Unit 4 - ELDU and Residues

Question 1

What are the major food animal species?

Answer 1

Cattle, pigs, chickens, and turkeys

Question 2

What are the minor food animal species?

Answer 2

All other animal species that are food animal species

Question 3

T/F: If you have a pet cow that is not intended for food, you do not have to follow the ELDU laws.

Answer 3

False - regardless of use, pets are food animals if traditionally considered a food or fiber species

Question 4

What is the dairy industry definition of a lactating dairy cow?

Answer 4

A dairy breed cow that is producing milk

Question 5

What is a dry cow?

Answer 5

A cow that has previously been lactating and is now non-lactating in preparation for the next lactation

Question 6

What is the FDA definition of a lactating dairy cow?

Answer 6

A dairy breed animal that is 20 months of age and older - lactating or dry

Question 7

What is tolerance in regards to residues?

Answer 7

The maximum legally allowable level or concentration of a drug or chemical in a food product at the time milk or eggs are marketed, or the animal is slaughtered

Question 8

What is the target test level (for milk only)?

Answer 8

The guide for deciding whether or not to prosecute

Question 9

What is a residue?

Answer 9

Any substance that is foreign to the body - in our case, we are interested in residues that are left after drug administration

Question 10

What is a violative resiude?

Answer 10

A drug residue found to be at or above the regulatory limit in a tissue, milk, or eggs

Question 11

When can there be a legally acceptable residues of drugs in edible tissues, eggs, or milk at slaughter?

Answer 11

IF there is an established tolerance in tissues/milk for that animal species

Question 12

T/F: For drugs without a label and corresponding tolerance in a species, then any residue detected is violative.

Answer 12

True

Question 13

What does AMDUCA stand for?

Answer 13

Animal Medicinal Drug Use Clarification Act

Question 14

There is an acronym for selecting the right drug. It is spaced. What does it stand for?

Answer 14

Spectrum
PK/PD
Adverse reactions
Compliance
Environment
Diagnostics/Break points

Question 15

What are the AMDUCA requirements?

Answer 15

Permitted only by or under the supervision of a licensed veterinarian
Only FDA approved animal and human drugs
Therapeutic purposes only - animal’s health is suffering or threatened
Valid veterinarian/client/patient relationship must be in place
Specific record requirements
Only in drugs administered parentally, intramammary, topically, or in water
Cannot result in violative food residue or a residue that may affect public health

Question 16

What drugs are prohibited for use in food animals no matter what the situation?

Answer 16

Chloramphenicol
Clenbuterol
Diethylstilbesterol
Dimetridazole
Ipronidazole
Other nitroimidazoles
Furazolidone, nitrofurazone, other nitrofurans

Question 17

What drugs are prohibited for extra-label use?

Answer 17

Sulfonamide
Phenylbutazone
Glycopeptides
Fluoroquinolones
Cephalosporins

Question 18

In what species are sulfonamide drugs prohibited for extra-label use?

Answer 18

Lactating dairy cows - except for approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine

Question 19

In what species is phenylbutazone prohibited for extra-label use?

Answer 19

Female dairy cattle 20 months old or older

Question 20

Enrofloxacin is only approved for extra-label use in what scenarios?

Answer 20

Respiratory diseases only in cattle
Respiratory disease and colibacillosis in weaned swine
Not in female dairy cattle >20 months of age

Question 21

Danofloxacin is only approved for extra-label use in what scenarios?

Answer 21

Beef cattle respiratory disease

Question 22

What are the rules for cephalosporins use?

Answer 22

No extra-label use in major food producing species
Cannot be used for disease prevention purposes
Cannot be used at unapproved doses, frequencies, durations, or routes of administration
Cannot be used if the drug is not approved for that species and production class

Question 23

What are the exceptions to the prohibition of cephalosporin use?

Answer 23

Extra label use of approved cephapirin products in food-producing animals
Use to treat or control an extra-label disease indication, as long as this use adheres to a labeled dosage regimen
Extra label use in food-producing minor species, such as ducks or rabbits