10482 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 

been filed, unless an exclusion is issued 

in final form by the Commission after 

notice and comment, materials or 

products subject to the lead limits under 

section 101 of the CPSIA are considered 

to be banned hazardous substances if 

they do not meet the lead limits as 

provided under paragraph (a) of this 

section. 

Dated: March 5, 2009. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. E9–5075 Filed 3–10–09; 8:45 am] 

BILLING CODE 6335–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

DEPARTMENT OF THE TREASURY 

19 CFR Part 12 

[CBP Dec. 09–05] 

RIN 1505–AC11 

Extension of Import Restrictions 

Imposed on Archaeological Material 

From Honduras 

AGENCIES: U.S. Customs and Border 

Protection, Department of Homeland 

Security; Department of the Treasury. 

ACTION: Final rule. 

SUMMARY: This document amends 

Customs and Border Protection (CBP) 

regulations to reflect the extension of 

import restrictions on certain categories 

of archaeological material from the PreColumbian cultures of the Republic of 

Honduras (Honduras) that were 

imposed by CBP Decision (Dec.) 04–08 

and expire on March 12, 2009. The 

Assistant Secretary for Educational and 

Cultural Affairs, United States 

Department of State, has determined 

that conditions continue to warrant the 

imposition of import restrictions. 

Accordingly, these import restrictions 

will remain in effect for an additional 5 

years, and the CBP regulations are being 

amended to reflect this extension until 

March 12, 2013. These restrictions are 

being extended pursuant to 

determinations of the United States 

Department of State made under the 

terms of the Convention on Cultural 

Property Implementation Act in 

accordance with the 1970 United 

Nations Educational, Scientific and 

Cultural Organization (UNESCO) 

Convention on the Means of Prohibiting 

and Preventing the Illicit Import, Export 

and Transfer of Ownership of Cultural 

Property. CBP Dec. 04–08 contains the 

Designated List of archaeological 

material that describes the articles to 

which the restrictions apply. 

DATES: Effective Date: March 11, 2009. 

FOR FURTHER INFORMATION CONTACT: For 

legal aspects, George Frederick McCray, 

Esq., Chief, Intellectual Property Rights 

and Restricted Merchandise Branch, 

Regulations and Rulings, Office of 

International Trade, (202) 325–0082. For 

operational aspects, Michael Craig, 

Chief, Interagency Requirements 

Branch, Trade Policy and Programs, 

Office of International Trade, (202) 863– 

6558. 

SUPPLEMENTARY INFORMATION: 

Background 

Pursuant to the provisions of the 1970 

United Nations Educational, Scientific 

and Cultural Organization (UNESCO) 

Convention, codified into U.S. law as 

the Convention on Cultural Property 

Implementation Act (Pub. L. 97–446, 19 

U.S.C. 2601 et seq.), the United States 

entered into a bilateral agreement with 

the Republic of Honduras (Honduras) on 

March 12, 2004, concerning the 

imposition of import restrictions on 

certain categories of archaeological 

material from Honduras. The 

archaeological materials subject to the 

bilateral agreement represent the PreColumbian cultures of Honduras and 

range in date from approximately 1200 

B.C. to 1500 A.D. On March 16, 2004, 

CBP published CBP Decision (Dec.) 04– 

08 in the Federal Register (69 FR 

12267), which amended 19 CFR 

12.104g(a) to reflect the imposition of 

these restrictions and included a list 

designating the types of archaeological 

material covered by the restrictions. 

Import restrictions listed in 19 CFR 

12.104g(a) are ‘‘effective for no more 

than five years beginning on the date on 

which the agreement enters into force 

with respect to the United States. This 

period can be extended for additional 

periods not to exceed five years if it is 

determined that the factors which 

justified the initial agreement still 

pertain and no cause for suspension of 

the agreement exists’’ (19 CFR 

12.104g(a)). 

After reviewing the findings and 

recommendations of the Cultural 

Property Advisory Committee, the 

Assistant Secretary for Educational and 

Cultural Affairs, United States 

Department of State, concluding that the 

cultural heritage of Honduras continues 

to be in jeopardy from pillage of certain 

archaeological materials, made the 

necessary determinations to extend the 

import restrictions for an additional five 

years on December 4, 2008. 

Accordingly, CBP is amending 19 CFR 

12.104g(a) to reflect the extension of the 

import restrictions. The Designated List 

of Pre-Columbian Archaeological 

Material from Honduras covered by 

these import restrictions is set forth in 

CBP Dec. 04–08. The Designated List 

and accompanying image database may 

also be accessed from the following 

Internet Web site address: http:// 

exchanges.state.gov/heritage/ 

culprop.html. The restrictions on the 

importation of these archaeological 

materials from Honduras are to continue 

in effect for an additional five years. 

Importation of such material continues 

to be restricted unless the conditions set 

forth in 19 U.S.C. 2606 and 19 CFR 

12.104c are met. 

Inapplicability of Notice and Delayed 

Effective Date 

This amendment involves a foreign 

affairs function of the United States and 

is, therefore, being made without notice 

or public procedure (5 U.S.C. 553(a)(1)). 

For the same reason, a delayed effective 

date is not required under 5 U.S.C. 

553(d)(3). 

Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. 

Executive Order 12866 

Because this rule involves a foreign 

affairs function of the United States, it 

is not subject to Executive Order 12866. 

Signing Authority 

This regulation is being issued in 

accordance with 19 CFR 0.1(a)(1). 

List of Subjects in 19 CFR Part 12 

Cultural property, Customs duties and 

inspection, Imports, Prohibited 

merchandise. 

Amendment to CBP Regulations 

■ For the reasons set forth above, part 12 

of Title 19 of the Code of Federal 

Regulations (19 CFR part 12), is 

amended as set forth below: 

PART 12—SPECIAL CLASSES OF 

MERCHANDISE 

■ 1. The general authority citation for 

part 12 and the specific authority 

citation for § 12.104g continue to read as 

follows: 

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

(General Note 3(i), Harmonized Tariff 

Schedule of the United States (HTSUS)), 

1624; 

* * * * * 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations 10483 

Sections 12.104 through 12.104i also 

issued under 19 U.S.C. 2612; 

* * * * * 

■ 2. In § 12.104g, paragraph (a), the table 

is amended in the entry for Honduras by 

removing the reference to ‘‘CBP Dec. 

04–08’’ in the column headed ‘‘Dec. 

No.’’ and adding in its place the 

language ‘‘CBP Dec. 04–08 extended by 

CBP Dec. 09–05’’. 

W. Ralph Basham, 

Commissioner, U.S. Customs and Border 

Protection. 

Approved: March 5, 2009. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. E9–5001 Filed 3–10–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 73 and 101 

[Docket No. FDA–1998–P–0032] (formerly 

Docket No. 1998P–0724) 

Listing of Color Additives Exempt 

From Certification; Food, Drug, and 

Cosmetic Labeling: Cochineal Extract 

and Carmine Declaration; Confirmation 

of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of January 5, 2011, for the 

final rule that appeared in the Federal 

Register of January 5, 2009. The final 

rule amends the regulations for 

cochineal extract and carmine by 

requiring their declaration by name on 

the label of all food and cosmetic 

products that contain these color 

additives. This final rule responds to 

reports of severe allergic reactions, 

including anaphylaxis, to cochineal 

extract-containing food and carminecontaining food and cosmetics and will 

allow consumers who are allergic to 

these color additives to identify and 

thus avoid products that contain these 

color additives. This action also 

responds to a citizen petition submitted 

by the Center for Science in the Public 

Interest. 

DATES: The effective date of the final 

rule published on January 5, 2009 (74 

FR 207), amending 21 CFR 73.100, 

73.2087, and 101.22, is confirmed: 

January 5, 2011. 

FOR FURTHER INFORMATION CONTACT: 

James C. Wallwork, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1303. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 5, 2009 (74 

FR 207), FDA amended the color 

additive regulation in 21 CFR 73.100 

that permits the use of cochineal extract 

and carmine in foods by adding new 

paragraph (d)(2) to require that all foods 

(including butter, cheese, and ice cream) 

that contain cochineal extract or 

carmine specifically declare the 

presence of the color additive by its 

respective common or usual name, 

‘‘cochineal extract’’ or ‘‘carmine,’’ in the 

ingredient statement of the food label. 

Because § 101.22(k) (21 CFR 101.22(k)) 

allows any certification-exempt color 

additive to be declared with a general 

phrase, such as ‘‘Artificial Color’’ or 

‘‘Artificial Color Added,’’ rather than by 

its specific common or usual name, FDA 

amended § 101.22(k) to disallow generic 

declaration of color additives for which 

individual declaration is required by 

applicable regulations in part 73 (21 

CFR part 73). 

For cosmetic products, FDA amended 

the color additive regulation in 

§ 73.2087 (21 CFR 73.2087) permitting 

the use of carmine in cosmetics by 

revising paragraph (c) to require that 

cosmetics containing carmine that are 

not subject to the requirements of 

§ 701.3 (21 CFR 701.3) specifically 

declare the presence of carmine 

prominently and conspicuously at least 

once in the labeling. This amendment 

covers all cosmetic products, including 

those cosmetics that are manufactured 

and sold for use only by professionals 

(e.g., makeup used in photography 

studios and by makeup artists for 

television, movie, and theater actors/ 

actresses, products intended for use 

only by professionals in beauty salons, 

and camouflage makeup dispensed by 

physicians and aestheticians to clients 

with skin conditions such as scarring) 

and those cosmetics that are gifts or free 

samples. FDA also included in 

§ 73.2087, as an example, the following 

statement: ‘‘Contains carmine as a color 

additive.’’ 

FDA gave interested persons until 

February 4, 2009, to file objections or 

requests for a hearing. The agency 

received no objections or requests for a 

hearing on the final rule. Therefore, 

FDA finds that the effective date of the 

final rule that published in the Federal 

Register of January 5, 2009, should be 

confirmed. 

List of Subjects 

21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Medical devices. 

21 CFR Part 101 

Food labeling, Nutrition, Reporting 

and recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act (15 U.S.C. 1453, 

1454, 1455; 21 U.S.C. 321, 331, 341, 

342, 343, 348, 351, 352, 355, 361, 362, 

371, 379e; 42 U.S.C. 243, 264, 271) and 

under the authority delegated to the 

Commissioner of Food and Drugs 

(1410.10 of the FDA Staff Manual 

Guide) notice is given that no objections 

or requests for a hearing were filed in 

response to the January 5, 2009, final 

rule. Accordingly, the amendments 

issued thereby become effective 

January 5, 2011. 

Dated: March 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5286 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2009–N–0665] 

Oral Dosage Form New Animal Drugs; 

Amprolium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an abbreviated new animal 

drug application (ANADA) filed by IVX 

Animal Health, Inc. The ANADA 

provides for the use of generic 

amprolium concentrate solution to make 

medicated drinking water for chickens 

and turkeys for the treatment of 

coccidiosis. 

DATES: This rule is effective March 11, 

2009. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: IVX 

Animal Health, Inc., 3915 South 48th 


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