As the regulator of animal feed, FDA plays a key role in protecting U.S. cattle from bovine spongiform encephalopathy (BSE), also called mad cow disease, and protecting the health of people who consume cattle products.
Since the 1997 feed regulation was established, FDA and state inspectors have conducted more than 66,000 inspections involving more than 15,000 firms that handle animal feed. More than 99 percent of these facilities are in compliance with the regulation.
again, bold is mine. There is much more that I could have made bold for appropriate emphasis, but I think I covered the basics.
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2009]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR589.2001]
[Page 589-592]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 589_SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR
FEED--Table of Contents
Subpart B_Listing of Specific Substances Prohibited From Use in Animal
Food or Feed
Sec. 589.2001 Cattle materials prohibited in animal food or feed
to prevent the transmission of bovine spongiform encephalopathy.
(a) Purpose--The purpose of this section is to prohibit the use of
certain cattle origin materials in the food or feed of all animals to
further reduce the risk of the spread of bovine spongiform
encephalopathy (BSE) within the United States.
(b) Definitions--(1) Cattle materials prohibited in animal feed
include:
(i) The entire carcass of BSE-positive cattle;
(ii) The brains and spinal cords of cattle 30 months of age and
older;
(iii) The entire carcass of cattle not inspected and passed for
human consumption as defined in paragraph (b)(2) of this section that
are 30 months of age or older from which brains and spinal cords were
not effectively removed or otherwise effectively excluded from animal
feed;
(iv) Mechanically separated beef as defined in paragraph (b)(3) of
this section that is derived from materials specified in paragraphs
(b)(1)(i), (b)(1)(ii), and (b)(1)(iii) of this section; and
(v) Tallow as defined in paragraph (b)(5) of this section that is
derived from materials specified in paragraphs (b)(1)(i), (b)(1)(ii),
and (b)(1)(iii) of this section.
(vi) Cattle materials prohibited in animal feed do not include:
(A) Tallow derivatives as defined in paragraph (b)(6) of this
section;
(B) Tallow as defined in paragraph (b)(5) of this section that is
derived from materials specified in paragraphs (b)(1)(ii) and
(b)(1)(iii) of this section and that contains no more than 0.15 percent
insoluble impurities. Insoluble impurities must be measured by the
method entitled ``Insoluble Impurities'' (AOCS 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
[[Page 590]]
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.
(C) Materials as defined in paragraphs (b)(1)(ii), (b)(1)(iii),
(b)(1)(iv) (other than mechanically separated beef from the carcass of a
BSE-positive cattle), and (b)(1)(v) of this section from cattle from a
country that has been designated under paragraph (f) of this section.
(2) Cattle not inspected and passed for human consumption means
cattle that did not pass antemortem inspection by the appropriate
regulatory authority. This term includes nonambulatory disabled cattle.
Nonambulatory disabled cattle are 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.
(3) Mechanically separated beef means a finely comminuted meat food
product, resulting from the mechanical separation and removal of most of
the bone from attached skeletal muscle of cattle carcasses and parts of
carcasses.
(4) Renderer means any firm or individual that processes slaughter
byproducts, animals unfit for human consumption, or meat scraps. The
term includes persons who collect such materials and subject them to
minimal processing, or distribute them to firms other than renderers (as
defined in this paragraph) whose intended use for the products may
include animal feed, industrial use, or other uses. The term includes
renderers that also blend animal protein products.
(5) 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.
(6) Tallow derivative means any product 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.
(c) Requirements. (1) No animal feed or feed ingredient shall be
manufactured from, processed with, or otherwise contain, cattle
materials prohibited in animal feed as defined in paragraph (b)(1) of
this section.
(2) Renderers that receive, manufacture, process, blend, or
distribute cattle materials prohibited in animal feed as defined in
paragraph (b)(1) of this section, or products that contain or may
contain cattle materials prohibited in animal feed, shall take the
following measures to ensure that materials prohibited as defined in
paragraph (b)(1) of this section are not introduced into animal feed:
(i) Exclude from use in animal feed the entire carcass of cattle not
inspected and passed for human consumption as defined in paragraph
(b)(2) of this section if:
(A) The brain and spinal cord are not effectively removed from such
cattle or the brain and spinal cord from such cattle are not otherwise
effectively excluded from animal feed; and
(B) Such cattle are 30 months of age or older.
(ii) If renderers remove brain and spinal cord from cattle not
inspected and passed for human consumption, or separate such animals
based on whether or not they are 30 months of age or older, renderers
must maintain adequate written procedures specifying how these processes
are carried out.
(iii) Once cattle materials prohibited in animal feed have been
separated from other cattle materials, provide for measures to avoid
cross-contamination;
(A) Use separate equipment while handling cattle materials
prohibited in animal feed; or
(B) Use separate containers that adequately prevent contact with
animal feed, animal feed ingredients, or equipment surfaces;
[[Page 591]]
(iv) Label the cattle materials prohibited in animal feed and
products that contain or may contain cattle materials prohibited in
animal feed in a conspicuous manner as follows: ``Do not feed to
animals'';
(v) Mark the cattle materials prohibited in animal feed and products
that contain or may contain cattle materials prohibited in animal feed
with an agent that can be readily detected on visual inspection; and
(vi) Establish and maintain records sufficient to track cattle
materials prohibited in animal feed to ensure such material is not
introduced into animal feed, and make the records available for
inspection and copying by the Food and Drug Administration.
(3) Renderers that receive, manufacture, process, blend, or
distribute any cattle materials shall take the following measures to
ensure that materials prohibited as defined in paragraph (b)(1) of this
section are not used in animal feed:
(i) Establish and maintain records sufficient to demonstrate that
material rendered for use in animal feed was not manufactured from,
processed with, or does not otherwise contain, cattle materials
prohibited in animal feed and make copies of all records available for
inspection and copying by the Food and Drug Administration. With respect
to cattle materials obtained from establishments which have segregated
cattle materials prohibited in animal feed, such records must
demonstrate that establishments supplying cattle materials to the
renderers have adequate procedures in place to effectively exclude
cattle materials prohibited in animal feed; and these records shall be
considered sufficient to meet this requirement if they include either:
(A) Certification or other documentation from the supplier that
material supplied to the renderer does not include cattle materials
prohibited in animal feed; such certification or documentation is
acceptable, provided that it includes a description of the segregation
procedures used, documentation that the supplier confirms that its
segregation procedures are in place prior to supplying any cattle
material to the renderer, and records of the renderer's periodic review
of the suppliers' certification or other documentation; or
(B) Documentation of another method acceptable to FDA, such as
third-party certification, for verifying that suppliers have effectively
excluded cattle materials prohibited in animal feed.
(ii) Comply with all applicable requirements under Sec. 589.2000
regarding animal proteins prohibited in ruminant feed.
(d) Adulteration and misbranding. (1) Failure of a renderer to
comply with the requirements in paragraphs (c)(2)(i) through
(c)(2)(iii), (c)(2)(v) and (c)(2)(vi), or (c)(3)(i) of this section will
render the animal feed or feed ingredients adulterated under section
402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act).
(2) Animal feed or feed ingredients that are not in compliance with
paragraph (c)(1) of this section are adulterated under section
402(a)(2), 402(a)(3), or 402(a)(5) of the act.
(3) Animal feed or feed ingredients that are not in compliance with
the labeling requirements of paragraph (c)(2)(iv) of this section are
misbranded under section 403(a)(1) or 403(f) of the act.
(4) Failure of a renderer to comply with the requirements in
paragraph (e) of this section will render the animal feed or feed
ingredients adulterated under section 402(a)(4) of the act.
(e) Inspection; records retention. Records required to be made
available for inspection and copying by the Food and Drug
Administration, as required by this section, shall be kept for a minimum
of 1 year.
(f) Process for designating countries. A country seeking designation
must send a written request to the Director, Office of the Center
Director, Center for Veterinary Medicine, at the address designated in
Sec. 5.1100 of this chapter. The request shall include information
about that country's BSE case history, risk factors, measures to prevent
the introduction and transmission of BSE, and any other information
relevant to determining whether the cattle materials from the requesting
country do or do not meet the definitions set forth in paragraph (b)(1)
of this section. FDA shall respond in writing to any such request and
may impose conditions in
[[Page 592]]
granting any such request. Any grant by FDA of such a request under this
paragraph will be subject to future review by FDA and may be revoked if
FDA determines that the granted request is no longer appropriate.
[73 FR 22756, Apr. 25, 2008]
Effective Date Note: At 73 FR 22756, Apr. 25, 2008, Sec. 589.2001
was added, effective Apr. 27, 2009.
PARTS 590 599 [RESERVED]
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