We are beginning to see results of the US congressional inquiries made last spring on the petfood recalls. In fact, both houses of Congress have proposed a host of new legislation in recent months, all related to food safety, imports and/or recall authority.
Most notable to date is the Food and Drug Administration Amendments Act of 2007 (FDAAA). It passed in both the US House of Representatives and the Senate by large majorities (I think unanimously by the latter) and was signed into law by President Bush in September.
Most of the FDAAA deals with various issues regarding drugs and medical devices; only a small portion actually pertains to food safety (approximately 10 out of 156 pages). Much of that food safety part applies to all foods under FDA jurisdiction, but it includes many specific references to petfoods. The complete document is available at www.fda.gov/oc/initiatives/HR3580.pdf.
Effects on FDA
The new law puts the burden on FDA to improve its capabilities when dealing with a food contamination incident. To help address some of the complaints about the agency during the recalls, FDA must establish an early warning and surveillance system to help identify adulteration of the petfood supply and outbreaks of illness associated with petfood. The law suggests emulating or coordinating efforts with warning systems already in place for human food and animal health. Congress has granted FDA only one year to put this system in place.
Another complaint was FDA's not communicating facts about the petfood recalls in a timely manner to the public. The new act directs FDA to improve its ability to collect and compile pertinent information from companies, associations and other organizations and disseminate it quickly and effectively. This would include posting all information in a single, easily accessible location on the Internet with a searchable database, easy for the public to understand and use.
Other aspects of FDAAA include coordinating efforts with state authorities on food safety issues and establishing a reportable food registry within the next year. Further, within two years, FDA must promulgate new regulations establishing petfood ingredient standards and definitions, processing standards and updated labeling standards that include nutritional and ingredient information.
Effects on industry
Under the current Bioterrorism Act, all food facilities (including animal feed and petfood facilities) must be registered with FDA. However, except for some record-keeping and the requirement for companies to provide the agency with information on its facilities in case of an emergency, the burden this places on the industry is arguably little.
But under the reportable food registry as part of the new FDAAA, companies must report to FDA, within 24 hours of discovery, any instance involving a food where "there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals." Also, the facility must investigate the cause of the adulteration within this 24-hour period if the adulteration may have originated internally.
The only exception to the reporting requirement is when the adulteration originated in the facility, was detected before any of the product was shipped out and was corrected or the product was destroyed. Facilities must maintain records on these incidents for two years. The records must be made available to FDA inspectors and could be subject to release to the public under the Freedom of Information Act. This puts a tremendous new responsibility on petfood manufacturers.
The new regulations pertaining to ingredient, processing and labeling standards will also likely impose additional burdens on the petfood industry, but it is not yet known what they might be. FDA is directed to consult with AAFCO and other stakeholders, including petfood manufacturers and veterinary medical associations, as the rules are developed.
What's not affected
Though the safety of imported food was identified as a driving force behind this legislation, the act mentions little about food importation. It has new directions to FDA regarding inspection of imported seafood and aquaculture products, and these new regulations and systems will certainly impact imported as well as domestic products. However, there's no mention of increased inspection of all food imports or new import fees.
Also, there's no mention of increasing FDA authority with regard to initiation of recalls under FDAAA. At this time, recalls of adulterated products are technically all voluntary, although with one exception I don't remember an instance where a company fought FDA's "suggestion" to initiate a recall. Still, this was seen by some in the US Congress as a great deficiency in existing law, and I expect we may see further legislation to grant FDA mandatory recall authority.
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