Developing regulations
The work of the Center for Veterinary Medicine’s Animal Feed Safety System (AFSS) Team is guided by a Framework Document, first drafted in 2005 and revised in December 2006. One of the gaps presented in the AFSS Framework Document is the need for a more comprehensive animal feed safety program in the United States.
To address that gap, the AFSS Team has begun to write process control regulations covering the procurement, receipt, manufacture, and distribution of all animal feed, including pet food, and feed ingredients.
Before the regulations can be proposed in the FederalRegister, the Agency is required to consider, among other things, the likely regulatory, paperwork, small business, economic, and environmental impacts resulting from the regulations. Thus, the AFSS Team does not envision the proposed regulations being available for public comment until calendar year 2008.
Public meetings
The Framework Document also says that the feed safety system must be risk-based to allow for FDA’s more effective use of its regulatory, inspectional, and research resources.
To make the system risk-based, the AFSS Team is developing a risk-ranking method and has been describing the method in public meetings.
FDA will use the risk-ranking method to help prioritize the use of its resources to ensure it is addressing those hazards that present the greatest risk to public and animal health. The risk-ranking formula takes into consideration physical, chemical, and microbiological contaminants in animal feed and feed ingredients.
At its second public meeting, held in April 2005, the AFSS Team presented a description of the feed hazards of concern. At the third public meeting, held in September 2006, the Team identified the hazards of concern (feed contaminants) and presented the concept of health consequence scoring. Health consequence scoring is made up of two factors: the likelihood of adverse effects if animals are exposed to a hazard, and the severity of the effects. (In animals, the effect could range, for instance, from temporarily going off feed to serious or permanent injury, or death.) The hazard could be faced by animals or by humans who consume food derived from animals.
The AFSS Team used the fourth public meeting, held in May 2007, to present the concept of exposure scoring for feed contaminants. The exposure scoring system addresses the presence of contaminants in source materials for feed ingredients and those factors in manufacturing or processing that may affect the levels of contaminants in final feed formulations. The AFSS Team used the production of swine feed as an example to illustrate how the risk-ranking method will estimate exposure to contaminants due to the presence of the contaminants in the feed that animals consume. The Team defined nursery, grower, and finisher swine rations and discussed the types and levels of contaminants that might be found in the feed ingredients and complete feeds for each of these rations. The Team also discussed the ways feed ingredient and feed processing steps could mitigate or increase exposure to some of the feed contaminants, thus reducing or increasing the relative risks of those contaminants for animal and human health.
As much as it could, the AFSS Team used available data, and where data did not exist the Team relied on expert opinion. The AFSS Team members emphasized that more data are needed for a more complete and accurate picture of the potential animal exposure to feed contaminants, including the degree to which such exposure can be mitigated by processing steps. The AFSS Team encouraged attendees at the May meeting, feed industry members, and anyone else who might have data to work in concert with CVM in compiling these data.
Attendance at the fourth public meeting was approximately 100. (The list of attendees is available on the AFSS page of CVM’s Web site, http://www.fda.gov/cvm/AFSS.htm.) The meeting brought in experts from the livestock and poultry feed and pet food industries, academia, regulatory officials from states and from other countries, animal welfare organizations, and private citizens.
Pet food recall
Although the May AFSS meeting had been scheduled months before, by coincidence it took place as one of the largest pet food recalls in FDA’s history was finishing up. In March 2007, a pet food manufacturer announced that it was recalling cat and dog food it had manufactured using a product labeled wheat gluten that was imported from China. The company initiated the recall following reports of deaths of cats and dogs that had eaten the food. FDA’s investigation found that the ingredient imported from China that was linked to the deaths was contaminated with melamine, a product with industrial and some fertilizer uses, but has never been approved for use in feed or food. Later, in April, another company initiated a recall after melamine was detected in rice protein concentrate imported from China.
During these recalls, FDA’s pet food Web site had millions of “hits.” Thousands of consumers contacted FDA Complaint Coordinators across the country to complain about the pet food. FDA dedicated each of its 20 district offices to the effort, and involved more than 400 employees in the recall to investigate, collect pet food samples, monitor recall effectiveness, take consumer complains, and prepare consumer-complaint reports. Veterinarians and toxicologists, pathologists, chemists, and other specialists from CVM and other parts of FDA were involved in researching potential causative agents and analyzing information.
The melamine problem (melamine and melamine analogues) was not limited to pet food. Salvaged pet food, sold as scraps to feed manufacturers, ended up in feed for swine and poultry. FDA and the U.S. Department of Agriculture conducted a risk assessment of the likelihood of a food safety risk, and found that the expected levels of melamine and its analogues in food reaching the consumer would be at least 250 times less than the level that could cause a human health concern.
As the recalls were in progress, they were widely reported in newspapers and on television news shows across the country. The recalls have made the whole country more aware of the need to protect the nation’s feed and food supplies.
Through all of the turmoil, AFSS maintained its focus and continued its work to address the gaps identified in the AFSS Framework Document.
Additional meetings
The AFSS Team will sponsor one or more additional public meetings before completing the risk-ranking model. The future meetings will be used to discuss how to combine health consequence scoring and exposure scoring to obtain a rank order of feed contaminant risks. The next meeting is tentatively planned for February 2008.
Meanwhile, the AFSS docket (Docket Number 2003N-0312) remains open for comments. Comments should be sent, with that docket number, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments.
July 2007
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