Explaining the different hazards associated with the production of pet and animal feed based on FDA's guidance under FSMA regulations (Preventive Controls for Animal Feed).
2. Definitions [§507.3]
Animal Food means food for animals other than man and
includes pet food, animal feed, and raw materials and
ingredients
Hazard requiring a preventive control means a known or
reasonably foreseeable hazard for which a person
knowledgeable about the safe manufacturing, processing,
packing, or holding of animal food would, based on the
outcome of a hazard analysis (which includes an assessment
of the severity of the illness or injury to humans or animals if
the hazard were to occur and the probability that the hazard
will occur in the absence of preventive controls), establish
one or more preventive controls to significantly minimize or
prevent the hazard in an animal food and components to
manage those controls (such as monitoring, corrections or
corrective actions, verification, and records) as appropriate to
the animal food, the facility, and the nature of the preventive
control and its role in the facility's food safety system.
3. Food Safety Plan Components
§507.31 Food Safety Plan
◦ (c) The written food safety plan must include:
◦ (1) The written hazard analysis as required by
§507.33(a)(2);
◦ (2) The written preventive controls as required by
§507.34(b);
◦ (3) The written supply-chain program as required by
subpart E of this part;
◦ (4) The written recall plan as required by §507.38(a)(1);
◦ (5) The written procedures for monitoring the
implementation of the preventive controls as required by
§507.40(a)(1);
◦ (6) The written corrective action procedures as required by
§507.42(a)(1); and
◦ (7) The written verification procedures as required by
§507.49(b).
4. Hazard Analysis Considerations
[§507.33/§117.130]
ANIMAL FEED HUMAN FOOD
B: microbiological hazards
such as parasites,
environmental pathogens,
and other pathogens
C: radiological hazards,
pesticide and drug
residues, natural toxins,
decomposition, unapproved
food or color additives,
drug carry-over and
nutrient deficiencies/
toxicities
P: stones, glass, metal
fragments, etc.
B: microbiological hazards
such as parasites,
environmental pathogens,
and other pathogens
C: radiological hazards,
pesticide and drug
residues, natural toxins,
decomposition, unapproved
food or color additives, and
food allergens
P: stones, glass, metal
fragments, etc.
5. Preventive Controls
Considerations [§507.34/§117.135]
ANIMAL FEED HUMAN FOOD
Process Controls
Sanitation Controls
Supply-Chain Controls
Recall Plan
Process Controls
Food Allergen Controls
Sanitation Controls
Supply-Chain Controls
Recall Plan
6. Special Considerations
[§507.36(c)/§507.36(d)]
If the customer, or the entity in the
distribution chain subsequent to your
customer, has determined that the identified
hazard is not a hazard in the animal food
intended for use for a specific animal
species, the customer’s, or entity’s, written
assurance (including animal species and why
the identified hazard is not a hazard) may be
provided instead of providing assurance of
the procedures that will significantly
minimize or prevent the identified hazard
7. NOTE
For complete feeds, recommend
separating plans (determining
number) based on intended species
For feed ingredients, recommend
separating plans based on
process/hazards/etc. (similar to
human food)
8. Major vs. Minor Species
Seven major species:
◦ horses, cattle, pigs, dogs, cats, chickens, and
turkeys
Minor species are:
◦ zoo animals, such as lions and tigers;
◦ “pocket pets,” such as guinea pigs, gerbils,
hamsters, and ferrets;
◦ laboratory rodents;
◦ fish; and
◦ pet birds, such as parrots and parakeets.
◦ Some minor species are important to agriculture,
including sheep, goats, catfish, salmon, emus,
llamas, bison, honey bees, and gamebirds such
as pheasants.
9. NOTE
When conducting a hazard analysis
NEED to consider all of the following:
◦ How the animal feed will affect the Animal
◦ How the animal feed will affect Humans
◦ How the animal feed will affect Humans
through the Animal
11. Examples of Biological Hazards
Salmonella spp.
Escherichia coli
Listeria monocytogenes
Avian Influenza
Staphylococcal infection
Clostridium perfringens Type D
Bovine Spongiform Encephalopathy
(BSE)
12. Salmonella spp.
Pet food can be contaminated with any
Salmonella serotype
High human health risk due to the
increased likelihood of direct human
contact with the pet food
Examples of pet food:
◦ Dog/cat food, aquarium fish food, raw
meat/poultry formulations
◦ Pet treats or chews
◦ Supplementation for pets
◦ Pet food ingredients
13. Salmonella spp.
Animal feed is considered adulterated
when contaminated with a Salmonella
serotype that is considered pathogenic
to the intended animal consumer and
will not undergo any kill step.
With other Salmonella serotypes, FDA
evaluates on a case-by-case basis
15. Salmonella spp.
Infection in animals results from
ingestion of Salmonella-contaminated
feed, water, or grass
Salmonellosis can cause fever,
diarrhea and severe dehydration in
animals
◦ Most susceptible – young, distressed or
pregnant aniamls
Salmonella infection can cause
Paratyphoid in chickens, turkeys,
ducks and other birds
16. Escherichia coli
E. coli may contaminate animal feed
from the supplier’s fields
Additionally, if the supplier raises
animals, the fecal matter may
contaminate the ingredient(s)
E. coli contamination may cause
diarrhea in young calves
Most cattle don’t show signs of infection,
but some may contract mastitis
(inflammation of the mammary gland and
udder tissue) and can cause permanent
damage to the udder
17. Listeria monocytogenes
In the past Listeria was not considered
to be a significant hazard in pet food
Recent data has shown the
contamination of raw, fresh and frozen
pet foods with Listeria monocytogenes
4 voluntary recalls of pet food
associated with Listeria occurred in
2015
18. Listeria monocytogenes
Listeria monocytogenes tends to occur in
poor-quality silage and big-bale silage
Big-bale silage may allow for a degree of
aerobic fermentation, raising the pH
levels and resulting in growth of Listeria
Listeria contamination of silage can
cause abortion, meningitis, encephalitis
(brain inflammation) and septicemia
(blood poisoning) in BOTH animals and
humans
19. Listeria monocytogenes
Cattle, sheep and goats are most
commonly affected
Listeriosis in animals/livestock can
cause swelling in the brain,
neurological-related circling,
incoordination, inability to chew and
swallow and pregnant animals can
have late-term abortions
20. Avian Influenza virus
Avian Influenza can be picked up by
bulk ingredients, such as wheat, and
eventually make its way to the
intended animal, especially poultry
May be controlled through Supplier
Verification to ensure that farms
growing crops and birds control any
cross-contamination
21. Staphylococcal Infection
May contaminate feed from the feed
mill environment, employees, etc.
Poultry - Staphylococcal infection can
cause septicemia (blood poisoning),
chronic arthiritis, omphalitis (in
turkeys), death
Swine – Methicillin-resistant S. aureus
contamiantion is an emerging problem
22. Clostridium perfringens Type D
Affects Sheep & Goats
Causes Enterotoxemia, also known as pulpy
kidney disease or overeating
Results from
◦ Excessive consumption of milk or feed with high
concentrations of grain
◦ When ration is rich in carbohydrates (grains) and low
in roughage
Can Cause
◦ Convulsions (kids or lambs)
◦ Sudden Death occurs in approximately 12 hours (only
minutes in kids or lambs)
◦ Loss of appetite
◦ Diarrhea
23. Bovine Spongiform Encephalopathy
(BSE)
A progressive neurological disorder of
cattle that results from infection by an
unusual transmissible agent called a
prion – CDC definition
FDA has multiple guidance documents
regarding BSE
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/Co
mplianceEnforcement/BovineSpongifo
rmEncephalopathy/default.htm
24. Animal Proteins Prohibited in
Ruminant Feed [§589.2000]
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.
25. Cattle Materials Prohibited […] to
prevent […] of [BSE] [§589.2001]
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.
26. KEEP IN MIND!
The biological hazards listed in this
presentation are only a few of the
many potential significant hazards
Research may show that previously
insignificant hazards are in fact
significant (see Listeria for an
exmaple)
27. Biological Hazards-Related Links
(n.d.). Bacteria contaminants associated with poultry feeds from three different companies. Retrieved from
https://nairaproject.com/projects/1508.html
(June 2008). Microbiological risk assessment in feeding stuffs for food-producing animals: Scientific opinion of
the panel on biological hazards. Retrieved from http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2008.720/epdf
(March 2012). Assignment to collect samples of poultry feed (layers, broilers and turkeys) and analyze them for
Salmonella. Retrieved from
https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/Contaminants/ucm316673.htm
Blackwell, T. E., Butler, D. G., Prescott, J. F., & Wilcock, B. P. (1991). Differences in signs and lesions in sheep
and goats with enterotoxemia induced by intraduodenal infusion of Clostridium perfringens Type D. American
Journal of Veterinary Research, 52(7), 1147-1152.
CPG 690.800 Salmonella in Food for Animals
https://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf
Crump, J. A., Griffin, P. M., & Angulo, F. J. (2002). Bacterial contamination of animal feed and its relationship to
human foodborne illness. Clinical Infectious Diseases, 35, 859-865. Retrieved from
https://academic.oup.com/cid/article/35/7/859/307143/Bacterial-Contamination-of-Animal-Feed-and-Its
D’Mello, J. P. F. (n.d.). Contaminants and toxins in animal feeds. Retrieved from
http://www.fao.org/docrep/ARTICLE/AGRIPPA/X9500E04.HTM
Furata, K., Morimoto, S., & Sato, S. (1980). Bacterial contamination in feed ingredients, formulated chicken feed
and reduction of viable bacteria by pelleting. Laboratory Animals, 14, 221-224.
Hines II, M. E. (2013). Enterotoxemia in sheep and goats. Retrieved from
http://vet.uga.edu/news/view/enterotoxemia_in_sheep_and_goats
Holmes, L. (2016). Impact and control of pathogens on poultry. Retrieved from
http://www.poultryworld.net/Health/Articles/2016/11/Impact-and-control-of-pathogens-2921226W/
Import Alert 71-04 “Detention Without Physical Examination of Animal Feeds, Other Than Pet Treats, Due to the
Presence of Salmonella” https://www.accessdata.fda.gov/cms_ia/importalert_217.html
McGuirk, S. M. & Peek, S. (2003). Proceedings from AABP ’03: Salmonellosis in cattle: A review. Columbus,
OH: Retrieved from https://www.vetmed.wisc.edu/dms/fapm/fapmtools/7health/Salmorev.pdf
Pelzer, K. D. & Currin, N. (2009). Zoonotic diseases of cattle. Virginia Cooperative Extension Publications, ID:
400-460. Retrieved from http://pubs.ext.vt.edu/400/400-460/400-460.html
Turlington, H. (2014). Contamination and animal feed. Retrieved from
http://www.foodqualityandsafety.com/article/contamination-and-animal-feed/
29. Physical Hazards (taken from participant manual)
Stones
◦ May be introduced with ingredients from fields
◦ Can cause choking, broken teeth
Glass
◦ May be introduced from broken lightbulbs or
other glass in manufacturing facility
◦ Can cause cuts
Metal
◦ May be introduced at a number of locations
throughout the process
◦ Most manufacturing of animal feed uses
equipment with metal parts
◦ Can cause punctures, cuts, broken teeth
30. Traumatic Reticulitis
Primarily a disease of adult cattle
The ingestion of sharp metal and plastic
objects (e.g. nails, wires, etc.) can penetrate
the reticulum wall (result of contractions
during the cudding process)
Infection spreads into the surrounding
abdomen and can produce abscesses and
adhesions in abdomen and chest
In severe cases can cause pericarditis
(infection of the outside of the heart)
Symptoms: reduced milk yield, abdominal
pain, reduced feed intake (to name a few)
31. Physical Hazards-Related Links
(n.d.). Traumatic reticulitis. Retrieved from
http://www.thecattlesite.com/diseaseinfo/24
1/traumatic-reticulitis/
FSPCA: Preventive Controls for Animal
Food https://www.ifsh.iit.edu/fspca/fspca-
preventive-controls-animal-food
Turlington, H. (2014). Contamination and
animal feed. Retrieved from
http://www.foodqualityandsafety.com/article/
contamination-and-animal-feed/
36. Aflatoxins – CPG 683.100
Action Level Ingredient Intended Species
300 ppb Corn & peanut products Finishing (i.e. feedlot) beef
cattle
300 ppb Cottonseed meal Beef cattle, swine, or poultry
(regardless of age or
breeding status)
200 ppb Corn or peanut products Finishing swine of 100 lbs. or
greater
100 ppb Corn and peanut
products
Breeding beef cattle,
breeding swine, or mature
poultry
20 ppb Corn , peanut products,
and other animal feeds
and feed ingredients
(excluding cottonseed
meal)
Immature animals
20 ppb Corn, peanut products,
cottonseed meal, and
other animal feeds and
feed ingredients
Dairy animals, for animal
species or uses not specified
above, or when the intended
use is not known
37. Aflatoxins
Can be transmitted through milk, meat
and eggs to humans
“…FDA does not allow blending of grains
to reduce the aflatoxin to an ‘acceptable’
level, nor is there a recognized
‘detoxifier’ by FDA […]. Some states
allow blending of such products and a
few allow ammoniation to destroy the
aflatoxin, but these are for intrastate use
only.” (Turlington, 2014)
Therefore, SUPPLY-CHAIN CONTROLS
38. Ochratoxin A and Zearalenone (ZEN)
No tolerances or guidance have been
established
Regulatory action will be decided on a
case-by-case basis
Ochratoxins can be nephrotoxic to a
wide range of species
◦ Porcine nephropathy
◦ Balkan endemic nephropathy (humans)
ZEN can cause reproductive
abnormalities in swine and ruminants
39. Fumonisins
FDA’s Guidance for Industry –
“Fumonisins are associated with a
variety of adverse health effects in
livestock and experimental animals.
Currently, there is no direct evidence
that fumonisins cause adverse health
effects in humans because available
studies demonstrate only inconclusive
associations between fumonisins and
human cancer. ”
41. Deoxynivalenol (DON)/
Vomitoxin
Can cause vomiting, diarrhea, feed refusal and
decreased milk production
FDA Advisory Levels
◦ 10 ppm vomitoxin on grains and grain by-products
destined for ruminating beef and feedlot cattle older
than 4 months and for chickens with the added
recommendation that these ingredients not exceed
50% of the diet of cattle or chickens.
◦ 5 ppm vomitoxin on grains and grain by-products
destined for swine with the added recommendation
that these ingredients not exceed 20% of their diet.
◦ 5 ppm vomitoxin on grains and grain by-products
destined for all other animals with the added
recommendation that these ingredients not exceed
40% of their diet.
42. Molds/Mycotoxins
Can be controlled through:
◦ Monitoring by the supplier – Supplier
Verification Programs
◦ Testing by the feed producer – special
considerations
“Mycotoxin testing is influenced by the type of
animal being fed and the crops in which
mycotoxins are most frequently associated.”
(Turlington, 2014).
44. Pesticides and Industrial Chemicals
Tolerances are established by the
EPA; See 40 CFR 180
FDA action levels can be found in
CPG 575.100 [link provided]
Regulatory action for pesticides and
industrial chemicals in feed and feed
ingredients will be decided on a case-
by-case basis
45. §509.30 Temporary Tolerances for PCB’s
“PCB's are transmitted to the food portion (meat, milk,
and eggs) of food producing animals ingesting PCB
contaminated animal feed.”
Temporary Tolerances
◦ 0.2 part per million in finished animal feed for food-
producing animals (except the following finished animal
feeds: feed concentrates, feed supplements, and feed
premixes).
◦ 2 parts per million in animal feed components of animal
origin, including fishmeal and other by-products of marine
origin and in finished animal feed concentrates,
supplements, and premixes intended for food-producing
animals.
◦ 10 parts per million in paper food-packaging material
intended for or used with finished animal feed and any
components intended for animal feeds. The tolerance shall
not apply to paper food-packaging material separated from
the food therein by a functional barrier which is
impermeable to migration of PCB's.
46. Pesticides and Industrial Chemicals
Affect humans by accumulating in the
fat tissue of food-producing animals
Examples of violative pesticide levels
◦ O-phenylphenol in Chicken Food
◦ Raisin pomice and piperonyl butoxide in
Soybean Meal
◦ Acephate in Vitamin E (feed ingredient)
◦ Pirimiphos-methyl in Soluble Wheat
Protein
◦ Diphenylamine in Canola Meal
47. Plant Toxins and Weed Seeds
Plant toxins may be found in principal
ingredients in the feeds
48. Chemical Hazards-Related Links
21 CFR 509 “Unavoidable Contaminants in Animal Feed and Food-Packaging Material”
https://www.ecfr.gov/cgi-bin/text-
idx?SID=64ee8f113648754523133aa1aba20116&mc=true&node=pt21.6.509&rgn=div5
21 CFR 509.30 “Temporary Tolerances for Polychlorinated Biphenyls (PCB’s)”
https://www.ecfr.gov/cgi-bin/text-
idx?SID=64ee8f113648754523133aa1aba20116&mc=true&node=pt21.6.509&rgn=div5#se21.
6.509_130
40 CFR 180 Tolerances andExemptions for Pesticide Chemical Residues in Food
https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr180_main_02.tpl
CPG 575.100 Pesticide Residues in Food and Feed – Enforcement Criteria
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm12323
6.htm
CPG 683.100 Action Levels for Aflatoxins in Animal Feeds
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm07470
3.htm
FDA. (2005). Feed contaminants program. Retrieved from
https://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/complianceenforcement/ucm
113409.pdf
Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ChemicalContamina
ntsMetalsNaturalToxinsPesticides/ucm109231.htm
Osweiler, G. D. (2016). Overview of mycotoxicoses. Retrieved from
http://www.merckvetmanual.com/toxicology/mycotoxicoses/overview-of-mycotoxicoses
Porter, R. E. (2016). Overview of poisonings in poultry. Retrieved from
http://www.merckvetmanual.com/poultry/poisonings/overview-of-poisonings-in-poultry
Turlington, H. (2014). Contamination and animal feed. Retrieved from
http://www.foodqualityandsafety.com/article/contamination-and-animal-feed/
49. Heavy Metal - Lead
Poisoning MTLs
Introduced into the received
ingredients by the supplier
(ex. contaminated foliage,
seeding/harvesting activities,
proximity to smelters)
Poisoning most common in
dogs and cattle (other species
reduced accessibility, more
selective eating habits)
Enters the blood and soft
tissues and eventually
accumulates in the bones
◦ Can be passed into the milk
(Dairy Cattle)
Cattle
◦ 100 mg/kg, can tolerate up to
◦ 30 mg/kg, MTL
Sheep
◦ 100 mg/kg
Equine, Poultry, Swine,
Rodents & Fish
◦ 10 mg/kg
7.2 mg/kg body wt of
metallic lead is lethal in
poultry
50. Heavy Metals - Mercury
Mercury MTLs
Quite toxic to both humans
and animals
Predator species (e.g. fish,
seals, polar bears, various
bird species) can
bioaccumulate significant
quantities of mercury from
their diet, especially in
tissues such as the brain,
kidneys and fetus
Detected in animal feed
containing fish meal
Inorganic Mercury
◦ 0.2 mg/kg
Organic Mercury
◦ 1 mg/kg – rodents, poultry,
equine and fish
◦ 2 mg/kg – swine, cattle and
sheep
51. Heavy Metals – Cadmium &
Arsenic
Cadmium Arsenic
Phosphate sources are
likely sources of
cadmium concentrations
WHO has set an upper
limit of 1 mg/kg of
cadmium in complete
animal feeds
MTL is 10 mg/kg –
rodents, poultry, swine,
equine, cattle, sheep and
fish
Can be introduced
through agricultural
practices (e.g.
pesticides/insecticides)
and the field environment
Arsenic MTL
◦ 30 mg/kg – rodents, poultry,
swine, equine, cattle and
sheep
◦ 5 mg/kg - fish
52. Chemical Hazards-Related Links
Blakley, B. R. (2016). Overview of lead poisoning. Retrieved from
http://www.merckvetmanual.com/toxicology/lead-
poisoning/overview-of-lead-poisoning
Blakley, B. R. (2016). Overview of mercury poisoning. Retrieved
from http://www.merckvetmanual.com/toxicology/mercury-
poisoning/overview-of-mercury-poisoning
Dai, S. Y., Jones, B., Lee, K-M., Li, W., Post, L., & Herrman, T. J. (2016). Heavy
metal contamination of animal feed in Texas. Journal of Regulatory Science, 01,
21-32.
Garland, T. (2016). Inorganic arsenicals (toxicity). Retrieved from
http://www.merckvetmanual.com/toxicology/arsenic-poisoning/inorganic-
arsenicals-toxicity
Garland, T. (2016). Organic arsenicals (toxicity). Retrieved from
http://www.merckvetmanual.com/toxicology/arsenic-poisoning/organic-arsenicals-
toxicity
Garland, T. (2016). Overview of arsenic poisoning. Retrieved from
http://www.merckvetmanual.com/toxicology/arsenic-poisoning/overview-of-
arsenic-poisoning
National Research Council of the National Academies. (2001). Nutrient
requirements of dairy cattle (7th ed.). Washington, D.C.: The National Academies
Press.
National Research Council of the National Academies. (2005). Mineral tolerances
of animals (2nd ed.). Washington, D.C.: The National Academies Press.
53. Nutrient Deficiencies/Toxicities
Vitamins
◦ any of a group of organic compounds that
are essential for normal growth and nutrition
and are required in small quantities in the diet
because they cannot be synthesized by the
body.
Minerals
◦ a solid inorganic substance of natural
occurrence.
a substance obtained by mining.
an inorganic substance needed by the human body
for good health.
54. Vitamin Source Examples
Vitamin Source(s)
A
Β-carotene, leafy-green forage, dehydrated hay, milk or
fish fat (variable), yellow corn
B-complex
Synthesized by rumen (sheep & goats), soybean meal,
dried leafy forage, dried brewers’ yeast, dry milk or whey,
cane molasses, alfalfa, feeds of animal or marine origin
(B12)
D Dam’s milk (sheep & goats), sun-cured hays, sunlight
E
High-quality legume hays, dehydrated alfalfa, wheat
germ, Vitamin E Supplement
K1 & K2
Green, leafy feedstuffs, K2 synthesized by rumen (sheep
& goats)
K3 Synthetic vitamin supplement
55. NE = Not Established
**supplementation
recommendation; no requirement
has been estalished
*decreases with age
A (IU/kgdiet
DM)
Thiamine
(mg/kg)
Riboflavin
(mg/kg)
Niacin
(mg/kg)
PantothenicAcid
(mg/kg)
Biotin
(mg/kg)
FolicAcid
(mg/kg)
B12
(mg/kg)
D(IU/kgdietDM)
E(IU/kgdiet
DM)
K(IU/kgdietDM)
Beef Cattle Feedlot Cattle 2,200
Pregnant Beef
Heifers and Cows
2,800
Lactating Cows and
Breeding Bulls
3,900
DairyCattle
Adult (Lactating and
Dry)
4,400
Growing Heifers 2,500
YoungCalves 9,000 600 75-100
Rumen Bacterial
Synthesis
Equine 1,200 3.0-5.0 2.0 NE NE 15-25** NE NE 500-1,000 500-1,000 NE
Poultry Turkeys 5,000 2.0 4.0-2.5* 60-40*
10-9.0(Breeding
Hens =16)
0.2-0.1 1.0-0.7 0.003 1,100
12-10(Breeding
Hens =25)
1.75-0.5
Leghorn-type 1,500-3,000 1.0-0.7 3.6-2.2* 27-10* 2.0-10 0.15-0.1 0.55-0.25
0.004-
0.08
200-300 5.0-10 0.5-1.0
Swine 2,200-1,300* 1.5-1.0* 4.0-2.0* 30 12-7.0
0.08-
0.05*
0.3
20-5.0*
mcg/kg
220-150(gestating/
lactating sows =800)
11-16(Sows =
44)
0.5
Sheep Mature Ewe 2,500-3,300
Rumen Bacterial
Synthesis
Young Lambs 1,500
Rumen Bacterial
Synthesis
Goats 1,500 300
Rumen Bacterial
Synthesis
Rumen Bacterial
Synthesis
Rumen Bacterial
Synthesis
Rumen Bacterial Synthesis
Rumen Bacterial Synthesis
Rumen Bacterial Synthesis
Rumen Bacterial Synthesis
Rumen Bacterial Synthesis
Rumen Bacterial Synthesis
Vitamin Requirements Based on Animal Species
260
1,200
150-220
15-60
30[lactation];
90[terminal
dry]
7.0-15
56. Vitamin A
Vitamin A requirements may be met by
β-carotene, naturally occurring, or by
active forms (e.g. retinol) in the diet
However, the feed may got through
oxidation during storage, thus,
reducing the amount of carotene
content
Additionally, vitamin A deficiency is
rare because of the ability of the liver
to store this vitamin in animals
57. Vitamin A
Cattle
◦ Supplementation is needed if there is a decreased amount
and quality of forage in the feed, and, if there is an
increased amount of corn silage in the feed
◦ Vitamin requirements vary depending on the type of cattle
Equine
◦ “Rations for all classes of horses should provide a
minimum of 30 IU active vitamin A/kg body wt (whether as
β-carotene or an active synthetic form such as retinyl
acetate)”
◦ MTL: Active vitamin A: 16,000 IU/kg diet DM/β-carotene:
no known toxicity
Sheep & Goats
◦ Supplementation may be needed in diets if certain feed
ingredients are included (e.g. poor-quality roughage, corn
silage, corn stalks, straw, etc.)
58. B-complex Vitamins
Thiamine (B1)
◦ Equine
Deficiency from poor-quality hay/grain
◦ Sheep & Goats
Aberrations in ruminal thiamine metabolism can lead to
polioencephalomalacia
Niacin (B3)
◦ Cattle
Supplementation is required in pre-weaned calves
Requirements are unknown for cattle at this moment
◦ Equine
No known dietary requirement in healthy horses
Vitamin B12
◦ Ruminants are more susceptible to B12 deficiencies than
other animals
◦ Equine
Provided there is sufficient cobalt in the diet, synthesis of B12 is
probably adequate
No deficiencies have been reported
59. Vitamin D
Cattle
◦ Deficiency is rare in beef cattle, however, conditions
of lodging location, turn-out times, etc. may affect this
occurrence
◦ Reliance on natural vitamin D formation in dairy cattle
is considered unreliable
Equine
◦ No requirements if exposed to ≥4hr of sunlight per
day or consume sun-cured hay
◦ If deprived of sunlight, supplementation suggested
Goats
◦ If Ca:P levels are low then the requirement increases
60. Vitamin E
Cattle
◦ Vitamin E functions to protect cellular membranes from
oxidative damage
◦ Requirements vary depending on antioxidant
concentrations, sulfur-containing amino acids, and
selenium in the feed
◦ IF environmental mastitis becomes an issue much higher
concentrations will need to be supplemented into the feed
Equine
◦ Excess supplementation >5,000 IU/day for an average
adult horse can affect Vitamin A absorption
Poultry
◦ May vary with type and level of fat in the diet, level of
selenium and trace minerals, presence/absence of other
antioxidants
Swine
◦ If selenium levels are low increase the required amount of
vitamin E
61. Vitamin K
Poultry
◦ Deficiency can be carried over from the
hen to the egg (layers)
◦ Including menadione at 1-4 mg/ton of
feed helps to prevent deficiency
Equine [§573.620]
◦ Vitamin K3 has been correlated with
nephrotoxicosis in horses
◦ It is recommend this compound not be
included in horse feed
65. Minerals
High-quality forages and/or grains
contain a majority of the required
minerals, therefore, supplementation in
the feed will need to consider multiple
factors (ex. Individual requirements,
existing levels, etc.)
The feed producer will need to ensure
that any additional supplementation
avoids mineral excess/toxicity that could
reduce productivity for the consumer.
Minerals can also be sold as mineral
supplements for animal feed
66. Some Minerals to Note
Magnesium
◦ Feed with high forage content tend to need to be
supplemented with magnesium
◦ Chicks fed a diet completely devoid of magnesium
will die
◦ *NOTE* Magnesium plays a central role in eggshell
formation
Copper
◦ Influenced by high intakes of Molybdenum
◦ Sheep are more susceptible than most other animals
to copper toxicity
Selenium [§573.920]
◦ Metabolism of selenium is closely related to Vitamin E
◦ Regulation: <0.3ppm
67. Some Minerals to Note
Manganese
◦ If excess Calcium:Phosphorus is in diet it
becomes difficult to correct Managnese
deficiency
Zinc
◦ Excess dietary calcium may increase the
likelihood of zinc deficiency
Vanadium*
◦ The presence of vanadium in poultry feed,
especially layer, may result in adverse effects on
albumen quality, thus effecting egg production
◦ Dicalcium phosphates have been associated with
the contribution of excess vanadium in the diet of
hens
68. NOTE
Levels of vitamins and mineral
required for the different species vary
based on
◦ Ingredients in feedstuffs
◦ Feeding practices used
◦ Mineral/vitamin levels in the environment
69. Drug Carry-Over
Monensin Poisoning in Horses
◦ Drug approved for use in cattle, poultry and
goat feed
◦ Horses are extremely sensitive (2-3 mg/kg of
body weight = death)
◦ No antidote
◦ §558.355 (d)(6) “All formulations containing
monensin shall bear the following caution
statement: Do not allow horses or other
equines access to feed containing monensin.
Ingestion of monensin by horses has been
fatal.”
70. Drug Carry-Over
Lasalocid Poisoning
◦ Not permitted for use in Equine and Swine feed
§558.311(d)(5) Required label statements:
◦ (i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain
and/or roughage prior to feeding. Feeding undiluted, mixing errors, or
inadequate mixing (recirculation or agitation) may result in an excess
lasalocid concentration which could be fatal to cattle and sheep. Do not
allow horses or other equines access to Type A articles or Type B feeds
containing lasalocid as ingestion may be fatal. Safety of lasalocid for use
in unapproved species has not been established.
◦ (ii) For Type A articles or Type B feeds (cattle and sheep): Feeding
undiluted or mixing errors may result in an excess lasalocid concentration
which could be fatal to cattle and sheep. Do not allow horses or other
equines access to Type A articles or Type B feeds containing lasalocid as
ingestion may be fatal. Safety of lasalocid for use in unapproved species
has not been established.
◦ (iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal
period has not been established for this product in preruminating calves.
Do not use in calves to be processed for veal.
For swine death can occur at 58 mg/kg, and symptoms can
start to occur at 35 mg/kg in the feed
71. Chemical Hazards-Related Links
Gadberry, S. (n.d.). Beef cattle nutrition series: Part 3: Nutrient requirement tables. Retrieved from
https://www.uaex.edu/publications/PDF/MP391.pdf
Herdt, T. H. (2016). Nutritional requirements of dairy cattle. Retrieved from
https://www.merckvetmanual.com/management-and-nutrition/nutrition-dairy-cattle/nutritional-requirements-of-
dairy-cattle
Hilton, W. M. (2016). Nutritional requirements of beef cattle. Retrieved from
https://www.merckvetmanual.com/management-and-nutrition/nutrition-beef-cattle/nutritional-requirements-of-
beef-cattle
Lalman, D. & Richards, C. (n.d.). Nutrient requirements of beef cattle. Retrieved from
http://pods.dasnr.okstate.edu/docushare/dsweb/Get/Document-1921/E-974web.pdf
Maxie, G., van Dreumel, T., & McMaster, D. (1992). Ontario: Menadione (vitamin k3) toxicity in six horses. The
Canadian Veterinary Journal, 33, 756-757.
Mohamed, W. A. M., Bayomi, Y. H., Attia, N. E., & Raouf, M. A. E. (October 2017). Diagnostic approach to
nephrotoxicosis with vitamin k3 in draft horses based on inos and selective urinary variables. Advances in
Animal and Veterinary Sciences, 5(11), 468-476.
National Research Council of the National Academies. (2005). Mineral tolerances of animals (2nd ed.).
Washington, D.C.: The National Academies Press.
Nationa Research Council of the National Academies. (2007). Nutrient Requirements of Horses (6th ed.).
Washington, D.C.: The National Academies Press.
Parish, J. & Rhinehart, J. (2008). Mineral and vitamin nutrition for beef cattle. Retrieved from
http://www.thebeefsite.com/articles/1549/mineral-and-vitamin-nutrition-for-beef-cattle/
Ralston, S. L. (2016). Nutritional diseases of horses. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-horses/nutritional-diseases-of-horses
Ralston, S. L. (2016). Nutritional requirements if horses. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-horses/nutritional-requirements-of-horses
Rasby, R. J., Berger, A. L., Bauer, D. E., & Brink, D. R. (2011). Minerals and vitamins for beef cattle. Retrieved
from http://extensionpublications.unl.edu/assets/pdf/ec288.pdf
72. Chemical Hazards-Related Links
(2009). A Beginner’s Guide to Raising Sheep. Retrieved from
http://www.sheep101.info/201/mineralsandvitamins.html
(2017). Urinary calculi in sheep and goats. Retrieved from https://www.sheepandgoat.com/urincalc
Bailey, E. (n.d.). Vitamins for beef cattle. Retrieved from https://extension2.missouri.edu/G2058
Cromwell, G. L. (2016). Nutritional diseases of pigs. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-pigs/nutritional-diseases-of-pigs
Cromwell, G. L. (2016). Nutritional requirements of pigs. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-pigs/nutritional-requirements-of-
pigs
Harris, L. E. (n.d.). Chapter 8. feedstuffs. Retrieved from
http://www.fao.org/docrep/x5738e/x5738e09.htm
Klasing, K. C. (2016). Nutritional requirements of poultry. Retrieved from
http://www.merckvetmanual.com/poultry/nutrition-and-management-poultry/vitamin-deficiencies-in-
poultry
Leeson, S. (2016). Vitamin deficiencies in poultry. Retrieved from
http://www.merckvetmanual.com/poultry/nutrition-and-management-poultry/vitamin-deficiencies-in-
poultry
Pugh, D. G. (2016). Nutritional diseases of goats. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-goats/nutritional-diseases-of-
goats
Pugh, D. G. (2016). Nutritional diseases of sheep. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-sheep/nutritional-diseases-of-
sheep
Pugh, D. G. (2016). Nutritional requirements of goats. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-goats/nutritional-requirements-of-
goats
Pugh, D. G. (2016). Nutritional requirements of sheep. Retrieved from
http://www.merckvetmanual.com/management-and-nutrition/nutrition-sheep/nutritional-requirements-of-
sheep
Wahlberg, M. L. & Greiner, S. P. (2006). Minerals and vitamins for sheep. Retrieved from
http://www.sites.ext.vt.edu/newsletter-archive/livestock/aps-06_10/aps-373.html
74. Fish Meal
Fish meal in animal feed
has been commonly
contaminated with Enteric
bacteria including
Salmonella and coliform
bacilli depending on the
procedure and handling of
the fish meal by the
supplier
Import Alert 71-04
addresses the
contamination of fish meal
in animal feed with
Salmonella
Fish meal may be high in
mercury due to mercury
bio-concentrating
throughout the aquatic food
chain
In the past, fish meal has
been adulterated with
melamine to increase the
protein content; the
presence of melamine has
resulted in renal failure in
cats and dogs
“When producing […] fish
meal, any PCBs present
will become more
concentrated in the oil
fraction and less
concentrated in the water
fraction, as compared with
the levels in the whole fish”
(FDA Seafood HACCP
Guidance)
75. Direct-Fed Microbial Products
Includes products that claim to contain
live microorganisms (bacteria and/or
yeast)
“A direct-fed microbial product that is
considered to be 1) an unapproved new
animal drug, or 2) an unapproved food
additive, or 3) a misbranded drug under
502(f)(1) should be considered for
regulatory action.”
CPG 689.100 lists policies associated
with the labeling of direct-fed microbial
products
76. Mineral Oil [§573.680]
Mineral oil may be safely used in animal feed,
subject to the provisions of this section.
◦ (b) It is used in animal feeds for the following
purposes:
(1) To reduce dustiness of feeds or mineral supplements.
(2) To serve as a lubricant in the preparation of pellets,
cubes, or blocks and to improve resistance to moisture of
such pellets, cubes, or blocks.
(3) To prevent the segregation of trace minerals in
mineralized salt.
(4) To serve as a diluent carrier in the manufacture of feed
grade biuret in accordance with good manufacturing
practice.
(5) For the removal of water from substances intended as
ingredients of animal feed.
◦ (c) The quantity of mineral oil used in animal feed
shall not exceed 3.0 percent in mineral supplements,
nor shall it exceed 0.06 percent of the total ration
when present in feed or feed concentrates.
77. BHT [§582.3173]
(a) Product. Butylated hydroxytol- uene.
(b) Tolerance. This substance is
generally recognized as safe for use in
food when the total content of
antioxidants is not over 0.02 percent of
fat or oil content, including essential
(volatile) oil content of food provided the
substance is used in accordance with
good manufacturing or feeding practice.
78. Ingredient-Related Links
CPG 689.100 Direct-Fed Microbial Products
https://www.fda.gov/ICECI/ComplianceManuals/Compli
ancePolicyGuidanceManual/ucm074707.htm
FAO. (2016). Probiotics in animal nutrition: Production, impact
and regulation. Retrieved from http://www.fao.org/3/a-
i5933e.pdf
Import Alert 99-29 “Detention Without Physical
Examination of All Vegetable Protein Products From
China for Animal or Human Food Use Due to the
Presence of Melamine and/or Melamine Analogs”
https://www.accessdata.fda.gov/cms_ia/importalert_267
.html
Karunasagar, I. (2009). Melamine in fish feed and
implications for safety of aquaculture products. FAO
Aquaculture Newsletter, 42, 29-31.
80. Medicated Feeds
Regulations vary depending on whether
Catergory I or II
[§558.3(b)(1)] New animal drugs approved for use
in animal feed are placed in two categories as
follows:
◦ (i) Category I—These drugs require no withdrawal
period at the lowest use level in each major species
for which they are approved or are approved for use
only in minor species.
◦ (ii) Category II—These drugs require a withdrawal
period at the lowest use level for at least one major
species for which they are approved, or are regulated
on a “no-residue” basis or with a zero tolerance
because of carcinogenic concern regardless of
whether a withdrawal period is required in any
species.
81. Categories I & II
Tables found in §558.4(d) “identifies
each drug by category, the maximum
level of drug in Type B medicated
feeds, and the assay limits for the
drug in Type A medicated articles and
Type B and Type C medicated feeds”
82. New Animal Drug Types [§558.3(b)]
◦ (2) A “Type A medicated article” is intended solely
for use in the manufacture of another Type A
medicated article or a Type B or Type C
medicated feed. It consists of a new animal
drug(s), with or without carrier (e.g., calcium
carbonate, rice hull, corn, gluten) with or without
inactive ingredients. The manufacture of a Type A
medicated article requires an application
approved under §514.105 of this chapter or an
index listing granted under §516.151 of this
chapter.
◦ (5) A Type B or Type C medicated feed
manufactured from a drug component (bulk or
“drum-run” (dried crude fermentation product))
requires an application approved under §514.105
of this chapter or an index listing granted under
§516.151 of this chapter.
83. New Animal Drug Types [§558.3(b)]
(3) A “Type B medicated feed” is intended solely for the
manufacture of other medicated feeds (Type B or Type C). It
contains a substantial quantity of nutrients including vitamins
and/or minerals and/or other nutritional ingredients in an
amount not less than 25 percent of the weight. It is
manufactured by diluting a Type A medicated article or
another Type B medicated feed. The maximum concentration
of animal drug(s) in a Type B medicated feed is 200 times the
highest continuous use level for Category I drugs and 100
times the highest continuous use level for Category II drugs.
The term “highest continuous use level” means the highest
dosage at which the drug is approved for continuous use (14
days or more), or, if the drug is not approved for continuous
use, it means the highest level used for disease prevention or
control. If the drug is approved for multiple species at different
use levels, the highest approved level of use would govern
under this definition. The manufacture of a Type B medicated
feed from a Category II, Type A medicated article requires a
medicated feed mill license application approved under
§515.20 of this chapter.
84. New Animal Drug Types [§558.3(b)]
(4) A “Type C medicated feed” is intended as the
complete feed for the animal or may be fed “top
dressed” (added on top of usual ration) on or
offered “free-choice” (e.g., supplement) in
conjunction with other animal feed. It contains a
substantial quantity of nutrients including
vitamins, minerals, and/or other nutritional
ingredients. It is manufactured by diluting a Type
A medicated article or a Type B medicated feed.
A Type C medicated feed may be further diluted
to produce another Type C medicated feed. The
manufacture of a Type C medicated feed from a
Category II, Type A medicated article requires a
medicated feed mill license application approved
under §515.20 of this chapter.
85. Types’ Relationship
Type A Medicated
Article
Type B
Medicated Feed
Type A Medicated
Article
Type B
Medicated Feed
Type C Medicated
Feed
Type C Medicated
Feed
86. New Animal Drug Types [§558.3(b)]
(6) A “veterinary feed directive (VFD) drug” is
a drug intended for use in or on animal feed
which is limited by an approved application
filed pursuant to section 512(b) of the Federal
Food, Drug, and Cosmetic Act, a conditionally
approved application filed pursuant to section
571 of the Federal Food, Drug, and Cosmetic
Act, or an index listing under section 572 of
the Federal Food, Drug, and Cosmetic Act to
use under the professional supervision of a
licensed veterinarian. Use of animal feed
bearing or containing a VFD drug must be
authorized by a lawful veterinary feed
directive.
87. New Animal Drug Types [§558.3(b)]
(7) A “veterinary feed directive” is a written
(nonverbal) statement issued by a licensed
veterinarian in the course of the veterinarian's
professional practice that orders the use of a
VFD drug or combination VFD drug in or on
an animal feed. This written statement
authorizes the client (the owner of the animal
or animals or other caretaker) to obtain and
use animal feed bearing or containing a VFD
drug or combination VFD drug to treat the
client's animals only in accordance with the
conditions for use approved, conditionally
approved, or indexed by the Food and Drug
Administration.
88. New Animal Drug Types [§558.3(b)]
(12) A “combination veterinary feed
directive (VFD) drug” is a combination
new animal drug (as defined in
§514.4(c)(1)(i) of this chapter) intended
for use in or on animal feed which is
limited […] to use under the professional
supervision of a licensed veterinarian,
and at least one of the new animal drugs
in the combination is a VFD drug. Use of
animal feed bearing or containing a
combination VFD drug must be
authorized by a lawful VFD.
89. New Animal Drug Types [§558.3(b)]
(8) A “medicated feed” means a Type
B medicated feed as defined in
paragraph (b)(3) of this section or a
Type C medicated feed as defined in
paragraph (b)(4) of this section.
90. Medicated Feed License [§558.4]
“A feed manufacturing facility must
possess a medicated feed mill license in
order to manufacture a Type B or Type C
medicated feed from a Category II-Type
A medicated article.”
Exemptions:
◦ Type B or Type C medicated feed using
Category I-Type A medicated articles or
Category I-Type B or Category I-Type C
medicated feeds
◦ Type B or Type C medicated feed using
Category II-Type B or Category II-Type C
medicated feeds
91. Drug Consideration: Minor Use
and Minor Species
A minor use in a major species is the
use of a drug in a major species for a
condition that occurs:
◦ infrequently and in only a small number of
animals each year; or
◦ in limited geographic areas and in only a
small number of animals each year.
Minor species have a lack of
available/approved drugs
92. CPG 615.115 Extra-Label Use of
Medicated Feeds for Minor Species
“This guide directs FDA field personnel to make
the use of medicated feeds for minor species a
low enforcement priority under the stated
conditions. Extra-label use of medicated feeds is
illegal. This guide does not make extra-label use
legal or allow unapproved medicated feeds to be
promoted or marketed for these uses. It simply
makes it less likely that action will be taken
against veterinarians and producers who use
medicated feeds approved for use in other
species for therapeutic purposes in minor
species under the conditions stated in the CPG.”
https://www.fda.gov/ucm/groups/fdagov-
public/@fdagov-afda-
ice/documents/webcontent/ucm074659.pdf
93. Example – Harry Austin Milling
Use of Monensin in Cattle Feed
Monensin is a category I animal drug
Therefore, HAM is exempt from
needing a Medicated Feed License for
that specific new animal drug
94. Animal Drugs @ FDA
Search tool you can use to determine
application #, sponsor name,
proprietary name, ingredient and
application status of animal drugs
https://animaldrugsatfda.fda.gov/adafd
a/views/#/search
95. Additional Helpful Links/Sources
(May 2015). Joint FAO/WHO expert meeting on hazards
associated with animal feed. Retrieved from
http://www.fao.org/3/a-az851e.pdf
(July 2016). Overview of FDA’s animal feed safety system.
Retrieved from
https://www.fda.gov/downloads/animalveterinary/safetyhealth/
animalfeedsafetysystemafss/ucm277673.pdf
(October 2017). Current good manufacturing practice
requirements for food for animals: Guidance for industry.
Retrieved from
https://www.fda.gov/downloads/animalveterinary/guidanceco
mplianceenforcement/guidanceforindustry/ucm499200.pdf
CPG 670.200 Status of Vitamins and Minerals in Type B and C
Medicated Feed and in Non-Medicated Feed
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyG
uidanceManual/ucm074691.htm
FSPCA: Preventive Controls for Animal Food
https://www.ifsh.iit.edu/fspca/fspca-preventive-controls-animal-food
Animal Food & Feeds.
https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/d
efault.htm
96. At what point in the animal industry
process does USDA take over from
FDA, and vice-a-versa?
Make note on how the minerals interact with each other ex. The deficiency of one could promote toxicity of another, toxicity of one could promote deficiency of another, deficiency of one could affect deficiency of another, toxicity/toxicity
Also Vitamin B12 and Cobalt have a special relationship
For example, the use of a drug to control pain in dogs with bone cancer is a minor use in a major species because fewer than 70,000 dogs typically get bone cancer each year.
MUMS Act – Minor Use and Minor Species Animal Health Act of 2004
"Extralabel use" means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling.
This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses. (21 CFR § 530.3(a)).