FDA Animal Feed Safety System (AFSS) Update #10
New “SafeFeed” Web page
Feed Safety topics of new videos
AFSS Identification mark
FDA issues new compliance guide about Salmonella in animal feed
Update on Pilot Project on Risk-Based Decision-Making for Animal Feed Facility Inspections
Animal Feed Regulatory Program Standards
The Animal Feed Safety System (AFSS) Team has developed an easy to use Web page for information about safe feed. The new page went “live” in July, so it’s available and ready for use. The AFSS Team encourages members of the feed manufacturing or animal feeding industry as well as the general public to view the page and to provide feedback, such as ideas to improve the page’s design as well as suggestions for additional material that could be posted there.
The page is available at www.FDA.gov/SafeFeed. It is designed so that it works on a computer screen or on a mobile device; the user does not need to be sitting at a computer to find FDA’s information on safe feed.
The page has six topic links at the top. They are:
- Seek Ingredient Approval
- Manufacture Animal Feed
- Learn about Good Animal Feeding Practices
- Report a Problem
- Ship Animal Feed
- Learn about FSMA (the Food Safety Modernization Act).
Those are followed by seventh link labeled “Get Assistance.” Users can send comments about the page via an e-mail address listed under Get Assistance. That address is AskCVM@fda.hhs.gov.
The ad hoc AFSS Team that designed the page identified these topics as the most useful in directing users to the information they want, so users will not have to do a great deal of searching to find information pertinent to their questions. For instance, the user does not need to search the “Guidance for Industry” Web page to find guidances applying to manufacturing animal feed. The user can click on the “Manufacturer Animal Feed” link, which will lead to the section of the page that contains links to all the pertinent guidance documents.
Along with the links to specific topics, the SafeFeed page also has navigational boxes on the side about “News,” “Pet Food Regulation,” “Feed Regulators,” (placed on the site for the convenience of State feed regulators) and “Videos.”
The AFSS Team has produced two new videos, one for livestock producers about what they need to look for on the label of a medicated feed, and one for animal feed manufacturers – including on-farm feed mixers – describing the rules they must know and follow when producing medicated feed.
The video for livestock producers, “Helping Animal Producers Understand Medicated Feed Labels,” posted on the Internet in June, runs 7 minutes and 48 seconds. It starts with a definition of what is a medicated feed:
“A medicated feed is a feed that contains a drug. We’re not talking vitamins or minerals. Instead, we are talking about drugs that can help treat or prevent animal disease or aid in an animal’s productivity.”
The video explains that, by reading and following the label directions, poultry and livestock producers can be sure they are using medicated feed properly. Proper use of medicated feeds is important to help ensure the safety of any food produced from animals. The video also describes what information is presented on the medicated feed label, and what that information means to the animal feeder.
The video for feed manufacturers, “Medicated Feed Rules for Animal Feed Manufacturers,” runs for 7 minutes and 21 seconds. It discusses the current Good Manufacturing Practice regulation and explains that any time a drug is mixed in animal feed, the feed becomes a medicated feed, and anyone who produces a medicated feed must comply with some portion of the Good Manufacturing Practice regulation. It doesn’t matter if the producer is a large commercial feed manufacturer or a poultry and livestock producer who mixes a drug into feed used on the farm, provisions of the regulation apply. Some commercial feed manufacturers must have licenses issued by FDA, because they use certain Type A medicated articles. However, most feed manufacturers don’t need FDA licenses. But licensed or not, the feed manufacturer must know the regulation and follow the provisions that apply.
Both videos were produced at FDA’s studio, which is operated by the Center for Devices and Radiological Health, and are high definition videos. They feature a professional narrator.
The new videos, as well as others that provide help on ensuring safe feed, can be found on the new SafeFeed Web site (see above).
To make information about feed safety instantly recognizable on the Web or on printed documents, the AFSS Team has developed this AFSS Identification Mark:
A key feature of the identification mark is that it includes the new AFSS SafeFeed Web page address. The AFSS Team members will put the mark on documents and even stickers provided to visitors who stop by the AFSS booth at trade shows, so visitors will know how to find more safe feed information after they’ve left from the trade show.
The work of the AFSS Team is becoming increasing one of outreach and education – programs to provide the information feed manufacturers and poultry and livestock feeders need so they can mix and use animal feed safely. The new identification mark will help in the outreach and education process by calling attention to safe feed material.
In July, FDA issued a new Compliance Policy Guide for field staff to advise them on actions they can take when Salmonella is discovered in animal feed or pet food.
For a discovery of Salmonella in animal feed, the guide advises FDA staff to consider taking regulatory action if the Salmonella serotype is pathogenic to the species of animals expected to get the feed, and if the feed will not go through a step to kill the Salmonella before being fed. If the type of Salmonella found is not pathogenic to the animals expected to get the feed, the guide suggests that no action is necessary.
By contrast, for pet food, the guide recommends that regulators consider taking action no matter what serotype of Salmonella is found and if the pet food will not be treated later to kill the Salmonella. This recommendation is “due to the heightened human health risk given the high likelihood of direct human contact with such food,” the guide says. Humans can become infected with Salmonella by handling contaminated pet food or when they come into contact with contaminated utensils used in handling pet food.
Salmonella can cause salmonellosis in humans. Vulnerable populations – children, the elderly, and individuals with compromised immune systems – are particularly susceptible to acquiring salmonellosis and may suffer more severe symptoms.
The regulatory actions suggested by the guidance are for the FDA field office to develop a recommendation for a seizure or import refusal.
As a Compliance Policy Guide, it presents FDA’s current thinking about the issue, and does not establish any requirements on the pet food or animal feed industry.
CVM, FDA’s Minneapolis District Office, and the States of Minnesota, North and South Dakota, and Wisconsin are conducting a pilot project to develop a harmonized process of establishing inspection priority lists, which will identify high-risk feed manufacturing facilities for inspection and frequency of inspections.
The goal of the pilot project is to ensure high-risk animal feed facilities across the Minneapolis District are identified and inspected in a timely manner and that inspection decisions are made using a risk-based work plan, cooperatively developed by all participants.
A team of officials of FDA’s District Office, CVM, and the States identified a list of site-specific risk factors. Those factors will be used to review and prioritize a consolidated list of feed manufacturers drawn up by the States and the District Office. The exercise will generate a list of high- and non-high-risk feed facilities. Once that list is developed, the States and the District Office will meet to prepare a work plan for inspecting high-risk and non-high-risk facilities.
For the first inspection phase, which began last year, the Team was working with 18 site-specific risk factors used to categorize feed manufacturing facilities as high-risk and non-high-risk. At a meeting earlier in this year (2013), officials from FDA and the States reduced the number of risk factors to nine and gave greater weights to those factors deemed more important from a risk to animal and human health respect.
The second inspection phase began in July. It will run about 6 months. If this phase is successful, the pilot program will be completed, and the program will be made available for use in other districts and with other States.
The program is expected to lead to greater coordination and better information flow between FDA’s District Offices and the States. The same outcome is expected as the program is applied elsewhere.
On July 10, 2013, FDA and the Association of American Feed Control Officials (AAFCO) released the draft Animal Feed Regulatory Program Standards (AFRPS), designed to provide a consistent foundation that promotes uniformity and consistency across animal feed regulatory programs among all States and with FDA.
FDA and AAFCO worked together to develop the AFRPS. FDA and AAFCO are members of the Partnership for Food Protection (PFP), which is a group of Federal, State, local, tribal, and territorial government officials with roles in protecting the safety of the food supply. The PFP is developing an Integrated Food Safety System (IFSS). One of the foundational principles of the IFSS is the use of uniform standards so that Federal, State, territorial, tribal, and local agencies conduct inspections using recognized national standards.
Implementing the standards is voluntary, but by using them a State would be able to develop a program that is consistent with programs in other States.
The draft AFRPS were released for comment on July 10. (The comment period was scheduled to close September 9, 2013.)
The AFRPS contains 11 standards that together “describe the best practices of a quality regulatory program.” The AFRPS Federal Register notice is online at https://www.federalregister.gov/articles/2013/07/10/2013-16517/agency-information-collection-activities-proposed-collection-comment-request-draft-animal-feed. To request a copy of the AFRPS, an email request should be submitted to OP-ORA@fda.hhs.gov.
The AFRPS serve as an objective framework to evaluate and improve components of a State feed program. Below is a list of the individual standards, with the corresponding purpose of each, as stated in the draft AFRPS.
- Regulatory Foundation: “This standard describes the elements of the regulatory foundation used by a State program to regulate animal feed.”
- Training: “This standard describes the elements of training for inspectors in a State animal feed regulatory program to ensure they will have the knowledge, skills, and abilities to competently inspect feed facilities and conduct investigations.”
- Inspection Program: “This standard describes the elements of an effective animal feed inspection program.”
- Auditing: “This standard describes the auditing procedures necessary to: 1) evaluate the effectiveness of inspections and sample collections, 2) recognize trends in the inspection and sampling programs, and 3) identify areas in need of corrective actions.”
- Feed-Related Illness or Death and Emergency Response: “This standard describes the functions to detect, identify, and respond to alleged feed-related illnesses, deaths, and emergencies, including coordinating roles and responsibilities with other jurisdictions and communicating with appropriate parties.”
- Enforcement Program: “This standard describes the elements of an effective enforcement program.”
- Outreach Activities: “This standard describes the elements of outreach activities developed and provided by the State program.”
- Planning and Resources: “This standard describes the elements of work planning and resource evaluation used by a State animal feed regulatory program.”
- Assessment and Improvement: “This standard describes the processes used to evaluate a State program’s fulfillment of the requirements in each standard within the AFRPS … and develop improvement plans to address requirements that have not been met.”
- Laboratory Services: “This standard describes the elements of utilizing regulatory testing laboratory services that support the State animal feed program.”
- Sampling Program: “This standard describes the elements of an effective animal feed sampling program.”
Besides the purpose statement, each standard has a summary of requirements, a description of the program elements, the projected outcomes, and a list of required documents.