[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.5]
[Page 592-593]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B Prohibited Cattle Materials
Sec. 189.5 Prohibited cattle materials.
(a) Definitions. The definitions and interpretations of terms
contained in section 201 of the Federal Food, Drug, and Cosmetic Act
(the act) apply to such terms when used in this part. The following
definitions also apply:
(1) Prohibited cattle materials means specified risk materials,
small intestine of all cattle except as provided in paragraph (b)(2) of
this section, material from nonambulatory disabled cattle, material from
cattle not inspected and passed, or mechanically separated (MS)(Beef).
Prohibited cattle materials 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 meets 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 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 trans-esterification of tallow; chemical
conversion of material obtained by hydrolysis, saponification, or trans-
esterification may be applied to obtain the desired product.
(b) Requirements. (1) No human food 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. (1) Manufacturers and processors of a human food that
is manufactured from, processed with, or
[[Page 593]]
otherwise contains, material from cattle must establish and maintain
records sufficient to demonstrate that the food is not manufactured
from, processed with, or does not otherwise contain, prohibited cattle
materials.
(2) Records must be retained for 2 years after the date they were
created.
(3) Records must be retained at the manufacturing or processing
establishment or at a reasonably accessible location.
(4) The maintenance of electronic records is acceptable. Electronic
records are considered to be reasonably accessible if they are
accessible from an onsite location.
(5) Records required by this section and existing records relevant
to compliance with this section must be available to FDA for inspection
and copying.
(6) When filing entry with U.S. Customs and Border Protection, the
importer of record of a human food manufactured from, processed with, or
otherwise containing, cattle material must affirm that the food was
manufactured from, processed with, or otherwise contains, cattle
material and must affirm that the food was manufactured in accordance
with this section. If a human food is manufactured from, processed with,
or otherwise contains, cattle material, then the importer of record
must, if requested, provide within 5 days records sufficient to
demonstrate that the food is not manufactured from, processed with, or
does not otherwise contain, prohibited cattle material.
(7) Records established or maintained to satisfy the requirements of
this subpart that meet the definition of electronic records in Sec.
11.3(b)(6) of this chapter are exempt from the requirements of part 11
of this chapter. Records that satisfy the requirements of this subpart
but that are also required under other applicable statutory provisions
or regulations remain subject to part 11 of this chapter.
(d) Adulteration. (1) Failure of a manufacturer or processor to
operate in compliance with the requirements of paragraphs (b) or (c) of
this section renders human food adulterated under section 402(a)(4) of
the act.
(2) Human food manufactured from, processed with, or otherwise
containing, prohibited cattle materials is unfit for human food and
deemed adulterated under section 402(a)(3) of the act.
(3) Food additive status. Prohibited cattle materials for use in
human food are food additives subject to section 409 of the act, except
when used as dietary ingredients in dietary supplements. The use or
intended use of any prohibited cattle material in human food causes the
material and the food to be adulterated under section 402(a)(2)(C) of
the act if the prohibited cattle material is a food additive, unless it
is the subject of a food additive regulation or of an investigational
exemption for a food additive under Sec. 170.17 of this chapter.
[70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006]
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