1. Feed Additive & Hormone Implant Regulations
Animal Science II Unit 3

2. Regulation of the Use of Additives
Regulated by the Federal Food and Drug Administration (FDA)
Regulations change from time to time as new information on effects and changes becomes available
Current detailed information may be found in the Feed Additive Compendium
This is published annually

3. Regulation of the Use of Additives*
Code of Federal Regulations (CFR) Title 21 contains official information from the FDA concerning approval of antibiotics and other animal drugs
Revisions are made annually as of April 1 and the CFR is updated in individual issues of the Federal Register
The CFR and Federal Register must be used together to determine the most current regulations concerning animal drugs

4. Label Requirements
Any feed that contains one or more drugs is defined as a medicated feed
May be complete feed mixes or pre-mixes that are mixed with other feeds
FDA requires all manufacturers of medicated feeds to provide information on the label relating to the use of the feed

5. Label Requirements
“Medicated” must appear under the name of the feed
Specific purpose of the drug or drugs must be on the label
Name and amounts of all active drugs must be listed
Required withdrawl period prior to slaughter must be given
Cautions against misuse must be listed
Directions for the use
Lot or control number for later identification
Medicated feeds that are mixed at the local feed mill must meet the same requirements

6. Mixing and Residue Avoidance
Proper mixing is important for safe use
Drug residues can cause financial losses
A regular procedure should be followed when mixing medicated feeds to avoid problems and drug carryover P

7. Keeping Records Recommended records Date the batch was mixed
Mixing order and amount of medication added
Mixing time
Storage location
Number, age, weight of animals fed from the batch and amount given per head
Medication that was used, amount, concentration in the batch
Date of cleaning mixers, bins, conveyors, feeders

8. Keeping Records
Have a long term plan for the use of the feed additives
Periodically changing the type of antibiotic used
Reduces the chance of the microorganisms building immunity
Should be made about once a year
Do not make frequent changes

9. Health Concerns
Growing concern that the continued use of antibiotics in animal agriculture will have an adverse effect on humans as well as animals
Centers around the use of antibiotics at subtherapeutic levels
feared that this continued use will lead to the development of resistant strains of microorganisms
Bacterial resistance to drugs has been observed almost from the time antibiotics were first used in animal feeding

10. Economic Impact Increased cost of animal products to the consumer
Less meat and livestock produced
Cost of production would be higher
More feed would be required per animal and decreased rate of gain
Death loss

11. No Evidence*
To date no persuasive evidence of animal or human health problems arising from nearly 30 years of using antibiotics in animal feeding
Many of the same antibiotics used today are the same as the ones that were used when antibiotic feeding began and they are still effective against most microorganisms
Critical experimental study is needed on the effect of low-level antibiotic feeding on animal and human health

12. Cancer Causing Effects
FDA has expressed concern
1958 Food Additives Amendments to the Food, Drug, and Cosmetic Act of 1938 include prohibitions against adding to food any substance that is a know carcinogen
Ongoing research into the possible carcinogenic effects of feed additives
If effects are found in any additive, it’s withdrawn from use