Animal & Veterinary
Team Revises Animal Feed Safety System (AFSS) Framework Document
by Jon F. Scheid, Editor
FDA Veterinarian Newsletter May / June 2008 Volume XXIII, No III
The Animal Feed Safety System (AFSS) Team has revised the AFSS Framework Document by adding a new component about reporting unsafe feed and by identifying additional gaps in the existing feed safety system.
The Center for Veterinary Medicine released the revised Framework Document (the 3rd version) in April 2008 and posted it on its Web site.
The changes to the Framework Document came about because of the requirements placed on the Food and Drug Ad-ministration by provisions of the FDA Amendments Act (FDAAA) of 2007. Besides continuing FDA’s user fee programs for human drugs and devices, FDAAA requires FDA to take steps designed to improve the safety of pet food and ingredients.
Title 10 of FDAAA requires FDA to establish, “by regulation,” ingredient standards and definitions, processing standards, and labeling standards - including nutritional and ingredient information - for pet food. It also requires FDA to establish an Early Warning Surveillance and Notification System to identify adulteration of the pet food supply and illness outbreaks and to notify veterinarians and other stakeholders of pet food recalls.
In addition, the legislation requires FDA to establish a searchable database of recalled human and pet foods to ensure efficient and effective communications during a recall. And it requires a “Reportable Food Registry” for animal as well as human food. Reportable food is any food that carries a reasonable probability that its use or exposure to it will cause serious adverse health consequences or death to humans or animals.
Revised AFSS Framework Document
The six components of the AFSS presented in the revised Framework Document now are:
- Ingredients and the approval process (includes a new gap)
- Limits for animal feed contaminants
- Process control for the production of feed ingredients and mixed feed
- Reporting of unsafe feed (new component, added for the 3rd draft of the Framework Document, and includes a new gap)
- Regulatory oversight
- Education and outreach (includes a new gap)
The focus of the new component, D (what used to be Component D is now Component E, and what was E is now F), is gathering information about feed problems. To help protect the health of animals and prevent food safety problems, FDA should know about the feed problems before they become widespread. Also, other feed users and the public should know about the incidents so that they can protect themselves.
The new Component D addresses the FDAAA provisions requiring FDA to establish a Reportable Food Registry. The component includes the lack of information about pet food, feed, and ingredient contaminants as a gap, and the requirements of the FDAAA as the fix for that gap.
Another gap noted in Component D of the revised Framework Document is that FDA needs to know quickly about un-safe pet food and feed incidents. Knowing about such incidents before they cause widespread injury or death would greatly assist FDA. Further, the public needs to be advised about those incidents to protect themselves and their pets.
In response to this gap, as required by FDAAA, FDA will implement an early warning and surveillance system to identify adulteration incidents affecting pet food supplies. It would also alert the public about any outbreaks of illness connected to pet food.
Component A was also changed in the revised Framework Document. An earlier version of the document noted that the AFSS Team had begun developing a Compliance Policy Guide to explain the relationship between the Association of American Feed Control Officials (AAFCO) and FDA and to establish a policy by which FDA could recognize the ingredient definitions presented in AAFCO’s Official Publication. FDA has no complete list of all acceptable animal feed ingredients. AAFCO’s Official Publication contains the most complete list available, and it includes comprehensive ingredient definitions. FDA relies heavily on the Official Publication, even though it is a non-Federal document and lacks the force and effect of law.
The revised Framework Document says that the AFSS Team has put on hold its plans to write the Compliance Policy Guide under Component A, while FDA works to implement FDAAA’s requirement to write regulations for feed ingredient standards for pet food.
The new gap listed under Component F concerns updating labeling standards for pet food, as required by FDAAA. Through that Act, Congress has required a regulation that includes standards for nutritional and ingredient information on the label.
AFSS, Food Protection Plan fit together
The AFSS initiative fits well into FDA’s overarching Food Protection Plan, which is designed to integrate all Federal, State, and local food safety and food defense (counter-terrorism) programs in the United States. The Food Protection Plan was developed last year and announced in November 2007. It has specific action items that involve FDA’s Federal and State counterparts.
At an AFSS public meeting held in May 2008, Dr. George Graber, consultant to CVM’s AFSS Team, pointed out that the AFSS Initiative and the Food Protection Plan have many “cross-cutting” principles.
- For example, FDA’s definition of food includes food for animals as well as humans. Therefore, food safety must mean feed safety, too.
- Both the AFSS and the Food Protection Plan focus on risks over a food product’s life cycle - from production to consumption.
- Both initiatives use a risk-based approach, targeting resources in a way that will permit the greatest reduction of risk.
- Both address accidental as well as deliberate contamination of food.
- And both rely on science and modern technology, including enhanced “IT” systems, to be most effective.