Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations 53069 

do not include tallow that contains no 

more than 0.15 percent insoluble 

impurities, tallow derivatives, hides and 

hide-derived products, and milk and 

milk products. 

(2) Inspected and passed means that 

the product has been inspected and 

passed for human consumption by the 

appropriate regulatory authority, and at 

the time it was inspected and passed, it 

was found to be not adulterated. 

(3) Mechanically Separated 

(MS)(Beef) means a meat food product 

that is finely comminuted, resulting 

from the mechanical separation and 

removal of most of the bone from 

attached skeletal muscle of cattle 

carcasses and parts of carcasses that 

meet the specifications contained in 9 

CFR 319.5, the regulation that prescribes 

the standard of identity for MS 

(Species). 

(4) Nonambulatory disabled cattle 

means cattle that cannot rise from a 

recumbent position or that cannot walk, 

including, but not limited to, those with 

broken appendages, severed tendons or 

ligaments, nerve paralysis, fractured 

vertebral column, or metabolic 

conditions. 

(5) Specified risk material means 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 tonsils and 

distal ileum of the small intestine of all 

cattle. 

(6) Tallow means the rendered fat of 

cattle obtained by pressing or by 

applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass 

parts and tissues. Tallow must be 

produced from tissues that are not 

prohibited cattle materials or must 

contain not more than 0.15 percent 

insoluble impurities as determined by 

the method entitled ‘‘Insoluble 

Impurities’’ (AOCS Official Method Ca 

3a-46), American Oil Chemists’ Society 

(AOCS), 5th Edition, 1997, incorporated 

by reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51, or another 

method equivalent in accuracy, 

precision, and sensitivity to AOCS 

Official Method Ca 3a-46. You may 

obtain copies of the method from the 

AOCS (http://www.aocs.org) 2211 W. 

Bradley Ave. Champaign, IL 61821. 

Copies may be examined at the Center 

for Food Safety and Applied Nutrition’s 

Library, 5100 Paint Branch Pkwy., 

College Park, MD 20740, or at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to http://www.archives.gov/federal

_register/code_of_federal_regulations/ 

ibr_locations.html. 

(7) Tallow derivative means any 

chemical obtained through initial 

hydrolysis, saponification, or transesterification of tallow; chemical 

conversion of material obtained by 

hydrolysis, saponification, or transesterification may be applied to obtain 

the desired product. 

(b) Requirements. 

(1) No cosmetic shall be manufactured 

from, processed with, or otherwise 

contain, prohibited cattle materials. 

(2) The small intestine is not 

considered prohibited cattle material if 

the distal ileum is removed by a 

procedure that removes at least 80 

inches of the uncoiled and trimmed 

small intestine, as measured from the 

caeco-colic junction and progressing 

proximally towards the jejunum, or by 

a procedure that the establishment can 

demonstrate is equally effective in 

ensuring complete removal of the distal 

ileum. 

(c) Records. Manufacturers and 

processors of cosmetics that are 

manufactured from, processed with, or 

otherwise contain, cattle material must 

make existing records relevant to 

compliance with this section available 

to FDA for inspection and copying. 

(d) Adulteration. Failure of a 

manufacturer or processor to operate in 

compliance with the requirements of 

paragraph (b) or (c) of this section 

renders a cosmetic adulterated under 

section 601(c) of the act. 

Dated: August 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17693 Filed 9–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. 2003D–0221] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Endotoxin Assay; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) published a final 

rule in the Federal Register of October 

31, 2003 (68 FR 62007). The final rule 

classified the endotoxin assay into class 

II (special controls). The agency 

classified the device into class II 

(special controls) in order to provide 

reasonable assurance of safety and 

effectiveness of the device. FDA is 

amending the agency’s regulations to 

redesignate the section number listed in 

the Code of Federal Regulations (CFR) 

from § 866.3610 to § 866.3210. 

DATES: This rule is effective September 

7, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Freddie M. Poole, Center for Devices 

and Radiological Health (HFZ–440), 

Food and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 240–

276–0496 ext. 1111. 

SUPPLEMENTARY INFORMATION: FDA has 

found that the endotoxin assay 

regulation does not reflect the correct 

section number listed in the CFR. 

Accordingly, FDA is amending the 

regulation in § 866.3610 (21 CFR 

866.3610) to correct the error by 

redesignating the section number from 

§ 866.3610 to 866.3210. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

§ 866.3610 [Redesignated as § 866.3210 ] 

■ 2. Section 866.3610 is redesignated as 

§ 866.3210. 

Dated: August 26, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–17645 Filed 9–6–05; 8:45 am] 

BILLING CODE 4160–01–S