53060 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

droplight and may require removal or 

opening of access panels or doors. Stands, 

ladders, or platforms may be required to gain 

proximity to the area being checked.’’

Corrective Actions 

(g) If any chafing of the electrical bundles 

or inadequate clearance is detected during 

the inspection required by paragraph (f) of 

this AD, before further flight, repair and 

rework, as applicable; in accordance with 

1124–Westwind (Israel Aircraft Industries) 

Alert Service Bulletin 1124–24A–154, dated 

March 22, 2005. 

Alternative Methods of Compliance 

(AMOCs) 

(h) The Manager, International Branch, 

ANM–116, FAA, Transport Airplane 

Directorate, has the authority to approve 

AMOCs for this AD, if requested in 

accordance with the procedures found in 14 

CFR 39.19. 

Related Information 

(i) Israeli airworthiness directive 24–05–

02–32, dated March 15, 2005, also addresses 

the subject of this AD. 

Material Incorporated by Reference 

(j) You must use 1124–Westwind (Israel 

Aircraft Industries) Alert Service Bulletin 

1124–24A–154, dated March 22, 2004, to 

perform the actions that are required by this 

AD, unless the AD specifies otherwise. The 

Director of the Federal Register approved the 

incorporation by reference of this document 

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

part 51. Contact Gulfstream Aerospace 

Corporation, P.O. Box 2206, Mail Station D–

25, Savannah, Georgia 31402–2206, for a 

copy of this service information. You may 

review copies at the Docket Management 

Facility, U.S. Department of Transportation, 

400 Seventh Street SW., Room PL–401, 

Nassif Building, Washington, DC; on the 

Internet at http://dms.dot.gov; or at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at the NARA, 

call (202) 741–6030, or go to http:// 

www.archives.gov/federal_register/

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on August 

24, 2005. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 05–17600 Filed 9–6–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

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, 191 

[CBP Dec. 05–31] 

Technical Amendments to Chapter 1 of 

Title 19 of the Code of Federal 

Regulations 

AGENCY: Customs and Border Protection, 

Homeland Security. 

ACTION: Final rule. 

SUMMARY: This document amends Title 

19 of the Code of Federal Regulations by 

making technical corrections to certain 

authority citations to reflect 

amendments to the Harmonized Tariff 

Schedule of the United States effected 

by the President’s Proclamation of 

December 30, 2003, to implement the 

United States-Singapore Free Trade 

Agreement. 

EFFECTIVE DATE: September 7, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne Kingsbury, Regulations 

Branch, Office of Regulations and 

Rulings, Customs and Border Protection, 

Tel. (202) 572–8763. 

SUPPLEMENTARY INFORMATION: 

Background 

Chapter I of Title 19 of the Code of 

Federal Regulations (19 CFR Chapter I) 

contains general and specific authority 

citations, several of which reference 

certain General Note provisions of the 

Harmonized Tariff Schedule of the 

United States (HTSUS). As a result of 

recent amendments to the HTSUS, 

several General Note provisions have 

been renumbered; however, the new 

designations are not yet reflected in 

Title 19 of the CFR. This document 

makes conforming technical corrections 

to Title 19 CFR to reflect the 

renumbered General Note provisions of 

the HTSUS. 

The amendments to the HTSUS were 

effected by the United States-Singapore 

Free Trade Agreement (‘‘USSFTA’’), 

Public Law 108–78, 117 Stat. 948 (19 

U.S.C. 3805 note), enacted on 

September 3, 2003. On December 30, 

2003, the President issued Proclamation 

7747 (68 FR 75793) to implement 

certain provisions of the USSFTA. 

Annex I of Proclamation 7747 modified 

the HTSUS, in pertinent part, as 

follows: 

• The text of General Note (GN) 19 to 

the HTSUS is transferred and 

designated as GN 3(e). 

• The text of General Note (GN) 20 to 

the HTS is transferred and designated as 

GN 3(f). 

• The text of General Notes (GN) 23 

and 24 of the HTSUS is transferred and 

designated as GN 3(i) and (j), 

respectively. 

This document makes technical 

corrections to those provisions of 19 

CFR Chapter 1 that contain references to 

the out-dated General Note citations. 

Inapplicability of Public Notice and 

Comment Requirement and Delayed 

Effective Date Requirement 

Because these amendments merely 

update certain authority citations in 19 

CFR Chapter 1, pursuant to 5 U.S.C. 

553(b)(B), CBP 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), CBP finds that good cause 

exists for dispensing with the 

requirement for a delayed effective date. 

The Regulatory Flexibility Act 

Because 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. 

Signing Authority 

This document is limited to technical 

corrections and is being issued in 

accordance with 19 CFR 0.1(b)(1), 

which provides, pursuant to Treasury 

Department Order No. 100–16, the 

Secretary of Homeland Security with 

the authority to prescribe and approve 

regulations relating to customs revenue 

functions on behalf of the Secretary of 

the Treasury when the subject matter of 

the regulations is not listed in paragraph 

1(a)(i) of the order. Such regulations are 

the official regulations of both 

Departments notwithstanding that they 

are not signed by an official of the 

Department of the Treasury. 

Accordingly, these regulations are 

signed by the Commissioner of Customs 

and Border Protection as the delegate of 

the Secretary of Homeland Security. 

Drafting Information 

The principal author of this document 

was Ms. Suzanne Kingsbury, Attorney, 

Regulations Branch, Office of 

Regulations and Rulings. 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53061 

List of Subjects 

19 CFR Part 7 

American Samoa; Coffee; Customs 

duties and inspection; Guam; 

Guantanamo Bay Naval Station, Cuba; 

Kingman Reef; Liquors; Midway Islands; 

Puerto Rico; Wake Island; Wine. 

19 CFR Part 10 

Caribbean Basin initiative; Customs 

duties and inspection; Exports; 

Reporting and recordkeeping 

requirements. 

19 CFR Parts 11 and 134 

Customs duties and inspection; 

Labeling; Packaging and containers. 

19 CFR Parts 12 and 141 

Customs duties and inspection; 

Reporting and recordkeeping 

requirements. 

19 CFR Part 18 

Common carriers; Customs duties and 

inspection; Exports; Freight; Penalties; 

Reporting and recordkeeping 

requirements; Surety bonds. 

19 CFR Part 19 

Customs duties and inspection; 

Exports; Freight; Reporting and 

recordkeeping requirements; Surety 

bonds; Warehouses; Wheat. 

19 CFR Part 24 

Accounting; Claims; Customs duties 

and inspection; Harbors; Reporting and 

recordkeeping requirements; Taxes. 

19 CFR Part 54 

Customs duties and inspection; 

Metals; Reporting and recordkeeping 

requirements. 

19 CFR Part 101 

Customs duties and inspection; 

Harbors; Organization and functions 

(Government agencies); Seals and 

insignia; Vessels. 

19 CFR Part 102 

Canada; Customs duties and 

inspection; Imports; Mexico; Reporting 

and recordkeeping requirements; Trade 

agreements. 

19 CFR Part 111 

Administrative practice and 

procedure; Brokers; Customs duties and 

inspection; Penalties; Reporting and 

recordkeeping requirements. 

19 CFR Part 114 

Customs duties and inspection; 

Exports; Trade agreements. 

19 CFR Part 123 

Canada; Customs duties and 

inspection; Freight; International 

boundaries; Mexico; Motor carriers; 

Railroads; Reporting and recordkeeping 

requirements; Vessels. 

19 CFR Part 128 

Administrative practice and 

procedure; Customs duties and 

inspection; Freight; Reporting and 

recordkeeping requirements. 

19 CFR Part 132 

Customs duties and inspection. 

19 CFR Part 145 

Customs duties and inspection; 

Exports; Lotteries; Reporting and 

recordkeeping requirements. 

19 CFR Part 146 

Administrative practice and 

procedure; Customs duties and 

inspection; Exports; Foreign trade 

zones; Penalties; Petroleum; Reporting 

and recordkeeping requirements. 

19 CFR Part 148 

Airmen; Customs duties and 

inspection; Foreign officials; 

Government employees; International 

organizations; Reporting and 

recordkeeping requirements; Seamen; 

Taxes. 

19 CFR Part 151 

Cigars and cigarettes; Cotton; Customs 

duties and inspection; Fruit juices; 

Laboratories; Metals; Oil imports; 

Reporting and recordkeeping 

requirements; Sugar; Wool. 

19 CFR Part 152 

Customs duties and inspection. 

19 CFR Part 177 

Administrative practice and 

procedure; Customs duties and 

inspection; Government procurement; 

Reporting and recordkeeping 

requirements. 

19 CFR Part 181 

Administrative practice and 

procedure; Canada; Customs duties and 

inspection; Exports; Imports; Mexico; 

Reporting and recordkeeping 

requirements; Trade agreements. 

19 CFR Part 191 

Alcohol and alcoholic beverages; 

Claims; Customs duties and inspection; 

Exports; Foreign trade zones; 

Guantanamo Bay Naval Station, Cuba; 

Packaging and containers; Reporting 

and recordkeeping requirements; Trade 

agreements. 

Amendments to the Regulations 

■ Chapter 1 of Title 19 of the Code of 

Federal 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 3(i), 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 3(i), 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 Note 3(i) and (j), 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 3(i), 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 3(i), 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 3(i), 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: 

53062 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 

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

66, 1202 (General Note 3(i), Harmonized 

Tariff Schedule of the United States), 1505, 

1520, 1624; 26 U.S.C. 4461, 4462; 31 U.S.C. 

9701; Public Law 107–296, 116 Stat. 2135 (6 

U.S.C. 1 et. seq.); 

* * * * * 

PART 54—CERTAIN IMPORTATIONS 

TEMPORARILY FREE OF DUTY 

■ 8. The authority citation for part 54 is 

revised to read as follows: 

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

Note 3(i); Section XV, Note 5, Harmonized 

Tariff Schedule of the United States), 1623, 

1624. 

PART 101—GENERAL PROVISIONS 

■ 9. 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 3(i), Harmonized Tariff 

Schedule of the United States), 1623, 1624, 

1646a. 

* * * * * 

PART 102—RULES OF ORIGIN 

■ 10. The authority citation for part 102 

is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1624, 3314, 3592. 

PART 111—CUSTOMS BROKERS 

■ 11. The general authority citation for 

part 111 is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1624, 1641. 

* * * * * 

PART 114—CARNETS 

■ 12. The authority citation for part 114 

is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1623, 1624. 

PART 123—CUSTOMS RELATIONS 

WITH CANADA AND MEXICO 

■ 13. The general authority citation for 

part 123 is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

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

1448, 1624, 2071 note. 

* * * * * 

PART 128—EXPRESS 

CONSIGNMENTS 

■ 14. The authority citation for part 128 

is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

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

1556, 1565, 1624. 

PART 132—QUOTAS 

■ 15. The general authority citation for 

part 132 is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

United States (HTSUS)), 1623, 1624. 

* * * * * 

PART 134—COUNTRY OF ORIGIN 

MARKING 

■ 16. 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 3(i), Harmonized Tariff 

Schedule of the United States), 1304, 1624. 

PART 141—ENTRY OF MERCHANDISE 

■ 17. 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 3(e); Chapter 

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

Additional U.S. Note 1; Chapter 98, 

Subchapter III, U.S. Notes 3 and 4; 

Harmonized Tariff Schedule of the 

United States), 1498; 

* * * * * 

§ 141.4 [Amended] 

■ 18. Section 141.4 is amended: 

(a) In paragraph (b)(1), by removing 

the reference to number ‘‘19’’ and 

adding in its place the term ‘‘3(e)’’; and 

(b) In paragraph (c)(2) by removing 

the word Customs’’ and adding in its 

place the term ‘‘CBP’’. 

PART 145—MAIL IMPORTATIONS 

■ 19. The general authority citation for 

part 145 is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1624; 

* * * * * 

PART 146—FOREIGN TRADE ZONES 

■ 20. The authority citation for part 146 

is revised to read as follows: 

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

(General Note 3(i), Harmonized Tariff 

Schedule of the United States), 1623, 1624. 

PART 148—PERSONAL 

DECLARATIONS AND EXEMPTIONS 

■ 21. 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 3(i), Harmonized Tariff 

Schedule of the United States); 

* * * * * 

PART 151—EXAMINATION, 

SAMPLING, AND TESTING OF 

MERCHANDISE 

■ 22. The general authority citation for 

part 151 is revised to read as follows: 

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

Note 3(i) and (j), Harmonized Tariff Schedule 

of the United States (HTSUS)), 1624; 

* * * * * 

PART 152—CLASSIFICATION AND 

APPRAISEMENT OF MERCHANDISE 

■ 23. 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 3(f), 

Harmonized Tariff Schedule of the 

United States (HTSUS)). 

§ 152.13 [Amended] 

■ 24. In § 152.13: 

(a) Paragraph (b)(1) is amended by 

removing the word ‘‘Customs’’ and 

adding the term ‘‘CBP’’, and by 

removing the reference to number ‘‘20’’

and adding in its place the term ‘‘3(f)’’; 

(b) Paragraphs (b)(2), (c) introductory 

text and (c)(1) are amended by removing 

references to number ‘‘20’’ each place 

they appear and adding in their place 

the term ‘‘3(f)’’; 

(c) Paragraph (c)(2) is amended by 

removing the word ‘‘Customs’’ and 

adding in its place the term ‘‘CBP’’, and 

by removing the reference to number 

‘‘20’’ and adding in its place the term 

‘‘3(f)’’; 

(d) Paragraph (c)(3) is amended by 

removing the reference to number ‘‘20’’

and adding in its place the term ‘‘3(f)’’; 

and 

(e) Paragraph (d) is amended by 

removing the references to number ‘‘20’’

each place they appear and adding in 

their place the term ‘‘3(f)’’. 

PART 177—ADMINISTRATIVE 

RULINGS 

■ 25. The 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 3(i), Harmonized Tariff 

Schedule of the United States), 1502, 1624, 

1625; 

Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53063 

PART 181—NORTH AMERICAN FREE 

TRADE AGREEMENT 

■ 26. The authority citation for part 181 

is revised to read as follows: 

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

Note 3(i), Harmonized Tariff Schedule of the 

United States), 1624, 3314; 

PART 191—DRAWBACK 

■ 27. 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 3(i), Harmonized Tariff 

Schedule of the United States), 1313, 1624; 

* * * * * 

Dated: September 1, 2005. 

Robert C. Bonner, 

Commissioner, Bureau of Customs and Border 

Protection. 

[FR Doc. 05–17662 Filed 9–6–05; 8:45 am] 

BILLING CODE 9110–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 189 and 700 

[Docket No. 2004N–0081] 

RIN 0910–AF47 

Use of Materials Derived From Cattle in 

Human Food and Cosmetics 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Interim final rule and request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

interim final rule on use of materials 

derived from cattle in human food and 

cosmetics published in the Federal 

Register of July 14, 2004. In the July 14, 

2004, interim final rule, FDA designated 

certain materials from cattle, including 

the entire small intestine, as ‘‘prohibited 

cattle materials’’ and banned the use of 

such materials in human food, 

including dietary supplements, and in 

cosmetics. FDA is taking this action in 

response to comments received on the 

interim final rule. Information was 

provided in comments that persuaded 

the agency that the distal ileum, one of 

three portions of the small intestine, 

could be consistently and effectively 

removed from the small intestine, such 

that the remainder of the small 

intestine, formerly a prohibited cattle 

material, could be used for human food 

or cosmetics. We (FDA) are also 

clarifying that milk and milk products, 

hide and hide-derived products, and 

tallow derivatives are not prohibited 

cattle materials. Comments also led the 

agency to reconsider the method cited 

in the interim final rule for determining 

insoluble impurities in tallow and to 

cite instead a method that is less costly 

to use and requires less specialized 

equipment. FDA issued the interim final 

rule to minimize human exposure to 

materials that scientific studies have 

demonstrated are highly likely to 

contain the bovine spongiform 

encephalopathy (BSE) agent in cattle 

infected with the disease. FDA believes 

that the amended provisions of the 

interim final rule provide the same level 

of protection from human exposure to 

the agent that causes BSE as the original 

provisions. 

DATES: The amendments to the interim 

final rule are effective October 7, 2005. 

Submit written or electronic comments 

on the amendments to the interim final 

rule by November 7, 2005. 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 certain publications in 

21 CFR 189.5 and 700.27 as of October 

7, 2005. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2004N–0081, 

by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 2004N–0081 and/or 

RIN number RIN 0910–AF47 in the 

subject line of your e-mail message. 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management, Food 

and Drug Administration (HFA -305), 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the agency name and 

Docket No. or Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received will be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm , including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Effective Date and Opportunity for 

Public Comment’’ heading of the 

SUPPLEMENTARY INFORMATION in section 

IV of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Buckner, Center for Food Safety 

and Applied Nutrition (HFS–306), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1486. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 14, 2004, FDA issued an 

interim final rule entitled ‘‘Use of 

Materials Derived From Cattle in 

Human Food and Cosmetics’’ (also 

referred to as ‘‘the interim final rule’’), 

to address the potential risk of BSE in 

human food and cosmetics (69 FR 

42256, July 14, 2004). In the interim 

final rule, FDA designated certain 

materials from cattle as ‘‘prohibited 

cattle materials’’ and banned the use of 

such materials in human food, 

including dietary supplements, and in 

cosmetics in §§ 189.5 and 700.27 (21 

CFR 189.5 and 21 CFR 700.27). In the 

interim final rule, FDA designated the 

following as prohibited cattle materials: 

Specified risk materials (SRMs), the 

small intestine from all cattle, material 

from nonambulatory cattle, material 

from cattle not inspected and passed for 

human consumption, and mechanically 

separated (MS)(Beef). The materials 

designated as SRMs were the brain, 

skull, eyes, trigeminal ganglia, spinal 

cord, vertebral column (excluding the 

vertebrae of the tail, the transverse 

processes of the thoracic and lumbar 

vertebrae, and the wings of the sacrum), 

and dorsal root ganglia of cattle 30 

months and older, and the distal ileum 

of the small intestine and tonsils from 

all cattle. The Food Safety and 

Inspection Service (FSIS) of the United 

States Department of Agriculture 

(USDA) designated the same list of 

materials as SRMs in its rule entitled 

‘‘Prohibition of the Use of Specified 

Risk Materials for Human Food and 

Requirements for the Disposition of 

Non-ambulatory Disabled Cattle’’ (69 FR 

1862, January 12, 2004). In addition, 

FDA provided an alternative standard 

for tallow in its interim final rule. 

Tallow must be produced by either 

excluding prohibited cattle materials or, 

if produced using prohibited cattle 

materials, must contain no more than 

0.15 percent insoluble impurities. 

Tallow derivatives were exempted from