Ingredient approval part of FDA feed safety framework

What's next in the quest for further safety measures from the agency?

June 25, 2009

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.

Elements of a system

In considering the basic elements of an animal feed safety system, FDA is recommending that every feed and/or feed ingredient transporter, processor, distributor, and user should be incorporating these elements into their animal feed business process. The detail and extent to which any of these elements apply to a specific product or line of products will vary depending on the product itself, its use, the facility structure and equipment, and the distribution and feeding mechanism.

In establishing its framework, FDA has identified ach element with a number and includes bulleted items to provide context and explanation:

1. Incoming materials - know what you are getting

Assure identity of material. If Certificates of Analysis [COAs] are used, consider periodic audits of suppliers of COAs.
Is the material susceptible to any contamination? Do you need additional assurance such as testing?
Receiving procedures - control measures (when does it occur, who does it, is the equipment dedicated, etc.), clean-out
Storage - labeled bins, designated bins, clean-out between receipt of different shipments, what else is stored with or near materials
Inventory and periodic accountability
Written SOPs

2. Processing/Manufacture

What are critical steps to the process? Are the mix times adequate? Are there other time and/or temperature/pressure requirements? Do you need in-line specifications? Do you need production schedules? Are there cross-contamination possibilities that need to be controlled? Is this a simple mix operation or are there special processes such as pelleting?
Equipment maintenance - what equipment is needed? Is it in working order? Are there QC checks that should be done on the equipment; if so, how and how often? Is equipment specified for particular production runs or products? What are the clean-out steps and when is clean-out done?
Product Labeling - labels on file; who prepares labels; how are labels verified; are checks needed to assure the correct label is on the product, etc.
Written SOPs

3. Record Keeping

Records of important steps in receipt, production, and distribution maintained.
Specify the minimum records and the information in each record (take from BSE, GMPs, etc.)
Written SOPs about how to keep records

4. Distribution/Transportation/Feeding

Know who, what, when, where, and how much for distribution of material. Distribution should include feeding of product to food-producing animals.
How is material transported? Are special precautions needed? What was transported previously? Do you need to have clean-out between transport?
Procedures for identifying and controlling product that is not sold, used, or fed.
Procedures to get product back from marketplace if needed (recall)
Written SOPs

5. Inspection/Audit/Corrective Action

Establish procedures to periodically conduct internal inspection and audit of control systems and test results - are SOPs being followed? Are internal specifications being met? Are labels current and accurate? Were deviations investigated?
Maintain a complaint file and review, evaluate, and implement corrective action when problems are identified. Do you need to provide notification of a corrective action [such as recall] to a regulatory agency?
Written SOPs

6. Responsibilities

Determine responsible individuals for controls and corrective action throughout the receipt, processing, and distribution.
Establish criteria that assures the individuals are trained and understand their responsibilities.
Include responsibilities in written SOPs

7. Training

Provide training to employees on regular basis - level and extent of training and oversight will depend on product and product ingredients and individual employee responsibilities
Include government requirements in training
Written SOPs