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
9366 Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Rules and Regulations

7). Because of the numerous

conservative assumptions used in

calculating the exposure estimate, the

actual lifetime-averaged individual

exposure to PCB’s is likely to be

substantially less than the potential

worst-case exposure, and therefore, the

upper-bound limit of lifetime human

risk would be less. Thus, the agency

concludes that there is a reasonable

certainty that no harm from exposure to

PCB’s would result from the proposed

use of the additive.

B. Need for Specifications

The agency has also considered

whether specifications are necessary to

control the amount of PCB’s present as

impurities in the additive. The agency

finds that specifications are not

necessary for the following reasons: (1)

Because of the low levels at which

PCB’s may be expected to remain as

impurities following production of the

additive, the agency would not expect

these impurities to become components

of food at other than extremely low

levels; and (2) the upper-bound limit of

lifetime human risk from exposure to

these impurities, even under worst-case

assumptions, is very low, less than 8 in

10 trillion.

III. Conclusion on Safety

FDA has evaluated the data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive as a colorant in polymers in

contact with food is safe, that the food

additive will achieve its intended

technical effect, and that the regulations

in § 178.3297 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.

IV. Environmental Impact

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.

V. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before April 2, 1997, 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.

VI. 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. Memorandum dated September 15,

1993, from the Chemistry Review Branch

(HFS–247) to the Indirect Additives Branch

(HFS–216), concerning ‘‘FAP 3B4349 (MATS

#678, M2.1)—Ciba-Geigy Corp. (CG)—Irgazin

DPP Red BO (Cromophtal DPP Red BP) as a

colorant in all polymers. Submission dated

10–29–92.’’

2. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology,’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger and J. K. Marquis, S. Karger, New

York, NY, pp. 24–33, 1985.

3. Memorandum dated February 21, 1995,

from the Chemistry Review Branch (HFS–

247) to the Indirect Additives Branch (HFS–

216), concerning ‘‘FAP 3B4349 (MATS #678,

M2.7)—Ciba-Geigy Corp. (CG)—Irgazin DPP

Red BO (Cromophtal DPP Red BP) as a

colorant in all polymers. Submission dated

8–31–94.’’

4. Norback, D. H., and R. H. Weltman,

‘‘Polychlorinated Biphenyl Induction of

Hepatocellular Carcinoma in the SpragueDawley Rat,’’ Environmental Health

Perspectives, 60:97–105, 1985.

5. Gaylor, D. W., and R. L. Kodell, ‘‘Linear

Interpolation Algorithm for Low Dose Risk

Assessment of Toxic Substances,’’ Journal of

Environmental Pathology and Toxicology,

4:305–312, 1980.

6. Memorandum, Report of the

Quantitative Risk Assessment Committee,

August 18, 1995.

7. Memorandum dated October 11, 1996,

from the Quantitative Risk Assessment

Committee (HFS–16) to the Indirect

Additives Branch (HFS–216) concerning

‘‘Clarification of QRAC Memorandum of

August 18, 1995, re FAPs 9B4158 and

3B4349.’’

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.3297 is amended in the

table in paragraph (e) by alphabetically

adding a new entry under the headings

‘‘Substances’’ and ‘‘Limitations’’ to read

as follows:

§ 178.3297 Colorants for polymers.

* * * * *

(e) * * *
Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Rules and Regulations 9367

Substances Limitations

* * * * * * *

3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (C.I.

Pigment Red 254, CAS Reg. No. 84632–65–5)

For use only at levels not to exceed 1 percent by weight of polymers.

The finished articles are to contact food only under conditions of use

B through H, described in Table 2 of § 176.170(c) of this chapter.

* * * * * * *

Dated: February 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–5077 Filed 2–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD07–97–002]

RIN 2115–AE46

Special Local Regulations: Intracoastal

Waterway, St. Augustine, FL

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: Special local regulations are

being adopted for the ‘‘Blessing of the

Fleet’’ ceremony. The event will be held

from 11 a.m. to 3 p.m. Eastern Standard

Time (EST) on March 23, 1997. The

regulated area includes those waters

between the Bridge of Lions and the

Fish Island Marina Daybeacon #2 in the

Matanzas River, St. Augustine, Florida.

The anticipated concentration of

participant and spectator vessels will

create an unusual hazard on the

navigable waters. The regulations are

needed to provide for the safety of life

on navigable waters during the event.

EFFECTIVE DATE: This rule becomes

effective 9 a.m. EST and terminates at 3

p.m. EST on Sunday, March 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Ensign G. Watson, Project Officer, Coast

Guard Group Mayport Florida, (904)

247–7398.

SUPPLEMENTARY INFORMATION: In

accordance with 5 U.S.C. 553, a notice

of proposed rulemaking was not

published for this regulation and good

cause exists for making it effective in

less than 30 days from the date of

publication. Following normal

rulemaking procedures would have

been impractical. The information to

hold the event was not received until

January 17, 1997, leaving insufficient

time to publish proposed rules prior to

the event or to provide a delayed

effective date.

Discussion of Regulations

The event requiring this regulation is

a ‘‘Blessing of the Fleet’’ ceremony.

There will be 150 participating vessels

in single file, parade style, transiting the

Intracoastal Waterway from the Bridge

of Lions south to Daybeacon number #2,

and returning north to the Bridge of

Lions. Approximately ten spectator craft

are expected. The total number of

vessels in the regatta area creates an

extra hazard to the safety of life on the

navigable waters.

The regulated area includes those

waters between the Bridge of Lions and

the Fish Island Marina Daybeacon #2,

LLNR 35420, position 29–52.15N, 081–

18.12W, in the Matanzas River, St.

Augustine, Florida. Datum: NAD 1983.

The event requires that vessel traffic

control be implemented within the area

of the Intracoastal Waterway between

the Bridge of Lions and Daybeacon

number #2. This regulation provides

that entry into the regulated area, by

other than parade participants or

spectator craft, is prohibited, unless

authorized by the Patrol Commander.

After termination of the ‘‘Blessing of the

Fleet’’ ceremony, all vessels may resume

normal operations.

Spectator craft will be allowed to

enter the regulated area; however, vessel

mooring, anchoring, and movement

restrictions will be directed by Coast

Guard and local law enforcement

officials.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

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

order. It has been exempted from review

by the Office of Management and

Budget 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). The Coast Guard

expects 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. The regulation will

only be in effect for a total of 5 hours

on the date of the ceremony.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

must consider whether this rule will

have a significant economic impact on

a substantial number of small entities.

‘‘Small entities’’ include independently

owned and operated businesses that are

not dominant in their field and that

otherwise qualify as ‘‘small business

concerns’’ under section 3 of the Small

Business Act (15 U.S.C. 632).

The Coast Guard certifies under

section 605 (b) of the Regulatory

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

this rule will not have a significant

economic impact on a substantial

number of small entities because the

regulation will be in effect for a total of

5 hours in a limited area of the

Intracoastal Waterway in St. Augustine.

Collection of Information

These regulations contain no

collection of information requirements

under the Paperwork Reduction Act (44

U.S.C. 3501 et seq.).

Federalism

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

the proposed rulemaking does not have

sufficient federalism implications to

warrant the preparation of a Federalism

Assessment.

Environmental Assessment

The Coast Guard has considered the

environmental impact of this rule under

paragraph 2.B.2 of Commandant

Instruction M16475.1B, (as revised by

59 FR 38654, July 29, 1994). In

accordance with that instruction,

specifically section 2.B.4 and 2.B.5, this

action has been environmentally

assessed (EA completed), and the Coast

Guard has concluded that this event

will not significantly affect the quality