[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of April 1,
2013] [CITE: 21CFR589.2000]
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND
RELATED PRODUCTS
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; tallow containing no more than 0.15 percent insoluble
impurities and tallow derivatives as specified in 589.2001; 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 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.
(4) Renderers shall comply with all applicable requirements under
589.2001.
(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.
(3) Renderers shall comply with all applicable requirements under
589.2001.
(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, as amended at 73 FR 22756, Apr. 25, 2008]
Effective Date Note:
At 62 FR 30976, June 5, 1997, 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.
Enforcement Report - Week of February 20, 2013
Product Detail Product Description Regular Chicken 50#
Ingredients: Corn, Wheat, Oats, Oyster shells, Medium Grit, CCC, ADS, Plant
Protein Products, Animal Protein Products, Processed Grain By-Products, Roughage
Products, Animal Fat procession with DHA, etc
Recall Number V-137-2013 Classification Class III Code Info 8/6/2012
Product Distributed Qty 5400lbs (50lb bags)
Reason For Recall During an FDA sample collection, the firms 50# Regular
Chicken Feed was found to contain mammalian protein. The label does not contain
the warning statement.
Event Detail Event Id 63743 Product Type Veterinary Status Terminated
Recalling Firm Cohoons Elevator Inc. City Midland State MI Country US Voluntary
/ Mandated Voluntary: Firm Initiated Recall Initiation Date 2012-11-21 Initial
Firm Notification of Consignee or Public Other Distribution Pattern Midland MI
area only.
Tuesday, July 2, 2013
APHIS USDA Administrator Message to Stakeholders: Agency Vision and Goals
Eliminating ALL remaining BSE barriers to export market
Saturday, July 6, 2013
Small Ruminant Nor98 Prions Share Biochemical Features with Human
Gerstmann-Sträussler-Scheinker Disease and Variably Protease-Sensitive
Prionopathy
Research Article
Tuesday, June 11, 2013
Weld County Bi-Products dba Fort Morgan Pet Foods 6/1/12 significant
deviations from requirements in FDA regulations that are intended to reduce the
risk of bovine spongiform encephalopathy (BSE) within the United States
Thursday, June 6, 2013
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI
ratings as at June 5, 2013
Greetings,
since our fine federal friends have decided not to give out any more
reports on the USA breaches of the feed ban and surveillance etc. for the BSE
TSE prion mad cow type disease in the USDA livestock, I thought I might attempt
it. I swear, I just don’t understand the logic of the SSS policy, and that
includes all of it. I assure you, it would be much easier, and probably better
for the FDA and the USDA INC., if they would simply put some kind of report out
for Pete’s sake, instead of me doing it after I get mad, because I am going to
put it all out there. the truth.
PLEASE BE ADVISED, any breach of any of the above classifications OAI, VAI,
RTS, CAN lead to breaches into the feed BSE TSE prion protocols, and CAN lead to
the eventual suspect tainted feed reaching livestock. please, if any USDA
official out there disputes this, please explain then how they could not.
paperwork errors can eventually lead to breaches of the BSE TSE prion mad cow
feed ban reaching livestock, or contamination and exposure there from, as well.
I would sure like to see the full reports of just these ;
4018 CHI-DO 3007091297 Rancho Cantera 2866 N Sunnyside Rd Kent IL
61044-9605 OPR FR, OF HP 11/26/2012 OAI Y
9367 3008575486 Rocky Ford Pet Foods 21693 Highway 50 East Rocky Ford CO
81067 OPR RE, TH HP 2/27/2013 OAI N
9446 DEN-DO 1713202 Weld County Bi Products, Inc. 1138 N 11th Ave Greeley
CO 80631-9501 OPR RE, TH HP 10/12/2012 OAI N
9447 DEN-DO 3002857110 Weld County Bi-Products dba Fort Morgan Pet Foods
13553 County Road 19 Fort Morgan CO 80701-7506 OPR RE HP 12/7/2011 OAI N
see full list of the fda mad cow bse feed follies, toward the bottom, after
a short brief update on the mad cow bse follies, and our good friend Lester
Crawford that was at the FDA.
ALSO, I would kindly like to comment on this FDA BSE/Ruminant Feed
Inspections Firms Inventory (excel format)4 format, for reporting these breaches
of BSE TSE prion protocols, from the extensive mad cow feed ban warning letters
the fda use to put out for each violations. simply put, this excel format sucks,
and the FDA et al intentionally made it this difficult to follow the usda fda
mad cow follies. this is an intentional format to make it as difficult as
possible to follow these breaches of the mad cow TSE prion safety feed
protocols. to have absolutely no chronological or numerical order, and to format
such violations in a way that they are almost impossible to find, says a lot
about just how far the FDA and our fine federal friends will go through to hide
these continued violations of the BSE TSE prion mad cow feed ban, and any
breaches of protocols there from. once again, the wolf guarding the henhouse $$$
NAI = NO ACTION INDICATED
OAI = OFFICIAL ACTION INDICATED
VAI = VOLUNTARY ACTION INDICATED
RTS = REFERRED TO STATE
Inspections conducted by State and FDA investigators are classified to
reflect the compliance status at the time of the inspection, based upon whether
objectionable conditions were documented. Based on the conditions found,
inspection results are recorded in one of three classifications:
OAI (Official Action Indicated) when inspectors find significant
objectionable conditions or practices and believe that regulatory sanctions are
warranted to address the establishment’s lack of compliance with the regulation.
An example of an OAI classification would be findings of manufacturing
procedures insufficient to ensure that ruminant feed is not contaminated with
prohibited material. Inspectors will promptly re-inspect facilities classified
OAI after regulatory sanctions have been applied to determine whether the
corrective actions are adequate to address the objectionable conditions.
VAI (Voluntary Action Indicated) when inspectors find objectionable
conditions or practices that do not meet the threshold of regulatory
significance, but warrant an advisory to inform the establishment that
inspectors found conditions or practices that should be voluntarily corrected.
VAI violations are typically technical violations of the 1997 BSE Feed Rule.
These violations include minor recordkeeping lapses or conditions involving
non-ruminant feeds.
NAI (No Action Indicated) when inspectors find no objectionable conditions
or practices or, if they find objectionable conditions, those conditions are of
a minor nature and do not justify further actions.
when sound science was bought off by junk science, in regards to the BSE
TSE prion mad cow type disease, by the USDA, CFIA, WHO, OIE, et al. $$$
when the infamous, and fraudulently USDA, FSIS, APHIS, FDA, gold card was
taken away that infamous day in December of 2003, all cards were off the table,
it was time to change the science, and change they did. ...tss
snip. ...please see full text ;
Thursday, June 6, 2013
BSE TSE PRION USDA FDA MAD COW FEED COMPLIANCE REPORT and NAI, OAI, and VAI
ratings as at June 5, 2013
IN A NUT SHELL ;
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate
declarations made by the official Veterinary Services of Member Countries. The
OIE is not responsible for inaccurate publication of country disease status
based on inaccurate information or changes in epidemiological status or other
significant events that were not promptly reported to the Central Bureau,
Thursday, May 30, 2013
World Organization for Animal Health (OIE) has upgraded the United States'
risk classification for mad cow disease to "negligible" from "controlled", and
risk further exposing the globe to the TSE prion mad cow type disease
U.S. gets top mad-cow rating from international group and risk further
exposing the globe to the TSE prion mad cow type disease
Tuesday, July 2, 2013
APHIS USDA Administrator Message to Stakeholders: Agency Vision and Goals
Eliminating ALL remaining BSE barriers to export market
Saturday, July 6, 2013
Small Ruminant Nor98 Prions Share Biochemical Features with Human
Gerstmann-Sträussler-Scheinker Disease and Variably Protease-Sensitive
Prionopathy
Research Article
TSS
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