Animal & Veterinary
Feed Safety System Group Initiative Revises Framework Document
by Jon F. Scheid, Editor
The team in the Center for Veterinary Medicine developing the Animal Feed Safety System (AFSS) issued a second draft of its “Framework Document” in December 2006 that says the system will cover all types of feed, including pet foods and all establishments involved in feed manufacturing, packaging, distribution, and use, and that CVM will develop process control regulations to cover all of these aspects of feed manufacturing.
The Food and Drug Administration began the AFSS initiative in 2003 when it announced its intention to make its animal feed safety program more risk-based and comprehensive. The modernized AFSS will incorporate risk-based, preventive control measures for ensuring the safety of animal feed. FDA, with State assistance, has developed and is now refining an AFSS framework document that identifies the current major processes, guidance, regulations, and policy documents that address feed safety and the documents that should be developed to make the Agency’s feed safety program comprehensive and risk-based.
The AFSS team released its first Draft Framework Document in 2005. In it, the team introduced the concept of risk assessment to identify and create limits for feed contaminants that were potentially hazardous. The second draft reflects the AFSS Team’s refinement of the concepts.
The revised Draft Framework document lists 11 operating principles, up from the 7 listed in the first draft framework (see sidebar, “11 AFSS Principles”), and 5 key components, up from 4 in the original draft (see sidebar, “Components of Animal Feed Safety System”). The four original components were aimed at making sure that ingredients used in feed were safe, rules are in place to limit contaminants, that the methods used to make, distribute, and use feed resulted in safe products, and that all levels had regulatory oversight adequate to address the risk at that level. In the revised Framework, the team highlighted as a component the importance of complete training for inspectors and outreach to the industry to help firms comply with the feed safety rules.
CVM began the AFSS effort because of the gaps in FDA’s current system of feed safety oversight. Feed produced in the United States is generally safe. “However,” the revised draft Framework says, “because oversight of this industry is limited and focused on a few known safety issues, potential -human and animal health problems may remain hidden. Recent incidents in which high levels of dioxins were present in mineral supplements used in animal feed reflect these types of hidden risks.”
The Framework says that oversight would be risk-based. Not all feed hazards are actually risks, and different hazards present different levels of risk, according to the Framework. It presents a risk equation, which is a hazard multiplied by exposure; the greater the exposure to a hazard (which could be a dangerous -contaminant in feed, for example), the greater the risk and the greater the need for oversight under a feed safety system.
The Framework Document enumerates gaps in the current feed safety system under each component and explains how the gap is to be addressed with the revised feed safety system.
For example, the current feed safety system does not fully address all aspects of feed safety from manufacturing to ultimate use, the Framework says. Therefore, the new feed safety system would use process control regulations, supplemented with industry guidance to help explain the -regulations.
The AFSS team held its third public meeting in September 2006. More than 100 individuals attended, including several representing foreign countries, which indicated the international interest in food safety.
The previous two meetings were designed to gather input from stakeholders. The AFSS team used the third meeting to present information to stakeholders. The team presented the concept behind the “Health Consequence Scoring” system, which involves two factors—the likelihood of illness, which can be expressed as the potency of the hazard, and the severity of the illness, which in animals can range from reduced feed consumption all the way to death.
The team is planning its next public meeting, to be held in the spring of 2007, to discuss the other aspect of the risk equation—exposure to risks. CVM will announce details of the meeting in the spring.
Eleven AFSS Principles
The Center for Veterinary Medicine’s Animal Feed Safety System (AFSS) Team listed 11 “operating principles” in its revised Draft Framework, released in December 2006, including 4 added since the first Draft Framework was released in 2005.
The new principles would extend AFSS to all types of feed and all types of manufacturing, add the concept of flexibility, and emphasize training.
The 11 principles are:
- The animal feed and animal production industries are responsible for the production, distribution, and use of safe animal feed.
- The Federal and State regulatory agencies provide the rules, guidance, and oversight to assist industry in producing safe animal feed and feed -ingredients.
- (New) Rules and guidance provide flexibility in the approaches individual producers of animal feed can use to meet acceptable safety criteria.
- Federal and State regulatory agencies cooperate on all aspects of feed -regulation.
- Feed regulatory agencies conduct inspections of feed-producing facilities, review product labels, sample and analyze feeds for hazards and for compliance with label guarantees, and take appropriate actions to address -violations.
- FDA directs its regulatory resources to those feed-related hazards that pose the greatest risks to animal and public health.
- Risk-based decision-making is used to help determine which feed-related hazards should receive the highest priority by FDA and the best methods for addressing them.
- Feed security measures as they relate to counterterrorism should become part of the AFSS.
- (New) Training is critical for ensuring that industry and regulatory agencies have the most up-to-date knowledge about FDA rules and guidance and for ensuring enforcement by FDA and States is consistent and conducted in an appropriate manner.
- (New) Feeds intended for food-producing and other types of animals, such as pets, are included in the AFSS.
- (New) Feed establishments covered in the AFSS include all facilities, equipment, and conveyances involved in the production, storage, packaging, and distribution of individual feed ingredients and mixed feed and the feeding of animals.
Components of Animal Feed Safety System
The revised Animal Feed Safety System (AFSS) “Framework Document” the Center for Veterinary Medicine issued in December 2006 presents the proposed AFSS program in five components (listed A through E), identifies gaps under each component, and explains how each will be addressed.
|Components||Gaps||How Gaps Are Being Addressed|
Ingredients and the Approval Process
|The Food and Drug Administration regulations do not provide a complete listing of ingredients and additives permitted in animal feed.|
A Compliance Policy Guide is being developed that will allow FDA to recognize the ingredients defined in the Association of American Feed Control Officials (AAFCO) Official Publication.
A Memorandum of Understanding is being developed between FDA and AAFCO to identify roles each party plays in adding, modifying, or removing definitions.
Limits for Animal Feed Contaminants
FDA needs a systematic process whereby it can distinguish among feed contaminants based on the risks they pose to animal and human health.
FDA needs a process for triggering development of official regulatory methods for detecting contaminants in feed.
A relative risk-ranking system is being developed for internal FDA use.
An internal Standard Operating Procedure is being developed.
Process Control for the Production of Feed Ingredients and Mixed Feed
FDA needs a program that covers the feed safety aspects of manufacturing, packaging, storing, distributing, and using medicated and non-medicated feed and feed ingredients.
FDA needs to update some aspects of the current Good Manufacturing Practice (cGMP) regulations for medicated feed.
Process control regulations are being developed to require firms to take adequate control steps for the entire feed ingredient and feed manufacturing continuum.
Regulations may be updated in response to a petition filed by industry groups and AAFCO that calls for a single set of cGMPs for all medicated feed manufacturers.
FDA’s current regulatory oversight has limited resources and competing priorities and is often based on factors that are not related to actual risk.
FDA’s current regulatory approach does not permit adequate inspection of all segments of the industry responsible for manufacturing, packaging, storing, distributing, and using animal feed.
FDA has out-of-date regulations requiring licensed feed mills to report clinical and other experiences associated with those medicated feeds that require the feed mill to be licensed.
Counterterrorism efforts are not included in the feed safety aspects of the AFSS, because hazards identified are those that are naturally occurring or result from inadvertent, not deliberate, contamination.
A risk-based inspectional approach is being developed for all feed-related inspections.
Regulations are being updated.
A risk-based inspectional approach is being developed for all feed-related inspections
The CVM Counterterrorism Coordinator will keep officials in the U.S. Department of Agriculture, the Department of Homeland Security and other government agencies informed about the AFSS, and obtain their advice.
Outreach and Education
Government feed inspectors and the regulated industries need to fully understand the new regulations before the regulations will be effective.
All feed mills do not have access to the most up-to-date “Blue Bird” labeling requirement.
An outreach plan will be developed; training is being developed for feed inspectors for use when the new regulations go into effect, and as needed thereafter.
A web-accessible database is being developed to house currently approved “Blue Bird” labeling.