68886 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Parts 7, 10, 11, 12, 18, 19, 24,

54, 101, 102, 111, 114, 123, 128, 132,

134, 141, 145, 146, 148, 151, 152, 177,

181, and 191

[T.D. 00–81]

Technical Amendments to the

Customs Regulations

AGENCY: Customs Service, Treasury.

ACTION: Final rule.

SUMMARY: This document amends the

Customs Regulations by making certain

technical corrections to various

authority citations to reflect

amendments to the Harmonized Tariff

Schedule of the United States made by

the President’s Proclamation of October

2, 2000, to implement the United StatesCaribbean Basin Trade Partnership Act.

EFFECTIVE DATE: November 15, 2000.

FOR FURTHER INFORMATION CONTACT:

Gregory R. Vilders, Attorney,

Regulations Branch, Office of

Regulations and Rulings, (202) 927–

1415.

SUPPLEMENTARY INFORMATION:

Background

In Chapter I of the Customs

Regulations (19 CFR chapter I) there are

many general and specific authority

citations and some sections that

reference certain General Note

provisions of the Harmonized Tariff

Schedule of the United States (HTSUS).

See, T.D. 95–29. Due to recent

amendments to the HTSUS, many of the

General Notes provisions have been

renumbered. Thus, those general and

specific authority citations and sections

in the Customs Regulations that

reference certain General Note

provisions are no longer accurate.

On May 18, 2000, the United StatesCaribbean Basin Trade Partnership Act

was enacted. To implement certain

provisions of this Act, on October 2,

2000, the President issued Proclamation

7351 (65 FR 59329), the Annex of which

modified the HTSUS by, among other

things, redesignating certain of the

General Notes of the HTSUS.

Specifically, HTSUS General Notes 16–

21 were redesignated as HTSUS General

Notes 18–23, respectively. Some of the

former General Notes are referenced in

the general or specific authority

citations for 24 parts and in 3 sections

of the Customs Regulations (19 CFR

parts 7, 10, 11, 12, 18, 19, 24, 54, 101,

102, 111, 114, 123, 128, 132, 134, 141,

145, 146, 148, 151, 152, 177, 181, and

191, and §§ 24.23, 141.4, and 152.13).

This document corrects those HTSUS

General Note references in the Customs

Regulations.

Inapplicability of Public Notice and

Comment Requirement and Delayed

Effective Date Requirement

Because these amendments merely

correct certain authority citation

referencing errors in the Customs

Regulations, pursuant to 5 U.S.C.

553(b)(B), Customs finds that good

cause exists for dispensing with notice

and public procedure as unnecessary.

For these same reasons, pursuant to 5

U.S.C. 553(d)(3), Customs finds that

good cause exists for dispensing with

the requirement for a delayed effective

date.

The Regulatory Flexibility Act

Since this document is not subject to

the notice and public procedure

requirements of 5 U.S.C. 553, it is not

subject to the provisions of the

Regulatory Flexibility Act (5 U.S.C. et

seq.).

Executive Order 12866

These amendments do not meet the

criteria for a ‘‘significant regulatory

action’’ as specified in E.O. 12866.

Drafting Information

The principal author of this document

was Gregory R. Vilders, Attorney,

Regulations Branch, Office of

Regulations and Rulings.

Amendments to the Regulations

Chapter I of the Customs Regulations

(19 CFR chapter I) is amended as set

forth below:

PART 7—CUSTOMS RELATIONS WITH

INSULAR POSSESSIONS AND

GUANTANAMO BAY NAVAL STATION

1. The authority citation for part 7 is

revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1623, 1624; 48 U.S.C. 1406i.

PART 10—ARTICLES CONDITIONALLY

FREE, SUBJECT TO A REDUCED

RATE, ETC.

2. The general authority citation for

part 10 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States (HTSUS)), 1321, 1481, 1484,

1498, 1508, 1623, 1624, 3314;

* * * * *

PART 11—PACKING AND STAMPING;

MARKING

3. The authority citation for part 11 is

revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Notes 22 and 23, Harmonized Tariff

Schedule of the United States), 1624.

PART 12—SPECIAL CLASSES OF

MERCHANDISE

4. The general authority citation for

part 12 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States (HTSUS)),

1624;

* * * * *

PART 18—TRANSPORTATION IN

BOND AND MERCHANDISE IN

TRANSIT

5. The general authority citation for

part 18 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States), 1551, 1552,

1553, 1623, 1624.

* * * * *

PART 19—CUSTOMS WAREHOUSES,

CONTAINER STATIONS AND

CONTROL OF MERCHANDISE

THEREIN

6. The general authority citation for

part 19 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States), 1624;

* * * * *

PART 24—CUSTOMS FINANCIAL AND

ACCOUNTING PROCEDURE

7. The general authority citation for

part 24 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 58a–58c,

66, 1202 (General Note 22, Harmonized Tariff

Schedule of the United States), 1505, 1624;

26 U.S.C. 4461, 4462; 31 U.S.C. 9701.

* * * * *

§ 24.23 [Removed and added]

8. In § 24.23:

a. The parenthetical reference in

paragraph (c)(1)(iii) to ‘‘(General Note

3(c)(v), HTSUS)’’ is removed and added,

in its place, is the reference ‘‘(General

Note 7, HTSUS)’’;

b. The parenthetical reference in

paragraph (c)(1)(iv) to ‘‘(General Note

20(c)(ii)(B), HTSUS)’’ is removed and

added, in its place, is the reference

‘‘(General Note 4(b)(i), HTSUS)’’; and

c. The reference in paragraph (c)(1)(v)

to ‘‘General Note 16, HTSUS’’ is

Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations 68887

removed and added, in its place, is the

reference ‘‘General Note 18, HTSUS’’.

PART 54—CERTAIN IMPORTATIONS

TEMPORARILY FREE OF DUTY

9. The authority citation for part 54 is

revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22; Section XV, Note 5, Harmonized

Tariff Schedule of the United States), 1623,

1624.

PART 101—GENERAL PROVISIONS

10. The general authority citation for

part 101 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66,

1202 (General Note 22, Harmonized Tariff

Schedule of the United States), 1623, 1624,

1646a.

* * * * *

PART 102—RULES OF ORIGIN

11. The authority citation for part 102

is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1624, 3314, 3592.

PART 111—CUSTOMS BROKERS

12. The general authority citation for

part 111 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1624, 1641.

* * * * *

PART 114—CARNETS

13. The authority citation for part 114

is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1623, 1624.

PART 123—CUSTOMS RELATIONS

WITH CANADA AND MEXICO

14. The general authority citation for

part 123 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States (HTSUS)), 1431, 1433, 1436,

1448, 1624.

* * * * *

PART 128—EXPRESS

CONSIGNMENTS

15. The authority citation for part 128

is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1321, 1484, 1498, 1551, 1555,

1556, 1565, 1624.

PART 132—QUOTAS

16. The general authority citation for

part 132 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States (HTSUS)), 1623, 1624.

* * * * *

PART 134—COUNTRY OF ORIGIN

MARKING

17. The authority citation for part 134

is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States), 1304, 1624.

PART 141—ENTRY OF MERCHANDISE

18. The general authority citation for

part 141 continues, and the specific

authority for § 141.4 is revised, to read

as follows:

Authority: 19 U.S.C. 66, 1448, 1484, 1624.

* * * * *

Section 141.4 also issued under 19

U.S.C. 1202 (General Note 18; Chapter

86, Additional U.S. Note 1; Chapter 89,

Additional U.S. Note 1; Chapter 98,

Subchapter III, U.S. Note 4, Harmonized

Tariff Schedule of the United States),

1498;

* * * * *

§ 141.4 [Removed and added]

19. In § 141.4:

a. The reference in paragraph (b)(1) to

‘‘General Note 16’’ is removed and

added, in its place, is the reference

‘‘General Note 18’’; and

b. The reference in the introductory

text of paragraph (c) to ‘‘General Note

16(e)’’ is removed and added, in its

place, is the reference ‘‘General Note

18(e)’’.

PART 145—MAIL IMPORTATIONS

20. The general authority citation for

part 145 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1624;

* * * * *

PART 146—FOREIGN TRADE ZONES

21. The authority citation for part 146

is revised to read as follows:

Authority: 19 U.S.C. 66, 81a–81u, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States), 1623, 1624.

PART 148—PERSONAL

DECLARATIONS AND EXEMPTIONS

22. The general authority citation for

part 148 is revised to read as follows:

Authority: 19 U.S.C. 66, 1496, 1498, 1624.

The provisions of this part, except for subpart

C, are also issued under 19 U.S.C. 1202

(General Note 22, Harmonized Tariff

Schedule of the United States);

* * * * *

PART 151—EXAMINATION,

SAMPLING, AND TESTING OF

MERCHANDISE

23. The general authority citation for

part 151 is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Notes 22 and 23, Harmonized Tariff Schedule

of the United States (HTSUS)), 1624.

* * * * *

PART 152—CLASSIFICATION AND

APPRAISEMENT OF MERCHANDISE

24. The general authority citation for

part 152 continues, and the specific

authority for § 152.13 is revised, to read

as follows:

Authority: 19 U.S.C. 66, 1401a, 1500, 1502,

1624.

* * * * *

Section 152.13 also issued under 19

U.S.C. 1202 (General Note 19,

Harmonized Tariff Schedule of the

United States (HTSUS)).

§ 152.13 [Removed and added]

25. In § 152.13:

a. The reference in both paragraphs

(b)(1) and (b)(2) to ‘‘General Note 17’’ is

removed and added, in its place, is the

reference ‘‘General Note 19’’;

b. The reference in the introductory

text of paragraph (c) and in paragraphs

(c)(1), (c)(2), and (c)(3) to ‘‘General Note

17’’ is removed and added, in its place,

is the reference ‘‘General Note 19’’; and

c. The references in paragraph (d) to

‘‘General Note 17’’ are removed and

added, in their place, are the references

‘‘General Note 19’’.

PART 177—ADMINISTRATIVE

RULINGS

26. The general authority citation for

part 177 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States), 1624.

* * * * *

PART 181—NORTH AMERICAN FREE

TRADE AGREEMENT

27. The authority citation for part 181

is revised to read as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 22, Harmonized Tariff Schedule of the

United States), 1624, 3314.

68888 Federal Register / Vol. 65, No. 221 / Wednesday, November 15, 2000 / Rules and Regulations

PART 191—DRAWBACK

28. The general authority citation for

part 191 is revised to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202

(General Note 22, Harmonized Tariff

Schedule of the United States), 1313, 1624.

* * * * *

Dated: November 8, 2000.

Stuart P. Seidel,

Assistant Commissioner, Office of

Regulations and Rulings.

[FR Doc. 00–29091 Filed 11–14–00; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F–0319]

Indirect Food Additives: Polymers

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 hydrogenated butadiene/

acrylonitrile copolymers, intended for

contact with food in repeated use

applications. This action is in response

to a petition filed by Zeon Chemicals,

Inc.

DATES: This rule is effective November

15, 2000. Submit written objections and

requests for a hearing by December 15,

2000. The Director of the Office of the

Federal Register approves the

incorporations by reference in

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

CFR 51 of certain publications in

§ 177.2600(c)(4)(i) (21 CFR

177.2600(c)(4)(i)), as of November 15,

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:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of October 4, 1993 (58 FR

51632), FDA announced that a food

additive petition (FAP 3B4377) had

been filed by Zeon Chemicals, Inc.,

Three Continental Towers, suite 1012,

1701 Golf Rd., Rolling Meadows, IL

60008 (now 4111 Bells Lane, Louisville,

KY 40211). The petition proposed to

amend the food additive regulations to

provide for the safe use of acrylonitrilebutadiene copolymer, hydrogenated,

intended for contact with food in

repeated use applications. (The additive

is currently listed in the regulation

under the nomenclature hydrogenated

butadiene/acrylonitrile copolymers, and

this nomenclature will be retained.)

In FDA’s evaluation of the safety of

this food additive, the agency reviewed

the safety of the additive itself 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 has been found to

contain residual amounts of

acrylonitrile and butadiene as

impurities resulting from its

manufacture. These chemicals have

been shown to cause cancer in test

animals. Residual amounts of impurities

are commonly found as constituents of

chemical products, including food

additives.

II. Determination of Safety

Under the general safety standard of

section 409(c)(3)(A) 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

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 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 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 standard using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the intended use of the

additive. (Scott v. FDA, 728 F.2d 322

(6th Cir. 1984.))

In evaluating the safety of a food

additive, FDA customarily reviews the

available data on each relevant chemical

impurity to determine whether the

chemical induces tumors in animals or

humans. If FDA concludes that the

chemical impurity causes cancer in

animals or humans, the agency

calculates the unit cancer risk for the

chemical and the upper bound limit of

lifetime human cancer risk from the

chemical’s presence in the additive (Ref.

1).

In some instances, the available data

and information may not allow the

agency to determine whether a

particular chemical impurity is a

carcinogen. However, the available data

may suggest, but not establish

definitively, that the impurity poses a

human cancer risk. In such

circumstances, the agency may perform

a risk assessment based upon the

assumption that the impurity is

carcinogenic. This approach permits the

agency to determine whether there is a

reasonable certainty that no harm will

result from the petitioned use of the

additive, even though the carcinogenic

status of the impurity is not clearly

established.

FDA followed this approach to

determine whether there is a reasonable

certainty that no harm will result from

the use of hydrogenated butadiene/

acrylonitrile copolymers; in so doing,

FDA assumed that butadiene, an

impurity in the additive, is a human

carcinogen. In inhalation studies,

butadiene has been reported to induce,

in mice and rats, tumors at the site of

exposure (lungs) as well as a variety of

tumors at numerous other sites (Refs. 2

to 4). However, FDA does not believe

that these inhalation studies are

necessarily determinative of the

carcinogenic potential of butadiene

when administered orally, the most

likely route of human exposure to food

additives. Because no long-term studies

are available in which butadiene was

administered orally, the agency

performed a risk assessment for

butadiene based on a twofold

assumption: That butadiene would

induce tumors in animals and humans

if administered orally and that its

potency by the oral route of exposure

would be no greater than its potency by

the inhalation route of exposure. In

FDA’s view, this is a conservative

assumption (Ref. 5). Using this

procedure, FDA estimated the upper

bound limit of lifetime human cancer

risk from butadiene under the proposed

conditions of use of hydrogenated

butadiene/acrylonitrile copolymers.

III. Safety of the Petitioned Use of the

Additive

FDA estimates that the petitioned use

of the additive, hydrogenated

butadiene/acrylonitrile copolymers, will