FDA’s Animal Feed Safety System (AFSS) Project Plans Update #2
The progress made by the Center for Veterinary Medicine’s (CVM) Animal Feed Safety System (AFSS) Team during 2006 puts the Team nearly to the end of its task of updating the animal feed system used in the United States.
Animal feed safety is an essential part of CVM’s mission. CVM did not start AFSS to create a new set of feed safety rules, but instead to “modernize” the program by calling for decisions based on risk and by coordinating all the elements applying to feed safety so they work efficiently and effectively.
During 2006, the Team held a public meeting to present information on how it would use risk-ranking in determining feed risks. The Team also expanded and revised the AFSS “Framework Document” to include more information about risk assessments and about training and outreach.
Framework Document
The AFSS Team’s first draft Framework Document, released in February 2005, introduced the concept of using risk assessment to identify and create limits for potentially hazardous feed contaminants. The second draft, dated December 2006, is more comprehensive in describing how the risk assessment will apply to the feed manufacturing and animal feeding industries, and to the government.
The Framework says that a risk-based preventive system, as proposed under AFSS, will require the feed manufacturing industry and related businesses to more fully consider the hazards that could harm human or animal health. “Thus, under a ‘modernized’ AFSS, feed producers’ knowledge would improve on how to identify and minimize or eliminate hazards associated with animal feed before those hazards result in decreased production, adverse health consequences to the animal, and potential risks to human health,” the second draft says.
Government regulators would benefit from the risk-based system, too. It will permit a “systematic approach to animal feed safety” that will allow FDA to more effectively focus its research, inspection activity, feed sampling, and feed analysis where they are most needed, according to the second draft.
The revised Framework now lists 11 operating principles, up from 7 previously. The new ones highlight the need for training as important for implementing AFSS, that AFSS will cover all types of feed (including pet food), and that the system will cover all establishments that are involved with feed and all the processes those establishments use.
The Framework Document has also been reorganized. The original Framework listed four major components. The revised Framework lists five. And instead of numbering them, it presents them as Component A through E, to make the document easier to read.
In addition, under each component, the revised Framework not only presents the gaps in the current system, but also describes the way AFSS will address each gap. For example, one gap mentioned in the Framework (Gap B1) says that not all feed contaminants carry the same risk for harming human or animal health. AFSS would address this gap, under the revised Framework, through the development of a method to evaluate each contaminant to determine the risk it poses (which was the subject of the 2006 public meeting). Also, filling Gap C1 would be addressed by process control regulations that cover the procurement, manufacture, storage, distribution, and use of all feed ingredients and mixed feed. The Team has begun writing the proposed regulations and is seeking to get them published by the end of 2007.
Finally, to make the draft easier to use, much of the detailed information is broken out and listed in Appendices at the end of the document.
Public meetings
In September 2006, the AFSS team sponsored its third public meeting. The first two meetings, held in September 2003 and April 2005, were designed primarily to give interested stakeholders an opportunity to present information to CVM about the direction and shape of AFSS. By contrast, the third meeting was the reverse and was aimed at presenting information to stakeholders.
More than 100 individuals attended the 2006 meeting. Several represented foreign countries, indicating the international emphasis on feed safety.
Information about the meeting is available on CVM’s Web site at http://www.fda.gov/cvm/AFSS092006PM.htm. More information from the meeting, including copies of presentations and the transcript, will be placed in the docket (at http://www.fda.gov/ohrms/dockets/default.htm), under Doc. #2003N-0312.
CVM used the meeting to explain the risk assessment aspects of AFSS. Dr. Barry Hooberman, a risk assessment manager in CVM’s Office of New Animal Drug Evaluation (ONADE), presented a description of the method the Team will use for assessing risk. He said, a risk assessment can be developed by answering four basic questions: What can go wrong (hazard identification)? What are the consequences (consequence assessment of hazard characterization)? How exposure can happen (exposure assessment)? And, what is the likelihood that something will go wrong (risk estimation)?
Under AFSS, risks for feed contaminants are to be ranked under a “Health Consequence Scoring” system. Dr. Hooberman explained that the Health Consequence Scores involve two factors – the likelihood of illness, which may be expressed as the potency of the hazard, and the severity of the illness, which, for animals, could range from reduced feed consumption to death.
For AFSS, FDA will develop Health Consequence Scores on a species basis (for example, developing separate scores for humans, dogs, pigs, etc.) and on an exposure basis (acute or chronic), Dr. Hooberman explained.
Dr. Karen Ekelman, leader of CVM’s Feed Safety Team, said that AFSS’s working definition of a hazard is any biological, chemical, or physical agent in feed, or a condition of feed, that has the potential of causing harm to humans or animals. The AFSS definition of a contaminant is any deleterious biological, chemical, or physical hazard inadvertently present in feed.
In addition, Dr. Ekelman presented a list of feed contaminants the AFSS Team has identified. (That list is available on the CVM Web site at http://www.fda.gov/cvm/Documents/FeedContaminants.pdf.)
Dr. Ekelman also explained the Health Consequence Scoring for chemical contaminants in animal feeds, explaining how the scoring system derives the severity score for acute and chronic effects from contaminants.
Dr. Phares Okelo, a biologist with CVM’s Office of Surveillance and Compliance, explained the Health Consequence Scores for biological contaminants.
Also at the 2006 meeting, Dr. Dolores Beblo, a risk analyst with ONADE, discussed challenges in developing a risk ranking model for feed contaminants, including combining factors for both chemical and biological contaminant classes and existing data gaps.
The 2006 meeting was the first of two (and possibly more) public meetings to discuss the risk-assessment aspects of AFSS. The Team used this first meeting to present information on the risk scoring formulas it is using. The Team will use the next meeting to present information about methods for determining likely exposure to risks.
Details of the next meeting, which is likely to be held in May 2007, will be released sometime in the spring of 2007.
Conclusion
As described in the revised Framework document, the goal for modernizing FDA’s animal feed safety program (AFSS) is to make it more sophisticated through the use of risk assessments and more cohesive by addressing a number of gaps in the current program.
Much of the improvement is due to the variety of comments and valuable advice stakeholders have provided the AFSS Team during the multi-year effort. As it enters its last phase of the project, the AFSS Team will continue to seek and use public comments to develop the best system possible.
December 2006
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