FDA Animal Feed Safety System (AFSS) Update #9
CVM’s Current Animal Foods GRAS Notices Inventory
Sampling Animal Food for Salmonella
Update on Pilot Project on Risk-Based Decision-Making for Animal Food Facility Inspections
AFSS Team Presence at Trade Shows and Conventions
Feed Safety Videos
Feed Hazard Identification and Control Guidance
Codex Task Force on Animal Feeding Restarted
What is the AFSS?
New AFSS Brochure
The Center for Veterinary Medicine began a pilot program in 2010 allowing individuals and firms to submit notifications to FDA declaring a non-drug feed ingredient to be Generally Recognized as Safe (GRAS), and the Center recently updated its online list of GRAS notices it has received.
Under the pilot program, individual and firm “notifiers” can declare a non-drug feed ingredient as GRAS for an intended purpose, and submit the justification for the claim to FDA for review. CVM will review the notice and respond, saying either that the Center has no questions about the ingredient or that the notice does not sufficiently support the claim that the ingredient is GRAS.
As of July 17, 2012, CVM has posted online the status of 13 GRAS notices; 5 did not provide a basis for a GRAS determination, 4 were withdrawn voluntarily by the notifier, 3 resulted in no-question letters from FDA/CVM, and 1 was pending.
CVM’s response to a notice saying that it has no questions does not represent CVM’s approval of the ingredient. Instead, it means that CVM has no reason to believe presently that the ingredient is a food additive for the use described in the notice.
FDA scientists have recently published findings from a study that indicate a decline in Salmonella in feed and pet foods and treats.
The results appeared in a manuscript published in FOODBORNE PATHOGENS AND DISEASE, pages 1-7, Volume 9 (2012). The manuscript presented the surveillance data from FDA’s Feed Contaminants Program (2002–2009) and a Salmonella Assignment (2007–2009).
A total of 2,058 samples were collected from complete animal feeds, feed ingredients, pet foods, pet treats, and supplements for pets. The samples were tested for the presence of Salmonella. Of the 2,058 samples, 257 were positive for Salmonella (12.5 percent). When Salmonella isolates were recovered, they underwent serotyping and testing for antimicrobial susceptibility.
The results presented in the article indicate a significant overall Salmonella reduction in animal feeds; declining from 18.2 percent in 2002 (187 samples tested) to 8.0 percent in 2009 (584 samples tested). Among these samples, feed ingredients and pet foods and treats had the most significant reduction.
Of the 45 Salmonella serotypes identified, Salmonella Senftenberg and Salmonella Montevideo were the top two common serotypes (8.9 percent).
Of the 257 Salmonella isolates obtained, 54 isolates (21 percent) were resistant to at least one antimicrobial.
The findings provide the animal feed industries with Salmonella prevalence information that can be used to address Salmonella contamination problems and credible information to educate pet owners when handling pet foods and treats at home to prevent salmonellosis.
CVM, FDA’s Minneapolis District Office, and the states of Minnesota, North and South Dakota, and Wisconsin have begun a pilot project to develop a harmonized process of establishing inspection priority lists and inspecting high-risk feed manufacturing facilities.
The goal of the pilot project is to ensure high-risk animal feed facilities across the FDA district are identified and inspected in a timely manner using a cooperatively developed, risk-based work plan approach.
Site-specific risk factors have been identified, which will be applied to a consolidated list of feed manufacturers generated by each state and the District Office. The outcome from this exercise will be a list of high- and low-risk feed facilities. Once the list is developed, each state and the District Office will meet to prepare a work plan for inspecting the high-risk facilities. The inspection phase is expected to begin on October 1, 2012, and last for up to a year.
Members of the AFSS Team brought an exhibit booth to the World Pork Expo, held during June in Des Moines, IA, to call attention to the Animal Feed Safety System. Earlier in the year, a Team member helped operate the CVM booth at the World Poultry Expo in Atlanta, GA. Plans were also developed to attend the American Veterinary Medical Association annual convention in San Diego in August.
The AFSS Team will also be taking the booth to the National FFA Organization National Convention, which will be held during October in Indianapolis, IN. In addition to having the booth there, members of the AFSS Team will be making a presentation in a lecture hall at the site to highlight the importance of feed safety in livestock production and pet food safety for pet health. For the presentation, AFSS Team members are developing descriptions of several cases of problems involving feed for the FFA attendees to try to resolve.
At the trade shows, Team members present information to livestock producers about AFSS, highlighting the importance of animal feed safety, and Team members answer the producers’ questions.
The AFSS Team has partnered with the video production staff of FDA’s Center for Devices and Radiological Health to produce videos about animal feed and pet food issues.
The first video, “Safe Animal Feed” (available on the FDA website and on YouTube), produced in 2010, emphasizes the important role in food safety that livestock producers and feed manufacturers play. The second one, “FDA and Pet Food,” produced in January 2012, describes the role FDA plays in the regulation of pet food. Another pet food video, which focuses on the need to properly handle pet food in the home to prevent foodborne illness, is expected to be released soon.
Also in the production pipeline are videos directed toward a feed industry audience. One will advise feed manufacturers that they must follow current Good Manufacturing Practice regulations if they produce medicated animal feeds, and the other emphasizes the importance to animal feeders of understanding and following the information on medicated feed labeling.
Additional videos are being planned, including one that will describe labeling requirements in more depth for medicated feed manufacturers, and another that will discuss safe on-farm feeding practices.
Dr. Gary Osweiler, Iowa State University professor emeritus, was recently awarded a contract to continue the work on a project for hazard identification, begun several years ago by Dr. Frank Jones, professor emeritus of the University of Arkansas.
CVM contracted with Dr. Jones and now with Dr. Osweiler to assist in the development of the guidance for industry on the identification of hazards likely to be found in animal feed and on procedures for controlling those hazards.
The work was initiated to assist the feed industry in complying with process-control regulations that were being developed by the AFSS Team. When the Food Safety Modernization Act (FSMA) of 2011 was signed into law, attention turned to utilizing this effort to help the feed industry comply with preventive animal food control rules and specifically with development of animal food safety plans.
Codex has restarted an Ad Hoc Intergovernmental Task Force on Animal Feeding. The first task force was able to reach a consensus on a Code of Practice on Good Animal Feeding, but some Codex members thought more could be done. So, in June 2008, Codex established an electronic working group to consider the scope of additional Codex work concerning feed standards.
Codex gave the working group two charges, or Terms of Reference. The first is to develop guidelines for governments to use in applying the existing Codex risk assessment methodologies to various types of contaminants or residue hazards in feed for food-producing animals. The second is to develop a list, for use by governments, of hazards in feed ingredients and feed additives. According to the charge, the list should rank hazards by priority.
Switzerland is hosting this task force and has taken on the task of developing the initial documents for review by all the delegates. For several months, the Task Force members exchanged comments electronically, making quite a lot of progress.
The exchange of comments was followed up with a physical meeting, held in Switzerland during February 2012. The meeting went well; the Task Force delegates agreed how to proceed. The Task Force generally completed its work on the first charge about developing risk assessment methodologies, and recommended that the document move on toward finalization. However, the Task Force held back its second task – which called on the delegates to develop the prioritized list of hazards. Some Task Force members were concerned that such as list would not be maintained, because the Task Force is to be disbanded after a few years. Some members were also concerned that the prioritization would be different for different countries, so the Codex guideline would not apply equally to all countries. (Aflatoxin, for example, is a significant hazard in the United States, but not in Europe.)
So, the Task Force agreed to change the title of the document to “Guidance for Use by Governments on Prioritizing Their National Feed Hazards,” and to revise it through an electronic working group. Meanwhile, the guidance remains at Codex Step 2.
CVM led the U.S. delegation to the original task force, which lasted from 2000 to 2005, and is leading the U.S. delegation to the restarted task force. Dr. Dan McChesney, Director of CVM’s Office of Surveillance and Compliance, is the U.S. representative to the working group and is coordinating U.S. stakeholders’ input to the working group. The next Task Force physical meeting is scheduled for February 2013.
In 2003 CVM organized a team of experts within the FDA and from State feed control offices to work on a project aimed at making FDA’s feed regulatory program comprehensive and risk-based. The AFSS Team, with external assistance gleaned from five public meetings, identified numerous gaps and developed means of addressing the gaps.
However, since the formation of the AFSS Team, FSMA – which is the most significant change to the manner in which FDA regulates human food and animal feed since the Federal Food, Drug, and Cosmetic Act was passed in 1938 – became law.
In keeping with the overall intent of the new legislation and with the goals of the AFSS project, CVM decided to use AFSS as the title of FDA’s program aimed at protecting human and animal health by ensuring production and distribution of feed that is safe.
As FSMA is implemented, the AFSS Team will continue to pursue projects previously identified, to work on assignments to implement FSMA, and to develop new projects which would benefit from having input from a cross section of FDA and state feed safety expertise.
The AFSS Team has developed a new brochure that describes the direction for the AFSS program and highlights some of the programs and policies FDA has put in place to help ensure the safety of animal feed. In addition, the brochure describes the AFSS Overview Document, which the AFSS Team uses to capture all the information possible about the FDA’s feed safety work.
The new brochure is titled, “Animal Feed Safety System: Coordinating Activities to Improve Food Safety.”
Copies of the brochure are available from CVM’s Communications Staff. You can request a copy at AskCVM@fda.hhs.gov.