FDA’s Animal Feed Safety System (AFSS) Project Plans Update #4
The Center for Veterinary Medicine has scheduled the fifth public AFSS meeting for May 14, 2008, in Gaithersburg, MD. The AFSS meeting will immediately follow a Food and Drug Administration-sponsored meeting on new requirements stipulated by legislation for pet food safety.
At the previous AFSS public meeting, held in May 2007, the AFSS Team explained the exposure component of the risk-ranking model it had developed. The Team discussed, for an example, the pathways by which swine would be exposed to dioxin via various swine diets. For the next meeting, the Team plans to present methods for ranking risks associated with biological and chemical hazards in feed, again using swine feed as an example. Details of these methods will be discussed at the meeting.
FDA will use the model internally to determine how best to use feed safety resources to make sure the Agency is addressing feed hazards with the greatest risks to public and animal health.
At previous public meetings, the AFSS Team discussed the concept of risk, saying that risks can be assessed relative to each other and subsequently ranked by:
Identifying potential hazards;
Characterizing the consequences of the hazard (the likelihood and severity of illness);
Characterizing the likely exposures to the hazard; and
Ranking the risks (the likelihood that something will go wrong) of the hazard, compared to other hazards.
Originally, the AFSS Team discussed using the model to assess physical hazards along with chemical and biological hazards. However, the Team has not been able to locate sufficient data on physical hazards. Therefore, the Team is concentrating its efforts on the analysis of chemical and biological hazards in the risk-ranking model.
The Team also plans to briefly present the risk-based approach being developed to prioritize inspections done by FDA under the Agency’s feed compliance programs.
In addition, at the upcoming meeting, the Team plans to present a third draft of the AFSS Framework document and to discuss in more detail several of the gaps identified in the recently revised Framework document. Additional steps are being taken to improve feed defense, which continues to be a priority for the Agency. Further, measures are being developed to ensure more widespread understanding and adoption of the AFSS initiative by our stakeholders.
Memorandum of Understanding about feed ingredient definitions
In August 2007, CVM signed a Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) to cooperate in the review and development of definitions for animal feed ingredients, as part of the AFSS initiative to strengthen the U.S. feed safety system.
AAFCO publishes an annual Official Publication (OP) that includes a list of all ingredients the Association has reviewed and found suitable for use in animal feeds. The OP also contains cross-references to certain sections of the Code of Federal Regulations that list approved food additives and ingredients that are considered by FDA to be “Generally Recognized as Safe” for specific uses in animal feed. The OP is considered to contain the most current and extensive list of common or usual ingredient names.
In the past, FDA has cited the OP’s ingredient definitions list and has acted as AAFCO’s scientific advisor in reviewing petitions for the addition of ingredients to the list or for changes in the ingredient definitions. However, although the definitions in the OP ingredient list can be enforced by those states that adopt the list, the OP list does not have a comparable status for FDA.
The MOU will clarify the responsibilities of FDA and AAFCO during the feed ingredient definition process and will provide mechanisms for resolving disputes that arise and for modifying the process when required.
Under the MOU, CVM assigns scientists to work with AAFCO in reviewing petitions for new feed ingredients or for modifications to existing ingredient definitions. Also, before it adopts a new feed ingredient definition or amends an existing one, AAFCO will ask CVM for advice and a letter of concurrence. In addition, the MOU requires AAFCO to remove a definition from its OP if FDA provides convincing scientific evidence that the ingredient is no longer suitable for its intended purpose.
FDA’s recognition of the AAFCO process is one of the specific recommendations made in the AFSS Framework Document. The document is available at http://www.fda.gov/cvm/AFSS2ndDraftFramework.html.
The MOU went into effect on August 30, 2007, and remains in effect until September 1, 2012.
FDAAA legislation
In September 2007, President Bush signed the FDA Amendments Act of 2007 (FDAAA), which, besides continuing FDA’s user fee program for human drugs and devices, has some significant new requirements in the area of pet food safety that are parallel to the work of the AFSS Team.
Section 1002 (a) of FDAAA gives FDA two years to establish, “by regulation,” ingredient standards and definitions, processing standards, and labeling standards, including nutritional and ingredient information, for pet food. The December 2006 draft of the AFSS Framework Document had identified the AFSS Team’s intent to develop process control regulations for all animal feed, including pet food. The Framework Document also indicated the need to recognize the ingredients listed in AAFCO’s OP as acceptable for use in animal feeds.
The law says this rulemaking will be done in consultation with stakeholders. On January 7, 2008, FDA published a Federal Register notice announcing its intent to hold a public meeting to obtain input from its stakeholders and opening a docket (2007N-0487) for receiving written comments. The public meeting is being planned for May 13, 2008, at the same site of the next AFSS public meeting, which as indicated above will take place the day after the FDAAA meeting. More information will be provided in future Federal Register notices and on CVM’s Web site.
April 2008
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