Feed Additive & Hormone Implant Regulations

1. Feed Additive & Hormone Implant Regulations Animal Science IIUnit 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. 157-8

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 subtherapeuticlevels • 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