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Safety & Health

FDA's Animal Feed Safety System (AFSS) Project Plans Update #5

Revised AFSS Framework Document

CVM has revised the AFSS Framework Document by adding a new component about reporting unsafe feed, and by identifying additional gaps in existing feed safety system. CVM released the revised Framework Document (the 3rd version) in April 2008. It was posted on CVM’s Web site.

The focus of the new component, D (what used to be component D is now Component E, and what was E is now F), is gathering information about feed problems. To help protect the health of animals and prevent food safety problems, FDA should know about the feed problems before they become widespread. Also, other feed users and the public should know about the incidents to protect themselves.

The FDA Amendments Act of 2007 (FDAAA) included provisions requiring FDA to establish a “Reportable Food Registry.” Cases of food or feed adulteration or contamination would be reported to the registry and listed there for anyone to see. The revised AFSS Framework Document’s Component D includes the lack of information as a gap, and the requirements of the FDAAA as the fix for that gap.

Another gap noted is that not all feed manufacturers are required to report adverse experiences with medicated feed. The feed mills licensed by FDA are required to submit records and reports concerning clinical and other adverse experiences with those types of medicated feeds that require the feed mill to have a FDA license. But feed mills are not required to report adverse experiences on any other type of feed – medicated or not.

The fix noted in the revised Framework Document is an update of the federal regulations (21 C.F.R. 510.301) concerning reporting requirements.

AFSS Outreach

Component F of the AFSS Framework Document is “Education and Outreach.” The Framework describes the need for timely education and outreach to affected groups as a gap of the current system, but it is really more of a constant requirement of the AFSS. No program will work well unless those affected by it understand the program and what is required by it.

The Team is identifying which parts of AFSS will affect which stakeholders, and planning outreach and training programs tailored to those stakeholders.

In addition, an AFSS Team member has explained the initiative in speeches presented, so far, to the American Chemical Society and the American Society of Animal Science. Another member will present a poster about AFSS at the AOAC International meeting, to be held in Dallas on September 21-24, 2008.

50-State meeting on Food Protection Plan

FDA’s Food Protection Plan, released to the public in November 2007, was created to integrate available resources in a strategy for protecting the Nation’s food supply. It has specific action items that involve FDA’s federal and state counterparts. To coordinate with those counterparts, FDA has called a 50-State Meeting in St. Louis, MO in August 2008, inviting selected representatives of State and local food and feed safety agencies to plan how to meet these action items.

At this historic meeting, federal, state, and local officials will identify and develop a series of action items and recommendations to better coordinate and integrate food and feed safety programs with the provisions called for by the Food Protection Plan.

Additional food safety meetings are planned for 2009 and 2010.

3rd Party Certification

FDA is seriously looking at the possibility of establishing 3rd party certification programs, and on July 10, 2008, issued a draft guidance, “Voluntary 3rd Certification Programs for Foods and Feeds,” to generate public comments on a possible program. In the draft guidance, FDA said that, if it has confidence in a 3rd party program, FDA may “provide incentives for establishments to obtain certification” under this sort of program.

The draft guidance describes the attributes FDA believes a 3rd party certifier needs in order to be acceptable. FDA is specifically asking for comments on the attributes – whether some should be added or removed, and whether the description of the attributes contained in the draft guidance is sufficient. In addition, FDA is looking for information on existing “well-accepted guidelines or requirements for certification programs.”

FDA will accept comments concerning the draft guidance at any time, but it said it would begin drafting the final guidance on September 8, 2008. To be sure that their comments are considered, interested parties need to be sent them to FDA before that date.

Earlier in the year, FDA issued a Federal Register notice to request comments on the use of 3rd party certification programs for food and feed production. Several of the 70 comments the Agency received said that many U.S. suppliers use 3rd party certification programs due to customer demand. The certification programs typically involved a document review as well as an on-site evaluation. The comments also revealed extensive support for programs that achieve compliance with the standards of international programs, including those of international trade associations.

FDA’s Food Protection Plan, a blueprint on ways to “bolster efforts to better protect” the food supply in the United States, emphasizes the use of certification programs.

Future Codex work on animal feed

Members of the Codex Alimentarius Commission, a voluntary international organization that sets food safety standards, agreed at their June 2008 meeting that the Codex should plan to do additional work in the area of feed standards. An earlier Codex ad-hoc task force on animal feeding had finished its work in 2004, but several Codex members had requested additional work.

At the June meeting of the Codex Commission, members agreed that an electronic working group (a group that communicates and discusses issues electronically rather than through face to face meetings) should be established to determine the scope of the future work concerning feed standards. The Commission will review the working group’s recommendations at its next meeting and decide how to proceed.

The United States participates in Codex. Dr. Dan McChesney, Director of CVM’s Office of Surveillance and Compliance, will be the U.S. representative to the working group.

By September 15, 2008, the group intends to circulate among the members a first draft of a proposal for scope and terms of reference for future work as well as a proposal for suitable mechanisms for Codex to carry out this work. It will give the members until October 15, 2008, for comments. The working group will issue a revised draft, and comments on it will be due by November 15, 2008.

CVM will seek input from stakeholders on issues raised in the electronic working group.  Also, CVM will welcome comments from stakeholders on issues that they would like brought to the work group.

August 2008