[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR589.2000]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 589--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Subpart B--Listing of Specific Substances Prohibited From Use in Animal Food or Feed
Sec. 589.2000 Animal proteins prohibited in ruminant feed.
(a) Definitions--(1) Protein derived from mammalian tissues means
any protein-containing portion of mammalian animals, excluding: Blood
and blood products; gelatin; inspected meat products which have been
cooked and offered for human food and further heat processed for feed
(such as plate waste and used cellulosic food casings); milk products
(milk and milk proteins); and any product whose only mammalian protein
consists entirely of porcine or equine protein.
(2) 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 here) whose intended use for the products may include animal
feed. The term includes renderers that also blend animal protein
products.
(3) Blender means any firm or individual which obtains processed
animal protein from more than one source or from more than one species,
and subsequently mixes (blends) or redistributes an animal protein
product.
(4) Feed manufacturer includes manufacturers of complete and
intermediate feeds intended for animals, and includes on-farm in
addition to off-farm feed manufacturing and mixing operations.
(5) Nonmammalian protein includes proteins from nonmammalian
animals.
(6) Distributor includes persons who distribute or transport feeds
or feed ingredients intended for animals.
(7) Ruminant includes any member of the order of animals which has a
stomach with four chambers (rumen, reticulum, omasum, and abomasum)
through which feed passes in digestion. The order includes, but is not
limited to, cattle, buffalo, sheep, goats, deer, elk, and antelopes.
(b) Food additive status. The Food and Drug Administration has
determined that protein derived from mammalian tissues for use in
ruminant feed is a food additive subject to section 409 of the Federal
Food, Drug, and Cosmetic Act (the act). The use or intended use in
ruminant feed of any material that contains protein derived from
mammalian tissues causes the feed to be adulterated and in violation of
the act, unless it is the subject of an effective notice of claimed
investigational exemption for a food additive under Sec. 570.17 of this
chapter.
(c) Requirements for renderers that are not included in paragraph
(e) of this section. (1) Renderers that manufacture products that
contain or may contain protein derived from mammalian tissues and that
are intended for use in animal feed shall take the following measures to
ensure that materials identified in paragraph (b) of this section are
not used in the feed of ruminants:
(i) Label the materials as follows: ``Do not feed to cattle or other
ruminants``; and
(ii) Maintain records sufficient to track the materials throughout
their receipt, processing, and distribution, and make the copies
available for inspection and copying by the Food and Drug
Administration.
(2) Renderers described in paragraph (c)(1) of this section will be
exempted from the requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of
this section if they:
(i) Use exclusively a manufacturing method that has been validated
by the Food and Drug Administration to deactivate the agent that causes
transmissible spongiform encephalopathy (TSE) and whose design has been
made available to the public;
(ii) Use routinely a test method that has been validated by the Food
and Drug Administration to detect the presence of the agent that causes
TSE`s and whose design has been made available to the public. Renderers
whose products test positive for agents that cause TSE`s must comply
with paragraphs (c)(1)(i) and (c)(1)(ii) of this section. Records of the
test results shall be made available for inspection by the Food and Drug
Administration; or
(iii) Use exclusively a method for controlling the manufacturing
process that minimizes the risk of the TSE agent entering the product
and whose design has been made available to the public and validated by
the Food and Drug Administration.
(3) Renderers described in paragraph (c)(1) of this section will be
exempted from the requirements of paragraph (c)(1)(ii) of this section
if they use a permanent method, approved by FDA, to make a mark
indicating that the product contains or may contain protein derived from
mammalian tissue. If the marking is by the use of an agent that cannot
be detected on visual inspection, the renderer must use an agent whose
presence can be detected by a method that has been validated by the Food
and Drug Administration and
whose design has been made available to the public.
(d) Requirements for protein blenders, feed manufacturers, and
distributors that are not included in paragraph (e) of this section. (1)
Protein blenders, feed manufacturers, and distributors that manufacture,
blend, process, and distribute products that contain or may contain
protein derived from mammalian tissues shall comply with paragraph
(c)(1) of this section.
(2) Protein blenders, feed manufacturers, and distributors, shall be
exempt from paragraphs (d)(1) of this section if they:
(i) Purchase animal products from renderers that certified
compliance with paragraph (c)(2) of this section or purchase such
materials from parties that certify that the materials were purchased
from renderers that certified compliance with paragraph (c)(2) of this
section; or
(ii) Comply with the requirements of paragraph (c)(2) of this
section where appropriate.
(3) Protein blenders, feed manufacturers, and distributors, shall be
exempt from paragraph (c)(1)(ii) of this section if they:
(i) Purchase animal protein products that are marked in accordance
with paragraph (c)(3) of this section or purchase such materials from
renderers that certified compliance with paragraph (c)(3) of this
section, or purchase such materials from parties that certify that the
materials were purchased from renderers that certified compliance with
paragraph (c)(3) of this section; or
(ii) Comply with the requirements of paragraph (c)(3) of this
section where appropriate.
(4) Pet food products that are sold or are intended for sale at
retail and feeds for nonruminant laboratory animals are exempt from the
labeling requirements in paragraphs (c) and (d) of this section.
However, if the pet food products or feeds for nonruminant laboratory
animals are sold or are intended for sale as distressed or salvage
items, then such products shall be labeled in accordance with paragraph
(c) or (d) of this section, as appropriate.
(5) Copies of certifications as described in paragraphs (d)(2) and
(d)(3) of this section, shall be made available for inspection and
copying by the Food and Drug Administration.
(e) Requirements for persons that intend to separate mammalian and
nonmammalian materials. (1) Renderers, protein blenders, feed
manufacturers, distributors, and others that manufacture, process, blend
and distribute both products that contain or may contain protein derived
from mammalian tissues or feeds containing such products, and protein
products from other animal tissues or feeds containing such products,
and that intend to keep those products separate shall:
(i) Comply with paragraphs (c)(1) or (d)(1) of this section as
appropriate except that the labeling requirement shall apply only to
products that contain or may contain protein derived from mammalian
tissues or feeds containing such products;
(ii) In the case of a renderer, obtain nonmammalian or pure porcine
or pure equine materials only from single-species slaughter facilities;
(iii) Provide for measures to avoid commingling or cross-
contamination;
(A) Maintain separate equipment or facilities for the manufacture,
processing, or blending of such materials; or
(B) Use clean-out procedures or other means adequate to prevent
carry-over of products that contain or may contain protein derived from
mammalian tissues into animal protein or feeds that may be used for
ruminants; and
(iv) Maintain written procedures specifying the clean-out procedures
or other means, and specifying the procedures for separating products
that contain or may contain protein derived from mammalian tissue from
all other protein products from the time of receipt until the time of
shipment.
(2) Renderers, blenders, feed manufacturers, and distributors will
be exempted from applicable requirements of paragraph (e)(1) of this
section, if they meet the criteria for exemption under paragraphs (c)(2)
or (c)(3) of this section, and (d)(2) or (d)(3) of this section.
(f) Requirements for establishments and individuals that are
responsible for feeding ruminant animals. Establishments and individuals
that are responsible for
feeding ruminant animals shall maintain copies of purchase invoices and
labeling for all feeds containing animal protein products received, and
make the copies available for inspection and copying by the Food and
Drug Administration.
(g) Adulteration and misbranding. (1) Animal protein products, and
feeds containing such products, that are not in compliance with
paragraphs (c) through (f) of this section, excluding labeling
requirements, will be deemed adulterated under section 402(a)(2)(C) or
402(a)(4) of the act.
(2) Animal protein products, and feeds containing such products,
that are not in compliance with the labeling requirements of paragraphs
(c) through (f) of this section will be deemed misbranded under section
403(a)(1) or 403(f) of the act.
(h) Inspection; records retention. (1) Records that are to be made
available for inspection and copying, as required by this section, shall
be kept for a minimum of 1 year.
(2) Written procedures required by this section shall be made
available for inspection and copying by the Food and Drug
Administration.
[62 FR 30976, June 5, 1997]
Effective Date Note: At 62 FR 30976, June 5, 1997, Sec. 589.2000
was added. Paragraph (e)(1)(iv) of this section contains information
collection and recordkeeping requirements and will not become effective
until approval has been given by the Office of Management and Budget.
PARTS 590-599 [RESERVED]
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