ARLINGTON, Va. -- At press time, there are 15 food/feed safety bills that have been introduced in Congress. These bills deal with a myriad of new food safety authorities for the Food & Drug Administration, USDA and other agencies. As one member of Congress said, "Our food safety system is broken and needs fixing." The administration disagrees and stated it needs to be smarter about import safety and issued an 83-page report detailing recommendations it should take to strengthen an already excellent system.
It's clear from all this rhetoric that changes are in the wind. Most of the food/feed safety bills provide some new type of import controls (e.g. taxes, more inspection, limited ports of entry, etc.), while others provide for mandatory recalls for federal food safety agencies, mandatory reporting, increased fines and other "remedies."
One bill that was signed into law, the Food and Drug Administration Amendments Act of 2007 (FDAAA), contains 500 pages of human drug and medical device controls and updates, but it also includes a short provision on food/feed/pet food safety near the end in section 10. This short portion is far-reaching and quite unclear as to how FDA is to accomplish what Congress is mandating. It says that FDA is to promulgate rules in two years that will create ". . . ingredient standards and process controls . . . " for pet food and update labeling and nutrition information for pet foods. Although the law does not define pet food, it probably means dog and cat foods, but since no hearings were held and no conference report between House and Senate was filed, one can only speculate. FDA has published a pre-meeting notice stating it will hold a public meeting soon to begin collecting information for rulemaking on these provisions. It has up to two years from Sept. 27, 2007, when the bill was signed into law.
Current FDA law allows ingredients in food for animals to be either a drug or a food, and the law provides for a time-tested system to approve ingredients for use in feed either through a food additive petition process, generally recognized as safe affirmation (including self-affirmation) or through an informal review process, such as the one the Association of American Feed Control Officials (AAFCO) provides. It is unclear what regulations FDA is to provide for pet food that will create "ingredient standards" that would be different than those provided in current law.
As for "process controls," FDA could provide for good manufacturing practices regulations, such as those for medicated feeds or create a new process control system based on the Hazard Analysis Critical Control System (HACCP). It's simply not clear what Congress intended by this legislation, which was passed by one house on one day, then another the next day and signed into law seven days later by President George W. Bush. However, it should be noted, this was "must pass" legislation, due to the expiration on Sept. 30th of the authority to pay for extra human drug reviewers under the Prescription Drug User Fee Act or PDUFA.
The third provision of this new law is the "Reportable Food Registry" that requires food, feed, ingredient and pet food facilities, as defined by and registered under the Bioterrorism Act and regulations, to report to FDA adulterated products that were not caused in the company's facilities, and that left the plants, any instance that has the potential for causing serious adverse health consequences or death in humans or animals. This is equivalent to a Class I recall in FDA's regulations. There are some additional exemptions. FDA is required to create a database to receive this information and an "electronic portal" companies can use to report these types of incidences. Then, FDA must decide what information, if any, it will report to the public about such incidences to protect the public health under another requirement in the law concerning rapid notification to the public.
The good news about this new law is the sponsors of the original bill in the Senate are interested in the American Feed Industry Association's amendments to "fix" or remedy this onerous language. Such language should further refine, define and provide FDA with clear directions in Congress' intent about the three areas mentioned above. AFIA has been holding discussions with congressional staff and drafting this new language.
Some in the Senate say any new food/feed safety legislation likely will not be considered until 2009. Many of the pending bills mentioned above are in the House of Representatives. Such a delay will allow AFIA working with other groups, including the food industry, to develop reasonable language and safeguards for industry that will assist in well-reasoned and balanced approach to new food/feed safety legislation. However, the U.S. Senate has begun collecting information on food/feed safety to craft its legislation that will undoubtedly need to be reconciled with any House version(s).
It's clear this New Year will bring new changes to the way we regulate feed, and there will be more government regulation of feed and pet food industries. Hopefully, AFIA and others will have a positive impact on this process to insure reasonable legislation is adopted that has adequate protections for our industries.
AFIA is the only national organization representing the total feed industry and is the recognized leader on international industry developments. AFIA boasts a membership of 550 domestic and international companies; state, national and regional associations. Companies are feed manufacturers, integrators, pharmaceutical companies, ingredient suppliers, equipment manufacturers and companies which supply other products, services and supplies to feed manufacturers.
For more information about its programs, contact AFIA, 2101 Wilson Blvd., Suite 916, Arlington, Va. 22201. Tel: 703-524-0810. E-mail: afia@afia.org; Fax: 703-524-0810. Internet: http://www.afia.org.
Richard S. Sellers is vice president for feed regulation & nutrition of the American Feed Industry Association with offices in Arlington, Va.
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