FDA's Animal Feed Safety System (AFSS) Project Plans Update #1
This statement is intended to both update our shareholders on our most important and immediate plans for the FDA’s Animal Feed Safety System (AFSS) project and to help clarify some misunderstandings that may exist among the public and the regulated industries concerning the goals and objectives of the AFSS project.
One source of possible misunderstanding originates from the incorrect assumption that this project is new and different from the agency’s historic and current approaches to feed safety. While the name, Animal Feed Safety System is new, FDA’s responsibilities for, and its historic and current processes, guidance documents, regulations, and policies addressing feed safety are not. FDA has been actively ensuring safe animal feed for as long as the agency has been responsible for ensuring the safety of the human food supply. The Food and Drugs Act of 1906, the first Federal food and drug law, includes under the term food, “articles used for food by man or other animals”. Although the FDA did not have a significant feed safety program at that time, many states did have active feed programs in the early 20th century.
FDA’s first major venture into feed safety came when the Agency was asked to permit the use of feed as a means of delivering antibiotics, such as penicillin and streptomycin, to animals. Research in the 1940’s and 1950’s showed that these antibiotics, when added to feed at low levels, improved animal productivity in addition to preventing and treating certain animal disease conditions. A significant concern on the Agency’s part was ensuring the safety of the food intended for human consumption (i.e., meat, milk and eggs) derived from animals that consumed the antibiotic-containing feed. This led to the development of FDA’s current medicated feed program.
The Agency has taken many other actions since that time to ensure the safety of animal feeds. For example, the Agency has approved ingredients for use in animal feed, has written regulations to address the safety of Salmonella-contaminated feed and of feed containing industrial contaminants, such as PCB’s, has implemented sampling programs to determine background levels of dioxins in feed, and has enforced regulations that have prevented the spread and amplification of Bovine Spongiform Encephalopathy (BSE) in U.S. ruminant animals. The actions taken by FDA to address these historic and current feed safety issues will remain as parts of the Agency’s feed safety program, now known as the Animal Feed Safety System. New feed safety initiatives that are identified in the draft AFSS Framework document are focused on making the agency’s feed safety program more comprehensive, preventive, and effective in addressing feed hazards that present the greatest risks to animal and human health.
The draft AFSS Framework document divides the agency’s feed safety activities into four operational components:
The ways in which the FDA ensures that the ingredients and additives used in making animal feed are safe for their intended use;
The manner in which the FDA ensures that levels of poisonous and deleterious substances (contaminants) in animal feed are not present at levels that pose risks to animal or human health;
The systems used by the Agency for ensuring that the manufacture, distribution and use of all feed ingredients and feeds result in the safe feed products; and,
The programs and procedures available to FDA for conducting regulatory oversight of the feed industry.
A critical feature of the draft AFSS Framework document is a section under each of the four operating components that is entitled “GAPS.” With the help of state, federal and industry input, the AFSS team has identified specific gaps in the current animal feed safety system that need to be filled before the AFSS will be comprehensive, preventive and effectively focused on those feed hazards that pose the greatest risks to animal and human health. In some cases, the AFSS Team has been very specific about how to fill an identified gap--for example, development of a compliance policy guide for recognition by FDA of the feed ingredients defined in the Official Publication of the Association of American Feed Control Officials (AAFCO) is the way in which the AFSS Team has chosen to close a gap listed in the first component of the framework document. In other cases the AFSS Team has not yet identified the way in which a gap will be filled; for example, the AFSS Team is developing its recommended regulatory approach for making oversight of feed safety by FDA more comprehensive. The AFSS Team’s intention is to post an updated AFSS draft Framework document on the CVM AFSS website soon, and to post other AFSS draft documents on the website as appropriate. These documents will be placed in the docket for the AFSS.
Another important goal of the AFSS is to make the Agency’s animal feed safety program more risk-based. While risk has almost always been considered by the Agency when making decisions about how to ensure the safety of animal feed, this has most often been implicit rather than explicit, and has most often been the result of internal FDA deliberations rather than of extensive discussions with the public and the regulated industry about feed risks and feed safety. The AFSS Team anticipates making risk considerations for the AFSS explicit and open to public review and comment. This is a challenging task. At the 2005 AFSS public meeting in Omaha, meeting participants were told of our planned approach for ranking feed hazards by their relative risks. Based on comments received at the meeting, we plan to share additional details of our relative risk-ranking method with the public as the method is developed. For example, one of the AFSS Team’s short-term goals is to hold public meeting-type “seminars” or “workshops” to present work-in-progress on its method of ranking feed hazards by their relative risks to animal and public health. All such public meetings will be announced in the Federal Register. The Agency will also post announcements for these meetings on the CVM AFSS website.
March 2006
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