Compliance package helps food companies meet tracing, tracking regulations

Wonderware , a business unit of Invensys Systems Inc. , is introducing a compliance solution package to help food companies meet U.S. Food and Drug Administration reporting and record-keeping mandates. The rule, announced by the FDA on Dec. 9, 2004, requires companies establish, maintain, and, upon request, provide access to records as directed by the U.S. Congress in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. eCompliance Solutions offer food processing companies of any size a way to cost-effectively track and trace manufacturing processes.

According to the new regulation, food companies must provide the FDA with ingredient source data, including immediate previous source (IPS) and immediate subsequent recipient (ISR) for every component used in the manufacturing process. The regulations affect U.S. food processing, transportation, and distribution companies, and international organizations that import or export food or other biological products to the U.S.

According to Wonderware, many companies have expressed concern about their ability to deliver so much detailed information in such a short time. “We’ve been following the FDA for months as they wrestled with literally hundreds of comments and concerns expressed by food companies that will be affected,” said Jay Jeffreys, program manager for Wonderware eCompliance Solutions. “The FDA has had to work hard to deliver rules that will allow it to deal with a national emergency involving our food supply, without putting an unbearable strain on the food companies themselves. In some areas the FDA made compromises from its original proposed rule; in some cases they stood firm. During that process, Wonderware monitored the process closely to ensure that the solutions package will enable users to comply with the full requirements of the final version of the regulations issued by the FDA.”

In addition to requiring IPS and ISR information, the regulations call for food companies to keep records needed to determine exactly which ingredient lots go into shipments of food released to the marketplace. Food processing companies will be required to keep these records at least six months for foods with a shelf life of 60 days or less and up to two years for foods with a longer shelf life. Firms with more than 500 employees must comply by Dec. 9, 2005. Small businesses (11-499 employees) must comply within 18 months and very small firms (10 or fewer employees) must comply within 24 months or by Dec. 9, 2006.

The solution is specifically designed to help food processing companies address FDA regulations for establishment, maintenance, and availability of records under 21 CFR, Part 1, Subpart J. The regulations affect more than 200,000 U.S. manufacturing, wholesale, and packaging sites. Electronic records are expected to simplify and accelerate the data-gathering process.

—Jeanine Katzel, senior editor, Control Engineering, jkatzel@reedbusiness.com

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