Animal & Veterinary
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FDA Animal Feed Safety System (AFSS) Update #8
(Editor’s note: The AFSS Team has previously informed stakeholders of its progress by issuing “Project Plan Updates.” However, the Team will now be using this AFSS Update rather than the Project Plan Update, because the new format reflects the changes in the initiative resulting from passage of the Food Safety Modernization Act. That Act provides FDA and CVM with new tools, which will result in new approaches to ensure the safety of animal foods. The Act and changes it brings are explained below.)
Food Safety Modernization Act (FSMA) - Implication for Feed Safety Enforcement
FSMA, which became law in January 2011, is designed to give FDA more authority to protect the safety of food for humans and animals. It gives FDA new authorities for addressing issues concerning the safety of food for animals and is altering some of the work of the AFSS Team.
Generally speaking, FSMA has four main themes: prevention; inspection, compliance, and response; import safety; and enhanced partnerships.
The prevention rules applying to animal food facilities will likely be similar to Good Manufacturing Practices regulation currently in place for human food and for some aspects of the CGMPs for medicated feed. They are expected to apply to personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, process and controls, and warehousing and distribution.
In addition, FDA is considering regulations that include preventive controls for animal food facilities. Those preventive controls would include:
- Having written food safety plans
- Conducting hazard analyses
- Implementing controls to address hazards
- Monitoring the controls to make sure they are effective, taking corrective action when a problem is discovered
- Verifying that the corrective action was effective
- Having a recall plan in place
- Having a supplier approval and verification program
FSMA gives FDA new authority to require a mandatory recall if a firm with an unsafe food product fails to act quickly to voluntarily recall the product. It also gives FDA a more flexible standard for administratively detaining products that are potentially in violation of food safety requirements. And under FSMA, FDA will continue working with industry and other experts to develop programs for rapidly tracing domestic and imported food.
FSMA also extends to animal food ingredient imports. It gives FDA unprecedented authority to make sure that imported products meet U.S. standards. Under FSMA, importers are responsible for making sure that their foreign suppliers have adequate preventive controls in place to ensure the safety of their products.
CVM Issues Animal Feed Safety System Overview Document, Replacing Framework Document
Ever since the AFSS Team was formed in 2003, it has keep stakeholders updated on its plans and progress by issuing AFSS Framework Documents. The Documents were used to identify gaps in system of animal food rules and guidances and to offer proposals for ways to address the gaps.
However, implementation of preventive control regulations, as called for by FSMA, will significantly change the regulations that apply to animal food, and thus also change the approach developed by the AFSS Team. Therefore, the Team is changing the way it presents its work to stakeholders by replacing the Framework with an AFSS Overview document.
Instead of presenting information about feed safety system gaps, the Overview lists projects that FDA has undertaken to address animal food safety issues. The list includes, for example, projects about antimicrobial resistance, a review of the rules concerning Veterinary Feed Directive drugs, and the AFSS Team’s pilot program for determining which feed facilities should be inspected first by using a system of risk factors. (See: CVM/District Office Developing Pilot Program on Risk-Based Decision Making for Animal Food Facility Inspections, below.)
The Overview document also discusses how FSMA requires the use of preventive controls in feed production instead of process controls.
The Overview document presents a description of the regulatory safety system for animal food by dividing it up into its major components. Topics of the components are:
- Safe feed ingredients; dissemination of information about feed problems;
- Levels of regulatory oversight that are based on the level of risk to human and animal health; and
- Training and outreach.
The Overview presents a new component on research, and it states that CVM uses an active research program to generate data that help to address animal food safety issues.
CVM/District Office Developing Pilot Program on Risk-Based Decision Making for Animal Food Facility Inspections
To develop and implement the most effective animal food facility inspection program possible throughout the United States, CVM has begun a pilot program with FDA’s Minneapolis District Office to see if CVM, District officials and the states of Minnesota, North and South Dakota, and Wisconsin can develop a harmonized process of establishing inspection priority lists.
To get the pilot program underway, the Minneapolis District Office organized a team of its own staff and included representatives from the four state feed control offices to help get the pilot project up and running. The District and state officials provide expert insight about conditions found in the field that can influence decisions about inspections. The state representatives joined CVM and FDA officials for the initial meeting in November 2010, and have since been helping to develop the key provisions of the program – definitions of terms and a common terminology, and the determination of which risk factors are to be considered.
CVM uses risk-based factors in its compliance programs for feed contaminants, BSE, tissue residues, and medicated feed. However, the risk-based factors CVM uses are not always consistent with those used on a daily basis by states and individual FDA field offices. The states and field offices encounter many factors that can influence priority setting.
The goal of the pilot project is to ensure high-risk animal feed facilities across the District are identified and inspected in a timely manner using a cooperatively developed, risk-based work plan approach.
As the pilot project team has been working, it has found that the terminology used by feed safety regulators, especially regarding the inventory of facilities to be inspected, is not uniform, especially when discussing details. So, one of the first steps taken by the team was to discuss terms.
The pilot program will take 3 years or more to complete. After that, the model developed and lessons learned can be used for programs with other districts
AFSS Team Developing Videos on Pet Food Safety
The AFSS Team is producing two videos, aimed at consumer audiences, about the safety of pet food; one about the regulations that apply to pet food, and the other about ways consumers can safely use pet food.
The video about regulation of pet food explains that FDA, working with its state partners, has the responsibility for enforcing the rules concerning safety of pet food and pet treats. The rules require manufacturers to use ingredients that are known to be safe, to list all ingredients on the label that were used in the manufacture of that product, to properly identify the product on the label, to make sure the labels provide a net quantity statement, and to include the manufacturer’s name and address on the label.
In addition, the video explains to consumers how they can report a problem with pet food or pet treats, and how FDA handles complaints it receives.
Dr. William Burkholder, the Center’s pet food safety expert, is featured in the video and narrates it.
The other video explains to consumers that they have an important role in preventing problems from pet food in their homes. It explains to consumers that pet food and treats can carry bacteria or, once in the home, become contaminated with bacteria that have the potential of making them or someone in their families sick. But consumers can take basic steps – like keeping children away from pet food and washing hands and any utensils used for handling pet food – to protect the health of their families.
The video also tells viewers that, if they believe they have a problem with pet food or pet treats that threatens the health of people or pets, they should let FDA know by calling an FDA Complaint Coordinator, or reporting the problem on FDA’s “Safety Reporting Portal.”
The expert and narrator of this video is Dr. April Hodges, a Consumer Safety Officer with the Center’s Complaint, Emergency, Recall Team.
Animal Feed Regulatory Program Standards
In 2011, FDA and the Association of American Feed Control Officials (AAFCO) entered into a partnership to draft standards for animal feed regulatory program standards.
As the United States moves towards integrating food safety resources, uniform standards across animal food regulatory programs are needed. Currently, the United States has no recognized national standards for animal food programs. The Animal Feed Regulatory Program Standards (AFRPS) are being designed to promote uniformity and consistency across feed regulatory programs. In addition, the AFRPS will allow for integration of the regulatory activities of partner agencies into an efficient and effective process for improving food and feed safety in the United States.
The AFRPS will provide a framework every state can use to determine the strengths and needs of its program. Implementation of these standards will build uniformity and consistency among state feed regulatory programs and will further efforts to develop an integrated food safety system.
A committee of representatives from AAFCO and FDA is developing the AFRPS, with a goal of completing a draft in 2012.