CVM GFI #76 Questions and Answers BSE Feed Regulations

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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GUIDANCE FOR INDUSTRY
QUESTIONS AND ANSWERS
BSE FEED REGULATION
21 Code of Federal Regulations (CFR) 589.2000
This document answers questions about “Animal Proteins Prohibited from Animal Feed”, the BSE
feed regulation. It is intended to supplement the Small Entity Compliance Guides for the
regulation, specifically the following FDA Guidance for Industry documents:
67 - Renderers
68 - Protein Blenders, Feed Manufacturers, and Distributors
69 - Feeders of Ruminant Animals With On-Farm Feed Mixing
Operations
70 - Feeders of Ruminant Animals Without On-Farm Feed Mixing
Operations
This guide represents the agency's current thinking on compliance with these regulations. It does
not create or confer any rights for or on any person and does not operate to bind the FDA or
public. An alternative approach may be used if such approach satisfies the requirements of the
applicable statute, regulations or both.
Comments and suggestions regarding the document should be submitted to Shannon Jordre,
Center for Veterinary Medicine, (HFV-230), Food and Drug Administration, 7519 Standish
Place, Rockville, MD 20855, 240-276-9229, E-mail: shannon.jordre@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
July 1998

QUESTIONS AND ANSWERS
BSE FEED REGULATION
21 Code of Federal Regulations (CFR) 589.2000
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Center for Veterinary Medicine (CVM)
July, 1998
Introduction:
This document answers questions about “Animal Proteins Prohibited from
Animal Feed”, the BSE feed regulation. It is intended to supplement the
Small Entity Compliance Guides for the regulation, specifically the following
FDA Guidance for Industry documents:
67 - Renderers
68 - Protein Blenders, Feed Manufacturers, and Distributors
69 - Feeders of Ruminant Animals With On-Farm Feed Mixing
Operations
70 - Feeders of Ruminant Animals Without On-Farm Feed Mixing
Operations
The Small Entity Compliance Guides are available through the Internet at
(http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/
ComplianceEnforcement/BovineSpongiformEncephalopathy/default.htm)
.
Inquiries:
Q1. Where can I direct any questions on the BSE regulation that are not
answered by this document or the Small Entity Compliance Guides?
A. Please direct your questions to Shannon Jordre, Center for Veterinary
Medicine, Division of Compliance, HFV-230, 7519 Standish Place,
Rockville, Maryland 20855 (240-276-9229). The questions can be faxed
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to (240-276-9241) or sent by email to shannon.jordre@fda.hhs.gov.
Effective Dates:
Q2. When was the regulation effective?
A. It was effective August 4, 1997. Printed packaging, labels, labeling and
finished products manufactured before the publication of the final regulation
(June 5, 1997) were allowed to be used until October 3, 1997.
Q3. I have seen several products that appear to be covered by the
regulation. Should they have the required label statement “Do not feed
to cattle or other ruminants” even if they were manufactured before
June 5, 1997?
A. Yes. If they are available for sale or distribution, such products should be
relabeled with the cautionary statement and fed only to nonruminants, or
disposed of in a way that ensures they will not be fed to ruminants.
Records:
Q4. It appears that mammalian proteins that have been exempted do
not have to be labeled with the cautionary statement “Do not feed to
cattle or other ruminants.” But what about the recordkeeping
requirements?
A. In general, exempted mammalian proteins are not subject to the
recordkeeping or any other requirements of the rule. There is one exception,
however. Ruminant feeders are required to keep invoices and labeling for
all feed they receive that contains animal protein products, whether or not the
animal protein is prohibited material.
Q5. If certain products are received in multiple container shipments in a
plant that separates prohibited from nonprohibited materials, must
records be kept documenting the final disposition of each container
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versus the entire shipment?
A. You are not required to document the final disposition of the contents of
each incoming container. The regulation requires records sufficient to track
the materials through their receipt, processing and distribution. Invoices or
similar documents for incoming and outgoing products will satisfy this
requirement. Since your firm separates prohibited and nonprohibited
materials, however, you are required to provide for measures to avoid
commingling and cross-contamination of prohibited and nonprohibited
materials. Neither the regulation nor the Small Entity Compliance Guides
provide for specific procedures, because of the variation in facilities and the
number of different procedures that would be acceptable. However, your
measures to avoid commingling and cross-contamination (which need to be
documented in written procedures) need to be adequate to prevent
commingling of individual containers that hold prohibited and nonprohibited
materials and cross-contamination from their contents.
Q6. If a Hazard Analysis Critical Control Point (HACCP) plan is
adopted for the facility, would this reduce the recordkeeping
requirement?
A. No. The Agency has indicated it would evaluate the use of HACCP at a
later date. We do encourage the use of HAACP plans, however, to assist the
agency in its evaluation.
Q7. My feed mill receives prohibited material, and the material is used
to produce feed for nonruminant animals. Am I required to annotate the
master and batch production records with a statement identifying the
ingredients added as prohibited material?
A. The regulation does not specifically require that entries be made in the
production records. Nor does the Small Entity Compliance Guide for feed
manufacturers suggest that this be done. However, if your firm also
manufactures feed for ruminant animals using nonprohibited materials, you
are required to provide for measures to avoid commingling and cross-
contamination of prohibited materials. Your measures to avoid commingling
and cross-contamination (which need to be documented in written
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procedures) could include entries in production records along with other
separation and/or clean-out procedures that would be adequate to prevent
commingling and cross-contamination.
Q8. My feed mill has a small retail sales section where feed is sold in
both bagged and bulk form. Should I record complete sales information
for feeds containing prohibited material in order to facilitate a recall if
one should be needed?
A. The regulation requires recordkeeping (and the cautionary statement) for
retail sales of all feeds containing prohibited product. This requirement can
be met through copies of sales invoices or similar documents. The records
should contain the following information:
C 	Date of the sale
CC 	Name and address of the seller
CC 	Name and address of the purchaser
CC 	Identification of the product
CC 	Quantity
Although this information is not intended specifically for recalls, it would be
useful for that purpose.
Q9. Do all feed retailers need to keep the records described in answer to
the previous question?
A. Yes. The regulation applies throughout the manufacturing and distribution
chain. Therefore, it applies to feed retail operations, whether or not the
facility is part of a feed manufacturing operation.
Q10. Do ruminant feeders have to maintain records of feeds they
receive if the feeds include only nonprohibited protein products such as
milk products and feather meal?
A. Yes. The rule states that you must maintain invoices and labeling for all
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feeds you receive containing animal protein products. So, these records must
be maintained of all feed containing protein products derived from animals
including non-prohibited animal protein products. However, you do not need
to keep records of feed containing only protein products derived from plants,
such as soybean meal.
Labeling:
Q11. My company collects inedible offal products, including beef, sheep
and pork offal, and sells them to other companies. Does my company
have to keep records and label these products?
A. If you sell the offal to traditional renderers, the regulation does not require
that you keep records or label the products. However, renderers may impose
their own requirements on you so that they can assure compliance with the
regulation. FDA has suggested that renderers who separate prohibited from
nonprohibited material may wish to have assurance from their supplier of
nonprohibited material about the product’s contents. This could include a
certification from the supplier, or specification of source in a business
contract.
However, if you sell the offal to feed manufacturers or others who are not
traditional renderers, you are considered a “renderer” under the regulation
and are subject to the recordkeeping and labeling requirements. This is true
whether you subject the materials to minimal processing or do not process
the materials in any way.
Q12. I produce a product containing mostly hog hair but also a small
o
amount of beef hair. The product has been cooked at 260 F for at least
30 minutes, then screened out in the milling process and hydrolyzed. Am
I required to put the statement “Do not feed to cattle or other
ruminants” on the label?
A. Yes. There is no exemption for the beef hair, which is a mammalian
protein. FDA does not consider the processing you describe to be adequate
to inactivate the agent that causes BSE.
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Q13. Can damaged and distressed pet food be salvaged by feeding it to
food-producing animals?
A. Damaged and distressed pet food may be salvaged as nonruminant feed
but because it contains or may contain prohibited material, it must be labeled
with the caution statement “Do not feed to cattle or other ruminants,” and
records of its distribution maintained.
Non-Prohibited or Prohibited Product:
Q14. Are paunch and paunch products prohibited?
A. The paunch is the cow’s stomach excluding the contents. The paunch,
itself, is considered an animal protein subject to the rule. The paunch
contents (ingested feed and water) are not subject to the rule and therefore are
not prohibited. The Agency understands that in the process of removing the
contents a very small amount of paunch tissue may be introduced into the
contents. The Agency does not believe this poses enough concern to prohibit
the use of the contents at this time.
Q15. If “specified bovine offal” (SBO) is removed from the carcass, will
the rest of the carcass be considered exempt?
A. No. All protein from bovine tissue is prohibited except blood and blood
products, milk products, gelatin and inspected meat products which have
been cooked and offered for human food and further heat processed for
animal feed.
Q16. Are bone meal and bone byproducts mammalian tissues, and are
they prohibited material?
A. Both bone meal and bone byproducts contain proteins from mammalian
tissue. They are prohibited material unless they are pure swine or horse
products. The regulation prohibits the feeding to ruminants of all proteins
from mammalian tissue unless specifically exempted.
Q17. Do all exempt materials have the same status? It seems that
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mammalian protein tissue from pigs or horses could be more of a
concern to the Agency than milk processing waste.
A. All exempt materials have the same status. They are all exempt and not
subject to the requirements of the rule.
Q18. My company processes fresh pork and other processed pork items.
My company also renders pork byproducts. In the past we have
rendered a tiny portion of rejected beef items that are returned to us
from the marketplace. Does this subject us to the rule?
A. Not if the beef products meet the requirement of the regulation. Beef
products such as hot dogs and ready-to-eat deli meats which have been
inspected, cooked, and offered for human food may be rendered and are
exempt from the rule after rendering. This is covered by the exemption for
inspected meat products which have been cooked and offered for human food
and then further heat processed.
Q19. Does the exemption for products that have been cooked, offered
for human food and then further heat processed require that the
products be sent to the marketplace and then returned in order to be
exempt?
A. No, it is sufficient that the products have been cooked in anticipation of
entering the marketplace. Those products such as hot dogs, which have been
cooked, and completely prepared for entering the marketplace, and then
rejected from the marketplace for quality control reasons, will be considered
exempt.
Q20. What does “further heat processed,” as used in the previous
question, mean?
A. The regulation does not specify what constitutes acceptable heat
processing because of the variety of commercial processes and the variations
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in temperature which could be used for heat processing.
Following are examples of acceptable “further heat processing”:
C 	Traditional rendering processes;
C 	Extrusion and cooking at 212 degrees Fahrenheit for 30 minutes,
as required for garbage under the Swine Health Protection Act;
C 	Pelleting, if the plate waste in the pellet conditioner reaches an
internal temperature of at least 190 degrees Fahrenheit, and the
retention time is such that the total heat energy applied is similar
to that achieved in the extrusion processes or required by the
Swine Health Protection Act;
C 	Pelleting at temperatures similar to those used in traditional
rendering or the holding of pellets at temperatures to comply
with the Swine Health Protection Act.
Other methods could meet the “further heat processing” requirement;
information on other methods would need to be submitted to CVM.
Q21. A USDA-inspected facility processes edible beef stock or broth
from edible and inspected beef bones, making a meat and bone meal
product. Does the meat and bone meal product require the labeling “Do
not feed to cattle or other ruminants”?
A. Yes. A “meat and bone meal” product by definition contains protein, and
is not exempt unless manufactured from pure pork or horse material. Bone
contains protein in the form of the marrow and collagen.
Q22. Does this mean that every product whose name includes “bone” is
prohibited?
A. No. Products meeting the Association of American Feed Control Officials
(AAFCO) definitions of Bone Ash, Bone Phosphate, Bone Charcoal and
Bone Charcoal, Spent are exempt because by definition they do not contain
protein.
Q23. Is “gel bone” prohibited material?
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A. Yes, unless it is from pure pork or horse material. Gel bone is bone that
has been coarsely crushed, rinsed and degreased. It is usually intended for
use in making gelatin.
Q24. Is collagen exempt under the BSE rule since it is “unprocessed”
gelatin?
A. Collagen is not exempt, unless it is obtained from pure pig or horse
material. However, gelatin is exempt under the BSE regulation. Data
available to the FDA suggests that gelatin does not transmit the transmissible
spongiform encephalopathy (TSE) agent. The conventional manufacturing
process for gelatin has been demonstrated to inactivate, in a significant way,
any residual activity that may have been present in source tissues. 	But see
the answer to the next question.
Q25. If I use collagen to formulate a deer feed, do I have to comply with
the rule?
A. Collagen is a protein found in all mammals and is not specifically exempt
from the BSE rule. Furthermore, collagen is not a recognized feed term, and
its listing in the ingredient list could cause the product to be misbranded.
Collagen protein is a starting material for gelatin; however, unprocessed
collagen is not gelatin and does not categorically qualify for the gelatin
exemption. Products in the market referred to as “hydrolyzed collagen” or
similar type names may be a “feed grade” gelatin, since the term “feed grade”
can be used to indicate products suitable for animal consumption. Whether
these types of “hydrolyzed collagen” products qualify for the gelatin
exemption are handled on a case-by-case basis. The decision is based on the
starting material and the process. Information on the starting material and the
process should be submitted to CVM for comment.
Q26. Can chicken litter be fed to cattle if the poultry might have been
fed prohibited material?
A. Yes. The FDA has no evidence that the agent that causes BSE would
survive the chicken intestinal tract. FDA expects the states to require
recycled animal waste to conform to the definitions promulgated by the
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Association of American Feed Control Officials (AAFCO) as published in its
official publication and as described in its "Model Regulations for Processed
Animal Waste Products as Animal Feed Ingredients." Under the AAFCO
Model Regulation, in order for this product to be used in a commercial feed,
it must be registered/licensed within a State, and be assayed periodically for
Salmonella and E. coli bacteria, heavy metals, pesticides, drugs, parasitic
larva or ova, and mycotoxins.
Q27. Can uncooked pizza dough that may contain beef materials be fed
to ruminants?
A. No. The pizza would have to have been inspected, cooked and offered for
human consumption, and further processed before it would qualify for the
“plate waste” exception.
Single Species Slaughter Facilities:
Q28. I am a renderer and I intend to separate prohibited material from
nonprohibited material. Why must I obtain my exempt material from a
single species slaughter facility as long as I comply with the separation
requirement?
A. FDA has no regulatory authority over the slaughterhouses, so the agency
could not require them to have the separation or cleanout procedures which
would be necessary to provide adequate protection.
Q29. My company slaughters pigs and lamb in separate facilities. We
render the pig offal, but send the lamb offal to another facility for
rendering. Waste water from the separate facilities is collected in a
common area and then flocculated to suspend the solids from the
separate kill floors. The solids, a mud-like material, are returned to the
pork rendering operation. May we treat the rendered pork products as
if it came from a single species slaughter facility?
A. No. The solid material which you return to the pork rendering operation
contains some portion of lamb offal from the kill floor. The addition of this
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prohibited mammalian product to the pork materials requires that you label
the material “Do not feed to cattle or other ruminants,” and comply with the
other requirements of the rule.
Separation of Prohibited and Nonprohibited Materials:
Q30. May prohibited and non-prohibited products be stored in the same
cooler so long as each product is in a separate container, is properly
labeled, and there are established procedures to prevent commingling
and cross-contamination of products?
A. Yes. It is likely that any method will be acceptable to FDA as long as it
achieves its intended purpose -- prevention of commingling or cross-
contamination.
Q31. Is it necessary to control dust on bin tops to prevent prohibited
product particles from entering nonprohibited product?
A. Yes. The rule states that you must use procedures adequate to prevent
cross-contamination. If your firm has a dust problem that results in prohibited
material contaminating nonprohibited product, then you have not met the
requirements of the rule.
Clean-out:
Q32. What procedures are considered acceptable by FDA for cleaning
loadout bins?
A. Clean-out could be accomplished by physical clean-out, flushing,
sequencing or other means that are adequate to prevent carryover of
prohibited materials into nonprohibited materials. The Small Entity
Compliance Guides provide additional guidance on clean-out methods. Upon
request, CVM’s Division of Compliance (see address and phone number on
page 1) will comment on specific clean-out procedures that a firm is planning
is to use.
Q33. The Small Entities Compliance Guide for Renderers states that
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flushing volume of nonprohibited material should be equal to one
complete change of operating volume. My operation has a 10-ton
capacity. Does this mean I have to run 10 tons of nonprohibited material
through my operation?
A. Not necessarily. The rule itself requires only that procedures be in place
to avoid cross-contamination. The Small Entity Compliance Guide for
Renderers states that flushing with a complete change of operating volume
will satisfy this condition. If you have established a different volume and/or
procedure that will also prevent cross-contamination, you may use it. For
feed manufacturing operations, off-farm or on-farm, the guide states that the
volume of flushed material should be sufficient to prevent carryover of
products that contain or may contain prohibited material. Feed mill operators
should determine their feed mills’ individual characteristics and apply
appropriate time and volume requirements for flushing materials. Additional
guidance appears in the Small Entity Compliance Guides.
Q34. Is it permissible to load nonprohibited protein in the same loadout
bay as prohibited material when separate conveyance systems are used?
A. Yes, as long as the clean-out procedure that you establish is adequate to
prevent cross-contamination.
Q35. In addition to providing rendered, non-prohibited product for
feeding to ruminants, my firm grinds 4-D meat (meat from dead, dying,
diseased or disabled animals) primarily for pet food markets. The 4-D
meat is usually ground and frozen but not heat processed. What are the
clean-out guidelines for processing these products?
A. We assume that the 4-D meat includes prohibited material, that is, it is not
pure horse or pig material. If the two operations share common equipment,
your firm needs to follow the clean-out guidelines in the Small Entity
Compliance Guide for Renderers. Washing the grinders with soap is an
acceptable example. “4-D” processing operations are subject to the same
rules as renderers since the regulation defines “renderer” to include any firm
or operation that processes animals unfit for human consumption. Whether or
not the two operations share common processing equipment, your firm needs
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to take steps to avoid commingling of the prohibited and nonprohibited
materials.
Q36. Will washing be considered adequate clean-out for small
Rubbermaid containers, barrels, totes and/or combo bins?
A. Yes.
Imports:
Q37. Who has the responsibility for assuring that imported meat and
bone meal is in compliance with the rule?
A. The firm or individual that enters or intends to enter the product into
domestic commerce should determine the origin and species of the imported
product to be assured that any prohibited material is handled in compliance
with the regulation. Import of all mammalian protein products from certain
countries is prohibited by U.S. Department of Agriculture (USDA)
regulations.
Q38. What is necessary to establish whether an imported mammalian
protein product intended for animal feed use contains prohibited
material and therefore must comply with the rule?
A. At this time, we are suggesting that the importer request certification from
the exporting country that the product does or does not contain prohibited
product.
Exports:
Q39. Are prohibited products that are ordinarily subject to the rule
required to comply with the labeling requirements if the products are
intended for export?
A. No. However, prohibited protein products destined for export, like all
other exported food products, must be marked “For Export Only” on the
shipping containers, if appropriate, and on documents accompanying the
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shipment. Other legal requirements for exported products must also be met.
Any prohibited product destined for export which is diverted into domestic
commerce will be subject to all the requirements of the regulation.
Responsibility for assuring that the products are not diverted into domestic
commerce rests with the owner of the product.
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Science:
Q40. Can the TSE causative agent affect humans or animals exposed to
airborne prohibited materials and dust from these products?
A. No. There is no evidence for direct transmission from animal to animal,
or animal to human, by incidental contact. Studies to date indicate that the
causative agent must be injected or ingested, or contaminated tissue must be
implanted, for transmission to occur.
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