1. Feed Laws & Labeling AnSci 320 2-27-12 Lance Baumgard baumgard@iastate.edu

2. Feed Regulations and Additives General Feed Industry information: –300 m tons manufactured each yr. in the U.S. Various forms Either in the feed mill, or on farms –~10,000 feed mills in the U.S. –~30,000 feed outlets ~20,000 sell feed Bag Bulk Feed products Must register w/ the FDA if they mix feed w/ drugs

3. Feed Regulations and Additives Feed Labeling –Required for all commercial feed products Primary communication between manufacturer and purchaser Critical information: Identify product Nature of the product & intended use Usage instructions Cautionary information

4. Feed Regulations and Additives General Feed Additive information –Doesn’t include any min/vit supplements –Some require approval for use by FDA –Withdrawal times may be necessary –Instructions must be followed carefully –>1000 drug products are approved for use

5. FEED LAWS AND LABELING Regulations & laws relating to feed manufacture and distribution have been established to safeguard the health of humans and animals. –Also to ensure orderly commerce & protect consumers. –And protect the feed industry from unfair competition and deceptive practices. In the U.S. the first regulations related to feeds were implemented in 1909. –Normally administrated by state Agriculture Depts. –In other countries, other agencies may administer these laws.

6. FEED LAWS AND LABELING Manufacture & distribution of commercial feeds, mineral & liquid supplements, feed supplements or premixes are controlled by these agencies. –All companies that commercially produce a feed are regulated by these laws. Feed regulations need to be universally applied so each regulated party follows the same rules. –Regulations should also include a means by which those in violation are made known to the public. In the U.S., most feed regulation agencies use the Model Feed Bill as the basis for their regulations.

7. Model Feed Bill Developed by American Feed Control Officials (AFCO) –Organization composed of individuals representing the regulatory agencies of North America –Endorsed by: American Feed Industry Association Pet Food Institute

8. LABELING REGULATIONS Label disclosure can inform consumers about product content. –With information about competing products, informed decisions relating to product purchases can be made. Regulations must specify minimum information provided on the label, optional information that can be included, and information prohibited from being put on the label of a feed product. –Unsubstantiated performance claims can be as misleading as unsubstantiated nutrient claims.

9. LABELING REGULATIONS Labeling must also direct proper use of the product, and regulations should ensure the label provides the minimum information necessary for correct use. –Directions may be as simple as naming the species for which the feed is intended. –Or could provide a lengthy explanation as to how the feed should be fed.

10. LABELING REGULATIONS Label information should… –Identify the product. –Inform the purchaser/user of the nature of the product and its intended purpose. –Provide instruction on how to use the product. –Convey any cautions pertaining to product use. Labels are required to be attached to individual bags of feed or to be available for inspection when feed is sold in bulk lots. –Except for custom formula feeds.

11. LABELING REGULATIONS Minor differences exist from state to state, but feed labels generally contain the following: –Product name and brand name, if any. –Purpose statement. –Guaranteed analysis. –List of ingredients. –Directions for use. –Warnings, if any. –Name and address of manufacturer. –Net weight.

12. LABELING REGULATIONS Custom feeds (prepared for a specific customer) are to be accompanied by a label, delivery slip, or other shipping document containing : –Name & address of the manufacturer. –Name & address of the purchaser; Date of delivery. –Product name & brand name, if any. –Net weight of each ingredient used in the mixture. –Adequate directions for use of feeds containing drugs or other ingredients to ensure their safe use. –Such precautionary statements as are necessary for safe and effective use of the feed.

13. LABELING REGULATIONS Labels on human food items require ingredients to be listed in order of amount. –Starting with the item in highest concentration, and continuing with those found in smaller quantities. –Followed by feed manufacturers, though not specified in the Model Feed Bill & most states do not require it. Most manufacturers use collective feed names to avoid re-registration &preparation of new labels if one or more ingredients are discontinued. –Also allows the maker to avoid listing every specific ingredient.

14. LABELING REGULATIONS Commonly used groups are: –Animal protein products; Forage products; –Grain products; Plant protein products; Processed grain by-products. –Roughage products; Molasses products. The "Guaranteed Analysis" found on the label normally requires that specific information be provided, which differs among species. When labeling liquid supplements, some states require a maximum moisture and minimum total sugar content be given.

15. LABELING REGULATIONS A partial listing of the information required by the Model Feed Bill.

16. LABELING REGULATIONS When nonprotein nitrogen (NPN) is used, the maximum percentage included must be listed. –NPN compounds can be toxic when fed to monogastric animals. Generally, if formulation exceeds 8.75% crude protein as NPN, or one-third of total CP, the label must give directions to ensure safe usage. –Usually including a precautionary statement. –Several states require that any feed formulation containing urea have a statement reading: "For Ruminant Use Only" or "Feed Only to Ruminants."

17. LABELING REGULATIONS Most species are subdivided by classes, and these classifications need to be listed on labels. –Details on differences from state to state may be found in the Feed Additive Compendium. Label requirements for nonmedicated & medicated feeds differ. –This table gives label requirements for both types.

18. LABELING REGULATIONS Figure 10.1 Example of nonmedicated feed label.

19. MEDICATED FEEDS A medicated feed is defined as any animal feed that contains one or more drugs at any level: –Medicated complete feed intended to be the sole ration for an animal. –Medicated supplements that are safe for direct consumption by the intended animal and can be offered in a free-choice feeding plan. –Medicated concentrates to be mixed with other feed materials to make either a supplement, or a complete feed, before being offered to the intended animal. A high percentage of commercial feeds contain some additive that can be classed as a drug.

20. MEDICATED FEEDS In addition to usual labeling requirements, adding an additive classed as a drug requires that the word "medicated" appear directly following and below the product name, and the label must… –State the purpose of medication –List the names and amounts of the active ingredients. –Include a warning statement (when required by the FDA) listing minimum withdrawal period required before slaughter for human food. –State warnings against misuse. –Provide appropriate directions for use of the feed.

21. MEDICATED FEEDS FDA requires that all medicated feed be labeled. –If bagged, each bag must be labeled appropriately. –Custom-mixed feeds are subject to the same basic labeling requirements as registered feeds. –Premixes must state intended mixing ratios, resultant drug levels & purpose of the final mixed medication. –Any instructions & warning statements must appear. For which requires FDA form 1900, the feed manufacturer must file these forms & receive FDA approval before selling the medicated feed.

22. MEDICATED FEEDS Figure 10.2 Example of medicated feed label.

23. MEDICATED FEEDS Feed manufacturers producing medicated feeds are expected to become familiar with the Good Manufacturing Practice (GMP) regulations. –Developed and published in the Federal Register for different classes of feeds. The manufacturer is responsible for taking periodic samples of feed to submit for analysis to determine whether the drugs are present at the specified levels.