Food Safety

1
Food Safety
Judicius Antibiotic Use Campaign

• Changing physicans prescribing antibiotic use.
• Model for prudent antimicrobial agent use in
  food-producting animals.

CDC (2), 1998
2
Food Safety
AMDUCA has become a drug safety issue. Use in
animals that can transfer resistance to humans.
Pathogens DT104 Salmonella E. coli
0157 Antibiotic Resistance Drug family
resistance Plasmid resistance transfer
3
Food Safety
Antimicrobial resistance emerging because of
Animal Production Practices leading to PUBLIC
HEALTH consquences
Antibiotic in feeds ( milk replacers) Antibiotic
used to promote growth Antibiotic excessive
therapy
CDC (2), 1998
4
Food Safety
Antimicrobial resistance emerging because of
Animal Production Practices leading to PUBLIC
HEALTH consquences
Fluoroquinolone - resistance in human poultry
Camplobacter isolates - only since introduction
of fluoroquinolones in poultry use.
CDC (2), 1998
5
Food Safety
Fluoroquinolone - resistance (since introduction
of fluoroquinolones in poultry use)
Resistance by

• Alteration of target on nucleus
• DNA gyrase mutation - point mutation
• Cross reaction to all quinolones

CDC (2), 1998
6
AMDUCA
Animal Medicinal Drug Use Clarification Act
Extra-label Drug Use
An Act to allow the legal Extra-label use of
in food producing animals.
7
Extra Label Drug Use
What is extra-label drug use?

• ELDU is the use of in an animal, way or a dose
  not on the label
• animal
• dose
• route

8
Extra Label Drug Use
Why do we need to use drug off label?
Limited number of drug approved for food
animal. High cost to produce approved drugs. FDA
limits many new antibiotic to human use.
9
Food Animal DrugsExperimental-1985
Mastitis - Gram-positive

• New Products Bacteriocidal proteins
• Nisin - Streptococci, Staphlyococci
• Lysostaphin - Staphylococci
• safe, digestible minimal withhold (zero)
• Effective against antibiotic resistant strains
• Human drug use persued

10
Food Animal DrugsExperimental-1990
Mastitis Gram-negative

• Needs Approved drugs for gram negative
  organisms (E. coli, Klebsiella sp Pseudomonas
  sp)
• Experimental Florfenicol - IMM effective
  against
• Staphylococcal mastitis
• coliform mastitis
• effective toward Gram-negative bacteria
• Not better than other products against
  Gram-positive
• Discontinued product research - loss product

11
Extra Label Drug Use
What drugs can be used extra-label?
Must be a FDA approved animal human drugs
12
Extra Label Drug Use
Who can use drug off label?
ELDU is permitted only by or under the
supervision of a veterinarian. Veterinarian must
have a valid Veterinarian/ Client/Patient
relationship. (Must be your regular veterinarian
and know your farm situation)
13
Extra Label Drug Use
I.
When can drugs be used Extra-label?

• ELDU can be used for
• animals health
• reduce suffering

14
Extra Label Drug Use
II.
When can drugs be used Extra-label?

• If an approved drug for the condition is not
  available for
• needed ingredient
• proper dose form
• label for the indication
• is clinically effective

Reason a veterinarian must be involved
15
Extra Label Drug Use
CAN NOT if use

• Result in a violative food residue
• Result in any residue which may
  present a
  risk to public health

16
Extra Label Drug Use
must be

• FDA approved animal human drugs

CAN NOT

• ELDU can not be add to feeds

17
Extra Label Drug Use
Can Not Use
Prohibitive drugs (new) Fluoroquinolones
(Baytril) Glycopeptides (vancomycin)
18
Drug Prohibited for Extralable Usein Food Animals
January 1998

• Chloramphenicol
• Clenbuterol
• Diethylstibestrol (DES)
• Ipronidazole
• Glycopeptides
• Fuoroquinoles

• other Nitroimidazoles
• Furazolidone
• Sulfonamides drugs
• (except approved sulfas)

List in Michigan MDBQA - Producer Manual
19
EXTRALABLE DRUG USE ALGORITHM
Treatment of Food Animals?
Yes Does a labeled drug exist for Food Animals?
NO Few restriction for non- Food Animals
Yes Must use labeled drug
NO Is there a drug approve for Food Animals
that can be ELU?
Yes ELU extend withdrawal time
NO Is there a drug approve for human or non-
Food Animals that can be ELU?
Yes Good scientific information
NO Compounding of approved drugs to prevent pain
20
Tetracycline Residue Extra-label Drug
use(example)
Bulk Tank Residue
Problem

• 150 cows _at_ 55 lb/day
• lame cow moved to barn with calves
• feed 10 lb calf feed (.8 gm Chlortet)
• lame cow was positive on testing

21
Tetracycline Residue Extra-label Drug
use(example)
Bulk Tank Residue

• Minimual level 3ppb HPLC Charm II
• 1992 accepted level .1mg/lb (130mg)
• 800 mg exceeds those levels
• 1996 feed grade tetracyline not allowed in
  lactating cows
• No extra-label use for feed additives

22
Tetracycline Residue Extra-label Drug useRisk
Bulk Tank Residue
Heel wart treatment

• Tetracycline in foot bath -
• drinking
• Tetracycline powder or ointments in bandages
• high concentration with time to absorb
• Tetracycline sprays
• not during milking, liquid on hands can
  contaminate next cow

23
Extra Label Drug UseFarm requirement
Record Requirements

• Identify animal or group
• Animal to be treated (Protocol for treatment)
• Condition treated
• Drug used
• Dosage route
• Withholding milk discard meat withhold
• Records for FDA access

Record must be kept for 2 yrs
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Extra Label Drug UseVeterinarians requirement
Label Requirements

• Name and address of veterinarian
• Drug ingredient
• Direction dose, frequency, route duration
• Withdrawal milk meat
• Cautionary statement

25
Extra Label Drug Use
FDA Requires

• Diagnosis of disease
• Treatment Plan
• Treatment Records (kept 2 yrs)

26
AMDUCA Extra-label Drug use
Records are the keys (MDBQA-records)
Animal Medicinal Drug Use Clarification
Act An Act to allow the legal Extra-label
use of in food producing animals.
27
AMDUCA Extra-label Drug use
Records are the key
Michigan Milk Dairy Beef Quality Assurnce
Program (MDBQA-records)
28
Quotes
Food Animal Presentation
These animals are from a minimal disease herd.
Although today it seems like they are all
minimal disease or poorly managed.
Western States Conference 1998