215

RIN 1294–AA14

Guidelines, Section 5333(b), Federal

Transit Law

AGENCY: Office of Labor-Management

Programs, Office of the American

Workplace, Labor.

ACTION: Deferral of effective date.

SUMMARY: The Office of LaborManagement Programs is deferring the

effective date of implementation of

guidelines for the employee protection

program under Title 49 U.S.C., Chapter

53, Section 5333(b) of the Federal

Transit law, which is currently January

8, 1996. The extension will add a time

period to the January 8, 1996 date equal

to the duration of the furlough caused

by the partial government shutdown

that began on December 16, 1995. The

effective date of the guidelines will be

the first business day after this

extension. This action is being taken

because the furlough of Department of

Labor (the Department) employees

responsible for the administration of

this program precludes the Office of

Labor-Management Programs from

undertaking the necessary staff training

and preparation of materials and

documents to allow for implementation

of the guidelines.

DATES: The effective date of the

guidelines is the first business day

following an extension from January 8,

1996, such extension to be calculated by

adding the total number of days of the

furlough which began on December 16,

1995. The Department will publish a

document in the Federal Register

confirming the new effective date.

FOR FURTHER INFORMATION CONTACT:

Kelley Andrews, Director, Statutory

Programs, U.S. Department of Labor,

200 Constitution Avenue, NW., Room

N–5411, Washington, DC 20210, (202)

219–4473.

SUPPLEMENTARY INFORMATION:

I. Rationale

On December 7, 1995, the Office of

Labor-Management Programs, Office of

the American Workplace, published

final guidelines for administration of the

transit employee protection program

pursuant to Section 5333(b) of the

Federal Transit law, commonly referred

to as ‘‘Section 13(c).’’ (FR Vol. 60, No.

235, pg. 62964.) The guidelines were to

become effective January 8, 1996.

In view of the ongoing furlough of

employees of the Department who are

responsible for the implementation of

these new guidelines, it will be

impossible to implement the guidelines

on January 8, 1996. The Department is

hereby extending the effective

implementation date. The extension

will add a time period to the January 8,

1996 date equal to the duration of the

furlough that began on December 16,

1995. The effective date of the

guidelines will be the first business day

after this extension.

The Department has taken this action

in recognition of its obligations to the

transit industry and the transit

employees for whom these protections

are provided. The extension is designed

to ensure effective and efficient

implementation of the new guidelines.

The furlough prevented the preparation

of explanatory material and documents

for staff and the public and interrupted

training of necessary staff, thus delaying

instituting procedures for a more timely

and predictable certification process.

This extension is intended to help

assure that the Department’s customers

are well-served and statutory

responsibilities are properly conducted.

II. Publication in Final

The Department finds public

comment on this referral to be

impracticable and unnecessary because

the Department is forced to take this

action due to the furlough, caused by

the partial government shutdown, of the

Department employees who administer

this program. 5 U.S.C. 553(b)(B).

List of Subjects in 29 CFR Part 215

Grant administration; Grants—

transportation; Labor-management

relations; Labor unions; Mass

transportation.

Accordingly, the amendment of 29

CFR Chapter II published at FR Vol. 60,

No. 235, pg. 62964 is deferred until the

first business day following an

extension from January 8, 1996, such

extension to be calculated by adding the

total number of days of the furlough

which began on December 16, 1995.

Signed at Washington, DC, this 2nd day of

January, 1996.

Charles L. Smith,

Deputy Assistant Secretary.

[FR Doc. 96–163 Filed 1–4–96; 8:45 am]

BILLING CODE 4510–86–M

DEPARTMENT OF THE TREASURY

Office of Thrift Supervision

31 CFR Part 1

[No. 95–148]

Privacy Act of 1974; Implementation

AGENCY: Office of Thrift Supervision,

Treasury.

ACTION: Final Rule.

SUMMARY: The Office of Thrift

Supervision (OTS) hereby exempts the

Criminal Referral Database from certain

provisions of the Privacy Act of 1974, 5

U.S.C. 552a (Privacy Act), to the extent

the system contains investigatory

material pertaining to the enforcement