Animal & Veterinary
FDA’s Animal Feed Safety System (AFSS) Project Plans Update #7
CVM Releases Revised AFSS Framework Document
In January 2010, CVM released a revised draft of the Animal Feed Safety System (AFSS) Framework Document. The new version is the fourth edition. It replaced the one posted in April 2008.
The new Document provides information about the Team’s progress in addressing the feed system regulatory gaps and provides greater insight about feed hazards, such as when such hazards can become a concern for animal and human health.
One of the developments described in the revised Framework Document is the pilot program for Generally Recognized As Safe (GRAS) notifications for feed ingredients. (See below for more information.) The new Framework Document also discussed the Reportable Food Registry rule, which applies to reportable animal feed. (Under Federal law, food includes animal feed). And it presents information about the Web-based system containing the most recently approved “Blue Bird” medicated feed labels. (The new system provides up-to-date information about feed labels to feed mills manufacturing medicated feed. This system will help feed mills make sure their medicated feed labels contain correct information.)
CVM Announces GRAS Notification Pilot Program
In June 2010, CVM announced a voluntary pilot program to accept and review Generally Recognized as Safe (GRAS) notices for substances used in animal feed.
The way the GRAS affirmation process has worked is that an individual would submit a petition that provided safety and use data that would allow the Food and Drug Administration to determine that the use of a substance was GRAS.
Under the pilot program, a “notifier” can inform FDA of the notifier’s determination that the use of a substance is GRAS. FDA will evaluate whether the submitted notice provides a sufficient basis for a GRAS determination. FDA will also try to determine whether information in the notice, or otherwise available to FDA, raises issues that cause FDA to question whether use of the substance is GRAS.
Information about what the notifier must include in the application is given in the June 4, 2010, Federal Register notice announcing the pilot program: http://edocket.access.gpo.gov/2010/pdf/2010-13464.pdf.
Following its evaluation, FDA will respond to the notifier with a letter that states either that FDA does not question the basis for the notifier's GRAS determination or that FDA concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information, or because the available data and information raise questions about the safety of the substance).
An inventory of GRAS notices and the Agency's response to those notices will be maintained on the FDA Web site.
FDA Issues Guidance on Salmonella in Animal Feed
In July 2010, FDA released a draft Compliance Policy Guide that explains the conditions under which FDA would consider taking regulatory action concerning Salmonella in animal feeds, including pet food.
The document is meant to provide guidance to FDA staff. It was released to the general public to show the direction FDA is taking in its policies.
The document can be found at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm220829.htm.
The guidance on “Salmonella in Animal Feed” will apply in cases in which feed is likely to come in contact with humans, contains Salmonella, and is not going to be further treated to eliminate the Salmonella.
The guidance says the definition of “direct human contact animal feed” includes pet food, pet treats or chews, feed intended to be given as food or treats to animals at petting zoos or agricultural fairs, and vitamins, minerals, and other supplements or treats intended for dogs, cats, or other household pets.
Salmonella in some cases will cause illness in animals, and Salmonella in animals creates a risk of infection for humans. A Salmonella infection in an animal, whether the infection is clinical or asymptomatic, can increase the number of bacteria to which humans could be exposed.
The draft Guidance describes when the Agency will take action to protect the health of animals that might be at risk. Animals, particularly when they are young, are susceptible to salmonellosis, the condition caused by a Salmonella infection. Infections are most often enteric (in the intestine), but can become systemic in the animals. And species-adapted Salmonella serotypes are more likely to cause systemic disease, the Guidance says.
According to the draft Guidance, regulators should consider the following criteria in deciding whether to recommend seizure or import detention of animal feed or feed ingredients:
- Salmonella are present on one or more samples of an animal feed or ingredient; and
- The animal feed or ingredient will not be further treated to eliminate the Salmonella, or FDA regulators have no information that indicates the ingredients will be further treated; and
- Salmonella could be transmitted directly to humans who handle or ingest the animal feed or ingredients; or the Salmonella serotypes identified on the feed or ingredients are pathogenic to the animal for which the feed or ingredients are to be given.
The draft Compliance Policy Guide will represent the Agency’s current thinking when it is finalized. The notice said that comments should be submitted by November 1, 2010, to be sure they are considered before the guidance is finalized.
Codex Animal Feed Task Force
The Codex Alimentarius Commission, at its meeting held in July 2010, authorized the establishment of a time-limited, ad hoc, intergovernmental task force on animal feeding.
The Commission has authorized the task force to meet twice and left open the possibility of a third meeting. The meetings will begin in 2011.
The Commission gave the task force two specific tasks:
- Develop guidelines governments can use to apply existing Codex risk assessment methodologies to different types of hazards that relate to contaminants or residues in feed ingredients, including feed additives, used in feed for food-producing animals. The Commission told the task force to use science-based risk assessment criteria for feed contaminants or residues, and be sure that the criteria are consistent with existing Codex methodologies. The Commission said the guidelines should also take into account the rate of transfer and accumulation in edible tissues of hazardous substances from feed and ingredients. In addition, the Commission told the task force to write the guidelines so that countries can assess and prioritize the risks based on local conditions, use, exposure of animals, and the effect, if any, on animal health.
- Develop a list of hazards that could be found in feed ingredients and feed additives. The list should be drawn up for governmental use, and should contain hazards that are of international relevance, likely to occur, and, therefore, likely to require attention in the future.
AAFCO Update on Animal Feed Risk Model
The AFSS Team is planning to present an update on its feed hazard risk model at the midyear meeting of the Association of American Feed Control Officials (AAFCO), scheduled for January 2011.
During previous public meetings, FDA covered various aspects of the model's development, including identification of feed hazards, and information about scoring of the health consequences and of the exposure of animals and humans to hazards in feed. Exposure scoring for swine feed was covered at a May 2009 meeting.
During the AAFCO midyear meeting, members of the AFSS Team will present exposure scoring for additional animal species. The Team will also discuss updates on methodology.
50-State Workshop on Food, Feed Safety
Denver, Colorado, was the location of an FDA-sponsored 50-state workshop on food and feed safety held August 17-19, 2010. Nearly 270 participants from Federal, State, local, and territorial offices with food or feed responsibility were in attendance.
The first day was devoted to:
- Reports from the six Partnership for Food Protection work groups that have been addressing assignments received subsequent to the 2008 50-State meeting held in St. Louis, Missouri;
- An overview of the work underway by the FDA’s Integrated Food Safety System task groups;
- A panel on the workings and usefulness of an incident command system during a foodborne outbreak; and,
- Breakout sessions on the resources crisis impacting State and local governments.
On the second day, workshop participants attended two breakout sessions during which they were asked to develop ideas, advice, and recommendations for FDA on several critical areas, such as:
- Response to food and feed contamination episodes;
- Communication in an integrated food safety system; and
- Conducting multi-agency investigations.
Reports from these breakout sessions were presented on the third day.
Next steps include submitting the recommendations to the Partnership for Food Protection Coordinating Committee for its review and consideration for follow-up action and ensuring that State and local officials have important roles in the work groups.
Animal Feed Safety Video
CVM has produced a 5-minute video highlighting the important role livestock producers, feed manufacturers, and transporters play in making sure feed is safe.
CVM Director Dr. Bernadette Dunham appears in the video, and Dr. Eric Dubbin, a veterinarian at CVM, provides the narration.
CVM’s goal in producing the video was to draw attention to the importance of safe feed in helping to protect the health of animals and the safety of food produced by animals. One of the first uses of the video was at the World Dairy Expo, where CVM officials used it in conjunction with a seminar they presented that included information for dairy producers about steps they can take to ensure the safety of feed. The seminar also included information about proper drug use to avoid unsafe residues in milk and meat.
The video will be posted on FDA’s Web site this fall.
AAFCO co-sponsored the video.
CVM has invited animal feed and livestock production groups to support the video outreach effort by showing it to their members and by distributing copies to members and other interested parties.