9364 Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Rules and Regulations

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6004 Class E airspace areas

designated as an extension to a Class D or

E surface area.

* * * * *

ASO FL E4 Mayport NS Mayport, FL

[Revised]

Mayport NAS, FL

(Lat. 30°23′31′′ N, long. 81°25′23′′ W)

Mayport (Navy) TACAN

(Lat. 30°23′19′′ N, long. 81°25′23′′ W)

That airspace extending upward from the

surface within 3.2-miles each side of the

Mayport (Navy) TACAN 035° radial

extending from the 4.2-mile radius of

Mayport NAS to 5 miles northeast of the

TACAN. This Class E airspace is effective

during the days and times established in

advance by a Notice to Airmen. The effective

days and times will thereafter be

continuously published in the Airport/

Facility Directory.

* * * * *

Issued in College Park, Georgia, on

February 10, 1997.

Wade T. Carpenter,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 97–5063 Filed 2–23–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Part 746

[Docket No. 961015286–6286–01]

RIN 0694–AB43

Exports to Cuba; Support for the

Cuban People

AGENCY: Bureau of Export

Administration.

ACTION: Final rule.

SUMMARY: On October 6, 1995, President

Clinton announced several changes to

the administration of the Cuban

embargo intended to promote

democratic change in Cuba.

Accordingly, this final rule amends the

Export Administration Regulations by

introducing a licensing review policy

for the approval, on a case-by-case basis,

of certain exports to human rights

organizations, news bureaus, and

individuals and non-governmental

organizations engaged in activities that

promote democratic activity in Cuba.

EFFECTIVE DATE: March 3, 1997.

FOR FURTHER INFORMATION CONTACT:

Bruce Cromack, Office of Strategic

Trade and Foreign Policy Controls,

Bureau of Export Administration,

Telephone: (202) 482–5537.

SUPPLEMENTARY INFORMATION:

Background

On October 6, 1995 the President

announced new measures designed to

improve enforcement of the U.S.

embargo against Cuba and to increase

support for the Cuban people. The

measures would permit U.S. persons to

engage in new categories of transactions

with eligible Cuban entities, providing

increased support for the Cuban people

by facilitating communications, and

supporting human rights and

democratic activities. This rule is

consistent with the Cuban Democracy

Act of 1992 and the Cuban Liberty and

Democratic Solidarity (Libertad) Act of

1996.

Although the Export Administration

Act (EAA) expired on August 20, 1994,

the President invoked the International

Emergency Economic Powers Act and

continued in effect, to the extent

permitted by law, the provisions of the

EAA and the EAR in Executive Order

12924 of August 19, 1994, as extended

by the President’s notice of August 15,

1995 (60 FR 42767) and notice of

August 14, 1996 (61 FR 42527).

Rulemaking Requirements

1. This final rule has been determined

to be significant for purposes of E.O.

12866.

2. This rule involves collections of

information subject to the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.). These collections have been

approved by the Office of Management

and Budget under control numbers

0694–0021 and 0694–0088.

Notwithstanding any other provision of

law, no person is required to respond to

nor shall a person be subject to a

penalty for failure to comply with a

collection of information subject to the

requirements of the Paperwork

Reduction Act unless that collection of

information displays a currently valid

OMB Control Number.

3. This rule does not contain policies

with Federalism implications sufficient

to warrant preparation of a Federalism

assessment under Executive Order

12612.

4. The provisions of the

Administrative Procedure Act (5 U.S.C.

553) requiring notice of proposed

rulemaking, the opportunity for public

participation, and a delay in effective

date, are inapplicable because this

regulation involves a military and

foreign affairs function of the United

States (5 U.S.C. 553(a)(1)). Further, no

other law requires that a notice of

proposed rulemaking and an

opportunity for public comment be

given for this final rule. Because a

notice of proposed rulemaking and an

opportunity for public comment are not

required to be given for this rule under

5 U.S.C. 553 or by any other law, the

requirements of the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.) are

not applicable.

Therefore, this regulation is issued in

final form. Although there is no formal

comment period, public comments on

this regulation are welcome on a

continuing basis. Submit comments to

Hillary Hess, Office of Exporter

Services, Regulatory Policy Division,

Bureau of Export Administration,

Department of Commerce, P.O. Box 273,

Washington, DC 20044.

List of Subjects in 15 CFR Part 746

Embargoes, Exports, Foreign trade,

Reporting and recordkeeping

requirements.

Accordingly, part 746 of the Export

Administration Regulations (15 CFR

Parts 730–774) is amended as follows:

PART 746—[AMENDED]

1. The authority citation for 15 CFR

part 746 continues to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50

U.S.C. 1701 et seq.; 22 U.S.C. 287c; 22 U.S.C.

6004; E.O. 12918, 59 FR 28205, 3 CFR, 1994

Comp., p. 899; E.O. 12924, 59 FR 43437, 3

CFR, 1994 Comp., p. 917; Notice of August

15, 1995 (60 FR 42767, August 17, 1995); and

Notice of August 14, 1996 (61 FR 42527).

2. Section 746.2 is amended by

adding paragraph (b)(4) to read as

follows:

§ 746.2 Cuba.

* * * * *

(b) * * *

(4) Applications for licenses may be

approved, on a case-by-case basis, for

certain exports to Cuba intended to

provide support for the Cuban people,

as follows:

(i) Applications for licenses for

exports of certain commodities and

software may be approved to human

rights organizations, or to individuals

and non-governmental organizations

that promote independent activity

intended to strengthen civil society in

Cuba when such exports do not give rise

to U.S. national security or counterterrorism concerns. Examples of such

commodities include fax machines,

copiers, computers (e.g., 486-level/CTP

of 24.8 MTOPS or less), business/office

software, document scanning

equipment, printers, typewriters, and

other office or office communications
Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Rules and Regulations 9365

equipment. Applicants may donate or

sell the commodities or software to be

exported. Reexport to other end-users or

end-uses is not authorized.

(ii) Commodities and software may be

approved for export to U.S. news

bureaus in Cuba whose primary purpose

is the gathering and dissemination of

news to the general public. In addition

to the examples of commodities and

software listed in paragraph (b)(4)(i) of

this section, certain telecommunications

equipment necessary for the operation

of news organizations (e.g., 33M bit/s

data signaling rate or less) may be

approved for export to U.S. news

bureaus.

* * * * *

Dated: February 26, 1997.

Sue E. Eckert,

Assistant Secretary for Export

Administration.

[FR Doc. 97–5169 Filed 2–28–97; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 93F–0028]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

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 3,6-bis(4-chlorophenyl)-

2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-

dione (C.I. Pigment Red 254) as a

colorant in polymers intended for use in

contact with food. This action is in

response to a petition filed by CibaGeigy Corp.

DATES: Effective March 3, 1997; written

objections and requests for a hearing by

April 2, 1997.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Richard H. White, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

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

202–418–3094.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 17, 1993 (58 FR 14402), FDA

announced that a food additive petition

(FAP 3B4349) had been filed by CibaGeigy Corp., 315 Water St., Newport, DE

19804–2434 (currently c/o Keller and

Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001). The

petition proposed to amend the food

additive regulations in § 178.3297

Colorants for polymers (21 CFR

178.3297) to provide for the safe use of

3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione (C.I.

Pigment Red 254) as a colorant in

polymers intended for use in contact

with food.

In its evaluation of the safety of this

food additive, FDA reviewed the safety

of the additive and the chemical

impurities that may be present in the

additive resulting from its

manufacturing process. Although the

additive itself has not been shown to

cause cancer, it may contain minute

amounts of polychlorinated biphenyls

(PCB’s), which are carcinogenic

impurities resulting from the

manufacture of the additive. Residual

amounts of reactants, manufacturing

aids, and their constituent impurities,

and byproducts, such as PCB’s, are

commonly found as contaminants in

chemical products, including food

additives.

I. Determination of Safety

Under the so-called ‘‘general safety

clause’’ of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

348(c)(3)(A)), a food additive cannot be

approved for a particular use unless a

fair evaluation of the data available to

FDA establishes that the food additive is

safe for that use. FDA’s food additive

regulations (21 CFR 170.3(i)) define safe

as ‘‘a reasonable certainty in the minds

of competent scientists that the

substance is not harmful under the

intended conditions of use.’’

The food additives anticancer, or

Delaney, clause of the act (21 U.S.C.

348(c)(3)(A)) provides that no food

additive shall be deemed to be safe if it

is found to induce cancer when ingested

by man or animal. Importantly,

however, the Delaney clause applies to

the additive itself and not to the

impurities in the additive. That is,

where an additive itself has not been

shown to cause cancer, but contains a

carcinogenic impurity, the additive is

properly evaluated under the general

safety clause using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the proposed use of the

food additive (Scott v. FDA, 728 F.2d

322 (6th Cir. 1984)).

II. Safety of the Petitioned Use of the

Additive

FDA estimates that the petitioned use

of the food additive, 3,6-bis(4-

chlorophenyl)-2,5-dihydro-pyrrolo[3,4-

c]pyrrole-1,4-dione (C.I. Pigment Red

254), will result in exposure to no

greater than 0.2 parts per billion (ppb)

of the food additive in the daily diet (3

kilograms (kg)) or an estimated daily

intake (EDI) of 0.6 micrograms (μg) per

person per day (μg/person/day) (Ref. 1).

FDA does not ordinarily consider

chronic toxicological studies to be

necessary to determine the safety of an

additive whose use will result in such

low exposure levels (Ref. 2), and the

agency has not required such testing

here. However, the agency has reviewed

the available toxicological data (acute

toxicity and mutagenicity studies) on

the additive and concludes that the

small dietary exposure resulting from

the proposed use of the additive is safe.

FDA has evaluated the safety of this

additive under the general safety clause,

considering all available data and using

risk assessment procedures to estimate

the upper-bound limit of lifetime

human risk presented by PCB’s,

carcinogenic chemicals that may be

present as impurities in the additive.

This risk evaluation of PCB’s has two

aspects: (1) Assessment of the worstcase exposure to these impurities from

the proposed use of the additive; and (2)

extrapolation of the risk observed in the

animal bioassays to the conditions of

worst-case exposure to humans.

A. PCB’s

FDA has estimated the hypothetical

worst-case exposure to PCB’s from the

petitioned use of the food additive as a

colorant in polymers to be less than

1x10-4 parts per trillion of the daily diet

(3 kg), or 0.3 picograms (pg)/person/day

(Ref. 3). The agency used data from a

carcinogenesis bioassay on PCB’s,

conducted by Norback and Weltman

(Ref. 4), to estimate the upper-bound

limit of lifetime human risk from

exposure to these chemicals resulting

from the proposed use of the food

additive (Ref. 5). The results of the

bioassay on a PCB mixture (Aroclor

1260) demonstrated that the material

was carcinogenic for male and female

rats under the conditions of the study.

The test material caused significantly

increased incidence of hepatocellular

tumors in both female and male rats.

Based on the estimated worst-case

exposure to PCB’s of 0.3 pg/person/day,

FDA estimates that the upper-bound

limit of lifetime human risk from the

use of the subject additive is less than

7.5x10-13, or 8 in 10 trillion (Refs. 6 and