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U.S. Department of Health and Human Services

Animal & Veterinary

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Second Feed Safety System Meeting Focuses on Framework, Risk Ranking Model

FDA Veterinarian Newsletter January/February 2005 Volume XX, No I

The team headed by Center for Veterinary Medicine (CVM) that is developing the Animal Feed Safety System (AFSS) has developed a draft framework to describe the features it believes should make up the feed system, and that framework was the focus of CVM’s second public AFSS meeting, that was held April 5-6, in Omaha, NE.

The docket for this meeting will remain open after the meeting, but the AFSS team intends to steadily move ahead.

Written comments should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

In the draft framework, published in February 2005, the AFSS team identified four components that will make up the feed safety system, explained the purpose and goals for each of the components, and identified gaps within each of them.

CVM’s goal under AFSS is to create a nationwide, comprehensive, risk-based system for regulating feed. The AFSS plan will describe how feeds can be manufactured, distributed, and used in a way that minimizes risks to animals and humans, particularly the risks from food derived from animals.

The AFSS team is made up of officials from CVM, from the Food and Drug Administration’s (FDA) Office of Regulatory Affairs and Office of the Commissioner, and State officials.

CVM held its first public meeting on AFSS in September 2003. At that meeting, CVM officials described the system they were hoping to create and asked for public comment about the plans. CVM collected comments during and after the meeting, using them to develop definitions for the principles of “comprehensive” and “risk-based,” and create a list of elements essential for process control under a feed safety system. The list of seven feed safety system elements, published in March 2004, covers the entire process of feed production and transportation.

Framework

For the next public step in developing the AFSS, the team created the draft framework, which was the focus of the April meeting. The framework reflects the comments received about the AFSS.

The draft framework separates the AFSS into four components that cover all aspects of feed production.

  • Component 1: Ingredients and the Approval Process. The purpose of this component of the feed safety system requires that all ingredients used in feed are safe. This component also describes the mechanisms FDA and CVM use to make sure all ingredients and additives used in feed are safe for the uses intended. The principal mechanism is the Federal Food, Drug, and Cosmetic Act.

    However, FDA has also relied on the Association of American Feed Control Officials to define ingredients. The gap identified under AFSS for this component is that a non-Federal organization is used to list -ingredients and provide information. The framework document identifies the use of an FDA Compliance Policy Guide to correct the gap.

  • Component 2: Limits for Animal Feed Contaminants. The purpose of this component is to identify the hazards that feed might contain and set limits to those hazards. Also, this component calls for developing test methods to find the hazards.

    One gap the AFSS team identified is the lack of a ranking process that would allow FDA to determine which hazards require limits and analytical methods. CVM is developing a risk assessment method, which was also discussed at the meeting. More information about the risk ranking system is presented later in this article.

  • Component 3: Process Control for the Production of Safety Feed. This component deals with proper manufacture, packaging, storage, and distribution of feed ingredients and mixed feed to keep hazards out.

    FDA has regulations covering medicated feed. However, under AFSS, FDA and CVM might need a broader regulatory approach to cover production, packaging, storage, distribution, and use of feed ingredients and non-medicated feeds.

  • Component 4: Regulatory Oversight. This part of the feed safety system calls for regulators to apply a risk-based system so that FDA can use resources for the greatest benefit in terms of keeping feed safe.

    A gap that the framework identified is that some segments of the feed industry, including transporters and on-farm mixers, are outside the normal regulatory scope of FDA and the States.

Risk ranking

Because AFSS will be a risk-based system, CVM is developing a risk-ranking method that can be used to identify and determine the relative levels of risks from contaminants in feed.

Karen Ekelman with CVM’s Division of Animal Feeds explained that AFSS will focus on actual risks to humans and animals from feed. She added that a risk is the likelihood of harm from a hazard, and the likelihood is based both on the significance of the hazard and the possibility an animal or human will be exposed to that hazard. Risk equals hazard times exposure, she said.

Decisions based on hazard alone typically overemphasize frightening or unusual hazards, but underemphasize common or familiar hazards, Dr. Ekelman said. In addition, a system focusing on hazards must require that the hazards be eliminated, which is not a practical approach for a feed system, she said.

The AFSS that CVM wants to create will allow FDA to quantify the actual risk reduction, or, in other words, quantify the benefit from actions. Dr. Ekelman said that a risk-based system will permit FDA to balance regulatory resources against the relative risks of feed hazards.

FDA has identified 175 feed contamination hazards, including biological, chemical, and physical. The relative risk of these -contaminants will be assessed using the AFSS risk ranking method.

Each feed hazard gets a consequence “score,” which ranks the danger of each hazard. For instance, a hazard that could cause a death would be assigned a greater score than a hazard that would cause slight injury.

The hazards are then given exposure scores under the risk model. If animals are not likely to be exposed to a particular hazard in feed, the hazard would get a lower score than one to which many more animals would be exposed.

The risk ranking method also adjusts for the potentially modifying or enhancing effects to the hazards from the feed manufacturing process.

FDA will use the risk ranking method to determine which feed contaminants present the greatest relative risks to animal or human health, and then to decide how to best eliminate, reduce, or control the risks.