FDA sets standards for state feed regulations
As February turned into March, The Food and Drug Administration (FDA) released standards for regulating animal feed. The standards themselves are not regulations, but rather a framework by which states or other governing bodies can regulate animal feed.
The stated purpose of the standards is to “promote uniformity and consistency among animal feed regulatory programs,” while “acknowledging the responsibilities and authorities of individual states.”
The standards were created by the FDA in partnership with the Association of American Feed Control Officials as a result of the Food Safety Modernization Act— signed into law by President Obama in 2011—and a 2009 FDA recommendation to create an Integrated Food Safety System (IFSS). Core to the IFSS is the need for model standards for the production, processing, and distribution of human food and animal feed. Prior to the release of these standards, standards only existed for the regulation of human food.
The standards cover 11 points ranging over the entire production system of animal feed, from creation to emergency response. The standards with a brief description are as follows:
• Regulatory foundation. Each state animal feed regulatory program must selfassess to ensure, among other things, that it has the legal authority to regulate animal feed and conduct the necessary activities to do so. Additionally the program must assess how the state’s legal authority and “regulatory provisions” correspond to the Federal Food, Drug, and Cosmetic Act.
• Training. Each state program must establish a training program for inspectors and documentation of said training. Training should include basic and advanced levels, as well as continuing education.
• Inspection program. Establishes definitions of inspection protocol and directs state programs to use risk-based assessment policies based on the type of feed/feed products, history of the feed processing facility being inspected, and type of processing.
• Auditing. State programs must create auditing procedures that ensure audits are effective in their purpose, able to identify trends between audits, and can identify areas of need.
• Feed-related illness or death and emergency response. Directs state programs to create ways to identify feed-related illness, death and other emergencies; respond to such situations effectively; and alert government agencies, law enforcement and other stakeholders in a timely manner.
• Enforcement program. State feed regulatory programs must have an effective means of enforcement for feed processing facilities. When considering enforcement action, the standards recommend state programs consider the compliance history of the facility, its responsiveness to an issue, the scope of the issue, the nature and impact of the violation, and resources available.
• Outreach activities. Outline the elements of an effective outreach program to inform “feed industry stakeholders, academia and consumers” of the state’s programs and requirements.
• Planning and resources. Effectively a requirement for a business model, this standard requires state programs to outline how they will conduct themselves, what resources (staff, funding, equipment, etc.) they need, and how they will conduct sample collection and time frames.
• Assessment and improvement. Every state program must have a set of internal assessment procedures by which it can identify its effectiveness and identify areas of improvement. Several worksheets and suggested self-assessment tools are made available.
• Laboratory services. Standards require state programs have access to laboratory services and base their regulatory activities on analytical data. Laboratory services should be from labs accredited in the relevant field by a recognized accreditation body.
• Sampling program. State programs must have a sampling plan when it comes to collecting, storing, transporting and documenting “surveillance, compliance, investigational or regulatory samples.”
The FDA stressed that the standards are voluntary despite frequent uses of “must,” “should” and “require” throughout the standards. The standards were created to create greater levels of consistency between states’ animal feed programs and between human food and animal feed regulations.
“A state’s implementation of the [Animal Feed Regulatory Program Standards] helps ensure a uniform and consistent approach to feed regulation among jurisdictions including the sharing of information and the coordination of resources.” — Kerry Halladay, WLJ Editor