Ingredient approval part of FDA feed safety framework
What's next in the quest for further safety measures from the agency?
Last year, the Association of American Feed Control Officials (AAFCO) and the Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) signed a Memorandum of Understanding (MOU) that allows FDA to formally recognize the AAFCO's list of feed ingredients and also defines the role FDA can play in deciding on the suitability of newly proposed feed ingredients.
AAFCO develops model regulations that can be adopted by states to help in enforcing their laws, but the regulatory authority rests with the individual regulatory agencies.
"This is a significant step forward in FDA's effort to enhance the safety of feed. And it allows FDA to formally recognize the valuable contribution AAFCO makes in determining suitability of feed ingredients," said Dr. Dan McChesney, Director of CVM's Office of Surveillance and Compliance, at the time the MOU was signed. AAFCO's annual Official Publication (OP) includes a list of all ingredient definitions reviewed and approved by AAFCO for use in animal feeds. Prior to the signing of the MOU last fall, FDA had frequently cited the OP's ingredient list and had acted as AAFCO's scientific advisor in reviewing petitions for the addition of ingredients to the list or for changes in the ingredient definitions. The MOU solidifies this relationship, say the agencies.
Animal Feed Safety System
FDA's formal recognition of AAFCO's ingredient definition list is yet another step in the agency's persistence in producing an Animal Feed Safety System (AFSS). Four years ago, FDA created an ad hoc AFSS Team to develop ways to modernize the feed safety system in the United States, with an anticipated completion date of 2007. That team has identified what it sees as numerous "gaps" in the current animal feed regulatory structure, including the absence of a formal list of suitable animal feed ingredients, and offered recommendations to the agency for closing such gaps. AAFCO representatives say the organization uses a "New and Modified Feed Ingredient Definitions Process" to determine the suitability of feed ingredients and to establish standard ingredient names. FDA considers the common or usual name used on feed labels as required by state and federal law. The memorandum allows FDA to recognize formally the AAFCO process and to have a clearly defined role in reviewing ingredients for the list.
Under the memorandum, CVM assigns scientists to work with AAFCO in reviewing petitions for new feed ingredients or for modifications to existing ingredient definitions. Also, before it adopts a new feed ingredient definition or amends an existing one, AAFCO will ask CVM for advice and a letter of concurrence.
The memorandum also makes provisions for AAFCO to remove a definition from its OP if FDA provides convincing scientific evidence that the ingredient is no longer suitable for its intended purpose. The memorandum signed last year will remain in effect for five years, until September 1, 2012.
FDA's more formalized partnership with AAFCO on ingredients is yet another tool in the toolbox that FDA uses to carry out its responsibility for the regulation of animal feed in cooperation with state and local partners, according to the agency. FDA currently cooperates with AAFCO and individual states for the implementation of uniform policies for regulating the use of animal feed products.
FDA has the responsibility for regulating the use of animal feed products, but ultimately, the responsibility for the production of safe and effective animal feed products lies with the manufacturers and distributors, and not with the agency.
In 2004, the American Feed Industry Association (AFIA) launched its Safe Feed/Safe Food program to aid manufacturers in meeting feed safety goals through voluntary means.Companies fulfilling the program's requirements may use the SF/SF seal on their labeling and packaging. Additional program details are available on the association's website, www.afia.org.
Costs versus benefits
FDA's new system has drawn concerns from some in the feed industry, Most criticisms have centered around the cost of some of the measures in relationship to the benefits to the animal feed industry and consumer.
AFIA has been among those voicing skepticism as FDA has moved forward, going on record as saying that it's difficult to negotiate model regulations, when the concept seems to be at odds with the marketplace. AFIA has said that it believes the regulations will add significant costs to operations with little resulting benefit and that it supports voluntary feed safety efforts, urging firms to apply for its Safe Feed/Safe Food Certification Program.